medicine&technology 02.2017

KonradinMediengruppe

02.2017

www.medicine-technology.com

RRP 11,20– €

Engineering for the

Medical Device Industry

FEATURE

Brain Computer

Interface

Signals from the Head

Page 44

Foreign Market Romania

Private healthcare companies

work on a Western level Page 12

Infection after Surgery

When the source of infection

is a medical device Page 20

TRADE FAIR

MEDICA/COMPAMED

New Products and Trends

13.11.–16.11.2017 Page 25


Even more drive

technology.

Get inspired, improve your knowledge.

Stay tuned and visit www.drive.tech now.

2 medicine&technology 02/2017


We are there

when reliability

is of top priority.

When Technology Gets Closer

and Closer to People

It is exciting. It is very promising – and even a little frightening: Our

cover story Brain-Computer Interfaces naturally focuses on what

researchers already have to offer for applications in medical devices

and even consumer electronics. Some fascinating aspects are brought

together in this area – you can read about this on page 44. What gave us

the idea of introducing this branch of research, however, was thoughtprovoking:

At TU Berlin, researchers at the Faculty of Biological Psychology

and Neuroergonomics are developing an algorithm that analyses

“unconscious brain signals” from a passive brain-computer interface.

This means: I don’t even know what my brain is telling the computer,

but the computer can do a lot with it. From this point of view,

hopefully research will not advance too quickly – so that society has

time to establish rules on what will be useful and allowed with this type

of technology and where boundaries need to be set.

Very close contact between people and technology is also seen when

robots learn how to feel: In doing so, the robots learn early on what is

happening in their environment and where they need to be especially

cautious (page 54). An exoskeleton can use sensors to indicate to paralysed

patients the type of surface on which they are walking. Researchers

envision using these sensors to give people with multiple

sclerosis more sensory stimuli.

Our innovative sensor solutions

make medical devices even safer

and more efficient.

Visit us!

COMPAMED

Hall 8a, Stand L14

Another future topic that could get very close to people are printed

circuits made of hybrid inks. Researchers from Saarbrücken, Germany

who will be guests at our stand at the Compamed trade fair in Düsseldorf

will explain the scenarios which result from this technology, including

electronics on the back of the hand. More on these topics and

the latest new items that will be presented at the trade fair can be found

in the trade show section starting on page 25. We look forward to

seeing you at our stand!

Dr. Birgit Oppermann

Medicine&technology in Düsseldorf at the Compamed trade fair:

Hall 8a, Stand J41

02/2017 medicine&tec hn ology 3

www.first-sensor.com


■ Medicine in Dialogue

44

Hospital Hygiene

Medical devices as sources of infection–

Prof. Hugo Sax explains what lessons can

be learned from recent cases ..............20

20

■ Technology

Development/Components

Intelligent Electronics: Keeping an Eye on

Health with the Smartwatch ..............50

Image: University Hospital Zurich

Prof. Sax: We are

not organised

well enough to

handle global

problems.

Surgical Bone Implant: A Bone Spring

that has no Spring ..............................52

Sensor Technology: Robot Skin Senses

and Blushes .......................................54

Additive manufacturing: Printed

Instrument is Faster than the Surgeon 58

Trade Fair

Medica/Compamed

Platform for Great Ideas

and Smallest Solutions .......................26

Device Control: Foot for Functions,

Voice for Device Selection ..................28

Packaging Machines: Medical Devices,

Automatic Infeed ...............................30

Flexible electronics:

Circuit on Soft Substrate ....................32

Microfluidics: Cooperation

for Wound Care .................................34

Medical Tubing:

Under High Pressure ..........................36

Small Motors: Noise-optimised Small

Motors for Medical Technology ..........60

Product Development: Simulation

Increases Pump Performance .............62

Metal Laser Melting: From the Printer

to the Operating Theatre ....................65

Manufacturing

3D-Printing: Titanium Hearing Aid

Shells Printed in Series ......................66

Ultrasonic Welding: Ultrasound

Reduces Lint in Surgery .....................68

Flexible Parts: Robot Masters Tube

and Spiral Reliably .............................70

■ Research

Research Landscape Ireland

Ireland sees itself as Europe‘s largest

hotspot for medical technology and

as a competence centre ......................72

3D Structures

Researchers at Empa have been able

to develop biologically-based Inks

for 3D Printing ...................................76

Virtual Reality: More Movement

in Virtual Environment ......................40

Video Management: Reliable Image

Transmission in the OR ......................42

12

Foreign Market

Romania:

The healthcare system

is changing in Dracula‘s

homeland

Photo: Cristian Balate/Fotolia

4 medicine&technology 02/2017


Feature

Brain Calling

Computer

Dozens of process

parameters to control…

Hundreds of ways for your

build to go wrong…

The merging of humans and machines

has been material for Hollywood films

for ages. In fact, the development of

brain-computer-interfaces is now close

to hitting the market ..........................44

■ Market and

Management

Health Care Market in Romania

The government is setting a course

for modernisation and announces the

construction of large hospitals ...........12

Post Market Surveillance

A study conducted by the Witten/Herdecke

University shows that there still is

potential in Medical Care Data ...........16

Medical Technology Trade Fairs

Around the globe, exciting events will

take place in 2018 ..............................18

54

Image: Tiko/Fotolia

Rubrics

Editorial ............................................03

Visions ...............................................06

News .................................................08

Innovations .......................................78

Imprint ..............................................82

Sensor

Technology

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Cover photo: The signals from the brain are

so complex that we are still a long way from

being able to read thoughts. However, some

information can already be read, interpreted,

and used in combination with medical

devices

Dedicated to the Science of Motion

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02/2017 medicine&tec hn ology 5


VISIONS

PROTECTIVE RUBBER

Gloves | Today they have become an indispensable part of all medical practices, hospitals,

and even care services: Next to hand disinfection, medical protective gloves

have become one of the most important actions to prevent infections—among medical

professionals as well as patients.

Gloves have been saving lives for over 100 years

in medicine, because they prevent the transmission

of infections. They were invented out of

love. At least that is how story goes about the

young American surgeon William Stewart

Halsted (1852–1922). His fiancée, surgical

nurse Caroline Hampton, suffered from dermatitis

from contact with carbolic acid. At that

time carbolic acid was the standard disinfectant

for medical personnel. So Halsted developed extremely

thin, sterilisable rubber gloves for her in

New York in 1890.

Love was not the only thing that paved the way

for medical gloves. Around the same time in

Germany, surgeon Paul Leopold Friedrich

(1864–1916) introduced the seamless rubber

glove—based on his knowledge about the risk

of wound infection. Friedrich is considered a

pioneer in surgical infection prevention and

therapy. Success proved the glove wearers right,

and the medical glove was implemented worldwide.

Today the global annual consumption of

surgical gloves is in the billions.

Anke Biester

Medical journalist in Aichstetten

www.krankenhaushygiene.de

www.smarterials.berlin

Astudy conducted in the USA in 2015 showed

that nurses contaminate their skin or clothing

nearly every other time when they remove their gloves

or apron. The study also showed however, that

this form of contamination can be reduced to 19%

with the proper training. The trick is not to touch

bare skin with the potentially contaminated outer

surface of the glove.

T

he Robert Koch Institute recommends

the use of low-protein

latex surgical gloves in the surgical

environment—they are unparalleled

in regard to wearing comfort,

accuracy of fit, grip, and mechanical

stress. However, latex proteins

can trigger allergies. For medical

personnel with a latex allergy, there

are various alternatives made

from synthetic isoprene, chloroprene,

nitrile rubber, and PVC. A surgical

glove made from a material si-

milar to natural latex, polyisoprene,

which is polymerised by UV

light, has been on the market for

the last year. Doctors who could be

exposed to x-ray radiation, for

example, during a catheter intervention,

wear x-ray protection gloves

that provide protection

through a certain lead content. The

crux: The higher the lead content,

the less elastic the glove.

6 medicine&technology 02/2017


E ve

n wi

th goo

ood ru

bb

er glo

love

ves,

100

00%

sa

fe

ty is no

t guar

aran

ante

teed

ed: Acco

co

rdin

ing

to the

Ger

man Soci

ciet

y for Hosp

ital

Hy-

gien

ene (D

GKH)

H), sm

al

l chan

nels

hav

avin

ing a

diam

amet

eter

er

of up to 5 μm can

be de-

tect

cted

in gl

oves, th

roug

ugh wh

ich vi

ru

ses

can pass

ss. Long

ope

rati

tion

s, esp

spec

ecia

iall

lly

deep

ep

in the bo

dy and

on bone

s,

res

esul

t

in per

fo

rati

on

rat

es

of up to 70%.

In in-

tens

nsiv

ive ca

re med

edic

icin

ine,

glo

love

ves shou

ould

ther

efor

e be cha

hang

nged

at leas

ast ever

ery

T he

raw

mat

ater

ial late

x is obt

ai

ned from

the sa

p of the

rub

ubbe

ber tr

ee

Hev

evea

ea bra

rasi

si-

li

en

s.

Ame

ri

can chem

is

t and inve

vent

ntor

Char

les Go

odye

ar dev

evel

elop

oped

the

vul

ulca

cani

nisa

sa-

ti

on

pro

roce

cess

, wh

ich is sti

ll use

d toda

y:

Sul

ulp-

hu

r is add

ed

to the liqu

quid

lat

atex

, form

rmin

g

brid

idge

ges be

tw

ee

n the macr

crom

omol

olec

ecul

es

of

the rubb

er

—t

he lat

atex

bec

ecom

omes

rub

ubbe

bery

ry.

Toda

y,

liq

iqui

uid late

tex for the indu

stri

rial

man

anu-

fact

ctur

ure of

lat

atex

glo

love

ves is obt

ai

ned from

pl

an

ta

tion

s in Tha

hail

ilan

d, Ind

ones

esia

ia, and Ma-

lays

ysia

.

15 min

inut

utes

and

aft

fter

was

ashing

each pa-

tien

ent,

as the perf

rfor

orat

atio

ion rate

increas

es

the long

nger

the

glo

love

ves are worn

. During

some

sur

urge

ries

es, doub

uble

glo

lovi

ving

is re

-

comm

mmen

ded—

d—an

and some

meti

time

mes repl

ace-

ment

of the outer glov

ove—

e—fo

for example, e,

be

fore

ins

nser

ti

ng an impl

plan

ant.

Cha

nging

of

the

out

uter

glo

love

was

abl

ble to

increase

the rate

of surg

rgic

ical

glo

love

ves th

at

remain

st

eril

ile on

the

out

er

sur

urfa

face

during sur-

ge

ry by 80%.

R ubbe

ber glov

oves

are

not

sim

impl

ply rubb

bber

glo

love

ves.

A dis

tinc

nction

is mad

e betw

een “p

erso

sona

nal prot

ecti

tive

equ

quip

ipme

ment

” an

d

“med

edic

ical

dev

ices

es.”

The

for

orme

mer is use

sed excl

clus

usiv

ivel

ely to pro

tect

the wear

arer

fro

rom chem

emic

ical

and

phy

hysi

cal risk

sks and from

bio

io-

logi

ca

l subs

tanc

nces

. The la

tter

is used

to prot

otec

ect th

e patient

from

inf

ecti

on and

onl

y seco

ndar

aril

ily as

pro

rote

tect

ction for the

we

arer

er. For oper

erat

ive or inv

nvas

asiv

ive diag

agno

nost

stic

interve

vent

ntio

ions,

surg

rgic

ical

glo

love

ves have

to be ste

teri

rili

lise

sed and pack

aged

in a per-

mane

nent

ntly

ste

teri

le con

diti

tion

. Ga

mm

a ra

di

atio

ion is usu

sual

ly

used

for

ste

teri

li

sa

tion

on.

S ma

rt mat

eria

ials

wil

ill al

so

imp

mpro

rove

sur

gica

cal glov

oves

es: A

star

t-

up

of th

e Hu

mbol

dt Uni

nive

vers

rsit

ity of Ber

erli

lin in

-

tend

nds to mak

e the gl

oves

mor

e resi

sili

lien

ent by add

ddin

ing mo-

di

fi

ed

sol

olid

par

arti

ticl

cles

. Th

e impr

prov

ed mec

hani

ca

l stab

il

ity

wi

ll red

uce th

e like

keli

hood

od of micr

cro-

pe

rfor

orat

ions

, prov

i-

di

ng bet

ette

te

r prot

ec

ti

on

aga

inst

inf

nfec

ti

ons.

At the same

ti

me

, the tact

ile sens

e wi

ll rem

ai

n unch

chan

ge

d.

The

pa-

tent

ed sur

urgi

cal glov

oves

are

exp

ecte

ted to be laun

unch

ed in

20

19.

02/2012 7 medicine&technology 7


■ [ NEWS ]

Medtech “Made in

Ireland” is Booming

Market Ireland | As the result of Brexit, companies on

the green island are intensifying their search for

partners in the EU. The medical technology sector can

also benefit from this move.

Photo: Enterprise Ireland

Irish medical

technology innovations

are

known worldwide

for their

high performance

and reliability.

Now the

Irish are looking

for partners in

the EU.

Goods and companies form Ireland enjoy growing popularity

in Europe. Also Ireland is an important innovation driver –

for example in medical technology. Evaluate Pharma’s World Review

reported that worldwide revenues were USD 392 billion in

2016 and are expected to grow to USD 414 billion in 2017. This

industry also creates jobs. The Irish medical technology sector is

regarded as very innovative and agile in an international comparison.

One example is Aerogen, which is located in Galway/

Ireland and is the world’s leading developer, manufacturer, and

distributor of innovative solutions for high-performance aerosol

drug delivery devices. Aerogen’s inhalation technology is used in

hospitals all over the world. Due to its success and the increased

use of its solutions, for example, in Germany, Aerogen is currently

intensifying its involvement in this market.

It is becoming apparent that more and more Irish companies will

be cooperating with more than just German companies in the future.

Brexit in particular, is promoting this development since

Irish companies will be looking towards the EU for their future.

“We are very optimistic about the future,” comments Eddie

Goodwin, Manager Germany, Switzerland, and Austria at Enterprise

Ireland, on the current situation. For medical technology

companies, trends such as IoT, sensor technology, robotics, wearables,

and networking are a springboard since these companies

have been able to continue to increase their ability to compete on

the international market thanks to the head start from Irish

know-how.

Enterprise Ireland is an organisation of the Irish government for

supporting business. It works closely alongside Irish companies

to help them tap into global markets, grow, advance innovations,

and increase exports.

https://irishadvantage.co.uk

Catheter production

Freudenberg Invests EUR 9 Million in Irish Facility

KPMG analysis

Growing Focus on Medtech

Companies in M&A

Freudenberg Medical is expanding its Vistamed

catheter production of to Carrickon-Shannon/Ireland.

This Freudenberg

affiliate is a provider of catheter development

and assembly services, complex extrusion

devices, and minimally invasive

devices. Total investments amount to approximately

EUR 9 million. The existing

facility is being expanded by 45,000 m 2 .

The plans include four new ISO class 7

clean rooms for contract manufacturing

of minimally invasive devices.

A modern research and development

centre for catheter

technology was built in Carrick-on-Shannon

in October

2016 for EUR 10 million, creating

approximately 200 new

jobs. The Freudenberg technology

company located in

Weinheim/Germany is continuously

broadening its involvement

within medical

technology. The business

group Freudenberg Medical is a manufacturer

of components for medical technical

devices, catheter systems for minimally

invasive procedures, and complete solutions

for the biotechnology, healthcare,

and pharmaceutical industry. In the 2016

fiscal year, Freudenberg Medical recorded

revenues of approximately EUR 168 million.

Photo: Freudenberg

www.freudenberg.com

Six of the ten largest life sciences deals

which have been announced are in the

medtech sector. In the first six months of

2017, 509 mergers and acquisitions were

announced, with a volume of USD 60 billion.

This was the conclusion of an analysis

conducted by the auditing firm KPMG

in Berlin/Germany, based on figures from

Thomas Reuters. According to the analysis,

the number of announced mergers

and acquisitions in the area of life

sciences and chemistry fell by 2% in the

first half of 2017 from 1,801 to 1,765

compared with last year. The transaction

volume fell by 29% from USD 293 billion

to USD 209 billion. The strongest activities

in mergers and acquisitions (M&A)

are in the USA and China. In the area of

life sciences, the number of announced

transactions increased in the first half of

the year by roughly 1% to 1,231.

www.kpmg.com

8 medicine&technology 02/2017


Trade Fair Dates

Moved Forward

MT-Connect | Organisers have selected a new date so

that the MT-Connect trade show and Medtech Summit

will not take place at the same time as Hannover

Messe next year. The trade fair will now be held two

weeks earlier in April than was originally planned.

Approximately 1,900 people attended première of the MT-Connect

trade fair in Nuremberg in June 2017.

Photo: Nürnberg Messe

The international trade fair MT-Connect and the medical technology

congress Medtech Summit will now be held in Nuremberg

on 11 and 12 April 2018 – earlier than announced previously.

The organisers made this announcement in July 2017.

“After having many conversations with exhibitors and visitors we

decided, among other things, that the MT-Connect should not be

held in parallel with Hannover Messe Industrie. We are now realising

this wish together with Forum Medtech Pharma in the second

week of April,” says event manager Alexander Stein from

Nürnberg Messe.

Approximately 1,900 visitors came to Nuremberg in July 2017 to

witness the première of MT-Connect with its 189 exhibitors and

to take part in the Medtech Summit which was held at the same

time. The next event was previously scheduled for a date at the

end of April 2018.

“The most pressing decision was setting the new date to give the

exhibitors planing certainty. Our next step is to fine-tune how

the content is arranged. The successful connection of people and

companies will continue to be our guiding theme, however—from

the suppliers to the medical device manufacturers,”

promises Stein.

With the new dates, MT-Connect will now be held the week before

the medical technology trade fair Medtec Europe in Stuttgart,

which UBM Canon is organising from 17 to 19 April 2018.

More about the MT-Connect trade show: www.mt-connect.de/en

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02/2017 medicine&technology 9


■ [ NEWS ]

Trade Fair: Meeting

Point for Industry

Swiss Medtech Expo | More than 1,600 medical technology

experts used the trade fair in September to exchange

knowledge and for networking. A highlight was

the introduction of the Medtech.plus digital platform.

Successful concept of Swiss Medtech Expo: The trade fair was also a

hit in its second year, with a good mix of exhibits, knowledge

transfer, and networking.

Photo: Messe Luzern

We are very satisfied with this year’s Swiss Medtech Expo,”

says trade fair director Fabrizio Raffa following two successful

trade fair days. The trade fair was able to mobilise about

10% more visitors. In addition, a pleasant atmosphere filled

well-visited trade fair halls, and stimulating discussions could be

heard at every booth. “The strength of the Swiss Medtech Expo is

the high quality of its visitors. We were able to get the right experts

together for the personal exchange,” summarises Raffa.

In Lucerne on 19 and 20 September, more than 170 exhibitors

showed where medical technology has potential, and how new

designs, materials, technologies, and processes spawn innovations.

Attending experts introduced proposals for their own

projects also during the 36 presentations in the Innovation symposium.

“Together with well-known competency partners we

were able to put together a high-quality program and give visitors

a glimpse behind the development of innovations,” explains

trade fair director Raffa. A highlight of the event was the launch

of Medtech.plus, the digital platform for medical technology,

which expands the concept of Swiss Medtech Expo into the digital

world. This platform was developed as a place where the

Swiss medical technology community can come together to exchange

ideas in the future—365 days a year.

“We are convinced that we are contributing to strengthening the

industry by creating places where the industry can exchange

ideas—physically and digitally,” explains René Ziswiler, director

of industry trade fairs at Messe Luzern. For Ziswiler it is clear

that the right direction has been taken with the digital expansion

of Swiss Medtech Expo. “There is still potential however, and we

are doing everything we can to significantly expand the trade

fair together with our partners.”

The next Swiss Medtech Expo will be held in Lucerne from 17 to

18 September 2019.

More about Swiss Medtech Expo: www.medtech-expo.ch/en/

On the digital platform Medtech.plus: www.medtech.plus/en/

Technical orthopaedics

Swedish Financial Investor EQT to Take Stake

in Ottobock Conzzeta Takes Over Plastics Business

Contract research

Gilde Healthcare Invests in

Mercachem-Syncom

Photo: Ottobock

Ottobock intends to concentrate more

heavily on medical technology. The

plastics business will be sold to the Swiss

group Conzzeta, and the Swedish financial

investor EQT is acquiring 20% of the

shares at Otto Bock Healthcare GmbH in

Duderstadt/Germany. EQT will be the

first non-family shareholder in the 98

years of the company’s history. Otto Bock

Holding GmbH & Co. KG, 100% of which

belong to the owner family Näder, will retain

an 80% share. Ottobock intends to

keep to its plans for a potential initial public

offering, according to Prof. Hans Georg

Näder, President and CEO of Otto Bock

Holding. However, due to the involvement

of EQT, this step will take place later

rather than sooner.

Ottobock is a market leader in technical

orthopaedics. Otto Bock Kunststoff recorded

revenues of approximately

EUR 130 million in 2016. According to reports,

by selling to Conzzeta the Ottobock

subsidiary will gain an owner that will expand

the PUR plastics business worldwide.

Conzzeta is represented in this sector

with the Foam Partner business unit.

Through the sale, ownership of the joint

venture of Ottobock and Foam Partner located

in Shanghai will be transferred to

Conzzeta. The businesses of Technogel

and Matrazzo are excluded and will remain

a part of Otto Bock Holding.

www.ottobock.com/en

Together with Dutch pension fund service

provider PPGM, Dutch investor Gilde

Healthcare Partners B.V. located in Utrecht

has invested in the European

contract research companies Mercachem

B.V., Nijmegen, and Syncom B.V., Groningen.

The resulting Mercachem-Syncom

Group, with subsidiaries in Nijmegen and

Groningen/Netherlands and in Prague/

Czech Republic, will become a contract

research organization (CRO) for the development

of innovative active chemical

substances. The merger will allow Mercachem-Syncom

to place its integrated services

for the development of active substances

on a broader base and to invest in

high-quality systems to be better able to

cover the demand for outsourcing solutions.

www.mercachem.com, www.syncom.nl

10 medicine&technology 02/2017


Lab-on-a-chip systems

Project Centre Improves Production and Design

The Fraunhofer Society started its

first “Project Centre” in Ireland in

May this year. The newly founded

Fraunhofer Project Centre (FPC) for

Embedded Bioanalytical Systems at

Dublin City University is a cooperation

of the Fraunhofer Institute for

Production Technology IPT from

Aachen/Germany and Dublin City

University (DCU). FPC combines the

expertise of the two partners for the

development of microfluidic labon-a-chip

systems. These systems are

used, for example, in medicine, pharmaceuticals,

production, and analy-

sis. Science Foundation Ireland and

Fraunhofer are supporting the partnership

with EUR 2.5 million each,

initially for a period of five years. The

new research institution will continue

to develop the systems and

technologies for manufacture, improving

availability and lowering application

costs. The Irish partner

Dublin City University is especially

familiar with the design and technical

specifications for various applications,

while the Fraunhofer IPT is

contributing production technology

know-how.

Slovenian healthcare market

Return to Slight Growth Course Following

Stagnation and Economic Crisis

The Slovenian government is planning a

reform of the healthcare system, which

includes better procurement planning

for medical technology.

Photo: jianghaistudio/Fotolia

The Slovenian market for medical technology

suffered during the country’s

economic crisis in recent years. According

to reports by Germany Trade and Invest

(Gtai), Slovenia had to bear severe declines

in gross domestic product (GDP) in

2009 as well as in 2012 and 2013, which

had an effect on the ability of public funding

of the healthcare system. Estimates

from the market research company Global

Research & Data Services (GR&DS) show

that the demand for medical technology

decreased by 13.1% between 2009 and

2015 from USD 187.8 million to

USD 163.2 million.

In the coming years, market researchers

expect to see an annual market growth of

between 0.7 and 2.8%. By 2020 the demand,

measured in US dollars, is expected

to increase by a total of approximately

7% in comparison with 2015, to

USD 174.6 million. The level of 2012 will

only be reached by 2020. The majority

will be in the product group “other medical

instruments and devices.” This is followed

by “other orthopaedic devices,” as

well as catheters, cannulae and needles,

UV and infra-red devices, and artificial

joints.

The government is currently planning to

reform the healthcare system and intends

to pass a reform bill by the end of 2017.

The key points of the reform are

strengthening medical care and improving

procurement planning, including for

expensive medical technology. The Slovenian

market for medical technology is

mainly served by imports. A number of

smaller, specialised manufacturers work

in the local medical technology sector.

Many of these are successfully active in

the export business. Slovenian exports

amounted to EUR 128.9 million in 2015.

In 2015, Slovenian imports of medical

technology products increased by 11.7%

in comparison with the previous year to

EUR 179.4 million. German providers led

with a share of 26.7% of the total imports

in 2015. They were followed by providers

from Italy (14.7%), Belgium (12.9%),

and the Netherlands (10.4%).

02/2017 medicine&technology 11


■ [ MARKET AND MANAGEMENT ]

Photo: Cristian Balate/Fotolia

Romania Needs the Right Bite

Market opportunities | Private healthcare companies in Romania work on a Western

level. In contrast, conditions in the state-run healthcare system are sometimes bleak.

This is to change: The new government is setting a course for modernisation and announces

the construction of large hospitals.

Hospitals in urgent need of renovation,

defective medical devices, a

lack instruments, poor hygiene, omnipresent

corruption, and far too few personnel:

Romania’s state-run healthcare system

has had a bad reputation for years.

The scandal about adulterated disinfectant

in the spring 2016 was the absolute

last straw. For years Romanian market

leader Hexi Pharma had been selling

hundreds of hospitals heavily diluted disinfectants

at an exaggerated price. The essentially

ineffective antiseptics were also

used in surgery.

YOUR KEYWORDS






Need for renovation

Corruption

Import market

Private healthcare networks

Large hospitals

With catastrophic consequences. Romanian

President Klaus Johannis spoke of

a “deep crisis of the healthcare system.”

Minister of Health Nicolae Banicioiu resigned,

and his successor Vlad Voiculescu

announced that he will remedy the shortcomings.

“It is important for us to restore

people‘s trust in the Romanian healthcare

system,” he said after taking office in May

2016. Six months later there was a reelection,

and a new Minister of Health,

Florian-Dorel Bodog.

Grindeanu’s government, which took

office in January 2017 and to which

Bodog belonged, immediately announced

the construction of nine large state-run

hospitals. Physician and entrepreneur Dr.

Wargha Enayati is rather sceptical. Romania

has had at least 25 Ministers of

Health in the last 25 years, and no or

hardly any state-run hospital has been

built since the revolution in 1989. The

problem is incompetence and a lack of

sustainability: “Nothing can be brought to

completion.” In June 2017 the previous

Romanian Minister of the Economy Mihai

Tudose took office as Prime Minister following

Grindeanu.

Enayati knows what he is talking

about. Born in Frankfurt/Germany,

Enayati came to Romania to study medicine

at the beginning of the 1980s. He

stayed. As a cardiologist he became a

pioneer in the private healthcare sector,

for which increasing numbers of the 20

million Romanians are signing up due to

the dilapidated state-run system.

Founded by Enayati, the organisation

Regina Maria is now the largest private

healthcare network in the country. In addition

to having the most modern maternity

clinic with its own stem cell bank, this

network includes other clinics, outpatient

departments, and diagnostic imaging

centres among other units.

The successful system of efficient

healthcare subscriptions for medical services

offered by private providers was also

introduced by Enayati. “More than one

million people have such a subscription,

compared to maybe 100,000 people on

private health insurance,” says 53-year-

12 medicine&technology 02/2017


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The outpatient

clinics of the

Regina Maria

foundation have

modern equipment

and also

provide treatment

to people

who do not have

health insurance.

Tenders

Romania reformed the public procurement

law and passed new laws on

public tenders in May 2016. Theoretically

this means that this is the first

time that not only the cheapest

bidders are awarded the contract.

Technical criteria and long-term costs

are also being factored into the decision,

explains Johannes Becker, Austrian

company consultant who works

in Bucharest. In practice, usually the

cheapest bidder is still awarded the

contract – for the simple reason because

this is a clear decision.

Tenders are made for everything that

is invested within public hospital projects,

including all medical devices

and equipment. The invitations for

bids are mainly in Romanian, according

to Becker. So you need someone

who can watch and translate this.

Since many projects are announced

well in advance of the bidding, it is

helpful to follow this news in the

media in order to be prepared in due

time. Becker is a partner of the TPA

group, a tax consulting and auditing

company working in Central and

South-East Europe. (bg)

www.tpa-group.com

www.e-licitatie.ro

Photo: Fundaţia Regina Maria

old Enayati. Market experts predict that

the number of Romanians who have this

type of service package will double by

2020.

The strong growth of the private

healthcare market is reviving the demand

for medical technology, up to 90% of

which is covered by imports. Health care

companies such as Regina Maria have the

latest technology and operate on a Western

level. In contrast, the public healthcare

system suffers from chronic underfunding.

While an average of nearly 8% of

the gross domestic product was invested

in the public healthcare sector in 2013

across Europe, only 4.3% was allocated to

this sector in Romania.

Dracula’s homeland does not have the

right bite. Not only is there a lack of modern

infrastructure. There is also a lack of

personnel. The medical brain drain is an

enormous problem. Medical students are

already being enticed away from Romania.

About 13,500 doctors worked in

the state-run hospitals in 2014 – half as

many as needed.

Funding from the European pot is

available to modernise the public hospitals

in EU member state Romania. The

foreign trade agency Germany Trade & Invest

(GTAI) reports that the Ministry of

Health is also planning a state fund to finance

the announced large hospitals: In

addition to eight regional hospitals each

with 1,000 beds and the latest technology

and telemedicine, a large hospital with at

least 2,500 beds and multiple research

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02/2017 medicine&tec hn ology 13


■ [ MARKET AND MANAGEMENT ]

Even though the public procurement

law was reformed, the cheapest

bidder still usually gets the

contract, says company consultant

Johannes Becker. He works in Bucharest.

Photo: TPA Romania

Physician and entrepreneur: Dr.

Wargha Enayati moved from Germany

to Romania, where he became

a pioneer in the private

healthcare sector.

Photo: Fundaţia Regina Maria

Romania has a high development

dynamic with good general conditions,

emphasises Alexander

Weiss, managing director of Oechsler

Romania.

Photo: Oechsler

construction of three regional hospitals in

Iași, Cluj-Napoca, and Craiova with EU

funding for the 2014 to 2020 funding

period in the amount of EUR 150 million

is already behind schedule.

Industry experts expect moderate

growth of the still relatively small Romanian

market for medical technology in the

medium term. In addition to the need for

modernisation, this is indicated by the

positive economic development. With annual

growth rates of 2.9%, the market volume

for medical technology is expected to

grow to approximately 504 million USD

by 2018. High technology is purchased

abroad. About one-third of the imported

medical technology comes from Germany.

So far no investor has regretted

coming to Romania

Wargha Enayati believes there is a large

potential, among other things in the area

of oncology and radiotherapy. Things are

also just getting started in rehabilitation

clinics, says Enayati. He sold the Regina

Maria empire and is dedicated to his own

non-profit foundation that provides

healthcare to people without health insurance

and with low-incomes. He is also

concentrating on new projects. The largest

of them is a luxury nursing home

with a rehabilitation hospital in Bucharest.

“With increasing incomes in Romania,

the demand for healthcare services and

the related medical technology also growing,”

says Alexander Weiss, managing director

of S. C. Oechsler Romania SRL in

Lipova. The factory, which employs 240

people, is a subsidiary of the Oechsler corporate

group, which among other things,

produces components and assemblies for

inhalation devices and blood glucose

meters. In Romania, Oechsler produces

technical plastic components and assemblies

largely for the automotive industry,

with the highest quality standards.

A supplier structure and demand for

medical devices that require certification

according to DIN EN ISO 13485 or GMP

have hardly been established in Romania

up to now, explains Weiss. In spite of this,

the dynamically developing automotive

industry is producing suppliers that now

manufacture technically complex components

and assemblies under high production

standards, which could facilitate the

transition to medical manufacturing.

The Romanian S.C. Biotechnik S.R.L.

in Cisnadie near Sibiu has already supplied

international medical technology

customers for years with high-quality

stainless steel components, such as pressure

vessels for the European and American

market. The company was founded in

1991. The owner is also a managing director

of a Germany company that intensively

utilises the advantages of manufacturing

of labour-intensive components at

this location. The demand from the field

of medical technology is growing, says

Simona Bontas, who is responsible for

after-sales. An advantage of this location

is the much lower cost of labour: “The

requirements on quality and material

prices are the same.”

Romania has a high development dynamic

with good framework conditions,

in particular for production with interesting

labour costs, emphasises Alexander

Weiss, who has worked in this country for

nine years and is one of the longest-serving

managers in Romania. However, in

the metropolitan areas it is difficult to

find qualified employees. Bureaucracy

and political stability continue to be challenges,

but corruption is already being

fought with considerable success.

The prejudices against Romania are

still large, says Wargha Enayati, who is

also a board member of the German-Romanian

Chamber of Industry and Commerce.

Whoever sets these prejudices

aside is at an advantage. “No investor who

has come to Romania has regretted it.” ■

Bettina Gonser

Freelance journalist in Stuttgart

Additional information

On the organisation Regina Maria:

www.reginamaria.ro

On the foundation Regina Maria:

www.fundatiareginamaria.ro

On Germany Trade & Invest:

www.gtai.de

On the plastic manufacturer

Oechsler:

www.oechsler.com

On biotechnology:

www.biotechnik-romania.de

14 medicine&technology 02/2017


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WATCHMAKING AND JEWELLERY - MICROTECHNOLOGIES – MEDTECH

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EXHIBITORS

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02/2017 medicine&tec hn ology 15


■ [ MARKET AND MANAGEMENT ]

STILL POTENTIAL

IN MEDICAL CARE DATA

Post market surveillance | A study conducted by the Witten/Herdecke University

shows how medical product manufacturers monitor the market. According to Dr.

Claus Zippel, one of the authors, the industry is well established, but information from

registries and clinical reporting systems could be used more intensively.

■ Dr. Zippel, what was the occasion for

the study on post market surveillance by

medical product manufacturers?

A literature review conducted in 2014

showed, there were basically only two

perspectives on post market surveillance

in the medical products sector.

On one hand, the objective in studies

with a legal focus were concerned with

the legal requirements which needed to

be fulfilled. On the other hand, manufacturers

looked at the information

which post market surveillance provided

for individual products such as

stents and pacemakers. With our study

we wanted to close an information gap

and record in detail how the manufacturers

observe the market and what instruments

they use to do so. We also

wanted to know if there were differences

in post market surveillance in

this market, which has very different

sizes of companies and product requirements

that vary on the basis of risk

classes.

Dr. Claus Zippel from Witten/Herdecke ■ In your opinion, what is the most important

information which was gained

University is one of the authors of a

study on post market surveillance in

from the present data?

medical technology.

Firstly we were positively surprised that

we received so many responses—118 to

be exact, which is a return rate of 36

percent. From our general experience

this is a very high number for this type

of survey and is really astounding for

the medical technology industry. This

YOUR KEYWORDS

goes to show how important this topic

is at present. Our experience has

■ Market surveillance

taught us that this type and scope of

■ Status quo of manufacturers

post market surveillance does not depend

on the size of the company.

■ MDR requirements

■ Benchmark

Rather, what manufacturers do or do

■ Incentives for innovation not do is correlated with the risk class

of its devices. There is no relationship,

Photo: Witten/Herdecke University

in terms of the statement: The larger

the company, the safer its products.

■ Most manufacturers use internal

sources of information, which includes

feedback from sales representatives,

complaints, or quality data from production.

How many of the 118 survey respondents

also use external information?

We classified a number of sources as

external sources for our study. Such

sources include market analyses, vigilance

data from federal authorities

such as the Federal Institute of Drugs

and Medical Devices (BfArM), the Paul-

Ehrlich Institute, and the FDA, as well

The market provides incentives

for products—it

is worthwhile to make

greater use of these.

as post-marketing follow-ups and data

from medical care research. The later

includes registries and information

from reporting systems in hospitals.

About half of the survey respondents

reported that they do not yet systematically

track data from medical care research

– depending on risk class the

percentage ranged from 44 to 52 percent.

However, about 15 percent of

those surveyed reported that they already

use these external sources very

often. In our opinion this shows that

this area is developing and there is still

great potential in the utilisation of

product-specific patient data.

■ Specifically, what sources

are available?

16 medicine&technology 02/2017


For manufacturers of plastic hip and

knee joints, it is naturally obvious to

use endoprosthesis registries –

whether the one in Germany that has

been in existence for a few years, or

those in Scandinavia that have been

operating for somewhat longer. A review

conducted by the University of Erlangen-Nuremberg

showed that there

are about 100 registries throughout Europe

that would be potential sources

for implantable medical products

alone. Manufacturers of anaesthetic

devices can additionally obtain information

on critical reports from the

clinical reporting systems that are well

developed in this area. The providers of

in-vitro diagnostics, in turn, obtain information

on quality control through

contact with laboratory physicians.

■ What effort does it take to use these

sources?

This aspect was not examined in the

present study. The variety of possible

sources readily suggest that it would be

worthwhile to work on unification of

data and registries so manufacturers

would be able to put this information

to better use. This would affect the language

as well as the structure of the

registry. The time and effort resulting

from using external sources becomes

relative, however, when the information

is also used to improve previous

products. In a study conducted in

parallel to this one, medical devices

manufacturers have already stressed

that things are moving in this direction.

■ What benefits can companies get

from your results?

Since we have received a large number

of responses, we can form subgroups,

for example, based on company size

and risk class. For companies this

means that they can be classified in a

benchmark and answer the question of

where they stand with regard to post

market surveillance. In addition, in this

study we were able to compile all currently

available measures for post market

surveillance so that companies can

use this as a type of check list to determine

the next steps they may want to

take.

■ The MDR intends to establish a proactive

system for the collection and

analysis of available information as well

as for similar products from other manufacturers.

If you compare this with your

data, how large is the gap?

Based on our results this point should

not be a reason for companies to worry.

Most are already very well established

and have also indicated that they already

obtain information on similar

products and other manufacturers.

■ What do you recommend for the field

of post market surveillance?

Do more with the data that you have at

hand. Post market surveillance should

not only be a matter for quality assurance.

It also needs to be seen as a potential

initiator. For this to happen, the

heads of regulatory affairs, quality assurance,

and development will have to

sit at the same table more often, not

only when they have to solve a specific

problem. Since data collection is prescribed

by law and the time and effort

has to be put in anyhow, there is hardly

a better opportunity to find out something

about safety-relevant requirements

for products.

■ What other studies are you planning

in this area?

At this time there is no specific project

that continues our study. However, it

would be interesting to obtain data on

post market surveillance in other European

markets and to see how the situation

will unfold in the transition period

for the new MDR. It would also be

exciting to conduct a study in the USA

so we could compare Europe and the

United States—and the two regulatory

systems.

Dr. Birgit Oppermann

birgit.oppermann@konradin.de

Additional information

Prof. Dr. Sabine Bohnet-Joschko and

Dr. Claus Zippel from Witten/Herdecke

Universities are the authors of

the study on post market surveillance

for medical products (Post

market surveillance in the German

medical device sector—current state

and future perspectives). Started in

2014, the study can be purchased

for download.

http://bit.ly/2uQuPOV

Components, objectives and

OEM imaging modules for

biotechnology machinery

Solutions in Optics - Reduced to Your Needs

www.opto.de

02/2017 medicine&tec hn ology 17


■ [ MARKET AND MANAGEMENT ]

A Market for Products and Ideas

Medical technology trade fairs 2018 | Even in the age of globalisation and digitisation,

trade fairs remain a communication and marketing instrument for brands and products.

Around the globe exciting events will take place next year in the highly innovative

medical technology sector.

Trade fairs and exhibitions are vital

initiators for international trade in

goods and services. As one of the most important

marketing instruments, they help

to intensify competition and increase

growth and employment.

According to calculations from UFI, the

Global Association of the Exhibition Industry,

there are approximately 1,200 exhibition

sites worldwide with a hall capacity

of over 32.6 million m2. Every year

these sites hold more than 31,000 trade

fairs and are contact points for some 4.4

million exhibitors and more than 260 million

visitors. According to reports from

the Statista statistics portal, the trade fair

organisers with the highest revenues

worldwide in 2016 were Reed Exhibitions

(Great Britain) and UBM plc, (Great Britain),

followed by Messe Frankfurt (Germany)

and GL Events (France). As a result

of globalisation and greater brand orientation,

the importance of these industry

market places will see further growth in

the future.

The innovative medical technology industry

will continue to be a growth market

due to demographic development, advances

in medical technology, and the dynamics

in emerging markets and developing

countries. Participating in international

trade fairs is, therefore, an essential

part of the marketing mix for most

companies.

In addition, export-oriented companies

face the question of whether they

should also participate in a trade show in

their target country or target region. In

most cases, the answer is “yes.” Participation

in foreign trade fairs gives exhibitors

additional opportunities, for

example, through greater audience potential,

direct conversations with visitors,

and local observation of the market in the

target country.


Additional information: http://www.ufi.org/

Trade fair

Arab Health

www.arabhealthonline.com

MD&M West

www.mdmwest.com

Pharmapack Europe

www.pharmapackeurope.com

Salmed

www.salmed.pl

Medical Fair India

www.medicalfair-india.com

Expo Med Eurasia

www.expomedistanbul.com

MT-Connect

www.mt-connect.de

Medtec Europe

www.medteceurope.com

Exposanita

www.exposanita.it

Rommedica

www.rommedica.ro

Bulmedica

bulmedica.bg/en

Hospitalar

www.hospitalar.com/pt/

Medicare Taiwan

www.medicaretaiwan.com

Medical Fair Asia

www.medicalfair-asia.com

Medtech China

www.medtecchina.com

Medica / Compamed

Zdravookhrneniye

www.zdravo-expo.ru

Description

International trade fair for medical technology and

hospital equipment

Medical Design and Manufacturing West Conference &

Exposition

Pharmaceutical Packaging & Drug Delivery Exhibition

International medical trade fair

International Exhibition & Conference India‘s No. 1 Trade

Fair for Hospitals. Health Centres and Clinics

International trade fair for medical technology and

hospital equipment

Inside Medical Technology

Trade show for the European medical technology

industry – Technology. Networking. Education

International exhibition for healthcare

International Trade Fair for Medical Instruments &

Equipment

International exhibition and conference for medical

technology. Ophthalmology, and dental technology

International Fair of Products. Equipment. Services

and Technology for Hospitals. Laboratories. Pharmacies.

Health Clinics and Medical Offices

Taiwan International Medical & Healthcare Exhibition

International Hospital. Pharmaceutical & Medical &

Rehabilitation Equipment & Supplies Exhibition

The exhibition dedicated to medical device design &

manufacturing

World Forum for Medicine – International trade fair

and congress with Compamed – International trade fair

for high-tech solutions for medical technologies

International trade fair for healthcare.

Medical technology

18 medicine&technology 02/2017


Photo: Messe Düsseldorf

Marketing instrument

trade fair: Innovations

are directly evaluated

by potential customers

at exhibitions around

the globe.

Exhibition topics

City

Dates

Organiser

Dental technology. Diagnostics. Electromedicine.

Hospital products. Medical devices. Medical technology.

Dubai, United Arab

Emirates (UAE)

29/01–01/02/2018

Cycle: annual

Informa Middle East, Dubai

Biotechnology. Medical technology. Hardware and software.

Design. Plastic processing. Laboratory technology

Anaheim (CA),

USA

06–08/02/2018

Cycle: annual

UBM Canon,

Santa Monica (CA)

Automation. Labelling technology. Logistics.

Testing and inspection technology. Sterile technology.

Packaging technology

Paris,

France

07–08/02/2018

Cycle: annual

UBM Canon,

London

Laboratory equipment and devices. Medical devices.

Medical technology. Rehabilitation. Rescue equipment

Poznań,

Poland

15–17/03/2018

Cycle: biennial

Poznan International Fair,

Poznan

Surgical equipment. Dental medicine. Diagnostics. Cardiology.

Hospital equipment. Laboratory technology. Medical

technology. Orthopaedic technology. Sterile technology

Mumbai,

India

16–18/03/2018

Cycle: annual, alternating in

Mumbai and New Delhi

Messe Düsseldorf,

Düsseldorf

Biotechnology. Surgical equipment. Medical technology.

Diagnostics. Nanotechnology. Orthopaedic technology

Istanbul,

Turkey

22–25/03/2018

Cycle: annual

Reed Tüyap Fuarcilik,

Istanbul

Electronics. IT services. Plastic technology.

Microtechnology. Surface technology. Materials

Nuremberg,

Germany

11–12/04/2018

Cycle: annual

Nürnberg Messe,

Nürnberg

Smart health. Digitisation. IT. Materials.

Research & development. Production. Packaging

Stuttgart,

Germany

17–19/04/2018

Cycle: annual

UBM Canon,

London

Medical instruments Hospital products. Medical devices.

Medical technology. Rehabilitation equipment

Bologna,

Italy

18–20/04/2018

Cycle: biennial

Senaf,

Bologna

Ophthalmic optics. Instruments. Biotechnology.

Opto-electronics. Dental technology. Medical technology

Bucharest,

Romania

19–21/04/2018

Cycle: annual

Romexpo,

Bucharest

Ophthalmic optics. Surgical equipment.

Dental medicine. Diagnostics. Electromedicine.

Laboratory. Medical technology

Sofia,

Bulgaria

16–18/05/2018

Cycle: annual

Inter Expo Center,

Sofia

Hospital products. Laboratory technology.

Medical devices. Medical technology. Orthopaedic

technology. Rehabilitation equipment. Wheelchairs

São Paulo,

Brazil

22–25/05/2018

Cycle: annual

UBM Brazil,

Sao Paulo

Surgical equipment. Dental medicine. Diagnostics.

Laboratory technology. Medical technology. Orthopaedic

technology.

Taipei,

Taiwan

21–24/06/2018

Cycle: annual

Taitra,

Taipei

Electromedicine. Hospital equipment. Nursing, hospital

products Laboratory technology. Medical technology

Singapore,

Singapore

29–31/08/2018

Cycle: biennial

Messe Düsseldorf,

Düsseldorf

Electronics. Laser technology. Plastic technology. Medical

technology. Sterile technology. Packaging. Supply parts

Shanghai,

China

September 2018

Cycle: annual

UBM Canon,

Santa Monica (CA)

Medical technology. Surgery. Orthopaedics.

Laboratory technology. Hospital products.

Electromedicine. Component technology

Düsseldorf,

Germany

12–15/11/2018

Cycle: annual

Messe Düsseldorf,

Düsseldorf

Diagnostics. Hospital equipment. Laboratory devices.

Medical devices. Medical technology. Therapy devices

Moscow,

Russia

December 2018

Cycle: annual

Messe Düsseldorf,

Düsseldorf

02/2017 medicine&tec hn ology 19


■ [ MEDICINE IN DIALOGUE ]

SOURCE OF INFECTION,

MEDICAL DEVICE

Hospital hygiene | After a number of infections occurred in patients with artificial

heart valves, scientists concluded in an international study that the source of the

pathogens was a medical device, a heater-cooler device. One of the authors, hospital

hygienist Prof. Hugo Sax explains how the infections started and what lessons can

be learned – including for manufacturers.

■ Professor Sax, 50 authors from around

the world collaborated and investigated

in a study the source of infections following

heart valve surgeries. What was the

occasion for a study of this magnitude?

Even on a larger scale, interdisciplinary

studies are increasing because we are

unable to answer many questions without

them. In this case one has to speak

of an emergency situation that required

clarification of the causes. In some patients

who had received an implanted

heart valve, a disease suddenly spread

throughout their body years after the

surgery, in some cases with a fatal outcome.

It soon became clear that the diseases

were caused by a particular bacteria,

Mycobacterium chimaera. This

bacteria lives anywhere where there is

standing water, it grows very slowly,

and, until then, it had never been associated

with such infections. Therefore,

researchers around the world were

intent on finding out how these bacteria

could cause an infection of artificial

heart valves.

Prof. Dr. med. Hugo Sax is a Senior Consultant

at the Department of Infectious ■ What conclusion did you reach

Diseases and Epidemiology at the University

Hospital Zurich and is the Head

in the study?

of Infection Control and Hospital Epidemiologyclusion

that the source of the infection

In the end the results led to the con-

was a medical device, a heater-cooler

device, which is used during these

types of surgery. When we replace a

YOUR KEYWORDS

heart valve, we work using a heart-lung

machine that takes over the functions

■ Heater-cooler devices in

of the organs. The blood cools in the device

and must be returned to the cor-

open-heart surgery

■ Biofilms in water circulation systems rect temperature before it re-enters the

of the device as source of infections body. This is the task of the heatercooler

device. It transmits heat using a

■ Role of manufacturers and users

■ Rethinking the global organisation temperature-controlled water circulation

system—which is ultimately

where the source of infection lies.

Photo: University Hospital Zurich

We are not organised

well enough to handle

global problems involving

medical devices.

■ How did bacteria from the device

get into the surgical environment?

The water circulates in the device.

Mycobacterium chimaera forms biofilms

on artificial surfaces, such as the

lines in the device, and can survive

there for a very long time. For physical

reasons, the bacterium is concentrated

ten-thousandfold at the surface of the

water. From there, the bacteria are released

into the air in small droplets,

since fans also operate in the heatercooler

devices. This flow of air carries

the bacteria into the surgical environment.

If they come into contact with

the artificial surface of the heart valve,

they attach to this surface and are introduced

into the patient’s body with

the valve. They can develop there long

after surgery and develop microbe

counts which are large enough to infect

the entire body.

■ This sounds like a large number of

factors have to come together...

Yes, you really have to use the picture

from the Swiss cheese model: An event

occurs only when the slices of Emmental

cheese are coincidently arranged in

such a way that all the holes line up directly

with one another. Practice has

shown however, that evidently even

this unlikely case occurs in modern

medicine.

20 medicine&technology 02/2017


■ How did these particular Mycobacteria

get into the heater-cooler devices?

To answer this question, we used a

–genetic method, whole genome sequencing,

which allowed us to differentiate

individual strains of a species of

bacteria. We examined 250 samples

taken worldwide. The results showed

that the exact same bacteria strain

was detected in the samples of the

affected patients, in the heater-cooler

devices, and in the production facilities

where the devices are made. Only one

patient sample contained a different

strain. This means that the key bacteria

came from the device. Since the primarily

affected device type is produced

by a globally dominant manufacturer

and the bacteria strain was detected

in this manufacturer’s production

facility, it is most likely that the infectious

strain got into circulation from

there.

■ Can all other sources of infection be

ruled out on the basis of the results?

Yes, the infection is caused by the

heater-cooler devices. As it turned out,

brand-new devices from other producers

were also contaminated.

■ Could the bacteria have also got into

the device during use?

This is theoretically possible.

■ What can users do at present to

prevent further infections?

We cannot do without the device or its

function. It is probably impossible to remove

the bacteria from the water circuit.

So far there is also no other alternative

to water as a medium to transfer

heat to the blood. Therefore, at our hospital

we enclosed the devices in a way

that stops a draught from being created

that could carry the aerosol into

the surgical environment. Other hospitals

have placed the heater-cooler device

in a separate room, if they had the installation

space to do so.

■ How many manufacturers put

such heater-cooler units on the market?

There are only a few. We detected the

bacteria in devices from two manufacturers

in our study. However, one of

manufacturers has a share of about

80 percent on the world market for

these devices.

■ What would manufacturers need

to do so that their devices do not pose

a danger?

This is a difficult task and takes a lot of

resources. Since the devices cannot be

operated with distilled water for technical

reasons, at least sterilised water,

boiled water, for example, should be

used in the production environment.

Also, samples would have to be taken

from the devices, and the devices

should not be sold until there is proof

that they do not contain Mycobacteria.

This proof takes while to produce, however,

because the bacteria grow very

slowly, up to six weeks. In addition, the

manufacturers would need to update

the instructions for users.

■ What do users need to pay attention

to when using these devices?

In the hospital, it must be ensured that

the devices do not become contaminated

by tap water—after all Mycobacteria

can also be detected naturally in

tap water, but do not cause any harm

when they reach the gastrointestinal

tract. Manufacturers would need to

02/2017 medicine&tec hn ology 21


■ [ MEDICINE IN DIALOGUE ]

specify that the air which is discharged

from the device must not mix with the

air in the surgical environment.

■ How can infections like those

described be prevented in the future?

They cannot be prevented since no one

can predict a future microbiological

problem. We really were confronted

with an entirely new phenomenon in

the case of the Mycobacteria. This

example has shown us however, what

we could do better if a similar problem

should occur.

■ What could be improved?

Internationally we are not well enough

organised to confront the dangers associated

with medical devices. In the

global economy, the devices are sold

everywhere, including across national

borders. Different authorities are responsible

within the various countries,

and users take different approaches.

When problems occur, the system is

much too complex and not transparent

enough to determine the cause quickly.

When we discover a problem in our

hospital, an interdisciplinary group is

immediately called into action to tackle

the problem and find a solution. In the

present case, this was not readily possible

in the international environment—the

first infections occurred in

2011, and it took a very long time until

we had the results which we have

today.

■ What do you recommend to the

manufacturers?

Each device poses a variety of risks,

many of which can be predicted in

advance. Microbiological problems in

particular are sometimes very difficult

to foresee. When they occur however,

manufacturers should deal with them

openly and find a solution in contact

with the authorities and, in some

cases, with scientists. Of course this is

difficult due to the prevalent competition

and the fear of image loss. We face

the same thing at our hospital

however. The hospital environment is

also a competitive situation. We had an

experience in which openly dealing

with a matter involving a patient who

was infected at our hospital actually

helped our image. We had a problem

but we took care of it as fast as we

could.

Infections with Mycobacterium chimaera

Since 2013 more than one hundred patients

in Europe, the USA, and Australia

have been found to have a disease

caused by the bacteria Mycobacterium

chimaera following open-heart surgery.

In many cases this infection became lifethreatening,

with infestation of the heart

valves used during the surgery.

Shortly after the first infections became

known, suspicion fell on a heater-cooler

device that is used during surgery with

heart-lung machines. For safety reasons,

The Medical Centre – University of Freiburg

and the University Heart Centre

Freiburg Bad Krozingen removed the

heater-cooler devices from all operating

theatres in 2014.

An international team of scientists has

now examined the genetic material of

250 isolates of Mycobacterium chimaera

and was able to prove that almost all of

the examined infections were caused by

contamination of the devices during production.

The researchers published their

results on 12 July 2017 in the journal The

Lancet Infectious Diseases.

In the study, the researchers examined

the pathogenic genetic material of 250

samples from sick patients, from the

water tanks of heater-cooler devices

from various manufacturers, and from

their production sites. They tested the air

of the operating rooms where heatercooler

devices were used, as well as other

medical devices, tap water, drinking

water dispensers, and other controls. The

genetic similarity of almost all patients

samples to the samples from the heatercooler

devices and their production facilities

was so great that the latter is extremely

likely to be the source of infection.

Study co-director Prof. Dr. Dirk

Wagner, Senior Consultant of the Division

of Infectious Diseases of the Department

of Medicine II at The Medical

Centre – University of Freiburg, says:

“Manufacturers need to fundamentally

change their production to prevent the

devices from becoming contaminated in

the first place.”

The genus Mycobacteria includes a

number of species that usually do not

cause diseases. Tuberculosis develops in

association with an infection by bacteria

from the Mycobacterium tuberculosis

complex, however. Leprosy is caused by

Mycobacterium leprae.

■ Will there be other studies on

Mycobacterium chimaera?

At the hospital level, our problem is

solved, and we are in contact with the

Swiss authorities to get to grips with

this matter across the country. At the

international level it is more difficult

to get the manufacturers involved

through the authorities. On the scientific

level, we want to know whether

there are other pathogens that are

harmless in themselves, but which

could potentially find loopholes in

the medical system through which

they can multiply and become dangerous.

■ What importance do such cases

have in your daily routine as a hospital

hygienist?

It is important to solve these types of

acute problems and learn from them.

One must see however, that the much

greater challenge in terms of numbers

is not in the technical sector, but in the

human sector. Without playing down

the roughly 100 infections with Mycobacterium

chimaera, one has to recognise

that a lack of hand hygiene causes

far more infections in hospitals.

Dr. Birgit Oppermann

birgit.oppermann@konradin.de

22 medicine&technology 02/2017


Polysaccharides

Fighting Arthritis with Sugar from Algae

MEDICA

Düsseldorf

13.–16.11.17

Hall 5, Stand E38

LOOKING FOR TARGET

ORIENTED PARTNER?

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that are available either with constant

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actuators are able to position your products

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moving ideas – typical HANNING.

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Holter Straße 90, D-33813 Oerlinghausen, Germany

Tel +49 (5202) 707-0, www.hanning-hew.com

Photo: Fotolia/m3ron

Proportional

Flow Control Valve

for Pneumatics

A Swedish-Norwegian research team is on the track

of a new approach for treating arthritis. The basis is

the polysaccharide alginate from brown algae.

Chemically modified, the long-chain sugar molecule

reduces oxidative stress, has an anti-inflammatory effect,

and suppresses the immune response to cartilage

cells.

The alginate obtained from sea rod (Laminaria hyperborea)

resembles certain extracellular biomolecules

from cartilage tissue. To study the response of various

cell types to the modified polysaccharide, the scientists

at the ETH Zurich University, the Swiss Federal

Laboratories for Materials Science and Technology

(Empa), and the Norwegian research institute Sintef

chemically modified the alginate and added it to cell

cultures in a dissolved form. Results have shown that

alginate sulphate can considerably reduce oxidative

stress – which causes cell damage and even cell

death; and was able do so even more effectively as

more sulphate groups were attached to the molecule.

Also, alginate sulphate was able to suppress the inflammatory

response. In human cartilage cells, the

chondrocytes, as well as in macrophages, the scavenger

cells of the immune system, alginate sulphate

can reduce the expression of genes that trigger an inflammatory

response.

www.empa.ch

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D-87700 Memmingen Tel.: +49 8331 10 40 Mail: info@Magnet-Schultz.com

Messe compamed, Halle 02/2017 08A medicine&tec Stand S13 hn ology 23


■ [ MEDICINE IN DIALOGUE ]

Brain-computer interfaces

Experts Call for Ethical Guidelines

Internationally leading scientists from the field of

neurophysiology, neurotechnology, and neuroethics

have formulated ethical guidelines for the use of

brain-computer interfaces. These guidelines are intended

to ensure data protection, liability, and safety

in brain-controlled systems– aspects that are still

somewhat unclear. The central request is a veto function

that interrupts unintentional commands. The researchers,

including Tübingen scientists Niels Birbaumer

and Surjo R. Soekadar, propose also that all

data should be stored temporarily and encrypted, like

in the black box of an aeroplane. Brain-computer interfaces

translate brain activity into control signals

for computers, robots, and prostheses. In 1999 neuropsychologist

Birbaumer had found a way to allow

patients with locked-in syndrome to use brain signals

to write letters. In 2017 he enabled fully paralysed

patients in the completely locked-in state (CLIS) to

give yes/no responses. Psychiatrist and neuroscientist

Soekadar has recently shown that brain-computer

interfaces can also be used in daily life. The system is

not yet able to read more complex thoughts, explains

Soekadar, but this could change soon: “Humans need

to be able to stop the machine at any time.”

www.uni-tuebingen.de

Photo: Surjo R. Soekadar/University of Tübingen

Cochlear implantation

Robot on Course for the Inner Ear

Photo: Artorg Centre, University of Bern

The world’s first robot-assisted cochlear

implantation was successful at Bern’s university

hospital Inselspital. The highprecision

surgical robots were developed

by surgeons and engineers at Inselspital

and the Artorg Centre for Biomedical Engineering

Research at the University of

Bern. To insert a cochlear implant into the

ear of a deaf patient, the surgeon has to

manually create an accurate access route

behind the earlobe, through the skull

bone, and into the inner ear; then the implant

electrode is introduced into the

cochlea. The goal was to examine

whether computer-assisted and robot-assisted

approaches

could lead to a better,

more reproducible

surgical result. In computed

tomography images

of the patient, a

tunnel is first defined

from behind the ear

into the cochlea: Its diameter

is 2.5 mm at

the entrance and

1.8 mm in the cochlea.

This trajectory is then

drilled by a robot,

which has to work with a precision of a

few tenths of a millimetre. Three safety

systems are interlinked: A camera system

measures the positions of the robot and

the patient and controls the robot’s movements.

A force measurement system compares

the drilling forces with the bone

thickness. A nerve stimulation system

transmits weak electrical pulses and

measures the feedback.

www.unibe.ch

EU project

How the Liver Changes

with Age

In the EU project Deliver, young scientists

are studying healthy ageing under the

microscope: They are developing novel,

minimally invasive optical procedures

that can be used to study the liver under a

high-resolution microscope. The aim is to

be able to explain how medications affect

the liver and how this organ changes as it

ages. In the long-term, the methods will

also be used to record the liver cells by

microscopy directly in the body.

The project is coordinated by Bielefeld

University. The junior researchers from

the fields of physics and biomedicine are

conducting research and working towards

a doctorate at six European partner universities

and firms in a total of nine countries.

Researchers at the Faculty of Physics

at Bielefeld University are developing

high-resolution microscopes that can be

used to view and study structures in body

cells that cannot be see with conventional

optical microscopes.

The European Commission is supporting

Deliver with roughly EUR 3.7 million.

www.uni-bielefeld.de/(en)/

24 medicine&technology 02/2017


Trade fair

Compamed/Medica 2017

Photo: Messe Düsseldorf

Industry meeting for

manufacturers and suppliers

Microsystems | Flexible Electronics | Technology in the OR | High-pressure Tubing | Cooperation

02/2017 medicine&technology 25


■ [ TRADE FAIR ]

PLATFORM FOR GREAT IDEAS AND

THE SMALLEST SOLUTIONS

Compamed / Medica | Since its start 25 years ago, Compamed has become the

number one industry platform for suppliers to the medical technology industry. Once

again, nearly 800 exhibitors will showcase their innovations in Düsseldorf. The suppliers‘

exhibition is held in parallel with the main trade fair Medica, which will host

roughly 5,000 exhibitors this year.

Compamed, the trade

fair for the medical

supplier industry, will

be opening its doors

from 13 to 16 November

in Düsseldorf – it

will also once again be

held in parallel to

Medica this year.

■ Microstructures in the 3D printer An important application field for

ment, which comprises mobile and barely

visible systems that can monitor and analyse

vital signs with great convenience

and under everyday conditions, to provide

medical professionals with data for

evaluation. Against this background, a

cuff-less measuring procedure for continuous

blood pressure monitoring is one

of the most important innovations at this

year’s Compamed. The sensors for this

technology were developed by scientists

The trend towards personalised medical

care, demographic development, parably large role, including at the Com-

Hans-Georg Ortlepp from CiS Research

Overall microtechnology plays a com-

in the team led by project director Dr.

and digitisation are important drivers for

advances in medical technology and the

healthcare sector. Almost two-thirds of

the microtechnology companies in Europe

provide products, technologies, or

services for medical technology and

healthcare; for nearly 20% of them this is

their most important sales market – with

an increasing tendency, according to the

forecast by the IVAM, the professional association

for microtechnology located in

Dortmund/Germany.

YOUR KEYWORDS

pamed 2017, the internationally leading

trade fair for the supplier market for

medical technology production. The trade

fair will take place from 13 to 16 November

at the Düsseldorf Exhibition Centre, at

the same time as the medical trade fair,

Medica. “In addition to the digital transformation

that no industry is able to ignore

nowadays, a key technological trend

is the miniaturisation of components to

create product applications that are increasingly

easy to handle and are lighter

in weight,” confirms Joachim Schäfer,

Managing Director of Messe Düsseldorf.

The product market “High-tech for Medical

Devices” with approximately 700 m2

and more than 50 companies and institutions

Institute for Micro Sensors, Erfurt, Germany,

who also created the sophisticated

analysis procedure. “The necessary raw

data are taken from the form of the pulse

wave and its behaviour over time. The

quality of the sensor signals and suitable

mathematical algorithms for data analysis

are essential for medically relevant applications,”

explains Ortlepp.

Active ingredients delivered




Trade fair duo in Düsseldorf

Trending topics of microsystem technology,

additive manufacturing, and digitisation

Personalised implants

(Hall 8a) will be set up, as it is every

year, by IVAM as a special exhibition platform

for microsystems for medical technology.

microtechnology is the wearables seg-

Photo: Messe Düsseldorf

directly under the skin

The Hahn-Schickard Society for Applied

Research is dedicated to the research, development,

and production of microsystem

technology. Together with the spinoff

company Verapido Medical GmbH, it

develops and produces devices, systems,

and technologies that can be used to administer

active ingredients without pain

and safely into instead of under the skin.

Cortec will be represented at Compamed

for the second time. This young

26 medicine&technology 02/2017


13.-16.11.2017

hall 8A, L01

Photo: Hahn-Schickard

The Dermaject injection

device

guides the injection

needle safely into

the upper layers of

skin.

medical technology company is working

on the next generation of active implants.

For example, it is developing and producing

implantable electrodes for conduction

and stimulation in the central and peripheral

nervous system. Cortec also manufactures

hermetic enclosures that support

high-channel applications. With 32 to

more than 200 channels, electrodes and

Two trade fairs –

one date

The exhibits at theCompamed (in

Halls 8a and 8b) will cover the following

key areas: components for medical

technology (such as electronics,

assemblies, tubes, filters, pumps, and

valves), materials/tools, microtechnology

and nanotechnology, contract

manufacturing, electronics manufacturing

services (EMS), complex manufacturing

and equipment partnerships

such as original equipment

manufacturers (OEM), packaging, and

services.

From 13 to 16 November and in combination

with the world’s largest

medical trade fair the Medica 2017,

Compamed focuses on the entire

value-added chain for medical technology

at one place and time: from individual

assemblies and measuring

processes for quality control to sterile

packaging of end products. This coordinated

combination of trade fairs

and themes is an important success

factor for the two events.

As in previous years, entry to the two

events is by ticket only.

www.compamed-tradefair.com

www.medica-tradefair.com

enclosures have considerably more leads

than comparable products. “With these

products we enable applications and therapies

that could not be addressed in this

way up to now,” explains CTO and CEO

Dr. Martin Schüttler.

Additive manufacturing for

products and bones

Another topic that has been growing in

importance at Compamed for years is additive

manufacturing. Fraunhofer Institute

IKTS has developed the “bone from

the printer.” This bone is designed for use

for facial disfigurement defects and for tumours

that have metastasised into bones.

IKTS’s ceramic replacement is made in

two steps: The ceramic shell is made in

the 3D printer; the filling—a ceramic

foam—is foamed in afterwards. Additive

manufacturing of the shell also allows

personalised adaptation to the skeletal

structure, and the porous foam filling can

be made to match the patient’s specific

porosity.

Also making progress in the field of 3D

printing is Multiphoton Optics. Multiphoton

Optics is the manufacturer of a

high-precision 3D printing platform (LithoProf3D)

and software (LithoSoft3D)

for additive and subtractive manufacturing

of irregularly shaped structures,

manufactured in the volume or on the surface

of materials. The technology supports

the manufacturing of 3D optical interconnects,

aspheric or free-form microoptics,

biomedical products such as scaffolds

for tissue engineering, microfluidic

cells, and drug delivery structures. Other

key areas at the Compamed this year include

microsystem technology, nanotechnologies,

production technology, and process

control.


Klaus Jopp

Freelance science journalist,

Hamburg/Germany

REALIZING DIGITAL

VISIONS. TOGETHER

We are convinced of the chances a

networked and dynamic world offers.

To design this world united and

reliably is our vocation.

We create digital solutions for the

needs of tomorrow, to enable the

people to focus on the essential.

medicine&technology

www.sie.at


■ [ TRADE FAIR ]

FOOT FOR FUNCTIONS,

VOICE FOR DEVICE SELECTION

Device control | At Medica, Steute Meditec will present a demonstrator for the interoperable

OR. The trade fair will also be the stage for the première of a new, modular

foot switch system.

Additional features

can be added to the

established device

control by foot

switch: A touchscreen

does not

need to be used to

determine which

function will be assigned

to which

control element.

Steute will discuss

the potential for

voice control at the

trade fair.

Photo: Steute

When surgeons control several medical

devices using a single operating

system, they become very familiar with

the particular user interface and can concentrate

better on the surgery. The Meditec

division of Steute Schaltgeräte GmbH

& Co. KG, Löhne/Germany, will showcase

a demonstrator at the Medica trade fair

that illustrates the interface between humans

and medical devices in an “interoperable

OR” and how this is now operated.

Surgeons select the functions which

they require for the respective device on a

YOUR KEYWORDS





Control of medical devices

New modular foot switches

Combination of foot switch and voice

control

Tests in research project

touchscreen. The individual commands

for controlling the selected device are

given using a standard foot switch. If surgeons

would like to change from an X-ray

machine to an ultrasound machine or

from the navigation to table adjustment,

intuitive operation of the touchscreen will

guide them through the steps, and the

central foot switch will assume the functions

that were newly assigned to it.

Special operating systems—

to be tested at trade fair

Surgeons can see the function to which

the pedal is currently set. However, the

pedal assignment can also be changed directly

on the foot switch. In this way the

operating systems become interoperable—which

can be seen live at the trade

fair.

In addition to this example, Steute

Meditec is involved in research projects to

study future control options, which

among other things could replace the

touchscreen. In the project “Optimal—multimodal

and adaptive design of

ideal user interfaces for the OR” from the

leading-edge cluster “Intelligent Technical

Systems – it’s OWL,” the focus is for

example, on whether and how the established

foot control can be enhanced to include

voice or gesture control. In this project,

the controller experts from Löhne/

Germany work alongside the Centre of

Excellence in Cognitive Interaction Technology

(Citec) at Bielefeld University,

which is conducting cutting-edge research

in robotics and mind-machine

communication.

Gesture and eye-movement control

have not been taken into further consideration

so far, on the assumption that gesture

control would have too great an effect

on the activity and eye-movement

control would impair the surgeon’s concentration.

In contrast, voice recognition

has proven to be realistic in the operating

environment and was tested along with a

28 medicine&technology 02/2017


New series of modular foot switches

A new series of foot switches, which will

be displayed at the Medica, features a

modular design and is ideal for use in the

interoperable OR for combination with

voice control. The manufacturers of

medical devices are flexible in the configuration

of the foot switch — the housing

of the MFS-MED GP712 foot switch

series can be equipped with various operating

elements. Available options are

pedals, buttons, rocker switches, and

joypads. The number of operating elements

can also vary from three to

six.

The flat shape of the housing and

the tactile feedback of the newly developed

rocker switch and joypad satisfy

the requirements for ergonomics and usability.

An optional bracket facilitates optimum

positioning of the switching system

using the foot.

The switches are very easy to clean

thanks to their hygienic design. Silicone

covers give the housing a protection rating

of IP X8 against ambient influences.

All functions can be designed with redundancy

to achieve high operational reliability.

The modular design with a uniform

housing and customised features

keeps the costs within limits, and time to

market is short in spite of high quality

and reliability.

Foot switches of the new modular series

MFS-MED GP712 have the option to

modify the switch between standard

and customer-specific designs.

Photo: Steute

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foot switch. Three operating concepts

were identified: The virtual medical devices

were controlled in the first case

through a universal foot switch, in the

second case through voice, and in the

third case through a multimodal system

using a combination of foot switch and

voice.

These concepts were tested by 60 subjects

in simulated spine surgery. The comprehensive

evaluation, which recorded

performance as well as cognitive stress of

the operators, produced the following

outcome: The best results and the highest

acceptance were achieved in task sharing

between foot and voice control.

The subjects mainly used the foot

switch to set the functions and issue commands,

i.e. for safety-relevant functions.

This was the previously the typical task

for foot switches in the OR, which was

once again determined again to be appropriate

and even optimum. As experience

increased, this tendency was confirmed

throughout the tests by a growing percentage

of the participants who used the control

in precisely this way.

The voice control was a practical

method to determine which device should

actually be operated by the foot switch. It

was able to fulfil the task which was previously

performed by the touchscreen.

From the perspective of usability and user

experience, many aspects are in favour of

the concept “foot for functions, voice for

device selection.” In the project, a clear

preference was seen for the design of innovative

operating interfaces in the OR,

which Steute Meditec will continue to

pursue in the future.


Julia Mönks

Steute Schaltgeräte, Löhne/Germany

www.steute.com/en.html

At Medica: Hall 11, Stand J3

COMPAMED

November 13-16, 2017

Visit us at Stand P02/ Hall 8b.

Riegler GmbH & Co. KG

Bahnhofstraße 80

64367 Mühltal • Germany

Phone +49 6151 919-0

info@riegler-medical.com

www.riegler-medical.com

A Wirthwein-Group Company

medicine&technology


■ [ TRADE FAIR ]

MEDICAL DEVICES,

AUTOMATIC INFEED

Packaging machines | Solutions for automated feeding and loading of medical devices

are designed to make the packaging process more efficient and increase process reliability.

Examples can be seen at Compamed.

With a length of approximately 3 m, R 081

can also be used in confined spaces for the

packaging of small quantities of medical

devices.

Photo:

Mu

lti

vac

The mobile and flexible T 260 tray sealer

can process a wide spectrum of trays.

Photo: Multivac

ultivac Sepp Haggenmüller SE &

Co. KG from Wolfertschwenden,

Germany shows how medical devices can

be fed automatically into the packaging

process. Among other things, their solution

includes a syringe conveyor system

that is used to feed pre-filled glass or

plastic syringes into the machine. Handling

modules and carrier systems ware

also on display in Düsseldorf. All of these

are intended to protect the product and

make the entire process on the packaging

line more efficient and more reliable.

When automation components are

used intelligently, there are also benefits

in hygiene and reliability, as is shown by

the example of a line for GMP-compliant

thermoformed packaging of medical devices.

Up to 300 glass or plastic syringes

can be fed into the packaging trays each

minute. The conveyor system consists of

an infeed conveyor, separating wheel,

trapezoidal belt, 3-axis robot, and the

H 242 handling module. All components

are synchronised with the packaging machine

and controlled from an operating

terminal.

One example is R 081, which can be

used to package sterile medical products

in smaller batch sizes or for test markets.

With a length of about 3 metres, it can

also be used in confined spaces. With a

maximum performance of 15 cycles per

minute, the machine processes rigid and

flexible films, Tyvek, and paper-based

packaging materials with an overall film

thickness of up to 400 micrometres (μm).

Options for vacuum and

modified atmosphere

The R 081 can be equipped with evacuation

and gassing equipment. This feature

allows the R 081 to be used for the manufacturing

of vacuum packages as well as

packages with a modified atmosphere

and reduced residual oxygen content.

Servo-driven lifting units provide a high

closing force and distribute sealing pressure

evenly.

Individually adjustable belts, carrier

systems, and infeed systems are available

for the alignment, separation, and infeed

of medical devices. For example, vibration

dampers and centrifuges can be used to

separate needles and plungers prepared

as bulk goods and transfer them to the

packaging machine in one or more rows.

Syringes, bags, ampoules, and vials are

fed to the machine by separating units

and transport conveyors which are modified

specifically for the product. A robot

can take the accurately positioned products

and place them in the packaging

trays.

Handling modules with various kinematics

and gripper systems unload the

packaged products and transfer them to

the downstream process steps. Coordinated

grippers minimise the fault rate and

ensure high packaging quality. All components

are GMP compliant with regard to

design and properties and can be integrated

into the machine’s control unit ■

Vera Sebastian

Journalist in Munich/Germany

At the Compamed trade fair: Hall 8a,

Stand H01, www.multivac.com

30 medicine&technology 02/2017


Brilliant performance | ENGEL medical

ENGEL medical

Fully-electric machines impress with great performance. The ENGEL e-motion

medical series combines best-of-class performance with maximum cleanliness.

Optimised for clean room applications, the machine has an encapsulated barrel to

minimize particle and heat load, along with encapsulated injection unit drives and

an oil return unit on the toggle lever as standard features. The ENGEL e-motion

medical is available as a continuous series with up to 500 tonnes clamping force.

Clean and precise. With ENGEL medical. Because it is about life.

www.engelglobal.com

02/2017 medicine&tec hn ology 31


■ [ TRADE FAIR ]

CIRCUIT ON SOFT SUBSTRATE

Flexible electronics | Hybrid inks can be used to print circuits that can perform their

job immediately after drying – without sintering. This development also steers the

ideas for applications in unusual directions. You can discuss the possibilities that this

product offers for medical devices at the medicine&technology stand at the Compamed.

YOUR KEYWORDS





Flexible electronics

Hybrid inks

Nanomaterials and polymers

Applying to paper, textiles,

or human tissue

cuits on a wide range of carrier materials.

However, for this to work, the conductive

ingredients in the inks still need to be

coated with polymers. The polymers

allow the liquid, and therefore the printable

inks to retain their intended shape on

the carrier material.

Biegsam sind die mit Hilfe von Hybrid-Tinten aufgebrachten leitfähigen Strukturen – gleich

nach dem Aufdrucken und Trocknen. Die Polymere in der Mischung sind so gestaltet, dass

ein Sintern nicht erforderlich ist

Please hold your hand in there for a

second,” says the supervisor to the

employee who will soon be responsible

for a machine tool and will be giving control

commands to the associated robot.

“In there” in this case is an opening in a

small housing that contains a very special

printer. The printer does not print on

paper or on film. Instead its carrier material

is “human skin.” The printer is not

made to apply an artistic design or an optically

readable access code which grants

machine operators access to the machine

control – actually, the printer applies a circuit

to the skin, which enables direct interaction

with the control.

Bild: INM

One has to admit that technology has

not come quite this far yet. However, the

scenario described above is one of the visions

that could become reality with recently

developed solutions. These solutions

can also be starting points for

medical technology.

One of the people who works out the

technical details for such ideas together

with his associates is Prof. Tobias Kraus

from the Leibniz Institute for New Materials

in Saarbrücken/Germany. After talking

with him it soon becomes clear that

many of the components are already a

part of everyday life. For instance,

printers already exist that can print cir-

New potential applications

possible without sintering

“To obtain a conductive circuit, these

sheath materials normally have to be

treated by sintering,” says Kraus. With

temperature-sensitive carrier materials,

such as paper and polymer films this task

becomes difficult, as these materials

would be damaged during sintering – a

process stage to which you could not expose

the back of your hand.

In Kraus’s laboratory inks are being developed

that can be applied without

spreading and which produce a conductive

circuit without sintering. “Our new

hybrid inks are conductive immediately

after drying, are mechanically very flexible,

and do not need to be sintered,” as

Kraus summarises the results of his research.

In one way, the hybrid inks can be

seen as a link between the classic rigid

electronics and the various forms of flexible

electronics, an area that is being

heavily researched at present.

The developers combine polymers and

metallic nanoparticles in the inks: Gold or

32 medicine&technology 02/2017


silver nanoparticles are coated with organic,

conductive polymers and then suspended

in mixtures of water and alcohol.

The organic compounds serve as ligands

ensuring that the nanoparticles remain

suspended in the liquid ink; agglomeration

of particles would cause problems

during printing. The second function of

the organic ligands is to have a positive influence

the arrangement of the nanoparticles

on drying. The third task is the

“hinge function.” When the printed material

is bent, the electric conductivity remains

intact.

Hybrid inks at Compamed

Scientists from INM who will be guests at

the medicine&technology stand at Compamed

will be talking about the possibilities

that hybrid inks offer.

See for yourself whether the special mixtures

meet the expectations. A test with

your own hand provides one example.

Writing, images, or conventional circuits:

What you draw on a piece of paper conducts

electricity just after the ink dries –

as the luminous evidence shows.

The experts would be glad to discuss

other ideas that could result from this

technology with you. For instance, conductive

hybrid inks could also be combined

with biofunctionalised gels. At

INM research is being conducted in this

direction with the aim of being able to repair

damaged nerve tissue at some point

in the future. The experts from INM and

the medicine&technology team look forward

to seeing you in

Hall 8a at Stand J41.

The circuit – a stroke of the pen, if the

writing utensil has been filled with the

“right” ink. The researchers from INM

will describe where printers can go from

here in an industrial environment.

Photo: INM

Resolutions in the range of

10 μm can be achieved

“In a layer of metal particles without the

polymer sheath, the electrical conductivity

would be quickly lost on bending,”

continues Kraus. Combining the two materials

makes the electrical conductivity

on bending much higher overall than with

a layer that is made purely of conductive

polymer or a layer made purely of sintered

metal nanoparticles. Depending on

which printing technique is used, hybrid

inks can achieve resolutions in the range

of 10 μm.

Their properties make the technology

an exciting development for applications

in medical technology. Polythiophenes

can be used as polymers and are generally

recognised as safe, for example by the

FDA. A good deal is known about the

metal particles themselves, and researchers

are attentively following the

discussion on nanosafety. Relevant results

could be factored into the selection of materials.

“Overall, a risk assessment could

very easily be made on this topic,” says

Kraus.

Since the circuits on films are not rigid,

but soft and even elastic, they can perform

the required functions on elastic textiles,

on skin, or in tissue – for which sintering

cannot be used. Unlike organic

electronics, hybrid inks are not sensitive

to sunlight either.

They could be used to monitor vital

signs, and the design of the “tattoos with

function” could even be personalised. The

same applies to wearables, such as stretch

sensors that could provide data to help

optimise the wearer’s sitting posture for

example. Conclusions about a person’s

emotional state could also be drawn from

the skin’s conductivity. Admittedly, such

developments would rather be “lifestyle

applications,” says Kraus.

Use in the body has only been

discussed up to now

The use of such technology in the body is

also being discussed, even though the

idea is still in its infancy. “Basically the

technology is compatible with physiological

fluids, and the printed circuits are

stable,” says Kraus. To protect them from

being dissolved by electrolytes in the

body, the circuits may have to be encapsulated.

The results of tests on applications

over an extended period of time are not

yet available. “And when we talk about direct

contact with living beings, it seems

obvious that chemically inert gold nanoparticles

should be used.” The application

areas for the silver particles that are also

basically suitable for creating circuits

would be more in the industrial environment.

There has already been interest from

the medical technology industry for using

hybrid inks on textiles and paper. The

samples that the researchers create are

still expensive. However, the gold nanoparticles

are used in such small quantities

that they do not drive up the costs. The

production technology to manufacture

the ink in larger quantities is not yet available

– but Kraus says, “a research application

for this purpose has already been

written.”


Dr. Birgit Oppermann

birgit.oppermann@konradin.de

Additional information

About INM:

www.leibniz-inm.de/en/

02/2017 medicine&technology 33


■ [ TRADE FAIR ]

Cooperation for

Wound Care

Microfluidics | At the Compamed, Fraunhofer ENAS and

Biflow Systems will be presenting the Midardi project,

in which a rapid test for detecting of wound pathogens

and antibiotic resistance has been developed.

Microfluidic cartridges for automated and miniaturised fluid handling

with integrated micro-pumps and heating elements

Photo: Biflow Systems

Europe and India find themselves confronted with a steady increase

in type-2 diabetes. In addition to the actual symptoms of

the disease, many associated diseases may occur, including, for

example, diabetic foot ulcers (DFU). In the case of DFU, damage

to nerve cells results in an impaired perception of pain and,

therefore, an increased incidence of ulcers and poor healing of

foot wounds. These wounds are usually quickly colonised by bacteria.

The severe infection complicates wound healing even

further. For the successful treatment of these wounds, rapid determination

of the pathogens in the wound and of any resistance

to antibiotics is essential.

In the Midardi project, which is supported by BMBF and IGSTC

(Indo-German Science & Technology Centre), experts from Germany

and India are working on the development of a new diagnostic

tool for rapid point-of-care testing over the duration of the

project, which will end on 30 November 2018. Unlike the established

microbiological determination of pathogens and resistance

using cell cultures, molecular diagnostics can produce the

diagnostic result significantly faster (< 1 hour). These procedures

need to be automated and miniaturised before they can be applied

to the complex molecular biology methods for point-ofcare

testing.

The Fraunhofer Institute for Electronic Nano Systems ENAS, located

in Chemnitz, Germany, has spent many years researching

microfluidic systems that can model macroscopic laboratory

procedures in small integrated systems. These systems can now

simplify the currently labour-intensive diagnostic procedures in

a way that allows less qualified people to perform the tests. In cooperation

with experts in the field of biochemistry (Fraunhofer

IZI-BB in Potsdam-Golm, Germany and the Manipal University in

Manipal, India) and medical device developers (Biflow Systems

GmbH in Chemnitz and Achira Labs, Ltd. in Bangalore) as well as

physicians at the Manipal University Hospital, a robust diagnostic

device is being developed for everyday clinical use.

www.enas.fraunhofer.de/en.html

At Compamed: Hall 8a, Stand H23

Smart textiles

Intelligent Sensors from the Knitting Machine

MDR

TÜV Süd Provides Information

on New Requirements

Photo: Texible

Specially developed machine enhancements

facilitate the processing of

wires with a diameter of 0.08 mm and

materials such as fibre glass, copper,

and steel using conventional knitting

machines.

The term smart textiles is associated

with normal items of clothing that

take on an additional function with

the aid of integrated electronics—such

as T-shirts that monitor

vital signs such as pulse and respiration

rate. To advance further innovations

in this area, textile companies

from Vorarlberg/Austria partnered

with the University of Innsbruck

in the spring of 2016 to establish

Texible, a start-up company located

in Hohenems. Texible develops

customised technical textile products

for its customers and sells its own

products. Specially developed machine

enhancements facilitate the

processing of wires with a diameter

of 0.08 mm and materials such as

fibre glass, copper, and steel using

conventional knitting machines. The

company received the Vorarlberg Innovation

Award 2016 for the development

of an incontinence bed pad.

www.texible.at

At Medica: Hall 7, Stand B07

The new Medical Device Regulation

(MDR) of the European Union expands

the authority of notified bodies with regard

to the assessment of clinical evidence

after products have been placed on

the market. This includes unannounced

audits, random sampling, and product

tests.

At the Medica, TÜV Süd Product Service

will provide information on how the

Medical Device Regulation (MDR) affects

medical device manufacturers. Other key

areas at the TÜV Süd stand are the new In

Vitro Diagnostic Regulation (IVDR) and

the Medical Device Single Audit Program

(MDSAP). Experts from numerous countries

will also explain to medical device

manufacturers which requirements must

be met for access to worldwide markets.

www.tuev-sued.de

At Medica: Hall 10, Stand C12

34 medicine&technology 02/2017


Clean-room injection moulding

Closer to μ than ever

Sterilisation

Scada Software for Process Control

and Monitoring in EO Sterilisation

At the new technology center (TC) of

Spang & Brands, Friedrichsdorf, all new

customer projects from the medical device,

pharmaceutical and dental technology

sectors enter the process chain – from

design and product feasibility right

through to pilot series. The CAD/CAM

product data are not transferred to the

manufacturing plant for production of a

given medical device in multi-million

batches until the quality assessment department

has given its approval. Specialised

in precision and clean-room injection

moulding, Spang & Brands will exhibit

more than 100 different medical products,

including component groups, precision

and micro products manufactured in

mono or multi-component injection

moulding technology.

www.spang-brands.de

At Compamed: Hall 10, Booth E35

With the Sysreg Scada software, developed

and presented by Sterisys Sàrl/Luxembourg,

companies can easily monitor,

visualise and control their entire EO sterilisation

process via a centralised HMI system.

The complete sterilisation unit, including

the gas treatment system, external

preconditioning and degassing cells

are connected and controlled through a

single interface. Sysreg complies with all

of the relevant standards and guidelines

and is designed to improve the efficiency,

security, productivity, and reliability of

sterilisation processes. During the sterilisation

cycle, the system automatically collects

all specified process data, while systematically

generating logs and precise

protocols. The process control software,

developed in accordance with GAMP 5

and FDA 21 CFR Part 11 guidelines, is

based on a standard WinCC client-server

architecture, which can be adapted to the

Pho

to:

St

eri

sys

s

specific equipment configuration and

requirements of the customer. It offers a

paperless workflow, real-time logging and

protocols, as well as a product/batch release

process based on electronic signature.

The intuitive software enables

straightforward parameterisation of sterilisation

cycles, while maintaining accurate

product/batch traceability records.

www.sterisys.eu

At Medica: Hall 17, Booth C41

International exhibition for the supply and

manufacturing sector of medical technology

11 – 12.4.2018

Nuremberg | Germany

New:

in April!

Inside Medical

Technology

Together with

The new highlight on the medical technology industry’s calendar is MT-CONNECT.

Reap the benefits of a concept that brings together suppliers and manufacturers

and focusses on professional knowledge-sharing. In association with the international

MedTech Summit – Congress and Partnering, MT-CONNECT provides

the ideal networking platform for the industry. Showcase your company at

an event that attracts interested experts from all areas of medical technology.

Welcome Inside!

Honorary sponsor

mt-connect.de/become-exhibitor

medicine&technology


■ [ TRADE FAIR ]

UNDER HIGH PRESSURE

Medical tubing | Disorders of the cardiovascular system are some of the most common

diseases of civilisation. They are usually caused by deposits in the arteries. With

the aid of angiography as a diagnostic procedure constricted or blocked blood vessels

can be detected at an early stage.

High-pressure medical tubing plays its

important role in the diagnosis of

cardiovascular diseases. The tubing transports

the contrast medium into the patient’s

blood vessels under extremely high

pressure. In an angiogram, pathological

changes such as circulatory disorders and

vascular occlusions can be reliably diagnosed.

For optimum imaging, high-pressure

medical tubing has to withstand the

powerful injection of the contrast medium,

while being highly flexible and kinkresistant.

Medical device manufacturer

Raumedic unites these contradictory

requirements. In the extrusion process,

Raumedic, located in Germany’s Upper

YOUR KEYWORDS





High-pressure medical tubing

Use in angiography

Made in extrusion process

Tubing available as monofilament-reinforced

or co-extruded variants

Franconia region, has manufactured reinforced

and co-extruded high-pressure

medical tubing for several decades.

“The tricky part in developing tubing

for high-pressure injections is to ensure

high pressure resistance and flexibility at

the same time,” explains Jürgen Bloss,

Head of Project Management in the Tubing

Division at Raumedic. “Our tubing

withstands extremely high internal pressure;

yet it is so flexible that it can easily

compensate for external influences.”

These features make handling and testing

easier for medical professionals later,

Bloss goes on to explain.

The best properties of two plastics are

combined with one another in the reinforced

tubing in the truest sense of the

word: A monofilament, made of polyester

for example, is embedded in a tube made

of transparent polyurethane, which

makes the final product extremely resistant

to pressure, flexible, and kink-resistant.

Raumedic customers can specify the

colour of the monofilament used for reinforcement

and the braid density. This customisation

allows users to distinguish visually

between different uses, and users

can also select the level of transparency of

the tubing. This is a decisive factor for the

later detection of air bubbles can be detected

later and observation of the

contrast agent. Raumedic produces

monofilament-reinforced, high-pressure

tubing in Helmbrechts, Germany in three

market-standard dimensions as well as according

to customers‘ specifications.

Monofilament-reinforced for

the highest demands

“At our company, exceptions can also be

made at any time,” states Jürgen Bloss

and explains: “Our application engineers

know what effects an individual product

specification have on the pressure resistance

and flexibility of the tubing. They

can therefore, offer specific advice so that

the final result is a customer-specific

product that has the desired requirements.”

With regard to packaging, Raumedic is

also customer-oriented. As standard, Raumedic

delivers its reinforced high-pressure

tubing on spools, which simplifies

handling in the logistic process. In further

processing, the customer can then cut the

tubing individually to the desired length,

which results in significantly less waste.

Of course, Raumedic can also provide tubing

with fixed lengths.

36 medicine&technology 02/2017


Photo: Raumedic

For use in medical technology, high-pressure

tubing must offer high flexibility, resistance

to pressure, and kink resistance. The

structure of the reinforced (left) and co-extruded

(right) tubing variants can be easily

seen in the cross-section.

In addition to the monofilament-reinforced

version, the polymer processor has

also developed high-pressure tubing that

is manufactured by the co-extrusion process.

Instead of monofilament braided reinforcement,

an inner polyamide layer assumes

the function of absorbing pressure,

while the outer layer is still made of

thermoplastic polyurethane. In this more

cost-efficient multi-layer variant, the two

polymer layers are co-extruded in a single

manufacturing process. Thanks to the reinforcement-free

design, the material has

exceptionally good transparency, making

it ideal for measuring flow rate and for air

bubble detection.

Raumedic tests the physical behaviour

under extreme pressure and the biological-toxicological

properties of the two

tubing variants according to internationally

valid standards. Pressure testing according

to the European DIN EN ISO 1402

and the American ASTM D1599 verifies

that the tubing withstands an internal

pressure of at least 83 bar (> 1,200 psi).

In addition, the polymer specialist performs

regular cytotoxicity, haemoloysis,

and endotoxin tests. “As an OEM supplier

for the medical technology industry, we

also produce our high-pressure tubing in

an ISO class 7 cleanroom,” as the project

manager highlights the manufacturing

conditions in the company.

Adhesive joint necessary for

better adhesive bond

The further processing of high-pressure

tubing is also very simple for the medical

device manufacturer. Different connectors

can be adhered using all suitable solvents

and reactive adhesives or injected

directly on the tubing in the injection

moulding process, which Raumedic can

also carry out thanks to its expertise in injection

moulding and assembly.

Jürgen Bloss offers a special tip for

manufacturing: “If the connectors are

adhered to the interface of the tubing, a

adhesive joint must be present in every

case for an optimum adhesive bond.” Also

the reinforcement on the front end has to

be protected against direct pressure. This

can be ensured through the design of the

connector, or by applying UV adhesive

over the entire cut surface to prevent expansion

during later pressure and leak

tests.


Markus Stier

Raumedic, Helmbrechts/Germany

www.raumedic.com

At Compamed: Hall 8a, Stand F28

02/2017 medicine&technology 37


■ [ TRADE FAIR ]

Danish Suppliers

as Industry Partners

Components | Danish suppliers provide the medical device

industry with the latest component technology.

Companies will showcase their most recent innovations

at the Compamed.

The global medical device industry outsources more and more

important know-how and product development functions to suppliers.

To meet this demand, Danish suppliers of the medical device

industry will present their latest production and component

technology at the Compamed 2017.

“The global device industry is currently going through a transition.

Cost reduction and outsourcing are on the agenda, and constant

new developments are a necessity for survival,” says Thomas

Andersen, Director of the Danish Health Tech Group, which

organises the Danish pavilion at the trade fair. In his opinion, this

transition has been going on in Denmark for many years already

and has produced many highly competent, specialised suppliers

and component suppliers for the medical device industry.

The Danish Health Tech Group is a member of the Danish Export

Association and is a network of Danish suppliers of production

The Danish Health Tech Group unites 33 Danish suppliers of products

and solutions for the international medical technology and

pharmaceutical industry.

technology and solutions for medical technology, the pharmaceutical

industry, and the hospital sector. One of the companies

that will have an exhibit at the Danish pavilion is Knudsen Plast

A/S, which specialises in plastic injection moulding solutions for

the healthcare sector. According to Frederic Bernard, Director of

Business Development at Knudsen Plast, medical device companies

are increasingly outsourcing injection moulding processes

and the manufacture of injection moulding tools, process

development, and testing, and they are, therefore looking for the

necessary skills and expertise among their suppliers. “The testing

and product introduction centre in Denmark allows medical

device companies to fully test and document the production line

for their products before production starts in Denmark or in our

Slovakian factory,” says Bernard.

www.dk-export.com

At Compamed: Hall 8a, Stand R11

Photo: Knudsen Plast

Switching technology

Hand and Foot Switches for Applications in Medical Technology

Medical cables

Biocompatible

and UL Approved

Where foot and hand switch solutions for

industry and medical technology are concerned,

the range of products from Herga

Technology Limited in Suffolk, UK stands

is at the focus. The switches are universally

available not only with electrical contacts,

but also as pneumatic switches (potential-free),

with infra-red technology

(wireless), and with USB or Bluetooth interfaces.

In addition to the application-specific

switching technology,

the ergonomic design

is also appealing to users. The

design must also be suitable for

a variety of types and classes

with different colours, labels,

cable lengths, and connection

types.

Examples are the hand control

switches of the 6310 series,

which can be supplied as a standard

or heavy-duty version and

which can perform up to eight

switching functions with switching

capacities of 24 V/1 A or

250 V/10 A. Instead of with electrical

contacts, the switches of the 6310 series

are also available as an infra-red version

with up to eight channels. Versions with a

USB connection can be programmed for

up to three functions. For applications in

the healthcare sector, highly stylish

switches are popular, such as for devices

for positioning patients or for mobilisation.

As hand switches, they fulfil the

relevant Directive of the European

Commission

(2014/35/EU) and achieve

a protection rating of up to

IPX8.

Photo: Herga

www.herga.com

At Compamed:

Hall 8a, Stand M31

The hand switches are available

with electrical, pneumatic,

infra-red, USB, and

Bluetooth technology.

Cable specialist SAB Bröckskes GmbH &

Co. KG, in Viersen/Germany, is launching

a whole family of new cable materials for

medical devices. The biocompatible material

series SABmed S, which will be

presented at the trade fair by SAB Bröckskes

includes the basic variant with high

notch and tear propagation resistance as

well as a material for ultra-flexible and

smooth lines, a variant with UL-approval,

and a non-blooming variant. In addition

to flexibility and safe cleaning options (by

wipe disinfection or autoclaving), properties

such as reliability due to long servicelife,

low weight, and a low-adhesion, nonsticking

cable surface are often required

in use. In special application areas, approval

in compliance with the American standards

is also requested. The new family is

also designed to prevent the typical torsional

effect (kinking) from occurring

when the line is wound on devices by

hand.

www.sab-cable.com

At Compamed: Hall 8b, Booth H17

38 medicine&technology 02/2017


MEDICAL

TECHNOLOGY

07. - 08.02.2018, Paris, France

From syringes to implants - what counts in medical technology is quality, precision and

absolute cleanliness. To ensure that you are well supported, a team of specialists from



our company’s own facilities.

www.arburg.com

02/2017 medicine&tec hn ology 39


■ [ TRADE FAIR ]

MORE MOVEMENT

IN VIRTUAL ENVIRONMENT

Virtual reality | In the joint project New Reality of the MedTech-Cluster of the business

agency Business Upper Austria, a new method was developed to increase mobility

among elderly and sick people: When exercising on the ergometer, patients immerse

themselves into a virtual world using VR glasses that are coupled to a device.

Virtual reality (VR) is a phenomenon

that puts people of all ages under its

spell. It gives you the feeling of being in

the midst of things that are happening virtually.

You become a witness to a situation

that surrounds you by 360 degrees and

that seems real. From this starting point,

the idea was developed to use virtual reality

technology to motivate older people to

engage in more physical activity. In addition

to solving technical challenges during

development, the makers also had to

clarify whether this new technology can

help to maintain mobility with age, and

whether it will be accepted among older

people.

Using virtual reality, the joint project

of the MedTech-Cluster (MTC) of Upper

Austria, the Office of Social and Regional

Planning, Netural GmbH, in Linz/Austria,

and the Forte continuing education centre

at Elisabethinen Linz GmbH & Co. KG

aims to increase mobility for the generation

50+. For this goal, the project managers

successfully linked training on an

ergonomic exercise machine to VR technology.

While exercising on the ergometer, the

users wear VR glasses and find themselves

in the middle of a virtual training route.

The speed of travel which they perceive

depends on their pace on the ergometer.

The ergometer’s step resistance is determined

by the degree of inclination on the

respective sections of the route. The “New

YOUR KEYWORDS





Project using virtual reality technology

Digitalisation

Mobility training using VR glasses

Cross-industry cooperation in the cluster

One of the subjects testing the new ergometer training with VR glasses.

Reality” training method includes software

as well as hardware components.

The project team developed its own prototype

for a virtual reality app, which has

two predefined virtual training routes,

one in a snowy landscape and another in a

coastal setting. The app also obtains information

from the ergometer about the

current pace, the calories burned, and the

distance covered.

Significant increase in

motivation with virtual reality

The prototypes of the new training

method were tested by 43 subjects from

three age groups—0 to 29 years, 30 to 49

years, and 50 plus—under supervision in

the Elisabethinen further education

centre. At that time, nearly three-quarters

of the participants had no experience

Photo: Netural

with virtual reality systems. Afterwards

approximately 80% of the subjects rated

the method with the highest marks and

reported that the new training method,

the combination of virtual reality and ergometer,

motivated them to exercise.

When asked whether they would use the

new training more often if offered, about

75% of the subjects answered “yes.” From

the age group of 50 plus, as many as

78.3% gave an affirmative answer. Everyone

from this age group would also recommend

the training to someone else.

The challenges in the development of

VR applications not only consist in the design

of the mechanics, but also health

topics that need to be considered. In the

“New Reality” project, kinetosis, better

known as motion or travel sickness, also

played a role, for example. Affected per-

40 medicine&technology 02/2017


sons had to cope with physical responses

such as dizziness and nausea, which can

be caused by unfamiliar movements, such

as when travelling in a car, by train, etc.,

and by using VR glasses. The development

team therefore removed tight bends

from the route and equipped the virtual

track with a visible trajectory.

Using results from the project

for further developments

The people who are training can concentrate

on this line and give their eyes a

“fixed point.” Contradictory stimuli are

reduced or avoided altogether, where the

brain visually perceives one movement,

but not the inner ear, which is responsible

or registering physical movement.

Most importantly the involved parties—the

Office of Social and Regional

Planning, Netural GmbH, and the Elisabethinen

continuing education centre –

want to use the medical results and aspects

from the “New Reality” project for

further developments in the future. They

plan to expand the training method to patients

with various disorders – specifically

patients suffering from dementia and

obese children and adolescents. (su)■

Cluster activities

The MedTech-Cluster of Upper Austria of the business

agency Business Upper Austria in Linz is the central interface

between economy, science, and medicine. The aim is to

bring together the roughly 230 partners in the area of

medical technology and initiate joint projects. Since its

founding in 2002, the cluster has successfully implemented

84 ideas into projects. Starting from the central topic of

medical technology, the cluster focuses its activities on

three key areas:

- MedTech.Transfer with the initiative MedTech.Transfer

- MedTech.IT with the initiative Digital MedTech

- MedTech.Newcomers with support of start-ups and existing

companies starting in and transitioning to medical

technology, with a focus on rules and regulations.

www.medizintechnik-cluster.at/en/

At Medica: Hall 17, Stand D20

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needs: KOCH medplus

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more. That is KOCH medplus. The

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ceu tical products. Including added

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and inspection in compliance with

UDI. Plus the modular portfolio of

KOCH Support + Services and the

K 4.0 range of digital services.

Everything it takes to reliably meet

your exacting needs.

November 13–16, 2017

Hall 8B

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Member of the Uhlmann medicine&technology

Group


■ [ TRADE FAIR ]

RELIABLE IMAGE TRANSMISSION

IN THE OR

Video management | In modern operating rooms, the requirements for the quality

and transmission of image and audio data and on the interactive combination of

video sources and display devices are increasing. Video over IP is increasingly being

used to meet the necessary specifications.

A video-over-IP solution

has been designed

to be able to

transmit video data

using the same

standardised network

technology inside

and outside of

the OR. The solution

can be incorporated

into the Caliop control

software for

integrated ORs.

the system can be used to operate a computer

in a data processing centre located

further away directly from the OR.

Video over IP is a transmission medium

that enables data transmission

within the OR and outside of the OR using

the same standardised network technology.

Also, the systems can easily be expanded

and scaled up as a modular design.

“For equipment in ORs, increasingly

flexible video routing systems are being

requested that make any image available

at any time and anywhere,” says Matthias

Lubkowitz, Vice President OR Solutions at

Eizo GmbH, the experts in video management

systems from Karlsruhe and Plauen/

Germany.

YOUR KEYWORDS






Photo: Eizo

Image management in the OR

Video-over-IP data transmission

Integration in control software

Full-HD resolution and full colour space

Networking of buildings also possible

Closed networks were once the standard

for image transmission within the

operating room, for example an endoscopic

camera on a monitor. Now thanks

to video over IP it is also possible to use

the same network technology for transmissions

within and outside of the OR:

“The video-over-IP technology now allows

for high transmission rates of 10 GB/s

and, therefore, uncompromised transmission

of videos,” so Lubkowitz. “This

makes this technology of interest for the

medical sector since it preserves quality

and can still bridge large distances.”

It is also about standardised data transmission

using a defined transmission

medium, which simplifies the infrastructure

in the OR considerably and increases

flexibility. The Internet Protocol (IP) is

packet-based and has the fundamental

advantage that the same network cable

can be used for the transmission of all information

– regardless of whether it is

image, audio, video, or control data for

the keyboard and mouse. For example,

Latency-free transmission in

best possible image quality

Eizo has designed its own transmission

system for ORs in order to be able to use

the advantages of this technology and

transmit data of exceptionally high

quality without losses. Unlike existing

video-over-IP solutions, the core functionality

of Curator Alipe is contained in a

hardware component that acts as both an

encoder and a decoder, depending on the

parameterisation, and can also be subsequently

integrated into Eizo’s Caliop software.

This solution reduces variants and

saves costs – for example, through greater

flexibility in planning and less storage

and maintenance work.

It is operated on Caliop through the

existing vm module, which manages the

available video sources. “All image and

video sources connected to Eizo media

technology are displayed in the module,”

says Lubkowitz. “A video source can be selected

by amouse click or by touch and assigned

to one or more monitors as

required. An existing connection is displayed

visually.” The transmission can be

recorded on a recorder via Caliop as

necessary. Optionally, Caliop can also

save the recordings in the patient records.

For this exchange, the control software

42 medicine&technology 02/2017


Photo: Eizo

The video-over-IP hardware component Curator

Alipe can be used as an encoder and a

decoder, depending on the software

parameterisation.

has special connectors that can communicate

via all common transmission standards

such as DICOM and HL7.

Transmitting image signals to

the recipient in real-time

The new video-over-IP solution is now expanding

these possibilities: “For example,

if an IP-compatible lamp camera is available,

it can be connected directly to the

Eizo system without additional components.

With conventional image sources,

an encoder converts

their image signals

into data packets

and then sends them to

the intended recipient in

real-time,” explains Lubkowitz.

“The receiving decoder converts them

back into images.” If one of the packets

gets lost in the process, it can be identified

by special algorithms and may be sent

again.

The data are transmitted over fibreglass

cables, with transmission lengths of

up to 10 km. In this way not only rooms,

but also buildings can be linked together.

DVI and HDMI 1.4 interfaces are supported.

Unlike conventional systems on

the market, the Eizo solution works without

using data compression, enabling

loss-free and latency-free transmission

with full retention of the colour space.

Videos with an image frequency of

60 Hz can be transmitted in full-HD resolution.

With 4K, currently 30 Hz can be

achieved, and a 60-Hz solution is in prog-

ress. “Usually only full-HD or 4K is discussed

in connection with the display

quality of image data. Ultimately, these

terms do not provide any precise information

on the quality of the images,

however. With our solution, we want

to ensure that the image and audio data

are transmitted with a quality that is

above the market standard,” says Lubkowitz.

(su)■

Additional information

Eizo’s range of products and services

include colour and greyscale monitors

with a resolution of up to 8 MP

as well as intelligent device and

video management systems including

integration, service, and maintenance,

individually tailored to the

requirements of each operating

room.

www.eizo-or.com

At Medica: Hall 10, Stand H41

www.kraussmaffei.com/px

Machines of the PX series can be

used flexibly in clean production

envi

ronments and are optimally suited

for your cleanroom applications.

Your advantages:

– Encapsulated, emission-free drive

units

– Lubricant-

free product area

– Qualification/validation

capability

The all-electric PX series

Flexibility meets cleanliness

Engineering Passion

medicine&technology


FEATURE

Brain calling Computer

Brain-computer interfaces | The merging of humans and machines has been material for

Hollywood films for ages. In fact, the development of brain-computer interfaces is now

close to hitting the market. The products could make daily life easier for paraplegic patients,

for example. With this technology, the boundaries between medical device and

smart consumer electronics become fluid.

44 medicine&technology 02/2017


Photo: Tiko/Fotolia

A stylish headset

coming soon?

Tim Schröder

Last year when an audience of men and Science journalist

women cheered in front of the computers

in the Swiss Arena in Kloten/Switzerland,

nothing seemed special at first

glance. A computer game was running on

the monitors whose images were projected

onto the video walls in the hall. An

avatar runs through an obstacle course,

jumping over deadly spikes and deep pits.

Yet the audience is enthralled. The computer

gamers may be sitting rigidly in

front of the devices, but they are working

at high mental capacity. Their discipline:

“virtual racing under brain-control.”

The gamers sit in wheelchairs, none of

them can walk, but they are making their

avatars run. The gamers do not use a

mouse or type on a keyboard. Instead they

are wearing caps with electrodes, electrodes

that measure their brainwaves and

send the signals to the computer as patterns

of brain activity, as an electroencephalogram

(EEG). The computer processes

the EEG and uses the information to determine

where the gamers want to move

YOUR KEYWORDS

■ Using EEG data

■ Rehabilitation, braces, replacement of

functions

■ Current state of research

■ First products for the consumer market

■ Design alternatives to caps

The signals from the brain are so

complex that we are still a long

way from being able to read

thoughts. However, some information

can already be read, interpreted,

and used in combination

with medical devices.

It is astounding that so many

companies are already working

on EEG sensors for consumers.

their avatars. The gamer who is best able

to concentrate and train the computer to

read his/her brainwaves wins the competition.

“Virtual racing under brain-control” is

one of several disciplines that can be practised

at the “Cybathlon” in Kloten. Other

opponents compete in the “arm prosthesis

race” or in the “functional electrical

stimulation bike race.” The Cybathlon is

one of the first international competitions

worldwide in which technical equipment

can be tested in a playful way for people

with physical disabilities. The event is organised

by ETH Zurich.

Futuristic enough,

even for the film industry

Brain-controlled systems are undoubtedly

futuristic. They show just how far technology

has developed in the last 20 years.

This technology is usually referred to as

brain-computer interface (BCI) or brainmachine

interface (BMI). These terms describe

a plethora of technical approaches

that have one thing in common: Human

neural signals are sent to a computer by a

cable, making it possible for humans and

machines to interact.

This technology has been giving the

Hollywood film industry material for new

blockbusters for decades: Electrodes are

implanted in human brains to give people

superhuman abilities or turn them into

subservient cyborgs. These films usually

do not have a happy end and have little in

common with reality. BCI technologies

have not yet advanced this far.

While the first applications do exist,

such as in rehabilitation, the solutions still

02/2017 medicine&tec hn ology 45


FEATURE

According to Moritz Grosse-Wentrup

from MPI for Intelligent Systems

in Tübingen/Germany we

still have a long way to go before

BCI prostheses can take over the

function of damaged areas of the

brain.

Photo: MPI Tübingen/Denise Vernillo

seem rather simplistic. One major obstacle

is understanding the complex activities

of the human brain: Images,

thoughts, and feelings cannot simply be

read out from the brain. Also, no algorithm

so far has been able to interpret

whether someone is thinking of the letter

“A” at the moment. However, phenomena

such as attentiveness, stress, or activities

in the regions of the brain that control

movement can be read using EEG signals.

The first, comparatively simple products

are on the market. The P300 speller is

well-known. This is a communication tool

which paraplegics with speech disorders

can use to dictate words to a computer

using their brain signals. Experts use

P300 to record noticeable fluctuations in

the brain, so-called potentials, which

stand out on the EEG when someone is

being more attentive. A person is attentive,

for example, when a letter that the

person was expecting appears on a

screen. The P300 speller takes advantage

of this change in attention to dictate a

text, such as “good day.” Letters appear on

the screen in a random order. If the

required letter appears – in this case, first

the “G” – a P300 potential is triggered,

which the computer can read.

However, a single potential is too weak

to provide reliable information. Therefore,

the system goes through multiple iterations,

in which new P300 potentials

are always activated whenever the “G” appears.

These signals add up until the computer

identifies the letter correctly. It

takes about ten seconds for each letter,

during which the system runs through the

alphabet several times.

There is great interest in these types of

solutions – in medical technology, as well

as for the gaming and entertainment market,

whereby the boundaries are fluid. For

instance, experts from the EU research

network BNCI (Brain-Neural Computer

Interaction), to which prestigious institutes

and universities belong, found out

that many companies around the world

deal with aspects of BCI: including 65

companies that specialise in BCI, 46 from

medical and rehabilitation technology,

and 7 companies from the automotive and

aviation sector. There are also 10 companies

from the entertainment industry

and 20 from other fields of technology.

Controlling braces using EEG

signals from the motor cortex

Among other products on the market are

robots which help stroke patients to relearn

movements such as grasping during

rehabilitation. These robotic braces are

worn like a type of exoskeleton in which

the hand or leg is secured. They perform

the same movement several times, such as

closing and opening the hand, which assists

physiotherapists. For its control, the

computer reads EEG signals from the

motor cortex – the section of the brain

that controls and regulates movements.

The computers can by now recognise

movement signals such as grasp commands.

As soon as the patient thinks of a

movement, the robot executes it. Usually,

the so-called alpha band of the EEG is

used for the signals. This is the band of

electrical oscillations the brain in the frequency

range between 8 and 13 Hz. These

signals are generated when people turn

their attention to the body part that they

want to move.

Recent studies conducted at the University

Department of Neurosurgery in

At the Cybathlon,

gamers keep still,

but their brain activity

gives their

avatars in the computer

game wings.

Photo: ETH Zurich/Alessandro Della Bella

46 medicine&technology 02/2017


Device pays

attention to mood

Concentration – so the computer understands what is required. Despite the

possibilities that BCI offers, conventional EEG caps would have a hard time on

the consumer market.

Tübingen show that the alpha-band approach

does not always work for the rehabilitation

of stroke patients. The actual

command for grasping is sent to the

muscles from the motor cortex through

beta waves, which have oscillations with

frequencies between 13 and 30 hertz.

While the alpha waves prepare the grasping

manoeuvre to a certain extent, the

beta waves are the ones that actually activate

the movement. “It would make more

sense to use the beta waves for the control

and to train the patients so that the natural

connection between brain and muscles

can be restored,” says Prof. Alireza Gharabaghi,

Medical Director of the Functional

and Restorative Neurosurgery unit

in Tübingen.

Photo: TU Graz

“More demanding” waves

would provide better signals

Since the alpha waves are stronger and

therefore, easier to record in the EEG,

they are the waves which are used for

preference. “With conventional robots,

computers and humans therefore usually

communicate via alpha waves. If the

weaker beta waves are used, re-learning

of movements can be assisted but it has so

far been a challenge, and this can frustrate

patients.”

Using studies involving healthy subjects

and stroke patients, Gharabaghi and

his team have been able to show however,

that beta waves can be trained through intelligent

algorithms and can be used to

control robots without making excessive

demands on the users. In the first patients,

this approach led to the desired

motor improvements – after training according

to the motto: challenge and encourage.

In general terms, BCI can be divided

into three application areas. Robotic

braces, for instance, are assigned to the

area of “improve”, where the focus is to relearn

lost abilities. The experts of the

BNCI network predict that there will be

large number of products on the market in

this area by 2025. Another area for BCI is

“enhance”. Here the boundaries between

medicine and private customers are fluid.

BCI products could be developed for

example, to help people learn.

The BNCI network states the third application

area for BCI as “replace”. In this

area damaged areas of the brain are repaired

with a type of BCI prosthesis. This

area is probably the most sophisticated

approach for modern BCI development.

There is still a great deal of basic research

needed here – the first products are expected

between 2025 and 2035.

This type of replace approach is being

developed at the Max Planck Institute for

Intelligent Systems in Tübingen/Germany

for patients with amyotrophic lateral

sclerosis (ALS). In this disease, the cells of

the motor cortex, which control the

muscles, degenerate. During this process,

patients gradually lose the ability to move

parts of the body, including, the arms,

legs, tongue, muscles controlling speech,

and eye muscles. In the late stage patients

are still fully consciousness, but are no

longer able to communicate with their environment.

They are not even able to roll

their eyes to signal “yes” or “no.” “SWe

therefore need to find other regions of the

brain, other signals, that ALS patients can

An example of a BCI application in the

consumer market is the Melomind

product, which selects music based

on the user’s mood. The product was

developed by the young Parisian company

Mybrain Technologies. Mybrain

Technologies started a crowdfunding

campaign using the kickstarter platform

to put its product on the market.

With success: The device has been

available since October 2016 – stylish

headphones with built-in electrodes.

Melomind measures how stressed the

user is and selects appropriate music

to play. The headphones measure how

well the user responds – and change

the music accordingly. In this way, the

device and user will gradually adapt

to one another. The developers, who

work together with the Parisian Institut

du Cerveau et de la Moelle Epinière,

a research institute for brain

and spinal cord diseases, assume that

this device will allow users to respond

to stress in a more relaxed way in the

long term. Whether this is actually the

case remains to be seen.

www.mybraintech.com

BCI is used to measure the stress

level, and the headphones compile

an appropriate music selection.

Photo: Mybrain

02/2017 medicine&tec hn ology 47


FEATURE

When people turn their

thoughts inward, the EEG

delivers different signals

than in phases in which

the brain is concerned

with surroundings. Researchers

at the Max

Planck Institute in Tübingen

want to utilise this

phenomenon for people

who are largely paralysed.

Photo: MPI Tübingen/Denise Vernillo

use to communicate,” says electrical engineer

Dr.-Ing. Moritz Grosse-Wentrup,

who is responsible for the “Brain-Computer

Interfaces” research group at the

Max Planck Institute.

An alternative which is of special interest

for Grosse-Wentrup is an activity pattern

that occurs when a person concentrates

on themselves, directs thoughts inwards,

meditates: the default mode network.

During this type of thinking, an area behind

the forehead and a second one

deeper in brain are simultaneously active

and can read out in the EEG. Patients

could train on the computer to generate

“yes” and “no” signals by switching between

deep-thought and being open. In

this case, the challenge is in programming

the algorithms that have to read the discrete

“yes” from the diffuse signals of the

default mode network that are distributed

Photo: Fotolia/nullplus

Placing electrodes into

the brain is more of a

niche in brain-computer

interfaces.

Usually readings are

taken from the scalp.

in the brain. As experiments show, this is

becoming increasingly successful.

Better to measure through the

skin than implant electrodes

A basic question with BCI is whether and

when signals should be captured using a

cap through EEG or whether electrodes

should be implanted in the brain. Implants

produce signals with less noise.

The Max Planck researchers in Tübingen

have so far decided against the implants

due to the risk of infection. Also, deposits

usually form on the electrodes as a result

of the body’s rejection response, which interfere

with signal transmission to the

computer.

It therefore not surprising that many

research groups around the world are currently

working on effective electrode implants

for medical BCI applications. Such

developments need to be well tolerated

and have as few electrodes as possible and

very small electrodes so that subtle nerve

impulses can be detected as accurately as

possible.

However, according to the BNCI network,

only 6% of companies involved

with BCI technologies are working on implants.

All other companies use EEG.

Many are also working to find a replacement

for the conspicuous cap. Industrial

designers have developed sophisticated

electrode headsets that can be elegantly

placed on the head. It is quite possible

that in a few years these products will be

just as popular as Bluetooth headphones

are for smartphones today.


Tim Schröder

Science journalist in Oldenburg/Germany

Additional information

On Cybathlon:

www.cybathlon.ethz.ch

EU research network BNCI:

http://bnci-horizon-2020.eu

Prof. Gharabaghi, University Hospital

Tübingen:

www.neurochirurgie-tuebingen.de/

en/ Direct: http://hier.pro/PG9Yc

Dr. Grosse-Wentrup,

MPI Tübingen:

http://

brain-computer-interfaces.net/

On Emotiv:

www.emotiv.com

48 medicine&technology 02/2017


02/2017 medicine&tec hn ology 49


■ [ TECHNOLOGY ]

Keeping An Eye on Health

with the Smartwatch

Intelligent electronics | Smartwatches and wearables with health features are the

focus of research and development in the Swiss watch industry. As a partner for serial

industrialisation, service provider Iftest brings to the table its know-how in applications

with integrated electronic technology.

Medical check-up on your wrist:

Smartwatches, fitness armbands,

and networked clothing measure

and continuously record the wearer’s

fitness status.

Photo: Fotolia.com/ra2 studio

Highly integrated electronics for applications

ranging from the smartwatches to

medical wearables

Photo: Iftest

YOUR KEYWORDS






Smartwatches and wearables

Integrated electronics

Wireless communication

PCB depanelling technology

Development partnership with CSEM

Precise, high-quality, and made to last:

Swiss watches have been the uncontested

number one on the world market

for decades. The development of smartwatches

has brought competition to this

branch of the industry. Apple and Google

they are suddenly called, The watch

manufactures whose products everyone is

talking about are called Apple and

Google. These so-called connected

watches link your wrist watch to all digital

resources. Wireless, of course. Even in the

healthcare sector, smart products are

keeping pace with fitness and health features,

such as continuous heart rate monitoring

or sleep monitoring: For the Swiss

watch industry this is a wake-up call not

to miss the signs of the times and to prove

that this industry will continue to be a

world market leader in the future thanks

to digital innovation.

New technologies based on

wearable devices

New technologies in the field of sensors,

low-power wireless communication, and

battery technology form the basis for new

applications in the electronics in smartwatches

and wearable devices. Bernd

Maisenhölder, Marketing Director of the

Swiss electronics service provider Iftest

AG, who sees great opportunities for the

application of innovative electronic technologies

in healthcare, thinks: “In Switzerland

we have solid know-how in the research

and development sector in medical

technology, especially around the ETH

universities in Zurich and Lausanne.

Looking at the cost explosion in health-

care, it is evident that more efficient

healthcare services resulting from new,

innovative ideas will be the challenge of

the future.

Iftest is one of the renowned service

providers for modern medical electronics

in Switzerland. The idea to couple this

technology with the Swiss watch industry

and a health-conscious lifestyle seems to

be as obvious as it is exciting. The manufacturer

from Wettingen is helped by the

many years of partnership with the Swiss

Centre for Electronics and Microtechnology

in Neuchâtel (CSEM).

Ultra-thin electronics for

smartwatches and wearables

Currently Iftest is involved as a partner for

the industrialisation and series production

of electronics of more than ten innovative

smartwatch models. This expertise

is based on a process that the company

developed which makes possible the continuous

processing of ultra-thin circuit

boards containing up to 100 components

50 medicine&technology 02/2017


Frankfurt, Germany, 14– 17 November 2017

formnext.com

Partners for health

The Centre Suisse d’ Electronique et de

Microtechnique (CSEM) in Neuchâtel/

Switzerland is a research organisation focused

on application-oriented research

and development. Key areas are microelectronics

and microsystem technology,

sensor technology, and communication

technology. Iftest AG is a close partner of

CSEM for PCB design, the production of

prototypes for function tests, verification,

validation, and the subsequent

series production of electronic products.

Various medical wearables that were developed

in part by CSEM are already on

the market:

■ The innovative fertility tracker from

Ava Women tracks physiological data

and determines fertile days.

■ Seniors or especially people affected

by dementia and Alzheimer’s can use

the Limmex emergency watch to

sound an alarm and call for help

thanks to an integrated GSM.

■ The Swiss-made quartz watch Ifit

Executive not only features an accurate

activity tracker, but also an innovative

calorie management.

www.csem.ch

On trend.

No one is more creative than kids – except engineers.

Join us and be inspired at formnext, the international

exhibition and conference for Additive Manufacturing

and the nextgeneration of intelligent industrial

production.

Where ideas take shape.

for each individual smartwatch board.

With a thickness of only 0.3 mm, these

boards can be ideally integrated in smartwatches

and wearables. With regard to

precision, Iftest is also aware of the high

standards of watch manufacturers. For instance,

the specified precision of up to

50 μm laterally goes far beyond the

requirements of the EMS industry.

A special separation technology makes

this possible. The PCB depanelling technology

that was developed at Iftest makes

it possible to separate the circuit boards

into individual smartwatch boards at the

end of the production process– with minimal

stress on the individual smartwatch

boards. Otherwise this separation could

damage important components.

As many as 4000 smartwatch

boards produced every day

An optimised PCB design is also important

to ensure that the optimised production

process can achieve a daily capacity

of up to 4000 smartwatch boards. Quality

control uses an automated optical inspection

(AOI) system of the latest generation

(3D), which can take about 40 images of

the products per second, precisely analyse

the production process and optimise it for

maximum process reliability.

So what can the products of the future

do that smartwatches don’t do already?

“We would definitely like to go in the direction

of medicine with the applications,”

says Maisenhölder. “This means

that there will be wearables in the future

that will for example provide great support

in drug therapy through complementary

medical devices, to make patients‘

lives much easier.”

While smartwatches are geared toward

the fitness and lifestyle sector, wearables

have great medical potential. Factors that

also need to be considered, however, are

the regulatory obstacles that prolong the

market authorisation process – as with

prescription drugs – and require the experience

of an electronics service provider.

Success will be inevitable if the interplay

of the expertise from the assessment

of demand to product launch is successful.


Stephanie Kleinlein

Technical journalist in Zurich, Switzerland

Additional information

Iftest offers the full range of a medical

EMS service provider: from development,

to industrialisation, to production.

www.iftest.ch

@ formnext_expo

# formnext

02/2017 medicine&tec hn ology 51


■ [ TECHNOLOGY ]

A Bone Spring That Has No Spring

Surgical bone implant | Ground-breaking innovations can result from collaborations

between medical experts and medium-sized specialist companies: Surgeon Prof. Dr.

Labitzke and H&R Medizintechnik received an industry award this spring for the development

of a bone spring.

Photo: Bonehelix

The bone spring is ideal for treating fractures

of long hollow bones, like those found

in the upper arm and lower leg.

YOUR KEYWORDS

■ Surgical bone implants

■ Long-term implant-grade steel 1.4441

■ Stabilisation of bone fractures

■ Shorter surgery times

■ Distinction with industry award

What is the result when a

surgeon works together

with a spring manufacturer? You

get a spring that has no spring.

This may sound like a paradox—yet

it was exactly what

surgeon Prof. Dr. Labitzke was

looking for when he came to

H&R Spezialfedern GmbH &

Co. KG, located in Lennestadt,

North-Rhine Westphalia/Germany,

with the idea of a “bone

spring.”

After decades of practice,

Prof. Dr. Labitzke was convinced

that a spring, which is

screwed into the bone marrow

similar to a corkscrew, would

provide better treatment of clean fractures

of the upper arm, shin, and thigh

than the use of intramedullary nails. In

the latter case, the bone marrow is removed

by reaming, and considerable

force is used to knock the intramedullary

nail into the bone.

The nail is also removed under comparable

conditions and leaves behind a

hollowed out medullar cavity. In contrast,

the bone spring ensures that the fracture

site is connected in a way that allows for

micro-movements without affecting stability

or blood supply. This mobility results

in improved callus formation (new

formation of the bone structure in the

fracture region), considerably speeding

up the time which it takes for the fracture

to heal. Bone marrow is present even after

the implant is removed because the spring

has only about 10% of the volume of an

intramedullary nail.

The first prototypes confirmed Labitzke’s

theory. Use of the spring reduced

the surgery time drastically, fewer x-ray

images were required, and the intervention

was much less invasive. Also, the titanium

screws that are needed to lock the

nail in place did not have to be used. Removal

of the implant was likewise a mi-

This illustration shows how the Bonehelix

spring can be screwed into the bone

of the upper arm (humerus) during

surgery for stabilisation.

Photo: Bonehelix

nimally invasive procedure and required

much shorter treatment times due to

faster wound healing.

The practitioner looked for a manufacturing

partner and found what he was

looking for at H&R Spezialfedern in Lennestadt.

Company owners Heine and

Remmen immediately recognised the

great potential and were convinced by the

idea. Their speciality as a component supplier

for the automotive and aerospace industry

is manufacturing springs that have

a “cushioning” property. With Bonehelix,

however, the material must not compress

and has to remain flexible in a controlled

manner, providing a specific amount of

„longitudinal“ stability. Like a spring that

has no spring.

To make this possible, mathematician

Michael Stiebeiner had to work on meticulous

calculations of the spring material

with regard to the wire diameter and

52 medicine&technology 02/2017


coil thickness. The first prototypes of Bonehelix

followed the idea, as did the first

practical experiences, and the approval

procedure was started. A tedious process

that required much time and energy.

H&R was accustomed to working for

sensitive industries and already had experience

with certifications and special

labels. However, with this device and its

newly established company H&R Medizintechnik,

H&R wanted to operate as a

manufacturer of accessory products. The

company knew: When you put yourself on

the market, you bear the full responsibility

and have to demonstrate functions.

The company had been used to this responsibility

for years from vehicle production.

However, one thing soon became

clear: The medical industry is a different

world.

Approved long-term implant-grade

surgical steel 1.4441 is used in the production

of Bonehelix. In spite of this, the

spring specialist had to prove that the material

can also really be tolerated. Even

though approved material was used, complete

technical documentation had to be

created to demonstrate the properties of

the material in clinical trials. In addition

to tolerability testing, other information

and instructions were needed. Apart from

the instructions for use, this information

About the

manufacturer

As a manufacturer of technical

springs and chassis components,

H&R Spezialfedern has been known

on the market for more than 35

years. With H&R Medizintechnik

GmbH & Co. KG, this Sauerlandbased,

family-run company enters

new terrain: Together with trauma

surgeon and orthopaedic specialist

Prof. Dr. Labitzke, H&R developed a

novel bone spring called Bonehelix,

which is used to stabilise bone fractures.

It offers many advantages

over the previously used locking

nails and plates. A special cleanroom

for the manufacture of the spring

was established at the main factory

in Lennestadt.

www.bonehelix.com/en

included instructions on cleaning and

sterilisation, the efficacy of which also

had to be proven.

The applicable requirements are specified

in the German Medical Devices Act.

The area of “Surgical bone implants pursuant

to Directive 93/42/EEC” applied to

Bonehelix, and the device received the

highest risk class of 2b. This classification

is determined by the sensitivity of the device.

Bonehelix is a foreign body in the

human bone marrow, which is also why it

is not allowed to permanently remain in

the body in certain indications. For these

reasons, the highest available level applied

to the device.

Industry award in the medical

technology category

Separate rooms were set up to categorically

prevent mix-ups from occurring in

production. For instance, there is a special

cleanroom with its own machines and

measuring equipment that is completely

separate from the industrial production.

This was also a requirement for the devices.

The devices are sterilised in the hospital

shortly before surgery, meaning that

in-house hygienic handling is only needed

to a limited extent since the individual helices

are sold in a non-sterile condition.

The first cooperations with hospitals

were very successful, and the first operations

confirmed the function of the Bonehelix,

so that sales activities have been

expanded significantly since 2016 and

marketing of the device has been fully

rolled out. After approval was granted for

the treatment of upper arm and lower leg

fractures, the paediatric versions of Bonehelix

have now also been approved.

The implant has now been used more

than 150 times.

In the spring of 2017, H&R received

the industry award in the medical technology

category for Bonehelix. This

award recognises solutions that are exceptional

due to a high economic, societal,

ecological, and technological benefit.

H&R is currently preparing a study focused

on the use of Bonehelix in osteoporosis

patients. This study will also examine

the extent to which the use of Bonehelix

can act as a prophylaxis to prevent fractures.

This study will be conducted in

close cooperation with one hospital. ■

Jan Fockele

Medical journalist in Hamburg

02/2017 medicine&tec hn ology 53


■ [ TECHNOLOGY ]

Robot Skin Senses and Blushes

Sensor technology | Using a variety of different interconnected sensors, robots can obtain

a non-visual “view” of their environment. This creates safety in industrial use and

opens up new possibilities for exoskeletons or other forms of therapy.

Tomm, the robot arm, is covered with artificial

skin. When its sensors report that

everything is okay, they light up green. They

turn red when something or someone

comes close.

YOUR KEYWORDS





Sensors for robots and prostheses

Exoskeleton

Feedback to the brain

Therapy options for neurological defects

When a feather is brushed across

Tomm’s arm, his arm turns red –

his skin is sensitive. Even though he is

only a machine, or more precisely, a robot

in a research institute, he is aware of

much of what is happening around him:

Equipped with sensors, his surface notices

whether it is hot or cold, whether and

where there is pressure, whether something

or someone is moving in his proximity

– or is drawing closer.

Tomm’s artificial skin was developed at

the Institute for Cognitive Systems (ICS)

of the Technical University of Munich, in

Prof. Gordon Cheng’s group. The many

sensors and related electronics of the

Photo: Astrid Eckert/TUM

“robot skin” are arranged in honeycombshaped

elements that form extensive

mats. An elastomer shell protects the elements

and allows them to be placed on a

curved surface such as Tomm’s arm.

The idea for robot skin came from the

grey area between what is usually called a

robot and that which is a medical prosthesis:

The scientists have been working with

exoskeletons for years in the Walk Again

Project, which aims to allow paraplegics

to walk. An example with media impact as

to what can be achieved with this technology

was seen during the opening ceremony

of the World Cup in Brazil in 2014

when a patient in an exoskeleton kicked

54 medicine&technology 02/2017


Details on the sensitive robot skin

the first ball in the stadium. On the soles

of this exoskeleton, the robot skin

“sensed” whether the foot was on the

ground or moving in the air, and gave the

patient feedback on the upper arm.

Robots stumble without

feedback from the feet

“As early as 2008 we found that a safe

upright gait requires such feedback,” reports

Prof. Cheng. This applies to humanoid

robots as well as to exoskeletons—without

feedback on the status of

the feet, these two systems tend to

stumble.

The simple word feedback is an understatement

however. Everything that a sensor

skin measures in milliseconds generates

an enormous amount of data. To process

this mountain of data, evaluation

starts exactly where the data were collected.

The electronics around the sensors

are designed in such a way that they use

special algorithms to analyse the

measured values and only transfer a fraction

of this data. The artificial control

centre receives the most important data

within 4 ms, which helps the robot to

stabilise. In comparison: It takes about

6 ms for people to notice pain when someone

pinches their arm.

What sounds more simple for the machine

than it was to implement – and took

researchers years to develop – was a real

challenge when applied to an exoskeleton.

Measuring the data with roughly 160

hexagon cell elements, is one thing. Getting

the human brain of a paraplegic to

understand what has measured is a completely

different matter. “At the beginning

we did not know whether our idea of giving

a patient tactile feedback on the arm

would produce the results we wanted,”

says Cheng.

In the end the observations were actually

much better than expected: Of

course the patient had to be given training

before she was able to associate the vibrations

on her arm created by small motors

with what was happening on the

The base unit of the robot skin is a flat hexagonal package of electronic components. It

contains an energy-saving microprocessor and sensors that record the proximity of

contact, pressure, vibration, temperature, and even movement in three-dimensional

space. Any number of “cells” can be

linked.

Their interaction with one another

and with the central system allows

the skin to be reconfigured for specific

applications and to recover

from certain types of damage automatically.

This ability makes possible

intelligent, safe interaction between

humans and machines, and

the quick installation of industrial

robots – such as in the EU-sponsored

project “Factory in a Day.” The

number of sensor cells that are

used for a robot range from the 600

currently used in each robot to

2,500 which are planned for future

applications.

The robot skin is used in two ways

in the Walk Again Project. Integrated

in the soles of the feet of the

exoskeleton, the skin sends signals

to small motors that vibrate on the

patient’s arm. By training with this indirect sensory feedback, patients can learn to integrate

the robot legs and feet into their own body perceptions. In addition the robot

skin will be wrapped around the patient’s body parts to show any possible signs of

stress.

Future developments need to produce suitable materials for a more flexible skin and

miniaturisation. At present a Japanese expert in printed and stretchable electronics

and in soft robotics has been working at the institute for the last three years as a guest

researcher.

On the Institute for Cognitive Systems: www.ics.ei.tum.d

ground. Eventually her brain was able to

link this information together; the feedback

worked, and she reported that she

perceived the steps by the exoskeleton as

her own.

The brain even forms

new neural connections

There is more to it, as Cheng explains:

“We found that the brain is actually

plastic enough to form new neural connections

after training with the exoskeleton

and the vibration on the arm, which

Sensors built into the soles of the exoskeleton

report whether the foot is touching the

ground or not.

Photo: Walk Again Project/TUM

patients can also use to once again perceive

other sensations from the legs.”

This information can now be used in

various ways. Such possibilities include

the use of the sensor skin in an industrial

environment where much research is

being carried out on how the activities of

the robots can be better integrated with

those of humans. Here the sensing robot

is a safety factor for the people at its side:

Previously the machine was only able to

find out only whether or what is in its environment

by means of image processing

02/2017 medicine&tec hn ology 55


■ [ TECHNOLOGY ]

According to Prof. Gordon

Cheng, the sensors of the

artificial skin provide the information

that humanoid

robots or exoskeletons need

to stop them from stumbling.

However much more

can be achieved with this

data, including in the field of

medicine.

More sensors

for robots

systems– or brake as soon as it hit something.

With the artificial skin, the robot is

informed earlier and stops when it gets

unexpectedly close to an object or a person

– before it makes physical contact.

Even in the medical field there are

other approaches. In a certain way Brazil

was a culmination of the research work

conducted up until then, but is not nearly

the end. Cheng believes that there is still

much to do and improve in this area. He is

thinking far beyond the exoskeletons for

paraplegics. For example, discussions

with Prof. Bernhard Hemmer, Head of the

Department of Neurology at the University

Hospital of TU Munich, resulted in

considerations as to how robot skin can

also be used for treating multiple sclerosis

patients.

Combining neuro- feedback

and assistive robotics

When this disease affects the senses and

patients can no longer feel where they are

putting down their feet, they can only

move when they can see their environment—they

would stumble or fall if their

eyes were closed or if they were in the

dark. Cheng suspects that a combination

of neuro-feedback and assistive robotics

can also help to compensate for the limitations

that multiple sclerosis produces in

the neurons in these patients.

This goal is by no means the end of his

plans for the future. Cheng’s long-term

objective: He wants to develop a full-body

suit made of artificial skin, which would

allow people with neurological disorders

to return to a normal life. He has already

introduced his ideas to an interested audience

at the Capital City Convention

(Hauptstadtkongress) on Medicine and

Healthcare in June in Berlin.

For cooperation with the healthcare

sector, Cheng would most of all like to see

an unbiased attitude among doctors and

patients when it comes to accepting new

methods and technologies. “Some developments

take place very quickly, making

everyone ask themselves, do I do this or

that or neither?” says Cheng. So far most

of the reactions have been very positive,

and Cheng is optimistic: “I hope it also

stays this way in the future.”


Dr. Birgit Oppermann

birgit.oppermann@konradin.de

Photo: A. Heddergott/TUM

■ Researchers at the Department of

Mechanical and Process Engineering

at ETH Zurich have developed a

highly sensitive and flexible temperature

sensor that may soon be

found in prostheses and robotic

arms. The project was inspired by

snakes, which use their temperature

sensor to locate their prey at

night. The researchers use the flexible

plant substance pectin for their

solution. Pectin’s electrical conductivity

changes depending on temperature,

which allows measurements

to be made. Between 10 and

50 °C, the pectin film, which is

about 100 μm thick, can measure

temperature with an accuracy of

one hundredth of a degree. This is

comparable with the sensitivity of

a pit viper and twice as sensitive as

human skin.

■ The Magdeburg Fraunhofer IFF develops

and produces tactile sensor

systems whose heart is a transducer

based on piezo-resistive

polymer composites. The principle

of resistive measurement, which

can be implemented in this way,

makes it possible to measure spatially

resolved pressure distributions

– in combination with a patented

matrix design. How well

these developments are suited for

safe collision detection in humanrobot

interaction was examined in

the Taksens tactile sensor systems

project in the summer of 2016, during

which a demonstrator was also

developed.

56 medicine&technology 02/2017


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industries since 1996, with currently over 550 employees at sites within the EU, Asia

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Tel +49 621 718858-092 apoth@knoell.com

www.knoell.com

02/2017 medicine&tec hn ology 57


■ [ TECHNOLOGY ]

Printed Instrument Stitches

Faster than the Surgeon

Additive manufacturing | When new instruments were being developed for cardiology,

the manufacturing process was important: Laser Cusing offered the developers

new freedom for the smallest parts. Even a holding system for the heart was produced

using additive manufacturing—and next in line is a heart pump.

Today stitches are placed in surgeries

almost exactly as they were at the

time of the ancient Egyptians. This includes

situations in which it is not uncommon

for physicians to suffer needle-prick

injuries, and even experienced surgeons

battle with impreciseness. To change this,

British company Sutrue from Chelmsford

contacted medical professionals and developed

an instrument that can guide any

type of curved threaded needle automatically

through the patient’s tissue. Additive

manufacturing was indispensable in making

this instrument.

Sutrue is a CAD and design development

centre that specialises in the development

of medical devices for cardiology.

The company was founded in 2012 by

Alex Berry and works with numerous

specialists. Cardiologist Richard Trimlett

from the Royal Brompton Hospital in London

is one of them. He advises Sutrue in

questions of surgery and specifies the demands

of medical professionals, helping

to spur on product developments. He also

evaluates the practical experiences that

medical professionals have using the new

devices during interventions.

The requirements on the new instrument

for wound closure include that the

stitches have to be positioned quickly and

accurately, have to be made reproducibly,

and can be executed with the necessary

amount of force. The better and faster the

YOUR KEYWORDS






Surgical suture in cardiology

Automatic placing of stitches

Special mechanism in the instrument

Metal 3D printing

Holding mechanism and heart pump

Automatic wound closure: The needle is rotated at the head of the instrument and

places reproducible stitches for the suture.

suture is made, the shorter the surgery for

patients, and a clean suture leads to faster

healing. An instrument for closing

wounds during heart surgery has to be extremely

narrow since it is brought into

position through an endoscope the size of

a drinking straw. The head of the instrument

has to be turned and rotated to

reach the correct site in the tissue. Even

the needle rotates carefully and very accurately

during wound closure.

In the instrument developed by Sutrue,

all of this is possible by means of a

complex miniature switch mechanism

that activates the needle. Using this instrument,

the surgeon can place the suture

at the correct site automatically and

can even make several small stitches in arteries

or sensitive areas. Up to three

needle rotations per second—and thus

three stitches—can be made instead of

one stitch in 25 seconds with manual

wound closure.

Photo: Sutrue

The mechanism making this possible

consists of a single component and is

manufactured using the Laser Cusing process,

which was developed by Concept

Laser GmbH in Lichtenfels/Germany. ES

Technology, Concept Laser’s distribution

parter located near Oxford/Great Britain,

makes the parts for the wound closure instrument

on an Mlab Cusing machine.

This machine is particularly suited to

manufacture sophisticated parts with

high surface quality.

No surface treatment necessary

after 3D printing

In this case the machine is able to manufacture

the teeth of the switching mechanism,

which are only 0.4 mm long. Up to

600 parts can be printed on a single build

plate. No surface treatment is needed

after the tooth system is removed from

the powder bed. Grade 316L stainless

steel is used.

58 medicine&technology 02/2017


Photo: Sutrue

The head of the instrument can be turned and rotated, allowing sutures to be

placed anywhere.

According to Sutrue’s CEO Alex Berry,

conventionally milled or cast parts have

disadvantages in comparison. Aside from

the geometrical limitation, he also mentions

the time needed to develop the

prototype, as well as the costs. He therefore

sees great potential for 3D printing in

regard to the bionic design, reproducibility,

miniaturisation, and, last but not

least, a reduction in components and assembly

time and effort. “3D printing can

help revolutionise medical instruments,”

he concludes.

However, for the development of the

wound-closure instrument, contact with

the surgeon was also important. Cardiologist

Trimlett already has another task

for the developers: The heart muscle must

be stabilised during open-heart surgery.

After all the heart is “in motion,” and yet it

has to be held as still as possible in the

small area on which the doctors are operating.

“I said to Alex: „Can’t you design

something that consists of individual

parts and can pass through a very small

incision?’” reports Trimlett. Ideally it

needs to be a single-use item that can be

adapted to many different shapes and

sizes and can be disassembled. Also the

instrument needs to be pre-assembled

with exposed channels.

Alex Berry met this challenge and,

three months later, presented a biocompatible

prototype that consisted of SLS

plastic and metal. This part was manufactured

using the Laser Cusing process and

was printed by ES Technology on an Mlab

Cusing machine within three to four seconds.

The system consists of a metal body

and several plastic suction points that can

be removed by a vacuum. The two parts

are joined using sandwich technology.

“The development cost about

15,000 pounds. Comparable conventional

developments previously cost over a million

pounds,” says Berry.

Trimlett and Berry see another challenge

for the future. The key word is “artificial

heart,” which means mechanical

pumps. Additive manufacturing should be

able to make up for the weaknesses of previous

models and make the pump smaller.

Trimlett sees this as a fascinating opportunity

to integrate electromagnetic functions

for the pump drive. The 3D printing

process appears to inspire the cardiology

experts.


Guido Radig

Medical journalist in Weichs/Germany

About the instrument developer:

www.sutrue.com

ADDITIONAL INFORMATION

Concept Laser GmbH from Lichtenfels/Germany

developed the Laser

Cusing process, which is used in

many industries. The machine spectrum

ranges from small systems (50

x 50 x 80 mm 3 ) to systems that have

the world’s largest installation

space, so the manufacturer (800 x

400 x 500 mm 3 ).

www.conceptlaser.de/en

02/2017 medicine&technology 59


■ [ TECHNOLOGY ]

Photo: ArToFotolia.com/

Noise-optimised Small Motors

for Medical Technology

Small motors | Studies in an anechoic chamber have revealed the starting points for

making small motors quieter. Changes to the motor, housing, and control can now

help to make medical devices less noisy.

YOUR KEYWORDS





Whisper-quiet – the less noise medical devices

make, the better it is for patients and

personnel.

Quiet medical devices

Drive optimisation

Tests in anechoic chamber

Changes to housing, motor, and control

Acoustic warning signals and medical

devices generate a constant noise

level in hospitals—which creates stress.

Even the quietest constant noises, such as

those caused by a refrigerator, lead to an

increase in stress indicators, as studies in

operating theatres confirm. Active management

of background noise therefore

benefits patients and personnel. Medical

devices should also contribute to this,

and studies recommend that such products

should achieve considerably

less than 50 dB in continuous operation.

One factor that contributes to

the background noise which devices

make are the drives which are used in

them. A Swiss manufacturer of small

drives, Sonceboz AG, has modified

its already quiet products

for medical technology so that

they operate at 35 dB and less,

depending on application. The

starting points for this were

changes to the motor structure,

material, and control.

Anechoic chamber

provides the basis for

improvements

To be able to examine its

own products, the Sonceboz

group invested in an anechoic

chamber. The room

completely filters sounds waves and provides

a sound level of less than

13 dB—which is quieter than a whisper

from one metre away. In the room, the engineers

can model an original noise precisely

using numerical calculations. This

know-how can be used to thoroughly test

the sound level of mechatronic solutions

and improve them accordingly.

Experts use the tests and measurements

at various speeds to calculat, for

example, frequencies which give them information

on where a noise originates.

This noise may be due to resonances resulting

from the outer design of the

motor, or vibrations from the gear-wheel

design. Patients and personnel respond

very sensitively, for example, to unpleasantly

high or low frequencies. Therefore,

the motor developers paid attention not

only to reducing the overall noise, but also

to the type of noise that a drive generates.

Modification of

motor structure and housing

Using the measurements from the anechoic

chamber, Sonceboz was able to

make considerable improvements to the

respective motor structure. For example,

tests of drives for ventilation systems

showed that the frequencies of the rotor

and stator did not produce an optimum

noise level. A new structure was, therefore,

developed for the stator, which reduced

the noise to 24 dB. In comparison,

normal drives operate at 27 dB.

Sonceboz was also able to optimise the

noise quality in this way. Direct drives

usually have very high speeds. The high

speeds generate high frequencies, which

are rather unpleasant for most ears. Here

the Swiss manufacturer changed the rotor

structure to flatter motors with a larger

rotor, resulting in lower frequencies. The

use of several different profiles of stator

gears also allows different frequencies to

be used. The mixture of these frequencies

is more agreeable to the human ear than

only a single frequency. Other options resulted

from the pump cycles, which were

changed from short pulses to constant intervals,

creating a continuous, pleasant

noise.

Developers were also able to use the results

from the measurements in the

anechoic chamber to modify the housing.

Sometimes only minor changes to the

material combination were needed –

for these changes, the plastic experts

worked in-house together with motor developers

and were able to create housings

adapted to each application, for example,

with intermediate housing or plastic

dampers.

60 medicine&technology 02/2017


Photo: Sonceboz

The design of the electromagnetic structure

in the motor needed to be optimised – this

was shown by tests in the anechoic

chamber. Ultimately the developers were

able to reduce the noise emission to 24 dB

for the drive that is used in ventilation systems.

Another development approach that resulted

from the tests is the type of control.

Clean sinus commutation of Load-Sense

motors forms the basis for quiet motor operation

as the play in the gear can be compensated

through motion control. This

has been possible for some time for intermittent

operation and now tests are being

performed for continuous operation.

Magnetic sensor gives values

for position feedback loop

Load-Sense technology describes brushless,

multi-pole drives, which have been

used successfully for years and also work

reliably in difficult environments. A robust

magnetic sensor determines the actual

value for the position feedback loop.

Due to its high resolution, the load angle

of the motor can be evaluated, which generates

an actual value equivalent to motor

load. The data for the current load regulate

the motor power, resulting in energyefficient

operation.

With Load-Sense motors, precise sinus

commutation has advantages over block

commutation. Since direct-drive motors

are used with a high number of pole pairs,

the requirements for sensor resolution

and the processing power of the drive

control are higher. Here Sonceboz uses a

sensor with a resolution of 0.06° for each

increment and a controller with high processing

power.

These improvements are adapted to

the respective application and do not involve

any sacrifices in performance. To

achieve this end result, Sonceboz used its

know-how and decades of experience in

the automotive sector to its advantage.

However, the results of usability studies

with users are also factored into the developments.


Nicole Hillmayr

Journalist in Tübingen/Germany

www.sonceboz.com

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02/2017 medicine&tec hn ology 61


■ [ TECHNOLOGY ]

Simulation Increases

Pump Performance

Product development | The use of computer-aided engineering (CAE) simplifies the

development of medical devices, while ensuring reliable products. For the production

of a new blood pump, a Japanese manufacturer benefited from shorter development

times and improved pump efficiency in the device.

The left ventricular assistance device

is implanted and provides reliable blood

circulation.

YOUR KEYWORDS





Development of a blood pump

Use of simulation software

Utilisation of computational

fluid dynamics

Prototype construction and design

Photo: Siemens PLM/Terumo

A

ventricular assist device (VAD) is a

mechanical pump that is used to

compensate for malfunctions in a heart

chamber and take over the work of a

weakened heart. In the development of

the system, computer-aided modelling of

the blood pump, the central component of

the VAD, is a proven way to find the optimum

form before the first prototype is

built. The blood pump has to deliver the

required blood flow, while avoiding damaging

the blood, such as from thrombosis

and clots. Also, the pump needed to

have a compact and simple design and a

large operating range.

Computational fluid dynamics (CFD)

can be used for analysis and optimisation

of the blood flow in the pump and can

provide qualitative information on thrombosis,

recirculation, and blood damage.

The latest further development in blood

pump development based on CFD and optimisation

technologies can be seen in the

Shonan Centre of the Terumo Corporation,

Tokyo/Japan. The Shonan Centre

houses the company’s research and development

departments. This centre develops

a wide range of innovative technologies—from

the application of information

gained from basic research, to

the development of new areas, such as

diagnostic or therapeutic devices, as well

as regenerative therapies for the heart

muscle and the development of medical

devices for emerging countries.

Takehisa Mori, who is responsible for

the basic research of medical devices in

cardiovascular surgery at Terumo, investigates

the feasibility and challenges of new

devices in the design phase. He uses CFD

technology for this. The basic research

team is not a specialised simulation department.

Instead it uses CFD and optimisation

technologies for design exploration.

In the field of devices for cardiovascular

surgery, at Terumo CFD is mainly

used in the development of blood pumps.

The purpose of introducing CFD-aided

design exploration is to increase the efficiency

of blood pump development and to

be able to put better solutions on the market

more quickly. In addition to blood

pumps, CFD is used in many other areas at

Terumo, for example, in artificial lungs, in

devices for the administration of medication,

in drug-eluting stents, and various

production processes.

Not only the simulation, but

also the prototype is important

“With the use of CFD, we determined very

quickly how much better the behaviour of

the devices can be understood,” says

Mori. However, he advises against using

the simulation ideas in product development

without giving them further

thought: “In reality it is important to truly

understand a task and the physical implications.

Especially in the development of

medical devices where the standards are

very high, one cannot simply accept a result

– the result has to be adequately verified.”

This is why CFD should not be used

exclusively. The prototype is also important.

“With CFD we can lay the basis for

the prototype construction to a certain degree,”

says development specialist Mori.

So far CFD has been used to evaluate

dozens of basic models to predict the performance

of all variants under the same

conditions, from which multiple candidate

models emerged. After this pump

performance measurements were taken

and blood-related experiments were preformed

to detect problems with the models.

This process was repeated as many

times as necessary to identify a final

prototype. Accordingly the development

of a product took many years.

Using Star-CCM+, a classic program

for fluid dynamic calculations from

Siemens, and Optimate+, the add-on program

for design exploration, Terumo was

able to drastically reduce the develop-

62 medicine&technology 02/2017


Takehisa Mori is Chief Developer

at Terumo.

Photo: Siemens PLM/Terumo

ment time and achieve an optimised result

more quickly. The start of the process

requires a basic design, which is stimulated

in the Star-CCM+ calculation program,

verified with experimental data,

and improved in Optimate+.

The simulations produced a prototype

that was subjected to tests to validate its

performance. The optimisation process

helps inexperienced developers find the

best form for the product.

The Terumo developers make it their

goal to develop an extracorporeal blood

pump with a typical design and improved

pump efficiency. The product that

was found in the optimisation process

has twelve impeller blades, an impeller diameter

of 60 mm, and a spiral-shaped

housing. Since it is necessary to factor in

the patient’s respiratory rate, the flow

rates were modified with the help of a

Javascript macro in Star-CCM+ in stages

between 2 and 8 l/min. The pump efficiency

and the torque at the impeller were

determined with the aid of the report

function.

The 3D geometry of the pump was

modelled using a 3D CAD modeller in

Star-CCM+. Since 3D CAD can use the design

variables as parameters, the optimisation

calculations can be implemented in

a seamless, efficient process without generating

additional licence costs. In the

analysis using the Star-CCM+ software

tool, blood was defined as the working

fluid and a model was also used to calculate

turbulence.

102 variants

calculated in six days

A total of 102 variants were calculated

within six days during the analysis

process. Based on the optimisation goals

and the basic case, Optimate+ simplified

the design variables for the impeller

diameter and housing and repeated

the simulation for all variants. Of these

variants, 38 fulfilled the validity restriction.

The best design was selected

not only on the basis of the best average

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02/2017 medicine&technology 63


■ [ TECHNOLOGY ]

A VAD type of

the Capiox extracorporeal

blood

pump system

“The calculations provided values for efficiency

and other information about the

pumps. However, there is still the risk of

concentrating too narrowly on these values,

without taking into account the overall

picture of fluid dynamics. After a week of

calculation you could end up with a completely

useless design in your hands.

Therefore, some variants should be modelled

in advance and their fluid dynamics

need to be examined. Only after this has

been done should you start with the optimisation

calculation.”

pump efficiency, but also on the lowest

variance over the range of flow rates.

One of the challenges in pump design

is that the risk of thrombosis increases if

too much priority is placed on pump efficiency—even

if one is looking for the

most efficient pump. So far the only way

to detect the development of thromboses

was by experimentation. The liquid used

in the experiment was blood, which previously

resulted in verification difficulties

due to the variations in the blood and in

the experimental results if no long-term

data were available.

Prediction closely matches

the experimental results

Also, the viscosity of blood varies from

person to person. The blood used for the

experiments came from animals, for

example, cows. Here the viscosity varies

depending on the breed and age of the

animal. In spite of this Terumo has now

been able to introduce a CFD-aided approach.

This approach is based on a situation

in which thromboses do not develop

as long as the shear forces in the pump remain

below a certain threshold. This prediction

closely matches the experimental

results. In this way Terumo was gradually

able to explain various phenomena using

CFD instead of experiments.

Development and troubleshooting became

extremely efficient with the implementation

of Star-CCM+ in pump development.

The structure of medical devices

Photo: Siemens PLM/Terumo

used to be relatively simple, allowing the

devices to be developed without CFD.

Since the number of important design

parameters has greatly increased with increasing

functionality, CFD and optimisation

calculations are now an indispensable

part of an efficient development process.

“A whole series of solutions resulted

from the optimisation calculations,” explains

Chief Developer Takehisa Mori.

No additional software

is needed

Star-CCM+ includes a 3D modeller,

which makes it possible to run through

the entire process from the generation of

the geometry to the evaluation within a

uniform user interface. What makes this

program highly attractive is that no additional

software is needed to implement

optimisation calculations. Also, meshing

is very easy using the surface wrapping

feature in Star-CCM+, which helps to

clear up problematic areas, says Mori.

“These advantages also tipped the scales

in favour of Star-CCM+ in our team.” ■

Kuninori Masushige, Yuka Takahashi

Siemens PLM, Plano, Texas/USA

www.siemens.com/plm

About the blood pump developer Terumo

Terumo was founded near Tokyo in 1921 as a small manufacturer of thermometers.

The company was established in response to the drastically reduced

number of imports of high-quality thermometers from Germany following

the First World War. One of the founders of the company was Dr.

Shibasaburo Kitasato, who is known as the father of modern Japanese

medicine and is venerated as the discoverer of plague bacillus and inventor

of the serum therapy for tetanus. The company name is derived from the

word “thermometer.”

Based on the company motto, “contributing to society through healthcare,”

Terumo expanded its products and services in the medical sector worldwide

within three disciplines: cardiovascular medicine, hospital in general,

and blood management. The company’s medical devices are used not only

in the Japanese market. A global perspective has therefore been important

to Terumo in the development of its products from the very beginning.

Today Terumo can develop better products more quickly by using the

Siemens Star-CCM+ and Optimate+ software. Terumo has an export rate of

63% and 37% of the sales in Japan (figures from 31 March 2015).

www.terumo.com

64 medicine&technology 02/2017


From the Printer to the

Operating Theatre

28. – 30.11.2017

Nürnberg

Hall 7A | Booth 100

www.elgo.de

Metal laser melting | A 3D-printed bone drill is designed

to prevent tissue damage, which can occur during

surgery with a conventionally manufactured drill.

For the research and development project “Development

of a bone machining tool to prevent

thermally induced osteonecrosis” (WesKo), the Institute

of Production Engineering and Machine Tools

(IFW) at Leibniz University in Hannover/Germany

contacted MBFZ Toolcraft GmbH, Georgensgmünd,

Germany. During bone machining, tissue damage can

result from the heat that develops during the process.

Tissue damage occurs at temperatures in excess of

approx. 48 °C. Cooling the tool involves a risk that

fluid can enter the wound. Therefore, conventional

tools with cooling cannot be used. Up to now, surgery

has been performed iteratively, meaning that drilling

is repeatedly interrupted to keep the temperature as

low as possible.

Metal laser melting now makes it possible to manufacture

drills with integrated cooling ducts. The coolant

can flow inside the tool, without entering the

wound. In addition to the drill design, Toolcraft developed

a non-rotating pre-spindle attachment with

an inflow and outflow function for the coolant. A

conventional bone drill with a diameter of 6 mm was

used as a model for the internally cooled prototype.

First the project team defined the cooling capacity in

relation to the volumetric flow rate, temperature,

and thermal capacity of the coolant. Then the developers

devised a method to introduce a closed cooling

circuit into the tool substrate, while preserving tool

stability and process capability. The next step was to

plan the geometric properties of the drill and the internal

cooling ducts using CAD and simulation software.

After the drill was manufactured using the 3D printing

process subsequent machining, IFW conducted

practical tests. The drill tests showed a temperature

reduction of up to 70% using the 3D-printed drill.

The internally cooled bone drill

will affect the success of bone

surgery in the future.

Photo: Toolcraft

02/2017 medicine&technology 65


■ [ TECHNOLOGY ]

Titanium Hearing Aid Shells

Printed in Series

3D printing | Hearing aid production without additive manufacturing is unthinkable

these days. What is new is the use of titanium for series production hearing aid shells.

This material is 15 times more resilient than acrylic and makes it possible to produce

very small and robust in-ear hearing aids.

Photo: Phonak

Hearing aids with a titanium shell are smaller, which allows them to be used for people

who have very small auditory canals.

YOUR KEYWORDS






3D printing in standard production

Titanium instead of acrylic

Thinner shell wall

Hearing aids even for small auditory

canals

More available space

Photo: Phonak

For hearing aid manufactures the use

of 3D printers has been routine for

many years. Phonak based in Zurich/

Switzerland was one of the first companies

worldwide to use this technology

in its production. At the turn of the millennium,

this Swiss manufacturer had already

started using additive manufacturing

to make the shells of its in-ear hearing

aids and later also the various ear moulds

for behind-the-ear and receiver-in-canal

hearing aids.

3D printing technology makes it possible

to match the shape of the shells to different

auditory canals and hearing loss.

Manufacturers benefit also from reproducibility

in production and can offer

hearing aid shells with the same quality

standard anywhere in the world. With 3D

printing, a degree of precision can be

reached that would be unachievable manually.

Therefore, hearing aids can be built

in smaller and smaller sizes with ever

thinner shell walls.

Hearing aids can be made

even smaller

However, for products made out of the

standard acrylic material, the shells cannot

be less than 0.4 mm thick. They would

break. So for years Phonak has been working

on the idea of using titanium, as titanium

is extremely light, resilient, and versatile.

Titanium can be used to make hearing

aids with a shell only half as thick as

conventional acrylic shells. This material

proves advantageous for the whole device,

allowing the hearing aids to be made

even smaller.

The Virto-B titanium hearing aid with

a printed in-ear shell has been available

from Phonak since the spring of 2017.

They are very discrete in the ear thanks to

Changing the material to titanium allows

shells to be thinner: The metal design is

only half as thick as the conventional acrylic

solution. The available space can be used in

other ways.

their small size. The fit rate for invisiblein-canal

(IIC) hearing aids was able to be

increased by 64%, so that people who

have not previously been able to wear a

hearing aid due to their small auditory

canal could be treated with this type of

device. In addition, the hearing aid is

much stronger than previous hearing aids

with a plastic shell.

When a hearing aid shell is made on

the 3D printer, many steps are similar, regardless

of whether the material is acrylic

or titanium. In either case, the silicone impressions

of the auditory canal that are

taken manually are scanned by a laser and

processed digitally on a screen. Then the

shell is printed and built up layer by layer.

While digital light processing (DLP) technology

is used for acrylic printing, selective

laser melting (SLM) technology is

used with the titanium printer: A laser

melts the hard titanium powder layer by

layer into the correct shape under a protective

atmosphere.

For SLM much larger and more complex

production machines and processes

are needed. The technology could, therefore,

not be introduced until it was certain

that it was actually feasible. Special processing,

which Phonak developed for its

66 medicine&technology 02/2017


Directly after SLM printing, the

shells for the hearing aids are still

rough (left). Final processing

makes them smooth enough for

the auditory canal (right).

purposes, is also required for the surface

of the SLM processed titanium. In this

way reliable high quality which is suited

for the auditory canal can be achieved.

However, some things also have

changed with the inner workings of the

hearing aid. The size of the electronics

has been reduced by 60%. This modification

and the thinner design of the shell

creates more space in the hearing aid. It

can therefore either be designed as a

smaller version – or the extra space can be

used to vary the ventilation or the power

level, enabling flexibility in the acoustics.

However, Titanium also has a limitation.

The classic wireless technology

used to simply connect hearing aids easily

to other devices such as televisions or

smartphones cannot be used, at least not

with the present state of development.

The reason: Titanium seals and does not

allow electromagnetic waves to pass. For

this reason, the hearing aid has so far not

been offered with a wireless coil in the

form factors IIC and CIC. Due to the limited

connectivity, titanium will not

supersede acrylic in the near future in

hearing aids. The majority of users adapt

well to the titanium hearing aid due to its

discrete shape. However, there are customers

who place a high priority on

streaming and would therefore accept a

larger hearing aid.

The Swiss company Phonak is already

working on further developments. For instance,

many advances and improvements

have been made with the acrylic materials

since their introduction in 2001. Titanium

will follow the same path: The technology

has great potential for the years ahead. ■

Leo den Hartog

Phonak, Stäfa/Switzerland

Additional information

The history of Phonak begins with

the founding of “AG für Elektroakustik”

in 1947 in Zurich. In addition to

titanium hearing aids, recent developments

by this Swiss company include

the “contact lens for the ear,” a

hearing aid that sits right in front of

the eardrum and can be worn for

several months at a time.

www.phonak.com

Photo: Phonak

Industrie

The

network of

expertise

for industry

18 media brands for all major sectors of industry

Information, inspiration and networking for professionals

and industry executives

Practical knowledge spanning all media channels: Trade

journals, websites, events, newsletters, whitepapers, webinars

Discover the appropriate media for

you and your specific industry sector:

konradin.de/industrie 02/2017 medicine&technology 67

media.industrie.de


■ [ TECHNOLOGY ]

Ultrasound Reduces Lint in Surgery

Ultrasonic welding | For the manufacturing of a novel surgical towel from Portugal,

German company Herrmann Ultrasonics designed a production line that reduces the

risk of bacterial impurities and prevents fraying. All laminating and sealing steps are

fully automated.

The new surgical towel

has exceptional absorbing

properties and

produces very little lint.

Photo: Herrmann Ultrasonics

Spunlace nonwovens have been used can be incorporated. “The polyamide is

as wound drapes for years, even in important because it collects heat that is

■ Less lint and bacteria on the nonwoven

surgery. In the manufacturing of these

nonwovens, high-pressure water jets are

used on the fibre web to make it compact.

However, in comparison with traditional

cotton gauze, this product loses volume

and stability in the wet state. During the

search for material for a novel surgical

towel, Portuguese manufacturer Bastos

Viegas S.A. from Guilhufe found a polyamide

polyester mixture in its in-house

production.

“We wanted to increase the volume

and stability when wet and the wear resistance.

At the same time, the absorption

capacity and softness of spunlace needed

to be retained or, even better, increased,”

as Luis Guimarães, owner of Bastos Viegas,

explains the material selection. It

must also be ensured that an x-ray thread

produced during sterilisation and propagates

it in a wavelike way. This, in turn, increases

the surface area and, therefore,

the absorption,” says Guimarães.

Ultrasonic welding was the only

option for production

However, how could the production process

be implemented in an ideal technical

and economic way? It soon became clear

to the manufacturer that ultrasonic welding

was the only option. “We had previous

experience with other ultrasonic compo-

YOUR KEYWORDS

■ Ultrasonic sealing technology

■ Automated production line

■ Elimination of hand seams and threads

Illustration: Bastos Viegas

Connection from

vibration

Ultrasonic vibrations can excite and

fuse the thermoplastic components

of nonwoven materials. A welding

tool called a sonotrode creates the vibrations

in the nonwoven. In industrial

use, ultrasonic frequencies of 20

to 35 kHz are common, with amplitudes

(tool movements) of 10 μm to

50 μm. Such nonwovens are usually

processed in continuous processes at

high line speeds. Processing speeds of

up to 800 m/min. can be achieved by

using rotating tools. A roller with a

surface structure is used as welding,

embossing, or cutting anvil. The contour

of the roller focusses the energy

and determines precisely the welding

points that are needed for the particular

product.

The three material layers of the Texart

surgical towel are welded by ultrasound.

68 medicine&technology 02/2017


Photo: Herrmann Ultrasonics

The fast and fully automated manufacturing process in the ultrasonic station

prevents contamination.

nents, but this time we needed a technology

supplier that would be able to support

us as a solution provider from start to finish.

Someone who can work on the concept

with us and carry out the test phase

to the successful prototype validation” recalls

Guimarães about the specifications.

He decided ultimately on specialist

Herrmann Ultrasonics in Karlsbad/Germany,

which designed a production line

for all of the required laminating and sealing

steps to produce the new surgical

towel Texart on an automated system. All

manual seams and additional materials,

such as yarns and threads, are completely

eliminated, which reduces the risk of bacterial

contamination and prevents fraying.

The novel surgical towel satisfies the

industry requirements for eliminating

tedious manual handling and automating

production steps. The layer sequence of

the towel is a patented invention of the

Portuguese manufacturer and supplier of

non-active medical devices.

Three material layers offer

soft, lint-free feel

Texart is composed of three layers and

combines the best properties of textile

and nonwoven technology. A textile web

of polyamide and polyester with an x-ray

strip is used as a middle layer between

two layers of spunlace nonwoven, which

consists of about 70% viscose and 30%

polyester. The compact surface of Texart

has a soft feel and absorbs liquids exceptionally

well due to its increased surface

area.

The term linting is used to describe the

release of fibre fragments and other particles

during use. A low tendency towards

precisely this linting is a major advantage

of spunlace nonwovens compared to

(natural) materials like cotton gauze. In a

test, the specifications for dry linting were

verified in accordance with EN 1644–1

and ISO 9073–10. The Texart towel

yielded significantly better results than

pre-washed gauze in this test.

Bastos Viegas was faced with the question

of how to combine the materials of

the novel towel without the development

of heat or the use of consumables such as

adhesives. The solution was an ultrasonic

process for laminating and sealing. Spunlace

nonwovens are very responsive to

ultrasonic vibrations. In Herrmann Ultrasonics

the Portuguese found the right

partner to develop the production line for

the new product. First the correct processing

steps needed to be constructed – followed

by the design of the ultrasonic

stations.

In the first process step, ultrasound is

used to laminate the three layers and, at

the same time, seal the left and right edge

of the towel. The second step is the crosssealing

of the end of the towel, which

means the start of the next towel. At the

end, the product is cut, folded, and stacked.

During sterilisation, the product surface

contracts and creates a “wave-like”

effect, improving the feel and absorption

capacity.

With its long-term production strategy,

Bastos Viegas already takes the new Medical

Device Regulation (MDR) into account,

which will come into effect in

2020. “With its high-performance properties,

the Texart surgical towel can replace

conventional cotton products and increase

safety in surgery,” so Luis Guimarães.


Astrid Herrmann

Herrmann Ultrasonics, Karlsbad

www.herrmannultraschall.com

Cleanroom Systems

From planning to

qualification

innovative

modular

economical

SCHILLING ENGINEERING

Industriestraße 26

D-79793 Wutöschingen

Tel. +49 (0) 7746 / 92789 - 0

www.SchillingEngineering.de

02/2017 medicine&tec hn ology 69


■ [ TECHNOLOGY ]

Robot Masters Tube and Spiral Reliably

Flexible parts | The Italian system house Elettrosystem used robots to automate the

demanding assembly of flexible spiral tubes for Medtronic. Four Stäubli six-axis robots

perform various tasks during assembly.

The larger of the six-axis robots has

a specially developed pneumatic

double gripper system. It can use

the gripper to simultaneously hold

two unprocessed tubes and two

tubes which are already wound

with wire.

Medical professionals use a tube to

keep a patient’s airway open. Insertion

of these tubes into the windpipe, intubation,

is a standard procedure in anaesthesia

and in intensive care and

emergency medicine. To do its job, the

medical aid must fulfil seemingly contradictory

technical requirements: For insertion,

it must be rigid, and it cannot constrict

under any circumstances. At the

same time, it needs to be as flexible as

possible to adapt to the particular human

anatomy.

To achieve these goals, the relevant

products from medical technology manufacturer

Medtronic consist of four-layer

composite tubes with an integrated spiral

YOUR KEYWORDS





Automated assembly of flexible

spiral-wound wires and PVC liner

Increase in capacity

Flexible cells

Process reliability

Photo: Stäubli

made of thin spring steel. However, it is

precisely this combination which causes

difficulties in production. The spiral tubes

have to be constructed in layers from the

inside out. The obstacles for automating

this process are great: The two components,

the PVC liner and steel spiral, are

flexible and are not easy to handle. In

spite of this, the result of assembly must

meet high quality requirements.

The fact that up to now assembly of the

spiral on the tube liner could not be automated

was a production engineering obstacle

to the necessary increase in capacity

at the Medtronic factory in Dublin, Ireland.

There, assembly was carried out

manually. Just recently the specialists at

the Italian company Elettrosystem implemented

a fully automated assembly cell

for this task. The cell is designed for the

simultaneous partial assembly of four spiral

tubes and consists of two cells designed

as a mirror image of each another,

in which four Stäubli robots and a large

number of linear systems work together.

In the cell, the fine steel wire spiral is

wound around a PVC tube, and the com-

ponent is coated with adhesive. During

this process, the windings of the steel wire

have to be distributed equally in a defined

manner, which in itself is a challenge. The

second challenge is the handling of the

flexible components. A Stäubli RX160

and a Stäubli TX90 robot perform this

task. Assembly of the spiral-wound wire is

carried out in an integrated process circuit

that is linked through the linear system.

In their standard configuration, the

robots already fulfil the requirements of

an ISO class 5 cleanroom, which was an

advantage in the tasks described above:

Elettrosystem did not have to utilise

special cleanroom designs.

Total production time of 3 s

for each tube

The cycle takes about 12 seconds, resulting

in a total production time of about

3 seconds for each tube. Two operators

monitor the work in the cell and watch

the workpieces coming in and going out

of the cell.

There was one aspect that still needed

to be considered, however: The product is

available in many variants so that so that

the right tube can be used to treat patients

from small children to the largest adults.

Elettrosystem development engineer

Simone Puccio reports: “We were able

to design the system in a such a flexible

way that it can assemble seven variants

with tube diameters ranging from 5.0 to

9.5 millimetres and tubes with different

lengths and flexibility.” The higherlevel

PLC even enables different variants

to be processed simultaneously in the

twin cells.

70 medicine&technology 02/2017


Photo: Stäubli

The flexible PVC tubing is

pulled over tubes. Here

the spiral steel wire is

screwed onto the inner

PVC tubing and coated

with adhesive.

and adhesive in the twin cell every hour.

Final assembly of the more stable composite

components is fully automated in subsequent

stations.


Sonja Koban

Stäubli Tec-Systems Robotics,

Bayreuth/Germany

www.staubli.com

At first glance, the large six-axis robot

RX160 seems oversized for these cells.

However, there were good reasons for this

choice: It has a range of 1,710 mm and

adequate load-bearing capacity for the

complex four-part gripper system. “In this

process, the weight gave us fewer worries

than the torques which are generated by

the large extension of the gripper,” explains

Puccio. “These place a heavy load

on the robot axis.” To keep the stress on

the gear unit to a minimum in the longterm,

it was decided that the powerful

RX160 robot should be used. “With a

nominal load of 34 kilograms and the

zero-play Stäubli gears, we are able to rely

on constant top performance by the

robot.”

Elettrosystem developed the pneumatic

double gripper system in coordination

with the user. The clearances of

the grippers can be changed to match the

dimensions of the workpiece variants. Retooling

is carried out in about 15 minutes.

Trimming and quality inspection is performed

by the smaller Stäubli TX90 robot.

In this way, roughly 900 intubation tubes

can be assembled with spiral-wound wire

About the specialist

in automation

Italian plant constructor Elettrosystem

from Asti near Turin specialises

in automation solutions for various

industries, including medicine and

pharmaceuticals. It has utilised the

advantages of industrial robots in its

solutions for a long time.

www.elettrosystem.com

Hall 8a, Stand H01

BETTER PACKAGING

MULTIVAC offers flexible

packaging solutions which protect

medical sterile products and pharmaceuticals,

and they enable process

security, reproducibility and traceability.

With the most comprehensive product

range, MULTIVAC covers all packaging technologies

and output categories. Our customers

benefit from the unique MULTIVAC Clean

Design, easy operation, high reliability, and a

service network with short reaction times.

www.multivac.com

02/2017 medicine&technology 71


■ [ RESEARCH ]

An Island of Success

Research landscape | Ireland sees itself as Europe’s largest hotspot for medical technology

and as a globally recognised competence centre. The Centre for Research in

Medical Devices—Cúram for short, in Galway—is a highly respected national research

centre.

Ireland has long been

known and valued as a

tourist destination. Now

it is well on the way to

acquiring a similar reputation

in medicine and

biotechnology.

Photo: VanderWolf Images/Fotolia

Without fail, Anyone who has ever

been there is certain to be enthusiastic:

so green, such wonderful colours,

such open and friendly inhabitants, an

lively cities. Even if you only have a small

amount of time, you can experience a

great deal, because the island is not very

large. The size factor is also an advantage

for the medical technology industry: “As a

global medtech hub we are unique in Ireland.

In a day’s drive you can visit 18 of

the world’s top 25 medtech companies,”

says Dr. Sinead Keogh, Director of the

Irish Medical Devices Association

YOUR KEYWORDS





Ireland

Research

Hotspot for medical technology

Academic-industry-clinical research

centre

(IMDA). “And of the 400 medtech companies

80% are SMEs.”

The openness and friendliness of the

Irish allow the international exchange of

students and open collaboration with international

experts and institutes to flourish.

In this spirit, competitors often become

collaborators—and lines between

industry and academia are not seen as

barriers to joint research, opening new

R&D possibilities. A spirit that promotes

innovations: Ireland is ranked 10 on the

Global Innovation Index 2017.

Third richest country

in Europe

Some people still like to remember Ireland

as poverty stricken island. Yet this

country has become a highly modern industrial

and service society. In 2016

Ireland was the third richest country

in Europe and eighth richest in the world

based on the gross domestic product

(adjusted for purchasing power). The island

has also successfully asserted itself

in the market for medical technology:

Following Germany, Ireland is the second

largest exporter in the EU – thanks in

part to the large American medical technology

companies that have branches in

Ireland. Eighteen of the world’s top 25

medical technology companies have a

base in Ireland, and 50% of the 450 medtech

companies based here are indi -

genous.

Ireland set the course for its success story

a few years ago by identifying priority

areas which were especially worthy of

support. For instance, biotechnology has

already been supported with great success.

Since 2012 medical technology has

also been one of the 14 priority areas.

They are mainly supervised by Science

Foundation Ireland (SFI). As a part of the

action plan, the country introduced, for

example, a master programme with occupational

training and provided continuous

support for the Bioinnovate Ireland

programme—a training programme in

which participants work directly with

72 medicine&technology 02/2017


clinicians to develop new innovative therapies.

Also as a part of the action plan, SFI

has pledged, for example, long-term

support through 2019 for the Irish Centre

for Foetal and Neonatal Translational

Research, “Infant” for short. Likewise

Ireland’s first stem cell manufacturing

centre at NUI Galway opened in January

2015. The National Health Innovation

Hub creates opportunities in which the

hospitals in Galway, Cork, and St. James

in Dublin, can each conduct in-house

clinical research. In addition, a clinical

research framework has been im -

plemented, and initiatives established for

the exchange of knowledge between

university research, medical institutions,

government departments, state-run institutions,

and the economy.

Other notable initiatives include collaboration

between Enterprise Ireland

and Mayo Clinic; the USA will see the

commercialisation of up to 20 novel medical

technologies in Ireland over the next

five years with the aim of creating several

high value medical technology spin-out

companies.

The Cork-based healthcare innovation

hub was established to help healthcare

companies deliver commercial products

and services more quickly by giving them

access to the health service in order to test

products in a real-life environment.

The “gem” of this support started its

work this year, the Cúram, the Science

Foundation Ireland Centre for Research in

Medical Devices, in Galway. The location

was not selected randomly: Galway is

From the Expert

Significant impact on global healthcare

Prof. Abhay Pandit is Scientific Director

of Cúram, Centre for Research

in Medical Devices.

Photo: Cúram

cal, and regulatory expertise in medical device

research.

■ The field of medical devices is wide.

What is the research approach at Cúram?

The research programme focuses on solutions

for specific disease states in the

areas of cardiovascular, musculoskeletal,

neural, soft tissue, renal and urology, and

respiratory. The target disease areas at

Cúram include therefore heart disease,

Parkinson’s disease, diabetes, respiratory illness,

and musculoskeletal disease. Cúram’s

devices are developed with strong clinical

collaborations to enable rapid translation of

research findings to clinical application.

■ What makes Cúram one of a kind in comparison

to other European R&D foundations/centres?

Cúram has the potential to have a significant

impact on both healthcare globally

and the Irish economy locally. The centre’s

core competence resides in its profound

biomaterials and tissue-engineering knowledge

and its ability to offer ready-to-go expert

services to a wide client spectrum

under one roof from basic research to good

laboratory practice and good manufacturing

practice (GLP/GMP) certified level manufacturing

of simple to complex tissue engineered

products.

The establishment of a national research

centre like Cúram brings a huge advantage

to the Irish medtech sector. Working with

Cúram can help de-risk the R&D process for

industry and ensures that R&D becomes a

much stronger part of the ecosystem for

■ Prof. Abhay Pandit, what’s the purpose

of Cúram—what gap does it close

in comparison to existing R&D centres?

Cúram aims to take the fruits of its research—new

medical device products—to

clinical trial, which will lead to

job creation and spin-out medtech companies.

For this purpose Cúram brings

together strands of biomedical science

which have come of age over the last

decade, including glycoscience, biomaterials

science, regenerative medicine,

tissue engineering, drug delivery, and

medical device design. In doing so

Cúram brings together an unparalleled

combination of scientific, industry, clinistart-up

businesses and SMEs. Working

with Cúram gives companies here in Ireland

a competitive edge and adds a

huge amount of value to an Irish location

for multinational medtech companies

looking to invest in Ireland in the

future.

■ Is there already a kind of success story

I could mention—even if Cúram is just

fresh founded?

A key achievement was securing funding

for Med Train, a new industry-academic

fellowship programme which will

see 31 researchers enrol with Cúram’s

investigators as fellows with support

from EU’s Horizon 2020 programme. The

funding application was ranked number

1 out of 72 applications submitted from

across Europe to the Marie Skłodowska

Curie Actions Scheme under the Horizon

2020 funding programme. As a result,

the two-year post-doctoral fellowships

are being awarded to experienced researchers

in the area of Medical Device

Research and Development, including

Tissue Engineering and Regenerative

Medicine, Biomaterials and Drug Delivery,

Glyco and Protein Engineering,

and Neuromodulation and Computational

Modelling. Seven fellows have already

been recruited and further positions

are now being advertised. The programme

provides a chance for researchers

to enhance their creative,

entrepreneurial, and innovative potential.

02/2017 medicine&tec hn ology 73


■ [ RESEARCH ]

Success stories

made in Ireland

Photo: Neosurgical

Neo Close assists surgeons in closing

port-side defects up to 3 cm by using

bio-absorbable anchors and a Vector-X

closure.

End-of-surgery helper

Neosurgical Inc. from Galway has received

FDA and CE-mark approval for its flagship

product, Neo Close, which semi-automates

the closure procedure following laparoscopic

abdominal surgery.

“Being in Ireland provides us with an excellent

quality employee base and also access

to the variety of government funding and

university supports available for start-ups.

There is also a very well-established medical

device industry in the west of Ireland

where we are based, from services to component

suppliers and finished goods

manufacturers,” says Ronan Keating, CTO

of Neo Surgical.

www.neosurgical.com

Breathing sensor

PMD Device Solutions Ltd., based in Cork,

developed Respira Sense, a device which

discreetly measures a patient’s chest and

gut movement when breathing. Using Respira

Sense, medical staff can better diagnose

the earliest signs of possible patient

deterioration, such as increasing severity

of sepsis, worsening pneumonia, or oncoming

heart attacks.

www.pmd-solutions.com

Blood clot trapper

Neuravi Ltd. in Galway developed a revascularisation

device: The Embo Trap targets

blood clots, capturing them within the device

and allowing for immediate restoration

of blood flow while also cleaning up

any particles disturbed during the clot removal.

http://neuravi.com

where one-third of the 25,000 medical

device employees of the country work.

The most important clusters of medical

device companies are located here,

including multinational corporations

Medtronic and Boston Scientific. The

clusters are characterised by strong

connections between universities and

industry, the growth of the supplier

industry, and the exchange of knowledge

that spawns new start-ups. Last but

not least, Galway is known for its specialisation

in coronary devices. Therefore, it

has the very best conditions.

Cúram plans to develop smart

implantable medical devices

As an academic-industry-clinical super

centre, Cúram also plans to develop smart

implantable medical devices that can radically

improve patients‘ health conditions:

Implants will be designed and manufactured

to respond to the body’s environ-

NUI Galway has an established international

reputation in the field of biomedical

science. It is the biggest university in Ireland

for biomedical science research, and

Galway is one of five global hubs—San

Francisco, California; Minneapolis, Minnesota;

Boston, Massachusetts; Galway, Ireland;

and Munich, Germany. The research

centre Cúram is located in this building, too.

ment and to deliver therapeutic agents,

such as drugs, exactly where needed. The

overarching goal: the outputs will particularly

benefit patients with chronic diseases

such as heart disease, diabetes, and

musculoskeletal diseases. For this purpose,

Cúram brings together more than

24 industry partners and 6 research institutes

to work closely with one another

and wants to facilitate a rapid transition

to clinical practice.

The medical technology industry in

Ireland is changing from being prominently

manufacturing to being more complex

and driven by R&D. Meanwhile 60%

of all medical technology companies in

Ireland are involved in research and development

activities. Therefore, Ireland

continues to offer an exciting view. ■

Anke Biester

Journalist from Aichstetten/Germany

Additional information

AMBER (Advanced Materials and

BioEngineering Research)

http://ambercentre.ie

BDI (Biomedical Diagnostics

Institute)

www.bdi.ie

Infant (Irish Centre for Foetal and

Neonatal Translational Research)

www.infantcentre.ie

IPIC (Irish Photonic Integration

Centre)

www.ipic.ie

HRB CRCI (Health Research

Board Clinical Research

Coordination Ireland)

www.hrb-crci.ie

Photo: NUI Galway

74 medicine&technology 02/2017


The Body as a

Power Source

Applied information technology | Humans as a

power supply: The Karlsruhe Institute of Technology

develops methods to supply electronic devices with

kinetic energy.

Whether smartphones or pacemakers – devices need power.

Researchers at Karlsruhe Institute of Technology (KIT)

are working on solutions to operate devices using the body’s own

kinetic energy. “The challenge in harvesting the body’s kinetic

energy is in making sure that the power the user generates does

not require any additional exertion of force,” says Christian Pylatiuk

from the Institute for Applied Computer Science (IAI). With

his team, medical professional Pylatiuk developed two systems

that meet this requirement.

One design uses the body’s own weight when walking. A small

cushion filled with fluid is located under the heel and ball of the

foot. When one steps and rolls through the foot, oil is pumped

back and forth through a hose connection and drives a piston –

similar to a tidal power station in a miniature form – which in

turn drives a generator. The mini-power plant is installed in a

The mini-power plant is installed in the prosthetic foot. Sensors

actively support the wearer‘s movements

prosthetic foot that is equipped with sensors, which actively supports

the wearer‘s movements. “You could just as easily put the

mechanism a running shoe and use it to run a Tempo Trainer or

performance diagnostics,” said Pylatiuk.

Another generator is worn like a watch and acts like an automatic

watch. While the energy in the watch mechanism is stored

using flywheel mass that tensions a spring, in this case an induction

motor is used in which an extender wheel moves a magnet

back and forth in a coil.

www.kit.edu

Photo: KIT/Andreas Kell

02/2017 medicine&technology 75


■ [ RESEARCH ]

Biologically-based Inks for 3D Printing

3D structures | Researchers at Empa have been able to develop an environmentally

friendly ink made of cellulose nanocrystals for 3D printing. The microstructures can be

produced with exceptional mechanical properties, making them very promising for

implants and other biomedical applications.

A jaw bone is made of

cellulose ink on the 3D

printer

To manufacture 3D-microstructured

materials lsuch as those for applications

in composite materials, researchers

at the Swiss Federal Laboratories

for Materials Science and Technology

(Empa) have spent the last year using

a new 3D printing method called direct

ink writing (DIW). In DIW a viscous compound

– the printer ink – is extruded from

the printing nozzle and deposited on a

surface, in a way similar to a noodle press.

Empa researchers Gilberto Siqueira and

Tanja Zimmermann from the Department

of Applied Wood Research were able to

work with Jennifer Lewis of Harvard University

and André Studart of ETH Zurich

YOUR KEYWORDS






3D printing process

Direct ink writing

Micro-structures

Cellulose nanocrystals

Applications in biomedicine

Photo: Empa

to develop a new, environmentally

friendly 3D printer ink based on cellulose

nanocrystals (CNC).

Next to lignin and hemicellulose, cellulose

is one of the main components of

wood. This biopolymer consists of long

glucose chains arranged into fibrous

structures. In some places the fibrillated

cellulose fibres have an organised structure.

“The places that are highly organised

appear in crystal form. What we

need for our research are exactly these

sections that we can purify using acid,”

explains Siqueira. The final products are

cellulose nanocrystals, rod-like structures

measuring 120 nm in length and 6.5 nm

in diameter. The researchers wanted to

develop a novel, environmentally friendly

3D ink from precisely this material.

Ink with large amount of

cellulose nanocrystals

Previous inks contain at most 2.5% CNC,

a rather small “biological” percentage.

The Empa team wanted to increase this

amount – and was able to do so: The new

inks contain a good 20% CNC. “The big-

gest challenge was in achieving a viscoelastic

consistency that can also be extruded

through the nozzles of the 3D

printer,” says researcher Siqueira. The ink

has to be “tough” enough to allow the

printed material to keep its “shape” before

drying or curing and to prevent it from

running away immediately. The first CNC

mixtures were based on water. They functioned

in principle, but resulted in a very

brittle material. Consequently Siqueira

and his team developed a second recipe

on a polymer basis – with a decisive advantage:

After printing and UV curing,

CNC was “cross-linked” with the polymer

building blocks, which gave the composite

material significantly better mechanical

stability.

Controllable alignment

of nanocrystals

What seems so simple after the event,

gave the Empa team quite a headache during

the project, as Siqueira explains: “The

majority of polymers are hydrophobic;

they repel water. Cellulose, however, attracts

water; it’s hydrophilic. Consequently

it is by nature not very compatible.”

Therefore, the researchers first had

to chemically alter the surface of the CNC.

After the first printing trials and x-ray

analysis of the microstructures, the researchers

noticed that the CNC was almost

perfectly aligned in the printing direction

in the printed object. They therefore

concluded that the mechanical force

used to extrude the ink through the printing

nozzles was enough to arrange the

structures in this way. “It is very interesting

that you can control the alignment of

the nanocrystals, for example, when you

want to print something that needs to

have a specific stability in a certain direc-

76 medicine&technology 02/2017


tion,” explains Siqueira. These outstanding

mechanical properties are a definite

advantage compared to other materials

such as carbon fibres, which are also used

in DIW inks. The result is that the novel

ink from the Empa laboratories is based

on a renewable material, cellulose.

Research in applications

in biomedicine

“Cellulose is the most abundant naturally

occurring polymer on Earth,” explains Siqueira.

It is found not only in trees, but

also in other plants and even in bacteria.

The crystals isolated from different cellulose

sources have different morphologies

and sizes, but share the same properties.

They could also be of interest in the automotive

industry or for any type of packaging.

“The most important area of application

for me is in biomedicine,” so Siqueira,

“for example, for implants or prostheses.”

Empa researcher Siqueira is convinced:

Due to its outstanding mechanical

properties and the possibility for chemical

modification and alignment during printing,

the CNC material will make possible a

large number of different applications.

Empa will continue to research these

prospects. At present a postgraduate student

is focusing on the further development

of the material and the printing

method for other applications. Also a

master student will develop other biologically-based

inks. “The research in this

area is just starting,” so Gilberto Siqueira.

“Printing using biopolymers is a really hot

topic right now.”


Ramona Ronner

Technical journalist in Langnau am Albis/

Switzerland

Direct ink writing

(DIW)

The advantage of direct ink writing

(DIW) is in the virtually limitless selection

of material for the inks. Cartridges

can be filled with any type of

ink with different compositions, and

the inks can be printed directly and in

an alternating way. The printer has a

high-temperature and low-temperature

cartridge. This means that when

certain polymers are initially melted,

the melting can take place directly in

the printer. The temperature of the

substrate on which the item is being

printed can also be adjusted, for

example to allow hot liquid to cool as

soon as it touches the substrate. This

feature offers much freedom in the

development of novel inks with customised

properties.

THE BIG UNIVERSE

OF SMALL PARTS

PRODUCT

DEVELOPMENT

TOOL SHOP

INJECTION

MOLDING

SILICONE AND

MULTI-COMPONENT

PARTS

MASS

PRODUCTION

MICRO

INJECTION

MOLDING

CLEAN ROOM

Visit us at the fair

FAKUMA Friedrichshafen,

Germany, 17.-21.10.2017

Hall A4, booth 4312

STARLIM Spritzguss GmbH, 4614 Marchtrenk, Austria

www.starlim-sterner.com

02/2017 medicine&tec hn ology 77


■ [ INNOVATIONS ]

Installation and

Connection Made Easy

Laser marker | The DFL Ventus Marker Industrial Design

laser marker was specially developed for the industrial

environment and for use in production lines. It is designed

to simplify device installation and connection

for integrators.

The laser system DFL Ventus Marker Industrial Design is available as

a 19“ built-in unit or tabletop device

The compact DFL Ventus Marker Industrial Design laser system

offers special features for integrators. The laser head

with 3-m fibre lengths (optionally 5 m) can be mounted separately

from the supply unit in four mounting positions, giving

users great flexibility. Available as a 19“ built-in unit or tabletop

device, the laser system is available in various beam qualities and

power classes between 20 and 70 W, depending on the application.

The 100% air-cooled laser marker can be used in ambient

temperatures up to 40 °C. Even under the most adverse conditions,

the laser is resistant to ambient influences due to its dustand

water-spray-protected housing. It also has functional safety

through PLe in accordance with EN ISO 13849-1. For the integrator,

uniform standard electrical interfaces simplify the re-use

of existing mechanical, control, and software concepts.

As an optional feature, vision systems for automatic object

identification (AOI) or camera-assisted positioning of markings

(CPM) can be added to the laser system. A focus shifter for realtime

height adjustment in the marking of objects that have different

component heights can also be selected. The laser marker

also features fully integrated control with support of various

communication protocols, including TCP/IP, Industrial Ethernet,

Siemens S7 connection, USB, RS232, and RS485. Furthermore,

an encoder input allows the marking of moving parts.

A comprehensive software package including a remote diagnostic

tool and predefined parameter sets is also included. The

architecture of the Magic Mark V3 laser marking software allows

systematic access to all of the laser’s functions and control options,

as well as the laser’s peripheral devices.

ACI Laser, Nohra/Germany

Phone +49-(0)-3643–4152–21

Photo: ACI Laser

Material

Polypropylene Powder Can Be

Selectively Laser-sintered

Adhesive

Transparent Silicone Adhesive

Adheres Better to Skin

After two years of development, Advanc3D

has succeeded in developing a polypropylene

that can be laser-sintered. The Ad Sint PP Flex

powder features good plasticity, a breaking

elongation of 29%, low moisture absorption,

and high durability. It is comparable with standard

polypropylene and is a good alternative

to PA. This SLS material can be used to make

prototypes and small series directly from PP so

that the constructed material is consistent

with the material used in series production.

Like normal polypropylene, Ad Sint PP Flex

can be used in a wide range of applications, including

in heath care and orthopaedic products.

It allows for post-processing such as thermoforming and sealing. Above

all, the recycling rate of 80 to 100% is a major cost advantage compared to

PA. Ad Sint PP Flex is already available and can be ordered in 2-kg canisters

or 20-kg bags. It has been successfully tested on most common 3D-printing

SLS machines.

Photo: Advanc3D Materials

Advanc3D Materials, Hamburg/Germany

Phone +49-(0)-40–303933–11

The high-adhesion skin adhesive for medical devices,

Dow Corning MG 7–1010 Soft Skin Adhesive, is a solvent-free,

transparent skin adhesive that provides

even greater skin adhesion in comparison to established

silicone Soft Skin Adhesives. The adhesive was

specially developed to provide accurate and reliable

adhesion without cold flow from wearable electronic

devices and for the manufacturing of medical tape.

Potential application areas are in diagnostics, drug

delivery systems, patient monitoring, and wound

care. In processing, the adhesive supports flexible

and efficient manufacturing processes. Required

coating thickness and adhesion can be selected on

the basis of the functional requirements of the end

application. The product is ideal for direct and

transfer coating. The solvent-free adhesive also cures

quickly over a wide temperature range, which allows

the processing of temperature-sensitive materials

and additives.

Biesterfeld, Hamburg/Germany

Phone +49-(0)-40–32008–0

78 medicine&technology 02/2017


Nov 13, 2017 - Nov 16, 2017

HALL 08B | BOOTH H07

The CPAP gas mixer:

the freedom to innovate

The Bürkert gas mixer for continuous positive airway pressure (CPAP) devices unites



The Bürkert CPAP gas mixer delivers an intelligent, modular platform for

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your customers’ needs today and in the future. Now you can combine

state-of-the-art functions across your entire product line.





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high-frequency oscillation, and percent-accurate FiO2 functions

Working hand in hand as a trusted innovation partner, we can help you

transform your vision into tangible success. It’s why our unique combination

of collaboration and know-how is just what you need to get your

next CPAP project designed, certified, and launched in record time.

Start engineering your

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Want to know more? Just call: +49 (0)79 40 10-0 or visit

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02/2017 medicine&tec hn ology 79


■ [ INNOVATIONS ]

Now also with 15 W

DC-DC converter | The 15-W models introduce a new

performance class to the wide-input-range DC-DC converters

with the size of a postage stamp with all-round

shielding.

The DC-DC converter series with the size of a postage stamp

added a new member to its family: the CCG15 module.

These are available in the standard format of 25.4 x 25.4 mm2

(1“ x 1“, 9.9 mm in height), have an ultra-wide range 4:1 input,

are shielded on all sides thanks to their metal housing, and are

designed primarily for applications in data communication and

telecommunication, industrial controllers, wireless communication,

and wearable battery-operated devices. The input voltage

range of the 15-W model can be selected as 9 to 36 V DC or 18 to

76 V DC. The output provides 3.3, 5, 12, or 15 V DC with currents

of up to 4 A, whereby the output voltage can be adjusted by

±10%. The large input voltage range helps to simplify inventory

management, stocks, and component availability since the same

module can be operated at nominal input voltages of 12 and 24 V

or 24 and 48 V DC, so that each nominal input voltage no longer

The same module can be operated at several nominal input

voltages. This helps to simplify inventory management.

needs to be catered for. The CCG15 converters have an efficiency

of up to 88% and operate at ambient temperatures from 40 to

85 °C. The standard version includes an adjustable output voltage

as well as a remote on/off function, overcurrent and overvoltage

protection, and a five-year warranty. The modules are

also fully insulated with an insulation voltage between the input

and output of 1,500 V DC and between the input or output and

the housing of 1,000 V DC. The safety certifications include IEC/

EN 60950–1 and UL/CSA 60950–1. DC-DC converters also have

CE marking in compliance with the Low Voltage Directive and

the RoHS2 Guideline.

TDK-Lambda Germany,

Achern/Germany

Phone +49-(0)-7841–666–0

Photo: TDK Lambda

MEMS inertial sensors

Capable of Resolutions of 10 μg or 0.0005°

3D coordinate measuring machine

Closes the Gap Between Manual Measuring

Instruments and Coordinate Measuring Devices

The high-precision capacitive silicon inertial sensors can

measure inclination, acceleration, and vibration. They

consist of a silicon sensor element

manufactured on the basis of patented

micro-mechanical technology

(Harms, AIM)

combined with ASIC

signal processing in a

hermetically sealed

SMD housing. Depending on

bandwidth, the inertial sensors

achieve resolutions of 10 μg or 0.0005°

(2 arc second) and can be mechanically or electrically

adapted to the customer’s application. Evaluation kits

are also available for simple and quick analysis and configuration

of the sensors. The inclinometers with

measurement ranges of ±30° achieve a noise density of

less than 0.0004°/√Hz and resolutions of less than

0.0015° at a measurement frequency of 10 Hz. The accelerometers

have measurement ranges of ±3 g, ±8 g,

and ±15 g and achieve a noise density of less than

30 μg/√Hz and resolutions of less than 40 to 95 μg at a

measurement frequency of 10 Hz.

Photo: First Sensor

First Sensor,

Puchheim/Germany

Phone +49-(0)-89–80073–0

The 3D coordinate measuring

machine from the XM model

series makes measuring times

even shorter and increases

productivity. The device is

easy to use, offers flexibility in

use, and is intuitive to operate.

The wide field of view can also

measure large components, as

the measuring points can be

set regardless of probe angle.

Thanks to its compact design,

it can be used anywhere as a

tabletop device, even outside

of the measuring room in nonair-conditioned

rooms. The

stylus is available in different

lengths and

sizes and can

take a large number of different

measurements. The angle

of the stylus can be changed

incrementally to take the optimum

measurement. A second

measuring sensor can also be

connected simultaneously.

Keyence Deutschland,

Neu-Isenburg/Germany

Phone +49-(0)-6102–3689–0

Photo: Keyence

80 medicine&technology 02/2017


Labelling solution

Version 3.0 of Browser-based Solution

Meets EU’s UDI and SEC Requirements

Metal bellows coupling

Mini-variant Functions from –20 to +90 °C

Version 3.0 of Spectrum, the

fully browser-based solution

for complex labelling requirements,

is aimed towards companies

that need solutions with

high volumes and have to satisfy

all country-specific statutory

requirements for labels. Spectrum

3.0 introduces an intuitive

Business Rules Configurator.

Users can now implement

complex business logic

quickly and easily by themselves,

without the aid of IT experts.

A library of predefined

blocks makes it possible to create

common logic sequences

that speed up the setup of complex

business processes. In addition,

a reusable library of

rules can be shared with

others. The Business Rules

Configurator can be used to

simply test and record data to

confirm that new business

rules meet the requirements.

Companies are given an interface

that optimises the creation

and management of label logic

through simple drag-and-drop

functions. Spectrum allows

companies to comply with the

EU’s regulatory requirements

for medical devices, including

the unique device identification

(UDI) requirements and

the new single European code

(SEC) coding system requirements

for standardised labelling

of human tissue samples.

This ensures proper identification

and traceability in the

healthcare sector.

Loftware, Hüfingen/Germany

Phone +49-(0)-771–8978–4250

Photo: Enemac

In the cost-effective

EWKA miniature

metal bellows coupling,

a special adhesive

is used to connect

the bellows and hubs.

This adhesion process

allows these

couplings to be used

within a temperature

range of –20 to +90 °C. The coupling is designed for

all applications in which high torsional rigidity and

high displacement compensation are required. It is

available in six sizes ranging from 0.4 to 8 Nm. Shafts

with diameters up to 26 mm can be used. The miniature

metal bellows coupling is frictionally secured to

the end of the shaft by means of set screws, which ensures

zero backlash and low-vibration torque transmission.

This version is primarily intended for use in

control and regulation technology.

Enemac, Kleinwallstadt/Germany

Phone +49-(0)- 6022–7107–0

Profile tool system

Combined Application Solutions in Trend

Label printing

App Improves Labelling Efficiency

and Accuracy

Photo: Schwanog

In the area of form tprofile systems,

Schwanog Siegfried

Güntert is increasingly developing

combination systems

which combine several applications

in a single tool. A current

example is a multi-use

tool that can be used to

achieve double-digit savings

in unit costs. For one customer,

a special tool was developed

that combines

three processing

steps:

• Solid carbide spiral

drill

• Turning tool

•Face grooving

using PWP insert

This combination

tool allows the customer

to achieve

significant, twodigit

savings in unit

costs and ensures

process reliability. Also customers

no longer have to

change tools, and testing

requires less effort.

Schwanog Siegfried Güntert,

Villingen-Schwenningen/

Germany

Phone +49-(0)7721–9489–0

This app prevents labels from

being printed twice or not

being printed at all following

an interruption in the printing

process. The app improves efficiency

and prevents errors

from occurring during printing

by enabling bidirectional,

PJL-controlled transmission of

data via VPSX to Sato label

printers of the CLNX series. In

the event of an unexpected interruption

of the process, this

functionality allows the

printer to resume printing

exactly at the place where it

was interrupted without the

operator needing to intervene.

The app is fully compatible

with the manufacturer’s application-enabled

printing technology.

It can be easily installed

directly on the printer

via USB or an internal network

and takes over all communi-

cation in PJL. The app has no

effects whatever on other

printer functions. Updates and

expansions can also be integrated

into the app and then

implemented from a central

point so that the printing functions

can be adapted quickly

and flexibly to the customer’s

requirements.

Sato Europe,

Heidelberg/Germany

Phone +49-(0)6221–5850–0

Photo: Sato/LRS


■ [ INNOVATIONS ]

Publisher:

Katja Kohlhammer

Publishing House: Konradin-Verlag

Robert Kohlhammer GmbH

Address: Ernst-Mey-Straße 8,

70771 Leinfelden-Echterdingen,

Germany

Managing Director: Peter Dilger

EDITORIAL STAFF

Editor-in-Chief:

Senior editor:

Contributing editors:

Editorial Assistant:

Design director:

Dr. Birgit Oppermann (op),

Phone +49 711 7594–459

Susanne Schwab (su),

Phone +49 711 7594–444

Bettina Gonser (bg),

Sabine Koll (sk)

Daniela Engel,

Phone +49 711 7594–452,

Fax +49 711 7594–1452

E-Mail: daniela.engel@konradin.de

Vera Müller,

Phone +49 711 7594–422

ADVERTISING

Advertising production Joachim Linckh,

director: Phone +49 711 7594–565,

Fax +49 711 7594–1565

Order management Matthias Rath,

director: Phone +49 711 7594–323,

Fax +49 711 7594–1323

Current advertising rate list no. 12 from Oct. 1, 2017

SUBSCRIPTIONS

Reader service:

Ute Krämer,

Phone +49 711 7594–5850,

Fax +49 711 7594–15850

E-Mail: ute.kraemer@konradin.de

Single copy € 11.20 (including tax, excluding shipping).

Contact the publisher to make an order.

Nanopositioning stage

Precise Positioning of Objectives with High Numerical

Aperture or Optical Instruments

Qfocus QF-50 nanopositioning stages facilitate

precise positioning of microscope

objectives and optical instruments. The

stages provide closed-loop travel of

400 μm and open-loop travel of 450 μm,

high positioning speed, linearity deviation

of 0.01%, increments in the sub-nanometre

range, and bidirectional repeatability

of 4 nm. The QF-50 can be used in

combination with optical instruments and

processes for laser micro-machining. Due

to its structural rigidity, the QF-50 can

also be used to position objectives with a

high numerical aperture. The stage is

positioned through zero-play guides,

which were calculated using finite element

analysis. This guarantees high

rigidity, high process throughput, and fast

closed-loop response times. Special attention

was paid to the flexure joints during

the design of the QF-50. Aerotech guarantees

a straightness error of less than

40 nm throughout the entire travel range.

For closed-loop operation, the positioning

stages can be equipped with optional capacitive

sensors. Unlike DMS sensors or

piezoresistive sensors, capacitive sensors

facilitate direct position measurement

and guarantee accuracy and repeatability.

Aerotech Germany, Fürth/Germany

Phone +49-(0)-911–967–9370

Computed tomography scanner

Combines Many Advantages of Various Device Classes in

Quality Assurance of Workpieces

Photo: Aerotech

INTERNATIONAL OFFICES

Belgium, France, Italy,

Luxemburg, Switzerland: Great Britain, Ireland:

IFF media ag

Jens Smith Partnership

Frank Stoll

The Court, Long Sutton

Technoparkstrasse 3

GB-Hook, Hampshire RG 29 1TA

CH-8406 Winterthur Phone 01256 862589

Tel: +41 52 633 08 88 Fax 01256 862182

Fax: +41 52 633 08 99 E-Mail: media@jens.demon.co.uk

e-mail: f.stoll@iff-media.ch

Japan:

USA:

Mediahouse Inc.

D.A. Fox Advertising Sales

Kudankita 2-Chome Building Inc. Detlef Fox

2–3–6, Kudankita 5 Penn Plaza, 19th Floor

Chiyoda-ku, Tokyo 102 New York, NY 10001

Phone 03 3234–2161 Phone +1 212 8963881

Fax 03 3234–1140 Fax +1 212 6293988

E-Mail: detleffox@comcast.net

Featured articles reflect the opinion of the author, but not

necessarily that of the editorial staff. We will not be responsible

for manuscripts sent without solicitation. All articles published

in medicine&technology are protected by copyright.

All rights, and translations, reserved.

Reproductions of all kinds are prohibited without the written

approval from the publisher.

The place of fulfillment and jurisdiction is Stuttgart.

Printing company:

Konradin Druck, Leinfelden-Echterdingen

Printed in Germany

© 2017 by Konradin-Verlag Robert Kohlhammer GmbH,

Leinfelden-Echterdingen

According to Werth Messtechnik, the Tomoscope

XS computed tomography

scanner offers the technology of large

scanners in a small format. The device

type combines many advantages of various

device classes. A small focal spot can

be achieved through the transmission

tubes even at high tube powers, allowing

for rapid measurements with high resolution.

The X-ray source combines the advantages

of closed and open micro-focus

X-ray tubes. The monoblock design of

tubes, generator, and vacuum generator

was implemented for the first time in an

open construction. This results in long

maintenance intervals and a theoretically

unlimited lifespan. Downtimes and operating

costs are minimised. The maximum

tube voltage is 130 or 160 kV, so that

workpieces with long scan lengths and

denser materials can be measured. The

air-bearings of the rotary axis ensure low

measurement uncertainty through highprecision

positioning of the workpiece.

The device can be installed almost anywhere

due to its compact design and low

weight. Reconstruction of the workpiece

volume takes place in real-time in parallel

with the imaging, allowing for rapid

measurements to be made during processing.

The use of the Win Werth

measurement software for the entire

measurement process facilitates traceability

of the measurements.

Werth Messtechnik, Giessen/Germany

Phone +49-(0)-641–7938–0

Photo: Werth

82 medicine&technology 02/2017


Tampering prevention

Permanently Stops Access by Unauthorised

Parties to Screws with Internal Drive

simply and reliably. A single user can

therefore control the tracker effortless

from anywhere in the measurement area.

Other workflow management functions

allow users to perform accuracy tests remotely

and set up a configurable warmup

phase. The remote control has also a

function with which the laser beam can be

automatically realigned indoors or outdoors

using simple gestures. Interruption

of the laser beam and manual recapture of

the target have now become things of the

past. The product family consists of two

modules—Vantage E with a 25-m range

and Vantage S with an 80-m range. The

compact modules are lightweight and

have an integrated main controller and

replaceable batteries. The industrial

WLAN function enables wireless communication.

THREAD-

LESS

Parryplug is a locking element for

internal drives and protects screw

connections on systems and machines

against unauthorised loosening.

This aesthetic solution

meets the growing demands for

tampering and theft protection in

many technical areas. Up to six

plugs in the magazine enable installation

without tools. A handling aid

enables assembly. The specially

constructed axial ribs guarantee a

defined and secure press fit in the screw

drive. Use of high-performance plastic,

which can be used without problems at

temperatures ranging from –50 to

+200 °C, and precision manufacturing

ensure that even the smallest tolerances

of hexagon socket drives can be taken into

account. The locking element can only be

Photo: Böllhoff

removed with the aid of a special tool.

Tampering protection can be made in any

colour at the customer’s request and also

protects the element from contamination

and corrosion.

Böllhoff Group, Bielefeld/Germany

Phone +49-(0)-521–4482–01

LEE Miniature Valves,

Orifices and Screens

Simply inserted and locked

by expansion method

Laser tracker

Product Line Now Equipped With Mobile Device Control

The Vantage laser tracker product family

is ideal for extensive measurement applications

and can easily be controlled remotely

from a mobile telephone or tablet

thanks to the remote control function.

The mobile device can control the movements

of the laser tracker, and also has

advanced functions. Users can transmit

live video feeds from the target cameras

Photo: Faro

Faro, Korntal-Münchingen/Germany

Phone +49-(0)-9797–0

VISIT US:

CompaMed

13.-16.11.17

Düsseldorf

Halle 8b - St.K09

LEE Hydraulische

Miniaturkomponenten GmbH

Am Limespark 2 · 65843 Sulzbach

Germany

Phone +49 (0) 6196 77369 - 0

E-mail info@lee.de

www.lee.de

02/2017 medicine&technology 83

THE LEE COMPANY SINCE 1948


Medical progress.

With high-performance plastics.

Innovations for biomedical engineering and laboratory technology. Tailor-made from high-performance plastics such as

Poytetraflon PTFE and the thermoplastic material Moldflon PTFE, PEEK, PFA, FEP and ETFE. Proven in endoscopy, analytics,

in implants and in device technology. For optimum therapeutic success, cost efficiency and high patient safety. Certified

according to EN ISO 13485, manufactured in class 8 cleanroom facilities.

Visit us in Düsseldorf

November 13-16, 2017

Hall 8b, Stand E03

www.elringklinger-kunststoff.de

sales.ekt@elringklinger.com

Phone +49 7142 583-0

Additional info: www.ek-kt.de/medical

84 medicine&technology 02/2017

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