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<strong>01.2019</strong><br />

www.medizin-und-technik.de<br />

RRP 11,20– €<br />

Engineering for the<br />

Medical Device Industry<br />

FEATURE<br />

New 5G Standard<br />

What a 5G Network could offer for<br />

production areas and hospitals<br />

Page 34<br />

Medical Device Regulation<br />

Lack of clarity for MDR<br />

implementation by May 2020 Page 12<br />

Research in Lithuania<br />

Combined know-how in engineering,<br />

life sciences, and IT like AI Page 62<br />

Trade Fair<br />

MEDICA/COMPAMED<br />

New products and trends<br />

18.11.-21.11.2019 Page 21<br />

medicine&<strong>technology</strong>


GF Machining Solutions<br />

Medical<br />

Production-oriented<br />

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and industrial knowledge, the DMP Flex 350 is engineered to bring repeatable part quality and high productivity<br />

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manufacturing processes.<br />

Unique vacuum chamber concept<br />

High repeatability for<br />

high-quality parts<br />

DMP Monitoring<br />

Enhanced quality control<br />

3DXpert all-in-one software<br />

Simplified metal AM<br />

process workflow<br />

www.gfms.com<br />

DMP Flex 350<br />

2 medicine&<strong>technology</strong> 01/2019


Digitalisation is the Future<br />

– but First Comes the MDR<br />

You know it has to be an important topic when a large in -<br />

dustry trade fair like Medica devotes an entire hall to it:<br />

digitalisation and related topics will be grouped together in<br />

Hall 13 this year. Read more about digitalisation and the trends<br />

at the Medica and Compamed trade shows in Dusseldorf in our<br />

trade fair section starting on page 21.<br />

The growing importance of data and data usage in healthcare<br />

and in medical <strong>technology</strong> is not only evident at the trade shows.<br />

Take, for example, the Internet of Medical Things, which will<br />

need to be developed around the new 5G standard. Test environments<br />

already exist, like the ones in Munich or Oulu. We<br />

dedicated the feature of this issue to these developments. Starting<br />

on page 34, you will learn which things are working and<br />

what still needs to be worked out.<br />

A forerunner in digitalisation is Lithuania, where an exciting research<br />

landscape has unfolded. Medical data are the basis for<br />

start-ups and pioneering research projects here (page 62).<br />

Yet, whoever is entering new territory should not disregard the<br />

old values or the old ethical questions. In an interview with<br />

Prof. Alena Buyx, the need for research on self-learning systems<br />

in medicine, in which not even doctors can determine how the AI<br />

came to its decision, becomes clear (page 16).<br />

Of course, you cannot talk about medical devices today without<br />

considering the current developments introduced by the<br />

Medical Device Regulation. TÜV Süd is one of the first de -<br />

signated notified bodies in Europe. Dr. Bassil Akra, Vice Pre -<br />

sident Global Strategic Business Development of Medical &<br />

Health Services, explains in an interview on page 12 why he<br />

thinks time-out on the MDR is needed.<br />

IN PURE FORM FOR<br />

MEDICAL, DIAGNOSTICS<br />

& PHARMA<br />

We bring plastics to life.<br />

As a system supplier for medical science,<br />

diagnostics and pharmaceutics we construct,<br />

develop and produce your ideas.<br />

We have the maximum passion for precision<br />

in both our in-house tool making as<br />

well as in clean room production.<br />

COMPAMED, Düsseldorf<br />

18 – 21 November 2019<br />

Visit us: Hall 8b, Stand D21<br />

Riegler GmbH & Co. KG<br />

Bahnhofstraße 80<br />

64367 Mühltal<br />

Germany<br />

www.riegler-medical.com<br />

A Wirthwein-Group Company<br />

Dr. Birgit Oppermann<br />

01/2019 medicine&tec hn ology 3


■ Market and<br />

Management<br />

MDR Implementation:<br />

A Lack of Clarity<br />

Too many details about MDR are still<br />

unclear, says Dr. Bassil Akra, Vice Pre -<br />

sident Global Strategic Business Development<br />

of Medical & Health Services at<br />

TÜV Süd ...........................................12<br />

Market Development in South Korea<br />

South Korea’s healthcare system is still<br />

dependent on imports of innovative<br />

medical <strong>technology</strong> ............................14<br />

Trade Fair<br />

Medica/Compamed<br />

Digitalisation, Key Focus Area for<br />

Medica and Compamed .....................22<br />

Medical-grade Plastics: New additive<br />

for smooth synthetic materials ...........24<br />

Laser Treatment: Heart valves with<br />

scaffold open up new therapies ..........26<br />

Assistance for the Development<br />

of IVD Analysers ................................28<br />

Multilayer Film for<br />

Sterile Touch Keyboards ....................30<br />

Access Catheter: A platform opens<br />

a window into the body .....................32<br />

34<br />

■ Medicine in Dialogue<br />

Ethical Questions on AI in Medicine<br />

There is an ethical framework for new<br />

technologies in medicine. For AI, however,<br />

many detailed questions have remained<br />

unanswered, reports Ethics Professor<br />

Alena Buyx ..............................16<br />

16<br />

■ Technology<br />

Mobile Communications on 5G<br />

The fifth generation (5G) is far more<br />

than the successor of LTE: Manufacturers<br />

of medical <strong>technology</strong> can use 5G to build<br />

their own networks. The starting gun for<br />

new medical devices? ........................34<br />

Development/Components<br />

Blood Sugar Measurement:<br />

Meter powered by sugar in the blood .40<br />

Small Motor Clears Clot from Vessel at<br />

40,000 Revolutions per Minute ..........50<br />

Manufacturing<br />

3D Printing of Individual Parts and<br />

Implants from Titanium Powder ........52<br />

Integrating 3D Printing for<br />

Contract Manufacturers .....................54<br />

Screws for Endoprosthetics:<br />

Better to broach than to ream ............56<br />

Photo: Klaus Ranger<br />

According to<br />

Dr. med. Alena<br />

Buyx, Professor<br />

of Ethics, AI in<br />

medicine raises<br />

new questions<br />

Medical Device Software: Licensing<br />

only for needed functions ..................42<br />

Decontamination with DBD Plasma:<br />

A new <strong>technology</strong> in disaster relief .....44<br />

Automated Analysis in the Lab: Precise<br />

movements around the blood sample 46<br />

AI Provides Rapid Conclusions<br />

for Quality Management ...................58<br />

Liquid Silicone Rubber:<br />

New properties available ...................60<br />

Polymer Plain Bearings in the Knee<br />

Prosthesis: Lighter and quieter ...........48<br />

58<br />

4 medicine&<strong>technology</strong> 01/2019<br />

Photo: Alexander Limbach/Fotolia<br />

Good or not good?<br />

Artificial intelligence<br />

can recognise<br />

relationships that<br />

remain hidden to<br />

human understanding


Photo: Elnur/stock.adobe.com<br />

Feature<br />

5G: Potential<br />

for the Medical<br />

Device Industry<br />

Manufacturers of medical devices can use<br />

5G to build their own networks and advance<br />

factory automation. Also, 5G makes<br />

the Internet of Medical Things possible<br />

through short latency times and high<br />

reliability. .........................................34<br />

■ Research<br />

Research in Lithuania<br />

In the area of medical <strong>technology</strong>,<br />

Lithuania stands out with its combined<br />

know-how in engineering, life sciences,<br />

and IT ................................................62<br />

Rubrics<br />

Editorial ............................................03<br />

Visions ...............................................06<br />

News .................................................08<br />

Innovations .......................................66<br />

Imprint ..............................................68<br />

Real-time Tracking<br />

Researchers in Dresden have been able to<br />

track moving micro-objects deep in the<br />

tissue in real time ..............................65<br />

62<br />

Photo: prosign/Fotolia.com<br />

Lithuania<br />

combines<br />

know-how<br />

in engineering,<br />

life<br />

sciences,<br />

and IT like<br />

AI<br />

Cover photo: The new 5G standard may<br />

be the solution to seek out new applications<br />

and to advance the Internet<br />

of Medical Things. Initial test environments<br />

have already been constructed<br />

(Photo: Elnur/stock.adobe.com)<br />

01/2019 medicine&tec hn ology 5


VISIONS<br />

6 medicine&<strong>technology</strong> 01/2019


Plates—for<br />

Implants Too<br />

It does not get much stiffer than<br />

this: Material researchers at ETH<br />

Zurich University and MIT have developed<br />

new internal structures for<br />

materials that have to absorb forces<br />

not just from one direction, but<br />

from all three dimensions, and that<br />

are extremely stiff at the same<br />

time. Mathematical calculations<br />

have shown that the new design<br />

comes extremely close to the maximum<br />

stiffness that is theoretically<br />

achievable. In other words: It is<br />

practically impossible to develop<br />

other material structures that are<br />

stiffer at this specific weight. Characteristic<br />

of the new design is that<br />

the stiffness of the material’s interior<br />

is not achieved with trusses,<br />

but with regularly reoccurring plate-lattice<br />

structures.<br />

The ETH scientists under Dirk Mohr,<br />

Professor of Computational Modelling<br />

of Materials in Manufacturing,<br />

developed the structures on the<br />

computer first. Next, the researchers<br />

created the structures<br />

out of plastic on the micrometre<br />

scale using 3D printing. The advantages<br />

of this design are universal,<br />

however: for all materials and on all<br />

scales of magnitude, from the nanometre<br />

scale to very large.<br />

Potential applications are practically<br />

limitless, states Mohr. Medical<br />

implants, laptop housing, and ultra-light<br />

vehicle structures are only<br />

three of many possible examples.<br />

Photo: ETH Zurich/Marc Day<br />

01/2019 medicine&tec hn ology 7


■ [ NEWS ]<br />

GS1 standards for<br />

the EU MDR<br />

Medical Device Regulation | GS1 Germany has been<br />

accredited by the European Commission as an official<br />

Unique Device Identification (UDI) issuing agency.<br />

GS1 standards make medical devices unmistakable.<br />

Photo: B. Braun Melsungen<br />

The European Commission has accredited GS1 Germany as<br />

an official Unique Device Identification (UDI) issuing agency.<br />

This means that companies can use the standards and<br />

solutions of GS1 Germany to meet EU requirements in accordance<br />

with the Medical Device Regulation (MDR).<br />

Medical devices must be clearly identified and completely<br />

traceable. The European Commission has laid out the relevant<br />

requirements for Europe in the MDR. This includes implementing<br />

the Unique Device Identification system, which uses a UDI<br />

Device Identifier (UDI DI) to identify medical devices in a clear<br />

and standardised manner. The UDI ADI is a unique numerical or<br />

alphanumeric code which is assigned to a product model. It can<br />

be used to access information about the product in a UDI database.<br />

In addition to meeting US requirements, GS1 standards now enable<br />

manufacturers of medical devices and in-in vitro diagnostics<br />

to meet the European requirements regarding the labelling and<br />

identification of their products laid out in the MDR, in addition<br />

to ensuring that the necessary product data is provided in a UDI<br />

database. “The GS1 standards also help companies and their<br />

business partners to improve the efficiency of their ordering<br />

and logistics processes and improve patient safety. I would therefore<br />

recommend that they start work on implementing the standards<br />

in the near future,” states Sylvia Reingardt, Senior Branch<br />

Manager at GS1 Germany.<br />

Manufacturers require a UDI DI for both new products and any<br />

changes which could lead to a product being misidentified or<br />

could result in traceability issues. These changes mainly involve<br />

alterations to a product’s name, version or models, guidance related<br />

to the sterile nature of a product or the need to sterilise a<br />

product before it is used, packet sizes, warnings and contraindications.<br />

Manufacturers must allocate this individual identifier to<br />

both the dosage unit of its device and each level of packaging.<br />

GS1 stands for Global Standards One. Cologne-based GS1 Germany<br />

is part of the international GS1 network. It is the second<br />

largest of the more than 110 GS1 national organisations after<br />

GS1 US.<br />

www.gs1.de/udi<br />

IERA Award<br />

UV Disinfection Robot<br />

Kills Hospital Bugs<br />

Apex Digital Health<br />

New Funds for Start-ups<br />

in the Healthcare Sector<br />

The winner of the 15 th Award<br />

for Innovation and Entrepreneurship<br />

in Robotics and<br />

Automation (IERA) is the UVD<br />

robot made by Danish company<br />

Blue Ocean Robotics.<br />

The collaborative robot moves<br />

through hospitals autonomously<br />

whilst emitting concentrated<br />

UVC light to remove<br />

bacteria and other harmful<br />

micro-organisms: The dis -<br />

infection rate is reported to be<br />

Photo : Blue Ocean Robotics<br />

99.99 percent. The UV dis -<br />

infection robot treats the surfaces<br />

with light from several<br />

angles at close range. It disinfects<br />

all contact surfaces and<br />

even stops at predefined hotspots<br />

that take longer to disinfect.<br />

Whilst the UVD robot is<br />

no replacement for manual<br />

cleaning, it is a complemen -<br />

tary system. The robot comes<br />

with a number of safety features<br />

to prevent people from<br />

being exposed to UVC light.<br />

For example, a tablet with a<br />

motion sensor is placed on the<br />

door to the patient’s room:<br />

The UVC light switches off<br />

when someone enters the<br />

room.<br />

www.ifr.org<br />

European venture capital firm<br />

Apex Ventures, with offices in<br />

Vienna and Frankfurt, announced<br />

a new fund: Apex<br />

Digital Health. The company<br />

intends to raise EUR 50 million<br />

in capital for this fund.<br />

The new fund is focused on<br />

young companies, primarily<br />

from the DACH region, that<br />

develop very promising technologies<br />

and applications for<br />

the healthcare industry.<br />

The partner for Apex Digital<br />

Health is Dr. Gordon Euller<br />

(36), a medical professional<br />

who has experience as a<br />

specialist in radiology, a corporate<br />

consultant for McKinsey,<br />

and an Apex founder. He<br />

is responsible for selecting and<br />

supporting companies.<br />

Photo : REDPIXEL/Fotolia<br />

With its first fund, Apex One,<br />

Apex Ventures has already invested<br />

in several digital health<br />

companies: The list includes<br />

Image Biopsy Lab, which provides<br />

AI solutions to doctors<br />

in orthopaedic diagnostic<br />

radiology, and Contextflow,<br />

which facilitates the work of<br />

radiologists with a search engine<br />

for 3D CT scan images.<br />

www.apex.ventures<br />

8 medicine&<strong>technology</strong> 01/2019


Lipid-resistant, BPA-free,<br />

and highly transparent:<br />

CYROLITE® acrylics are<br />

the reliable invisible helpers<br />

in hospitals and labs.<br />

CYROLITE® has been working in hospitals and<br />

labs for more than 40 years. Thanks to their<br />

excellent properties, our high- performance<br />

acrylics are perfect for use in a wide range of<br />

medical devices. CYROLITE® is highly transparent<br />

and easily processed into intricate<br />

parts. It can be reliably sterilized using most<br />

common methods and is BPA- and DEHP-free.<br />

This has impressed both patients and healthcare<br />

professionals alike: CYROLITE® meets<br />

the requirements of USP Class VI, ISO 10993-1,<br />

and REACH. You can find more details at<br />

www.cyrolite.com.<br />

01/2019 medicine&tec hn ology 9


■ [ NEWS ]<br />

MedTech<br />

from Ireland<br />

Export growth | In response to the imminent Brexit,<br />

Irish companies are turning their sights more and more<br />

to the EU—and with success. Medical <strong>technology</strong><br />

manufacturers are reporting increasing sales figures in<br />

the eurozone.<br />

In recent years, Ireland has become one of the world’s most important<br />

competence centres in medical <strong>technology</strong>: Ireland’s<br />

inward promotion agency (IDA Ireland) reports that 450 medical<br />

<strong>technology</strong> companies have established offices on the Emerald<br />

Isle, including 18 of the 24 leading specialists in the world. They<br />

produce 80 percent of the global market volume in stents, 75 percent<br />

of orthopaedic knee devices, and 50 percent of ventilators.<br />

Also, as a supplier partner, Ireland supplies a large number of<br />

medical <strong>technology</strong> manufacturers in the European Union,<br />

which benefit from duty-free commerce and a strong partner in<br />

service.<br />

Enterprise Ireland is currently providing ample support to companies<br />

to reduce their dependence on exports from the United<br />

Kingdom. The goal is to increase exports to the European market<br />

by 50 percent by 2020. The eurozone is Ireland’s second largest<br />

MedTech made in Ireland: Irish exports to Germany increase in response<br />

to the imminent Brexit.<br />

export market after the United Kingdom—within the eurozone,<br />

Germany is first, so Enterprise Ireland. “Given Brexit, German<br />

companies are looking increasingly for innovative medical <strong>technology</strong><br />

and partners in Ireland, which is reflected in growth<br />

among our Irish customers in exports to Germany,” explains<br />

Eddie Goodwin, Manager Germany, Switzerland, and Austria at<br />

Enterprise Ireland. The Irish government’s inward promotion<br />

agency works closely with Irish companies and offers support in<br />

developing global markets and increasing exports. “The Republic<br />

of Ireland is and will be an integral part of the European Union,”<br />

continues Goodwin. “The United Kingdom’s exit from the EU is a<br />

challenge not only for Ireland, but also for all of our European<br />

neighbours.”<br />

www.enterprise-ireland.com<br />

Photo: Enterprise Ireland<br />

Blockchain and IoT<br />

TCS and SAP Simplify Inventory<br />

Management of Surgical Instruments<br />

Visualisation systems<br />

Intuitive Surgical Takes<br />

Over Robotic Endoscopes<br />

Photo : alfa27/Fotolia<br />

Together with SAP, Tata Consultancy<br />

Services (TCS) places on the market a<br />

solution for the inventory management of<br />

surgical instruments for medical device<br />

manufacturers. Based on technologies<br />

within SAP Leonardo, TCS’s Intelligent<br />

Field Inventory Management (IFIM) uses<br />

the Internet of Things (IoT) to keep track<br />

of instruments. In addition, IFIM employs<br />

blockchain <strong>technology</strong> to enable greater<br />

transparency of the inventory<br />

for all parties involved—from<br />

manufacturers, to distributors<br />

and hospitals. The solution<br />

also helps optimise inventory,<br />

eases compliance with regulatory<br />

requirements, and processes<br />

returned instruments.<br />

Intelligent Field Inventory<br />

Management can be integrated<br />

into existing core systems and<br />

is scalable to meet the dynamic<br />

requirements of the supply<br />

chain in the life sciences industry.<br />

Tata Consultancy Services has been a<br />

partner to international companies in IT<br />

services, consultation, and business solutions<br />

for the last 50 years. As part of the<br />

Tata group, the largest multinational<br />

business group in India, TCS has more<br />

than 424,000 employees in 46 countries.<br />

www.tcs.com<br />

Intuitive Surgical is acquiring Schölly<br />

Fiberoptic’s robotic endoscope business.<br />

Based in Sunnyvale, California/USA, Intuitive<br />

Surgical is a pioneer and one of the<br />

world‘s leading companies in the field of<br />

robot-assisted minimally invasive surgery.<br />

It also makes Da Vinci Surgical Systems.<br />

Schölly’s manufacturing line for robot-assisted<br />

endoscopes and two of Schölly’s<br />

sites will be integrated into Intuitive’s surgical<br />

business: the robotic-related manufacturing<br />

line in Denzlingen/Germany,<br />

the manufacturing site in Biebertal/Germany,<br />

and the repair site in Worcester,<br />

Massachusetts/USA. Intuitive will integrate<br />

roughly 200 employees at these sites<br />

into its team over the next 18 months.<br />

Schölly, headquartered in Denzlingen,<br />

has been working as a strategic supplier<br />

for Intuitive for more than 20 years.<br />

www.intuitive.com<br />

10 medicine&<strong>technology</strong> 01/2019


MEDICAL<br />

TECHNOLOGY<br />

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

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01/2019 medicine&tec hn ology 11


■ [ MARKET AND MANAGEMENT ]<br />

CLARITY LACKING FOR MDR<br />

IMPLEMENTATION BY MAY 2020<br />

Notified bodies | TÜV Süd was able to start working as the first notified body outside<br />

of Great Britain. Still, far too many details about MDR are unclear for us to get<br />

started in earnest, says Dr. Bassil Akra, Vice President Global Strategic Business<br />

Development of Medical & Health Services. He would like to stop the clock.<br />

TÜV Süd Vice President Global Strategic<br />

Business Development of Medical &<br />

Health Services, Dr. Bassil Akra knows all<br />

about the MDR.<br />

Photo: TÜV Süd<br />

■ Dr. Akra, TÜV Süd is a notified body<br />

according to the MDR. How long did it<br />

take to become designated?<br />

Overall, about one-and-a-half<br />

years—which put us a little ahead of the<br />

formally scheduled completion, which<br />

expected the first designations in July<br />

2019.<br />

■ How does the designation process<br />

work?<br />

We had to wait at least six months after<br />

the publication of the MDR to apply for<br />

designation. Audits were planned to take<br />

place within the following six months.<br />

After this, the applicants received a list<br />

of deviations. Another six months were<br />

needed to correct the deviations. After<br />

the inspection, we were designated by<br />

the national body, which, for Germany, is<br />

ZLG, the Central Authority of the Federal<br />

States for Health Protection. This information<br />

is available in Nando to give<br />

other member states the opportunity to<br />

object. If there are no objections, designation<br />

is complete. The first to complete<br />

this process were BSI in Great Britain and<br />

TÜV Süd, followed by Dekra in Germany<br />

in August and IMQ in Italy.<br />

■ There aren’t very many...<br />

We are actually hoping that there will be<br />

other notified bodies before the summer<br />

holidays. In 2018, there were 16 audits in<br />

total, and, as far as I know, another 15<br />

audits are planned for 2019. The reason<br />

things went so quickly for us was,<br />

amongst other things, because there<br />

were not very many potential notified<br />

bodies at all applying to the Commission<br />

for designation in the first wave. But I<br />

am happy about every additional one.<br />

Even though we have expanded our capacities<br />

considerably, we cannot fully<br />

cover the market alone.<br />

■ What new requirements does a notified<br />

body need to meet?<br />

A lot more documentation needs to be<br />

submitted, even from us, to prove we are<br />

qualified. The fact that we employ<br />

specialists, for example, is no longer<br />

good enough. We have to show in writing<br />

through detailed CVs that surgeons<br />

have the expertise on surgical suture<br />

material. Also, we have to go more in<br />

depth to assess the devices. Every manufacturer<br />

needs to be treated the same,<br />

and every device needs to be treated as if<br />

it had never been on the market before.<br />

Even if the device has been tried and<br />

tested for 50 years.<br />

■ How much does the MDR change the<br />

work your experts do?<br />

Technically speaking, we have no clue<br />

yet, and I think that is the biggest<br />

problem. Another corrigendum or<br />

guidance paper always comes along,<br />

new information from the European<br />

Commission on how certain passages of<br />

the MDR are to be interpreted. It was like<br />

this during the application phase, and<br />

we updated our processes accordingly<br />

and trained employees. Sometimes it<br />

happens that one passage is subject to<br />

one correction after another. So we have<br />

had to be very reserved when starting to<br />

process applications from medical device<br />

manufacturers.<br />

■ How have you been able to gain personnel<br />

for the upcoming duties?<br />

We started stocking up our capacities<br />

four years ago. But we have to train every<br />

new expert in our duties—it takes one to<br />

one-and-a-half years before newcomers<br />

can process files on their own. And in<br />

some areas we are still following the<br />

rules of the previously valid MDD.<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

Lack of clarity in the implementation<br />

of the MDR<br />

Applications from manufacturers<br />

not processed yet<br />

Criteria for prioritising the applications<br />

are in process<br />

Special national regulations<br />

12 medicine&<strong>technology</strong> 01/2019


■ Will there be supply bottlenecks?<br />

There are many circumstances that could<br />

cause problems. For instance, three device<br />

groups that used to need a de -<br />

claration of conformity from the manufacture<br />

to reach the market will now<br />

need certification from a notified body:<br />

Class Ir reusable devices, medical apps,<br />

and substance-based medical devices<br />

like nasal spray. Since there are only two<br />

notified bodies so far, there is no way to<br />

foresee how everything is supposed to<br />

get done. And because of a possible Brexit,<br />

many manufacturers are looking for<br />

a notified body that is not located in<br />

Great Britain, which exacerbates the<br />

situation. Furthermore, existing certificates<br />

need to be extended—when permissible—according<br />

to the MDD so devices<br />

can be sold after May 2020 and to<br />

allow re-certification to take place a little<br />

later. If the notified bodies do not have<br />

the capacity to reach the goal, these devices<br />

would likewise disappear from the<br />

market until they are re-certified.<br />

The way we are<br />

moving forward with<br />

the MDR now, we are<br />

only wasting resources.<br />

■ How do you determine the order in<br />

which applications from manufacturers<br />

are processed?<br />

We cannot discriminate against anyone.<br />

So our only option is to work on a firstcome-first-serve<br />

basis when it comes to<br />

capacities. We do not differentiate between<br />

big companies and small ones, or<br />

existing customers and new ones. The<br />

MDR is a restart, so all customers start at<br />

nil. To ensure patients will still be supplied,<br />

we are currently working on criteria<br />

for how we can organise the work.<br />

We will look at the clinical relevance of<br />

devices, the level of innovation, and the<br />

validity period for existing certificates.<br />

■ What do you see as the biggest challenge<br />

for companies?<br />

The most difficult challenge is that even<br />

companies have to deal with the uncertainty<br />

of not exactly knowing what is<br />

required of them, but they still have to<br />

make the capacities available. Experts in<br />

this area are rare and expensive, which<br />

makes the situation difficult, especially<br />

for many small companies.<br />

■ What is not being talked about<br />

enough regarding the MDR?<br />

The patients. There is actually too little<br />

emphasis on the goal of developing safe<br />

and effective devices, and there are way<br />

too many formalities. Something is falling<br />

out of balance here because the actual<br />

effort all manufacturers have to put<br />

forth will be reflected in the price for devices.<br />

■ What do you hope will happen for<br />

dealing with the new MDR?<br />

Even if it is unrealistic, a reset would be<br />

fantastic. We need to stop the clock until<br />

all guidances are available, until there is<br />

a clear idea of what is expected, until<br />

there is a Eudamed database and<br />

enough capacities at notified bodies to<br />

process the large number of applications.<br />

Until then we cannot start implementing<br />

the regulations of the MDR<br />

in earnest and in a timely matter. The<br />

way things are moving now, we are<br />

burning through only resources that<br />

could instead be going towards innovations<br />

or improving the healthcare system.<br />

■ What will the implementation of the<br />

MDR look like in May 2020?<br />

I think it will be very chaotic. So far the<br />

European Commission has practically<br />

not responded to comments from notified<br />

bodies. Since there will be difficulties,<br />

many member states will resort to<br />

the option of introducing special na tio -<br />

nal regulations to keep their healthcare<br />

systems running—until there is finally a<br />

working system based on the MDR.<br />

■ What do you recommend for companies<br />

given this situation?<br />

Don’t spend your time waiting and hoping.<br />

Prepare as best as possible using<br />

your technical and scientific expertise,<br />

and get in touch with potential notified<br />

bodies early. I wish everyone much<br />

strength and courage so that the MDR<br />

regulations can be implemented on time<br />

for the patients’ sake and that medical<br />

devices remain available in the meantime.<br />

Dr Birgit Oppermann<br />

birgit.oppermann@konradin.de<br />

Automation<br />

for Medical Device<br />

Manufacturers<br />

Together with their customers,<br />

Invotec develops customized<br />

solutions with a focus on<br />

feasibility and flexibility for<br />

individual needs and budgets:<br />

• Customized assembly and<br />

test systems<br />

• Collaborative engineering<br />

process<br />

• Validation to support<br />

documentation for FDA/EMA<br />

Bio-MEMS<br />

Cardiovascular Devices<br />

Drug Delivery Systems<br />

Surgical Devices<br />

www.invotec.com<br />

01/2019 medicine&tec hn ology 13


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High-tech for the Tiger State<br />

Market development | The rapid ageing of society is a problem for South Korea’s<br />

healthcare system—and an o. This ist an pportunity for international manufacturers:In<br />

innovative medical <strong>technology</strong>, this high-tech nation is still dependent on imports<br />

to a large degree.<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

■<br />

Tiger state<br />

Ageing society<br />

Digitalisation<br />

Moon Care<br />

KIMES trade show<br />

From the poorhouse to an economic<br />

power: South Korea made the climb<br />

within a few decades. Today this largest<br />

amongst the rapidly rising Asian tiger<br />

countries is ranked eleventh amongst<br />

leading industrial nations, measured by<br />

gross domestic product. However, the<br />

country has not only become rich faster<br />

than any other, but life expectancy is also<br />

sky-rocketing. Experts predict South Koreans<br />

will live the longest in the world by<br />

2030. The birth rates sunk to a record low<br />

of 0.98, one the lowest in the world, however.<br />

Rapid ageing is a problem for the<br />

healthcare system—and, at the same<br />

time, an opportunity for international<br />

manufacturers of innovative medical<br />

<strong>technology</strong>, an area in which the hightech<br />

nation of South Korea still relies<br />

heavily on imports. “The challenges of the<br />

future, including the demographic transition<br />

and rising healthcare costs, are important<br />

drivers for public health policy<br />

and the resulting use of technologies like<br />

IoT and AI,” says Holger Klein, Managing<br />

Director of Dräger Korea.<br />

For Dräger, South Korea is an attractive<br />

market with enormous potential for<br />

growth. The medical and safety <strong>technology</strong><br />

company based in Lübeck/Germany<br />

has had a subsidiary in Korea since 1990,<br />

where it employs around 30 people today.<br />

Together with sales partners, Dräger<br />

offers its customers—mainly general hospitals<br />

and maximum-care hospitals—product<br />

solutions as well as aftersales<br />

service and support from clinical experts.<br />

South Korea relies on artificial<br />

intelligence and digitalisation<br />

As a specialist in acute medicine, Dräger<br />

focuses on the areas of intensive care,<br />

trauma care, and emergency medicine.<br />

Its goal is to improve clinical results, and,<br />

in doing so, to manage costs, improve<br />

patient experiences, and ensure employee<br />

satisfaction, says Klein. “We imagine a<br />

future in which medical devices are<br />

connected as a system and interact with<br />

one another and allow for new clinical applications<br />

like data analysis, remote control,<br />

and, ultimately, hospital automation.”<br />

South Korea’s government is building<br />

on digitalisation and artificial intelligence.<br />

Also, President Moon Jae-In announced<br />

he would expand the range of<br />

services in the national health insurance<br />

system significantly: The insurance system<br />

needs to accept 70 percent of the<br />

costs for medical treatment. Thanks to<br />

“Moon Care,” patients should receive,<br />

amongst other things, assistance for dental<br />

prostheses, implants, magnetic re -<br />

sonance imaging, ultrasound, and dementia<br />

treatment.<br />

The signs point to growth. From 2010<br />

to 2016, healthcare expenses increased<br />

from 6.5 percent to 7.7 percent, measured<br />

on the gross domestic product. There is<br />

still room for improvement. The medical<br />

<strong>technology</strong> market recorded aboveaverage<br />

growth rates of, most recently,<br />

11.5 percent in 2016 and 8.3 percent in<br />

2017. The market volume was USD 5.1<br />

14 medicine&<strong>technology</strong> 01/2019


Sees South Korea as an attractive<br />

market with enormous<br />

growth potential:<br />

Holger Klein, the Managing<br />

Director of Dräger Korea.<br />

Photo: Dräger<br />

Platform for innovative technologies: Zimmer Medizinsysteme at<br />

KIMES in Seoul. The annual Korean International Medical & Hospital<br />

Equipment Show is an excellent networking opportunity.<br />

Photo: Zimmer Medizinsysteme<br />

Relies on South Korea:<br />

Thomas Herrmann, CEO of<br />

Herrmann Ultrasonics,<br />

shown with trainee Soon-<br />

Woo Huang from the sales<br />

representative Ecosonic.<br />

Photo: Herrmann Ultrasonics<br />

billion in 2017 and is expected to increase<br />

to USD 5.9 billion for 2018.<br />

Roughly two thirds of the demand are<br />

covered by imports. The USA contributed<br />

to nearly 50 percent of imports with<br />

goods worth USD 1.6 billion in 2017.<br />

Next followed Germany (USD 549<br />

million), Japan (349 million), and<br />

Switzerland (159 million). Foreign trade<br />

agency Germany Trade and Invest (GTAI)<br />

reports imports from Germany rose<br />

faster than average by 15.9 percent. Overall,<br />

industry imports increased by 10.9<br />

percent.<br />

Growing demand<br />

for premium products<br />

“The market is characterised by high development<br />

and rapid growth,” says Gerold<br />

Gabele, head of exports for Physical<br />

Therapy at Zimmer Medizinsysteme in<br />

Neu-Ulm/Germany. The demand for premium<br />

products like those supplied by<br />

Zimmer for physical therapy and aesthetic<br />

medicine is growing strongly.<br />

Zimmer works in South Korea together<br />

with distribution partners. The majority<br />

of the business is concentrated on staterun<br />

hospitals and private clinics in Seoul,<br />

including the metropolitan area Sudogwon,<br />

where roughly half of the 51 million<br />

residents live. According to Gabele, the<br />

Soleo SonoStim products for electrotherapy,<br />

ultrasound therapy, and combined<br />

therapy are currently very popular in<br />

physical therapy, and the enPuls devices<br />

for shockwave therapy are in higher and<br />

higher demand.<br />

As one of numerous European manufacturers,<br />

Zimmer had a booth at the Korean<br />

International Medical & Hospital<br />

Equipment Show (Kimes) in Seoul again<br />

in 2019. Held each year in March, Kimes<br />

is an excellent networking opportunity. In<br />

2018, around 1,350 exhibitors and<br />

75,000 guests attended.<br />

Market relies on growth<br />

and bilateral relations<br />

For the rapidly growing domestic sector,<br />

Kimes is the platform for showcasing<br />

innovative technologies and products, including<br />

from the areas of robotics, 3D<br />

printing, and wearables. The Moon<br />

government wants to promote the de -<br />

velopment of innovative healthcare technologies<br />

and pave the way for faster marketing<br />

approval.<br />

South Korea’s <strong>technology</strong> giant Samsung<br />

is also one of the large domestic<br />

manufacturers of medical <strong>technology</strong> and<br />

offers imaging devices and diagnostic accessories.<br />

Together with Samsung, engineering<br />

company Herrmann Ultrasonics<br />

from the Baden city of Karlsbad/Germany<br />

implemented a demanding welding project:<br />

a medical test cassette for blood<br />

analysis. “Ultrasonic welding has replaced<br />

an adhesive step including UV curing,” explains<br />

CEO Thomas Herrmann. This is<br />

necessary to receive approval from the<br />

FDA for North America, which opens access<br />

to global sales.<br />

In industries like automotive and electronics,<br />

South Korea has already proven it<br />

can compete at the very top, which makes<br />

this market extremely attractive, states<br />

Herrmann. It is modern, oriented to<br />

growth and bilateral relations, and open<br />

to the West—in the customer as well as<br />

supplier role. Herrmann Ultrasonics has<br />

been in Korea since 2009 and sells ultrasonic<br />

welding machines for medical device<br />

parts made of thermoplastic mate -<br />

rials. A local sales representative helps<br />

customers from application consulting to<br />

production optimisation, including sales<br />

and after-sales support.<br />

“We work through our partner company<br />

Ecosonic to smooth out intercultural<br />

differences more quickly and penetrate<br />

the market more efficiently,” says Herrmann.<br />

His company relies heavily on<br />

South Korea: “The fact that the son of<br />

Ecosonic’s managing director started a<br />

one-year training programme with us in<br />

Karlsbad underscores this partnership.” ■<br />

Bettina Gonser<br />

Journalist from Stuttgart/Germany<br />

Additional information<br />

On the Dräger enterprise:<br />

www.draeger.com<br />

On Zimmer Medizinsysteme:<br />

www.zimmer.de/en<br />

On Herrmann Ultrasonics:<br />

www.herrmannultraschall.com<br />

01/2019 medicine&tec hn ology 15


■ [ MEDICINE IN DIALOGUE ]<br />

AI HAS GREAT POTENTIAL, BUT<br />

HAS TO BE DONE WELL ETHICALLY<br />

AI in medicine from an ethical perspective | Engineers, medical professionals, and<br />

ethicists must work more closely together to take advantage of the opportunities offered<br />

by learning algorithms. Even though there are ethical frameworks for new technologies<br />

in medicine, many detailed questions remain open, reports Ethics Professor<br />

from Munich Alena Buyx.<br />

■ Professor Buyx, which ethical questions<br />

are asked in medicine?<br />

Basically, ethics deals with good and<br />

just actions—in other words, what we<br />

should and should not do and how we<br />

justify that. Given the great advancements<br />

in many areas, we now often<br />

find ourselves also asking whether we<br />

want to implement everything that we<br />

can in medicine.<br />

When a system is capable<br />

of self-learning, a whole<br />

slew of new ethical<br />

questions are raised.<br />

Photo: Klaus Ranger<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

Artificial intelligence in medicine<br />

Ethical framework and detailed<br />

questions on patient applications<br />

New interdisciplinary concept of<br />

“ethical <strong>technology</strong> development”<br />

Dr. med. Alena Buyx is Professor of Ethics in<br />

Medicine and Health Technologies at the<br />

Technical University of Munich (TU Munich)<br />

and has been a member of the German<br />

Ethics Council since 2016.<br />

■ Where do these questions come up in<br />

medicine?<br />

Medical ethics can be broadly divided<br />

into three areas: The first is clinical<br />

ethics, which is concerned, for example,<br />

with how to choose the best treatment<br />

for a patient or what can happen if a<br />

doctor suggests something but the patient<br />

has different wishes. At the end of<br />

life, a common question is when is it<br />

right to limit therapy. The second area<br />

is innovation and research ethics, which<br />

deal with how new things should be researched,<br />

what risks researchers should<br />

expect, how a clinical study is designed<br />

ethically—but also, for example,<br />

whether and which manipulations on<br />

human embryos should be allowed. The<br />

third area concerns socio-ethical questions.<br />

Two examples are the fair distribution<br />

of limited resources and optin<br />

or opt-out for organ donation.<br />

16 medicine&<strong>technology</strong> 01/2019


Industrie<br />

About the German Ethics Council<br />

The German Ethics<br />

Council comprises 26<br />

experts and deals with<br />

topics from various<br />

areas that could have<br />

consequences for individuals<br />

through life<br />

sciences and their applications<br />

in humans,<br />

and for society as a<br />

whole. The Council<br />

discusses natural<br />

science, medical, and legal questions,<br />

amongst others.<br />

The members of the Ethics Council are<br />

recommended by the German Federal<br />

Government and the German Parliament.<br />

They cannot be members of Parliament<br />

or of the Government. This is to ensure<br />

the independence of the council.<br />

The monthly sessions are public.<br />

The Ethics Council encourages social discussion<br />

through public events and de -<br />

velops opinion papers and recommendations<br />

for politics and the legislature.<br />

For example, in 2017 it published an<br />

opinion paper on “Big Data and<br />

Health—Data Sovereignty as the Shaping<br />

of Informational Freedom.” It covered<br />

According to the Ethics Council, big data<br />

may not affect the data sovereignty of<br />

the people.<br />

the opportunities and risks of digitalisation.<br />

Legal, extra-legal, and technical<br />

framework conditions are needed to ensure<br />

“that people can exercise and deve -<br />

lop their data sovereignty.”<br />

The opinion on Big Data and Health<br />

can be downloaded as a PDF file (in German).<br />

https://bit.ly/2UCJmLk<br />

On the Ethics Council:<br />

www.ethikrat.org<br />

Photo: issaronow/Fotolia<br />

The<br />

network of<br />

expertise<br />

for industry<br />

18 media brands for all major<br />

sectors of industry<br />

Information, inspiration and<br />

networking for professionals<br />

and industry executives<br />

Practical knowledge spanning<br />

all media channels: Trade journals,<br />

websites, events, newsletters,<br />

whitepapers, webinars<br />

■ What challenges for ethics do artificial<br />

intelligence and big data introduce?<br />

The things currently being done in AI in<br />

terms of medicine are still mostly at<br />

the early experimental phase. The first<br />

algorithms are published, but there<br />

have not yet been large trials on resul -<br />

ting products. Thus, we face questions<br />

regarding innovation and research<br />

ethics. We have ethics frameworks from<br />

other developments in biomedicine<br />

that we can translate for medical digitalization,<br />

and this process is currently<br />

ongoing. However, we are talking about<br />

broad frameworks. In detail, much will<br />

still need to be discussed for specific<br />

applications. Unique to AI so far is the<br />

autonomy of some systems, their<br />

ability to learn themselves—which is<br />

where they might slip through established<br />

frameworks of medical oversight.<br />

If medical professionals no longer<br />

understand how the system reached a<br />

decision, how should we assess that<br />

decision from an ethical perspective?<br />

Finding answers here is a challenge and<br />

a very exciting task.<br />

■ How intensely have ethicists dealt<br />

with this subject so far?<br />

Digitalisation has been around for se -<br />

veral decades already. There are EUwide<br />

and international ethical frameworks<br />

and suggestions from various institutions,<br />

rules that companies like<br />

Google or Microsoft have written, and<br />

also very specific, somewhat older<br />

works on, e.g., cyborg rights that are<br />

now again becoming relevant. The first<br />

guiding principles are, therefore, already<br />

in place. We are now confronted<br />

with AI in many concrete forms, however.<br />

There are avatars for the treatment<br />

of a mental illness, algorithms<br />

that support surgeons during surgery,<br />

or virtual reality training programmes<br />

for educating radiologists. Every trans-<br />

Discover the appropriate<br />

media for your specific<br />

industry sector:<br />

konradin.de/industrie<br />

01/2019 medicine&tec hn ology 17<br />

media.industrie.de


■ [ MEDICINE IN DIALOGUE ]<br />

lation of a <strong>technology</strong> designed to be<br />

used near the hospital bed poses different<br />

ethical questions in detail. Answe -<br />

ring them is a task we still need to complete.<br />

■ What role does ethics need to play<br />

in the development of digital medical<br />

devices?<br />

The right considerations should be factored<br />

in from the very beginning. Technical<br />

experts do not need to do this<br />

alone. Ethicists exist—please, ask us.<br />

Digital engineers influence and change<br />

our world to a previously unfamiliar<br />

extent, not only in medicine. Hence, I<br />

wish that developers and companies<br />

would be more open to considering<br />

ethical questions. Taking them into<br />

account also increases acceptance of<br />

devices amongst users.<br />

■ Who can best answer ethical<br />

questions?<br />

For medical AI, that can best be done by<br />

interdisciplinary teams made up of engineers,<br />

medical professionals, and<br />

ethicists. All sides need to be brought in<br />

as soon as possible so the right questions<br />

are asked during programming:<br />

What parameters should or must I consider?<br />

What happens if an error occurs?<br />

In Munich, we are working on these approaches,<br />

which we, in <strong>technology</strong> development,<br />

call embedded ethics. There<br />

hasn’t been anything like this before,<br />

and the process is challenging. It can,<br />

however, lead us to best-practice models<br />

that we can more easily transfer to<br />

other applications later.<br />

■ The fact that an AI is able to calculate<br />

human survival probability is unnerving<br />

at first glance. What do you make of such<br />

developments?<br />

Medical professionals are already using<br />

what are known as risk scores before<br />

every operation to make themselves<br />

aware of the patient’s state of health<br />

and to plan the right measures for a<br />

procedure. AI makes these assessments<br />

more precise, more individual, and is, in<br />

some circumstances, real-time-capable:<br />

It can also factor in changes to the risk<br />

AI research in Munich<br />

The Munich School of Robotics and Machine<br />

Intelligence (MSRM) directed by<br />

Prof. Sami Haddadin is an integrative research<br />

centre at TU Munich. MSRM<br />

studies the principles of robotics, perception,<br />

and artificial intelligence. More than<br />

30 professors from the fields of philo -<br />

sophy, law, and ethics, like Prof. Alena<br />

Buyx, share their expertise here. This approach<br />

is designed to ensure responsible<br />

<strong>technology</strong> development and integration<br />

into society.<br />

during the process. Whether and how<br />

this option influences the work of doctors<br />

and whether they want something<br />

like this is what we are currently studying<br />

in a project at TU Munich. The<br />

German Ethics Council said that highly<br />

predictive risk profiles, a type of life expectancy<br />

prediction for individual<br />

people, need to be prohibited for use in<br />

statutory health insurance funds. We<br />

rarely issue such calls for bans, but did<br />

in this case. Even if health predictions<br />

are possible in principle based on giant<br />

datasets, life circumstances and, with<br />

them, risk factors can change quickly at<br />

any time. And AI-based risk prediction,<br />

like “this or any treatment for the patient<br />

is not worth it anymore,” could remove<br />

the solidarity principle in healthcare.<br />

■ What opportunities does AI offer?<br />

The potential that AI offers medicine is<br />

huge. Anticipating risks can make us<br />

uncomfortable. But in medical cases,<br />

the opportunity arises to practice prevention<br />

very individually and to ensure<br />

that the prediction does not come true.<br />

Specifically, the advantage can be explained<br />

using chemotherapy: A particular<br />

Patient should undergo this stressful<br />

and taxing treatment only when the<br />

prognosis afterwards is good, and the<br />

prediction might tell us about that.<br />

Scientific and technical results, such as<br />

on the future of health, work, and mobi -<br />

lity, are intended to be applied to the real<br />

world in this way.<br />

MSRM establishes a close relationship<br />

with industrial partners and founders of<br />

high-tech start-ups as part of the industrial<br />

advisory board.<br />

www.msrm.tum.de<br />

■ How well prepared are users—medical<br />

professionals—to use the new digital<br />

technologies?<br />

Medical professionals face ethical questions<br />

in their training, and the entire<br />

field works with vulnerable people who<br />

are ill. That requires healthcare providers<br />

to act responsibly. Patients are<br />

dependent; it is often a matter of life<br />

and death. So overall, doctors are well<br />

prepared. In the use of new digital<br />

technologies, more technical expertise<br />

amongst doctors would be desirable, as<br />

would more expertise on medical ethical<br />

matters amongst engineers. This is<br />

a challenge for university policy stra -<br />

tegy.<br />

■ A study showed that two thirds of the<br />

german population favour the use of AI<br />

in medicine. What do you think, should<br />

we be wanting more AI?<br />

Yes. Artificial intelligence is a very exciting<br />

topic that takes us beyond our previous<br />

levels of expertise. Naturally, it is<br />

fun to work in such a field. But the AI<br />

must be made well in an ethical sense.<br />

The <strong>technology</strong> has potential and the<br />

population is open to it, which was also<br />

shown in the study. We should not<br />

jump the gun. We should move forward<br />

but we do need to act well deliberately<br />

and tackle all ethical questions.<br />

Dr Birgit Oppermann<br />

birgit.oppermann@konradin.de<br />

18 medicine&<strong>technology</strong> 01/2019


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39 %<br />

production<br />

environment<br />

40 %<br />

components<br />

and materials<br />

29 %<br />

services<br />

Feedback from exhibitors at the first<br />

T4M trade fair:<br />

“T4M‘s focus on manufacturing and production<br />

is perfectly aligned with our portfolio and<br />

the event is very well organized.”<br />

Giampaolo Meana, General Manager, Qosina Corp.<br />

“T4M in Stuttgart has attracted high-quality<br />

visitors from large multinational companies.”<br />

Tony Crofts, Sales & Marketing Director, Shawpak<br />

Riverside Medical Packaging Company Limited<br />

Decision-makers<br />

65 %<br />

of the visitors are involved<br />

in pur chase and procurement<br />

decisions<br />

* Multiple answers possible<br />

Visitor groups by sectors*<br />

16 % 16 %<br />

implants<br />

surgical<br />

instruments<br />

20 %<br />

focus on<br />

Electromedicine /<br />

Electronics<br />

3.163<br />

25<br />

visitors of the exhibition<br />

from<br />

countries<br />

visitors from abroad: 16 %<br />

10 %<br />

services, mainly<br />

certifications<br />

and consulting<br />

“We have made a number of useful new<br />

contacts here in Stuttgart.”<br />

Sascha Gersmann, Head of Marketing & Key Account<br />

Manager, Citizen Machinery Europe GmbH Riverside<br />

Medical Packaging Company Limited<br />

These companies<br />

have visited us in 2019:<br />

Dürr Dental Bayer Medi1one medical<br />

SAMSUNG Medical MED-EL Stryker<br />

Robert Bosch Roche Diagnostics Evonik<br />

Geistliche Pharma Aesculap Olympus<br />

Zimmer Medizin Systems<br />

Siemens Healthcare<br />

QIAGEN<br />

Fresenius<br />

Maquet Philipps Dräger<br />

Erbe Elektromedizin<br />

and many more<br />

Any questions? We are here to help!<br />

Tanja Wendling<br />

Email: tanja.wendling@messe-stuttgart.de<br />

Telephone: +49 711 18560-2186<br />

Promotional supporters<br />

Book your stand now:<br />

T4M-expo.com/stand-booking


Trade fair<br />

Compamed/Medica 2019<br />

Photo: Messe Düsseldorf, Constanze Tillmann<br />

Competence Platform for Medical Technology<br />

Industry meeting in Dusseldorf | Medical-grade plastics | Development services | Laser processing<br />

01/2019 medicine&<strong>technology</strong> 21


■ [ TRADE FAIR ]<br />

DIGITALISATION IS A KEY FOCUS<br />

AREA FOR MEDICA AND COMPAMED<br />

Industry meeting in Dusseldorf | Compamed has established itself in the medical device<br />

sector as a hotspot for high-tech solutions for medical device manufacturers.<br />

Both Compamed and Medica, which will be happening at the same time, will focus on<br />

digitalisation, miniaturisation and the requirements of the MDR.<br />

Despite the general downturn in the economy,<br />

the market for medical devices and<br />

medical equipment remains robust and<br />

growth-oriented. Nevertheless, Diener<br />

believes that the sector faces a number of<br />

challenges going forward.<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

Compamed trade fair<br />

Medica trade fair<br />

New trade fair structure<br />

Comprehensive general programme<br />

Ohoto : Messe Düsseldorf/Constanze Tillmann<br />

Wolfram Diener is the<br />

Managing Director of Messe<br />

Düsseldorf.<br />

The tandem Compamed and<br />

Medica trade fairs have established<br />

themselves as an internationally<br />

leading market and<br />

information platform for the<br />

medical <strong>technology</strong> sector.<br />

Photo: Messe Düsseldorf<br />

Both halls are due to be completely full<br />

once again at Compamed 2019. 800<br />

exhibitors from almost 40 nations will be<br />

in attendance at the industry meeting,<br />

which will be running alongside the<br />

Medica medical trade fair between 18 and<br />

21 November. The industry meeting in<br />

Dusseldorf is now a key date in the calendar<br />

for many medical device suppliers, as<br />

confirmed by Wolfram Diener, Managing<br />

Director of Messe Düsseldorf: “Companies<br />

attend Compamed to showcase<br />

their commitment to innovation and assert<br />

themselves in a market environment<br />

which is more challenging than ever.”<br />

Pressure on margins,<br />

MDR and Brexit<br />

“Increased trade restrictions, lengthy approval<br />

procedures, increased pressure on<br />

margins and Brexit – the situation in the<br />

market right now means that players need<br />

to be resilient in many different areas.<br />

What is needed most as a focus on the future<br />

of the industry and close partnerships<br />

between suppliers, medical equipment<br />

providers and users. Compamed<br />

and Medica provide a unique combination<br />

and the ideal platform for forging<br />

partnerships and fostering business relationships,”<br />

explained Wolfram Diener<br />

when asked about the healthy attendance<br />

figures. In total, around 6100 exhibitors<br />

will be showcasing their new products<br />

and technologies.<br />

They range from small SMEs through<br />

to major groups like Covestro, Evonik and<br />

Panasonic. Micro<strong>technology</strong> will once<br />

again be well represented at Compamed<br />

2019. According to a recent industry survey<br />

conducted by the IVAM Micro<strong>technology</strong><br />

Network, more than half of European<br />

micro-<strong>technology</strong> companies are involved<br />

in the medical <strong>technology</strong> market and the<br />

healthcare sector. In fact, one in five of<br />

the companies surveyed said that the<br />

medical <strong>technology</strong> market was their<br />

most important target market. It is therefore<br />

no surprise that the “High-tech for<br />

Medical Devices” product market of the<br />

IVAM Micro<strong>technology</strong> Network will be<br />

the largest shared booth at Compamed,<br />

with around 50 exhibitors covering 700<br />

m2 in hall 8A. This product market will<br />

22 medicine&<strong>technology</strong> 01/2019


More digital health at Medica<br />

Digitalisation is becoming more and<br />

more commonplace in medicine. It is also<br />

having a significant impact on product<br />

development and business processes,”<br />

said CEO Wolfram Diener. A change has<br />

been made to the structure of the Medica<br />

trade fair due to the increased interest<br />

in digital health and the digital transformation.<br />

Attendees at the trade fair between<br />

18 and 21 November will notice<br />

that some subject areas have<br />

been allocated to a different<br />

hall: The information and communication<br />

<strong>technology</strong> segment<br />

has been reallocated from<br />

Hall 15 to Hall 13, and now has a<br />

direct connection to the halls<br />

dedicated to medical <strong>technology</strong><br />

and electromedicine (Halls<br />

9 to 14).<br />

In future, the popular Medica<br />

Connected Healthcare Forum<br />

and Medica Health IT Forum will<br />

provide sessions and presentations<br />

about digital health trends<br />

for the public in Hall 13. Around<br />

10,000 attendees at last year’s<br />

showcase innovations in the key technologies<br />

of micro<strong>technology</strong>, nano<strong>technology</strong>,<br />

photonics and new materials.<br />

Micro<strong>technology</strong> and usability<br />

are important<br />

The field of micro<strong>technology</strong> is experiencing<br />

a particularly strong boost as a result<br />

of miniaturisation and digitalisation<br />

trends. Medical devices, instruments and<br />

products are getting more and more compact<br />

and easier to use, whilst also seeing<br />

an increase in performance and networking<br />

options. As a result, medical <strong>technology</strong><br />

providers need their suppliers to provide<br />

small format high-tech components,<br />

like actuators, chips, cameras, sensors,<br />

wireless modules, batteries and data storage.<br />

Examples of these include micro-endoscopes,<br />

lab on a chip applications for<br />

rapid diagnostic tests and a wide range of<br />

implants.<br />

Halls 8A and 8B at tDusseldorf Exhibition<br />

Centre will focus on components<br />

for medical <strong>technology</strong>, materials and<br />

tools, micro<strong>technology</strong> and nanotechno -<br />

logy, electronics manufacturing services<br />

trade fair were interested in these subject<br />

areas.<br />

Hall 13 will also see the Medica Start-up<br />

Park transformed into a platform for the<br />

creative, digitally driven start-up scene. It<br />

will also host the shared booths for the<br />

Wearables Technologies Show and Entscheiderfabrik,<br />

which will be presenting<br />

best practice projects for the digitalisation<br />

of hospitals.<br />

In future, Hall 13 at Medica will focus on<br />

digital issues in healthcare.<br />

(EMS) or electronics contract manufacturing,<br />

complex manufacturing and<br />

equipment partnerships, and packaging<br />

and services.<br />

The product show will be completed<br />

with a general programme with a great<br />

deal of variety. The Compamed Suppliers<br />

Forum (Hall 8b) will focus on the entire<br />

process chain involved in the manufacture<br />

of medical <strong>technology</strong>. The Compamed<br />

High-Tech Forum (Hall 8a) of the<br />

IVAM Micro<strong>technology</strong> Network is<br />

centred around microsystem <strong>technology</strong>,<br />

nanotechnologies, production <strong>technology</strong><br />

and process control.<br />

Compamed is aimed primarily at technical<br />

purchasers, specialists from research<br />

and development and packaging, heads<br />

of production, designers, and process engineers.<br />

Around 120,000 industry visitors<br />

attended Medica and Compamed in the<br />

previous year, with almost 20,000 interested<br />

specifically in the subject areas<br />

covered by Compamed.<br />

■<br />

Susanne Schwab<br />

susanne.schwab@konradin.de<br />

Photo: Messe Düsseldorf, Constanze Tillmann<br />

Your Innovative<br />

System Partner<br />

For plastic processing in the<br />

medical industry. Technical<br />

product development, clean room<br />

manufacturing, and regulatory<br />

services – all from a single source.<br />

Pharma<br />

Surgery &<br />

Interventional<br />

Fluid<br />

Management<br />

Diagnostics<br />

Visit us at COMPAMED<br />

hall 8b | stand J31<br />

Röchling Medical. Passion for 01/2019 medicine&<strong>technology</strong> 23 Health.<br />

www.roechling-medical.com


■ [ TRADE FAIR ]<br />

NEW ADDITIVE FOR SMOOTH<br />

SYNTHETIC MATERIALS<br />

Medical-grade plastics | Raumedic wants to use a new biocompatible additive to improve<br />

the sliding properties of its medical-grade plastic components whilst maintaining<br />

the mechanical and chemical properties of the underlying material.<br />

Raumedic AG manufactures medical<br />

grade plastic compounds, and has<br />

been testing a new additive along with a<br />

base polymer for over half a year. The new<br />

material can be added to thermoplastic<br />

elastomers, polyamides, polystyrenes and<br />

polyolefins. These combinations reduce<br />

the coefficient of friction significantly,<br />

leading to improved sliding properties.<br />

The company performed comparative<br />

tests on extrudates with and without the<br />

additive to demonstrate that the material<br />

has no significant impact on parameters<br />

like dimensional stability, flow rate and<br />

tensile strength.<br />

Intended use<br />

for catheter products<br />

It should also be possible to use the material<br />

for radio-opaque applications and<br />

customer-specific colour schemes. “We<br />

think this material has the potential to improve<br />

our catheter products significantly,<br />

as the decreased friction would make<br />

them easier to insert into the body. It<br />

would also make it easier to move any<br />

Photo: Raumedic<br />

Dr. Katharina<br />

Neumann’s team<br />

performed a comprehensive<br />

set of<br />

chemical and mechanical<br />

tests for the<br />

new material combinations,<br />

in addition<br />

to a series of<br />

processing trials.<br />

guide wires,” explained Dr. Katharina<br />

Neuman, Head of the Material Chemistry<br />

Department at the Helmbrechts-based<br />

company.<br />

The new combination of materials can<br />

also be used to optimise syringe systems.<br />

“The additive is suitable for any application<br />

where you want one synthetic material<br />

to slide smoothly against another<br />

one,” explained Dr. Katharina Neumann<br />

concisely. This means that the additive<br />

could be used for regional anaesthesia,<br />

drug administration and minimally invasive<br />

surgery.<br />

The new combination also has the<br />

potential to cut costs, Dr. Katharina<br />

Neumann explains: “Thermoplastic PTFE<br />

is relatively expensive. Our new compound<br />

could be a more cost-effective alternative,”<br />

That’s why she believes manufacturers<br />

should take a closer look at the<br />

material before starting the process of developing<br />

a new medical device. ■<br />

Tina Lück<br />

Raumedic, Helmbrechts/Germany<br />

Medical Grade<br />

Plastics and MDR<br />

Raumedic follows the requirements<br />

of the Medical Grade Plastics directive<br />

for the materials which it processes.<br />

As a result, it is crucially important<br />

to provide evidence of biocompatibility<br />

in accordance with<br />

European and American regulations.<br />

The company is also committed to<br />

complying with the requirements of<br />

the directive related to the procurement<br />

and consistency of polymer<br />

materials.<br />

Raumedic is also familiar with the<br />

enhanced requirements laid out in<br />

the new Medical Device Regulation,<br />

the transition period for which is set<br />

to end in May 2020. The company<br />

ensures that its processes and the<br />

materials which it uses are sufficiently<br />

validated, qualified and in<br />

line with the requirements of the<br />

new MDR. The material specialists<br />

in Helmbrecht also help its business<br />

partners with the new legislation so<br />

that the final product can be properly<br />

registered in line with the new<br />

regulation. They do this by providing<br />

relevant information and documentation<br />

about the components which<br />

they use for the purpose of approval<br />

www.raumedic.com<br />

At Compamed: Hall 8a, Stand F28<br />

24 medicine&<strong>technology</strong> 01/2019


WATCHMAKING AND JEWELLERY MICROTECHNOLOGIES MEDTECH<br />

16 - 19 JUNE 2020<br />

GENEVA PALEXPO<br />

OVER<br />

800<br />

EXHIBITORS<br />

20,000<br />

PROFESSIONAL VISITORS<br />

WWW.EPHJ.CH<br />

01/2019 medicine&tec hn ology 25


■ [ TRADE FAIR ]<br />

NEW THERAPIES: HEART VALVES<br />

WITH NITINOL SCAFFOLD<br />

Laser treatment |Minimally invasive treatment with replacement valves is increasingly<br />

taking the place of conventional open-heart surgery. The hybrid valves based on a Nitinol<br />

scaffold are cut using a fibre laser system.<br />

Nitinol is being used more and more in medical <strong>technology</strong> – the memory metal can be<br />

mechanically deformed before regaining its original shape when it is exposed to a specific<br />

temperature.<br />

The human heart needs four main<br />

valves to function correctly to maintain<br />

the efficiency of the body’s systemic<br />

and pulmonary circulation. Some people<br />

are born with congenital heart defects.<br />

Many others suffer from acquired defects<br />

due to various causes, such as chronic<br />

high blood pressure or chronic obesity.<br />

In recent decades, medical researchers<br />

have developed a wide variety of heart<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

Processing with the fibre laser<br />

Minimally invasive heart valve<br />

replacement<br />

Sophisticated nitinol scaffold<br />

Medical approval has been requested for<br />

the valves in Europe and the USA<br />

Photo : STI Laser Industries<br />

valve replacement options which can restore<br />

a patient’s quality of life or (in the<br />

worst case scenario) prevent death due to<br />

heart failure. Denatured heart valves can<br />

be taken from animals, normally pigs, to<br />

replace defective mitral valves. Other<br />

technologies include mechanical aortic<br />

valves. Recent years have seen the use of<br />

valves with tissue grown from the stem<br />

cells of the patient using a synthetic or<br />

animal scaffold.<br />

Each one of these options has their<br />

own drawbacks. Mechanical valves involve<br />

a significant risk of thrombosis, and<br />

commit the patient to taking blood<br />

thinners. Valves made from biotech material<br />

tend to shrink and become permeable<br />

over time as the tissue is slowly<br />

absorbed by the body. All of these valves<br />

also involve major open heart surgery,<br />

which is painful, risky and expensive.<br />

Furthermore, this procedure is ruled<br />

out for many patients due to the advanced<br />

stage of their illness, their age or other<br />

medical issues. This is reason enough to<br />

develop a range of new valve types, and<br />

even more importantly, the transcatheter<br />

valve replacement.<br />

These newer heart valve designs are<br />

multilayered structures on nitinol scaffolds.<br />

STI Laser Industries, based in Or<br />

Akiva, specialises in laser cutting, micromaterial<br />

processing and finishing medical<br />

products. The Israeli company is one of<br />

the main manufacturers of nitinol heart<br />

valve frames, as explained by CEO and<br />

Board Member Tovy Sivan: “STI has a<br />

long tradition of manufacturing medical<br />

products, with a focus on laser cutting<br />

and welding. We use many different types<br />

of laser to process a wide variety of pro -<br />

ducts and materials.”<br />

Laser cutting<br />

of nitinol scaffolds<br />

The lasers used by the company range<br />

from traditional optically pumped<br />

Nd:YaG lasers through to cutting-edge<br />

ultra-short pulse lasers, which are used to<br />

manufacture medical consumables made<br />

from synthetic material. “Almost all of<br />

these lasers come from Rofin (now called<br />

Coherent),” says Sivan. He is convinced<br />

that the new hybrid valves will revo -<br />

lutionise the treatment of heart valve defects<br />

in the near future.<br />

Using nitinol is the key to unlocking<br />

minimally invasive valve replacements<br />

using catheters. Nitinol is a nickel-titanium<br />

alloy with a shape memory. After<br />

processing, a structure made from a<br />

shape-memory alloy is thermally treated<br />

to preserve its shape. The part will then<br />

always return to its original shape when it<br />

is heated above its transformation temperature,<br />

even if it is twisted, bent or<br />

otherwise deformed. By optimising the<br />

nickel/titanium ratio and adding a small<br />

amount of additives, this transformation<br />

26 medicine&<strong>technology</strong> 01/2019


The fibre laser cuts the scaffolds for heart valves made from nitinol tube material.<br />

temperature can be set to a range of between<br />

10 to 20°C lower than human body<br />

temperature. Using a nitinol frame means<br />

that the valve can be mechanically compressed<br />

until it reaches 20% of its original<br />

diameter. This means that even a large<br />

valve like a mitral valve can be inserted<br />

through the femoral artery using a catheter.<br />

The valve retains its original<br />

shape at body temperature<br />

Once the valve has reached the heart, the<br />

surgeon carefully extracts it from the<br />

transport system. When exposed to body<br />

temperature, the valve recovers its original<br />

shape and anchors itself in position.<br />

Photo: STI Laser Industries<br />

Only the scaffold is made from nitinol, according<br />

to Sivan. STI supply these customer-specific<br />

nitinol scaffolds to medical<br />

device manufacturers, who then attach<br />

the valves and a sheath made from denatured<br />

animal tissue. Any exposed metal<br />

would increase the risk of thrombosis and<br />

valve stenosis.<br />

The Israeli medical device manufacturer<br />

already produces nitinol structures<br />

for three different heart valve types: aortic<br />

valves, mitral valves and shunts for<br />

regulating the pressure between the right<br />

and left chambers of the heart. The dia -<br />

meters required range between 10 and 30<br />

mm. STI begin the process by cutting the<br />

support structures out of the raw nitinol<br />

tube material. The company then uses a<br />

Coherent Starcut Tube SL tube cutting<br />

system with a Star Fiber 320 FC fibre laser<br />

at a wavelength of approximately one μm.<br />

The Starcut uses a fixed lens and highprecision<br />

rotation and linear axes to move<br />

the tube, and cuts three-dimensional<br />

structures out of the tube material with<br />

an exceptionally high level of precision.<br />

STI then ensures that the support structures<br />

have the required shape before<br />

using an electropolishing process to prepare<br />

them for the biocompatible sheath.<br />

Sivan summarises the main advantages<br />

of the fibre laser cutting system as<br />

follows: “This approach requires a high<br />

level of precision, repeatability and outstanding<br />

surface quality. We also have to<br />

keep the time required for these highly<br />

complex contour cutting processes to a<br />

minimum. Our fibre laser system meets<br />

these requirements and provides additional<br />

advantages.” Some of these valve<br />

types have already been approved in<br />

Europe. Clinical trials in the USA have<br />

reached an advanced stage. Sivan is confident<br />

that these new products will soon<br />

have a positive impact on the outcome of<br />

many heart valve operations.<br />

■<br />

Roland Wölzlein<br />

Coherent, Santa Clara, CA, USA<br />

www.coherent.com<br />

At Compamed: Hall 8a, Stand F35<br />

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■ [ TRADE FAIR ]<br />

Assistance with the development<br />

of IVD analysers<br />

Fluid management | In-vitro diagnostics make it possible to provide targeted<br />

care for patients. Bürkert Fluid Control Systems makes this possible by<br />

developing modules for IVD analysers.<br />

Photo: Bürkert Fluid Control Systems<br />

Fluid management solution for in vitro<br />

diagnostics: Bürkert’s system specialists<br />

worked together with the OEM to develop a<br />

dosing unit for a new analyser.<br />

New in-vitro diagnostic devices must<br />

provide advantages in terms of performance,<br />

precision, specificity and sensitivity.<br />

They also need to reduce overall<br />

costs whenever possible. This is a challenge<br />

for developers. However, help is<br />

available from Bürkert GmbH & Co. KG’s<br />

system houses at Bürkert Fluid Control<br />

Systems. The Ingelfingen-based engineers<br />

developed a new solution for an IVD<br />

analyser for the precise and reliable<br />

measurement, control and regulation of<br />

flow rates in dosing units. Five different<br />

versions of the analyser are available. The<br />

engineers also needed to reduce the<br />

model diversity of the integrated dosing<br />

units and integrate the installed components.<br />

These consist of two or three<br />

valves, a pressure sensor and a filter, all<br />

on a transparent injection moulded plate.<br />

The OEM responsible for developing the<br />

dosing unit turned to the system specialists<br />

at Bürkert to help them overcome<br />

these challenges in as little time as possible.<br />

The engineers developed a base<br />

module which is compatible with all five<br />

models of the analyser. It consists of a<br />

translucent and UV-resistant material<br />

which makes it possible to integrate a<br />

window for inspecting the pump<br />

chamber. Users can then adapt the various<br />

components to this base module. Following<br />

this basic design phase, the engineers<br />

turned their attention to the dead<br />

space in the system with a view to optimising<br />

the analyser’s cleaning process.<br />

www.burkert.co.uk/en<br />

At Compamed: Hall 8b, Stand H07<br />

Sensors<br />

Low pressure sensor for life-saving applications<br />

Laser <strong>technology</strong><br />

Microprocessing of medical<br />

components<br />

Ventilation and dialysis equipment<br />

require special sensor models. Precision<br />

components are also used for diagnostic<br />

purposes, particularly for CT equipment<br />

and endoscopes. First Sensor AG, Berlin<br />

will be presenting their L and H series low<br />

pressure sensors at Compamed. These<br />

range from reinforced low pressure sensors<br />

in the HCLA and HDT series through<br />

to high-sensitivity ultra-low pressure sensors<br />

in the LMI, LME and LDE series. They<br />

are used in ventilation equipment to detect<br />

even small breaths taken by a patient.<br />

The manufacturer also provides reliable<br />

Visitors can<br />

see First<br />

Sensor’s low<br />

pressure<br />

sensors at<br />

Compamed.<br />

Photo: First Sensor<br />

sensors and tailored sensor systems for<br />

ventilation purposes. These include highsensitivity<br />

rapid thermal MEMS flow sensors.<br />

First Sensor has a flexible supply<br />

chain and a complete range of construction<br />

and connection <strong>technology</strong> at its disposal<br />

in order to provide comprehensive<br />

integrated solutions.<br />

It will also be presenting HDI and HCE<br />

sensors equipped with digital interfaces.<br />

These are used by health professionals for<br />

dialysis purposes. First Sensor also provides<br />

multi-sensor modules which are<br />

used to integrate numerous components<br />

like valves, pumps or microcontrollers.<br />

The sensor company will also be showcasing<br />

diagnostic solutions at Compamed.<br />

For instance, the provider produces largescale<br />

x-ray detector arrays for computer<br />

tomography.<br />

www.first-sensor.com<br />

At Compamed: Hall 8a, Stand L14<br />

Meko Laser Material Processing produces<br />

components with demanding tolerances<br />

and a high service quality for companies<br />

in the medical sector. The Sarstedt-based<br />

company will be attending Compamed to<br />

exhibit its high precision laser systems<br />

which can be used to laser process metals<br />

and bioresorbable materials with tolerances<br />

of less than 5 μm . Modern ultrashort<br />

pulse lasers are used for high precision<br />

cutting and drilling. They also provide<br />

clean and perfect cut surfaces.<br />

In addition to the precise laser cutting of<br />

implants like stents and cardiac valve<br />

frames, one of Meko’s core competencies<br />

is the laser drilling of microscopic holes<br />

for drug delivery balloon catheters. Their<br />

laser systems can create holes with a<br />

diameter as small as 2 μm. These tiny<br />

holes allow the catheters to release medication<br />

when they dilate.<br />

www.meko.de<br />

At Compamed: Hall 8a, Stand J07<br />

28 medicine&<strong>technology</strong> 01/2019


Absorbable Implant<br />

Stabilises Spine<br />

Polymers | Spine Welding received FDA approval for its<br />

screw system for spinal stabilisation. The system includes<br />

a bioabsorbable component made by Samaplast.<br />

Photo: Spine Welding<br />

The screw system<br />

for stabilising the<br />

spine received FDA<br />

approval.<br />

The new screw system made by Spine Welding AG in<br />

Schlieren facilitates the fixation and stabilisation of spinal<br />

segments in patients with a fully developed skeleton and is used<br />

for several diseases. One part of the new Elaris Pedicle Screw<br />

System, the Elaris Pin, is made by Samaplast AG, St. Margrethen,<br />

out of a bioabsorbable polymer and stabilises the spinal segments<br />

being treated. This absorbable material is decomposed by<br />

the body’s metabolic processes after a certain amount a time and<br />

disintegrates in water and CO 2<br />

. To ensure this type of implantable<br />

polymer is clean and free of residual materials, Samaplast<br />

manufactures these devices in GMP cleanrooms of ISO Class 7<br />

and monitors permanently the ambient conditions like air humidity,<br />

temperature, air pressure, and particles.<br />

With their many years of experience in processing absorbable<br />

polymers and implants, the Swiss experts get involved in the process<br />

as early as possible during product development. Flaws and<br />

errors can be eliminated from the beginning through design and<br />

development support and the construction of components and<br />

tools. Samaplast makes the high-precision steel tools needed for<br />

error-free production in its own tool shop. Samaplast processes,<br />

in addition to absorbable implants, other implant materials like<br />

PEEK, PSU, and PPSU, and it manufactures instruments made<br />

from other polymers for the medical market.<br />

www.samaplast.ch<br />

At Compamed: Hall 8b, Booth C20<br />

starlim is a world leader<br />

in the processing of<br />

liquid silicone.<br />

Originating from Marchtrenk, our parts reach the whole world and are<br />

widely used in medical <strong>technology</strong>, industrial applications and in the<br />

automotive industry. As a full-service provider, we take care of the<br />

entire production chain – from the initial idea to the finished product.<br />

This way, we save valuable time and resources.<br />

www.starlim.com<br />

Visit us at COMPAMED<br />

Duesseldorf, Germany<br />

18. - 21.11.2019 - Hall 8a booth L04<br />

01/2019 medicine&<strong>technology</strong> 29


■ [ TRADE FAIR ]<br />

Multilayer film for<br />

sterile touch keyboards<br />

Sterility in the operating theatre| Saxonymed GmbH<br />

has developed Stertouch Pro, a multilayer film which<br />

makes it possible to operate displays in a sterile<br />

manner without making them difficult to read.<br />

More and more surgical environments are being kitted out<br />

with touch displays. Reichenbach-based Saxonymed<br />

GmbH developed a multilayer film to prevent these displays<br />

being contaminated by surgeons. The film makes it possible to<br />

touch surfaces without obscuring valuable information on the<br />

screen or having a negative impact on sterility. In addition to<br />

touchscreens, Stertouch Pro can also be applied to buttons like<br />

eyeglass keypad or when using a touchpad to control an endoscopy<br />

tower.<br />

The system which Saxonymed will be presenting at Medica is a<br />

sterile multilayer film system: the central element is a seethrough<br />

PE film which does not affect image quality or usability,<br />

and can also be used to display medically relevant images. One of<br />

the main focus areas for Stertouch Pro was the special acrylate<br />

adhesive, as traditional film adhesives have a significant<br />

negative impact on image quality and leave adhesive remnants<br />

on the monitor. These issues were solved in partnership with the<br />

Belgian company Nitto Belgium NV. The film itself is sterile,<br />

guaranteeing a validated process. The company Steris in Radeberg,<br />

Saxony use a validated and batch-certified gamma radiation<br />

process to sterilise the film. Each film has a batch and serial<br />

Surgeons normally require assistance to prevent contamination<br />

as a result of them touching displays and keyboards. However,<br />

Stertouch Pro means that surgeons no longer require assistance<br />

to maintain a sterile environment when touching surfaces.<br />

number, in addition to a production date and information about<br />

the expected shelf life.<br />

Due to the patented layer system, Stertouch Pro can be attached<br />

to smooth surfaces quickly and easily, with no need for medical<br />

training. The film also includes a positioning strip and two pull<br />

tabs on the sides. Stertouch Pro is normally used for keyboards<br />

and displays up to 32 inches. However, the film is not limited to<br />

monitors or tablets. It can also be used to provide sterile protection<br />

for other surfaces. In fact, it can be used for any critical surface<br />

in an operating theatre.<br />

www.saxonymed.de<br />

At Medica: Hall 12, Stand B50<br />

Photo: Saxonymed<br />

Packaging <strong>technology</strong><br />

Packaging solutions for modular wound dressings<br />

Health Informatics Initiative<br />

Improving research<br />

and patient care<br />

Photo: Optima<br />

Complex wound dressings frequently<br />

need to be cut and stretched in a particular<br />

way, which can be a challenge for patients.<br />

Optima Packaging Group GmbH,<br />

based in Schwäbisch Hall, will be exhibiting<br />

solutions for the manufacture<br />

and packaging of wound dressings at the<br />

Compamed trade fair. The Optima TDC<br />

125 is a scalable machine which can be<br />

used on a laboratory scale for both product<br />

development and the subsequent production<br />

phase. Users with a focus on high<br />

output will benefit from the MDC300 production<br />

and packaging system. Up to 600<br />

products per minute exit the “Advanced”<br />

version of the system. As a provider of<br />

turnkey solutions, Optima integrates<br />

other steps in the process, such as the<br />

packaging of products in sealed bags or<br />

boxes. The modular design of the systems<br />

means that they are easy to install and do<br />

not take up any unnecessary space. The<br />

line management software programme<br />

Opal improves the overall efficiency of the<br />

system.<br />

www.optima-packaging.com<br />

At Compamed: Hall 8a, Stand J12<br />

The autosplicers and extraction grids<br />

ensure that there is no downtime in production.<br />

The Health Informatics Initiative is<br />

funded by the German Federal Ministry of<br />

Education and Research. Its aim is to use<br />

IT solutions to improve research opportunities<br />

and patient care. The solutions<br />

developed as part of the initiative will<br />

make it possible for healthcare data and<br />

clinical and biomedical research data to<br />

be exchanged and used beyond the walls<br />

of institutions and locations. By doing<br />

this, the initiative will enable physicians,<br />

patients and researchers to have access to<br />

the information which is important to<br />

them. This will lead to dia gnosis and<br />

treatment decisions which are a better fit<br />

for the individual patient.<br />

www.medizininformatik-initiative.de<br />

At Medica: Hall 13, Stand F46<br />

30 medicine&<strong>technology</strong> 01/<br />

1/201<br />

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01/2019 medicine&tec hn ology 31


■ [ TRADE FAIR ]<br />

The Composer is used as a controllable<br />

access catheter for minimally<br />

invasive procedures.<br />

Photo: Freudenberg Medical<br />

A PLATFORM WHICH OPENS<br />

A WINDOW INTO THE BODY<br />

Access catheter | The Composer platform is a real all-rounder: it opens up new opportunities<br />

for minimally invasive surgery, keeps patients safe and allows medical device<br />

manufacturers to reduce their development times.<br />

The roughly 20 cm component might<br />

not seem too impressive at first<br />

glance. However, it has a lot of spectacular<br />

abilities at its disposal. Freudenberg<br />

Medical’s team of developers spent two<br />

years designing the high-tech Composer<br />

platform for medical device manufacturers<br />

at its site in Jeffersonville, USA.<br />

Minimally invasive surgery has proven<br />

to be particularly successful in the field of<br />

cardiology. Diseases which once would<br />

have required open-heart surgery and the<br />

use of heart- lung machines can now be<br />

treated by specialists on an outpatient<br />

basis using local anaesthetic. They do this<br />

by inserting a small catheter into an<br />

artery in the patient’s groin and then<br />

guiding it to the part of the patient’s body<br />

where treatment is required.<br />

The Composer is a controllable access<br />

catheter which opens a window into the<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

Composer platform<br />

Minimally invasive surgery<br />

Expansion connectors<br />

Development network<br />

body. It can be used to get a wide range of<br />

diagnostic or therapeutic catheters to<br />

their required location. For patients, this<br />

kind of procedure means less risk, a quicker<br />

recovery and fewer complaints. It enables<br />

physicians to provide patients with<br />

quicker treatment at a lower cost.<br />

The Composer platform<br />

lowers development costs<br />

But there is no progress without side effects:<br />

“The pace of innovation in the<br />

medical device market is truly breathtaking,”<br />

explains Dr Max Kley, CEO of Freudenberg<br />

Medical. He also believes there is<br />

something of a gap in the market when it<br />

comes to commercialisation. The rate at<br />

which new products are coming on to the<br />

market is struggling to keep up with all of<br />

the new ideas being explored in this field.<br />

That’s what inspired Freudenberg’s engineers<br />

to come up with the Composer.<br />

Officially, it is designated a “steerable access<br />

for diagnostic and therapeutic interventions”;<br />

but it’s more than just that. It<br />

also provides a platform which specialised<br />

providers can use to create their own innovations<br />

and market them under their<br />

own brand names. “Development is<br />

accelerated for all stakeholders, and development<br />

costs are reduced,” is how Kley<br />

summarises the benefits. Various expansions<br />

can be added to the Composer, making<br />

it suitable for a variety of applications.<br />

Freudenberg Medical’s Composer is a<br />

patented <strong>technology</strong> platform which<br />

opens up a wide range of possibilities<br />

thanks to its sophisticated design. The innovation<br />

has already led to 12 new pro -<br />

duct development projects with Freudenberg<br />

business partners. The interior of the<br />

Composer is also less complex. This was<br />

particularly important for one of Freudenberg’s<br />

strategic sales partners, which has<br />

worked for the company for at least seven<br />

years. The company is a leading provider<br />

of disposable medical devices. “The<br />

Composer is easy to dismantle, and its<br />

core components are easy to access. This<br />

allows a partner to insert an alternative<br />

catheter shaft so that they can provide the<br />

product without any loss of functionality.<br />

That reduces waste in a field where devices<br />

are frequently designed to be used<br />

once and then thrown away after surgery,”<br />

explains Kaeferlein.<br />

■<br />

René Heilmann<br />

Freudenberg Medical,<br />

Kaiserslautern/Germany<br />

www.freudenbergmedical.de<br />

At Compamed: Hall 8b, Stand H01<br />

32 medicine&<strong>technology</strong> 01/2019


01/2019 medicine&tec hn ology 33


FEATURE<br />

Machines will Communicate<br />

Wirelessly on 5G<br />

Mobile communications | The fifth generation (5G) is far more than the successor of LTE: Manufacturers<br />

of medical <strong>technology</strong> can use 5G to build their own networks and advance factory<br />

automation. Also, 5G makes the Internet of Medical Things possible through short latency<br />

times and high reliability. The starting gun for new medical devices?<br />

34 medicine&<strong>technology</strong> 01/2019


Photo: Elnur/stock.adobe.com<br />

Don’t expect too much<br />

Sabine Koll<br />

Normally, new smartphones are all<br />

the hype at the Mobile World Congress<br />

(MWC) in Barcelona. That was so<br />

until February, however, when a medical<br />

application stole the show: the first live<br />

surgery on a 5G network. Specifically,<br />

streaming in real time took place between<br />

a medical team in the Hospital Clinic and<br />

Dr. Antonio de Lacy, Chief of Gastro -<br />

intestinal Surgery at Hospital Clinic, who<br />

was in the main auditorium at MWC.<br />

During the demonstration, de Lacy made<br />

the markings, which the surgical team in<br />

the hospital could see immediately, in<br />

the transmission of moving images. “Before<br />

5G, we had to freeze the picture to<br />

draw, but the surgeon would continue<br />

working, and that is not ideal,” explained<br />

de Lacy. The first 5G telesurgery took<br />

place in China at nearly the same time: A<br />

neuro stimulator was implanted in the<br />

brain of a Parkinson’s patient in Plagh<br />

Hospital in Peking. For the procedure, the<br />

physician was located in a hospital on<br />

Hainan island, 2,700 km away from<br />

Peking.<br />

These two examples illustrate the huge<br />

advantage 5G has for telemedicine: Compared<br />

to LTE with latencies between 40<br />

and 100 ms, 5G is expected to have delays<br />

YOUR KEYWORDS<br />

■ 5G in products for medical <strong>technology</strong><br />

■ 5G for production facilities<br />

■ Campus networks<br />

■ Latency<br />

■ Internet of Medical Things<br />

The new standard 5G may be the<br />

solution to seek out new applications<br />

and to advance the internet of medical<br />

things. Initial test environments have<br />

already been constructed.<br />

Whilst 5G can do a lot, it can’t do<br />

everything—especially not at the<br />

same time and straight away.<br />

of much less than 10 ms. Some experts<br />

are even speaking of 1 ms. The general<br />

public views 5G, most notably, as being<br />

fast with high data transmission rates of<br />

up to 20 Gbit/s. More important for industry,<br />

however, is that 5G comes with<br />

advantages for tackling the challenges in<br />

machine-to-machine communication. For<br />

instance, as many as one million end devices<br />

per square kilometre need to be able<br />

to send and receive. Also, 5G will be more<br />

than 99.999 percent reliable.<br />

Not all functionalities are available in<br />

one go, however. “The current version of<br />

the standard covers only the high data<br />

rates for the typical consumer industry.<br />

The other functionalities that are exciting<br />

for industrial applications won’t be available<br />

until Release 16, which is expected to<br />

come out at the end of 2019,” explains Dr.<br />

Andreas Müller. He is the Head of Communication<br />

and Network Technology at<br />

Bosch Corporate Research and, at the<br />

same time, Chair of the 5G Alliance for<br />

Connected Industries and Automation<br />

(5G-ACIA) in the German Electrical and<br />

Electronic Manufacturers’ Association<br />

(ZVEI).<br />

TU Munich: pilot study on 5G<br />

and medical devices<br />

Also Klinikum rechts der Isar, the hospital<br />

of the Technical University of Munich (TU<br />

Munich), has already examined the opportunities<br />

5G could offer. Between 2017<br />

and 2018, the Department of Surgery of<br />

TU Munich conducted a 12-month pilot<br />

study using 5G prototypes. The study<br />

evaluated three medical use cases: One<br />

was already mentioned above, telesurgery.<br />

“The appeal of having the surgeon in<br />

a separate room from the technical equipment<br />

doing the work is that specialists<br />

could offer anything from medical assistance<br />

to surgeries, even for people in re-<br />

01/2019 medicine&tec hn ology 35


FEATURE<br />

Professor Jan Stallkamp, Head of the<br />

Fraunhofer Project Group for Automation<br />

in Medicine and Bio<strong>technology</strong><br />

(PAMB) in Mannheim: “In the operating<br />

theatre of the future, the surgeon will<br />

no longer have to be physically present.<br />

Instead, the surgeon can operate a telesurgery<br />

system from a remote location.<br />

For this vision, you need video images in<br />

real time, which is what 5G promises<br />

with its low latency times. We want to<br />

test it out.”<br />

Photo: Fraunhofer IPA<br />

mote areas. Yet, we found out that 5G<br />

can’t let you use all its advantages at the<br />

same time,” says PD Dr. med. Michael<br />

Kranzfelder, Senior Physician of the Department<br />

of Surgery. “We need a large<br />

bandwidth with high data transmission<br />

rates to transmit CT data, for example.<br />

Yet, low latency is important for telesurgeries.<br />

So you have to decide what is important<br />

for your application. 5G <strong>technology</strong><br />

cannot do everything.” Another discussion<br />

that needs to be had is whether<br />

public 5G networks are secure enough to<br />

have telemedical applications running on<br />

them. “You also need to understand that<br />

there will not be a ubiquitous 5G network<br />

in Germany. So there will be difficulties<br />

with applications like telesurgery in rural<br />

areas.”<br />

Transmitting ultrasound data<br />

on 5G<br />

This could also be a disadvantage for the<br />

second 5G scenario piloted at Klinikum<br />

rechts der Isar: transmitting ultrasound<br />

data from a moving object (like an ambulance)<br />

and then sending the diagnosis<br />

back to the point of care. “The more information<br />

we have on a patient and the<br />

earlier they arrive, the better and faster<br />

we can help them. With its bandwidth<br />

and reliability in data transmission, 5G<br />

could provide a breakthrough here.”<br />

The third scenario the medical professionals<br />

in Munich studied could, in<br />

Olli Liinamaa, Project Manager at Nokia<br />

Finland, oversees the 5G test network in<br />

Oulu: “We get greater flexibility in the<br />

healthcare sector with 5G. Also, 5G<br />

opens up the possibility for intelligence<br />

to be introduced into existing devices.”<br />

contrast, work independently of public 5G<br />

networks: optimising processes in the<br />

hospital using track & trace—of patients<br />

as well as equipment. “The goal would be<br />

to use 5G to know exactly where a patient<br />

is in the hospital. With this <strong>technology</strong>, we<br />

would be able to improve the processes in<br />

the hospital and reduce long wait times,<br />

for example,” explains Kranzfelder. In<br />

principle, it is already possible to know<br />

where the patient is located today using<br />

WLAN and the patient’s smartphone. “Security<br />

requirements and data protection<br />

aspects pose challenges to us in this area,<br />

however.”<br />

He envisions a clinical app for patients<br />

that not only is a real-time planner for<br />

hospital appointments, but also provides<br />

diagnostic information, such as from imaging<br />

procedures. For Kranzfelder, the<br />

ability to track equipment in the hospital<br />

Photo: Nokia<br />

Photo: Ypsomed<br />

A 5G application in the test network<br />

of Ypsomed, a Swiss manufacturer<br />

of injection and infusion<br />

systems for self-medication: Augmented<br />

reality allows quality tests<br />

to be conducted more quickly in<br />

the factory in Burgdorf in the Canton<br />

of Bern during the production<br />

process. The data are sent to the<br />

SAP system automatically over 5G.<br />

36 medicine&<strong>technology</strong> 01/2019


Massive machine-type<br />

communication (mMTC)<br />

● Scalable connectivity<br />

● Full area coverage<br />

● Good illumination<br />

inside buildings<br />

Enhanced mobile broadband (eMBB)<br />

● High data rates for data-intensive applications<br />

● Broad spectrum<br />

● Wide range of uses<br />

Number<br />

of devices<br />

Transmission<br />

rates<br />

Latency/<br />

reliability<br />

Ultra-reliable low-latency communication<br />

(URLLC)<br />

● Ultra-reliable for business-critical<br />

applications<br />

● Low latency for real-time<br />

application<br />

● Ideal for industrial monitoring<br />

and control<br />

Illustration: Siemens<br />

The general public sees 5G,<br />

most notably, as having high<br />

data transmission rates of up<br />

to 20 Gbit/s. More important<br />

for industry is, however, that<br />

5G comes with functionalities<br />

for tackling the challenges in<br />

machine-to-machine communication<br />

in the Industry 4.0<br />

scenario. For instance, as<br />

many as one million end devices<br />

per square kilometre<br />

need to be able to send and<br />

receive in 5G networks. The<br />

latency times are very close<br />

to industrial requirements at<br />

up to 1 ms. The same applies<br />

for the reliability of more<br />

than 99.999 percent.<br />

would be another advantage of<br />

5G—namely if expensive medical devices<br />

could be located in the hospital at any<br />

time. “The Internet of Things has not been<br />

a reality in the hospital until 5G came.”<br />

Kranzfelder also adds that real-time imaging<br />

is not that easy to realise, even with<br />

5G—since rooms can be relatively small<br />

and network coverage is not ubiquitous.<br />

To increase process efficiency in the<br />

hospital, Kranzfelder believes we should<br />

be talking about a private 5G network for<br />

security reasons. This, too, is a novelty<br />

compared to the current generation of<br />

mobile communication: For the first time,<br />

5G allows local campus networks to be set<br />

up. For these, the regulatory authority<br />

will allow companies, regional network<br />

operators, or communities, upon application,<br />

to broadcast at frequencies of 3.7<br />

to 3.8 GHz starting in the second half of<br />

2019. This possibility is being discussed at<br />

Klinikum rechts der Isar. But first, a 5G<br />

test bed sponsored by the State of Bavaria<br />

will be set up at TU Munich to focus on<br />

e-health.<br />

A 5G test platform will also be created<br />

at the University Hospital Mannheim in<br />

upcoming months. The Project Group for<br />

Automation in Medicine and Bio<strong>technology</strong><br />

(PAMB) of Fraunhofer Institute for<br />

Manufacturing Engineering and Automation<br />

(IPA) will establish a test environment<br />

for assessing the potentials of using<br />

5G in the hospital and for developing and<br />

testing 5G-compatible applications. Researchers<br />

see possible uses, for example,<br />

in digitally networked operating rooms<br />

with wireless instruments like endoscopes<br />

and (capsule) robots and in the constant<br />

monitoring of vital parameters during patient<br />

transport.<br />

Preparation for surgery could<br />

be done in the patient’s room<br />

“Our first thoughts were that we can use<br />

equipment like endoscopes wirelessly and<br />

without cables in surgery since 5G pro -<br />

mises high data transmission rates and<br />

low latency. Cables are always a nuisance<br />

and take up a lot of time during preparation.<br />

A wireless surgery facilitates not<br />

only a general improvement in ergonomics,<br />

but also efficient processes during setup<br />

for surgery,” says Professor Jan Stall -<br />

kamp, Head of Fraunhofer PAMB. “In the<br />

closed intervention room, 5G competes,<br />

amongst other things, with the new<br />

WLAN standard, Wi-Fi 6. These systems<br />

offer similarly high data rates and low<br />

transmission times, but they lack mobility<br />

and a smooth transition between local<br />

and mobile networks. When locations<br />

change due to the process, 5G ensures<br />

continuous data recording inside and outside<br />

of the hospital.”<br />

Stallkamp pictures other future scenarios<br />

for using 5G: “In principle, 5G<br />

makes it possible to develop medical devices<br />

without intelligence. The intelligence,<br />

which is part of the software, can<br />

be moved away from the end device to<br />

a central cloud, for example, with all<br />

advantages of central system and data<br />

management. The life cycle of devices<br />

could be continuously monitored with<br />

5G, allowing special activities like predictive<br />

maintenance to increase device availability<br />

and lower maintenance costs. This<br />

only works when there is a highly reliable<br />

transmission path covering a large area,<br />

but it is also a regulatory nightmare.”<br />

Like Kranzfelder, Stallkamp observes<br />

that manufacturers of medical <strong>technology</strong><br />

are very interested in uncovering the potential<br />

of this new <strong>technology</strong>. “They are<br />

also still holding back, however,” says<br />

Stallkamp. “Industry would have to start<br />

from scratch to redevelop and approve<br />

wireless endoscopes with 5G functionality,<br />

for instance. So it is first rather up to<br />

us as a research institute to establish endoscopes<br />

as a reference, for instance, and<br />

to test their feasibility.”<br />

“Network slicing, the separation of networks<br />

of differently defined services, will<br />

definitely become a topic for hospitals to<br />

ensure quality for individual services,”<br />

stresses Olli Liinamaa, Nokia Project Manager<br />

for the 5G Test Network in Oulu/Finland.<br />

Network slicing has been in use<br />

since 2015, but is still being connected externally<br />

to the 4G network. Nokia intends<br />

to establish the first 5G base stations here<br />

starting in the second half of the year. In<br />

addition to the University of Oulu, the<br />

VTT Technical Research Centre of Finland,<br />

roughly 500 companies (including<br />

100 medical <strong>technology</strong> and life sciences<br />

companies), and Oulu University Hospital<br />

are connected.<br />

Finland is thinking on a very large<br />

scale: “The City of Oulu has decided to<br />

build an entirely new hospital to replace<br />

the existing one that can no longer meet<br />

changing demands. The future hospital is<br />

expected to maximise the use of techno-<br />

01/2019 medicine&tec hn ology 37


FEATURE<br />

Public network<br />

with its own cell tower on<br />

company premises<br />

Cellular/public<br />

LTE/5G network (Internet)<br />

High data security<br />

No access to private<br />

network from outside<br />

Private LTE/5G network<br />

Closed campus network<br />

Server and software<br />

for private<br />

mobile<br />

network<br />

Optional:<br />

edge cloud<br />

Predictive maintenance<br />

Fast response<br />

to abnormalities<br />

Illustration: Deutsche Telekom<br />

Information<br />

on processes/<br />

configuration of<br />

production processes<br />

Connecting to existing networks without problems<br />

Machines<br />

on campus interacting<br />

with one another<br />

Autonomous and<br />

on the shortest route with<br />

the truck<br />

logical innovations not only in healthcare,<br />

but also in the services for staff and hospital<br />

visitors,” says Liinamaa. Oulu University<br />

Hospital built a test lab for studying<br />

new e-health solutions based on 5G.<br />

Health professionals and engineers work<br />

hand in hand at the lab. Nokia experts report<br />

this lab will also be used for practical<br />

training of medical students and for flexible<br />

testing of new surgical alternatives<br />

with mobile walls.<br />

“The decision as to whether the hospital<br />

will end up using a private or public<br />

network has still not been made in Oulu<br />

either. A private network would give the<br />

hospital the independence and transparency<br />

to decide on network quality, robustness,<br />

security, private sphere, and services<br />

based on its own requirements,” says<br />

Liinamaa. “On the other hand, operating<br />

a mobile network is its own business with<br />

regulated frequency licensing, and someone<br />

has to establish and maintain the network.<br />

Trust in the public network and the<br />

current licence holders would free healthcare<br />

organisations from learning and investing<br />

in communication <strong>technology</strong>. A<br />

reliable network can be established with<br />

both models since the network components<br />

are the same for both options.”<br />

Not only hospitals, but producers are<br />

wondering whether to become the operator<br />

of a 5G network. Swiss medical <strong>technology</strong><br />

manufacturer Ypsomed has tested<br />

5G in its factory in Solothurn, where it<br />

makes insulin pens, and it does so using<br />

four applications in production.<br />

In particular, the analysis of sensor<br />

data provided by injection moulding machine<br />

data brought advantages: The data<br />

can be recorded and analysed in real time<br />

using 5G. This capability provides a constant<br />

overview of the production parameters.<br />

“Also, 5G allows for predictive<br />

maintenance on the machines,” says company<br />

spokesperson Julian Stressig. Moreover,<br />

5G is well suited for the virtualisation<br />

of machine computers on a mobile<br />

end device. This simplifies troubleshooting<br />

for production workers and creates<br />

the flexibility to optimise production independently<br />

of wiring. This feature is becoming<br />

increasingly important, especially<br />

for assembly equipment.<br />

The six-month pilot with Swisscom<br />

ended in the spring of 2018. “The bottom<br />

line is that 5G was worth it for us. We see<br />

that there will be no way around it in the<br />

future if we want to produce according to<br />

the latest standards in Switzerland,” says<br />

Stressig. “5G ultimately allows us to reach<br />

an even higher level of automation and<br />

digitalisation in production.”<br />

■<br />

Sabine Koll<br />

Journalist from Böblingen/Germany<br />

Campus networks are exclusive mobile networks<br />

for defined local company premises,<br />

a university, or individual buildings. The<br />

networks are tailored to fit individual user‘s<br />

needs. The campus network cannot be accessed<br />

from the public network. On the<br />

other hand, the private wireless network is<br />

connected to the normal cellular network<br />

so that companies can communicate with<br />

partners, external service providers, and<br />

suppliers. Experts call this combination of a<br />

private and public network the “dual slice<br />

solution.”<br />

Additional information<br />

On the Project Group for Automation<br />

in Medicine and Biotech -<br />

nology (PAMB) at Fraunhofer IPA:<br />

www.pamb.ipa.fraunhofer.de<br />

On the Finnish ecosystem<br />

Ouluhealth:<br />

www.ouluhealth.fi<br />

On the Technical University<br />

of Munich:<br />

www.tum.de/nc/en<br />

On Swiss manufacturer of medical<br />

<strong>technology</strong> Ypsomed:<br />

www.ypsomed.com<br />

38 medicine&<strong>technology</strong> 01/2019


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Tie-bar-less <strong>technology</strong> ensures an accessible mould area,<br />

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success – from 1989 until the present.<br />

engelglobal.com/tie-bar-less<br />

01/2019 medicine&tec hn ology 39


■ [ TECHNOLOGY ]<br />

Meter Powered by Sugar in the Blood<br />

Blood sugar measurement | A blood glucose meter developed by researchers in Barcelona<br />

is fully printable and self-powered. It is paper-based and is powered by sugar<br />

found in the blood sample.<br />

Measuring blood pressure<br />

is important for all<br />

types of diabetes. The<br />

simpler and faster, the<br />

better.<br />

Photo: TwilightArtPictures/Fotolia<br />

YOUR KEYWORDS<br />

About the Smart Systems<br />

Integration Conference<br />

Diabetes can appear in different<br />

forms and damage the heart, blood<br />

vessels, eyes, kidneys, and nerves. There -<br />

fore, early diagnosis is crucial. Point-ofcare<br />

tests (POCT), for instance, allow<br />

early detection without the need for technicians<br />

or laboratory infrastructures.<br />

The current, commercially available<br />

POCT devices are still usually battery operated,<br />

however, or require an external receiver<br />

to read the result. Generally they<br />

are disposable devices that need only a<br />

small part of the energy stored in the battery.<br />

The fully printable blood sugar meter<br />

developed by the Barcelona Microelectronics<br />

Institute (IMB-CNM, CSIC), however,<br />

provides the opportunity to detect<br />

diabetes early in an environmentally<br />

friendly way at the point of care, which<br />

can even be done in remote and isolated<br />

places and without an external power<br />

supply: The paper-based disposable meter<br />

uses energy from the blood sample itself<br />

for power.<br />

The glucose found in the blood sample<br />

creates an enzymatic fuel cell that acts as<br />

a glucose sensor at the same time. The<br />

fuel cell works using an enzymatic anode<br />

and a cathode on silver-oxide basis. The<br />

glucose is oxidised, creating a flow of<br />

electrons proportional to the glucose concentration.<br />

Thus, by measuring the flow<br />

the fuel cell generates, the meter can de-<br />

The Speed Research Group presented its results under the original title “Fully<br />

printable single-use self-powered glucometer” at the Smart Systems Integration<br />

Conference in Barcelona in April 2019.<br />

The conference provides a overview of developments, applications, opportunities,<br />

and visions in the field of system integration of miniaturised components,<br />

with a practical orientation.<br />

Event information: www.smartsystemsintegration.de<br />

■<br />

■<br />

■<br />

■<br />

Point-of-care testing<br />

Printable, paper-based device<br />

Energy-efficient electronics<br />

Glucose in the sample as<br />

sole energy source<br />

termine the glucose concentration in the<br />

sample. The current charges a capacitor<br />

that stores the energy and powers the device’s<br />

electronics.<br />

This measurement technique is based<br />

on voltage monitoring and the use of tiny<br />

printable electronic components like transistors,<br />

diodes, capacitors, and resistors.<br />

These parts are connected to the fuel cell<br />

through an electrofluidic timer.<br />

Electronic components<br />

connected to enzymatic fuel cell<br />

The timer was developed for this device.<br />

Through capillary action, the fluid moves<br />

through a medical paper and creates an<br />

electric contact at a pre-defined time. In<br />

this way, the electronic components are<br />

connected to the enzymatic fuel cell at the<br />

right times: first the capacitor, then the<br />

printed electronics used to record the glucose<br />

concentration, and finally the electrochromic<br />

indicators.<br />

One of the main challenges was the<br />

low voltage generated by the fuel cell. The<br />

40 medicine&<strong>technology</strong> 01/2019


voltage was too low to operate the connected<br />

electronics. Yet, high open-circuit<br />

voltage of about 0.85 V generated by the<br />

enzymatic fuel cell, combined with energy-efficient<br />

electronics, allowed the meter<br />

to have an energy-autonomous power<br />

supply.<br />

Operation is simple: The user applies a<br />

small amount of blood to the device and<br />

adds a phosphate-buffered saline solution<br />

from a blister pack. The displays show the<br />

result after 75 seconds:<br />

• Normal is when only the control indicator<br />

is on, which is equivalent to an<br />

amount of less than 7.8 mM glucose.<br />

• Pre-diabetes is when the control and<br />

first indicator are on—in which case the<br />

concentration is above 7.8 mM glucose.<br />

• Diabetes at more than 11.1 mM glucose<br />

is present when all three indicators<br />

are active.<br />

Photo: IMB<br />

The device was developed to diagnose<br />

gestational diabetes, a type of diabetes<br />

that can occur temporarily during pregnancy.<br />

The meter can also be adapted to<br />

glucose concentrations needed to dia -<br />

gnose other types of diabetes.<br />

The disposable device is, therefore, an<br />

energy-efficient, environmentally friend -<br />

ly, and cost-effective alternative to conventional<br />

point-of-care test systems. ■<br />

Irene Merino<br />

Instituto de Microelectrónica de Barcelona<br />

(IMB)/ Spain<br />

The blood sugar<br />

meter has extremely<br />

energy-efficient<br />

electronics.<br />

The number of active<br />

indicators reveals<br />

the measured<br />

result: If all three<br />

are activated, the<br />

glucose concentration<br />

indicates<br />

diabetes.<br />

Additional information<br />

In the Self-Powered Engineered<br />

Devices Group, Speed Group for<br />

short, researchers work in an<br />

multidisciplinary team to develop<br />

autonomous, self-powered devices.<br />

To do so, the group combines<br />

<strong>technology</strong>, paper microfluidics,<br />

printed electronics, biocatalysis,<br />

and electrochemistry.<br />

www.speedresearchgroup.com<br />

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01/2019 medicine&<strong>technology</strong> 41


■ [ TECHNOLOGY ]<br />

Medical Device Software:<br />

Licensing Only for Needed Functions<br />

Software licensing | Software comes with a number of medical devices today and supports<br />

doctors and nursing staff in many ways. The user does not necessarily have to<br />

buy the software with the device, however. The software can also be licensed, offering<br />

advantages for device manufacturers as well as users.<br />

The conventional sales channel for<br />

medical device manufacturers has<br />

been to sell the device with all related<br />

software to hospitals or doctor’s surgeries<br />

in the form of a single transaction. But<br />

there are disadvantages: Manufacturers<br />

do not have regular income, and users<br />

have to make high investments. There is<br />

another approach, however. It is called<br />

software monetisation: Instead of selling<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

The available functions for a ventilator are determined by the software that comes with<br />

the device. Smart licensing allows users to adapt the device to their needs.<br />

Devices with software-based<br />

functions<br />

Licensing on request<br />

Encryption tool<br />

One tool for licence management<br />

Photo: Fritz Stephan<br />

devices with a standard software package<br />

that has a number of functions, manufacturers<br />

can design the software to meet the<br />

customer’s needs. In this way, users will<br />

receive with their medical device only the<br />

functions they want. Users can purchase<br />

additional functions later as needed,<br />

which can be charged based on usage<br />

time or units.<br />

The basis for this approach is that,<br />

from the beginning, software manufacturers<br />

and manufacturers of medical devices<br />

can divide their software into functional<br />

blocks, define reasonable usage<br />

times, and sell the blocks based on demand.<br />

Appropriate technical licensing<br />

solutions and the right licence models will<br />

be needed.<br />

There are many other variants aside<br />

form an unlimited licence. Conventional<br />

models for licensing include the following<br />

examples:<br />

• Licence for single machine or network:<br />

In this case, the manufacturer determines<br />

where the user’s licence is valid:<br />

on single machines or in a network. If<br />

the number of workstations is not sufficient,<br />

users can purchase additional<br />

usage rights.<br />

• Pay-per-use:<br />

In this model, users are only charged<br />

for the actual usage of the software—with<br />

all available functions included.<br />

For example, each image taken<br />

using digital computed radiography<br />

would cost a certain amount. Actual<br />

usage can be based on time or actions.<br />

•Subscriptions:<br />

Users purchase all functions of the<br />

medical device and pay at a certain,<br />

regular interval.<br />

• Activation of modules:<br />

The users can buy the functions of the<br />

medical device as needed. For a type of<br />

ventilator, the software would be divided<br />

into the functions of ventilation<br />

of newborns, children, and adults.<br />

Users can purchase functions later at<br />

any time. The usage rights would be<br />

updated accordingly.<br />

• Maintenance:<br />

To ensure that only authorised and<br />

trained personnel have access to the<br />

medical device’s software functions<br />

and maintenance documents, manufacturers<br />

can issue time-limited authorisation<br />

licences for the maintenance<br />

period.<br />

The Codemeter solution developed by<br />

Wibu-Systems AG in Karlsruhe/Germany<br />

allows companies to use all of these licensing<br />

options and more. This solution encrypts<br />

a complete executable file or the<br />

software’s individual function blocks for<br />

the medical device. The usage rights,<br />

which the user acquires with the device,<br />

will be stored securely in the CM Dongle<br />

protection hardware.<br />

42 medicine&<strong>technology</strong> 01/2019


Photo: Wibu-Systems<br />

Codemeter <strong>technology</strong> that securely manages<br />

usage rights has a modular design and<br />

comes in several variants.<br />

This variant gives medical device<br />

manufacturers licensing options for different<br />

models as well as protection from<br />

product piracy and reverse engineering,<br />

unintentional changes, and deliberate<br />

manipulation.<br />

Wibu-Systems offers the CM Dongle<br />

hardware in several designs: USB sticks<br />

with and without flash drive; SD,<br />

MicroSD, CF, and CFast memory cards;<br />

and Asic are available. Other possible options<br />

are software-based Cm Act Licence<br />

containers and cloud containers.<br />

The Codemeter Licence Central tool<br />

creates, supplies, and manages the<br />

licences. It stores the expiration dates, defines<br />

values for usage, and has counters.<br />

The tool analyses user activities as well.<br />

When a licence portal is set up, users can<br />

view their purchased and activated<br />

licenses.<br />

Medical device manufacturers can protect<br />

or license their computer software,<br />

embedded systems, controllers, and mi -<br />

cro controllers. For these cases, Wibu-Sys-<br />

tems developed a Codemeter module that<br />

contains Codemeter Runtime, Codemeter<br />

Embedded, or Codemeter μ-Embedded. ■<br />

Oliver Winzenried<br />

Wibu-Systems, Karlsruhe/Germany<br />

Additional information<br />

For more information on the manufacturer<br />

and on applications of the<br />

Codemeter tool already in use, go to<br />

www.wibu.com<br />

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01/2019 medicine&<strong>technology</strong> 43


■ [ TECHNOLOGY ]<br />

What plasma could achieve for<br />

disaster relief using a new <strong>technology</strong><br />

Decontamination with DBD plasma | The partners involved in the Moplasdekon joint<br />

project have developed a mobile plasma disinfector which can be used to disinfect<br />

ambulances, for example. The <strong>technology</strong> differs from industrial processes as well as<br />

from approaches based on plasma sterilization.<br />

Photo: Plasmatreat<br />

The mobile plasma decontamination system<br />

can disinfect the interior of the entire<br />

ambulance during emergency situations.<br />

This is done without using chemicals.<br />

YOUR KEYWORDS<br />

■ Plasma for mobile decontamination<br />

■ Dielectric barrier discharge<br />

to generate the plasma<br />

■Proven efficacy<br />

■ Suitable for different surfaces<br />

Atmospheric plasma systems for industrial<br />

applications are generally<br />

permanently integrated into their production<br />

line. The type of low-pressure plasma<br />

units that have been developed for steri -<br />

lizing products are normally large and<br />

heavy because they require a vacuum<br />

chamber. Both these systems operate<br />

under boundary conditions that have<br />

been adapted to an industrial environment.<br />

So the idea of making plasma available<br />

as a surface treatment for mobile applications<br />

was not an obvious one. But<br />

that is precisely what the partners in the<br />

Moplasdekon joint project have succeeded<br />

in doing: The <strong>technology</strong> they<br />

have developed makes it possible to decontaminate<br />

contaminated surfaces using<br />

plasma without having to use chemicals<br />

that are harmful to health and the environment.<br />

Since this approach is of interest to<br />

disaster relief organizations, the project<br />

has been funded for three years – until the<br />

middle of this year – by the German Fe -<br />

deral Ministry of Education and Research<br />

(BMBF) as part of its “Research for Civil<br />

Security” program. During this time the<br />

partners have not only developed the innovative<br />

mobile plasma system, but tested<br />

its effectiveness and practical applications<br />

on diverse surfaces as well. For instance,<br />

44 medicine&<strong>technology</strong> 01/2019


protective suits worn by emergency personnel<br />

that may be contaminated with<br />

dangerous bacteria can be decontaminated<br />

just as rapidly and effectively as the<br />

interior of ambulances.<br />

As joint project partners Plasmatreat<br />

GmbH from Steinhagen, the Fraunhofer<br />

Institute for Process Engineering and<br />

Packaging IVV in Freising and M-U-T<br />

GmbH, a manufacturer of measuring instruments<br />

for use in medical and environmental<br />

engineering from Wedel have collaborated<br />

on this project. The job of developing<br />

and designing the plasma unit itself<br />

fell to Plasmatreat, a company that<br />

specializes in atmospheric plasma surface<br />

<strong>technology</strong>. Experts at Plasmatreat built<br />

the power generator which is required to<br />

generate the plasma, as well as the plasma<br />

nozzle and other parts for the de -<br />

monstration model.<br />

Plasma gas concentration is<br />

measured inside the vehicle<br />

The demonstration model is currently in<br />

Freising, where the system is undergoing<br />

microbiological evaluation at the Fraunhofer<br />

IVV. The researchers there have<br />

used bacteria, fungi and viruses to test<br />

whether the plasma effectively de con -<br />

taminates and disinfects the surfaces of<br />

different materials. M-U-T in turn has developed<br />

special gas analyzers which send<br />

data directly to the mobile power gene -<br />

rator of the plasma system. One of these<br />

instruments measures the plasma at the<br />

nozzle outlet at the start of the decontamination<br />

phase. The other is located inside<br />

the area to be decontaminated – for<br />

example, in the ambulance – and signals<br />

to the generator when the concentration<br />

of plasma gas inside is sufficient.<br />

The Moplasdekon demonstration<br />

model uses plasma gas generated under<br />

normal pressure. However, unlike<br />

Openair-Plasma used in industry to clean<br />

and activate material surfaces, this plasma<br />

is not generated using an arc-like discharge.<br />

Instead, the newly developed<br />

CD-40 sterilization nozzle generates the<br />

plasma by means of dielectric barrier discharge,<br />

or DBD as it is known for short.<br />

“In contrast to conventional atmospheric<br />

pressure plasma, this <strong>technology</strong> produces<br />

a reactive plasma gas with a long<br />

life which is suitable for disinfecting and<br />

even sterilizing larger areas up to five<br />

cubic meters in volume“, explains Dr.<br />

Alexander Knospe, director of Innovation<br />

Management at Plasmatreat and coordinator<br />

of the joint project. “This corresponds<br />

approximately to the volume of an<br />

ambulance vehicle, which can be decontaminated<br />

using the DBD process in<br />

around one to two hours without the need<br />

for chemicals.”<br />

Support from experienced<br />

rescue workers<br />

For general questions on disaster management,<br />

the organizations involved in the joint project<br />

consulted four associated partners:<br />

The Analytical Task Force (ATF) of the Essen Fire<br />

Service that specializes in biological threats, the<br />

rescue and disaster management specialists at<br />

the Bavarian Red Cross (BRK) and the supplier of<br />

specialist tents and equipment Thorsten<br />

Schöppner Inhag Zelte und Zubehör, based in<br />

Hesse. The fourth practical advisor was the<br />

German government‘s center for the monitoring<br />

and prevention of diseases – the Robert Koch<br />

Institute (RKI) in Berlin, which itself operates a<br />

task force for biological threats.<br />

No difference in perfomance on<br />

glass, plastic, or metal surfaces<br />

The plasma process is monitored spectros -<br />

copically to ensure continuous and reproducible<br />

operation. When asked which materials<br />

had so far been treated during testing,<br />

Prof. Dr. Thomas Schmitt-John, director<br />

of the systems engineer’s Plasma<br />

Life Science department replies: “We have<br />

tested it on glass, plastic and metal surfaces<br />

and so far found no difference in disinfection<br />

performance.“ Since the DBD<br />

plasma gas is relatively cold and the distance<br />

between the nozzle and the substrate<br />

is already large, it would also be<br />

possible to decontaminate heat-sensitive<br />

plastics.<br />

The CD-40 nozzle achieved a 6-log<br />

microbial reduction rate. This equates to a<br />

reduction in the bacterial load by a factor<br />

of one million, which meets the requirements<br />

for sterilization. The decontamination<br />

test thus demonstrated the bactericidal<br />

and fungicidal effect as well as the<br />

antiviral and sporicidal effect of the <strong>technology</strong>.<br />

One thing that makes the new system<br />

particularly interesting is that unlike conventional<br />

decontamination processes<br />

which rely on chemical active substances<br />

such as peracetic acid (PAA) or hydrogen<br />

peroxide, it requires only electrical energy<br />

and air as the process gas. The chemicals<br />

are not only dangerous to the health of<br />

emergency workers, they are also harmful<br />

to the environment. As a result, delivery<br />

to the contaminated areas, storage and<br />

eventual disposal involves significant effort.<br />

If there is no mains power supply available<br />

at the point of use, rescue services<br />

have emergency power generators which<br />

can be used to operate the plasma unit. If<br />

these also fail, the system has a built-in lithium-ion<br />

battery to fall back on. If<br />

necessary, this can even be recharged<br />

using the vehicle‘s battery.<br />

The declared technical goal of the research<br />

project was that the plasma disinfector<br />

should be compact and relatively<br />

light so that one person could carry it. No<br />

such device currently exists. The future<br />

Moplasdekon product will weigh 25 kg<br />

and be rapidly deployable and even more<br />

user-friendly than the demonstrator<br />

model.<br />

■<br />

Inès A. Melamies<br />

Specialized journalist from Bad Honnef<br />

01/2019 medicine&tec hn ology 45


■ [ TECHNOLOGY ]<br />

Precise Movements<br />

Around the Blood Sample<br />

Automated analysis in the lab | High-tech machines analyse human blood samples,<br />

detect bleeding disorders, and, in this way, help saves lives. To function reliably, these<br />

automated machines have to be equipped with the right drives and conveyor systems.<br />

Human blood carries oxygen and nutrients,<br />

attacks foreign bodies, and<br />

closes wounds. Yet, some people have<br />

bleeding disorders that can be unpleasant<br />

and have serious consequences. Tests that<br />

detect bleeding diseases and check therapy<br />

options are carried out in labs and<br />

hospitals: Modern analysers can pipette<br />

samples independently around the clock<br />

and produce rapids results. Based on the<br />

model of industrial applications, these<br />

automated devices work precisely and reliably.<br />

The requirements on components<br />

and the expectations of developers are<br />

high.<br />

French company Stago specialises in<br />

analysis instruments for haemostasis<br />

diagnostics—hence, issues concerning<br />

blood coagulation. Stago has about<br />

20,000 devices in use worldwide, including<br />

the fully automated analyser Star<br />

Max. This system has a three-axis robot<br />

and room for 215 samples and 1,000 cuvettes.<br />

The machine works independently,<br />

verifies results, compares them,<br />

and monitors processes. It is ideal especially<br />

for labs that have a high sample<br />

volume.<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

■<br />

Lab automation<br />

Drive <strong>technology</strong> in the device<br />

Automated pipetting<br />

Moving the samples<br />

Conveyor system as an assembly<br />

Photo: Maxon Motor<br />

The Star Max analyser has room for<br />

215 samples and 1000 cuvettes.<br />

The machine works independently,<br />

verifies the results, and monitors<br />

the processes.<br />

Used in Star Max: At 6 W, the A-Max 22<br />

brush DC motor (left) offers a very good<br />

price-performance ratio. The GP 22<br />

planetary gear (right) has a diameter of<br />

22 mm and creates enough torque in the<br />

application.<br />

Photo: Stago<br />

The Star Max system was released in<br />

2014. Yet, Stago had already developed<br />

an analyser with an X-Y-Z axis robot in<br />

1991. MDP drive experts were involved in<br />

its development at that time. MDP is the<br />

French sales office of Swiss manufacturer<br />

of drive systems, Maxon Motor. MDP was<br />

contacted again in the first phase of development<br />

of the Star Max device to answer<br />

important questions on the precise movements<br />

on all three axes and full-automated<br />

pipetting of reagents. “With its extensive<br />

experience, MDP ultimately modified<br />

the standard products to meet our<br />

requirements,” says Jean-François Gelin,<br />

project director of Innovation R&D at<br />

Stago.<br />

This project also benefited from the expertise<br />

of MDP and Maxon Motor in the<br />

form of helpful tips from each company.<br />

Meanwhile, the partnership has been<br />

going so well that the drive experts are<br />

building the conveyor system for the<br />

pipette racks in their factory in Neyron<br />

46 medicine&<strong>technology</strong> 01/2019


and delivering them to Stago for final assembly.<br />

Different types of Maxon’s A-Max DC<br />

motor—with diameters between 16 and<br />

26 mm—are used to move the racks.<br />

These DC motors are very dynamic and<br />

easy to control. MDP also uses the right<br />

planetary gears to achieve the necessary<br />

torque.<br />

“When we started developing haemostasis<br />

analysers, almost no one believed we<br />

would be successful,” asserts Stago’s<br />

Jean-François Gelin. Today the company<br />

has over 2,100 employees and supplies<br />

high-end devices to 110 countries. ■<br />

Stefan Roschi<br />

Maxon Motor, Sachseln/Switzerland<br />

About MDP<br />

MDP engineer Yannik Charel assembles the transport<br />

unit for the Star Max medical analyser.<br />

MDP was founded in 1982 and first dealt with micrometers<br />

from several manufacturers. Later the company<br />

saw strong growth thanks to standard products that<br />

could be shipped quickly, and it provided technical support<br />

from its call centre. Today it employs 41 people at<br />

its headquarters in Neyron near Lyon—in sales, development,<br />

and its own production, amongst other departments.<br />

MDP provides its customers with drives and<br />

complete drive systems.<br />

In the autumn of 2014, MDP stopped being just a sales<br />

partner for Maxon Motor in France and became an official<br />

part of the Maxon Motor Group and one of the<br />

Swiss company’s production facilities. The other five are<br />

in Switzerland, Germany, Hungry, the Netherlands, and<br />

Korea.<br />

www.mdp.fr<br />

www.maxongroup.co.uk<br />

Photo: Maxon Motor<br />

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47


■ [ TECHNOLOGY ]<br />

Polymer Plain Bearings in<br />

Knee, Lighter and Quieter<br />

Plain bearings in the prosthesis | Plain bearings made of high-performance polymers<br />

are self-lubricating and are lighter and quieter than bronze bearings. Thus, after extensive<br />

testing, manufacturer of prosthetic knee joints, Otto Bock, decided to go with<br />

the plastic solution.<br />

Iglidur plain bearings<br />

allow the available<br />

space to be<br />

used ideally in the<br />

3R60 (left) and<br />

3R60-Pro (right)<br />

polycentric prosthetic<br />

knee joints.<br />

The Iglidur piston ring<br />

for a pneumatic prosthetic<br />

knee joint has a<br />

special shape and was<br />

developed and manufactured<br />

to meet Otto<br />

Bock’s specifications.<br />

Photo: Otto Bock<br />

Photo: Igus<br />

A<br />

prosthesis has to be fit to each individual<br />

wearer and support the body<br />

during challenging physical activities, like<br />

running. To make these requirements<br />

seem natural and as comfortable as<br />

possible for wearers of prosthetics, Otto<br />

Bock SE & Co. KGaA, based in Duderstadt/<br />

Germany, has spent years developing innovative<br />

products like the C-Leg: When<br />

first introduced in 1997, it was the world’s<br />

first microprocessor-controlled knee joint<br />

that measured movements in real time.<br />

Wearers of this prosthesis can, for<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

■<br />

Plain bearings for prosthetic knee joints<br />

Self-lubricating<br />

Replacement for metal solution<br />

Tests under load<br />

Advantage for limited space<br />

example, direct their gaze ahead when<br />

walking through the forest instead of having<br />

to keep an eye on the ground at all<br />

times.<br />

To be able to develop these devices,<br />

Otto Bock has been working very closely<br />

together with prosthesis wearers with the<br />

goal of understanding their needs. For<br />

everyday activities, these people want coordinated<br />

movement sequences, good<br />

shock-absorbing properties, and a functional<br />

capacity at least equal to the natural<br />

joint.<br />

Some of the bearing zones in prosthetic<br />

knee joints used to have bronze<br />

bearings. But the experts at Otto Bock determined<br />

that fretting corrosion can be<br />

common when small pivoting movements<br />

are made. This can make knee joints stiff<br />

and pose a risk to people with prosthetics.<br />

Several materials were tested in the<br />

search for an alternative. Ultimately, the<br />

prosthetics specialist decided to use Iglidur<br />

polymer plain bearings made by Igus<br />

GmbH in Cologne/Germany. They are optimised<br />

for use under high friction and<br />

have a very low wear rate. “The plain<br />

bearings are made of a mixture of basic<br />

polymers, fibres, fillers, and solid lubricants,”<br />

states Ulf Hottung, Industry Manager<br />

for Medical Technology at Igus. The<br />

solid lubricants are embedded in the solid<br />

material as microscopically small particles.<br />

“This is enough to lubricate the immediate<br />

environment adequately and to<br />

do away with external lubricants like oils<br />

and greases.”<br />

In its own testing lab, Otto Bock examined<br />

more closely just what these bearings<br />

can do. Prosthetic knee joints with<br />

the Iglidur plain bearings were bent<br />

under load to gain knowledge about the<br />

wear behaviour of the components under<br />

realistic conditions.<br />

Otto Bock made the decision to use Iglidur<br />

bearings not only because they are<br />

corrosion resistant. They offered other<br />

advantages for prosthetic knee and hip<br />

48 medicine&<strong>technology</strong> 01/2019


ALL FROM<br />

ONE SOURCE!<br />

Research<br />

Product idea<br />

High-performance<br />

polymer plain bearings<br />

are used in<br />

prosthetic knee<br />

joints without the<br />

need for additional<br />

lubrication.<br />

Design<br />

Concept<br />

Prototyping<br />

Photo: Igus<br />

joints: Unlike bronze bearings, the plain<br />

bearings were not affected by dirt or dust.<br />

Even the noises that occur with increasing<br />

use of the bronze bearings were significantly<br />

reduced by the polymer plain bearings.<br />

With the special bearings,<br />

space is used best as possible<br />

In the polycentric, or multi-axis, 3R60<br />

prosthetic knee joint, the use of Iglidur<br />

plain bearings allowed the available space<br />

to be utilised as best as possible. “Here<br />

several bearing zones are close to one another,<br />

and the usable wall thickness is so<br />

small that roller bearings cannot be used<br />

with this geometry,” explains Andreas<br />

Schuh, expert for fluidic control systems<br />

at Otto Bock. Schuh has spent many years<br />

working in the development of prosthetic<br />

knee joints and has extensively tested and<br />

analysed several bearing elements.<br />

In addition to available space, weight is<br />

also a crucial part of development. For<br />

wearers, a heavy prosthesis can be a<br />

hindrance instead of a helper. “We fight<br />

for every gram. With their light weight,<br />

these plain bearings have an advantage<br />

over metal bearings,” Schuh clarifies.<br />

Being easy to maintain and requiring<br />

neither maintenance nor additional lubrication,<br />

the polymer plain bearings are<br />

also cost advantageous to Otto Bock: No<br />

lubrication means that the prosthetic<br />

joints are not as susceptible to contamination,<br />

says Schuh. “Hence, no cover caps<br />

or additional sealing elements are needed<br />

to protect the bearing zones from contamination<br />

and water.” Plain bearings are<br />

more cost-efficient than comparable<br />

metal products. The axes do not need hardening<br />

for use. This shortens the manufacturing<br />

process, which also lowers<br />

costs.<br />

The plastics specialists in Cologne<br />

make individual components in addition<br />

to numerous standard parts, available in a<br />

large selection of materials. In one of its<br />

most popular mechanical joints with<br />

pneumatic control—type 3R78—Otto<br />

Bock uses, for example, a piston ring that<br />

is not available in the standard product<br />

range due to the special geometry. For<br />

such cases, Igus is initially using several<br />

manufacturing processes to make costefficient<br />

prototypes, which will later<br />

be made in quantities of one to series of<br />

several millions.<br />

■<br />

Stefan Loockmann-Rittich<br />

Igus, Cologne/Germany<br />

www.igus.de<br />

Manufacturing<br />

concept<br />

Product<br />

Production<br />

EXTRUSION<br />

MOLDING<br />

ASSEMBLY<br />

HALL 8A / F28<br />

01/2019 medicine&tec hn ology 49<br />

www.RAUMEDIC.com


■ [ TECHNOLOGY ]<br />

At 40,000 Revolutions per Minute,<br />

Small Motor Clears Clot from Vessel<br />

Small motors | At high speed, a drive is able to break up thrombi in the leg inside the<br />

vessel and remove them. Very small, high-speed motors are used in such catheters<br />

made by Straub Medical. That’s not all. This Swiss manufacturer is already working on<br />

even smaller solutions for the treatment of heart attacks and strokes.<br />

A metal spring in the catheter<br />

rotates quickly to<br />

break up and remove a<br />

blood clot blocking a<br />

vessel. In the catheter<br />

head, chisel-like structures<br />

can break up solid clots.<br />

The fragments are transported<br />

by a vortex current<br />

into the catheter’s openings<br />

and out of the body.<br />

Photo: Straub Medical<br />

A<br />

thick clot, a thrombus of coagulated<br />

blood, that gets stuck in the artery<br />

from the knee into the thigh can practically<br />

stop the flow of blood in the leg.<br />

Smaller blood vessels are not able to compensate<br />

fully for the blocked flow in the<br />

artery, however. The outcome: Lack of<br />

oxygen to the muscles makes walking<br />

painful after a few steps. Patients are<br />

forced to stand still, and in the city they<br />

may inconspicuously browse the merchandise<br />

in store windows. Peripheral artery<br />

disease (PAD) has this behaviour to<br />

thank for the colloquial name Germans<br />

use: “shop-window disease.”<br />

This type of blockage can be treated,<br />

amongst other methods, with a medical<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

■<br />

Small motor<br />

High speed<br />

Contactless magnetic coupling<br />

Protection of motor and vascular wall<br />

Special vortex method<br />

device that breaks up the clot and removes<br />

it from the vessel. The Rotarex S<br />

catheter, developed by Straub Medical in<br />

Switzerland, features a head not much<br />

bigger than that of a match. The doctor introduces<br />

the catheter into the artery<br />

through puncture and advances the device<br />

to the occluded blood vessel. There,<br />

the catheter head starts to rotate and suction<br />

at the press of a button. A little while<br />

later the thrombus is completely removed.<br />

Chisel breaks up clot,<br />

fragments removed by suction<br />

To generate the rotational movement, a<br />

motor outside of the body is connected to<br />

the catheter through a contactless magnetic<br />

coupling. The rotation generated by<br />

the motor is transmitted to the head inside<br />

the body by a high-strength steel spiral<br />

(also called a helix) located inside the<br />

catheter tube. The end of the catheter<br />

head itself is slanted on both sides—like a<br />

chisel. Once the head starts spinning,<br />

these surfaces break up the solidified material<br />

of the thrombus from inside out and<br />

set the fragments spinning in a vortex that<br />

cleans out the entire diameter of the<br />

blood vessel.<br />

The catheter head has two small side<br />

openings where the helix is exposed. The<br />

rotating helix suctions the free fragments<br />

into the tube, based on the principle of<br />

Archimedes’ screw. Inside the tube, the<br />

fragments are broken down even further<br />

by internal blades, making for smooth<br />

passage to the retrieval bag outside of the<br />

body.<br />

“Removal of the occluded material<br />

takes about three minutes on average,”<br />

explains Dirk Dreyer, Director of Sales<br />

and Marketing at Straub Medical. Known<br />

from thrombolysis and other procedures,<br />

effects like a stay on the intensive care<br />

unit or damage to the vascular wall can be<br />

avoided. For fresh thrombi, the Aspirex S<br />

variant is used, which does not need the<br />

rotating chisel of Rotarex S at its suction<br />

head. The suction effect of the rotating<br />

helix is enough to aspirate the clot<br />

through the side openings and transport<br />

it out of the body.<br />

High, constant speed is needed so the<br />

head of Rotarex S can break up the clot<br />

50 medicine&<strong>technology</strong> 01/2019


werkzeugbau-ruhla.de<br />

The brushless drive of<br />

series 2444...B is small,<br />

lightweight, quiet, and<br />

low-vibration.<br />

Photo: Faulhaber<br />

and create enough suction. The recommended<br />

speed, depending on catheter<br />

size and model, ranges from 40,000 to<br />

60,000 revolutions per minute. For technical<br />

reasons, the speed may not go significantly<br />

faster or slower than the<br />

limit—depending on whether the hard<br />

occlusion is being broken up or the last<br />

particles are being removed. Thus, the<br />

controller responds very quickly to any<br />

change in load, and the motor has to implement<br />

the signals with the same<br />

amount of precision.<br />

“There are not many motors available<br />

that meet our quality standards,” explains<br />

Dreyer. The motors used in the device are<br />

made by Dr. Fritz Faulhaber GmbH & Co.<br />

KG, located in Schönaich/Germany.<br />

“Faulhaber supported us in the developed<br />

of the first prototypes and provided important<br />

know-how,” adds Dreyer. Not<br />

least, the use of a motor in medical devices<br />

raises questions about medical device<br />

approval. Faulhaber has “the necessary<br />

certificates that give us an additional<br />

advantage with regards to the obligation<br />

to provide proof and traceability of device<br />

components as well.”<br />

The motor in the device’s hand-held<br />

unit has to be small and lightweight, and<br />

has to work without vibrating. The brushless<br />

drive of series 2444...B is, therefore,<br />

being balanced during production and<br />

undergoing additional precision balancing.<br />

The magnetic coupling also provides<br />

torque protection: If the helix or Rotarex<br />

head gets blocked during operation, the<br />

coupling element on the motor side continues<br />

to spin without introducing additional<br />

force. This protects not only the<br />

motor and device, but, more importantly,<br />

the blood vessel as well.<br />

The Rotarex S and Aspirex S catheters<br />

are available in diameters ranging from<br />

2 mm to 3.3 mm. Usually a blood vessel<br />

has to have a diameter of at least 3 mm to<br />

be accessible for devices. Blood vessels in<br />

the brain and coronary vessels are too<br />

narrow or twisted. “Our developers want<br />

to make even smaller catheters,” reports<br />

Dreyer. “This is a medical-technical challenge<br />

that we want to master with Faulhaber’s<br />

support.”<br />

■<br />

Volker Beck<br />

Faulhaber, Schönaich/Germany<br />

www.faulhaber.com<br />

ABOUT THE<br />

INVENTOR<br />

The story of how the Rotarex S<br />

method was created is typical for<br />

the mid-sized medical <strong>technology</strong><br />

industry in Switzerland: A high-tech<br />

engineer runs across an unsolved<br />

medical problem and thinks of<br />

something. Founder Immanuel<br />

Straub, who passed away in 2012,<br />

had been developing novel high-performance<br />

springs since the 1950s,<br />

which were installed, amongst<br />

other places, in the valves of Formula<br />

One engines. A doctor and friend<br />

of his made him aware of the difficulties<br />

in removing blood vessel occlusions<br />

near the end of the 1980s.<br />

The engineer came up with the idea<br />

to combine catheters with high-performance<br />

springs and rotating<br />

chisels. Thus, Straub created a new<br />

treatment method that has been in<br />

clinical use since 2000.<br />

www.straubmedical.com/en/<br />

Quality and<br />

Precision<br />

Medicine<br />

Diagnostics<br />

Packaging<br />

Complex injection moulding tools<br />

for precise plastic parts in high<br />

output quantities.<br />

Industriestrasse 01/2019 medicine&tec 14 | D-99846 hn ology Seebach 51<br />

+49 36929 7780 | info@werkzeugbau-ruhla.de


■ [ TECHNOLOGY ]<br />

Individual Parts and Implants in Series<br />

Straight from the Printer<br />

3D printing from titanium powder | Conmet, a company based in Moscow, prints<br />

maxillofacial implants for the CIS market, and soon for Europe as well. Conmet uses a<br />

3D printing system made by the Ditzingen-based company Trumpf. In the future, even<br />

components for the spinal region and serial prostheses are expected to be created in<br />

the powder bed.<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

■<br />

3D printing of facial implants<br />

Printer and titanium powder from the<br />

same source<br />

Process monitoring<br />

Devices compliant with EU standards<br />

Plans for series production<br />

Photo: Trumpf<br />

Russian manufacturer Conmet wanted<br />

to use 3D printing for its maxillofacial<br />

implants ten years ago, but the available<br />

<strong>technology</strong> did not meet Conmet’s<br />

requirements until 2017.<br />

Sometimes a surgeon is also an artist:<br />

For facial implantations, surgeons<br />

still have to cut out the implant from a<br />

perforated titanium plate during the surgery<br />

and modify the shape to fit the patient.<br />

This creates time pressure and<br />

stress, and fluctuations in quality can<br />

occur. With 3D printing, implants can be<br />

custom-fit and prepared ahead of surgery.<br />

Conmet employees in Moscow have<br />

been discussing this possibility for ten<br />

years now. Several system manufacturers<br />

were contracted to print a few benchmark<br />

parts, but the experts at Conmet were not<br />

satisfied with the quality at the time. They<br />

told this to Andreas Margolf, who, as a<br />

Project Manager of Additive Manufacturing<br />

at Trumpf GmbH + Co. KG in Ditzingen/Germany,<br />

came into contact with the<br />

Russians. Then in 2017, Conmet wanted<br />

to start a new test project using 3D printing<br />

and received information from<br />

Trumpf about the advancements in the<br />

<strong>technology</strong>. Today, the Moscow-based<br />

company uses a Truprint 1000 3D printer<br />

to make maxillofacial implants for the CIS<br />

market and will soon be expanding into<br />

Europe as well.<br />

Things progressed quickly after Conmet<br />

first contacted Trumpf. This time, the<br />

client was happy with the quality of the<br />

components, and the system’s design was<br />

right. Conmet likewise valued the assistance<br />

from Trumpf during the process.<br />

Fibre lasers ideal for<br />

conventional titanium alloys<br />

First, Conmet had to find the best suited<br />

system and determine the parameters for<br />

the requirements. The decision was to use<br />

a Truprint 1000 3D printer with a focus<br />

diameter of 30 μm. This system is extremely<br />

compact. As a beam source with a<br />

strength of 200 W, the fibre laser has no<br />

problems processing the titanium alloys<br />

commonly used in medical <strong>technology</strong>.<br />

Finesse was needed in deciding on the<br />

focus diameter the laser beam projects on<br />

the powder bed. “Our series of tests<br />

showed that surface roughness is about<br />

20 percent better at a focus diameter of<br />

30 micrometres than at a larger one. The<br />

process takes longer and is a little more<br />

expensive, but those things are not the deciding<br />

factors in medical <strong>technology</strong>,”<br />

says Margolf.<br />

The equipment manufacturer also<br />

supplies the titanium powder used to<br />

make the implants. In this way, reproducible<br />

material quality is ensured for all<br />

printed implants.<br />

In Moscow, Conmet has been using<br />

Truprint 1000 since the beginning of<br />

2018. The company makes a variety of devices<br />

including facial implants for cancer<br />

patients and maxillary implants for the<br />

CIS and European market. Hospitals provide<br />

the CT data for their patients. The<br />

engineers at Conmet design the implant<br />

in coordination with the surgeon and<br />

print it.<br />

“With Truprint 1000, we are currently<br />

making 60 implants a month, but plan to<br />

increase production by ten percent,” explains<br />

Nadezhda Morozova, Project Man-<br />

52 medicine&<strong>technology</strong> 01/2019


ager at Conmet. She adds, “compared to<br />

traditional processes like milling and<br />

turning, we now save 40 percent in manufacturing<br />

costs.”<br />

To ensure the components maintain a<br />

consistently high level of overall quality,<br />

the manufacturers make several test<br />

blocks during every printing process in<br />

addition to the medical device parts. The<br />

manufacturers can then perform mechanical<br />

tests and take density measurements<br />

on the test blocks to rule out deficiencies<br />

in the medical device component.<br />

Also, automated monitoring functions<br />

in the 3D printer can detect process deviations<br />

early and assess them. In Trumpf<br />

systems, examples of these functions include<br />

Powder Bed Monitoring and Melting<br />

Pool Monitoring. Sensors and image<br />

processing monitor the application of the<br />

powder and the laser’s melting pool.<br />

Individual spinal implants<br />

planned<br />

The Russian company plans to use<br />

3D printing in the near future to make<br />

customised prostheses for the spine as<br />

well. Future plans also include the manufacturing<br />

of prostheses in series. The<br />

U.S. FDA has already approved around<br />

100 standard parts of this type. A large<br />

number of them are joint replacement<br />

parts and spinal implants. To reach<br />

its goals, the Moscow company is bulking<br />

up its machinery: We need Truprint<br />

3000 with a larger printing area, says Morozova.<br />

Advantages of 3D printing<br />

Advantages of 3D printing in medical<br />

<strong>technology</strong>:<br />

■ Patient data can be used to create a<br />

CAD model specific to each patient,<br />

from which the implant is constructed—and<br />

the printer creates the<br />

complex, personalised geometry.<br />

■ Prostheses from the 3D printer<br />

achieve high damping, whilst remaining<br />

stable. Porous structures that integrate<br />

well with healthy tissue, but are<br />

solid and long-lasting can likewise be<br />

printed.<br />

■ Since the implants are made to fit<br />

from the printer, there is no need for<br />

cutting in the operating theatre. Physicians<br />

receive cleaned and sterile implants<br />

that can be used directly.<br />

■ Three-dimensional printing is resource-efficient<br />

since no chips or<br />

shavings are produced. Thus, when expensive<br />

titanium alloys are being<br />

The Conmet medical devices are certified<br />

according to the latest European<br />

standards. All elements for 3D-printed<br />

implants are designed to work with one<br />

another since 3D printers and accessories<br />

come from the same source. Coating tool,<br />

substrate plate, software, parameters—Trumpf<br />

supplies everything.<br />

The experts at the Trumpf Group in Moscow<br />

will answer questions about 3D print-<br />

used, material costs can be reduced.<br />

Even the tool costs that occur to a<br />

greater extent due to wear during the<br />

turning and milling of titanium become<br />

obsolete when additive manufacturing<br />

is used.<br />

For individual maxillofacial implants,<br />

Conmet uses the “small” Truprint 1000<br />

system. The company intends to use the<br />

larger system for series production.<br />

Photo: Trumpf<br />

ing in Russian. “And it is important that<br />

the customer not only buys the equipment<br />

from us, but also uses it to make money,”<br />

says Margolf.<br />

■<br />

Ramona Hönl<br />

Trumpf, Ditzingen/Germany<br />

www.trumpf.com<br />

01/2019 medicine&<strong>technology</strong> 53


■ [ TECHNOLOGY ]<br />

Integrating 3D Printing<br />

for Contract Manufacturers<br />

3D printing | In the last decade, 3D printing has firmly established its place in the<br />

medical device manufacturing chain. Contract Manufacturers need to include this<br />

<strong>technology</strong> in their portfolio.<br />

These acetabular cups with porous outer surface<br />

were manufactured in a 3D printer out of<br />

Grade 23 titanium.<br />

As metal additive manufacturing (AM)<br />

grows in importance in the medical<br />

device industry, Contract Manufacturing<br />

Organizations (CMOs) are investigating<br />

how to best integrate the <strong>technology</strong> in<br />

order to better serve their customers‘<br />

needs. The key point is to create a profitable<br />

business from 3D metal printing.<br />

Understanding which approach is the<br />

right one for the needs and planning for<br />

the changes associated with AM, especially<br />

regarding the operations that are<br />

upstream and downstream of the printer,<br />

are key to achieving success.<br />

Although there are many ways to print<br />

metals, the dominant approach today<br />

creates solid material by the targeted<br />

YOUR KEYWORD<br />

■<br />

■<br />

■<br />

■<br />

Implementing Additive Manufacturing<br />

E-beam vs. laser melting<br />

Mastering oxygen<br />

in the printing environment<br />

Post-processing steps required<br />

Photo: GF Machining<br />

melting of a metal powder. The energy to<br />

fuse the powder comes from either a<br />

beam of electrons (e-beam) or a laser.<br />

Both methods print „slice by slice“, depositing<br />

and melting thin layers of<br />

powder in the printer‘s build chamber and<br />

tracing a pattern on the freshly layered<br />

powder. E-beam allows products to be<br />

printed that have little residual stresses as<br />

the build chamber operates at an elevated<br />

temperature (generally above 700°C).<br />

However, e-beam also has its drawbacks,<br />

notably that the minimum layer thickness<br />

and beam size are both larger than with a<br />

laser.<br />

In general, products made with a laserbased<br />

process (called „selective laser<br />

melting“) can have a better surface finish<br />

and smaller features than is generally<br />

possible with e-beam. Therefore, a wider<br />

range of products can be manufactured<br />

with laser-based systems—and laser<br />

melting has a much larger share of the<br />

market than e-beam.<br />

Another point to consider is the range<br />

of materials that can be printed on a system,<br />

and the ability or not to change materials<br />

if necessary. Instruments are most<br />

often made of stainless steel, while implants<br />

usually require titanium; if your<br />

target is to fully load your printer with<br />

jobs of different types, it may push your<br />

choice towards a flexible system.<br />

Whenever metals are in the presence of<br />

oxygen, there is the risk of oxygen uptake.<br />

Metal powders are made of spheres that<br />

are only a few microns in diameter and<br />

therefore have dramatically more surface<br />

area per unit weight than solid metal bars.<br />

This puts powders at an even greater risk<br />

of oxidation.<br />

Oxidation of metal powder<br />

has to be avoided<br />

Oxidation of titanium, for example,<br />

brings a significant change in its mecha -<br />

nical properties, with higher levels<br />

resulting in a material that is brittle and<br />

more prone to certain types of failure.<br />

Once certain alloys have passed a limit<br />

(defined by the grade of metal—for Gr. 23<br />

titanium it is 1300 ppm of oxygen), the<br />

powder must be discarded. This can add<br />

significant expense to the running costs.<br />

There are different approaches to<br />

mastering oxygen in the printing environment.<br />

Some printers will have a continuous<br />

flow of shield gas (most often argon)<br />

that is fed into the build chamber and<br />

keeps it positively pressured. This approach<br />

typically results in an oxygen level<br />

of 300 to 700 ppm (parts per million) in<br />

the build chamber during the print cycle;<br />

however this also results in a continuous<br />

consumption of argon.<br />

Powdered metals in this environment<br />

will have an oxygen uptake that degrades<br />

the material over time. Typically, a manufacturer<br />

producing with Grade 23 titanium<br />

would be able to use a batch of<br />

powder for 20 to 30 build cycles. Running<br />

costs also include the cost of shield gas,<br />

54 medicine&<strong>technology</strong> 01/2019


3D printing of metals<br />

Metal Additive Manufacturing (Metal<br />

AM, or the 3D printing of metals) is an<br />

important process used on many new<br />

medical devices entering the market. For<br />

orthopedic implants, the development of<br />

products using lattice structures (to<br />

mimic the behavior of normal bone) and<br />

porous surfaces have led to significant<br />

improvements in patient outcomes.<br />

Simply stated, it is impossible to make<br />

products with these features without<br />

AM. And it‘s not just implants—surgical<br />

tools and instruments are also benefitting<br />

from designs only possible via AM<br />

thanks to the weight savings that can be<br />

achieved and the ability to create innovative<br />

forms that allow more ergonometric<br />

designs and simplify the manufacturing<br />

process.<br />

Versioned<br />

catalog<br />

production<br />

and these are higher when shield gas is<br />

continuously fed into the build chamber<br />

(as opposed to a closed system).<br />

A different design of printer makes use<br />

of a sealed (or closed) build chamber<br />

whereby all the air is evacuated from the<br />

chamber and then replaced with argon.<br />

With this approach, the oxygen level during<br />

the build is usually below 25 ppm. A<br />

hidden benefit is the improved control of<br />

humidity in the powder, which enables a<br />

more consistent quality of printed metal.<br />

The powder life in this environment often<br />

can extend beyond 70 build cycles.<br />

But the printer is only one part of the<br />

puzzle: Successful manufacturing<br />

requires having a product design that has<br />

been adapted for 3D printing, a validated<br />

process, as well as mastering the downstream<br />

operations that are necessary. Almost<br />

all parts made with metal AM will<br />

need at least one post-processing step, as<br />

• stress relieving,<br />

• removal from the build plate,<br />

• machining operations, etc.<br />

In order to reduce the manufacturing<br />

lead times and the cost per part, it is important<br />

to consider solutions that allow<br />

an integration of the AM <strong>technology</strong> into<br />

a complete manufacturing chain.<br />

Taking a product idea and modifying<br />

the design to make „printable“ requires<br />

both experience and the appropriate software.<br />

3D printing is a vertical process:<br />

The powder present in the bed is not able<br />

to support the weight of printed metal. As<br />

such, designs need to be adapted with<br />

support structures. Build simulation software<br />

allows for the verification of the size<br />

and geometry of support structures, however<br />

training and design experience remain<br />

valuable assets. Some software<br />

packages, such as 3D-Xpert, offer build<br />

simulation tools that consider wall thicknesses,<br />

weight and the behavior of the<br />

powder being used to ensure minimized<br />

supports of sufficient size and strength.<br />

The most advanced software packages<br />

also link the printer design, its laser, and<br />

the characteristics of the powder in order<br />

to develop a printing process that optimizes<br />

the laser path and build strategy to<br />

ensure that the desired mechanical pro -<br />

perties of the product can be achieved.<br />

Stress relieving will very often<br />

be part of post-processing<br />

A validated AM process includes the<br />

entire ecosystem, quality control processes<br />

for incoming powder, software,<br />

post- processing, and process controls on<br />

finished products. Post-processing will almost<br />

always require stress relieving,<br />

which may be done in an oven using<br />

a shield gas, or via HIP (Hot Isostatic<br />

Pressure). Basic heat treating is often<br />

done at the manufacturing site, however<br />

HIP requires specialized equipment and is<br />

often done via an outside supplier.<br />

The controls on finished products need<br />

to include destructive and non-destructive<br />

testing, via an accredited lab to confirm<br />

that the printed material matches<br />

the material specification.<br />

Companies that are looking to bring<br />

AM into their production portfolio will<br />

need to carefully consider their staffing to<br />

ensure they have the necessary level of<br />

expertise. Working with a partner is a key<br />

way of mastering the process.<br />

■<br />

Erik Poulsen<br />

GF Machining Solutions,<br />

Schaffhausen/Switzerland<br />

Ruben Wauthle<br />

3D Systems Healthcare,<br />

Moerfelden-Walldorf/Germany<br />

We are well-equipped for the production<br />

of your multilingual or multi-version<br />

catalogs – especially when it comes to<br />

managing your highly complex jobs.<br />

Individual tools, perfectly adapted for your<br />

project, accelerate and simplify the<br />

entire process.<br />

We can do much for you, please contact us.<br />

druck@konradin.de<br />

www.konradinheckel.de<br />

01/2019 medicine&tec hn ology 55


■ [ TECHNOLOGY ]<br />

The screws made of a CoCr<br />

super alloy are used in endoprostheses.<br />

Making<br />

their hexagon socket<br />

structure was a particular<br />

challenge. Thus, the manufacturers<br />

sought the advice<br />

of tool specialists.<br />

Photo: Paul Horn<br />

Screws for Endoprosthetics:<br />

Better to Broach than to Ream<br />

Cobalt-chrome (CoCr) processing | A manufacturer changed its process to make implant<br />

screws from a CoCr alloy precisely and to achieve the necessary tool life. The<br />

manufacturer switched from reaming to broaching and obtained the tool, modified to<br />

suit its application, from the tool maker.<br />

We have very high requirements on<br />

the tool in processing cobaltchrome<br />

alloys,” says Tibor Veres. Amongst<br />

other things, this is due to high costs for<br />

the tool—and this is the reason why the<br />

managing director of Hymec Fertigungstechnik<br />

GmbH from Norderstedt/Germany<br />

relies on tools from Paul Horn<br />

GmbH in Tübingen/Germany to machine<br />

the super alloys.<br />

The precision tools from the company<br />

in Tübingen are used, amongst other<br />

things, for broaching a hexagon socket<br />

into implant screws. These screws belong<br />

to the assembly group for an artificial<br />

knee joint. Hymec makes screws of this<br />

type in hex key sizes of 2.5 mm, 3.5 mm,<br />

and 5 mm with low tolerance, allowing<br />

the screw to sit securely on the hex key.<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

■<br />

CoCr implant screws<br />

Hexagon socket<br />

Long tool lives<br />

Process modification<br />

Customised special tools<br />

The surface quality has to be very high so<br />

as to prevent bacterial growth.<br />

Usually a hexagon is relatively easy to<br />

make in titanium using profile reaming,<br />

explains managing director Veres. “Reaming<br />

in series is practically impossible with<br />

cobalt-chrome due to its high stiffness,<br />

and tool wear is considerable.” CoCr is<br />

one of the highest-performance materials<br />

for endoprosthetics; it is biocompatible<br />

and corrosion-resistant.<br />

Since such implant screws are challenging<br />

to process, the Hymec experts consulted<br />

Thomas Wassersleben at Horn for<br />

technical advice. Wassersleben suggested<br />

making a change to the process. The hexagon<br />

socket needed to be easy to make<br />

using the precise and process-reliable<br />

broaching method. The geometry of the<br />

cutting edge and carbide substrate can<br />

easily be adapted to the material.<br />

The first attempts produced the<br />

solution quickly. “Exact fits can be created<br />

using the broaching tool, and the surfaces<br />

are very good,” says Veres. In the broaching<br />

process, a solid carbide drill from<br />

Horn’s DD system creates a hole that has a<br />

diameter of 4.9 mm in the head of the<br />

screw. The drill from the standard pro -<br />

duct range has an internal coolant supply<br />

and a geometry for rust-free steels.<br />

During the broaching process, the<br />

sprue of the blind hole acts as the<br />

discharge or free-wheel area of the<br />

broaching tool. The low height of the<br />

screw head left no room for a recess for<br />

chip discharge. The tool moves along a<br />

programmed path into the free-wheel<br />

area to break away the chips at the end of<br />

the hexagon surface.<br />

Adjustments needed<br />

due to hard material<br />

A super-mini, type N105 tool takes over<br />

the broaching of the hexagon socket with<br />

a hex key width of 5 mm. The setting of<br />

the single strokes is 0.02 mm. After finishing<br />

one surface, the chuck continues spinning<br />

to move on to the next surface. The<br />

processing time for the broaching procedure<br />

takes about two minutes, and the<br />

process is carried out on a Mori Seiki CNC<br />

turning machine. Broaching is done<br />

through the motion of the turret.<br />

The hard and tough material cobaltchrome<br />

made adjustments necessary: in<br />

the geometry of the cutting edge, the carbide<br />

substrate, the coating, the processing<br />

conditions, and the cooling lubricant.<br />

Hard particles in the alloy tend to produce<br />

abrasive and crater wear. In addition, cold<br />

working the surface is a problem with ma-<br />

56 medicine&<strong>technology</strong> 01/2019


chining. Here, the tool blade is sharp and<br />

not rounded—as with the machining of<br />

titanium—but unlike with titanium processing,<br />

the cutting wedge has a more<br />

stable design. A tough fine-grained type<br />

is used as a carbide substrate. The coating<br />

of the tools has to be hard and heat resistant<br />

for such applications. The cooling lubricant<br />

of the contact zone between the<br />

tool and workpiece also has a large influence.<br />

The production experts<br />

at Hymec (left) have<br />

been working together<br />

with consultants at<br />

Paul Horn, a tool manufacturer<br />

in Tübingen,<br />

for 30 years.<br />

Photo: Paul Horn<br />

Veres is pleased with the new processing<br />

solution: “The tools are very precise;<br />

hardly any correction is needed following<br />

a change. Also the service life we achieved<br />

of 100 screws per blade makes us very<br />

happy.” Due to the high surface quality of<br />

the hexagon socket, further post-processing<br />

is not necessary.<br />

■<br />

Nico Sauermann<br />

Paul Horn, Tübingen/Germany<br />

About Hymec<br />

Hymec Fertigungstechnik GmbH<br />

specialises in medical <strong>technology</strong><br />

devices, custom-built machinery,<br />

and sophisticated small<br />

series—such as orthopaedic implants<br />

and all related instruments.<br />

The company makes precision elements<br />

and complete assemblies<br />

made of high-tech materials like<br />

high-strength aluminium and titanium<br />

alloys, implant steels, and<br />

super alloys like cobalt-chrome<br />

(CoCr). Hymec also offers technical<br />

consultation from conception and<br />

designing to quality audits. Tibor<br />

Veres is the second generation to<br />

head the company founded by his<br />

father in 1972.<br />

www.hymec.de<br />

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01/2019 medicine&<strong>technology</strong> 57


■ [ TECHNOLOGY ]<br />

AI Provides Rapid Conclusions<br />

for Quality Management<br />

Statistical process analysis | Thus far, individual human experience has gone into the<br />

analysis of process data for quality management. Now, an AI system could make its<br />

own conclusions. Trust in the results needs to be developed in a transition phase, in<br />

which the AI will be compared with its predecessor system.<br />

Good or not good?<br />

Artificial intelligence<br />

can recognise<br />

relationships that<br />

remain hidden to<br />

human under -<br />

standing. Thus,<br />

humans need proof<br />

that they can rely<br />

on the conclusions<br />

the AI reaches—<br />

especially in quality<br />

assurance.<br />

Photo: Alexander Limbach/Fotolia<br />

Few topics have received as much attention<br />

in recent years as artificial intelligence<br />

(AI), which uses different<br />

methods to recreate intelligent, human<br />

problem-solving. Machine learning is an<br />

important part of AI: Here, an algorithm<br />

with training data is able to find its own<br />

solutions to unknown problems. To do so,<br />

the algorithm not only relies on rules that<br />

humans predefined, but also uses abstractions<br />

it made on its own in the learning<br />

phase.<br />

One part of machine learning is artificial<br />

neural networks that act like the<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

Artificial intelligence<br />

Improving statistical process analysis<br />

Faster evaluation of large<br />

amounts of data<br />

Independent of individual experience<br />

human brain. The most popular representatives<br />

of artificial intelligence resort to<br />

these artificial neural networks. Examples<br />

include Google’s Deep Mind algorithm<br />

that defeated the former Go champion<br />

Lee Sedol in 2016 and Microsoft’s image<br />

recognition that made fewer mistakes<br />

than humans in 2015.<br />

Expanding and replacing<br />

known approaches through AI<br />

Artificial intelligence methods can also be<br />

introduced to quality management to<br />

make production more reliable. This is<br />

where Iconpro GmbH, a start-up in<br />

Aachen/Germany, comes in. The company<br />

specialises in AI-based software for<br />

quality management in production companies.<br />

These solu tions help new information<br />

to be gained from present data.<br />

Existing processes for information processing<br />

in quality management can be replaced<br />

by more efficient and more effective<br />

methods. In statistical process control<br />

(SPC), for example, quality management<br />

can benefit from artificial intelligence.<br />

For the SPC standard tool, defined parameters<br />

like the diameter of the components<br />

that are made on a machine are<br />

recorded throughout production time.<br />

The recorded values allow conclusions<br />

to be made on the quality of the production<br />

process. If critical outliers or noticeable<br />

trends are detected in the readings,<br />

the person in charge can be warned.<br />

For the readings to be interpreted, their<br />

influence on the process is analysed.<br />

For this, you have to know how the data<br />

need to be distributed. The user enters the<br />

right strategy for this, prompting the algorithm<br />

to perform the necessary hypo -<br />

thesis tests.<br />

Unfortunately, this approach requires<br />

expertise on process and statistical relationships.<br />

Artificial intelligence can simplify<br />

the procedure. A well-trained AI can<br />

replace a large amount of the previously<br />

needed expertise and simplify handling<br />

by controlling processes. Process monitoring<br />

will become easier to operate, more<br />

58 medicine&<strong>technology</strong> 01/2019


eliable, and, especially for larger process<br />

datasets, faster.<br />

Despite the advantages to machine<br />

learning, there is an important disadvantage<br />

to algorithms that are based on artificial<br />

neural networks: the limited ability to<br />

follow how decisions are made. Users are<br />

given a result, but they cannot figure out<br />

About the start-up<br />

Iconpro was formed as a spin-off of<br />

the Laboratory for Machine Tools<br />

and Production Engineering (WZL)<br />

at RWTH Aachen University. The employees<br />

develop process-mining<br />

software for analysing data on production<br />

processes and quality. Process<br />

data are extracted from ERP,<br />

MES, or SPC systems, and analysed<br />

and correlated by machine learning<br />

algorithms to recognise relationships.<br />

Iconpro provides individual<br />

consultation projects and workshops.<br />

www.iconpro.com<br />

Strong and weak AI<br />

There are two types of artificial intelligence—strong and weak.<br />

Whilst strong AI deals with cross-domain problem-solving, weak AI is<br />

limited to a specific task it tries to solve. Great advancements have<br />

been made in recent years in the field of weak AI, which also includes<br />

Iconpro’s solutions. In many special tasks, the algorithm’s ability is<br />

meanwhile surpassing human capacity.<br />

why exactly the algorithm came to this result.<br />

This is often referred to as the “black<br />

box” model. It is in contrast to the “white<br />

box” model, in which the decision-making<br />

process is mapped out because either the<br />

user set the rules or the software deve<br />

loper explicitly programmed it that way.<br />

The lack of transparency in decisionmaking<br />

results, first, in regarding lack of<br />

trust—users remain sceptical. Iconpro<br />

takes two approaches to confront this effect.<br />

One is to allow the two systems, the<br />

old and new, to be used in parallel during<br />

the introduction phase of the AI software.<br />

If the two systems agree over an extended<br />

period of time, user trust in the new algorithm<br />

increases. However, the new software<br />

can also calculate the quality of their<br />

proposed solution, which can likewise be<br />

compared with that of the old system.<br />

This is particularly helpful when the AIbased<br />

software solution produces a better<br />

result than the comparator model. These<br />

two approaches increase trust in the new<br />

<strong>technology</strong>.<br />

AI for statistical process control is only<br />

one of many possibilities for how artificial<br />

intelligence can be used in production—after<br />

all, with digitalisation, more<br />

and more production data are being recorded.<br />

An AI can recognise patterns, illustrating<br />

the relationship between various<br />

factors in production. This capacity facilitates<br />

simpler, more effective, and automated<br />

process optimisation that not only<br />

responds to problems that have occurred,<br />

but also warns of potential future problems.<br />

Iconpro’s software solutions are compatible<br />

with standard quality management<br />

platforms like Q-DAS or SAP QM.<br />

With these solutions, companies can take<br />

another step towards zero-defect production<br />

and, most notably, further increase<br />

the safety in production stressed in<br />

ISO 13485 through improved processes. ■<br />

Raphael Maas, Markus Ohlenforst<br />

Iconpro, Aachen/Germany<br />

www.iconpro.com<br />

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01/2019 medicine&<strong>technology</strong> 59


■ [ TECHNOLOGY ]<br />

Liquid Silicone Rubber:<br />

New Properties Available<br />

LSR | In medical <strong>technology</strong>, more and more devices are being made of liquid silicone<br />

rubber (LSR). One reason is the growing number of materials: New types of LSR, for<br />

example, have fewer volatile compounds or vulcanise in less time.<br />

Types of LSR that have a low coefficient<br />

of friction are in demand<br />

for LSR syringes. Oilbleeding<br />

of the substance is not<br />

desired here.<br />

Many medical devices need to be biocompatible,<br />

last long, and be resistant<br />

to chemicals. They also have to maintain<br />

their properties over a wide temperature<br />

range to stay safe and effective for<br />

their users. For this reason, more and<br />

more devices are being made from LSR in<br />

the injection-moulding process. A recent<br />

study from Freedonia reports the US market<br />

for LSR will grow annually by 8.3 percent<br />

by 2023. This US market research<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

Liquid silicone rubber (LSR)<br />

Low concentration of volatile<br />

compounds (LV LSR)<br />

Curing at lower temperatures (LTC LSR)<br />

Photo: Wacker Chemie<br />

company expects sales to increase, especially<br />

through the growing number of<br />

special LSR materials, including self-lubricating,<br />

self-adhesive, and non-postcure<br />

types. These new materials improve<br />

processing efficiency with injection<br />

moulding by rendering unnecessary additional<br />

time- and labour-intensive production<br />

steps like those following curing or<br />

the application of coatings or binders.<br />

Freedonia analyst Kent Furst is confident<br />

that the medical market for LSR will<br />

grow faster than in any other industry—with<br />

the effect that the medical market<br />

will have overtaken the automotive industry<br />

as the leading market within four<br />

years. LSR will be increasingly used, in<br />

particular, for implants and mobile devices,<br />

such as, for measuring blood pressure<br />

or heart rate. Furst identifies as the<br />

third group, new, ever smaller medical<br />

devices with more complex designs. LSR<br />

is ideal, in particular, for the manufacture<br />

of micro-components.<br />

For medical device manufacturers, LSR<br />

has advantages over solid silicone, including,<br />

for example, shorter curing times<br />

through addition-curing <strong>technology</strong>,<br />

higher hardness, less of a tendency to develop<br />

ridges, lower curing temperatures,<br />

and better consistency and predictability<br />

between batches. “The material is also<br />

well suited for automation. This helps to<br />

limit contamination for production in<br />

cleanrooms,” says Freedonia analyst<br />

Furst.<br />

Low viscosity facilitates faster<br />

filling of cavities<br />

Dr. Hans Peter Wolf from Dow Silicones<br />

Deutschland pointed out at the Silicone<br />

Elastomers US Summit 2018 in Cleveland,<br />

Ohio/USA, that, compared to solid<br />

silicone, LSR has the advantage during<br />

processing on the injection-moulding machine<br />

that this material can fill more cavities<br />

in a shorter injection time due to the<br />

lower viscosity. Also, the low viscosity—LSR<br />

can vary in consistency from<br />

water to honey—helps realise thin-walled<br />

and complex component shapes. Long<br />

flow paths in the tool are no problem for<br />

LSR.<br />

With the new type of LSR called Silastic,<br />

Dow also made further improvements<br />

to viscosity, making possible lower<br />

injection pressure and higher injection<br />

speed. The injection moulder can now<br />

double injection speed compared to the<br />

predecessor material Xiameter.<br />

60 medicine&<strong>technology</strong> 01/2019


Additive manufacturing with LSR<br />

Meanwhile, LSR is being used in additive<br />

manufacturing as well. In recent years,<br />

Dow and Wacker developed types of LSR<br />

for 3D printers. At the end of 2016, Dow<br />

introduced Evolv3D LC 3335 LSR which<br />

was developed for German Reprap’s 3D<br />

printer. Wacker is going against the grain<br />

to stand out as a service provider by developing<br />

a new printing <strong>technology</strong>, a industrial<br />

3D silicone printer, and<br />

the necessary materials—and<br />

offers the service under the Aceo<br />

brand. The next-generation device<br />

can print four different silicone<br />

materials at the same time.<br />

It can make objects in colour and<br />

with silicones of different hardness.<br />

Tumours or vascular diseases<br />

recorded using imaging<br />

procedures can now be highlighted in<br />

colour and reconstructed with different<br />

degrees of hardness. This allows surgeons<br />

to prepare for surgery with accuracy<br />

and gives them a better picture of<br />

possible complications. The 3D printer<br />

also has a new auto-control function:<br />

The device measures the silicone layer<br />

applied with every printing operation.<br />

Any deviations from the target value of<br />

the CAD model detected by the programme<br />

will be corrected automatically<br />

when the next layer is applied.<br />

Three-dimensional silicone model of a<br />

human liver. The new generation of the<br />

Aceo K2 printer can print up to four different<br />

silicones at the same time.<br />

Photo: Wacker Chemie<br />

In addition to standard materials,<br />

manufacturers are developing more and<br />

more special LSR materials. The new materials<br />

include oil-bleeding types of LSR<br />

like Dow’s Silastic CV 9204–30 LSR and<br />

Wacker’s Elastosil LR 3072/50. After curing<br />

and the development of adhesion, a<br />

thin film of silicone oil forms. The released<br />

oil gives the vulcanised rubber a<br />

smooth surface. In this way, a cable can,<br />

for example, be easily be advanced<br />

through an injected single-wire seal.<br />

In medical <strong>technology</strong>, however, surfaces<br />

that release oil are usually undesirable.<br />

If slipperiness is wanted, the<br />

LSR types with intrinsically smooth<br />

surfaces like Silpuran 6760/50 work well.<br />

Wacker Chemie AG from Munich/<br />

Germany recently gave the material a<br />

second property: self-adhesion. The material<br />

can be combined with PA or PBT to<br />

form combinations of hard and soft materials.<br />

Another trend is low-volatile (LV),<br />

non-post-cure (NPC) LSR, such as Momentive’s<br />

Silopren LSR 2640 LV, Dow’s<br />

Silastic NPC 9300, and Wacker’s Silpuran<br />

6xxx. Typically, the concentration of volatile<br />

compounds is 0.25 percent without<br />

post curing, according to Dow expert<br />

Wolf. To lower the concentration of volatile<br />

compounds in conventional LSR<br />

<strong>technology</strong> so that the concentration<br />

stays under the limit, components have to<br />

be post-vulcanised in an oven at temperatures<br />

of 200°C, or tempered—which<br />

comes with the disadvantage of additional<br />

process steps and handling, leading<br />

to higher costs and a greater risk of crosscontamination.<br />

At last year’s German Rubber Conference<br />

(DKT) in Nuremberg, injectionmoulding<br />

machine manufacturer Engel<br />

demonstrated how to make seals for<br />

ventilation masks using Dow’s Silastic<br />

NPC 9300–50 LSR. Elmet’s four-cavity<br />

tool and dosing system were used for this<br />

application.<br />

Wacker has been selling types of LSR<br />

with at least a 90-percent-lower concentration<br />

of volatile compounds since the<br />

beginning of 2019. Specifically, this<br />

applies to the product groups Elastosil LR<br />

3xxx, Elastosil LR 6xxx, and Silpuran<br />

6xxx, which were made in Europe. The<br />

upgrade is not reported to have an effect<br />

on the mechanical, physical, or chemical<br />

properties of the elastomer. The device releases<br />

and certificates that are so important<br />

in medical <strong>technology</strong> thus retain<br />

their full validity. Testing conducted by<br />

the chemical company in Munich showed<br />

also that the injection-moulding and demoulding<br />

behaviour does not change with<br />

the LV formulation.<br />

Cross-linking<br />

at lower temperatures<br />

Another development in this area is lowtemperature-cure<br />

(LTC) LSR that can be<br />

cross-linked at temperatures from 100°C<br />

to 110°C. Within this temperature<br />

window, curing slows considerably with<br />

conventional LSR. The advantages of the<br />

new LTC materials: They can be processed<br />

with thermosensitive thermoplastics<br />

like PE or PP in the two-component<br />

injection-moulding process to form<br />

combinations of hard and soft materials.<br />

Also, they allow for the integration of<br />

pharmaceutical substances or sensitive<br />

electronic components.<br />

Dow manager Wolf says pot lives of<br />

more than 72 hours can still be reached<br />

with Silastic LTC LSR. The pot life is how<br />

long the LSR, which is mixed from two<br />

cross-linking components at the injection<br />

moulding machine, stays pumpable. LSR<br />

processing is namely a challenge for injection<br />

moulders in that the two components<br />

cross-link quickly after mixing, making<br />

the mixed material in the machines no<br />

longer pumpable over the weekend without<br />

having to be rinsed with fresh material.<br />

Together with Engel, Dow presented<br />

the use of Silastic LTC 9400–50 LSR<br />

for the production of an air valve for<br />

beverage bottles at Fakuma two years<br />

ago. The air valves with a diameter of<br />

roughly 50 mm have a geometrically complex<br />

structure with fluctuating wall thickness.<br />

■<br />

Sabine Koll<br />

Journalist in Böblingen/Germany<br />

01/2019 medicine&tec hn ology 61


■ [ RESEARCH ]<br />

Rising Tiger<br />

Research in Lithuania | Companies can easily find research partners in Lithuania. Its<br />

open, interdisciplinary cooperation network makes the country unique. In the area of<br />

medical <strong>technology</strong>, Lithuania stands out with its combined know-how in engineering,<br />

life sciences, and IT like AI.<br />

Vilnius, Lithuania’s capital (shown here), is in positive competition with Kaunas, the engineering<br />

city located only a few kilometres away and has excellent transport connections.<br />

Photo: prosign/Fotolia.com<br />

As one of the three Baltic states, Lithuania<br />

borders Russia—but is part<br />

of Northern Europe, as opposed to Eastern<br />

Europe. This is how the Lithuanians<br />

see it, and this distinction is very important<br />

to them. They would rather compare<br />

themselves with their oversea Scandinavian<br />

neighbours and, for example, the<br />

pioneering role Scandinavia paves in digital<br />

health, than with their former occupying<br />

power from the times of the Soviet<br />

Union.<br />

There is more to the story than random<br />

chance. Lithuania has one of the best developed<br />

4G networks in Europe and introduced<br />

a central digital e-health system in<br />

YOUR KEYWORDS<br />

■<br />

■<br />

■<br />

■<br />

■<br />

■<br />

Lithuania<br />

Medical <strong>technology</strong><br />

Research<br />

Interdisciplinarity<br />

Partnerships<br />

Open-access networks<br />

2015. In matters of production and research<br />

in medical <strong>technology</strong>, the southernmost<br />

of the three “Baltic Tigers” rises<br />

up with strong roots in electronics and engineering,<br />

which nowadays is prominently<br />

complemented by software engineering<br />

capability.<br />

This combination allows the nation to<br />

seize the potential of global MedTech<br />

trends of medical devices increasing connectivity<br />

and more digital health solutions,<br />

like a strong value shift from devices<br />

to software and services. With success:<br />

“Lithuania’s Life Sciences sector,<br />

which also includes medical and health<br />

technologies, already makes 1 percent of<br />

the country’s GDP,” says Gediminas Koryzna,<br />

the director of the Business Development<br />

Department at Invest Lithuania.<br />

“Lithuania Life Sciences sector companies<br />

revenue grew on average 19 percent annually<br />

making Lithuania one the fastest<br />

growing life sciences industry in the EU.<br />

The country‘s ambition is to keep up the<br />

momentum of growth with a goal for the<br />

Life Sciences sector to yield 5 percent of<br />

GDP by 2030 in Lithuania.”<br />

The country creates the know-how<br />

itself with its good universities: According<br />

to IMD World Competitiveness Yearbook<br />

2019, the digital/technological skills are<br />

ranked first worldwide—and by the way:<br />

fourth worldwide is ranked the agility of<br />

companies. Over 27% of students enrol in<br />

STEM (science, <strong>technology</strong>, engineering,<br />

and mathematics) study fields for their<br />

higher education, whilst another 18%<br />

enrol in the biomedical science area.<br />

Well educated and eager<br />

to go the extra mile<br />

The country is educated: 56% of the<br />

population have a higher education degree<br />

and 84% of young professionals<br />

speak English proficiently. What also<br />

makes Lithuania particularly attractive<br />

for European companies is the work mentality<br />

of employees. According to a study<br />

by fDi Markets (Financial Times, USA),<br />

75% of surveyed companies in Lithuania<br />

rate their employees’ eagerness to go the<br />

extra mile as “excellent” and employee<br />

dedication and ability to learn as “outstanding.”<br />

62 medicine&<strong>technology</strong> 01/2019


Photo: Oxipi<br />

The Oxipit team led by<br />

CEO Gediminas Peksys<br />

(with beard, in the<br />

middle). He says, “We<br />

took a ‘<strong>technology</strong> deterministic’<br />

route. We<br />

devoted a lot of time to<br />

scientific research,<br />

clinical trials, and developed<br />

a fully functional<br />

medical imaging<br />

solution which received<br />

CE certification in less<br />

than two years.”<br />

Every<br />

child<br />

is one of a kind and<br />

unique. Each child<br />

needs individual<br />

support according to<br />

their needs. Please<br />

help us by donating.<br />

Thank you!<br />

The country is not yet providing<br />

enough work for these young professionals—and<br />

some move abroad. Still, Lithuania<br />

sets the course to provide a future<br />

for the innovative talents in their home<br />

country as well: By funding start-ups and<br />

fostering a unique, open cooperation<br />

landscape between research facilities and<br />

companies, Lithuania wants to support<br />

not only its own MedTech industry, but<br />

also attract foreign companies: Coor -<br />

dinated by the Agency of Science, Innovation,<br />

and Technology (MITA), the openaccess<br />

network for R&D consists of 14 universities,<br />

13 research units, 7 science &<br />

<strong>technology</strong> parks, and 25 open-access<br />

centres, making it the largest innovation<br />

infrastructure, service, and competence<br />

network in the Baltic states. Large and<br />

small companies alike can easily find the<br />

right research partner here.<br />

Successful cooperation<br />

between players<br />

Even universities themselves generate a<br />

good output of innovation in medical<br />

<strong>technology</strong> with their own start-up sponsorships,<br />

open-access networks, and research<br />

parks—leading the way are the Lithuanian<br />

University of Health Sciences<br />

(LSMU) in Kaunas, the largest institution<br />

of higher education for biomedical<br />

sciences in Lithuania, and the Kaunas<br />

University of Technology (KTU), the largest<br />

of its kind in Lithuania and the Baltic<br />

states, amongst others, with the Health<br />

Telematics Science Institute. An example<br />

of such successful cooperation is a non-invasive<br />

blood test by laser spectroscopy developed<br />

by LSMU researchers and laser<br />

experts at Brolis Semiconductors in Vilnius:<br />

The new sensor could be installed in<br />

Research & Funding<br />

Lithuanian University of Health<br />

Sciences (LSMU)<br />

https://lsmuni.lt/en<br />

Kaunas University of Technology<br />

(KTU)<br />

https://en.ktu.edu/<br />

KTU National Innovation and Entrepreneurship<br />

Centre<br />

https://niec.ktu.edu/<br />

KTU Open Access Centre<br />

https://oac.ktu.edu/<br />

KTU Start-up Space<br />

https://startupspace-en.ktu.edu/<br />

Incubator “Kaunas Science and Technology<br />

Park”<br />

http://kaunomtp.lt/en<br />

Santaka Valley<br />

www.santakosslenis.lt/en<br />

Sunrise Valley Science<br />

https://ssmtp.lt/en<br />

Santara Valley2<br />

http://santariskes.eu/<br />

MedTech Clusters<br />

Wellness cluster iVita<br />

www.i-vita.lt/en.html<br />

IT in Medicine Cluster<br />

http://klaster.lt/en/klateris/inform<br />

aciniu-technologiju-medicinojeklasteris/<br />

Odontology Innovation Cluster<br />

http://klaster.lt/en/klateris/odonto<br />

logijos-inovaciju-klasteris-2/<br />

Advanced Orthopaedics and Rehabilitation<br />

Cluster<br />

http://klaster.lt/en/klateris/pazan<br />

giu-ortopedijos-ir-reabilitacijospriemoniu-klasteris/<br />

Stem Cell & Regenerative Medicine<br />

Innovation Cluster<br />

www.kltc.lt/<br />

Tel.: 0800/50 30 300 (free of charge)<br />

IBAN DE22 4306 0967 2222 2000 00<br />

BIC GENO DE M1 GLS<br />

www.sos-kinderdoerfer.de<br />

2016/1<br />

01/2019 medicine&tec hn ology 63


■ [ RESEARCH ]<br />

smartphones and -watches, becoming an<br />

easily accessible blood test. An exciting alternative<br />

to the otherwise necessary<br />

needle pricks for diabetics, for example.<br />

Often the researchers themselves are<br />

able to turn their ideas into market-ready<br />

products—and sell them worldwide. A<br />

From the Expert<br />

well-known example is inventor Prof. Arminas<br />

Ragauskas, head of the Health<br />

Telematics Science Institute, KTU, who<br />

received the European Inventor Award<br />

2016 for his invention of two devices for<br />

measuring intracranial pressure and<br />

blood flow. These advancements can be<br />

We work on an innovative open-access principle<br />

The Lithuanian University of Health<br />

Sciences (LSMU) is the largest Lithuanian<br />

university in the field of biomedicine and<br />

one of the founders of the Kaunas<br />

Clinics and the Kaunas Clinical Hospital.<br />

■ How important is medical <strong>technology</strong><br />

for LSMU?<br />

Lithuania’s life sciences sector is the fastest<br />

growing in the EU with annual<br />

growth of 19 percent. LSMU actively contributes<br />

to the process of growth of the<br />

life science sector in Lithuania. The current<br />

spotlight of research is pointed on<br />

bioinformatics. LSMU aimed to create<br />

and develop an infrastructure and<br />

human resources for modern fundamental<br />

and applied research and to use it<br />

rationally. The research conducted at<br />

LSMU is more practical in nature, with<br />

theories applied to solve problems. We<br />

can offer a variety of innovative solutions<br />

that can be applied in the sector, from IT<br />

solutions, medical technologies, and<br />

software to implants, prostheses, and<br />

new or improved bio<strong>technology</strong> products.<br />

■ What is special about medtech research<br />

at LSMU?<br />

LSMU creates new knowledge for the improvement<br />

of both human and animal<br />

health and life quality. The university’s<br />

infrastructure works on an innovative<br />

open-access principle, which means that<br />

both internal and external users have<br />

the opportunity to use modern and upto-date<br />

scientific equipment to meet the<br />

needs of both science and business, the<br />

public sector, or study. LSMU is often<br />

reached by companies that have ideas<br />

for creating or improving a particular<br />

medical device. LSMU can offer a complete<br />

services cycle—from molecular<br />

Photo Laurynas Jarukas<br />

Laurynas Jarukas is<br />

Head of the Development<br />

Department<br />

of LSMU.<br />

mechanisms via preclinical development<br />

till clinical investigation.<br />

■ How is the cooperation between university,<br />

clinic, and industry organised?<br />

LSMU has a quite unique structure—all<br />

activities are being implemented at<br />

medical and veterinary academies. This<br />

ensures the overall approach to health<br />

and gains many additional values for integrated<br />

studies, research, and clinical<br />

practice. For our innovative culture development<br />

and for the creation and implementation<br />

of health-related innovations,<br />

we are working closely with our<br />

community members: LSMU gymnasium,<br />

LSMU Hospital Kaunas Clinics,<br />

Kaunas Clinical Hospital, Animal Research<br />

Centre for pre-clinical research<br />

and testing for early stages in innovations<br />

development, and others. LSMU<br />

has the whole facilities to generate the<br />

idea and to develop it through various<br />

testing phases until reaching the final<br />

stage—production. For example we can<br />

scout the ideas for health sector innovation,<br />

develop it in our studies/research<br />

departments, test the product on animals<br />

(if necessary) or other models, and<br />

run the biomedicine study/clinical investigation<br />

in order to measure the impact<br />

(any of it) on human health, and, finally,<br />

manufacture the product in the partnering<br />

business institution.<br />

used as an unique, non-invasive method<br />

for diagnosing traumatic brain injury,<br />

strokes, glaucoma, and brain tumours<br />

quickly and reliably. The devices are sold<br />

by the Boston Neurosciences (USA).<br />

Good examples of successful interdisciplinary<br />

cooperation are the founders of<br />

Oxipit, a team of five scientists, coming<br />

from diverse academic backgrounds, including<br />

mathematics, theoretical physics,<br />

data science, and medicine—and who received<br />

several awards in the fields of artificial<br />

intelligence and machine learning.<br />

The idea for the company came out of a<br />

tech hackathon: A radiologist reported of<br />

increasing work volume, which delayed<br />

diagnostics. The solution: Chesteye.<br />

Quick „second opinion“<br />

for the radiologist<br />

CEO Gediminas Peksys explains: “After a<br />

chest x-ray is taken, Chesteye CAD automatically<br />

analyses the image and provides<br />

preliminary diagnosis and diagnosis report.<br />

The doctor is already provided with<br />

the report for the first time when he sees<br />

the x-ray image. He can concur with the<br />

diagnosis or augment the report with his<br />

own remarks. This saves time for manual<br />

diagnosis description, helps to identify<br />

overlooked findings, and provides a valuable<br />

‘second opinion’ to the medical<br />

specialists.” Using Chesteye could save up<br />

to at least 30% of the time spent on each<br />

patient. Another advantage: Chesteye<br />

also arranges patient scans by urgency<br />

automatically, reducing the time to treatment<br />

for time-sensitive medical conditions.<br />

Founded in 2017, the company received<br />

the CE certification mark this year.<br />

That Lithuania has been playing in the<br />

premier league still unnoticed by many is<br />

shown not lastly in that LSMU and KTU<br />

have become the centres for health innovations<br />

of the European Institute of Innovation<br />

& Technology (EIT) Health in<br />

2018. Likewise, Lithuania organises the<br />

biannual Life Sciences Baltic event. Last<br />

but not least, the science and innovations<br />

centre, KTU Santaka Valley, one of the largest<br />

in the Baltics, is now being regarded<br />

as “the new Silicon Valley of the Baltics.”<br />

The Baltic Tiger is on the rise.<br />

■<br />

Anke Biester<br />

Science journalist from<br />

Aichstetten/Germany<br />

https://mita.lrv.lt/en/<br />

www.oxipit.ai<br />

64 medicine&<strong>technology</strong> 01/2019


Under Your Skin<br />

Real-time tracking | Researchers in Dresden have been<br />

able to track moving micro-objects deep in the tissue in<br />

real time.<br />

Visions for minimally invasive micro-surgery—real-time tracking<br />

of moving micro-objects deep in the tissue is an important<br />

step in the right direction.<br />

Micro-implants, mini-catheters, and tiny medical instruments—smaller<br />

and smaller objects are moved through<br />

the human body. Researchers are now working on the next generation<br />

of minimally invasive micro-surgery: Small micro-robots<br />

with their own drive need to be sent through the body and tissue<br />

to transport substances and objects. At the same time, new<br />

methods must be developed to locate these micro-objects and<br />

monitor their movement.<br />

Researchers at the Leibniz Institute for Solid State and Materials<br />

Research Dresden (IFW) have made an important step in this direction:<br />

They were able to track the movement of individual<br />

micro-objects below centimetre-thick tissue in real time. To do<br />

so, they used multi-spectral optoacoustic tomography (MSOT).<br />

This new <strong>technology</strong> combines the advantages of ultrasound imaging<br />

in terms of depth and resolution with the possibilities of<br />

optical methods to map molecular structures. MSOT can distinguish<br />

clearly the spectral signatures of artificial micro-objects<br />

from those of tissue molecules. The micro-objects were coated<br />

with gold nano-rods, which significantly improves the contrast<br />

of the signal.<br />

The photoacoustic effect was discovered by Alexander Graham<br />

Bell in 1881. He proved that the light energy absorbed by a material<br />

is converted into an acoustic signal. Modern optoacoustic<br />

imaging systems use high-energy pulsed lasers and high-sensitivity<br />

broadband ultrasound detectors. Optical absorption in tissue<br />

can be recorded and visualised by stimulating tissue with a laser<br />

pulse and measuring the sound waves.<br />

www.ifw-dresden.de<br />

Photo: Science Picture Co/Alamy Stock Photo<br />

SIMPLY<br />

SAFE<br />

VALIDATABLE PACKAGING PROCESSES<br />

FOR THE MEDICAL INDUSTRY AND<br />

CLEANROOM SECTOR.<br />

hv 321 K-V MediVac<br />

Vacuum chamber machines<br />

with touchscreen<br />

hv 460-1300 AP2/4-V<br />

Nozzle style vacuum sealers with or<br />

without gas purge applications<br />

Hall 11.1<br />

Stand G10<br />

Hall 8a<br />

Stand F43<br />

medtech@hawo.com 01/2019 medicine&<strong>technology</strong> | www.hawo.com 65


■ [ INNOVATIONS ]<br />

Diversity Thanks to<br />

Modular System<br />

Cleanroom laser cabin | Cleanroom laser cabins ensure<br />

technical cleanliness during the manufacturing of optics<br />

and lasers.<br />

Laser cabins are offered in the modular construction typical<br />

for BC Technology, which allows them to be tailored to the<br />

customer’s specific requirements. If needed, mobile and adjustable-height<br />

versions are also available and can be installed flexibly,<br />

exactly where there is a need. The compact laser cabins are<br />

DIN EN ISO 14644–1 qualified and achieve at least cleanroom<br />

class 5 through the principle of low-turbulence displacement<br />

flow over the optical table. In the environment of the optical<br />

table, ISO class 6/7 is achieved, which reduces to a minimum the<br />

risk of contamination from personnel. The special design of the<br />

cabins makes them easy to clean as well.<br />

Depending on requirements, a special laser-protection partition<br />

wall system, laser-protection curtains, or PVC cleanroom curtains<br />

are also available as a side enclosure. The right protective<br />

housing is determined for each application in close consultation<br />

with the customer and according to the valid DIN EN 12254 and<br />

DIN EN 60825 standards. For achieving the necessary cleanroom<br />

class in compliance with DIN EN ISO 14644–1, fully adjustable<br />

The laser cabins are DIN EN ISO 14644–1 qualified and achieve<br />

at least cleanroom class 5 through the principle of low-turbulence<br />

displacement flow over the optical table.<br />

EC fans that create low-turbulence displacement flow were integrated<br />

into the cabins. The EC fans are extremely energy efficient<br />

too. The dimensions of the laser cabins can be selected<br />

from standard variants or modified individually to meet requirements.<br />

In addition to permanently installed and mobile cabins,<br />

ceiling suspension of the cabins is also possible. The frames are<br />

made of steel coated with epoxy resin in RAL 9010 for protection.<br />

Depending on requirement, comprehensive protective<br />

housing can be selected to separate the work area.<br />

BC Technology, Dettingen an der Erms/Germany<br />

www.bc-<strong>technology</strong>.info<br />

Photo: BC Technology<br />

BLDC servo motor<br />

Motor, 45 mm Long, Reaches 100,000 RPM<br />

Coordinate measuring system<br />

Simple Handling Eliminates User Error<br />

A new model was added to the<br />

BHx series of brushless DC<br />

servo motors with a 16-mm diameter:<br />

the 45-mm model<br />

1645 … BHS. At 100,000 rpm,<br />

the BLDC motor achieves a<br />

much higher speed than the<br />

same size motors currently<br />

available on the market. The<br />

maximum radial load is 18 N,<br />

power density 58.5 W, and<br />

torque 8 mNm. With the right<br />

Photo: Fritz Faulhaber<br />

planetary gear, the motor can<br />

generate a torque of 800 mNm<br />

at 12,000 rpm. Efficiency of<br />

90% as well as minimal heat<br />

build-up and vibration make<br />

this motor extremely energyefficient<br />

as well. Its very short<br />

response time is achieved<br />

thanks to exceptionally low<br />

values in mechanical start<br />

time constant and rotor inertia<br />

as well as very fast angular acceleration.<br />

Together with the<br />

flat slope of the n/M characteristic<br />

curve (429 rpm/<br />

mNm), the result is good running<br />

performance of the<br />

motor.<br />

Dr. Fritz Faulhaber,<br />

Schönaich/Germany<br />

www.faulhaber.com<br />

The fully mobile DPA Industrial<br />

coordinate measuring<br />

system was combined with the<br />

C1 Camera and the tried and<br />

tested DPA photogrammetry<br />

measuring system. The complete<br />

solution is ideal for<br />

measuring volumes of up to<br />

10 m on the diagonal and generates<br />

digital models with an<br />

accuracy of up to 10 μm.<br />

Thanks to its wi-fi functionality<br />

and long battery life, DPA<br />

Industrial is a user-friendly<br />

system for taking measurements<br />

directly in the manufacturing<br />

environment without<br />

causing costly interruptions in<br />

production. DPA Industrial<br />

was developed to make photogrammetry<br />

measurements as<br />

simple as they are robust. The<br />

C1 Camera is a durable DSLR<br />

camera unit designed for use<br />

in harsh manufacturing environments.<br />

The robust housing<br />

also facilitates a highly<br />

simplified measurement process,<br />

in which adjustments in<br />

settings and operating elements<br />

take a back seat. Even<br />

non-experts can use the pointand-shoot<br />

camera to obtain<br />

measurement results that<br />

meet the highest metrology<br />

standards. The unit has its<br />

own button for image capture<br />

and a viewfinder for controlling<br />

the visual field.<br />

Hexagon Manufacturing<br />

Intelligence, Wetzlar/Germany<br />

www.hexagonmi.com<br />

66 medicine&<strong>technology</strong> 01/2019


Additional Laser Brings More Flexibility<br />

Photo: Zorn Microsolution<br />

Processing centre | It can do more than just machining:<br />

Zorn Maschinenbau’s five-axis processing centre<br />

Micro One not only mills, cuts, and welds; it can also<br />

laser after a simple modification.<br />

Thanks to an additional laser module, the Micro One five-axis<br />

processing centre made by Zorn Maschinenbau GmbH,<br />

Stockach/Germany, produces with more flexibility than conventional<br />

variants. The existing work spindle can quickly be replaced<br />

by a laser source. Machine operators can make the modifications<br />

themselves in virtually no time and without much effort.<br />

A fibre laser can currently be installed as a laser source. If<br />

desired, operators can change over to other laser sources at any<br />

time to meet requirements. This feature gives end users different<br />

options for being able to manufacture their sophisticated workpieces<br />

precisely.<br />

The laser can process a wide range of materials and workpiece<br />

sizes. For example, users can utilise the laser to assist in drilling,<br />

cutting, welding, soldering, stripping, labelling surfaces, and<br />

giving surfaces structures. Metals and ceramics can be processed,<br />

but so can other materials—on request. Feeding or racking<br />

equipment and even equipment for visually measuring components<br />

can be integrated into the production workflow.<br />

The coordinated lasers and optics allow for extremely flexible<br />

and precise production, especially in medical and dental <strong>technology</strong>.<br />

The five-axis processing centre can cover virtually all<br />

requirements in these industries with high quality.<br />

The work spindle of the five-axis processing centre can quickly be<br />

switched for a laser.<br />

Zorn Maschinenbau, Stockach/Germany<br />

www.zorn-maschinenbau.com<br />

Packaging machine<br />

Traysealer Added to Portfolio<br />

Multivac expands its X-line machine generation<br />

by adding the TX 710 traysealer<br />

which is equipped with a comprehensive<br />

sensor system and achieves seamless digitalisation.<br />

The high capacity of this versatile<br />

and compact system results from the<br />

interplay of a robust mechanical concept<br />

and an intelligent control system. The<br />

output is up to 25 cycles per minute for air<br />

packs and up to 18 cycles per minute for<br />

modified atmosphere packages. A comprehensive<br />

sensor system is key to the<br />

rapid and precise processes. As part of intelligent<br />

machine control, Multi Sensor<br />

Control determines, amongst other<br />

things, the switching times for different<br />

control circuits and compensates them<br />

specifically by starting the subsequent<br />

processes early. As another component of<br />

intelligent machine control, the Flow<br />

Manager controls the servo drives and can<br />

synchronise coordinated sequences with<br />

precision and process reliability. This<br />

guarantees maximum output and high<br />

process stability with every cycle. Thanks<br />

to the modular design of TX 710, the frequent<br />

format changes typical for traysealers<br />

can be done in less than five minutes.<br />

The related racking and preheating sys-<br />

Photo: Multivac<br />

tems can be used to preheat the tool to the<br />

production temperature, making TX 710<br />

ready to produce the next batch right<br />

after the change.<br />

Multivac Sepp Haggenmüller,<br />

Wolfertschwenden/Germany<br />

www.multivac.com<br />

01/2019 medicine&tec hn ology 67


■ [ INNOVATIONS ]<br />

Publisher:<br />

Katja Kohlhammer<br />

Publishing House: Konradin-Verlag<br />

Robert Kohlhammer GmbH<br />

Address: Ernst-Mey-Straße 8,<br />

70771 Leinfelden-Echterdingen,<br />

Germany<br />

Managing Director: Peter Dilger<br />

EDITORIAL STAFF<br />

Editor-in-Chief:<br />

Senior editor:<br />

Contributing editors:<br />

Editorial Assistant:<br />

Design director:<br />

Dr. Birgit Oppermann (op),<br />

Phone +49 711 7594–459<br />

Susanne Schwab (su),<br />

Phone +49 711 7594–444<br />

Bettina Gonser (bg),<br />

Sabine Koll (sk)<br />

Daniela Engel,<br />

Phone +49 711 7594–452,<br />

Fax +49 711 7594–1452<br />

E-Mail: daniela.engel@konradin.de<br />

Vera Müller,<br />

Phone +49 711 7594–422<br />

ADVERTISING<br />

Advertising production Joachim Linckh,<br />

director: Phone +49 711 7594–565,<br />

Fax +49 711 7594–1565<br />

Order management Matthias Rath,<br />

director: Phone +49 711 7594–323,<br />

Fax +49 711 7594–1323<br />

Current advertising rate list no. 14 from Oct. 1, 2019<br />

Radio-opaque stainless steel wire<br />

Custom Material for Fully Visible Stents and Guidewires<br />

Anomet’s radio-opaque stainless steel<br />

wire can be made with controlled intensity<br />

of radio opacity to optimise visibility<br />

under fluoroscopy for manufacturing<br />

stents, guidewires, or other implantable<br />

Photo: Anomet<br />

devices. The wire is made of gold, platinum,<br />

tantalum, and similar alloys metallurgically<br />

bonded to a stainless steel core<br />

with 2% or more cladding thickness. The<br />

product is offered in outer diameter sizes<br />

0.05 to 1.52 mm and has a smooth, even<br />

finish. The wire is easier to see than a<br />

large wire with marker bands, and OEMs<br />

are able to select the radio-opaque alloys<br />

best suited for their own devices and their<br />

own applications. Two or three precious<br />

metals and core materials, including Nitinol<br />

wire, can be selected to achieve a wide<br />

range of desired properties like resistance<br />

to corrosion and high conductivity. Anomet<br />

can meet precise specifications up to an<br />

outer diameter of 3.2 mm.<br />

Anomet Products, Shrewsbury, MA/USA<br />

www.anometproducts.com<br />

SUBSCRIPTIONS<br />

Reader service:<br />

Ute Krämer,<br />

Phone +49 711 7594–5850,<br />

Fax +49 711 7594–15850<br />

E-Mail: ute.kraemer@konradin.de<br />

Single copy € 11.20 (including tax, excluding shipping).<br />

Contact the publisher to make an order.<br />

Stepper motors<br />

Torque, 15% to 30% Better than<br />

Comparable Motors<br />

INTERNATIONAL OFFICES<br />

Belgium, France, Italy,<br />

Luxemburg, Switzerland: Great Britain, Ireland:<br />

IFF media ag<br />

Jens Smith Partnership<br />

Frank Stoll<br />

The Court, Long Sutton<br />

Technoparkstrasse 3<br />

GB-Hook, Hampshire RG 29 1TA<br />

CH-8406 Winterthur Phone 01256 862589<br />

Tel: +41 52 633 08 88 Fax 01256 862182<br />

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

e-mail: f.stoll@iff-media.ch<br />

Japan:<br />

USA:<br />

Mediahouse Inc.<br />

D.A. Fox Advertising Sales<br />

Kudankita 2-Chome Building Inc. Detlef Fox<br />

2–3–6, Kudankita 5 Penn Plaza, 19th Floor<br />

Chiyoda-ku, Tokyo 102 New York, NY 10001<br />

Phone 03 3234–2161 Phone +1 212 8963881<br />

Fax 03 3234–1140 Fax +1 212 6293988<br />

E-Mail: detleffox@comcast.net<br />

Featured articles reflect the opinion of the author, but not<br />

necessarily that of the editorial staff. We will not be responsible<br />

for manuscripts sent without solicitation. All articles published<br />

in medicine&<strong>technology</strong> are protected by copyright.<br />

All rights, and translations, reserved.<br />

Reproductions of all kinds are prohibited without the written<br />

approval from the publisher.<br />

The place of fulfillment and jurisdiction is Stuttgart.<br />

Printing company:<br />

Konradin Druck, Leinfelden-Echterdingen<br />

Printed in Germany<br />

© 2019 by Konradin-Verlag Robert Kohlhammer GmbH,<br />

Leinfelden-Echterdingen<br />

Photo: Nanotec<br />

With SCA5618, Nanotec now offers a<br />

stepper motor that has 15 to 30 percent<br />

more torque than comparable<br />

motors with a flange size of 56 mm<br />

(NEMA 23). Thanks to improved<br />

stator geometry and optimised magnet<br />

materials, rotor inertia is no<br />

higher than that of the predecessor<br />

model. SCA5618 comes in three<br />

lengths and with two different windings.<br />

This stepper motor’s holding<br />

torque ranges from 0.6 to 2.3 Ncm,<br />

depending on length; its resolution is 1.8 degrees. For higher<br />

resolution, SCA5618 can also be combined with an optical or<br />

magnetic encoder. The integrated connector allows for easy connection<br />

to customer-specific cables and simple motor replacement.<br />

The high-torque stepper motor can be ordered with one or<br />

two motor shafts. The shaft end comes in two versions—with<br />

D-cut and an 8-mm diameter or with a 6.35-mm diameter without<br />

D-cut. Together with the newly developed GP56 high-torque<br />

planetary gearboxes, the result is a good motor-gear combination.<br />

Nanotec Electronic, Feldkirchen/Germany<br />

www.nanotec.de<br />

68 medicine&<strong>technology</strong> 01/2019


Force and displacement sensors<br />

Sensors Measure Forces in Medical Devices<br />

Photo: Inelta<br />

Inelta’s force sensors are used, amongst<br />

other things, in the compression mechanisms<br />

of mammographs. Based on the<br />

requirement and forces, variants are<br />

available as load cells, S-form sensors, or<br />

shear beam sensors. The FS12 shear beam<br />

force sensor weighs 20 g and is available<br />

in variants 100 N, 200 N, or 500 N for<br />

pull/push forces. LVDT sensors are used<br />

to record very small displacements and<br />

changes in position. They take inductive<br />

and contactless measurements, achieving<br />

practically unlimited resolution that<br />

depends only on the quality of signal<br />

enhancement. Inelta also makes miniature<br />

LVDTs: Sensors from the Izal series<br />

are only slightly larger than a match.<br />

Inelta, Taufkirchen/Germany<br />

www.inelta.de/en/<br />

Twice the Measuring Volume<br />

of the Predecessor<br />

Coordinate measuring machine | Werth Tomo Scope XS<br />

Plus can record workpieces up to about 450 mm in<br />

length and smaller objects with high resolution or<br />

shortened measurement time.<br />

By using the Tomo Scope XS Plus coordinate<br />

measuring machine with computed<br />

tomography from Werth Messtechnik<br />

GmbH, Giessen/Germany, users see<br />

many benefits including double the<br />

measuring volume of the Tomo Scope XS.<br />

Werth transmission tubes can take highresolution<br />

measurements at high performance<br />

and with short measurement<br />

times. The monoblock design, consisting<br />

of tube, generator, and vacuum generator,<br />

makes the x-ray tube practically maintenance-free.<br />

The open design results in unlimited<br />

service life since wearing parts can<br />

be replaced as needed. The tube comes<br />

with 130 or 160 kV maximum tube voltage,<br />

allowing for a wide range of uses for<br />

plastic and metal workpieces. In grid tomography,<br />

multiple x-ray images of various<br />

workpiece areas are taken one after<br />

another. The workpiece volume is reconstructed<br />

from the images taken of the<br />

workpiece at different angles, and the<br />

The Tomo Scope XS Plus coordinate measuring<br />

machine has a large measuring range<br />

and a small footprint.<br />

subvoxeling method is used to calculate<br />

the measuring points at the transitions<br />

between materials. This method can be<br />

used to measure workpieces up to about<br />

450 mm long. Alternatively, smaller objects<br />

can be recorded with high resolution<br />

or together with reduced measurement<br />

times. The measurement results are complete<br />

workpiece volumes at nearly any<br />

resolution setting in all coordinate axes.<br />

Werth Messtechnik, Giessen<br />

www.werth.de<br />

Phozo: Werth Messtechnik<br />

Genvi TM the new generation<br />

of 3-port solenoid valves<br />

Highly useful for molecular diagnostics,<br />

oxygen delivery, compression therapy,<br />

ventilators, environmental analyzers,<br />

breath analysis in<br />

portable or stationary<br />

instruments.<br />

In a miniature<br />

10mm package,<br />

genvi features<br />

high flow capacity,<br />

low leakage and<br />

ultra-low power<br />

consumption.<br />

LEE Hydraulische<br />

Miniaturkomponenten GmbH<br />

Am Limespark 2 · D- 65843 Sulzbach<br />

+49(0)6196 /7 73 69 - 0<br />

info@lee.de<br />

www.lee.de<br />

01/2019 medicine&tec hn ology 69<br />

THE LEE COMPANY MORE THAN 70 YEARS SINCE 1948


Düsseldorf, 18. - 21.11.2019<br />

Hall 08B, Booth 8BL27<br />

FAULHABER applications<br />

Dynamics and power.<br />

Aquestionof<strong>technology</strong>.<br />

With FAULHABER drive systems for prosthetics you push the limits<br />

of what is possible for people with disabilities.<br />

Further information at faulhaber.com/p/bxt/en<br />

WE CREATE MOTION<br />

70 medicine&<strong>technology</strong> 01/2019

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