medicine&technology 01.2019
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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 />
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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 />
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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
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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
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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 />
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• Customized assembly and<br />
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• Collaborative engineering<br />
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• 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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Photo: anekoho/Fotolia<br />
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 />
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Practical knowledge spanning<br />
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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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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 />
BRINGING YOUR MEDICAL<br />
DEVICES TO LIFE<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
Going further with<br />
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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