Swiss medtech industry 2015 en

Edition

2015 E PRECIS ESSIVE PROGR SMART

Football legend Köbi Kuhn “Sometimes I have to stop and think which side the prosthesis is on.”

> SPECIAL ENDOPROSTHETICS +++ Knee, hip, shoulder +++ Manufacturers, suppliers +++ Innovations and market environment

12 Endoprosthetics: innovation at a time of pressure on costs +++ 36 – 41 Quality, certification and compliance +++ 44 CTI Swiss Medtech Award: presented for surgical robots, bioprinting and anatomy simulation +++ 46 Biomedical technology: what makes the Bern network successful

Universe of heat treatment.

Hardening. Consulting. Contracting.

Safety. Reliability. Reproducibility.

Leader treatment for medical technology.

Leader in in heat Wärmebehandlung für Medizintechnik.

Hardness alone is not a sufficient quality criterion for the heat treatment of medical instruments.

Experience shows that even though one instrument functions perfectly, another instrument of the very same type and with identical hardness can break during use. „All roads lead to Rome“; likewise it is possible to produce the same target hardness using diverse parameter combinations – however, the products’ micro-structures will vary substantially.

That is precisely why the medtech

industry attaches great importance to validated equipment and processes.

Validated heat treatment for maximum patient safety The micro-structure can only be evaluated by destroying the component, so verification is ruled out. Only validated equipment and processes guarantee reproducibility and patient safety. As leader in heat treatment for medtech products, we therefore offer hardening in validated furnaces using validated processes according to ISO 13485 and 21 CFR part 820 (FDA). Our test equipment is obviously validated

too. By maintaining complete records of every batch in combination with device history records and treatment parameters frozen after first article inspection, we guarantee perfect traceability, consistent results and maximum patient safety. We support you comprehensively – with hardening, consulting and contracting. Trust the leader with your products too.

Härterei Gerster AG 4622 Egerkingen/Switzerland www.gerster.ch

+++ Editorial

Exchange rate calls for a change of course “Forecasts are difficult, particularly if they concern the future.” There could hardly be a better way of describing the situation of the Swiss med-tech industry. Just one year ago we were celebrating the revival of growth expectations after the crisis years before 2013: companies across all subsectors were expecting just under ten percent more sales – that is what they told the Swiss Medical Technology Industry Report in 2014. But as early as January 2015 this euphoria gave way to disillusionment when the Swiss National Bank changed its previous support policy because of increasing pressure on the Swiss franc.

Since then, the increasing weakness of the euro against the franc has resulted in massive losses of margins for the Swiss export industry and with it the med-tech sector.

If a market changes like that, companies have to review their options for action. And there really are options, even though they are not new. Manufacturers and suppliers in medical technology are changing course: either by concentrating more on niche products, or by increasingly relying on innovation or by making maximum efficiency in production and administration their top priority.

Many examples from endoprosthetics show that companies can implement these options successfully. We have chosen this important subsector of the Swiss medical technology industry as the main subject of the second issue of our magazine Swiss Medtech Industry, and are devoting about half the issue to it. Read what decision-makers do when they see what is admittedly an uncomfortable situation as an opportunity, prepare and implement a fitness programme for their company, and turn their eyes – despite everything – to the future with a degree of optimism. I make no predictions about timing, but one thing I do know for certain: as soon as the exchange rates settle down, Swiss companies will again be as profitable and at least as competitive as before January 2015.

And so I hope that we will be able to see proof of that in the very next industry survey in the year to come.

Yours faithfully

Rubino Mordasini President Medical Cluster

PS: Current trends in the Swiss medical technology industry can be seen in the coming year too at the Swiss Medtech Day, on 7 June 2016 in Bern. Further information is available at w www.medical-cluster.ch/smd 2015_Swiss Medtech Industry

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Editorial

> SpeCial: Endoprosthetics

+ + ++++++++++++++++++++++++++++ + 3 Exchange rate calls for a change of course

From the industry

Panorama

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+ + ++++++++++++++++++++++++++++

12 Innovation times three: how manufacturers and suppliers produce innovative knee, hip and shoulder prostheses despite pressure on costs 18 Orthopaedics worldwide: market trends

6 Working of titanium materials – service chain for complex plastic disposables – cutting oil for rapid and precise production – partner for sheet metal working

Know-how & components

+ + ++++++++++++++++++++++++++++

Focus on manufacturers

+ + ++++++++++++++++++++++++++++ + 20 Mathys: supporting the self-healing of torn cruciate ligaments 21 Stemcup Medical Products: minimal bone loss in the thigh – Zimmer: positioning the knee prosthesis precisely using a guidance system 22 Symbios: as close as possible to individual joint geometry with the modular system 23 Atesos: sterile marker system for navigation in the operating theatre

31 Blaser Swisslube: choosing the right cooling lubricant can reduce tool costs 32 maxon motor: how drive solutions from oil production benefit medical technology 33 Micronel: ventilators adapt in a flash to human respiratory rhythm 34 Moser-Baer: services for medical technology – from concept to series production

In conversation

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26

27

24 Football legend Köbi Kuhn: fit and active with a prosthesis

Focus on suppliers

+ + ++++++++++++++++++++++++++++ 26 Jossi Orthopedics: toolbox makes implant manufacturers flexible SAMAPLAST: know-how for plastic parts 27 from the idea to the final packaging 28 SMB Medical: forging the metastable beta-titanium alloy, too 29 Thelkin: implants on test Meister: braided textile components from 30 the clean room

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> Eine deutsche Version dieser Ausgabe ist erhältlich. w www.medical-cluster.ch/smi

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+++ Content

Economics & law

Innovative regions

+ + ++++++++++++++++++++++++++++ 35 Hotspot Switzerland: why big companies locate their med-tech departments here 36 BSI: supporting quality management and product certification 37 Regulation and innovation: how to handle the apparent contradiction smartly 38 CSA Group Switzerland: certification with no nasty surprises 39 New business model for med-tech start-ups – consultancy for visible management success 40 Maetrics: investment in quality and compliance pays off 41 Bern med-tech incubator initiative: unique business ideas wanted

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+ + ++++++++++++++++++++++++++++ 42 Medical technology in Switzerland: regional centres

Research & development

+ + ++++++++++++++++++++++++++++ 44 +CTI Swiss Medtech Award: recognition for surgical robots, bioprinting and anatomy simulation 46 Bern Biomedical Engineering Network: researchers from all disciplines working for the benefit of patients 48 Measuring blood glucose through skin contact – technical assistance for supermicrosurgery

Three questions for …

+ + ++++++++++++++++++++++++++++ 50 Rubino Mordasini and Urs Gasche explain how Medical Cluster and FASMED will collaborate in future

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44 PUBLISHING INFORMATION EDITOR Medical Cluster, Schwarztorstrasse 31, 3007 Bern Telephone +41 31 330 97 79, mail@medical-cluster.ch, www.medical-cluster.ch PROJECT MANAGEMENT Peter Biedermann (Medical Cluster) Jonas Frey (Medical Cluster) Jennifer Bühling (Konradin Relations, Leinfelden) Concept: Editorial staff of medizin&technik, Konradin Verlag, 70771 Leinfelden Text: Anke Biester, Sabine Koll Cover: Jonas Frey Layout: Nicole Gauch (Konradin Relations, Leinfelden) Translation: SFL Regulatory Affairs & Scientific Communication Ltd., Basel Proofreading and Print: Schwabe AG, 4132 Muttenz Edition: 8000 copies (total edition) © Medical Cluster, 2015

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2015_Swiss Medtech Industry

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Precision turned parts made to order

The most varied semi-finished products for medical technology products are part of the vast range of goods stocked by BIBUS METALS (Photo: BIBUS METALS).

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ANDRES AG from Lohn-Ammannsegg produces made-to-order, ready-to-install precision-turned parts with diameters of 0.2 millimetre to 20 millimetres for medical technology. These include various components for hearing aids, eye surgery instruments and dental technology plus instruments and implants for orthopaedics and spinal reconstruction. Bone screws made of titanium or implant steel for traumatology are a company speciality. Using modern, automated CNC machines the supplier carries out special processes such as deep-hole drilling, thread whirling, hex broaching and high-frequency milling. Andres AG is certified to ISO 9001 and ISO 13485 and manufactures med-tech parts using validated processes. To mark its 60th anniversary next year, the family company is planning to double the size of its production area at the Lohn-Ammannsegg site.

w www.andresag.com

Much experience with titanium and medical materials

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BIBUS METALS AG from Fehraltorf specialises in stocking semifinished products made of titanium, titanium alloys, cobalt-chrome alloys and other medical materials. With its stocks of bars, sheets, pipes, wires and strips, its own service centre and extensive know-how, the company guarantees rapid and reliable deliveries. In addition, modern automatic sawing machines, guillotine shears and water-jet cutting units are available for work in the microscopic range, to a tolerance of ± 0.01 millimetre. At customers’ requests, BIBUS METALS also offers cylindrical grinding, marking and warehousing facilities with just-in-time deliveries.

The family company founded in 1979 is regarded as one of the most important suppliers of the aviation, chemicals, automobile, medical, oil and gas industries. It meets high requirements regarding traceability and ISO 9001 / 13485, which is particularly relevant to medical technology.

w www.bibusmetals.ch Just what the customer ordered: precision-turned parts from Andres are needed for hearing aids and for implants (Photo: Andres).

Successful Production Partnership

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> STOPPANI AG,

allocated in Neuenegg, is the dedicated outsourcing partner of the start-up company Omniroll. Stoppani’s LEAN assembly expertise in combination with backwards-integrated precision milling and metal processing allows a highly efficient production of the Omnichair electric wheelchair. Omniroll has recently been awarded with the InnoPrix SoBa for practical use of the further engineered “Mecanum wheel”.

The cooperation between Omniroll and Stoppani allowed an effective implementation of this innovation for medical and industrial applications.

For future products with the Mecanum wheel concept, e.g. for operating tables, a class 7 clean room (5) production is also available.

w www.stoppani.com w www.omniroll.ch

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The Omnichair electric wheelchair is manufactured very cost-effectively

by Stoppani in best “Swissness” quality (Photo: Omniroll).

+++  From the industry

A clear commitment to the Swiss business location

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> Cicor is a globally active group of leading companies in the

Graphic showing the planned building superimposed on a picture of the landscape (Photo: Cicor Technologies LTD.).

electronics industry with a wide range of production capabilities in printed circuit board assembly, system assembly and box building, control cabinet construction, cable assembly and in the areas of toolmaking and plastic injection molding. Swisstronics Contract Manufacturing AG, a group company, is constructing, at Bronschhofen in the Canton of St. Gallen, a new, modern building just a few hundred metres away from the present site. All the manufacturing, engineering and administrative activities of Swisstronics, and its group management, will be housed in a multistorey building complex occupying an area of about 9,300 cubic metres. Cicor Management AG is to move its premises from Zurich to Bronschhofen. With this new building the group is strengthening its commitment to Switzerland as a business location. Cicor employs 1,950 people at eleven production sites in Europe and Asia, of which 350 are in Switzerland.

w www.cicor.com

For more news visit www.medical-cluster.ch/news-en

Successfully being visible

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The advisory team at IFF Media AG (from left): Martina Kohler, Eva Härri, Frank Stoll, Carla Stahel and Salome Brunner (Photo: IFF Media).

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IFF MEDIA AG from Winterthur has for 50 years been a competent advisor on media activities to industry customers around the world. It ensures that their products remain visible at all times, even away from trade fairs. IFF Media turns companies’ declared export objectives into a media planning proposal and runs the full range of media activities.

The main focus is on a comprehensive marketing mix, with the aim of bringing brands or products to the attention of potential customers, both optically and as regards their technical aspects. However, the challenges facing every single export strategy have become simultaneously more varied and more detailed because of the growing complexity and faster pace of market activity. That is why the company's marketing experts adapt advertising work to individual countries to make “business without frontiers” a reality for their customers.

Complex plastic parts

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> MECAPLAST SA from Botterens

produces disposable products for medical applications, such as handpieces for mobile surgical robot systems. These devices are combined with optical inspection processes and assist surgeons during the various stages of difficult spinal operations. To this end Mecaplast develops complex plastic parts and produces injection moulding tools in its own tool shop. The entire production process including assembly of all electronics takes place in a clean room (ISO 7). Products are supplied to customers ready assembled and blister-packed. The Swiss company has been developing The production of dosing syringes in the and producing technical plastic one-component procedure is just one examparts for over 40 years and offers ple from the range of one- or two-component its customers the complete sup- injection moulding procedures which Mecaplast uses to process every type of plastic ply chain from tool development, material (Photo: Mecaplast). manufacture, production of injection mouldings, cleaning and assembly through to labelling and specific packaging. Sterilisation is done at the customer’s request by partners with established reputations. w www.mecaplast.ch

w www.iff-media.com

Complete value chain for complex disposables made of plastic

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>

Insulin pens are produced completely automatically at Phillips-Medisize (Photo: Phillips-Medisize).

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PHILLIPS-MEDISIZE has for more than 35 years been a leading

outsourcing partner at its Swiss site in Nürensdorf. The company develops and produces medical and pharmaceutical systems such as pharmaceutical primary packagings, plastic products for medical technology and diagnostics, plus drug delivery systems.

The company is certified to ISO/EN 13485 for the manufacture of medical technology products. Its particular strengths on the market are complex disposables subject to comprehensive inspections throughout the process – through highly prioritised quality assurance in accordance with ISO 13485, FDA standards or CGMP (current good manufacturing practice). Thus Phillips-Medisize offers its customers a complete value chain from initial concept to finished solution, from product design and development to the readyto-use, sterile-packed medical device. The complete industrial production process from prototype to finished product is done on the premises of Phillips-Medisize. w www.phillipsmedisize.com

+++ From the industry

Faster and more precise production

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MOTOREX AG LANGENTHAL supplies the cutting oil Ortho NF-X which enables manufacturers of sophisticated med-tech components to speed up their manufacture and make it more precise. The cutting oil performs, as process parameters, functions such as the cooling of component and tool, lubrication and the removal of metal cuttings. Ortho NF-X cutting oil incorporates the Vmax technology developed by MOTOREX. It deliberately exploits the heat generated in the process. One good example is the production of a sophisticated stainless steel bone cutter which is used to cut bone to fit a prosthesis into the bone shaft. MOTOREX was approached by the cutter’s manufacturer about optimising the manufacturing process. A comparison test and the analysis of various parameters showed that the positive properties of the universally usable high-performance Ortho NF-X cutting oil had a direct and positive effect on all the measured parameters. This greatly increased tool service life.

At the same time a better surface quality was achieved and productivity was increased. w www.motorex.com Drills like the one shown in our picture can be produced faster and in better quality using high-tech cutting oils (Photo: Motorex).

SFL - Solutions For Life sciences Global strategic and operational support in healthcare Regulatory

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Cross-functional roject management • P support • Q uality management

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Identifying the finest residues and substances

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The FT-IR microscope can be used to identify residues on implants or in packagings (pictures: RMS Foundation).

THE RMS FOUNDATION in Bettlach offers its customers independent analytical and testing services for materials and medical technology products. These include mechanical, physical and chemical investigations. In the area of organic analysis the company has a fully automated Fourier-transformed infrared spectroscopic (FT-IR) microscope with ATR crystal (attenuated total reflection) at its disposal.

FT-IR is used for the identification of organic substances, residues and polymers.

The FT-IR microscope allows measurements of very small amounts of solids, powders and liquids. This makes it possible, for example, to identify residues in the form of particles and fibres on implants or in packaging. Another application is the determination of the oxidation index of implants made of ultra-high molecular weight polyethylene (UHMWPE) after ageing in the packaging, accelerated ageing or implantation in the patient. Depth profiles of the degree of oxidation can be determined between the surface and the bulk of the material. This makes it possible to characterise the stability and the condition of the polymer. These services are accredited to ISO/IEC 17025. w www.rms-foundation.ch

Your partner for the industrialised serial manufacture of products for the medical technology sector

Pierre-Mikael Legris, CEO of Pryv (Photo: Pryv).

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FAES AG of Wollerau is one of Switzerland’s largest industrial service providers, manufacturing precision parts, sub-assemblies, devices and equipment on behalf of technology enterprises. The company supports the customer’s product throughout its entire life cycle. This reduces a customer’s own share of the production work for its products, making the manufacturing process more cost-effective. The range of services includes full upstream and downstream services, beginning with the design study and continuing through the development and construction stage, prototype manufacture and pilot production. It also covers supplier selection and auditing, production and assembly planning, procurement, testing and documentation, extending through packing, delivery and distribution logistics to maintenance, repairs and a replacement parts service. FAES’s world-wide Supply Chain Management service is supplemented by the company’s own precision parts manufacturing facility in Switzerland, using stateof-the-art CNC machining centres and well-qualified specialist employees.

w www.faes.com FAES is the contract manufacturing partner for sub-assemblies and equipment in the medical technology sector (Photo: FAES).

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Getting onto the market more simply

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> PRYV SA based in Lausanne is a specialist in

sensitive and health data management. The company has developed a trusted and state-of-the-art software back-end solution. Pryv empowers small and medium-sized med-tech companies and the associated healthcare sector to go to market in a shorter time and with fewer IT costs. The back-end solution from Pryv allows effortless connectivity to any data source, data exchange and storage at the highest security level. The package also enables full-fledged management of data, storage location and access rights. The platform includes tools that operate using various sensors, tracking apps and devices to ensure data interoperability and continuity. In addition, the software solutions enable Pryv’s partners and customers to comply with the healthcare system’s guidelines and laws for multinational product distribution. w www.pryv.com

+++ From the industry

Partner for all aspects of sheet metal working

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SCHWARZ AG FEINBLECHTECHNIK from Würenlingen is the specialised partner for the sheet metal process chain and the rapid implementation of product ideas – from the prototype to series supply on the specified day. The knowledge and experience of its specialists cover many different subjects: for example simple, ergonomic and service-friendly handling, the clear product character, stability and the optimisation of production. The company adapts the engineering process to customer needs. Through project management and with the involvement of its interdisciplinary partner network, SCHWARZ AG FEINBLECHTECHNIK promises high speed and quality of development.

w www.schwarzag.ch

SCHWARZ AG FEINBLECHTECHNIK specialises in sheet metal working.

Seen here is a component for a medical device (Photo: SCHWARZ AG FEINBLECHTECHNIK).

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>

SPECIAL: Endoprosthetics

Innovation times three The worldwide market for knee, hip and shoulder implants continues to grow, but the medical technology industry is increasingly feeling the effect of pressure on costs in healthcare systems. Swiss manufacturers and suppliers are responding to this trend with solutions on three levels: product innovation, process innovations and innovations in business processes.

Hip and knee implants are increasingly becoming high-volume commodity products. This leads to price erosion that is likely to continue in coming years. On the other hand, the manufacturers of shoulder joint replacements are not yet under such pressure (Photo: Š decade3d - Fotolia.com).

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+++ SPECIAL Panorama

“Switzerland has always been a stronghold for endoprostheses. That is particularly true for hip implants,” says Dr. Martin Schmidt, head of Business Development at Jossi Orthopedics AG. The company with headquarters in Islikon supplies manufacturers of endoprostheses worldwide. Often, Jossi’s precision components for hip prostheses do not have to be sent very far, because many customers have their headquarters or at least a production site in Switzerland.

Knee and shoulder implants are also made here, and the market for all three types of endoprosthesis is continuing to grow – by between 2 and 5 percent a year, depending on the joint. “That is the good news,” says Schmidt. “The bad news is: prices for hip and knee implants are continuing to fall every year. Pressure on costs in healthcare systems in Europe is affecting implant manufacturers and us suppliers very badly. We are expecting a further global collapse in prices.”

Swiss manufacturers are being hit particularly hard, because the exchange rate of the Swiss franc against the euro rose by about 20 percent at a stroke in January 2015; the Swiss National Bank had abolished the minimum exchange rate of 1.20 francs that had applied until then and is no longer propping it up with currency purchases.

Hip and knee implants are becoming commodities “Exchange rate fluctu-

to reposition ourselves with innovations,” stresses Yvan Sandoz, Sales Director at Symbios Orthopédie SA, headquartered in Yverdon-les-Bains. The times when high margins could generally be expected for medical devices are over. “We are seeing the normalisation of the market for hip and knee implants,” says Sandoz. “Both product groups are becoming ‘commodities’. This means that implants are technologically mature and patients are guaranteed long service lives. They have become mass products that can be made by many. Volumes are high. And this means for manufacturers that markets are being hotly contested and margins are getting smaller.”

Shoulder implants are the only area that is not yet affected by pressure on costs. No wonder: volumes here are well below those for hip and knee implants.

“Classical innovations on the product side, concerning materials or the design of implants, for example, will be increasingly harder to achieve in this tense mar-

ket environment,” confesses Dr. Daniel Delfosse, Director of Innovation & Technology at Mathys AG Bettlach. The reason for this must be seen mainly in the effects of the recalls of metal-on-metal hip endoprostheses a few years ago: wear on the metal created an increased safety risk for patients. Although only a few manufacturers were responsible for the problems, the whole product class fell into disrepute. That is why metalon-metal combinations are no longer used today.

Although metal continues to be used in femoral heads, the proportion in Europe has been declining for years, and the proportion of ceramic heads is increasing all the time. Ceramic is also commonly used with the hip sockets.

But polyethylene (PE) has clearly gained ground as an articulation partner.

The right articulation pairing is important in order to minimise wear or abrasion, since an artificial hip joint has to go through more than one million

>

> “We either do it differently or we do it better, but above all cheaper, because today innovations always have to result in cost savings.”

Dr. Martin Schmidt, head of Business Development at Jossi Orthopedics

(Photo: Jossi)

ations are just one reason why we need

2015_Swiss Medtech Industry

13

Counting the financial advantages

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ The financial auditing company Ernst & Young (EY) has investigated, in its 2014 Medical Technology Report with the title “Pulse of the industry”, how medical technology companies can differentiate themselves at a time when many products are becoming commodities.

Accordingly, commodity means that consumers cannot tell products apart – because they are in fact functionally identical or because customers are not willing to pay a premium price for differentiating features or functionalities.

Added to this are changes in hospitals: according to EY surveys, the influence of individual doctors in purchasing decisions will decrease still further in coming years. On the other hand, the influence of administrators (CFO, finance department or Purchasing) is rising – and the primary focus of this target group is on measuring and achieving benefit. Accordingly, purchasing decisions are becoming increasingly centralised, as the example of Germany shows.

These changes have clear effects on the way in which medical technology companies market their goods and how customers perceive their products. In the past suppliers have traditionally collaborated closely with practising doctors to push through “patient-near innovations” in order to develop new product variants that meet the specific requirements and preferences of these “end users”. Product advantages such as “simple to use” are important for this target group, but not for managers in administration. For them, when purchasing they concentrate on data about the financial benefit of the product for the

Headline: Differentiate differently – or become commoditised?

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Old ways of differentiation are less relevant

According to EY, medical technology manufacturers will in future be differentiated on a new basis of competition:

> > >

>

T here is still money to be made with revolutionary technological innovations.

Medical technology companies can extend their field of activity with services and solutions.

Additional offers such as innovative contracts are in demand.

One example of that are complete packages at fixed prices for everything to do with a simple hip joint or a more complex, complete hip replacement. This enables medical technology manufacturers to change their business model, moving away from unit costs to a system of payment.

A ny solutions which help to reduce costs in the healthcare system are welcome.

Purchasers prioritise devices that reduce the total cost of care

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Differentiation must be based on data and value

2,5

77 % 77 %

62 %

2,0

25 % 6 %

27 % 35 %

31 % 35 %

22 % 18 %

32 % 22 %

2,4

1,6

51 %

55 % 27 %

2,4 2,1

Ranking

Price remains the top factor

hospital or on services that go beyond the product. Ultimately, their aim is to reduce costs.

That will not always be simple to achieve, concedes EY: product innovations are appreciated only if they at the same time have a financial advantage for the hospital. In many cases purchasers will prefer a “good enough” product with fewer functionalities, at a lower price.

0

Price of device

Today

Physician Userpreference friendly for specific design device

Training in use

In three years

Source: EY 2014 Pulse Hospital Survey

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Data “Beyond Data demonthe demonstrating product” strating value clinical services outcomes

Risksharing agreements

Reduced total costs of care

Reduced hospital stays

Improved surgical efficiency

Reduced Reduced pharmaceutical readmission rates utilisation

The lower the score, the more important the economic outcome in differentiating a med-tech product.

Source: EY 2014 Pulse Hospital Survey

+++ SPECIAL Panorama

properties even over several decades in the human body.

In 2013 and spring 2015 respectively, Mathys and Zimmer Biomet published corresponding results of in-vitro tests to support this theory. This benefits mainly young patients, since a complete hip could last up to 30 or 40 years.

As long ago as 2009, Mathys launched its RM Pressfit-vitamys socket, in which vitamin E stabilises highly cross-linked PE. “We do not yet have any long-term results, but the findings to date are promising,” says Delfosse.

Innovations must lead to cost savings Jossi’s innovation formula is

A product innovation which also helps to reduce costs in hospitals: break-out seals from Jossi: from the outside, only a fine, partially scored line can be seen, indicating where the opening is, like on a drinks can. This technology can be applied to all surface structures (Photo: Jossi).

movement cycles a year. The crux of the matter is: the plastic wears down, produces wear particles and so can lead to loosening of the implant.

Complete

avoidance

of

metal

“Now, we at Mathys are trying to avoid metals such as nickel, cobalt and chromium in all implants,” explains Delfosse. For the optimal articulation pairing, Mathys has in past decades built up its own expertise in polymers and ceramic, and is therefore making hip sockets and femoral heads itself. “This enables us to make process and product innovations simultaneously: today we can produce more efficiently and therefore more cost-effectively. We are thereby also able to improve the service lives of endoprostheses.”

This example makes it clear for Delfosse: “For us, innovation means either: we develop products which meet new needs of patients and surgeons or which better meet existing needs. Or we can meet existing requirements more cost-effectively to respond to the pressure on prices in the health sector.”

Thus, Mathys has developed highly cross-linked polyethylenes which, for example, make possible larger femoral heads which in turn become dislocated less often than smaller ones. With these highly cross-linked PEs, far fewer wear particles are generated in the body.

A further improvement in service life can be achieved by adding vitamin E to the highly cross-linked PE. The effect: the polyethylene retains its material

similar to that of Mathys: “We either do it differently or we do it better, but above all cheaper, because today innovations always have to result in cost savings,” says Schmidt. For hip sockets made of titanium and titanium alloys the supplier has revived a 20-year-old patent from the USA for “break-out seals” and, using its own know-how in metalworking, has developed a suitable process for their manufacture: preformed but closed screw holes can now be opened by the surgeon as required with an instrument; this means that a closed socket can be converted into one with screw holes. This trick, which does not alter the implant as such, reduces the number of variants by more than half, and thus also the amount of capital tied up in hospitals’ consignment stores.

“Whether an artificial hip is anchored with or without cement depends mainly,

>

Material innovation: Mathys has developed highly crosslinked polyethylenes that can for example be used for purely polymer tibia components in total knee replacements (Photo: Mathys).

2015_Swiss Medtech Industry

15

Process innovation: the HIP-PLAN 3D planning software from Symbios can be used to plan an operation precisely in advance (Photo: Symbios).

in the USA and in central Europe, on the patient’s bone quality and condition,” says Jossi manager Schmidt. “However, cement-free implants are classed as higher quality and longer-lasting.” For years more than half of all hip implants have been anchored without cement.

This trend could continue in the next few years, in view of the pressure on costs.

“The manager of a large orthopaedics

With the increasing number of minihips, a further trend which is beneficial for both patients and hospital finances is emerging: they can be implanted in a minimally invasive procedure which is thus tissue-conserving. This reduces the patient's recovery and rehabilitation period – and thus the length of stay in hospital. To allow the individual components to be positioned precisely during the operation, implant suppliers are providing surgeons with computer-aided navigation systems, also called computer-aided surgery or CAS. Zimmer Biomet has in its portfolio several CAS systems for hip and knee operations. These include the new iASSIST for the total knee endoprosthesis that was developed in Winterthur. Accelerometers and gyroscopes ensure the precise positioning of the implant during the operation by recording the mechanical axis of the tibia and femur so that the cut blocks can be aligned accordingly – with a very small number of instruments.

Operations are planned on the computer “Computer-assisted systems

in operations are where the future lies,” is also the firm belief of Symbios manager Sandoz. “But that starts even at the planning stage.” IT-based systems for planning and carrying out operations

> “Computer-assisted systems in the

operating theatre are where the future lies.

And that starts right at the planning stage.”

Yvan Sandoz, Sales Director at Symbios Orthopédie SA (Photo: Symbios)

company encouraged his employees to think about the 100-dollar hip – like the 100-dollar netbook for school children in the third world,” reports Schmidt. “This then made some specialists think that, with the operation, there simply would not be enough money left for the bone cement.”

16

minimise their risks and cut costs at the same time: “Even before the operation, it is possible to establish precisely which complications may occur and which implants and instruments the surgeon will need later.”

The requirement for the Symbios HIP-PLAN 3D planning software is for

a CT image to be available. “Something that looks simple on X-ray pictures can sometimes prove to be a much more complex operation after a CT – for example, if torsion of the femur is found,” argues Sandoz.

Medacta too has a programme of this kind in its product range, called MyKnee, which needs CT or MRI images.

Mathys is at present thinking about such 3D planning systems for use in surgery: “However, we must adapt to the situation in hospitals,” says Delfosse. “And in European countries where the pressure on costs is greatest, for a hip or knee replacement no CT is taken, just two X-ray images. That is why we are currently investigating, together with Bern University and the company Medivation AG, the possibility of generating three-dimensional images from X-ray pictures.”

Patient-specific implants and instruments Symbios now has a com-

plete product portfolio devoted to 3D planning. “As a small supplier, our strategy is different to that of the mass manufacturers in orthopaedics,” explains Sandoz. “Instead of putting pressure on the price of individual implants, we aim to reduce overall costs through a holistic approach.” This means that the planning software shows whether a standard implant is sufficient for the patient – which according to Sandoz is true in 80 – 85 percent of cases – or whether a special implant needs to be made. Besides the implant, Symbios also supplies the hospital with exactly those instruments needed for this operation.

Sandoz: “A large number of standard instruments worth 40,000 euros are generally available in theatre for a hip operation because it is not known exactly which instruments are needed. These instruments have to be sterilised and brought to the hospital specially packed – and after the operation they have to be washed, disinfected, sterilised and taken back. In our view, this type of logistics is no longer appropriate.”

Disposable instruments from the 3D printer That is why Symbios has for

the last year been supplying disposable instruments for knee operations. These

+++ SPECIAL Panorama

are partly standard, partly patient-specific instruments. The company produces the patient-specific ones from powdered polyamide on 3D printers.

Sandoz: “Disposable instruments are guaranteed sterile and so carry no contamination risks. After the operation, the material is simply destroyed. This type of personalised medicine covering implants and instruments is a success.

We repeatedly hear from the hospitals that this improves their efficiency.”

A few years ago, Zimmer Biomet took a step in this direction with the Gender Knee for women. Symbios stands for patient-specific implants ever since it was founded. This approach is repeatedly being discussed in the industry because people’s anatomy, morphology and pathology differ worldwide. However, costs generally preclude broad-based individual solutions.

“That is squaring the circle,” says Mathys manager Delfosse. “Pressure on costs forces us manufacturers to make standardised products, but at the same time, there is a trend towards products

> “Tissue engineering as an alternative to

an endoprosthesis works, but is more timeconsuming and more expensive. That is why, in our view, it will not gain acceptance for mass use in future.”

Dr. Daniel Delfosse, Director of Innovation & Technology at Mathys AG Bettlach (Photo: Mathys)

designed to better meet patients’ individual needs.” Mathys has analysed thousands of morphological data from various patient groups around the world and used them as the basis for supplying knee prostheses in special not so common sizes as part of a standard system of components.

Expensive tissue engineering On the other hand, Delfosse is less optimistic about tissue engineering, i.e. the development of cartilage cells in a clean room. The cultivation of tissue is attractive because at present the service life

of all endoprostheses is finite – and the patient then has no choice but to undergo revision surgery. Delfosse: “We know that tissue engineering works in some patients, but it is more time-consuming and expensive than implants. That is why, in our view, it will in future not gain acceptance for mass use. We still believe that a better approach is to make materials so smart and intelligent in the factory that they colonise themselves with cells in the body.”

New business models: For well over a year, Symbios has been making available disposable instruments for knee operations. These are partly standard, partly patient-specific instruments. The company produces the patient-specific ones from powdered polyamide on 3D printers (Photo: Symbios).

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Market on stand-by Worldwide sales of knee, hip and extremity endoprostheses in 2014 were worth 16.7 billion US dollars. Driven by increasing life expectancy in the industrialised nations, the associated increasing frequency of joint wear, good treatment outcomes and people’s greater expectations of activity, all three segments have for years shown continuous growth – but not on all markets, and at different rates.

In 2014, the worldwide market for orthopaedic products grew by 4.4 percent to a total of 37.4 billion US dollars, as figures from Avicenne, Paris, demonstrate.

The French market research company includes in these figures not just endoprostheses – i.e. artificial joint implants for knee, hip and extremities – but also products for the spinal column, traumatology (such as plates and screws for securing endoprostheses) and orthobiology, e.g. biological implants.

Accordingly, the lion’s share of sales is 23 percent or 8.5 billion US dollars for knee endoprostheses; in 2014, 5.1 percent growth was achieved in this segment. The growth rate for hip endoprostheses was lower, at 2.9 percent, and, with sales of 6.4 billion US dollars, this

The worldwide market for orthopaedic products

+++++++++++++++++++++++++++++++++++++++

segment reached fourth place after spinal-column and traumatology products.

Implants for extremities and shoulders accounted for just a small share of the market, with 1.8 billion US dollars, but here there is a clear plus of 11.3 percent.

The reasons for the rather moderate growth of individual segments such as hip endoprostheses are, in the view of Ali Madani, General Manager at Avicenne, both hospital reimbursements and pressure on the prices of mature products, which these days also include hip and knee implants: thus, not only on the large German market but also in many other parts of Europe, group purchases are forcing down prices.

Swiss market shrinking According to Armin Schrick, Vice-President of

The major players in the orthopaedics sector in 2014

++++++++++++++++++++++++++++++++++++++

37.4 billion US dollars Extremities

Others 5 %

Orthobiologics

Hip

2 %

Knee 23 %

13 %

Others

21 %

35 %

DePuy Synthes

13 %

17 %

Stryker

22 %

Spinal 18 %

Trauma

In 2014, artificial knee joints accounted for 8.5 billion US dollars, the lion’s share of worldwide sales of orthopaedic products. Hip implants are at number four, behind spinal implants and trauma products (Source: Avicenne).

18

Smith & Nephew

6 % 6 %

Biomet

11 % 8 %

Zimmer

Medtronic

DePuy Synthes and Zimmer – both with production sites in Switzerland – are heavyweights among the manufacturers of orthopaedic products. In mid-2015, Zimmer completed a deal to buy Biomet; the market shares of the two companies are therefore still shown separately here (Source: Avicenne).

FASMED, the umbrella organisation of the Swiss Trade and Industry Association, the volume of sales on the Swiss market has “if anything even fallen.” He says that the widely quoted volumeincreasing effect due to demographic change has so far not materialised. According to Swiss implant registry SIRIS, currently about 20,000 artificial hip and 16,000 artificial knee joints are being implanted every year. “In recent years the number of endoprosthetic implants used has stagnated, and this is likely to continue in the next few years, since – and according to corresponding media reports – joint pain is increasingly being treated conservatively until replacement of the joint really does become necessary,” says Schrick. He said that the population was living and working more health-consciously than 20 years ago, which could lead to endoprostheses being implanted later.

Political decisions are hampering the German market The most im-

portant foreign market for most Swiss suppliers is Germany – and here, too, a trend similar to that in Switzerland can be observed: the number of patients treated with an artificial hip or knee joint is stagnating or falling. “Because of the rising life expectancy of the German population, the associated increase in the frequency of joint wear and patients’ right to regain quality of life, an increase would actually be expected.

However, for a variety of reasons that has not happened,” says Michaela Münnig, spokeswoman of the Endoprosthetic Implant department at German trade association BVMed. She said that this market trend was crucially influenced by media reports which led to a lack of confidence in pa-

+++ SPECIAL Panorama

tients and caused them to delay having these operations. She said that politics had also – and to some extent with unwanted side effects – influenced market trends through regulatory measures such as the system of diagnosis-related case groups or of minimum quantities.

At present, for example, clinics can provide total knee endoprosthesis services (knee TEP) only if they implant at least 50 artificial knee joints a year. “Such decisions lead to redistribution of the market,” says Münnig confidently.

Also, clinics have closed in past years. “This also means that elderly patients in particular put off a knee or hip operation for as long as possible if the nearest clinic is not close at hand.”

Patients’ expectations in Germany are also very high, and these are in some

Endoprosthetics in Switzerland

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ In Switzerland, seven companies produce endoprostheses, a further six market joint replacement products. These are implanted by about 600 doctors in about 150 hospitals. This means that endoprosthetics is an economic factor that must not be neglected. According to FASMED Vice-President Armin Schrick, the Swiss market for endoprostheses (with the focus on knee, hip and shoulder implants) is currently worth 150 – 200 million Swiss francs a year.

cases not being met. Patients’ aim today is no longer to achieve freedom from pain – as it was 30 years ago – but to go on living exactly as before. An artificial joint is a very good replacement, but it is still just a replacement, says Münnig.

General practitioners in turn conclude, from dissatisfied patients, that they should recommend other patients to

choose conservative methods instead of an operation, and for longer.

However, the BVMed spokeswoman is quite sure: “Conservative methods merely put off the operation. They cannot cure osteoarthritis. This means that we can expect a wave of endoprosthesis operations in the next few years. Then the German market will grow too.”

Promoting self-healing Until now, it has been held that a torn cruciate ligament does not grow back together again. This dogma prompted a research group, together with Mathys, to develop a new method of treating torn cruciate ligaments. The result: the Ligamys implant. It creates optimal conditions for biological self-healing of the ligament.

The initiative that in the end led to the Ligamys product emanated from the two Bernese hospitals Klinik Sonnenhof and the Inselspital, under the direction of Prof. Stefan Eggli. The doctors consulted medical device manufacturer Mathys AG about developing the new treatment method. Since then, dynamic intraligamentous stabilisation (DIS) has proved successful with torn cruciate ligaments. With this treatment method, the torn ligament is stabilised using the Ligamys implant so that the injured ligament ideally grows back together again and regains full functionality. Removal and replacement of the injured ligament is unnecessary, as is a donor tendon (transplant) from the patient’s own body.

Ligamys is therefore particularly suitable for the treatment of patients actively involved in sport and those who do physical work who, in the fine control of movements, benefit greatly from having proprioception maintained in the knee joint. Ligamys is thus, in addition to conservative treatment or arthroplasty, an innovative way of treating torn cruciate ligaments.

The procedure The Ligamys implant consists of a polyethylene filament which is fastened rigidly in the thigh bone and flexibly (dynamically) in the shin bone with a patented monobloc. During treatment, the implant immediately ensures the mechanical stability of the injured knee. The spring mechanism stabilises the joint across the whole range of movement but, through its dynamic fit, reduces the tensile forces acting on the cruciate ligament. In this way, the torn cruciate ligament can grow together and form a scar without being overloaded.

Ideally, it regains its full functionality over time.

After the operation As early as the fifth day after the operation, the leg is fully mobile. During the five-month rehabilitation phase the knee is gradually returned to full use in sport.

After healing has been completed, the Ligamys implant can in principle stay in the knee permanently. About a third

20

Besides conservative treatment or an arthroplasty, Ligamys is an innovative option for the treatment of torn cruciate ligaments (Picture: Mathys).

of patients may experience troublesome paralgesia at the “monobloc”. In such cases this can be removed from the bone after the cruciate ligament has healed. This can be done in just a small procedure which can be carried out on an outpatient basis and under local anaesthesia, in pain-free twilight sleep (analgosedation).

Hugo Mathys, company CEO and chairman of the Board of Directors: “With Ligamys we have a genuine Swiss innovation which creates clear added value for patients.”

A traditional family company

+++++++++++++++++++++++++++++++++++++++++++++ The family-run Mathys AG with headquarters in Bettlach in the Canton of Solothurn can look back on 56 years of experience in the field of medical technology. Since 2003, the company has concentrated exclusively on the development, production and distribution of joint replacement products. Manufacturing is done mainly in Switzerland, but also in Germany. The company’s products include knee, hip and shoulder implants and synthetic bone replacement material. In 2013 Mathys also ventured into sports orthopaedics. The company has a total of eleven subsidiaries.

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www.mathysmedical.com

+++  SPECIAL Focus on manufacturers

With the femur-neck-preserving short stem BreXis, only a minimum amount of bone has to be sacrificed (Photo: Stemcup).

Leads to minimal bone loss Stemcup Medical Products AG, with its BreXis short stem, has developed a femur-neck-preserving short stem that combines very good clinical results with minimal bone loss. That is the response of the medium-sized medical device company from Zurich to the increasingly young age of hip endoprosthesis patients for whom bone-sparing solutions are increasingly in demand. Thanks to the proximal anchorage of the stem in the metaphyseal region of the femur, only a minimum amount of bone has to be sacrificed. The short-stem prosthesis, made of a high-quality titanium-aluminium-vanadium alloy, transmits the loading forces into the bone in the same way as in healthy bone.

The forces are transmitted via the femur neck into the metaphysis in an anatomically and physiologically correct manner. The BreXis stem is available in ten sizes.

w www.stemcup.ch

Alignment in no time at all Zimmer GmbH of Winterthur has, with iASSIST, the personalised guidance system for total knee endoprostheses, developed a new technology which allows the surgeon to align the implant precisely, intraoperatively and intuitively. The system uses accelerometers and gyroscopes. Exact positioning of the implant during the operation can be supported by recording the mechanical axis of the tibia and femur and aligning the cut blocks accordingly – without a major navigation system, but with a very small number of instruments. Two measuring pods are used per operation; they are also used to validate the alignment of the cuts. The direct feedback allows the user to concentrate exclusively on the operation, since he/she does not have to look at a computer or cameras. Immediate audible and visual feedback via the pods keep the operating surgeon informed at all times about his accuracy and about what to do next.

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www.zimmerbiomet.com

iASSIST aids exact positioning of the implant during the operation with a very small number of instruments (Photo: Zimmer).

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21

The SPS Evolution is a cement-free anatomical stem made of the titanium alloy Ti6Al4V (Photo: Symbios).

For long service lives and mobility Every human being is unique. Hip and knee prostheses should take account of this fact. Symbios has therefore developed systems which allow the precise reconstruction of joint geometry. Surgeons’ work is also made much easier by 3D planning.

The results of intensive research and clinical experience have been incorporated in the product range of Symbios Orthopédie SA. The Swiss company headquartered in Yverdon-les-Bains, in the Canton of Vaud, is today offering anatomically adapted standard hip prostheses (SPS) and straight-stem hip prostheses (Harmony). SPS Evolution products have a cement-free anatomical stem made of the titanium alloy Ti6Al4V, coated with porous titanium and hydroxylapatite. SPS Modular products also have a modular neck part made of chrome-cobalt molybdenum.

This concept of modular necks is also used by Symbios in the cement-free straight-stem hip prostheses of the Harmony product range. All components are available in different sizes to meet individual patient requirements. The Harmony Hip System also exists as a monobloc system.

Numerous studies demonstrate the very long service life of both standard and individual prostheses. Symbios hip prostheses thus provide the optimum solution for all primary treatments, irrespective of anatomy.

3D planning is the basis for success

+++++++++++++++++++++++++++++++++++++++++++++ Symbios Orthopédie SA is a highly specialised supplier of hip and knee joints. The founder of the family company, Jean Plé, from the outset placed the focus on 3D planning and individual patient solutions with the aim of precise joint reconstruction. The 3D planning and millimetre-accurate reproduction of the individual joint geometry are based on the computed tomography of the diseased joint.

Planning software The company also provides a 3D software planning package called HIP-PLAN for doctors and hospitals. This allows orthopaedic surgeons to carry out three-dimensional preoperative hip planning and optimal hip reconstruction for every anatomy. The software allows the surgeon to check and correct, in one process, all the important parameters of a hip arthroplasty, such as offset, leg length, anteversion and stability. The software does this using the patient’s CT images recorded at hospital or by a specialist. In this way, intraoperative surprises are minimised at the outset, the risk of dislocation is reduced and patient limping is avoided.

Knee prostheses In the field of knee prostheses, Symbios has also developed the F.I.R.S.T implant. This prosthesis provides anterio-posterior stability across the whole range of movement.

Individually-made cut blocks KNEE-PLAN and disposable instruments KNEE-PLAN Set round off the product range and allow a more rapid and more precise reconstruction of the artificial knee joint. This patient-specific focus, with its precise 3D planning, makes it possible to optimally position the prosthesis for the patient. In addition, the logistics are simplified for all concerned, i.e. the supplier, hospital and the sterilisation unit. Only instruments and implants that can be used effectively are supplied, making it unnecessary to send out, clean, sterilise and then reject storage cabinets full of instruments and implants before the operation. The smaller number of parts also reduces the error rate.

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www.symbios.ch

+++  SPECIAL Focus on manufacturers

Retroreflective markers Atesos medical AG with headquarters in Aarau has developed a retroreflective marker system called SORT for a contact-free, optical measuring technique that is used in innovative therapy procedures. The sterile disposable markers work smoothly under the special conditions of sterile operating environments and are thus safer than conventional products. One advantage over conventional markers is the lack of sensitivity to fluids and contamination of the optically active surfaces. The result is increased measuring accuracy in the

This instrument, fitted with four SORT-P markers, is used with optical measuring systems or surgical navigation systems (Photo: Atesos).

surgical environment and the ability to open up new areas to navigated operating techniques. In the meantime, more than 60,000 of these markers have been used in operating techniques supported by measurements in orthopaedics, liver surgery and interventional radiology.

w www.atesos.ch

Wear-resistant ceramic hip-cap prostheses

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

>

METOXIT AG from Thayngen has developed a solution to the previously existing problem of wear on resurfacing prostheses: The high-tech ceramic company manufactures the caps used here as full ceramic blocks with wall thicknesses of under five millimetres. The material used was ATZ (alumina-toughened zirconia) which is notable for excellent wear-resistant properties. In collaboration with the Federal Materials Testing and Research Institute (EMPA), the company developed a surface with a porous microstructure. It is based on the well-known ZircaporeÂŽ surface which is already being used successfully for tooth implants, and promotes bone ingrowth. An additional macrostructure provides the necessary primary stability and was optimised by means of FE modelling and press-fit experiments. Such resurfacing prostheses are intended to give active patients a high degree of mobility and can be implanted in a bone-sparing operation, since unlike a total endoprosthesis they allow the preservation of the upper part of the thigh bone, and facilitate revision surgeries. w www.metoxit.com

The newly developed product for hip endoprosthesis made of ATZ high-performance ceramic is a winner with its good tolerability and low wear (Photo: Metoxit).

2015_Swiss Medtech Industry

23

“Sometimes I have to stop and think which side the prosthesis is on.”

Photo: picture-alliance / Keystone

Köbi Kuhn is a Swiss footballing legend. He shaped the Helvetian football history both as a player for FC Zurich and later also as national trainer. He does not play football anymore, but he keeps himself fit with inline skating, cross-country skiing and swimming – despite having a hip prosthesis.

An eventful career

+++++++++++++++++++++++++++++ Born in 1943 in Zurich, Jakob “Köbi” Kuhn spent the whole of his active career as a footballer playing in the midfield for FC Zurich. Between 1962 and 1977 he won the Swiss championship six times and the Swiss cup five times with the club.

On two occasions the team also reached the semi-finals of the European Cup. Kuhn won 63 caps with the national team. In 1983 and 1984 he was trainer of FC Zurich, between 1985 and 2001 youth trainer at the Swiss Football Association and then became coach of the national team. During this period the national team took part in the 2004 European Championship in Portugal, the 2006 World Championship in Germany and the 2008 European Championship in Austria and Switzerland.

Kuhn ended his time as trainer with the last qualifying match.

24

Mr. Kuhn, what aroused your love of football in your youth?

Kuhn: Near my parents’ house in the Zurich district of Wiedikon there was a large meadow on which we as children and adolescents used to play football every afternoon. At that time someone always had a ball with them.

And since a lot of Italian immigrants lived in the area, there were one or two Switzerland-Italy “internationals” every evening.

Did you think of a professional career even then?

Kuhn: No, not at all. My only motivation was a great passion for this sport. That is why I was mighty proud when, at the age of ten, I was allowed to sell programmes in front of the stadium in Zurich during the 1954 World Cup in Switzerland. I was able to get really close to my idols. I can still remember clearly that after the final I was extremely sad that the Hungarians, who had played so magnificently during the tournament, had lost to the Germans.

You played in the first team of amateur club FC Zurich at a very early stage, while still an adolescent. FC Zurich then discovered your talent and signed you in 1960, at the young age of 16 years.

Even in the second half of the 1960/61 season you played in the first team and so belonged to the team that gave FC Zurich its “golden years”. Would you recommend a similar career to a young man today?

Kuhn: There is no comparison between football then and now. When I started at FC Zurich, we trained on just three evenings. It was only when we made it to the semi-final of the European Cup in 1964 that we started training in the afternoons too. This meant that in today’s terms we were semi-professional footballers. Professional status did not come until a number of years later. To that extent the demands made of young professionals are much higher today.

Parents and youngsters, particularly in highly developed countries, have to ask themselves whether it is right to put all their eggs in one basket and accept the

+++ SPECIAL In conversation

Köbi Kuhn

Swiss footballing legend

“Playing soccer is not really advisable for men of my age,” says Köbi Kuhn. But he keeps himself fit with different kinds of sports (Photos: Jonas Frey).

risks of a professional career. However, with the necessary talent and enthusiasm, there is no reason not to.

You mentioned the risks. They also include the health risks. 12 years ago you had an artificial hip joint inserted – a delayed effect of playing football?

Kuhn: Yes, absolutely. That is essentially down to a meniscus operation that I underwent at 22 or 23 years of age, when my entire meniscus was removed. It was standard practice then. As a result, the entire knee joint was destabilised. During my active football career and later also as trainer I was able to compensate for that with the appropriate muscles and the help of doctors who removed joint fluid and injected me with cortisone. But over the years the joints were

placed under such strain that the whole of the locomotor apparatus, including the hip, was compromised. That was a gradual process. When I was 60 years old, the pain was so great that I decided to get an artificial hip joint which was implanted at the osteoarthritis clinic in Zurich.

How have you found the hip prosthesis?

Kuhn: So far I have not had the slightest problem with the hip, apart from small extension and flexion deficits, but I quickly came to terms with them.

Basically, I can move quite normally, so that I sometimes even have to stop and think which side the prosthesis is on. One great side effect is that since then my knee joint has also been largely pain-free. When I was in hospital having

my hip replacement operation they predicted that I would need an artificial knee joint within the next two years.

Do you also still do sport with the hip joint?

Kuhn: Well, I cannot play football anymore, and I try to avoid sudden movements because of the prosthesis.

But playing football is not really advisable for men of my age. I still do sport regularly though, and keep myself fit with inline skating, cross-country skiing and swimming. And my hip joint likes it too. I am only passively involved with football now: I sit comfortably in the stadium, either at a top-flight Swiss game or, as in summer 2015, at the FIFA Women’s World Cup in Canada.

2015_Swiss Medtech Industry

25

Toolboxes for customer-specific innovations For about a decade the market for joint implants has increasingly been characterised by price wars and pressure on costs, which has a direct impact on innovation processes. Jossi Orthopedics has therefore developed a “toolbox”. This offers orthopaedics companies the ability to put together flexible, customer-specific implants from a standard set of solutions.

The deep drawing of titanium alloys, or more accurately the manufacture of the outer shells of hip sockets, is the technological unique selling point of Jossi Orthopedics AG with headquarters in Islikon in the Canton of Thurgau. However, orthopaedics firms now want far more than an extended workbench: they expect active assistance in the design and further development of implants. Essentially, though, it is about their need for tried and tested generic concepts. True innovation is an option only if it leads to significant cost savings.

Jossi Orthopedics long ago reacted to this trend by offering a toolbox containing not only tried and tested but also new design elements. Two examples of this are the PrimeFit macrostructure and a process for the manufacture of “breakout seals”, which are screw holes in the implant which can be opened as required. Both processes are patented.

Jossi PrimeFit macrostructure For a good fit and later ingrowth of bone, a hip socket needs an adapted surface structure. The PrimeFit macrostructure not only meets all clinical criteria, but is also the cheapest form of structuring. The inside of the hip socket is worked customer-specifically so that existing socket inserts can be used. However, even the predefined outside structure leaves enough leeway to be able to tailor it to exclusive parameters. A big orthopaedics company for example, by including such a macrostructured socket in its range, now has an implant in its product range which can hold its own in the current price war.

“Break-out seals” Acetabular shells are available intact and in versions with small and large numbers of holes. These holes can be used to place screws in the bone to provide additional anchorage for implants. With about 15 sizes (diameters), the number of variants of a shell type soon rises to about 40.

A hospital must have a stock of these products and even needs several of them in the most commonly used sizes. The cost of investment in this consignment stock is borne by the orthopaedics company, and gets paid only after one has been implanted and stocks are replenished. A globally operating company can easily have a year’s production lying in hospitals’ storerooms, i.e. an enormous amount of capital is tied up. This is where the process for the manufacture of “break-out seals” comes into its own: preformed but closed screw holes can be opened by

26

the surgeon as required; a closed cup can thus be converted into one with screw holes. This trick, which does not alter the implant as such, reduces the number of variants by more than half, and thus also the amount of capital tied up.

Producer of endoprosthetic implant components

+++++++++++++++++++++++++++++++++++++++++++++ Jossi Orthopedics AG > is a technology and manufacturing partner for the production of high-quality endoprosthetic implants > offers a full range of development and manufacturing services > reduces material and processing costs by means of complex deep-drawing processes > has special know-how in the manufacture of hip sockets > operates with quality management in accordance with ISO 13485.

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www.jossi-orthopedics.ch

Macrostructuring is the simplest, cheapest and thus also modern solution for the sound and effective bony anchorage of a hip socket. (Photo: Jossi Orthopedics).

+++ SPECIAL Focus on suppliers These spinal implants called PEEK cages are manufactured using the injection moulding process and are produced entirely by SAMAPLAST, from the original idea to the sterile-packed medical device (Photos: SAMAPLAST).

The SAMAPLAST clean room (ISO class 7 in operation) including permanent monitoring.

From the idea to the final packaging SAMAPLAST handles medical devices such as spinal implants known as “PEEK cages”, from the idea and through manufacture to the sterile final packaging. The necessary quality can be guaranteed only if all steps are handled by a single company.

Numerous types of expertise are needed to ensure that spinal implants such as PEEK cages can be manufactured by injection moulding, from the first idea to the sterile-packed medical device: long years of industrial experience in the manufacturing of medical devices are needed, as is highly qualified personnel.

This is complemented by a machine park of a very high technical standard. SAMAPLAST AG from St. Margrethen in the Canton of St. Gallen has been offering all that for over 50 years.

Using data from the design process and the design FMEA, specialists from the company design and build clean room-compatible, high-precision injection moulding tools in house. In addition to functionality and production stability, great attention is paid to ensuring that particle concentration and cross contamination remain as low as possible. Thus, only low-corrosion steels are used, and no lubricants. This means that moving

Plastics technology with a good name

+++++++++++++++++++++++++++++++++++++++++++++ Medical devices from SAMAPLAST AG are in demand from the dental industry, orthopaedics and many other areas. The company also produces many other implants such as vertebral prostheses, components for knee and hip implants, port catheters or hearing implants.

In addition to certification to ISO 13485, SAMAPLAST is certified or registered by FDA, ANVISA and JPAL for the global distribution of these products.

parts run dry, even when working high-temperature materials such as PEEK at a tool temperature of 200 centigrade.

Assembly, storage, maintenance The know-how requirements in cleaning, assembly, storage, servicing, maintenance and documentation are also particularly high. Thus, SAMAPLAST keeps tools chemically and physically clean by cleaning them using an ultrasound bath and ultrapure water. This process is, like all other processes in the manufacturing chain, validated to the latest standards (ISO 13485, GHTF, GMP).

Expertise in manufacturing long-term implants The products are made in two GMP-compliant clean rooms in ISO class 7 (in operation) in accordance with EN ISO 14644, as soon as the process FMEA and all process validations have been implemented or process freeze has occurred on the basis of design verification. Final packaging meets the requirement of ISO 11607. Validated new processes such as laser marking or final rinsing with HPW water also help to implement customer-defined requirements.

To achieve the required sterility of the medical devices, the company has these sterilised by various means. In the case of the PEEK cages this is done using (gamma) radiation sterilisation by the VD Max25-method in accordance with ISO 11137. The validation plans and loads (min-max) are first developed and implemented by SAMAPLAST in agreement with the customer. The supplier also carries out the subsequent tests to establish ISO 10993 biocompatibility in joint cooperation with the customer.

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Titanium alloy Ti15Mo with a homogeneous, single-phase β state and an elastic modulus of 55 – 85 GPa (Photo: SMB Medical).

Precision forging For more than 25 years, SMB Medical has been forging implants for international customers active in the field of endoprosthetics and osteosynthesis. A team of specialists meets new, technically demanding customer requirements – such as for the metastable beta-titanium alloy Ti15Mo.

The titanium alloys Ti6Al4V and Ti6Al7Nb that are mainly used in endoprosthetics and osteosynthesis have far more rigid elasticity properties than the human bone material surrounding the implant. This means that in hip endoprostheses with long stems, “stress shielding” may occur – so much so that loading forces in the uppermost part of the femur, which are altered by the stiffer implant, cause the bone to be less stressed, ultimately leading to the break-up of bone material. Through the use of beta-titanium alloys which, with an elastic modulus of 55 to 85 GPa, are slightly closer to the value for human bone material, this adverse effect can be avoided, both in endoprosthetics in forged hip stems and in osteosynthesis in forged trauma plates.

Reliable partner for forged implants

+++++++++++++++++++++++++++++++++++++++++++++ For over 25 years, SMB Medical SA has been a reliable partner to its customers for forged implants in endoprosthetics and osteosynthesis. The company’s forging expertise ranges from the titanium alloys mainly used for implants (cp-Ti grade 2, 3 and 4; Ti6Al4V; Ti6Al7Nb; Ti15Mo) to steels and CoCrMo alloys authorised for use in implants.

Customer-specific forging tools are designed and manufactured in our in-house tool shop. Thanks to the large number of processes in which the company has expertise, it can provide its customers with a one-stop service offering forged implants, finished machined and with the required surface finish, for endoprosthetics and osteosynthesis. SMB Medical SA has an in-house test laboratory accredited to ISO/IEC 17025 in which, besides mechanical and metallographic tests for internal batch release, test orders for third-party companies are also processed.

Through a homogeneous single-phase β-phase state, the high corrosion resistance requirements can be met and to some extent improved in comparison with the titanium alloys used to date.

Precise setting of the elastic modulus SMB Medical SA, with headquarters in S. Antonino in the Canton of Ticino, has in recent years developed a forging process for the metastable beta-titanium alloy Ti15Mo (ASTM F2066). This means that the desired elastic modulus of the forged part can be set precisely under process control. Account is also taken of the particular stability requirements. With the metastable beta-titanium alloy Ti15Mo, the molybdenum component in the alloy acts as a “beta stabiliser” and leads to mixed crystal hardening. In this way, and through the fine particle size distribution, a yield strength of over 700 MPa is achievable and a tensile strength of over 800 MPa. When developing a forging process validated for Ti15Mo, SMB Medical was able to draw on decades of internal company experience in the design and manufacture of forging tools and in the selection of the appropriate tool coating.

Exact process parameters The process must take due account of the special contraction and cooling properties of this alloy. In the multistage forging process the raw material is first heated in accordance with a precisely defined heating curve and is then forged in the forging dies which are kept at a constant temperature. Between the individual work stages, all parts are checked for possible surface defects using dye penetrant inspection. A cooling rate adapted to the technological requirements and an optional heat treatment carried out immediately afterwards adjust the technological properties of the forged part to the relevant specifications.

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+++  SPECIAL Focus on suppliers

Efficient tests of implants

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THELKIN AG from Winterthur simplifies the extensive mechanical testing of orthopaedic implants and their materials for research, development and product certification: the company develops and markets test systems and simulators for the mechanical characterisation of products, components and their materials that are exclusively electrically powered. Test systems and simulators are equipped with a newly developed drive technology. This makes the systems highly precise, efficient and clean. It also takes very little effort to maintain them. These are clearly advantages over traditional test machines that are hydraulically or pneumatically powered and are thus high-maintenance and expensive. After the initial focus on applications in orthopaedics and medical technology, the systems are also being used for testing in automotive engineering, aviation and the watch industry, and for testing plastics and other materials. w www.thelkin.com

pub_presse_EN.pdf

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The THELKIN test systems facilitate mechanical tests of orthopaedic implants and their materials. Thanks to newly developed drive technology, they are highly precise, efficient and clean (Photo: THELKIN).

A gentle procedure for replacing an artificial hip joint

Motion preserving implant for the spinal column

> PRECIPART with sites in Switzer-

SpineSave AG from Embrach has developed a new system for the dynamic stabilisation of the lumbar spine. The system offers the surgeon polymer rods with differing degrees of stiffness which he can optimally adapt to the patient’s indications.

The system has been intensively tested on specially designed test machines. The implant eliminates degenerative diseases and makes the patient pain-free without stiffening his motion segments.

The implant has CE marking and is already in use in three countries. w www.spinesave.com

+++++++++++++++++++++++++++++++++++++++++++++++++++++++ land, the USA, the UK and India, supplies high-quality precision parts and components and offers a large selection of high-precision mechanical components for surgical instruments used in endoprosthetic procedures. These components have a diameter of 1.5 × 3 up to 25 × 130 millimetres and tight tolerances of Picture caption: Precipart supplies precision parts and components such as this ± 3 micrometres. reamer holding head (Photo: Precipart).

The company is now working with one of the largest medical OEMs on a surgical device that allows for the much less invasive removal of a hip implant that has reached the end of its life. A growing aging population means that the number of such procedures will increase. Precipart is currently already manufacturing assemblies and preparing the PPAP (production part acceptance procedure) submission for the instrument that is expected to launch in the first quarter of 2016.

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The new SpineShape system allows a dynamic stabilisation of the lumbar spine (Photo: SpineShape).

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For more news visit www.medical-cluster.ch/news-en

Braided textile components for medical devices

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The high-precision medical braids produced in a clean room are suitable for the most varied applications (Photo: Meister).

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MEISTER & CIE AG from Hasle-Rüegsau has launched a new product concept to meet increasingly stringent regulatory requirements in the medical sector. In the new production concept “Clean room in the clean room”, there are several clean-room cells within one clean room. This guarantees that the complete manufacturing process takes place in compliance with ISO 14644-1 class 8, thus preventing impurities such as cross-contamination. In this way the company achieves maximum patient safety with increased cost efficiency. As a “trustworthy specialist” from group DSM, the company Meister & Cie AG have access to its fibres made of Dyneema-Purity®, which are the only ones approved by the FDA (US Food and Drug Administration) for long-term implants. These fibres made of ultra-high molecular weight polyethylene (UHMWPE), which are designed and made specifically for the production of medical devices, are very well suited to the areas of sports medicine and osteosynthesis and any others in which minimally invasive surgery is used.

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+++ Know-how & components

More efficient with the right metalworking fluid Metalworking fluids for machining and grinding have a greater influence on the results of the finishing process than what is assumed in production by medical device manufacturers.

The choice of the right metalworking fluid can lower tool costs.

At most metalworking plants, processes have to be continuously optimised, for the most varied reasons. For example, to reduce manufacturing costs or in an attempt to boost productivity. The metalworking fluid has a great leverage effect and influences productivity, economic efficiency and machining quality. However, such adjustments are uncommon in the medical technology sector.

The reasons are obvious: the materials used are very demanding with regard to their processing. Cobalt chromium, stainless steels and titanium are materials that are difficult to machine and cause above-average tool costs. In addition, implant and instrument manufacturers need either CE marking for their products or, in the USA, FDA approval.

Metalworking fluid tests for risk assessment Under these circumstances, the cost of changing a process specification is enormous. Problems in the existing manufacturing process, changed or new requirements or new product projects may however provide the impetus to consider a new metal-

Blaser Swisslube

+++++++++++++++++++++++++++++++++++++++++++++ Blaser Swisslube develops, produces and sells high quality metalworking fluids. Medical technology customers also use these worldwide to make implants and medical devices. The aim of Blaser Swisslube is to improve customers’ machining processes with the “liquid tool” and to optimise productivity, economic efficiency and machining quality.

working fluid. In this case almost all medical device manufacturers carry out tests of metalworking fluids in order to assess cleanliness and biocompatibility and to estimate the risk or effects of a change. These tests are unavoidable, since the product benefits of metalworking fluids and listed references are no guarantee that the required cleanliness and biocompatibility is achieved.

Tool life increased by a factor of four There is however evidence that it is advisable to also investigate other factors in such tests. Internal machining tests of titanium and stainless steels, for example, performed at the in-house technology centre of Blaser Swisslube at Hasle-Rüegsau, showed that tool life, with identical machining processes, can differ by a factor of up to four when the metalworking fluids is changed.

These results show that a medical device manufacturer can be certain that he/she has chosen the optimal metalworking fluid only on the basis of specific tests. Even though the costs of testing when changing a metalworking fluid are high, it was possible to reduce overall tool costs by a figure of up to 25 – 50 percent, which would justify a certain amount of effort.

Being able to meet the requirements of the medical sector for the ideal metalworking fluid is the aim of Blaser Swisslube.

The company therefore sets great store by understanding current needs and, through the metalworking fluid used, providing maximum benefit and the associated services.

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www.blaser.com

The choice of the right metalworking fluid can reduce tool costs (Photo: Blaser Swisslube).

2015_Swiss Medtech Industry 31

What powers medical technology

A brushless DC motor from maxon is used in this miniature pump measuring just 6 millimetres which supports the blood circulation. The pump is inserted without a surgical intervention and gives the weakened heart brief pauses so that it can recover (Photo: maxon motor).

Whether in operating robots, prostheses or heart pumps: precise DC motors from maxon motor can be found everywhere in medical technology. To adapt drives perfectly to customer wishes, engineers at the Swiss company sometimes also resort to solutions from oil production.

Patients with chronic heart disorders are looking expectantly towards Texas. There, bioscientists have developed the first circulatory support pump which can be inserted using a cath-

> The drive for the aortic pump was in-

spired by the technology in the giant pumps for oil production.

eter and is intended for long-term use. It is as small as half of a ballpoint pen, just 6 centimetres long and 6 millimetres thick, and will soon be available on the market. It is powered by a micromotor from Switzerland: a brushless DC drive from maxon motor AG headquartered in Sachseln in the Canton of Obwalden.

The motor is efficient, powerful and above all has a very long service life – properties that are crucial when developing medical devices for use inside the human body.

The right solution for every task But maxon does not just supply precision motors, drives and controls; it also helps customers to find the right solution to meet their needs. In the case of the aortic pump for circulatory support, the aim was to develop a magnetic drive that allows the motor to be enclosed in a hermetically sealed chamber. This prevents blood from getting inside the motor. This type of construction is normally found in giant oil production pumps. Because the engineers at maxon have cross-sector know-how, they also advised the customer and helped transfer this technology to the aortic pump.

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Sterilisable drives in the operating theatre With its large selection of drive solutions from 4 to 90 millimetres in diameter, maxon is very well placed to serve its customers.

That is why numerous drives made by the company are in use worldwide in hospitals, in doctors’ practices and in patients’ homes. They can be found in surgical robots, insulin pumps, prostheses, ventilation equipment and in many other applications. Each of these requires a specific drive solution. Highspeed, dynamic or high-torque and autoclavable – this last property is crucial for use in the operating theatre. The devices used there have to be sterilised before each procedure.

That is why maxon drives are, as part of product qualification, routinely tested in autoclaves for 1,000 sterilisation cycles.

The extensive development work and tests in the company’s own laboratory help to ensure that the DC motors can work smoothly even under adverse operating conditions. And so the drives help to improve patients’ quality of life and facilitate the work of doctors and therapists.

Specialist in DC motors

+++++++++++++++++++++++++++++++++++++++++++++ maxon motor AG, Sachseln, develops and builds high-precision DC motors, drives, encoders and controls. The drives are used wherever high demands are made, such as in the NASA rovers on Mars, in surgical hand devices, robots and precision industrial plants. To stay ahead in this demanding market, each year the company invests 8 percent of its turnover in research and development. maxon employs more than 2,000 people worldwide at four production sites and has distribution companies in 40 countries.

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+++ Know-how & components

The Micronel U-Line series achieves – through their high speeds of up to 50,000 rotations per minute in continuous operation – a very high level of efficiency of over 60 percent (Photo: Micronel).

High performance requiring little space Worldwide, fans and blowers from Micronel provide reliable respiratory support. The blowers’ air output in milliseconds must be adapted to the human respiratory rate. This is made possible by ultrafast speed variation.

Technical support for respiration is very varied and demanding. Depending on the clinical condition, there are more than 100 respiration algorithms to which a fan must respond correctly. An additional challenge is use of the devices in emergency medicine – on land and in the air – and their use under extreme conditions in crisis regions.

Leak-tightness is required Modern blowers from Micronel AG, which has its headquarters in Tagelswangen in the Canton of Zurich, have come to be greatly trusted by medical device manufacturers for their quality and reliability. For this reason Micronel was commissioned to also develop blowers that can move not only air but also anaesthetic gases and elevated concentrations of oxygen. Here the leak-tightness of the blowers is particularly important to ensure that no gasses can escape and do harm.

Very high efficiency The U-Line series of Micronel blowers is a series of high-performance power blowers. They

The inventor of the flat fan

+++++++++++++++++++++++++++++++++++++++++++++ Micronel AG was founded in January 1968 by Peter Meier Snr. Many ideas have been put into practice since then. One of these ideas gave rise to the very first flat fan on the world market. It was a sensation at the time and was made possible only by adopting a completely new approach to a compact flat fan drive. This approach was later used to develop fans with a higher operating pressure, which gave rise to the Micronel radial blower line. Radial blowers today set the standard for medical ventilation technology.

achieve – through high speeds of up to 50,000 rotations per minute in constant operation – a very high level of efficiency of over 60 percent. The resultant low energy consumption is a valuable contribution to the sustainable protection of the environment and of our resources. Before now, no radial blower was thought capable of these efficiency values. However, this property too is beneficial for medical device manufacturers: heat development within their ventilation unit is minimal because of the high level of efficiency.

Another milestone was the development of high-performance Micronel electronics integrated in the blower. Blower and electronics were “fused” to form a single unit. This opened up many new applications in medical technology.

In addition, Micronel is, together with the medical device manufacturers, breaking new ground to further reduce the energy consumption, weight and dimensions of medical devices and thus increase miniaturisation.

Air volume carried, pressure, voltage and current are the key parameters for collaborative, project-related development work. To meet individual requirements, the engineering team of Micronel works with and for the customer to find a solution for the desired application. An experimental setup in the airflow laboratory is used to determine the operating point in collaboration with the client. Initial guide values, performance requirements and ventilator types can be defined even during the prototype phase in the acoustics laboratory. Experience from long-term test runs and valuable tips for users are also incorporated in every project.

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Hand control for high-precision microscopy (left) and an integrated basic print with an FPGA module (right) produced by Moser-Baer (Photo: Moser-Baer).

Know-how from concept to series production Moser-Baer AG ran a high-precision microscopy project from the concept phase through to series production. This project shows the company’s expertise in the fields of development and electronic contract manufacturing.

Moser-Baer developed, for a customer, a hand control used to level microscope tables. The electronics incorporated in the hand control consist essentially of an FPGA module. This serves as an interface for all operating elements and contains the control logic for the high-precision piezomotor drivers. The FPGA module and a basis print are housed in a robust casing.

The product is notable for its high quality and precision, and the operating concept is optimally tailored to the application.

From A to Z For this project, Moser-Baer did all the development work for the customer – design, specification, pattern design, print layout, FPGA programming, testing and external standard tests (electromagnetic compatibility, environment and safety). The prototype series comprised ten units – and today the hand control is produced in 100 unit batches in Sumiswald in the Canton of Bern.

This project shows the expertise of Moser-Baer in the field of development and contract manufacturing: the company has both a modern infrastructure for electronic manufacturing and long years of experience in the development of electronic products. The core areas of expertise in the development department include mechanics, electronics, embedded software, network/communication technology and PC applications.

Including embedded software Electronics manufacturing includes component logistics, SMD insertion, component testing and final assembly. Apart from series of up to 10,000 units, today small series or prototypes are also produced on a

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contract basis. This means that, with Moser-Baer, medical devices can be made which also include electronics with embedded software.

The customer for whom Moser-Baer developed and currently manufactures the hand control benefited from having a complete solution: since it ranges from specification to series production and development, and production know-how is included even during the design stage, the maturity of prototypes or zero series is increased. Projects are also completed within a short time.

Roots in the clock industry

+++++++++++++++++++++++++++++++++++++++++++++ Moser-Baer AG was founded in 1938 and has been in family ownership ever since. The traditional company from Emmental today employs about 100 people and belongs to Moser-Baer Holding AG which has 300 employees worldwide. Moser-Baer AG is a leading company in the industry for clocks and electronic time systems under the brand name Mobatime. It provides services to medical technology and other sectors under the brand name Mobatec.

Moser-Baer is certified to ISO 9001 and ISO 13485.

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+++ Economics & law

“The quality of dental medicine in Switzerland is in the top class worldwide. That is why we regard the inclusion of a Swiss address in our company brochure as being definitely positive for our image,” says Makoto Nakao, Chairman & CEO of GC International AG (Photo: S-GE).

Hotspot Switzerland Switzerland is a hotspot for technology and innovation.

The country is regarded as one of the most important locations of the medical technology industry. Thanks to very good basic conditions, various big international companies have decided to locate their medical technology departments here.

Medical technology holds an important place in Switzerland: there is no other country in which, by comparison with the total gross domestic product and the economically active population, it has such a high value as here. Here, first-class research facilities are combined with a highly developed health service which demands the appropriate products and stimulates innovation.

The watch industry supplies the sector also with talents that have expertise in the precision machinery industry. In addition, Switzerland is able to attract the top people for research and development in this field.

SWITZERLAND IS NUMBER 1 Switzerland Global Enterprise, the national agency which promotes the country as a business location, confirms: according to the Swiss Medical Technology Industry Report (2014), 1,450 medical technology companies create about 52,000 jobs. Switzerland is thus number one in terms of the proportion of medical technology employees in the overall working population, ahead of Germany and the United Kingdom.

The optimal basis for research and technology is created by unique know-how transfer, cooperation in the Swiss medical technology industry and the Swiss Federal Institutes of Technology (ETH), the nerve centre for medical technology.

In 2013, Swiss medical technology manufacturers invested 17 percent and suppliers invested 11 percent of their turnover in research and development. In addition, due to a large network of experts and the presence of various international intellectual property protection agencies in Switzerland, the registration and management of intellectual property is easy and favourable.

Medical technology’s share of all patent applications is almost three times as great in Switzerland as in the global average.

IDEAL conditions Switzerland is also the leader in capital procurement. Close proximity to one of the world’s most important financial market places creates ideal conditions for different types of financing, particularly for new companies,

One example: Quality is a source of attraction!

+++++++++++++++++++++++++++++++++++++++++++++ The GC Corporation is a Japanese company specialising in research and development and in the manufacture and sale of dental materials and services. Besides three production sites in Japan, the company has subsidiaries in Belgium, the USA, China and India. It also has sales locations in 34 countries. When expanding within Europe, the GC Corporation initially selected five countries, among them Switzerland. After careful on-site investigation, Switzerland got the best assessment. Besides the high quality of dental medicine, the well-developed infrastructure, the excellent educational facilities for children and safety in everyday life were arguments in favour of Switzerland.

also thanks to the good availability of venture capital and private equity funds.

Switzerland is home to what is by far and away the most important stock exchange for life-science companies in Europe: about one third of the market capitalisation on the SIX Swiss Exchange comes from life-science companies.

The optimal basic conditions and simple market access give Switzerland the status of a hotspot for technology and innovation. Thanks to the international outlook of the Swiss medical technology market, the medical technology departments of various big international companies can be found here. Companies who export from Switzerland can benefit from free trade agreements with the EU and 38 other countries and the mutual recognition of product legislation and conformity assessments who give an optimised access to the most important markets.

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Get ahead through good preparation The global regulatory landscape for medical device manufacturers is going through significant changes. BSI is prepared to support its clients with high level medical device services as global Notified Body and Accredited Body.

BSI provides rigorous quality management reviews and product certifications for customers around the world (Photo: BSI Group Deutschland GmbH).

As a Notified Body under the Medical Devices Directive, BSI possesses the expertise and experience necessary to provide services for CE marking and quality assurance system certification.

The area of medical device technology stands out with its high level of innovation. Products are subject to mandatory testing and approval by Notified Bodies before they can be placed onto the market.

BSI Group has many years of experience in the assessment of medical devices. It supports medical device manufacturers in meeting all the regulatory requirements through to market launch.

TRUSTING PARTNERSHIP “Our customers value working with us because we understand the challenges manufacturers of medical devices are facing in getting compliant products to market quickly,” said Peter U. E. Leveringhaus, Chairman of BSI Group Deutschland. The company offers customers a wide range of product reviews to help clients achieve CE marking within their timeline and budget, regardless of their specific needs or product requirements.

TAILORED PROGRAMMES “CE-90 Standard” is the standard BSI service for technical documentation reviews. As long as

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the documents meet the quality requirements, this service aims to conclude the assessment within 90 days.

The “CE-FastTrack” programmes go faster: by pooling resources, they aim to conclude the assessment within 45 working days from submission of complete documentation. With “CE-Onsite FastTrack”, the review is performed at the customer’s premises. Onsite reviews usually allow for a faster timeline thanks to dynamic communication and the ability to get immediate response to questions.

GLOBAL EXPERTISE BSI works on a partnership approach offering a wide range of proven regulatory and quality management programmes to deliver full international compliance.

Its quality management solutions cover ISO 13485, ISO 9001, ISO 14001 and many others. BSI’s experts work with international regulatory authorities and know what is required to achieve approval for its customers’ products in Europe as well as the markets of Canada, Japan, Australia, Hong Kong, Malaysia and Taiwan.

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+++ Economics & law

Regulation and innovation – a conflict?

Today, corporate success and competitiveness can be achieved by medical device manufacturers only if they can find smart approaches to meet the regulatory requirements. ments in Annex I to the Directives in order to demonstrate its product safety and performance. This freedom of action is a strength of the current regulation and an opportunity to introduce innovative technology – but it usually goes unrecognised and so is too little used.

MORE INTENSIVE SURVEILLANCE NBs check in conformity assessment procedures whether the requirements for class IIa/ IIb and class III devices have been met. Thus they have a key function to ensure product safety. The fact that NBs would not all assess a device in the same way had been identified as a weak point in regulation even before the PIP scandal and tangible corrective action has now been taken Europe-wide. Implementing Regulation No. 920/2013/EU makes NBs subject to stricter control by the appropriate authorities – which has already led to a clear reduction in the number of NBs. Manufacturers are also subject to stricter supervision: Recommendation 2013/473/EU contains more specific requirements for audits – every manufacturer gets an unannounced visit from auditors within three years; at the same time the competent authorities supervise manufacturers more strictly under the terms of Regulation 765/2008/EC. The effects of these intensified surveillance programmes – currently with unchanged product requirements – are perceived by companies particularly in the review of technical documentation and clinical data.

CHOICE OF NB The choice of the NB is important for future success and therefore should be part of the corporate strategy. ManufacLoop control system of surveillance turers should implement the current ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ regulatory requirements in order to be prepared to the increased requirements of the medical device regulation EU Directives currently under discussion. If regulatoNational law ry considerations are included already Harmonised standards Conformity in development phase, the risk can be assumption assessed more accurately and access to the market planned more realistically.

Then innovation and regulation are no Increased supervision longer a conflict – quite the opposite, > o f manufacturer by Notified Body (NB) if regulation is applied smart as part 2013/473/EU, Nov 2013 – UAA of corporate culture, this cuts costs > o f Notified Body by Competent Authority Evidence of and affords protection from corrective Regulation (EU) 920/2013 – joint assessments product performance & -safety actions or serious incidents. > Technical documentation Regulation – a term which many companies associate with delayed market access, higher costs and obstacles to innovative strength. Is this justified? Certainly, the implementation of the regulation is complex and affects all business processes. However, for product innovation in particular, it is helpful that business processes reflect the regulatory requirements.

Medical device safety is achieved in a loop system in which every actor has tasks, rights and obligations. For medical devices, the key actors in Europe are the EU Commission or Competent Authorities (CA), manufacturers, their suppliers and distributors and the Notified Bodies (NBs). They are accredited and designated by the competent authorities.

MANUFACTURERS’ OWN RESPONSIBILITY To place a medical device on the European market, the product must demonstrably meet the requirements of the appropriate EU Directive (90/385/ EEC, 93/42/EEC, 98/79/EC). The manufacturer is responsible to prove and document that the requirements are fulfilled – that is the basic principle of medical device regulation. The NBs supervise by random inspections whether a manufacturer actually does meet those requirements. This principle takes account of the diversity of medical devices, with about 10,000 product groups: specific specialist knowledge is needed for manufacture and for risk assessment.

Thus, as regards the properties of their particular medical device, manufacturers have to “interpret” the essential require-

Manufacturer

Conformity assessment

Dr. Margit Widmann, Regulatory Coaching, Günsberg

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Source: Dr. Margit Widmann 2015_Swiss Medtech Industry

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> “We essentially of-

fer our clients global market access.”

Photos: CSA

OLIVER BÖSL, Managing Director of CSA Group Switzerland

Certification without unpleasant surprises In an environment of global competition, playing in the big league means being present in many markets. Oliver Bösl, Managing Director of CSA Group Switzerland, helps to avoid the pitfalls.

Mr. Bösl, among other things you are a specialist in the area of product testing and the certification of electrically operated medical devices. In which countries do you support export-driven manufacturers?

Bösl: We essentially offer our clients global market access. Our on-site specialists are familiar with the norms and standards in numerous countries and communicate directly with the local authorities in the national language. We have our own offices and laboratories in North America, China, Japan, South Korea, India and Europe.

Could you give a brief example of how such a certification is granted?

Bösl: China is a very unique market for the manufacturers of medical devices.

The approval process there has two steps: first, devices undergo preliminary testing in a Chinese laboratory. The results of this preliminary test are then used by the Chinese Food and Drug Administration, the responsible administrative authority, as the basis for certification. We streamline this process by cooperating with one of the leading Chinese laboratories. We are also able to

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carry out the required performance tests by the Chinese authorities here in Switzerland as part of witness testing.

Your testing certifies the safety of these products. Which safety aspects are relevant for this purpose?

Bösl: The safety requirements fundamentally changed with the issuing of Safety Standard 60601-1 Edition 3: particular significance is attached to the risk management process and usability.

Requirements have been added for all devices with respect to software security that go beyond established safety aspects such as electricity, mechanics and thermal. In order to be able to carry out the actual certification process efficiently and without surprises, we support our clients with projects from the early development stage.

Which kinds of products are awarded the CSA certification mark?

Bösl: We are able to certify nearly all electrically operated medical devices based on IEC 60601-1.

CSA Group is originally a Canadian company. Are your product certifications

now accepted in approval processes outside of North America?

Bösl: Our certificates are recognised worldwide and are also used in approval processes in other countries. We are also an active participant in the CB Scheme, a global programme that is currently supported by more than 70 international certification institutes. Its objective is the mutual recognition of test results among member institutions so that safety indicators in the respective countries may be upheld. Many national authorities already require the CB test report and certificate as the basis for certification.

CSA Group

+++++++++++++++++++++++++++ CSA Group is an international testing and certification institute. It has set and developed safety standards for North America for nearly 100 years and tests and certifies products for global market access.

CSA Group and its proprietary test laboratories are accredited by many official approval offices around the world.

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+++  Economics & law Business economist Eric R. Perucco, Managing Director of MedBrainTec (Photo: MedBrainTec).

Management success made visible

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> MEDBRAINTEC AG

from Rapperswil-Jona offers interim management for the quick completion of important subject-specific tasks in organisations. The company allows itself to be measured on results and paid according to its success. Such time-limited management could for example concern the founding and building up of companies and business areas. Projects for the realignment of companies and departments, logistics and engineering are also supported.

Also in the portfolio is the preparation and implementation of marketing and sales strategies, advising on and implementing purchasing management for hospitals and purchasing companies or the coaching of management personnel and coverage for staff shortages. The focus of MedBrainTec AG is on medical technology and there, among other things, on traumatology, spinal column, endoprosthetics, endoscopy and hospital management. However, the company has also successfully gained a footing in other areas, such as door and window technology and waste management.

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New business model for med-tech start-ups

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>

MEDTECH INNOVATION PARTNERS (MTIP) with headquarters in Basel is a start-up investor specialising in the medical technology sector. The company aims to give researchers and companies the tools and network to build up a sustainable business model and thus achieve a competitive advantage. To this end, MTIP deliberately supports start-ups in business development, a systematic approach to IP management and in building up an interdisciplinary culture.

An international network, consisting of renowned universities and research centres with strengths in medical technology, forms a proprietary “innovation ring�. This gives researchers and companies a very good basis for pushing new products through to market maturity. The basis for MTIP supports start-ups in business interaction with companies and development, IP management and in partners for MTIP is a value sys- building up an interdisciplinary culture tem based on integrity, trust and (Photo: MTIP). mutual respect. w www.mtip.ch

We support, expedite and connect: Business and Economic Development.

Canton of Zurich Department for Economic Affairs Office for Economy and Labour www.location.zh.ch www.lifescience-businessnetwork.ch

Photo: Š storm - Fotolia.com

What trust in medical products is worth The life sciences sector has a good reputation which companies should not put at risk.

Those who place a high priority on Quality and Compliance are investing well in their company. Neglecting this area, however, can lead to high losses for a company.

By most financial measures it can be said that the life sciences sector worldwide is doing well. One of the reasons is that over the years the big variety of products has built a high degree of confidence on the user side. A great set of regulatory rules exists which should grant the security of the products, and companies have regularly brought new innovations on the market which show how innovative the sector is. Under the previous conditions, customers were willing to pay a price which promised a good margin to the manufacturers.

The success of new technologies at risk However, the atmosphere is currently changing. On the one hand, the number of innovations is declining. On the other hand, in an increasing number of cases manufacturers did not comply with the regulatory requirements. This does not only risk the trust in existing products but can also compromise the success of completely new technologies such as mobile applications or 3D printers.

Against this background, it is worth to think about why these trends appear and how they affect the positive images of the sector, what it means for the companies and what the decision makers can do in the long term to avoid economical losses in such a changed environment.

Reasons for lack of compliance Many factors are discussed as causes for the declining number of innovations and the rise of compliance deviations. For certain, the large number of company mergers plays a role. For a certain amount of

40

time, the attention of the employees is drawn to internal processes and changes. At the same time, the range of requirements on the international market make it more difficult to comply with all rules. Sometimes it seems that, where there are pressures to save costs, scaling down the quality requirements can seem more important and on occasion to the extent of criminality and at the expenses of patient safety.

Companies which don’t comply for cost reasons put themselves at risk. Due to stricter legal regulations, the probability will increase that deviations from the regulations will be discovered and punished in the future. Current studies show that good quality has a positive impact on the economical balance. For example companies which are listed on the New York stock exchange and which have an ISO 9001 certification perform better.

Committed to quality But how can we achieve quality?

In recent history, through irregularities in the financial market we have learned to develop and implement many control and improvement solutions. For the Life Sciences sector, the possibility now exists to profit from these experiences and secure their growth. One option is the use of independent Compliance Consultants, to which companies can turn to discover fraud, non-compliance or unknown risk in their own company.

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www.maetrics.com

+++ Economics & law

Medtech Incubator as start-up generator

Mock-up of SonoView ultrasound device for early detection of breast cancer (Photo: SonoView).

The Bern Medtech Incubator Initiative is seeking unique, scalable business ideas in the field of medical technology with the aim of working with the originator to take them from prototype to product launch. The Bern Economic Development Agency provides the start-up financing for this initiative.

From a biological point of view, an incubator creates the perfect conditions for “breeding and growth processes”. And that’s precisely what the brand-new Medtech Incubator project is designed to do – after all, innovations are not individual achievements but an interplay of different disciplines and areas of expertise. The Medtech Incubator provides a meeting ground for innovative business ideas and other specialist skills, bringing them together with contacts in areas such as science and enterprise.

TRUE WIN-WIN SITUATION The Medical Cluster and BaseCamp4HighTech (BC4HT), the platform for high-tech startups in the Canton of Bern, work closely together to achieve this. The result is a true win-win situation: the Medical Cluster brings together around 400 companies along the entire value chain, and BC4HT supports highly scalable high-tech start-ups from the idea to stable business growth.

The Medtech Incubator project is made up of three phases per year: PHASE 1 – IDEA CHALLENGE The evaluation process kicks off with a one-day event at which teams, start-ups or SMEs can present their ideas to investors in person. Next, the ideas are tested and assessed by experts for feasibility, level of innovation, method, business potential and other factors. If they rate the business idea as promising, the team is invited to the Idea Competition, where they have the opportunity to pitch their ideas to a committee of experts who then select around half the ideas to put through to the next phase.

PHASE 2 – COACHING The coaching phase lasts for three months and is financed by the Medtech Incubator. The candidates are given support and assistance by experts such as trustees, marketing specialists, developers and lawyers. Together they work out an efficient business model and a sound business plan. The search for investors to finance the business idea and for the suitable infrastructure starts in this phase.

The best coaching cases make it through to the final phase.

PHASE 3 – ACCELERATOR The start-ups selected for this phase receive a package consisting of fundraising, business development and sales coaching. The individual elements last between three and twelve months depending on the team’s

Successful start-up promotion

++++++++++++++++++++++++++++++++++++++++++++ An example of successful promotion using the three-phase model is the Nidau-based start-up SonoView Acoustic Sensing Technologies Ltd. Their ultrasound device for early detection of breast cancer produces 3D MRI-level images – comfortable for the woman being examined and ten times cheaper than the current cost of conventional mammography. SonoView is currently based at Innocampus in Biel/Bienne and employs two research engineers. w www.sono-view.com

needs and are paid back by the start-ups in line with the success of their idea.

The Bern Economic Development Agency provides startup financing for this initiative, with the aim of boosting innovative high-tech products and services in the Canton of Bern as a centre of medical expertise and enhancing its appeal as a base for foreign companies as well. The first event for medtech start-ups takes place at the Innocampus in Biel/Bienne on 30 November, 2015.

w w

www.medical-cluster.ch/insight4innovators www.basecamp4hightech.ch

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SOLOTHURN

+++++++++++++++++++++++++++

These are the Swiss medical technology hotspots

Medical technology and precision industry are two of the most important industries in the Canton of Solothurn. Business history was made particularly in orthopaedics.

Today, the brand Synthes is recognised in almost every operating theatre in the world.

w www.standortsolothurn.ch

The medical technology sector is of great economic importance for the whole of Switzerland. But there are some clear regional hotspots.

SCH

BASEL-STADT BASE L-LANDSCH AFT A A RGAU

J URA

JURA

SOLOTH URN

+++++++++++++++++++++++++++ Thanks to know-how in precision technology, the Canton of Jura successfully positions itself in the med-tech sector.

The highlights:

• Medtech-Lab: business incubator for life-science companies • Tax advantages for companies and investors • Active policy of promoting innovation •3 0 kilometres from Basel, the biggest life-science cluster in Europe

LUCERN E NEU C H ÂTE L

NIDWA BE RN

w www.jura.ch/eco

OBWALDEN

F RIBOURG VAU D

BERN

Neuchâtel

+++++++++++++++++++++++++++

+++++++++++++++++++++++++++

GENEVA

The success of Neuchâtel as a strong cluster in medical technology is based on over 300 years of industrial history. The expertise and precision needed to develop medical technology products originate from the watch industry and microelectronics. In addition, close collaboration between research centres and companies make the canton the ideal place to turn ideas into products.

w www.neuchateleconomie.ch 42

TOTAL MED-TECH COMPANIES: 216 TOTAL EMPLOYEES: 2,880

VALAIS

RESEARCH & DEVELOPMENT: Many renowned research institutes in the med-tech area, among them the Faculty of Medicine of the University of Bern and the University hospital Insel, the Artorg Center for Biomedical Engineering and the MEM Research Center, as well as the Institute for Human Centered Engineering of the Bern University of Applied Sciences.

w www.berneinvest.com

+++ Innovative regions

AARGAU

+++++++++++++++++++++++++++ TOTAL COMPANIES: 42,000 TOTAL EMPLOYEES: 320,000 UNIQUE ADVANTAGE: Ten percent lower costs of labour compared to the other surrounding economic centres.

RESEARCH & DEVELOPMENT: The number of employees involved in R&D is twice as high as the Swiss average.

w www.aargauservices.ch

HAFFHAUSEN THU RG AU

ZURICH

+++++++++++++++++++++++++++

ZUR ICH

APPENZELL AUSSERRHODEN APPENZELL INNERRHODEN S T. G ALLEN

ZUG

Economic motor: Zurich companies earn 20 percent of Swiss GDP. Out of about 100,000 companies, 360 are in medical technology.

Site of innovation: University, ETH and Zurich University of Applied Sciences provide excellent basic and applied research, a large pool of talent and innovative spin-offs.

w www.location.zh.ch w www.lifescience-zurich.ch

SC HWYZ GLARU S

ALDEN

U RI G R AU B Ü NDEN

Lucerne

+++++++++++++++++++++++++++ total companies: 30,000 total employees: 240,000

TI CIN O

Ticino

+++++++++++++++++++++++++++ • Headquarter of innovative, internationally active medical technology companies such as DePuy Synthes, KerrHawe, Aptar and Medacta • Population of 6 million people within a radius of 50 kilometres around Lugano • Many renowned research institutes, a university and a university of applied sciences

Plus point: Here, local work meets global outlook.

Community: International and Lucerne companies operate successfully on the global market. A total of 80 medical technology companies, ten of them with between 20 and 250 employees.

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www.luzern-business.ch

w www.copernico.ch

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CTI Swiss Medtech Award

(From left to right): Alfredo E. Bruno (CEO AOT), Philippe C. Cattin (University of Basel), Annalise Eggimann (CEO CTI), Gábor Székely (Head CTI Medtech), Kaspar Loeb (host) (Photo: CTI).

It was another thrilling event on 8 September at the Kursaal Bern as the audience chose their favourite from three innovative projects that were in the running for the CTI Swiss Medtech Award. Out of the three projects – all of which are funded by the Commission for Technology and Innovation – a laser robot came out on top.

Every year, the Commission for Technology and Innovation (CTI) nominates three of the projects it supports for the CTI Swiss Medtech Award, which includes prize money of 15,000 swiss francs. The audience voted for their favourite project live at the event, at which around 400 industry experts met to talk and discuss ideas.

First Place goes to a laser robot that cuts bones

AOT AG, a spin-off of the University Hospital of Basel, won the first price. AOT AG has developed a system with which a robot can precisely cut cranial and other bones contact-free with a laser. The robot, called CARLO (Computer-Assisted, Robot-guided Laser Osteotome), is the product of a collaboration between laser physicist and entrepreneur Alfredo E. Bruno, oral and maxillofacial surgeons Hans-Florian Zeilhofer and Philipp Jürgens of the University Hospital of Basel, and Philippe Cattin, professor for image-guided therapy (IGT) at the University of Basel. They founded their company, Advanced Osteotomy Tools AOT AG, in 2010. CARLO processes several hundred megabytes of data per second and can make its own decisions

Contact-free and precise: CArlO cuts bone with a laser beam (Photo: CTI).

based on sensor data. This CTI project is ongoing; a first procedure is in the works for 2016. In this procedure, a surgeon will perform surgery on the cranium of a child whose growth plates have fused too early.

The use of CARLO will reduce the operating time – and with it the amount of time the little patient is under anaesthesia – by one hour. The procedure will be less invasive and lead to less blood loss. Demand for “CARLO can do far more than the CARLO from other surgical fields is already so pre-existing da Vinci surgical robot, great that, following corwhich simply executes what the surgeon responding clinical trials, tells it to do.” further procedures on all Philippe C. Cattin, professor at the University of Basel and parts of the skeleton will development manager at AOT be carried out.

>

CTI – government innovation promotion

+++++++++++++++++++++++++++++ The CTI is the federal government’s innovation promotion agency. It supports the transfer of knowledge and technology between universities and industry, promotes entrepreneurship by offering courses and coaching services and supports joint R&D projects between companies and universities. The CTI helps optimise the transfer of knowledge and technology through networks and platforms. The CTI Medtech Initiative has been supporting innovative research and development projects since 1997. Organising the CTI Medtech Event, at which the CTI Swiss Medtech Award ceremony is held, is also part of this Initiative.

w www.kti.admin.ch 44

+++ Research & development

The 3D printer made by regenHU in laboratory use (Photo: CTI).

Second place skin

goes to 3D-printed

The Zurich University of Applied Sciences (ZHAW) and biomedical company regenHU Ltd. from Villaz-Saint-Pierre came second place with their tissue bioprinting device. Biologist and chemist Ursula Graf-Hausner and her tissue engineering and cell cultivation technique team, fellow ZHAW biologist Markus Rimann, and engineer Marc Thurner, who is the head of regenHU, all worked together on this project. They realised and refined their idea in two consecutive CTI projects. They have even devel-

oped chemically defined bio ink for their print“The CTI showed confidence in us at a er. This ink is filled into time when no one believed that bioprintcartridges similarly to a ing was possible. Thanks to the funding regular ink-jet printer.

“This has led to an interwe received, we are now a global frontesting business model: runner in this field.” our partner, regenHU, Ursula Graf-Hausner, ZHAW biologist and chemist now sells not only printers, but also the consumables they use,” says Rimann, one of the product developers. printing projects currently under way Meanwhile, some large pharmaceutical at ZHAW. Switzerland is now one of the companies, including Roche and Novar- world’s leading countries in the field of tis, have become involved in several bio- bioprinting.

>

ical devices’ effects on the human body. MRI data tak“Over 580 scientific papers have en from a selection of peoalready quoted Sim4Life and its ple served as the basis for models – at conferences, they are high-resolution human body models that are both comconsidered the gold standard.” plex and realistic. The first Niels Kuster, founder and manager of the IT’IS version of Sim4Life has been Foundation available with great success since 2014. Its use has led to over 100 applications to the U.S. Food Third place goes to a simulation proand Drug Administration (FDA) for new gramme for personalised medicine ETH spin-off ZMT Zurich MedTech AG medical implants. In its subsequent CTI and research foundation IT’IS got third project, S4L-Capitalis, the platform was place with a simulation platform that extended to provide industry, regulators makes personalised medicine and treat- and researchers with realistic conditions ment planning possible through com- for analysing and optimising neurologiplex anatomic models. This platform is cal devices and treatment courses for used to predict the effect and safety of medical conditions such as epilepsy, new implants and procedures. In a pre- Parkinson’s disease, depression and vious CTI project, the IT’IS Foundation aneurysms. This software can be used, designed a simulation platform called for example, to examine certain design Sim4Life, which reliably predicts med- and safety aspects of pacemakers that

>

would be impossible to test in vivo or in vitro. The researchers are already working with the FDA to realise their next vision, which is to further develop their software to accompany or even replace costly clinical studies.

The simulation platform predicts the effect of medical devices on the human body (Photo: CTI).

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Network for the benefit of patients Anyone who wants to achieve something in the development of medical products is well advised to collaborate not just with other disciplines but also with companies. A strategy which the Bern Biomedical Engineering Network has been following successfully for years.

An engineer is fiddling about with an algorithm. It is used to turn just two 2D pictures into good 3D images. But it still takes medics, engineers, hospitals and medium-sized companies to turn the original idea into an exciting prod-

THE BERN BIOMEDICAL ENGINEERING NETWORK

+++++++++++++++++++++++++++++ Those involved in the Bern Biomedical Engineering Network are the Inselspital Bern, the University of Bern, and the University of Applied Sciences Bern. In this way, a total of eleven institutes or groups are networked not only with each other but also with other research groups and companies in Switzerland and abroad – from Europe to the USA or even Japan.

The current 54 research subjects cover all human organs, ranging from the brain and the sensory organs through the heart, liver and digestive system to the spine and the musculoskeletal system.

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http://bbme.ch

uct that is more sparing for the patient and cheaper for hospitals. They were all brought together by the Bern Biomedical Engineering Network.

A TRADITION OF INTERDISCIPLINARY THOUGHT But let us start from the be-

ginning: the Bern Biomedical Engineering Network in which such approaches are followed had early pioneers: at Bern University, Nobel Prize winner and surgeon Emil Theodor Kocher (1841 – 1917) had already combined a knowledge of medicine and engineering to develop his Kocher forceps which are today used as a standard instrument. He recognised that innovations are difficult to put into practice without interdisciplinary thought. This was also exactly the view of one of his later successors, the surgeon Maurice E. Müller (1918 – 2009). He complemented this knowledge through collaboration with companies, in his case instrument makers – and made a name for himself not just as a surgeon but also as an inventor, entrepreneur and later as the creator of a foundation and a patron of the arts.

This tradition is being continued today, and in the Bern Biomedical En-

gineering Network, various disciplines, different departments and institutes collaborate on new diagnostic options and therapies as a matter of course.

This close collaboration and exchange of ideas have to date worked without any controlling institution, simply by tradition, various events such as the Biomedical Engineering Day, and by active networkers such as Prof. Lutz-P. Nolte. The engineer not only built up the Artificial Organ Center for Biomedical Engineering Research, ARTORG for short, in Bern.

He is also director of the Institute for Surgical Technologies and Biomechanics (ISTB) at Bern University and Vice-President of the Committee for Technology and Innovation, CTI. Nolte knows both the Swiss and the international research landscape and has contacts with the companies that work on or could work on the appropriate subjects.

2D BECOMES 3D The ISTB is also where engineer Prof. Guoyan Zheng works, the one who developed the mathematical algorithms described earlier. That is now ten years ago. A definite research project has emerged from the research work: a team of researchers at the ISTB,

+++ Research & development

A patient’s existing X-rays with the patented calibration cage (Photo: IPMI, Bern University).

the Inselspital Bern, Heidelberg University in Germany, the University of Osaka in Japan and the New England Baptist Hospital in Boston, USA, is now carrying out tests to see whether the method is also suitable for the assessment of hip joints. Their question: can normal two-dimensional X-ray images, which are in any case taken to examine a problematic hip joint, be used to produce a 3D image of the joint which would allow precise three-dimensional planning of a hip joint replacement to be done?

“Something like this has to happen in the early phase of such a research project,” stresses Nolte, “otherwise it ultimately does not work.“ But in the example mentioned it works: the joint project had such a positive effect that the network became active again. This time, it was to find a suitable production partner. A medium-sized company will in future be turning the idea into a service. Hospitals will then be able to send in their patients’ X-rays and receive a patient-specific plan for the later operation, including the sizes of the various components of the artificial joint.

The reconstructed 3D models of the pelvis, the proximal femur (yellow), and the planned implant components, projected onto the existing X-ray image (Photo: IPMI, Bern University).

KIND TO THE PATIENT AND THE WALLET

This has many advantages: firstly it reduces the costs of 3D CT images for the hospital – particularly as no CT images can be acquired with the leg under loading. Secondly, patients are spared

of that happening are greater,” stresses Nolte. Accordingly, he would like to see the network institutionalised – with a lean organisation and no straitjacket: “It is important that, quite apart from the collaboration, for example when select-

> “Not every research idea turns into a new product, but through the network the chances of that happening are greater.”

Prof. Lutz-P. Nolte, director of the Institute for Surgical Technology and Biomechanics at the Medical Faculty of the University of Bern

the additional radiation dose of the CT examination. And, last but not least, the idea offers a medium-sized company and its employees a new revenue stream.

“Of course, not every research idea or every joint research project turns into a new product or a start-up company.

But through the network the chances

ing new research group leaders, we all sit together at one table – doctors, engineers, mathematicians, etc. Or that we can analyse strategic fields together and identify key areas for research, education, and training,” says Nolte to explain his objective. “It is all about more effective cooperation – for the benefit of patients.”

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Blood monitoring in real time: the chip under the skin

+++++++++++++++++++++++++++++++++++++++++++++++++++++++

>

A new biosensor chip measures just one square centimetre and is implanted under the skin. It gets its power from an external plaster and communicates with a smartphone. “It is the first chip in the world which measures not just pH value and temperature but also substances relevant for metabolism, such as glucose, lactate and cholesterol, and medicines,” says Sandro Carrara from the Integrated Systems Laboratory of the Swiss Federal Institute of Technology (EPFL) in Lausanne, where the chip was developed in collaboration with the Radio Frequency Integrated Circuit Group. “If we can find out the effects of medicines on the metabolism precisely and in real time, that is an important step towards personalised medicine, which is our ultimate aim.” w www.epfl.ch

The biosensor chip of the EPFL in Lausanne is intended to make it possible to monitor the effects of medicines on the metabolism and to dose drugs more exactly (Photo: Alain Herzog / EPFL).

Light instead of an injection

+++++++++++++++++++++++++++++++++++++++++++++++++++++++

Intelligent treatment of chronic wounds

++++++++++++++++++++++++++++++++++++

>

The measuring head of the “Glucolight” with the “smart” membrane (Photo: EMPA).

>

A newly developed sensor measures the blood glucose level merely through skin contact. No blood sample is needed, not even for its calibration. The Glucolight sensor developed by EMPA and Zurich University Hospital is to be used first in premature babies to avoid hypoglycaemia and subsequent brain damage. Until now, this could not be done without taking blood samples. However, regular collection of blood from sensitive little babies for hours is not possible, as the blood loss and stress would be too great. Glucolight saves the premature baby all blood sampling and at the same time allows continuous monitoring of the blood glucose level. This is made possible by a new measuring technique developed by the EMPA and Zurich University Hospital. The sensor consists of a microdialysis measuring head with a smart membrane, light sources, a pump and a microfluidic chip with a fluorometer. The researchers have had Glucolight patented. The first clinical studies at Zurich University Hospital are planned for later this year. w www.empa.ch

Medilight is an EU-sponsored project in which seven European partners have formed a new consortium. From Switzerland, the Swiss Center for Electronics and Microtechnology (CSEM) in Neuchâtel is involved. Within the project, researchers want to develop an intelligent, self-adapting system for the personalised light therapy of patients with chronic wounds. The potential is enormous: in Europe alone, more than 40 million patients are suffering from chronic wounds. These cause costs of about 40 billion euros a year. The research cooperation is being cofinanced by the Horizon 2020 research and innovation programme of the European Union and coordinated by the Technical University of Berlin (TUB). The project started in February 2015 and is being sponsored by the EU with 3.2 million euros over a 36-month period.

w www.medilight-project.eu

A simplified view of how red and blue light acts on human skin (Photo: © MEDILIGHT).

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+++ Research & development

Supermicrosurgery: first lymph node transfer

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

>

In supermicrosurgery, doctors join together structures with a diameter of less than 0.5 millimetres. Plastic surgeons do this using not only ultrafine needles and sutures, but also a high-resolution fluorescence microscope which shows the operating area magnified up to 40 times. It is manoeuvred over the affected area using a controllable “arm”. Shortly before the procedure doctors inject a fluid into the tissue which makes the blood vessels or lymphatic vessels light up under the microscope, thus facilitating the precision work. Thanks to this new technique, doctors at Zurich University Hospital (USZ) were able to transfer a lymph node packet from the throat to the groin of a woman suffering from chronic lymphoedema. This procedure is of great benefit to patients: if the fine lymphatic vessels are connected together or to small veins, the accumulated fluid is better able to drain from the swollen tissue. Specialists hope that the better connection of the fine lymphatic vessels will also improve the prospects of success in transplanting tissue or in reattaching severed limbs.

Surgeons performing supermicrosurgery need a steady hand: the vessels are 0.5 millimetres wide, the needles and sutures ultrafine – and when patients breathe, the affected tissue may move too (Zurich University Hospital).

w www.usz.ch

Prototype of a brain scanner

++++++++++++++++++++++++++++++++++++ Longitudinal section through the retina of a blind mouse with modified photoreceptors.

These are labelled with a fluorescent dye and therefore show up as red (Photo: Sonja Kleinlogel, Bern University).

A light switch against blindness

+++++++++++++++++++++++++++++++++++++++++++++++++++++++

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Researchers in Bern are giving blind mice their sight back. Their newly developed technique could be used in the hereditary and incurable eye disease retinitis pigmentosa, from which about two million people worldwide are suffering. Those affected gradually lose their sight, since the light receptors of the retina, called photoreceptors, die. “Even though the photoreceptors lose their function, the nerve cells underneath them, which normally receive and process the visual information, are still fully functional,” explains Sonja Kleinlogel from the Institute of Physiology at Bern University. “These remaining cells can be made sensitive to light and as it were turned into replacement photoreceptors.” To this end the researchers altered the molecular structure of the nerve cells so that they now respond to light stimuli and not to chemical stimuli. Mice suffering from retinitis pigmentosa from birth were treated using this method and were able to see daylight again, respond to visual stimuli and learn behaviour patterns triggered by light. w www.unibe.ch

>

An international research group is developing a scanner for brain research. The three-year project called "TT-PET” is based on a technology which was originally developed for the ATLAS experiment at the CERN European particle physics centre in Geneva. Now it is being used for brain research: a scanner developed on the basis of this technology is intended to make possible highly precise images of the brain – in much higher resolution than before. PET stands for positron emission tomography. Radioactively labelled molecules can be used to visualise biological processes in tissue. The new TT-PET scanner has been so miniaturised that it can record images of the brain directly in a conventional NMR scanner used to visualise the structure and function of tissue and organs. “Through the combination of these two techniques, biological processes can now be located directly in the anatomy of the brain,” explains Prof. Michele Weber from the Laboratory for High-Energy Physics and the Albert Einstein Center (AEC) of Bern University. The first prototype of the new scanner will be built and tested in the next three years in Bern. The Swiss National Science Foundation is supporting the project with 1.9 million Swiss francs.

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www.insel.ch

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Three questions for … +++

Achieving more together Urs Gasche (UG)

President Fasmed

Rubino Mordasini (RM)

President Medical Cluster

At their last general meetings, FASMED and Medical Cluster announced that they both want to work more closely together. What exactly do you hope to gain therefrom?

UG: The two organisations have been collaborating on selected projects for years. Our longest experience of collaboration is in the industry study called the Swiss Medical Technology Industry Survey which Medical Cluster carries out and publishes. FASMED supports the study financially and in its media work. By consolidating and

focusing on our collaboration, we are strengthening our potential influence in the interests of the industry as a whole and drawing attention to its great importance for the national economy.

RM: Although some manufacturers are involved in both organisations, there are clear differences between the membership structures of Medical Cluster and FASMED. What we have in common, however, is the aim for the medical technology industry to continue to enjoy good general conditions in our country. To this end we need to

PROFIL

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ MEDICAL CLUSTER Medical Cluster is a network of about 400 companies from the whole medical technology supply chain in Switzerland. With its events, conferences and services it helps companies and experts to have an exchange of views and to enter into new cooperations.

Membership structure 170 suppliers (43 %), 122 service providers (31 %), 55 manufacturers (14 %), 19 members from trade and distribution (5 %), 13 private individuals (3 %), 9 research establishments (2 %), 9 non-profit organisations (2 %), 1 pharmaceutical company

50

FASMED The umbrella association of Swiss medical technology represents about 230 med-tech companies in trade and industry. FASMED is dedicated to the maintenance and promotion of market economic structures in the healthcare system and to good basic conditions in the Swiss med-tech industry, maintains contacts with the political authorities, with the administration and with doctors, hospitals and health insurance funds in Switzerland. It also provides advice on specialist, economic and legal matters.

Membership structure 129 members from trade and distribution (55 %), 58 manufacturers (25 %), 40 service providers (17 %), 6 suppliers (3 %)

coordinate our work well and if possible to speak with one voice. In the management boards of both bodies, we are aware that increased cooperation is the way forward.

What do these joint activities bring the member companies?

RM: They benefit from the improved organisation of the industry. Through our combined size we can offer even better services covering the whole life cycle of medical devices, support innovations and even tackle matters of economic policy and law.

UG: The context in which the Swiss med-tech sector operates is deteriorating visibly. This affects both the production location and the target market. If we fully represent our common interests, we can do more to counteract this trend, both in Bern and in Brussels.

So what happens next?

UG: We have asked our managing directors to produce models for closer cooperation. The governing bodies of both organisations will then select the preferred model. This will be followed by the consultation process in which the members of both organisations will be called upon to give their views on the proposed cooperation model.

RM: We hope that during the annual meetings next year we will be able to hold a vote to get the proposed model accepted by both associations.

6

Swiss Medtech Day 2016 DATES: 6 – 7 June 2016 PLACE: Kursaal Bern MEETING LANGUAGES: German, English, French PROGRAMME: available online from 25 January 2016

SUBJECTS FOR 2016 +++ Market access framework +++ Innovation promotion system +++ Production site Switzerland 2020

WHAT’S ON OFFER +++ Talks +++ Workshops +++ Supporting industry exhibition +++ Medical Cluster general meeting +++ Networking dinner +++ 1to1Partnering

The annual meeting for all stakeholder groups in Swiss medical technology Creating an annual forum for an exchange of views between the various med-tech stakeholders in Switzerland was the aim of the initiators of Swiss Medtech Day. The premiere in 2015 in Bern was attended by about 160 representatives of industry, universities, politics and authorities who learned about national and international trends and what to make of them.

Following this successful start, the date for the industry’s meeting next year has already been set. On 6 June 2016 the Medical Cluster will hold its general meeting and host the networking dinner that follows. The actual Swiss Medtech Day will be held at the same venue on 7 June 2016.

Further information: www.medical-cluster.ch/smd

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