Swiss Medtech

Writer: Phoebe Harper | Project Manager: Deane Anderton

The industrial prominence and relevance of Medtech has reached new heights worldwide. Switzerland is one country at the nexus of this field, as public interest in the sector has escalated in the wake of the COVID-19 pandemic.

Major contributors to the Swiss Medtech sector include distributors, specialised service providers, the supplier industry, and manufacturers – the latter of which produce medical devices that are applied across 29 specialist medical fields worldwide. The most prominent sectors within this are orthopaedics and traumatology, diagnostics, cardiology, dentistry, injection systems and hearing system technology.

The industry is proven as a major source of employment and a key economic staple for Switzerland, increasing its revenue to CHF20.8 billion within the last two years alone. This dynamic period saw the Medtech workforce rise to a record figure of 67,500 people. Complementing these recent strengths, industry sales grew by an average of 7.6 percent a year throughout 2020 and 2021, with companies in all medical segments recording positive figures of growth.

Despite this growth, the sector must confront the specific challenge of the flawed regulatory framework within which all Medtech players must operate – the European medical device regulations (MDR and IVDR).

Incorporated into national legislation, the European MDR and IVDR demonstrate a fracture between the readiness of the industry versus its systems, highlighting a stark disparity between the number of medical devices requiring certification, and the official bodies able to do it. The implementation of these regulatory

In hardly any other area are stakes as high as they are in medical technology. As human life depends on it, medical equipment needs to fulfil the highest standards possible in terms of reliability, safety, and cleanliness. Many medical devices move media or create vacuums – be it blood, medication, oxygen, air, reagents, etc. Therefore, the pumps used in the systems need to adhere to the same strict standards.

In short: pumps are a cornerstone of modern medical technology. Here, KNF, the world market leader for diaphragm pumps and systems, has taken over a globally leading role in providing cutting-edge pumps for the medical sector.

Within the medical field, diaphragm pumps have proven superior in many aspects to other pump types for a wide variety of applications. First and foremost, diaphragm pumps, by design, are extremely clean and offer maximum safety as well as reliability.

They work oil-free, are leak-tight and move fluids in a very gentle way. Contamination of the medium by the pump or leakage can thus be reliably avoided. Another designrelated advantage is their compact size, making them fit even in the most limited spaces.

As diaphragm pumps offer so many advantages in medical technology, it is no wonder that KNF provides diaphragm pumps for nearly every medical application where media need to be moved. Customers trust in KNF because the company builds long-lasting relationships.

This allows customers to find the ideal solution and to be able

The liquid pump KNF FP 70 offers Smooth Flow Technology for minimum pulsation and is therefore perfectly suited for medical applications close to the patient.

to receive help with engineering challenges as well as aspects like certification. The decades of experience KNF has gained with agency regulations, audits and the complex approval process in the medical sector, help the company to quickly and reliably get to the optimal individual pump solution.

In addition to their design-based advantages, diaphragm pumps are also used in medical technology due to their versatility. Suitable for all kinds of fluids as well as vacuum applications, they can perform various tasks. In addition, many pump aspects can be customised to a specific application.

Diaphragm pump parts that touch the media can be manufactured using many different materials like PTFE, EPDM, PPK, PP, stainless steel and many more which make the pumps chemically resistant. Also, the motor can be chosen starting with low cost DC motors options to high-performance, long running advanced BLDC motor options. Depending on the specific application, many other aspects can be customised as well.

At KNF, customisation opens lots of options, many of which are especially interesting for medical applications. As many medical devices operate near patients or are even directly connected to patients, it is crucial that medical pumps work discreetly. For this, KNF offers a number of options like using a smaller eccentric, silencers, pulsation dampeners or shock mounts.

For liquid pumps, KNF has also developed a special Smooth Flow Technology that creates almost no

Customers value the individual customising options which allow for tailoring KNF pumps to the specific needs of every application.

pulsation and therefore works very discreetly. These measures not only help with fluid dynamic issues but directly contribute to patient comfort and therefore improve recovery directly.

The development of medical equipment often involves very long validation and certification processes. Once the device has been approved and launched on the market, manufacturers highly appreciate if the components used in the device remain available over a long time horizon.

KNF pump series are available over very long periods of time. When a standard product reaches the end of its life cycle, KNF informs customers well in advance. For customer-specific products, the lifecycle can even be defined to the choice of the customer.

Medical applications can roughly be divided into the areas of diagnostics and therapy. KNF offers pump solutions for both. In diagnostics, KNF pumps take on tasks like degassing, liquid waste handling, needle washing and drying, tissue preparation for pathology and histology as well as recirculation and replenishment of liquids.

Pump applications for therapy and treatment are also very diverse. KNF pumps are used in autoclaves, cardiology, cosmetics, dental treatments, dialysis, endoscope cleaning, ear, nose and throat treatment, negative pressure wound therapy (NPWT), non-invasive therapies, orthopaedics and pulmonary function as well as suction units. Typical examples of KNF pumps used in medical applications are the KNF FP 70, NMP 830 HP and KNF N 96.

Compact and high-performing – the N 96 is suited for gas sampling analysis and all other procedures requiring reliable and precise transfer of liquid or gaseous samples. As the world market leader for diaphragm pumps, KNF provides OEM pumps for nearly all medical applications that need pumps.

The KNF Group is the world market leader for diaphragm pumps. Its portfolio includes OEM, process, and lab solutions for gases, liquids, and vacuum applications. The technologies are used in areas like medical, inkjet, gas analysis, food, chemical and nanotechnologies.

Founded in 1946 in Freiburg, Germany, the family-owned company currently operates 24 locations worldwide and employs more than 850 people. Production is in Switzerland, Germany, France and the US. The Swiss locations are special competence centres for liquid pumps and for micro gas pumps and KNF operates a sales centre dedicated specially to the Swiss market.

Customers value a pump that truly fits their needs. Therefore, most of the KNF pumps sold are customised to perfectly fulfil application-specific needs. For this purpose, KNF has developed a special modular design approach for all its pumps. This way, main components like mechanics, materials, and motors, as well as the electrical and hydraulic connections, can be adapted based on proven options which makes customising fast, reliable and economic.

Drawing from the many customising options aspects like high capacity, extended service life, high pressure, leak tightness, high chemical resistance, noise reduction, different port configurations, and much more can be realised.

Another advantage of the modular approach is that any batch size from one unit to thousands of units can be easily realised in this way.

The high engineering and product quality of all KNF products have a great beneficial impact on their total cost of ownership. Their long and reliable service life allows for uninterrupted operations over long periods of time, keeping productivity at a maximum. This way, costly downtimes and servicing can be avoided. In addition, most KNF pumps are repairable which enables users to only maintain affected parts without the need to replace the entire pumps.

For pumps used in less demanding applications, KNF also offers options to achieve an optimum total cost of ownership. For example, pumps that do not have to run for very long can be fitted with a more economical motor. This way, customers do not have to use overengineered solutions and only pay for parts and components that are really needed for their specific application.

With a high performance to size, efficiency and weight ratio, the micro diaphragm gas pump KNF NMP 830 HP is the ideal choice for medical devices and analytical equipment alike.

Knowledge of the human body and how we should respond to failures in its systems have progressed at an unprecedented pace. We now know that due to genetics, no two people will react to the same disease, drug, or treatment in the same way. Even environmental and lifestyle choices can affect a person’s medical outcome. This is where personalised healthcare comes in.

Personalised healthcare is no longer about targeting and treating; it has shifted towards understanding how all of life’s nuances can be factored into a patient’s care plan to improve their health outcome.

CSEM has challenged itself to create future technologies that positively impact the Swiss economy, society, and our planet. It contributes to this new era of healthcare by innovating gold-standard (ISO 13485 certified) digital, life science, and wearable medical technologies for partners in the healthcare, fitness, and wellness industries who share CSEM’s vision.

Transformation of the personalised healthcare sector can be linked to the advancement of connected devices. Smartphones, watches, and other wearable solutions are now equipped with sensors for monitoring multiple human vital signs and AI-powered data analytics. These technologies collect the nuances in life that enable precise and tailored patient treatment.

With its partners, CSEM has already launched several digital solutions that improve patients’ lives. For example, its data science and algorithms have helped thousands of people conceive a child via a fertility bracelet that provides non-invasive detection of the fertility window in real-time.

CSEM’s cuffless optical blood pressure monitoring technology combines optical sensors and clinically validated software algorithms to revolutionise how people with hypertension manage

their condition. This technology has since been linked to a wrist-worn wearable that can monitor an individual’s blood pressure 24 hours a day. Another development sees CSEM’s non-invasive optical algorithm technology enable accurate blood pressure monitoring by placing a fingertip on a smartphone camera.

“Medical Wearables, connectivity, flexibility and scalability offer unrivalled benefits,” says Jens Krauss, Vice President of Systems at CSEM. “Our technologies can monitor the cardiovascular system, the respiratory system, the brain, our muscle movements, and more – these technologies collect the digital biomarkers that make each person unique, our nuances.

“We work with our partners to understand how they want to use these biomarkers and help them find ways to efficiently manage their health data, using the most appropriate technologies. Ultimately, this means patients can gain easier access to advanced healthcare technologies, encouraging them to be a part of their diagnosis, treatment, and care from the outset.”

Data on its own cannot save lives. Correctly managing, analysing, and extracting the proper insight from data makes the difference.

“CSEM’s data science experts design, implement, and validate all our custom data-driven medical diagnostic models and decision support. We have decades of experience in designing and miniaturising medical wearables, which we strengthen with our ultra-low-power ASICs, ensuring their autonomy and portability,” says Krauss.

The benefits of this mean not only can diagnostic times be reduced, but in this online era, patients can access their data quickly and receive care in the comfort of their homes while being monitored by their medical practitioners. During the pandemic, CSEM worked alongside the European and Italian Space Agencies and other partners to develop a remote, real-time, patient vital sign monitoring service based on wearable technologies and a cloud platform. This allowed healthcare providers to monitor the health evolution of COVID-19 patients in their homes. It also helped reduce medical costs and stress on the healthcare infrastructure.

CSEM also works in the life sciences to narrow the gap between applied sciences and industrialisation, bringing together emerging microtechnologies and the biotech and pharmaceutical industries.

The central role of life sciences companies in drug pricing and access to medicines puts them on the frontline of societal challenges, such as aging populations or disease outbreaks. Through the convergence of biology and technology, new possibilities have been opened to diagnose better, plan therapies and treat diseases.

Combining engineering, biological understanding, and having a cutting-edge infrastructure CSEM is pushing the boundaries of life sciences technologies to accelerate drug discovery and enable personalised therapies.

“From design to technology validation in biosafety laboratories, CSEM uses the latest advances in cell microsystems, biomonitoring, and lab automation,” outlines Vincent Revol, Head of Research and Business Development in Life Science Technologies at CSEM. Most recently, CSEM and its partners have developed a multi-axis bioreactor to help treat lower back pain. While this condition is not life-threatening, it is a social burden with a high socioeconomic impact.

Regarding automated cell microsystems, CSEM’s solutions enable the standardisation and parallelisation of microphysiological systems on chips and plates. Equally, CEM is developing solutions to standardise the production, sorting, positioning, maturation, and testing of complex 3D models, a game-changer for personalised medicine, drug discovery, preclinical drug testing, and regenerative medicine. Data analytics at the single-cell level are also being conducted at CSEM, as the company masters cell biosystems to develop novel cellular technologies. Meanwhile, low-cost solutions created by CSEM measure biomarkers in body fluids and access biological data in real-time for biomonitoring and point-of-care diagnostics.

“We also develop electrochemical, mechanical, and optoelectronic sensors for application within diagnostics and cell cultures, and harnesses proprietary low-cost fabrication technologies for sensing, sample preparation, and interface layers,” Revol shares.

“All the while, lab automation and AI are utilised to achieve reproducible and valuable results in a broad range of applications, enable faster results with fewer materials and reagents consumed, and free users from tedious manual work,” Revol concludes.

From life sciences to medical wearables and digital health, CSEM is enhancing healthcare. With nearly 40 years of technological experience, the company combines its multi-disciplinary skills to meet the personalised health industry’s specialised needs. The company has six sites across Switzerland, with two locations, Allschwil and Bern, focused entirely on progressing wearable medical devices, data-driven digital health solutions, and life science tools that enable the best patient outcome.

Chief Operating Officer of Medeco-ch, Sheela Bagnoud, tells us more about the Swiss family business providing quality medical implant distribution

Sheela Bagnoud, COO (SB): Medeco-ch is a Swiss family business created and developed in 2011 by Sheela and Cédric Bagnoud. The company is located in Duillier in the Canton de Vaud, halfway between Lausanne and Geneva. With a dedicated team of 23 people, our company distributes exclusively medical implants to hospitals and clinics throughout Switzerland to treat traumatology cases (broken bones) or patients affected with orthopaedic diseases such as arthrosis, bone deformity, etc. All products are stored, packed and shipped from our 1,000m2 facility located in the countryside. Our main partners are mostly situated in other European countries, including Kerimedical, Newclip, Orthofix, Bonalive and Bioretec, among others. We also have one supplier in the US (Viscot).

SB: We are known for providing sterile set solutions that are immediately available whenever needed and without delay. We have a wide portfolio of such sets that allow you to immediately operate on patients with broken bones or deformity corrections. Products are on the shelf and surgeons can operate according to their needs without taking the decontamination and sterilisation process into account. These types of products are also proven to have a better carbon footprint than traditional reusable sets.

Our second strength is training. A lot of companies have decided to cut down on investments in this area, however we have decided that training our customers is a major focus. In partnership with our key manufacturers, we propose a wide range of professional courses on various supports (online and in person) which combine theory and practical sessions. Most of these courses are provided by peers, and this allows an exchange of good practice and case discussions.

The proper placement of implants assures a better fit and efficiency in their purpose. Our surgeon customers and the medical staff need to be confident in the implants and products that they are using in order to provide the best treatment to their patients.

Finally, we believe that service is crucial. We deal with all requests with the same intensity and care as if the patient treated were a family member. We deliver orders in 24 hours and our team is available to help and assist our customers at every step. We even have an emergency number available 24/7 if needed.

SB: As a well-established Swiss distributor, we have the chance to partner with the manufacturers that we choose. Quality and reliability of the products as well as compliance with the present regulations in Switzerland are key factors in our selection. In the past year, we have invested a lot to secure product availability in the Swiss market. We have accepted the role of Swiss Representative in addition to our responsibilities as importer and distributor for our major manufacturers.

SB: Bringing disruptive technology to the market allows the restoration of patients’ functions and gives access to treatments that are challenging or that the human mind finds complicated. Innovation is also about listening to the problems that our customers are facing and thinking out of the box to find the solution.

For example, for the treatment of rhizarthrosis of the thumb, we can propose a dual mobility thumb prosthesis called TOUCH which has proven to have excellent results in restoring the functions of the thumb.

SB: We have been a member of Swiss Medtech since its creation. We were in fact already members of the former Fasmed group. Being part of an association like Swiss Medtech allows us to be active in the decisions that could affect us and the medical business in Switzerland. We get the support, feedback and advice of the whole sector and it is reassuring. We also get regulatory information and explanations in time without having to look for it.

SB: Our priority is to understand the market needs even better and continue developing our services to our customers. We also want to maintain the sustainability of middle and small companies which can provide attractive and flexible solutions to patients in Switzerland. Competition is healthy!

Route de Trélex 8, 1266 Duillier, Switzerland T: +41 22 3070170 info@medeco-ch.com

changes is having a detrimental effect, as many Medtech products are disappearing from the market entirely as companies are forced to reduce their portfolios, whilst other products are increasing in price by an average of six percent due to escalated expenses.

Additionally, the dissolution of the institutional agreement between Switzerland and the EU threatens the country’s Medtech sector after it was relegated to third-country status in 2021, resulting in a host of negative implications including increasingly stringent requirements for placing products on the Swiss market.

The consequences of this are impacting Swiss importers, who are shifting away from the market. Indeed, research from the Swiss Medtech industry report demonstrates a recorded loss of 15 percent in product portfolio due to the country’s new third-country status. It is a sad story for what has traditionally been an extremely healthy trade balance within the Medtech field between Switzerland and the majority of foreign countries, with Germany and the US as the two most prominent trading partners.

• 1,400 companies • 67,500 employees • Contributes 11.5 percent to Switzerland’s positive trade balance • CHF6 billion imports • CHF11.9 billion exports • CHF20.8 billion turnover • 6.4 percent sales growth per annum, 2012-2021 • 3.1 percent employment growth per annum 2012-2021

Source: Sector Study Swiss Medical Technology Industry (2022)

The combination of these three unique conditions - the proven growth recorded during the pandemic period, together with regulatory change and prohibitive policy frameworks - place Switzerland’s Medtech sector in a state of uncertainty.

To guarantee a prosperous future, industry players must also overcome the shortage of skilled workers it currently faces. This applies to the supplier field, and for manufacturers who are struggling to recruit a workforce with expertise in regulatory affairs and R&D in addition to production personnel.

Meanwhile, the Medtech sector, as with all fields, continues to adapt to the key drivers of innovation, by improving its ecological footprint in terms of sustainability and diversity to increase competitiveness, whilst also advancing the other prevailing industry trend of digital transformation. This includes the incorporation of Industry 4.0 in manufacturing processes and product innovation with the development of smart devices. The latter represents a major hurdle looking ahead.

Nevertheless, survey results show that above-average sales growth of 8.5 percent is predicted for the next two years. Switzerland continues to maintain its reputation as an attractive destination for investment, with the country’s stable economic environment and wealth of Medtech expertise representing the two major contributing factors.

Preserving its status as one of the best healthcare systems in the world, the entire industry will move forward united by the ambitious vision of Medtech 2030, which entails a series of goals designed to channel its collective will to shape a diverse and innovative economic sector.

Sophisticated solutions in the field of medical device implants often require a range of skills that a single company can hardly muster alone. Such developments require close cooperation with partners who offer complementary competencies. Cendres+Métaux, a Swiss manufacturer of high-precision implantable components, specialises in offering related skills and services to further the market success of its customers.

Medical technology developments require the interdisciplinary cooperation of partners with comparably high levels of competence in the field. An important prerequisite is in-depth experience with the rules and prescriptions governing the activities related to the development and approval of medical technology products. In the early stages of such a project, an assessment of the basic feasibility of expectations and of the processes that might be suited to master the production of the desired device often plays a decisive role. This in turn means that a positive outcome of such a project is more likely the earlier in the development process that partners begin to cooperate. For such endeavours, Cendres+Métaux can contribute a host of very experienced specialist teams along the whole value chain. The number and extent of customer projects that it has been able to foster until market maturity and successful commercialisation underscores its role as a competent and trustworthy partner for new development undertakings.

Cendres+Métaux masters the full range of manufacturing technologies in its healthcare, from basic production processing such as casting, forming, turning, milling or injection moulding through surface treating, cleaning, assembly and packaging to supply chain and E2E (end-to-end) order management.

The association was founded in 2017 through the merger of two predecessor organisations with the aim of joining forces and speaking with one voice. Our overarching goal is to make a valuable contribution to people’s high quality of life: excellent products, attractive jobs, and a substantial contribution to the gross national product.

PB: Since May 2021, the Swiss medical technology industry has been in third-country mode vis-à-vis Europe. This has placed great demands on exporting companies, as they are now forced to appoint an authorised representative in the EU. These are not letterbox companies, as an authorised representative requires specialist expertise, has to deal with liability issues and must have technical product documentation ready.

Uncertainties and additional work have also arisen for importers. Obstacle-free import is history with the third country mode. Importing has become more complicated and more expensive.

Swiss companies, like all other players, are affected by the implementation difficulties of the European Medical Device Regulation. The transition from an old to a new certificate is also expensive and often without added value. This is a source of concern for all players.

At Congenius, we provide tailored MedTech consultancy services to global firms, established SMEs and aspiring start-ups. Our experts are ready to help with challenges related to medical devices, combined products and in vitro diagnostics.

enhanced medical solutions.

Find out more at congenius.ch

PB: One of the new features is that from now on all manufacturers, distributors and authorised representatives must register in the new Swiss medical device database, Swissdamed. This is because Switzerland no longer has access to the central European medical device database. In a second step, all products imported into Switzerland must also be registered, with the aim of enabling Switzerland to carry out its market surveillance autonomously.

PB: Many young companies are emerging in our country in the life sciences, including medical technology. They transfer the latest clinical findings and technologies into practice. It is great that there are always start-ups that survive the critical initial phase to grow and flourish independently. This ensures the ongoing renewal of this vibrant and technology-driven industry.

PB: The home market is simply too small for our companies to legitimise the high investments that are needed in our industry. Internationalisation is therefore a must. Producing companies weigh up the advantages and disadvantages of Switzerland as a location very carefully: which processes should remain in Switzerland because of their complexity and can best be realised here. And, which operations can take place more cost-effectively in Europe or even in Asia in order to realise the best cost/benefit ratio.

PB: In our last industry survey of April 2022, our members were very optimistic. Spending on medical devices will continue to increase globally. After all, the COVID-19 pandemic has impressively shown that health comes first for many people. Our industry, together with the pharmaceutical industry, offers excellent solutions. However, from Switzerland’s point of view and our background as a high-priced production location, it is a constant effort to keep pace with international competition.

Tel: +41 31 330 97 79 office@swiss-medtech.ch www.swiss-medtech.ch