Dissecting the unique quandary of the Swiss Medtech sector and hopes for the future in the wake of regulatory and policy change.
SWISS MEDTECH SPOTLIGHT
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.
A CHALLENGING FIELD
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 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.
AN UNCERTAIN FUTURE
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.