The EU Medical Device Regulation heralds a new era for the medical technology sector: in future, any company wishing to bring medical devices to market must face the requirements of this new regulatory framework. This implies a sizeable challenge for the many small and medium-sized enterprises in Germany. The 9th edition of the joint media service “MedTech Radar”, published by the German Medical Technology Association (BVMed), Earlybird Venture Capital, High-Tech Gründerfonds (HTGF) and BIOCOM AG, discusses strategic considerations currently being developed and major consequences for innovative businesses. The latest MedTech Radar is available for download in the box on the right.
Since the EU MDR (Medical Device Regulation) entered into force in May 2017, the medical technology sector has undergone an upheaval. The 200-page MDR document includes in the main stricter rules at every stage of the CE marking process which a medical device must demonstrate before it may be sold on the market. How then will small and medium-sized enterprises and technology start-ups cope with this situation? What must companies do to adapt themselves? What consequences will the MDR have on the market and the innovations of the future? What strategic considerations presently exist among companies?
The current edition of “MedTech Radar” provides an overview of the most important changes which the MDR brings about that are relevant for medical technology companies. At the same time it helps young companies in particular with their orientation. The publication presents four companies which are involved with ultrasonics in dentistry (whitesonic), laser devices for dermatology (GME German Medical Engineering), 3D printing (Mecuris) and hip implants (PETER BREHM). The founders and CEOs report on how they are dealing with the higher requirements of the MDR and which aspects they believe are the most important for start-ups and medium-sized companies.
“The companies, whitesonic, GME German Medical Engineering and Mecuris, are representative of young medical technology firms that are well-prepared for the MDR. Start-ups in particular need to deal promptly with the new regulations and adapt their strategies accordingly,” says Dr Michael Brandkamp, CEO of High-Tech Gründerfonds.
“The MDR demands higher requirements in clinical research. Compared to other countries, Europe and especially Germany can build upon an excellent infrastructure which enables cost-efficient implementation of clinical studies,” adds Thom Rasche, partner at venture capitalist Earlybird.
“The current edition of MedTech Radar addresses the question as to how these innovative businesses are dealing with the profound changes related to the MDR,” says Dr Boris Mannhardt, CEO of BIOCOM AG. “The companies presented show that even as a start-up you can be well-positioned strategically.”
“According to our recent autumn survey, many medical technology companies see the MDR as an obstacle to technological progress and say they are worried about Germany as an innovation location,” says Joachim M. Schmitt, CEO and board member of BVMed. “We need planning reliability and clear implementation routes, both for transition periods and also for the clinical evaluation rules.”