🌟 What an incredible event we had yesterday on navigating "The Medical Device Road-to-Market"! 🌟 A huge thank you to our distinguished speakers from Lymphatica Medtech (Marco Pisano), Euresearch (Irina Sakharova Quitt), Swiss Medtech association (Daniel Delfosse), and F+R services (Mayella Favre) for sharing their invaluable insights! 👏 Here are some personal takeway from the event: 1. Financing Clinical Studies: It's essential to target a large addressable market (>500M USD/year) and gather support from clinical communities and strategic partners. Beyond venture capital, Horizon Europe funding can significantly aid in financing these studies. 2. Regulatory Challenges: The phrase "US innovates," "Asia manufactures," and "EU regulates" highlights the unique landscape. However, EU regulations introduce significant uncertainties regarding time and cost. EU regulators need to understand that patient safety is not just about product safety but encompasses product safety, availability, and innovation! 3. Achieving Reimbursement: Gaining CE certification is just the beginning. The next phase—securing reimbursement—requires navigating a complex process involving a different set of stakeholders. So bringing a medical device to market is a long and challenging journey that demands extensive planning and the engagement of a diverse range of stakeholders at various stages. The event truly underscored that the success of innovation extends well beyond mere technological advancements. Thank you to everyone who participated and made this event a success. Looking forward to more such enriching sessions in the future! #Medtech #Innovation #RoadtoMarket #MedicalDevices #VDtech Innovaud
Doesn’t make addressing orphan and rare pathologies slightly easier for sure…
Thanks for the invitation, dear François Capel, to speak about the reimbursement of medical devices in 🇨🇭 and for the interesting conversations with the participants!
Vice Director, Head of Regulation & Innovation at Swiss Medtech
2moWhat a pleasure to talk to such an interested audience! But sad to see that no one opted for CE-mark first, but chose instead FDA first or both in parallel. This highlights the fact that under MDR, Innovation in Europe is taking a back seat!