From Clinical Innovation to the Market, Choices of a StartUp to Navigate the current Regulations. Fitting a promising innovative technology (applying photonics and pics) into solving a relevant clinical problem requires many critical choices to consider early on.
Based on a real-world example in measuring cardiac output in heart patients, Arthur Bouwman, cardio-anaesthesiologist and co-founder of a medical device start-up, and Claus Schaffrath, partner at a medical device consultancy, describe clinical and regulatory choices, and their consequences for bringing a medical device to the market.
Being innovative requires a lot of specific technological expertise from companies. In order for a medical device to become a success in the market and to improve people’s lives, these technical challenges come with hurdles such as compliance with applicable regulations.
International experts on stage!
- Lisette van Steinvoren, Competence Lead MedTech, Holland Innovative
- Geofrey De Visscher, Head of Notified Body 1639, SGS, Belgium
- Joris Jaspers, Head of Innovation / Associate professor, Medical Technology, UMC Utrecht
- Massimo Marcon, President, I-TECH Medical Division, Italy
- Lieven de Maesschalck, Innovation Manager, Mobilab & Care, Thomas More, Belgium
- Duo presentation
- Arthur Bouwman, Board member, Amazec Photonics / Cardiac anesthesiologist, Catharina Hospital Eindhoven
- Claus Schaffrath, Managing Director, MD squared B.V.
- Jos van der Wijst, Tech lawyer, BG.legal
- Edwin van der Heul, Business Development Manager Healthcare, Albis
- Duo presentation
- Holger Willems, Co-Founder & CEO, Relu
- Jonathan Boel, Senior Project Manager, QbD Group
- Peter Julius, CEO / Partner, Public Intelligence, Denmark
- Rosario Iannella, Founder | CTO | Board Member, Qardio, Inc., USA / The Netherlands
Tikcit – Health Tech Event, The International Conference for Medical Innovation & Regulation, November 22-2022