On Wednesday June 14, InSciTe and the orthopedic department of Maastricht UMC+ organized a symposium first-in-man medical device clinical trials at the NH hotel in Maastricht.
Why this Symposium?
The setup and successful realization of first-in-man medical device clinical trials are immense challenges requiring elaborate planning and documentation. The upcoming changes in regulations makes this even more complex. Therefore, the organizing committee decided to host a Symposium on this topic to share knowledge, expertise and network to create awareness and stimulate collaborations for a more effective process towards and during clinical trials.
The opening of the Symposium was done by Albert Scherpbier, dean of Faculty LFH Maastricht UMC+. As a dean of the faculty and chairman of the Board of InSciTe he stressed the importance of this topic for InSciTe as well as the academic partners. Paul Willems, orthopedic surgeon at MUMC+ started the day with explaining his current projects and the hurdles he needs to overcome to get ‘from bench to bedside’.
Other presentations were given by, among others, life sciences and IP lawyer, Erik Vollebregt about legal issues relating to clinical investigations of medical devices and expert consultant in international medical device regulations, Peter Ruys about legislation for medical devices and risk management process by Jeanette van Loon.
The symposium was visited by around 100 invitees from Maastricht UMC+, Brightlands Chemelot Campus, InSciTe, Technical University Eindhoven, KU Leuven and affiliated (startup) companies.