Including Clinical data into the development of a new Medical Device, from the idea to post-market follow-up
This 10 day summer school strengthens the skills of engineers and executives of medical device companies – including the skills needed to generate the clinical data that satisfies EU regulation 2017/745 on market approval of new products. Participants receive experiential training in the appropriate steps to take throughout the development cycle of a new medical device, with an initial phase of immersion in a hospital followed by theoretical and practical training.
About this activity
This summer school will take place in the mountains near Grenoble, France from 2-12 July 2019. After the success of the first ClinMed Summer School in 2018, we choose to keep the same organisational framework, but to extend it to more partners, to enlarge dissemination and increase the critical mass of suggestions and ideas. The aim is train attendees on the subject of technological innovation in health by giving a global vision of a medical device maturation cycle, from the idea to the market. The course is based on the pedagogical concepts of experiential learning and design thinking. It starts with a three-day immersion phase at a hospital or a living lab, where teams of 5-7 participants exchange ideas with healthcare professionals and/or patients about a problem or challenge that can be addressed with an innovative new product. In a second, seven-day phase, participants attend lectures and work on project development, with remote coaching from the lecturers and experts they met during the immersive experience. At the end of this second phase, projects will be presented, with the best ones receiving awards.