Speaker

David Bouchez

Presentation title

Clinical Trials with Medical Devices

Presentation outline

The medical devices industry plays an increasing role in health- and social care. It is now accounting for a significant amount of public health expenditure and is in the top tier in Europe for R&D spend, investing around €7.5 billion each year - around 8% of annual sales. As major societal challenges such as an ageing population will call for innovative healthcare systems, medical devices technology has the potential to deliver innovative solutions that address diagnosis, prevention, or treatment of patients, mitigate the shortage of healthcare professionals and address the sustainability of healthcare systems. One of the key driver for innovation in this industry is the exceptionally short lifecycles, inducing strong competition and will for innovation. However, challenges to innovation are building up, some being very similar to pharma industry: escalating costs, reimbursement and pricing, lack of innovation funding, the healthcare markets (private consumers and public payers), … Detailed clinical data is also required to get regulatory authorizations and to convince healthcare markets, especially by proving  clinical & cost benefits. Mindsets need to be changed not only to integrate this but also innovation should increasingly be centered on the patient and the user, and should be demand driven. Part of these challenges are quite time-intensive, demanding resources that are often in short supply in SMEs, which are 80% of medtech companies in Europe.

Job title

Clinical Program Manager Stentys, Consultant at Unamec

Biography

David graduated as Civil Engineer from UCL, Louvain-la-Neuve, and owns an MBA from Solvay Brussels School. He started his career as research engineer in Fluid Mechanics at the von Karman Institute. He has over 10 years of experience in the medical device industry, mainly in clinical research, in large and small structures, in cardiology and neurology. He is currently clinical program manager in Stentys, a startup company which has developed a stent technology dedicated for coronary lesions in acute myocardial infarction patients and for coronary bifurcation lesions. He is consultant for the Unamec for Clinical trials with medical devices, and is lecturing in the frame of the Unamec Masterclasses. He is interested in promoting clinical trials with medical devices.