The evaluation of medical devices: are we getting closer to solve the puzzle? A review of recent trends

Abstract

Over the last decades, the fast pace of innovation, high profile regulatory failures and updates in the medical devices directives, together with intrinsic or environmental characteristics of the products and industry, have turned the attention to the evaluation of medical devices. Medical devices are recognized to be different from drug technologies, however it is still not entirely clear whether these differences really matter with respect to their evaluation. In the title we ask the question of whether we are getting closer to solve the puzzle of the evaluation of medical devices. Thanks to years of research work, debates, discussion, experimentation and learning from errors, we have certainly made progress and developed a better understanding of what it is needed for a better evaluation of medical technologies. In this manuscript we present innovative approaches and promising trends, from in silico trials to early HTA, parallel submissions and, overall, adaptive pathways to evidence generation that could enable better, safer, and faster regulatory and patient access to devices. In the next future, it will be important to monitor the development and diffusion of these approaches and assess their impact. If the regulatory and HTA evaluation of medical devices is to continue to improve, establishing inter-disciplinary collaborations between clinicians and engineers, policy makers, patients and industry representatives will become key.