Published in Health Policy and Technology the article “A Regulation-Based Project Life Cycle for Innovative Medical Devices: Delphi Consensus from an Italian Expert Panel”.
Bringing medical innovation from academic laboratories to the patient’s bedside is a challenging journey. A major obstacle for public research institutions is the early and effective integration of regulatory thinking into research projects and the development of innovative medical devices.
Developed within Spoke 5 of THE Tuscany Health Ecosystem, our study addresses precisely this gap. Through a modified Delphi process involving a dedicated panel of Italian experts in regulation and development, we established 33 practical statements covering the entire project lifecycle—from initial concept to final closure.
Our goal is to provide a concrete and well-informed regulatory framework that helps researchers seamlessly translate medical device innovation into clinical practice, fully supporting the core mission of public research: scientific excellence, patient benefit, and social impact.
The article is available QUI.
