Early Feasibility Studies for Medical Devices: HEU‑EFS Progress and Implications for Early Evidence Generation and HTA

This webinar will provide an update on the HEU-EFS project from the first introduction in the HTAi Seville Annual Conference and explore the role and impact of Early Feasibility Studies (EFS) in early clinical evidence generation for innovative medical devices.

Participants will gain insights into the project’s objectives, key achievements, and the current state of EFS implementation across Europe. The session will also discuss how EFS can support health technology assessment (HTA) by reducing evidence uncertainty and informing decision-making throughout the medical device lifecycle.

The webinar will conclude with an interactive discussion on opportunities and challenges for integrating EFS into European innovation and assessment pathways.

The MDIG Co-Chair, Richard Charter, will serve as the webinar moderator.

Speakers: 

Adrian ValledorProject Manager, The Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain

Laura Sampietro-Colom                  Deputy Director of Innovation, Head of Assessment of Innovations (HTA), Hospital Clinic de Barcelona, Spain

Giuditta CalleaAssociate Professor of Practice, SDA Bocconi, Italy