ISPOR 2023

Copenhagen, Denmark

Session Title: Setting up a Harmonized Methodology to Promote Uptake of Early Feasibility Studies for Clinical and Innovation Excellence in the European Union: What Value(s)?

Why This Matters

The European Union currently lacks standardized procedural frameworks for the uptake of Early Feasibility Studies (EFS). This gap creates significant challenges for applying a lifecycle approach to clinical evidence generation for medical devices. As a result, patient access to innovative technologies is delayed, and EU competitiveness suffers.

To address these issues, the HEU-EFS Project, a 4-year initiative funded by the Innovative Health Initiative (IHI) and co-funded by six industry partners, aims to establish a harmonized approach to EFS for medical devices across Europe.

Giuditta Callea represented Università Bocconi, the leader of the HEU‑EFS Consortium, presenting the project’s rationale and objectives. She also moderated an engaging discussion on the potential of a future EU‑wide EFS Program with:

• Melvin Tom – Trinity College Dublin
• Kristian Kidholm – Center for Innovative Medical Technologies, OUH Odense Universitetshospital – Svendborg Sygehus
• Fanny van der Loo – Edwards Lifesciences

This session was designed for:

• EU and national regulators
• Competent authorities & notified bodies
• HTA bodies
• Healthcare providers
• Patient organizations
• Research organizations
• Legal & ethical experts
• CROs
• Health technology developers