The Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) presented @ISPOR Europe 2023: an opportunity to raise awareness and fuel dialogue on Early Feasibility Studies in the European Union

ISPOR is the leading professional society for Health Economics and Outcomes Research (HEOR) globally, dedicated to promoting HEOR excellence to improve decision-making for health. The ISPOR annual conferences represent a unique arena to discuss cutting topics issues with a multi-stakeholder audience including, among others, health technology developers, regulators, healthcare providers and professionals, patient organizations, and research organizations.

The abstract “Setting up a Harmonized Methodology to Promote Uptake of Early Feasibility Studies for Clinical and Innovation Excellence in the European Union: What Value(s)?” submitted by the HEU-EFS Consortium had the privilege of being accepted as a Breakout Session at the 2023 edition of the European ISPOR annual conference held in Copenhagen (Denmark) from 12-15th November 2023.

The session was a unique opportunity to raise awareness regarding the 4-years project ‘Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union’ (HEU-EFS) funded by the Innovative Health Initiative (IHI) and engage participants in the discussion.

Giuditta Callea, Associate Professor of Practice at SDA Bocconi School of Management (Italy), presented the HEU-EFS Project rationale and objectives and discussed the potentials of the future EU EFS Program with Tom Melvin, Associate Professor at Trinity College Dublin (Ireland), Kristian Kidholm, Professor and Head of research at Center for Innovative Medical Technologies at Odense University Hospital and University of Southern Denmark, and Fanny van der Loo, Director Public Affairs at EU | EMEA | CAN | LATAM at Edwards Lifesciences.

The inspiring comments and questions from the audience contributed to advancing the conversation on the establishment of a robust framework for the conduction of EFS in the EU and confirmed the strategic importance of improving pre-market clinical evidence generation pathways in the EU, to facilitate patient access to innovative medical technologies and positioning the EU as a leader in the global MedTech ecosystem.

Link to ISPOR Breakout Session