HEU-EFS KICK-OFF MEETING
30-31st OCTOBER 2023, MILAN: the launch of an innovative EU initiative to foster innovation in the MedTech sector.
In an exciting and collaborative atmosphere, the kick-off meeting of the “Harmonized Approach to Early Feasibility Studies for Medical Devices in the European Union” (HEU-EFS) project took place on October 30-31 at SDA Bocconi campus in Milan, marking the initiation of a ground-breaking initiative aimed at fostering patient-centred innovation and cooperation within the EU MedTech sector.
TheHEU-EFS project will facilitate access to innovative medical devices (MDs) in the European Union (EU) by developing a shared and breakthrough program dedicated to Early Feasibility Studies (EFS), small clinical studies designed to gain early insights into an innovative medical technology during the development process. This program will contribute to making the EU an attractive jurisdiction for innovative MDs developers and accelerate patients’ access to the best possible care. This 4-year project secured €10.53 million in funding from the European Commission and €8.47 million from industry partners, for a total of €19 million, as part of the Innovative Health Initiative (IHI). The commitment of IHI – a public-private partnership between the European Commission and major industry associations – and the partners reflects the relevance of EFS and the common understanding of the need to evolve toward a collaborative, system-wide approach to support innovation in the EU.
The kick-off provided an opportunity to bring together for the first time the diverse group of stakeholders composing the consortium, for a total of 22 partners from 13 different countries, and representatives of the Advisory Board, and to establish a solid foundation for successful collaboration.
The kick-off was opened by Rosanna Tarricone (Associate Professor at the Department of Social and Political Sciences Bocconi University and Associate Dean for Government, Health and Non-Profit Division SDA Bocconi) as Project Coordinator, Andrea Rappagliosi (Senior Vice President Public Affairs, EMEA, Canada and Latin America, Edwards Lifesciences) coordinator of the private part of the consortium and Geraldine Joanny (IHI Scientific Project Officer), who emphasized the significance of this collaboration among public and private stakeholders in tackling EU health challenges.
After a roundtable presentation of all the partners, an overview of the project’s background, goals, timelines, and expected outcomes was provided, followed by a deep dive into the specificities of the 9 WPs composing the project.
The meeting facilitated fruitful discussions on the relevance of early clinical evidence generation as a first step in a lifecycle approach. It was also an occasion to clarify legal and administrative rules, discuss the distribution of responsibilities among the consortium members, and emphasize the importance of continuous and effective communication. A key highlight was the discussion on how to engage patients in the project to effectively implement patient centricity in decision-making.
The enthusiasm and collaborative spirit witnessed during the kick-off meeting set a positive tone for the journey ahead, promising breakthroughs and advancements that will elevate healthcare innovation within the EU.
ISPOR
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
