Work Package 2 Video Guide

In this video, you will hear from Tom Melvin (Trinity College Dublin) and Nicolas Martelli (Hôpital Européen Georges-Pompidou) as they elucidate that Work Package 2 of the HEU-EFS project is dedicated to ensuring the future EU EFS Program aligns with existing regulations and standards, and involves evaluating the readiness of EU competent authorities to support robust pre-market clinical investigations, particularly for Digital Health Technologies.

At HEU-EFS, we believe that collectively, as a consortium of 22 institutions, SMEs and private companies, we can impact the health and well-being of people in Europe and beyond.

To learn more about the HEU-EFS’s progress and outcomes, follow us on LinkedIn and X.

Work Package 1 Video Guide

A diverse group of female medical students listen attentively while seated for a lecture.

In this video, you will hear from Giuditta Callea (SDA Bocconi) and Marta Kerstan (DePuy Synthes) as they explain the comprehensive research and analysis we employ as a consortium to understand Early Feasibility Studies (EFS) and their regulatory environment, ultimately aiming to develop a harmonised EU methodology that will enhance their adoption and support medical innovation in Europe.

At HEU-EFS, we believe that collectively, as a consortium of 22 institutions, SMEs and private companies, we can impact the health and well-being of people in Europe and beyond.

To learn more about the HEU-EFS’s progress and outcomes, follow us on LinkedIn and X.

HEU-EFS Interim Consortium Meeting

Advancing Premarket Programmes and Communication

[10 April 2024, online] – The HEU-EFS Consortium convened an online interim review meeting, marking a significant milestone in our journey towards harmonising Early Feasibility Studies (EFS) across Europe.

Key Outcomes:

  • Conducted detailed research of the regulatory framework and premarket programmes, pinpointing challenges to the implementation of Early Feasibility Studies (EFS).
  • Strategies are being developed to address these challenges, aiming to streamline the process for healthcare innovations.
  • The website is evolving into a key resource for disseminating research findings and engaging the healthcare community.
  • Communication enhancements are underway to build a network of stakeholders vital for the EFS implementation across the EU.
  • Tools for monitoring the performance of the EFS programme are in the development phase.

The collaboration and expertise of our consortium members were on full display as we worked together to address the challenges and opportunities within the EFS ecosystem. We are excited to share that our collective efforts are paving the way for a more efficient and effective European Health System.

Stay tuned for more updates as we continue to break new ground in healthcare research and patient care.

You can follow us on LinkedIn and X.

A Video Guide to the HEU-EFS Project

In this video, you will hear from Rosanna Tarricone (SDA Bocconi) and Andrea Rappagliosi (Edwards Lifesciences Europe) as they explain the challenges and opportunities of medical device innovation in the European Union. You will also learn more about the HEU-EFS project’s objectives, activities, and expected impact.

At HEU-EFS, we believe that collectively, as a consortium of 22 institutions, SMEs and private companies, we can impact the health and well-being of people in Europe and beyond.

To learn more about the HEU-EFS’s progress and outcomes, follow us on LinkedIn and X.

Call for interest: Applications welcome for HEU-EFS’s Patient Advisory Group

Consortium partners are pleased to announce a call for representatives for a Patient Advisory Group (PAG) for the project ‘Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS)’. Applications remain open until 20 February 2024.

The Patient Advisory Group will discuss and provide recommendations for structured patient contribution to Early Feasibility Studies, in short EFS, to make more patient-centred medical devices. Early Feasibility Studies (EFS) are small-scale research studies or tests done in the very early stages of developing a medical device or treatment to see if it is practical, safe, and worth pursuing further. EFS help assess whether an idea or concept has potential before investing more time and resources into full-scale development and testing. The patient perspective in Early Feasibility Studies is highly important.

The PAG is meant to form a hub for patient centricity and engagement across HEU-EFS’s implementation. The aim is to recruit a maximum of ten representatives. Read more here

CSI Focus for Heart Failure

On December 4th, the HEU-EFS IHI initiative was presented at the annual leading conference in the field of device-based heart failure therapy, CSI Focus for Heart Failure (D-HF).

The HEU-EFS Consortium was invited to introduce the HEU-EFS project at a session dedicated to moving the field of heart failure focused devices forward. Moderated by Drs. Horst Sievert and William T. Abraham, the topic complemented the other speakers and was presented to a audience of clinicians and industry.

The program was positively received and enabled the expansion of the external advisory board to include representation of ethics committees.

More information on the conference and the session can be found here:  https://www.csi-congress.org/conferences-courses/focus-workshops/csi-focus-d-hf/archive

Tutorials & Training

Executive Summary

HEU-EFS Project Video

Work Package 1 Video

Leader: Bocconi University

Co-leader: DePuy Synthes

Work Package 2 Video

Leader: Trinity College Dublin

Co-leader: Assistance Publique – Hôspitaux de Paris

Reports

Coming soon!