HEU-EFS at the EU HTA Conference

Giuditta Callea (SDA Bocconi)

A week later, we’re reflecting on the insightful discussions and collaborative spirit at the EU Health Technology Assessment Conference: “Advent of a New Era of Collaboration”. We were proud to see the HEU-EFS project represented at this key event, which marked an important step toward a harmonised approach to Early Feasibility Studies (EFS) for medical devices in the EU.

A special thank you to Giuditta Callea (SDA Bocconi) for her valuable contributions during the panel discussion, helping to shape the conversation around innovation in health technology assessment.

With pilot cases set to launch in 2026, momentum is building!

Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe

#HTA #MedicalDevices #EarlyFeasibilityStudies #ClinicalResearch

Other Materials

Newsletters

Issue #2 June 2025

Issue #1 November 2024


Project featured in Journals

Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table 

Stephan Windecker; Alan G. Fraser; Piotr Szymanski; Martine Gilard; Thomas F. Lüscher; Leila Abid; John Brennan; Robert Byrne; Lia Crotti; Inga Drossart; Jennifer Franke; Mario Gabrielli Cossellu; Ajay J. Kirtane; Jana Kurucova; Mitchell Krucoff; Gearóid McGauran; Patrick O. Myers; Donal B. O’Connor; Radosław Parma; Paul Piscoi; Archana Rao; Andrea Rappagliosi; Giulio Stefanini; Eigil Samset; Alphons Vincent; Ralph Stephan von Bardeleben; Franz Weidinger 
European Heart Journal, 46 (16), April 2025, Pages 1469–1479, https://doi.org/10.1093/eurheartj/ehaf069


FutureTrials25

We are excited to announce that Associate Professor Tom Melvin from the University of Galway, and a member of the HEU-EFS consortium, presented our project at the #FutureTrials25 event.

Event Overview: Organised by the University of Galway – Institute for Clinical Trials in partnership with Medtronic, a member of the HEU-EFS public-private consortium, this event brought together leading experts and stakeholders to discuss the critical systems, infrastructure, and policy frameworks needed to drive innovation in clinical trials. The audience included researchers, policymakers, healthcare professionals, and industry leaders.

HEU-EFS Presence:

  • In the session titled “Fostering an Enabling Landscape,” Prof. Tom Melvin shared valuable insights on the “EU Harmonised Approach to Early Feasibility Studies.” This session highlighted the importance of regulation, collaboration, and infrastructure in creating a thriving clinical trials environment.
  • The session also featured a panel discussion with our advisory board member, Dr Donal O’Connor, representing the Health Products Regulatory Authority (HPRA). The discussion emphasised the need for greater harmonisation and stronger connections between policy and practice.
  • In the third and final session, “Future Innovation/Emerging Technologies” Despina Voulgaraki, Senior Director for Clinical Research and Medical Science at Medtronic, delivered a keynote on the technologies and trends shaping the future of clinical trials, including artificial intelligence, decentralised models, and personalised approaches.

About HEU-EFS: The HEU-EFS project aims to develop a harmonised framework for conducting Early Feasibility Studies (EFS) for medical devices in the EU. By enhancing the uptake of EFS, we strive to boost the EU’s competitiveness and ensure that patients have access to innovative, safe, and effective medical technologies.

Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe

#ClinicalTrials #EvidenceGeneration #PatientCare #IHITransformingHealth #MedTech

HEU-EFS @ EORS 2025

HEU-EFS attending European Orthopaedic Research Society Annual Meeting

We are pleased to announce that the HEU-EFS project will be showcased at the 33rd Annual Meeting of the European Orthopaedic Research Society Annual Meeting, taking place from June 16 to 19, 2025, in Davos, Switzerland. The Summit aims to promote research and development in orthopaedic surgery, as well as related sciences, through interdisciplinary coordination, exchange of scientific and technical experience, and education. The event will take place at the Conference Center Davos, a renowned venue for the World Economic Forum.

The HEU-EFS project will use #EORS2025 as a platform to disseminate its latest results and developments.

The session will begin with an introduction to the HEU-EFS Project by Alexandra Poulsson from the Norwegian Institute of Public Health and Marta Kerstan from DePuy Synthes, followed by a keynote address from Chief Medical Officer Thomas Randau. A series of short expert presentations will be delivered by Marta Bragagnolo from Global Heart Hub, Yasemin Zeisl from European Patients’​ Forum, Ana Matos Machado (Neurosurgeon and Advisory Board Member of HEU-EFS), Sebastian Kuhn from The Philipp University of Marburg, Susan Partridge from BSI, and Roland Herzog from AO Foundation, culminating in a panel discussion featuring all speakers.

You are welcome to join us on Tuesday, 17 June, 11:15-12:40 (Room Sertig), to learn how HEU-EFS is driving innovation and improving clinical outcomes in orthopaedic research. Don’t miss this chance to connect with leading professionals and explore groundbreaking developments in the field.

Stay tuned for more updates and follow our journey at heuefs.eu.

Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe

#IHITransformingHealth #EvidenceGeneration #MedTech

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ISPOR 2025

Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders From the US FDA Early Feasibility Studies Program

Date: 15/05
Time: 13:45 – 14:45 (PDT)
Location: Montreal, QC, Canada
Session Type: Concurrent Breakout Session

Join us for an engaging session on Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders From the US FDA Early Feasibility Studies Program. This event will explore the challenges and opportunities in early-stage clinical investigations for medical devices (MDs) and what the EU can learn from the US FDA’s Early Feasibility Studies (EFS) Program.

Moderator:

  • Giuditta Callea, PhD, SDA Bocconi School of Management, Milano, Italy

Speaker:

  • Kevin Drisko, Edwards Lifesciences, Irvine, CA, United States

Session Overview:

  • Issue: Developing innovative, significant risk MDs often requires early-stage clinical investigations when non-clinical testing is unavailable or not informative. The US FDA’s EFS Program, established in 2013, provides guidance and oversight to MD developers while safeguarding patients. The fragmented EU regulatory system poses challenges to conducting EFS, potentially hindering innovation. This session will discuss what the EU and other global jurisdictions can learn from the FDA’s experience to facilitate safe and harmonized EFS.
  • Kevin Drisko (EDW) will offer insights into the advantages of EFS as an integrated step in MD clinical evidence generation.
  • Prof. Giuditta Callea will discuss the challenges of pre-market clinical research for MDs in the EU, representing multi-stakeholder perspectives and presenting findings from the HEU-EFS project.
  • Audience Q&A: Prof. Callea will direct audience questions.

This session is highly beneficial for regulators, healthcare providers, patient associations, academic and research organizations, CROs, ethical and legal experts, and technology developers. Don’t miss this opportunity to gain valuable insights and engage with experts in the field. Register here!

MedTech Forum 2025

Empowering European Innovators With Early Feasibility Studies

Date: 14/05
Time: 14:10 – 15:00 (GMT+1)
Location: Lisbon, Portugal
Session Type: Parallel session

Join us for an insightful session on Empowering European Innovators With Early Feasibility Studies (EFS). This event is part of the HEU-EFS project, an initiative by the Innovative Health Initiative (IHI) aimed at developing a harmonized EU framework to enhance the uptake of EFS for medical devices across Europe. EFS are vital in the evidence-generation cycle for medical devices, and conducting these studies in a coordinated manner will bring significant benefits to patients, innovators, and the entire healthcare system.

Moderator:

  • Niklas BLOMBERG, Executive Director, Innovative Health Initiative (IHI)

Speakers:

  • Alexandra POULSSON, Senior Advisor, Division for Health Services, Norwegian Institute of Public Health
  • Laura SAMPIETRO-COLOM, Innovation Deputy Director, Head Assessment Innovation and New Technologies Unit, Clinic Barcelona University Hospital
  • Rosanna TARRICONE, Associate Dean at SDA Bocconi, SDA BOCCONI SCHOOL OF MANAGEMENT
  • Fanny VAN DER LOO, Senior Director Government Affairs EMEA, Canada, Latin America, Edwards Lifesciences
  • Yasemin ZEISL, Project Coordinator, European Patients’ Forum (EPF)

Don’t miss this opportunity to learn from leading experts and engage in discussions that will shape the future of medical device innovation in Europe. Register here!

HEU-EFS at the ESC Cardiovascular Round Table with EMA

Advancing Patient-Centered Innovation

(l-r): Prof Piotr Szymański (ESC Regulatory Affairs Committee Chair), Dr Maria Sejersten Ripa (Novo Nordisk), Prof Cecilia Linde (ESC President Elect and CRT Academic Chair), Prof Lis Neubeck (ESC Patient Forum Chair), Dr Prodromos Anthopoulos (Cytokinetics)

The HEU-EFS consortium was proud to be represented at the European Society of Cardiology Cardiovascular Round Table (CRT) meeting with the European Medicines Agency (EMA) in Amsterdam. This high-level event brought together leading voices from cardiology, regulatory bodies, industry, and patient communities to explore how Patient Experience Data (PED) and Patient Reported Outcomes (PROs) can shape the future of cardiovascular care.

Notably, Maria Luisa Buzelli (SDA Bocconi) and Prof. Piotr Szymański, Advisory Board member of HEU-EFS and Chair of the ESC Regulatory Affairs Committee (2024–2026), contributed to the discussions, reinforcing the consortium’s commitment to regulatory innovation and patient-centered research.

Key Outcomes from the Round Table

The roundtable featured open and constructive dialogue on the role of PED and PROs in clinical trials and regulatory decision-making. Highlights included:

  • Elevating PROs to Primary Endpoints
    There is growing consensus that Patient-Reported Outcomes (PROs)—including quality of life, fatigue, and symptom burden—should be recognized not merely as supportive data but as primary endpoints in cardiovascular clinical trials. This shift reflects a broader commitment to capturing outcomes that matter most to patients.
  • Patient Experience Data (PED) as a Lens on Real-World Impact
    Patient representatives provided compelling narratives illustrating how PED can reveal treatment effects that traditional clinical endpoints may overlook. These insights underscore the value of integrating lived experiences into evidence generation.
  • Regulatory Alignment and Openness
    EMA representatives reaffirmed their commitment to incorporating PED and PROs into regulatory decision-making. Ongoing initiatives aim to refine methodologies and frameworks that support this integration.
  • Strategic Role of ESC Volunteers
    ESC volunteers are instrumental in operationalizing patient engagement. By identifying and preparing patient contributors with relevant clinical experience and communication skills, they ensure that patient voices are authentically and effectively represented in ESC initiatives

As Prof. Szymański noted, “This is a pivotal moment for aligning regulatory science with what truly matters to patients.”

Why This Matters for HEU-EFS

The HEU-EFS project is deeply aligned with these goals. By integrating patient perspectives into the design and evaluation of future cardiovascular therapies, HEU-EFS aims to ensure that innovation translates into meaningful patient benefit. The CRT meeting served as a powerful platform to showcase this vision and to engage with key stakeholders shaping the future of cardiovascular regulation.

Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe

#ESCardioCRT #HealthcareInnovation #PatientAccess #MedTech #EvidenceGeneration #ClinicalTrials

ESC Patient Forum

Annual Consortium Meeting in Geneva

[7-8 October 2024, Geneva] – The HEU-EFS Consortium gathered for our annual consortium meeting, marking a significant milestone in our journey towards harmonizing Early Feasibility Studies (EFS) across Europe.

Meeting Recap:

  • Research and analysis on the state of play of premarket programs and implementation barriers to EFS (WP1) & regulatory framework and institutional and organizational characteristics of EU competent authorities (WP2)
    • The initial results of the research-focused work packages have been shared and discussed with the HEU-EFS advisory bodies, including the Patient Advisory Group and the Advisory Board. Their feedback is crucial to ensure that both WP1 and WP2 provide a solid foundation for methodology development activities.
    • In reviewing the premarket programs, the University of Bocconi has designed a survey for MedTech innovators, including companies, SMEs, and start-ups involved in medical device development and clinical investigations. The survey aims to gather their experiences and challenges in pre-market clinical investigations. Take the survey here.
    • Click here to watch what WP1 and WP2 are focusing on, as described by our Work Package leaders.
  • Research and analysis on the regulatory framework and institutional and organizational characteristics of EU competent authorities (WP2)
    • Engaged in interactive sessions with the Patient Advisory Group (PAG) and Advisory Board (AB) to gather valuable feedback.
  • Methodology development: evidence requirements, data, and statistical tools (WP3)
    • The orchestration of methodology development activities is now the primary focus of the HEU-EFS project. To establish a widely accepted framework, HEU-EFS ensures the inclusion of all key stakeholders in the methodology development process.

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.

Online Survey for Sponsors of Medical Device Clinical Investigations

Introduction
Sponsors of pre-market clinical investigations for medical devices are invited to participate in an online survey conducted as part of the Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) project (Grant Agreement no. 101112185).

Funded by the Innovative Health Initiative (IHI), HEU-EFS aims to develop a robust, standardized methodology and set recommendations to streamline Early Feasibility Studies (EFS) within the EU.

Establishing a clear, harmonized framework for EFS in the EU is expected to benefit patient access, innovation uptake and investment attractiveness in Europe.

Survey
This survey focuses on pilot pre-market clinical investigations (CI) to assess a medical device early in its development phase. These include first-in-humanearly feasibility, and traditional feasibility clinical investigations. When answering, please consider specifically the challenges of planning, monitoring and conducting CI in Europe.

Take the survey https://bit.ly/HEU-EFS_Survey

The survey will be open until 11 November.
The results will be presented in a dedicated webinar and on the HEU-EFS project webpage.