Webinar on HEU-EFS Pilot Programme

Date: 5 December 2025
Time: 15:00 – 16:00 CET
Location: Online

Join us for an insightful Follow-Up Webinar on the HEU-EFS Pilot Programme, taking place on 5 December 2025 from 15:00 to 16:00 CET.

During this session, we will:

• Dive deeper into the objectives and outcomes of the HEU-EFS Pilot Programme
• Answer your questions live
• Explore opportunities for your involvement in future activities

Whether you’re already engaged or just curious to learn more, this webinar is a great chance to connect, clarify, and collaborate.

Save the date and register below to secure your spot!

Public Forum on Early Feasibility Studies

Date: 11/04
Time: 15:30 to 17:30 CET
Location: Online

Join us online for the HEU-EFS Public Forum, a key opportunity to explore how Early Feasibility Studies (EFS) can accelerate access to innovative medical technologies in Europe.

This virtual event will bring together regulators, industry leaders, clinicians, and patient representatives to discuss a harmonised EU approach to EFS. The forum aims to highlight the importance of EFS in improving patient access and supporting clinical excellence.

Agenda

Annual Consortium Meeting 2025

Medical Innovation in Barcelona

[15-16 September 2025, Barcelona] This year, the HEU-EFS Consortium gathered in Barcelona for its Annual Meeting, hosted by the Hospital Clínic de Barcelona. This special event coincided with World Patient Safety Day, highlighting our collective commitment to putting patients at the heart of medical advancements.

The meeting brought together an inspiring group of experts, researchers, industry leaders, and patient representatives, all focused on advancing the development of Early Feasibility Studies (EFS) for medical devices across Europe. It was an opportunity to reflect on the progress we’ve made and set the stage for the next steps in medical innovation.

Key Highlights from the Agenda:

• Improving Early Clinical Evidence Pathways
  A crucial discussion around harmonizing regulatory practices across the EU to streamline clinical pathways and improve early clinical evidence.
• Evidence & Data Tools
  Presenting new frameworks designed to enhance clinical investigation planning and strengthen statistical validation tools that will shape future clinical trials.
• Patient Engagement
  Strengthening partnerships with patient organizations to ensure that patient voices remain central to the development of new technologies and treatments.
• Ethics & Legal Foundations
  Addressing the complexities of informed consent, trial agreements, and insurance protocols to ensure that every study is ethical and compliant.
• Monitoring & Piloting
  Establishing performance metrics and criteria for pilot studies that reflect real-world clinical needs, ensuring that future trials meet actual patient care challenges.

A Special Guest Contribution:

We were privileged to welcome Flora Giorgio from the European Commission (DG SANTE), who shared valuable insights into how EU policy is fostering safer, more inclusive innovation in the medical tech sector.

Thank You to Our Partners:

A big thank you to all our 𝗽𝗮𝗿𝘁𝗻𝗲𝗿𝘀 for your ongoing dedication to innovation, safety, and putting patients first:

• SDA Bocconi
• Fundació Clínic per a la Recerca Biomèdica
• IDIBAPS
• Hospital Clínic de Barcelona
• Agenas
• Greater Paris University Hospitals – AP-HP
• Idris Oncology BV
• Meditrial
• Norwegian Institute of Public Health
• Trinity College Dublin
• University of Galway – Institute for Clinical Trials
• The Philipp University of Marburg
• CIMT
• Carmat
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• European Patients’ Forum
• Newronika S.p.A.
• Global Heart Hub
• Qurasoft
• Edwards Lifesciences
• Medtronic
• W. L. Gore & Associates
• Philips
• Abbott
• DePuy Synthes
• Johnson & Johnson

Supported By:

• Innovative Health Initiative (IHI)
• MedTech Europe
• EFPIA
• COCIR
• EuropaBio
• Vaccines Europe

Together, we’re driving meaningful change in medical technology, always with the goal of making healthcare safer and more accessible for patients everywhere. Thank you to everyone who attended and contributed to making this year’s meeting a success.

Stay informed and inspired!
Follow us on LinkedIn to see how we’re driving change in medical innovation with the HEU-EFS Consortium.

HEU-EFS at the EU HTA Conference

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

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

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

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

ISPOR Europe 2024

[17-20 November 2024 | Barcelona, Spain] Representing the HEU-EFS project, partners from SDA Bocconi and Trinity College Dublin will present a series of poster sessions.

Subject of Debate

Innovative, high-risk medical devices can revolutionize treatment but often require numerous modifications before arriving at a final design. Addressing both the important risks and significant benefits for patients, research centres, regulatory bodies, and sponsors is crucial. The main objective of the 4-year HEU-EFS Project, funded by the Innovation Health Initiative and involving 22 public and private partners, is to develop a harmonized methodology for the uptake of Early Feasibility Studies (EFS) in the EU that mitigates risks and reinforces benefits for various stakeholders.

Poster Sessions and Presenters:

• Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization across 55 Jurisdictions
  Session Time: 18 November 4:00 PM – 7:00 PM – HPR67
  Speaker: Francesco Malandrini from SDA Bocconi
• Use of Early Feasibility Studies to Inform Development of Medical Devices
  Session Time: 20 November 9:00 AM – 11:30 AM – MT58
  Speakers: Franco Luigi Zurlo from SDA Bocconi
• The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?
  Session Time: 18 November 4:00 PM – 7:00 PM – HPR98
  Speaker: Majella Geraghty from Trinity College Dublin

Who Should Attend:

These poster sessions can provide valuable insights for a diverse group of stakeholders, including EU-wide and national regulators, competent authorities, notified bodies, HTA bodies, healthcare providers, patient organizations, research organizations, legal and ethical experts, CROs, and health technology developers.