HEU-EFS @ ISPOR 2025

Advancing Early Feasibility Studies for Medical Devices

The HEU-EFS consortium was honoured to participate in ISPOR 2025, held from May 13–16 in Montréal, Canada—the leading global conference for Health Economics and Outcomes Research (HEOR). This year’s theme, “Collaborating to Improve Healthcare Decision Making for All: Expanding HEOR Horizons,” emphasized the importance of cross-sector collaboration in shaping equitable, data-driven healthcare systems 

As part of the conference’s dynamic Issue Panel sessions, the HEU-EFS team presented “Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders from the US FDA Early Feasibility Studies Program“

Moderated by Giuditta Callea (SDA Bocconi), the panel featured expert insights from:

• Dorothy Abel, Abel & Wolf Consulting
• Kevin Drisko, Edwards Lifesciences

The session explored the structure and impact of the US FDA’s Early Feasibility Studies (EFS) Program, highlighting its role in accelerating medical device innovation. Panelists discussed how similar strategies could be adapted within the EU regulatory landscape to address fragmentation and support early-stage clinical research.

Representing a collaboration of 22 public and private partners, the HEU-EFS project aims to develop a harmonized framework for EFS across Europe. The panel emphasized the importance of regulatory alignment, patient-centered design, and international knowledge exchange to foster innovation and improve patient access to novel technologies.

Why It Mattered

The HEU-EFS initiative aligns closely with ISPOR’s mission to make HEOR insights more actionable and inclusive. By integrating EFS into the broader conversation on evidence generation and value-based healthcare, the consortium contributes to shaping a more agile and responsive regulatory environment for medical devices.

Tags: ISPOR2025, HEUEFS, EarlyFeasibilityStudies, MedicalDevices, RegulatoryAffairs, EvidenceGeneration, InnovationForPatients, HealthTech

MedTech Forum 2025

𝗔𝗱𝘃𝗮𝗻𝗰𝗶𝗻𝗴 𝗘𝗮𝗿𝗹𝘆 𝗙𝗲𝗮𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 𝗶𝗻 𝗘𝘂𝗿𝗼𝗽𝗲

The #MTF2025 event in Lisbon, Portugal was a significant milestone for the project, which aims to revolutionize Early Feasibility Studies (EFS) for medical devices in Europe.

𝗞𝗲𝘆 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀

1. 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗘𝗳𝗳𝗼𝗿𝘁𝘀: The session highlighted the power of collaboration among industry, academia, healthcare, and patient associations. This cross-sectoral partnership is crucial for developing a harmonized EFS methodology.
2. 𝗣𝗮𝘁𝗶𝗲𝗻𝘁-𝗖𝗲𝗻𝘁𝗿𝗶𝗰 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵: Integrating patient input ensures that medical devices are tailored to patient needs, enhancing their effectiveness and acceptance.
3. 𝗖𝗹𝗲𝗮𝗿 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲: Providing a roadmap for EFS will streamline processes for innovative companies, hospitals, and competent HTA authorities, making Europe a more attractive location for medical device innovation.

𝗙𝘂𝘁𝘂𝗿𝗲 𝗜𝗺𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀

1. 𝗕𝗼𝗼𝘀𝘁𝗶𝗻𝗴 𝗖𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀: A harmonized EFS methodology will enhance Europe’s competitiveness in the global medical device market.
2. 𝗔𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗶𝗻𝗴 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻: Well-run EFS will speed up the development and patient access to innovative devices, ultimately improving healthcare outcomes.
3. 𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻: The involvement of all stakeholders, driven by a common objective, increases the likelihood of successful implementation in the real world.

Next Steps

1. 𝗖𝗼𝗻𝘁𝗶𝗻𝘂𝗲𝗱 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻: We will continue to work closely with our partners to refine and implement the EFS methodology.
2. 𝗘𝗻𝗴𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗙𝗲𝗲𝗱𝗯𝗮𝗰𝗸: Ongoing engagement with stakeholders will be essential to ensure the methodology meets the needs of all parties involved.

Thank you to the moderator and excellent speakers at #MTF2025 for their insightful contributions and for making complex issues accessible and engaging to a wider audience.

Moderator

Niklas Blomberg, Innovative Health Initiative (IHI)

Speakers

• Rosanna Tarricone, SDA Bocconi
• Alexandra Poulsson, Norwegian Institute of Public Health
• Laura Sampietro-Colom, Hospital Clínic de Barcelona
• Fanny van der Loo, Edwards Lifesciences Europe
• Yasemin Zeisl, European Patients’​ Forum

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

#IHITransformingHealth #PatientCare #EvidenceGeneration

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!

Call for Papers on Early Feasibility Studies for Medical Devices

Clinical Therapeutics is inviting submissions for a special issue on Early Feasibility Studies for Medical Devices. This issue aims to delve into the characteristics, patterns, and growth of EFS studies, comparing regulatory systems between the US and Europe, and evaluating the impact of the FDA EFS Program.

Key Aspects

• Focus: Initial clinical safety and performance of medical devices in early development.
• FDA EFS Program: Established in 2013 to foster innovation and early access for American patients.
• Topics: Success in attracting early clinical investigations, safety issues, patient benefits, and feedback mechanisms.

Case studies on technologies that reached the market post-EFS are welcomed, as well as submissions with a focus on initial clinical safety and performance of medical devices in early development.

𝗚𝘂𝗲𝘀𝘁 𝗘𝗱𝗶𝘁𝗼𝗿𝘀:
Giuditta Callea, Associate Professor and Carlo Federici, Research Fellow, from SDA Bocconi, and members of the HEU-EFS coordination team.

𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗗𝗲𝗮𝗱𝗹𝗶𝗻𝗲: September 30, 2025
For more details, visit the Clinical Therapeutics journal page https://www.sciencedirect.com/special-issue/321847/early-feasibility-studies-for-medical-devices-goldmine-or-fool-s-gold.

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

#EFS #HealthcareInnovation #MedicalResearch #EvidenceGeneration

World Health Day 2025

Celebrating World Health Day 2025: Embracing Healthy Beginnings for Hopeful Futures

Our commitment to healthcare innovation ensures that every individual has access to the medical advancements they need.

As we acknowledge the importance of April 7, #WorldHealthDay, we highlight the transformative impact of technology in innovating for better healthcare systems.

At HEU-EFS, a public-private partnership of 22 institutions, funded by the European Commission, our lifecycle approach to clinical evidence generation involves stakeholders from the outset, aligning medical innovation with safety and regulatory standards to foster a robust healthcare ecosystem.

The Early Feasibility Studies (EFS) initiative is a testament to our dedication to timely innovation. It’s not just about access to new technologies but ensuring these advancements are safe, effective, and enhance patient care.
Together, let’s celebrate the cause of health equity and uphold the right to health as a fundamental human right.

Join the cause for a healthier future for all!

HEU-EFS Interim Consortium Meeting

On Monday, April 7th, our Consortium partners, Advisory Board, and Patient Advisory Group held a productive interim meeting, focusing on the latest advancements from several work packages.

Key Highlights:

• Guest Speaker: We were delighted to welcome Danielle Giroud, who presented the latest updates to ISO Standard 14155.
• Valuable Input: The Advisory Board and Patient Advisory Group provided essential feedback on the importance of clear processes, stakeholder involvement at both EU and national levels, data collection, templates, and checklists.
• Next Steps: We outlined the next steps for the pilot use-cases, aiming to test and improve the future EU EFS Program.

A big thank you to all contributors for making this meeting valuable and productive. Together, we are laying a strong foundation for future success!

SDA Bocconi Fundació Clínic per a la Recerca Biomèdica Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) Hospital Clínic de Barcelona Agenas Greater Paris University Hospitals – AP-HP Idris Oncology BV Meditrial Norwegian Institute of Public Health Trinity College Dublin The Philipp University of Marburg CIMT – Centre for Innovative Medical Technology Carmat Fondazione Policlinico Universitario Agostino Gemelli IRCCS European Patients’​ Forum Newronika S.p.A. Global Heart Hub Qurasoft Edwards Lifesciences Europe Medtronic W. L. Gore & Associates Philips Abbott DePuy Synthes

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

Work Package 3 Video Guide

We are pleased to share the progress being made in Work Package 3 of the HEU-EFS consortium, dedicated to enhancing early feasibility studies (EFS) for medical devices across Europe.

We invite you to watch the video to learn more about our work and its impact.

Alexandra Poulsson from the Norwegian Institute of Public Health and the Norwegian Medical Products Agency is leading efforts to develop comprehensive eligibility criteria for EFS. Her work ensures that technologies, medical conditions, patient severity, evidence levels, clinical sites, and expertise are all meticulously evaluated to pave the way for successful studies.

Nataliya Deych, Regulatory expert at Edwards Lifesciences Europe, emphasises the importance of collaboration between industry and regulators, highlighting the critical role of patient perspectives in shaping regulatory decisions. This commitment to innovation drives efforts to bring cutting-edge clinical programmes to European stakeholders.

Carlo Federici from SDA Bocconi contributes his expertise in health economics and technology assessments. Carlo’s research focuses on analysing the current state of pre-market clinical investigations and proposing a robust framework for EFS in the EU. His work is crucial for ensuring that medical devices are evaluated with the right evidence at the right time.

Visit heuefs.eu and follow us on LinkedIn https://lnkd.in/ekMx-4mp and X https://twitter.com/HEUEFS as we advance towards a harmonised approach to early feasibility studies, ultimately enhancing patient access to innovative 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

#IHITransformingHealth #PatientCare #Evidence #MedTech

Privileged Talk on Enhancing Access to Innovative Medical Devices

At SDA Bocconi premises, the event titled “Privileged Talk: Adopting a Lifecycle Approach to Enhance Access to Innovative Medical Devices: Regulatory Insights and Future Perspectives Amid the Ongoing Targeted Evaluation” gathered experts from industry, regulators, and academia. The discussion focused on the ongoing evaluation of the EU Medical Device Regulation (MDR), Early Feasibility Studies (EFS), the potential for an Accelerated Access Program, and the evolving link between the MDR and the Health Technology Assessment Regulation (HTAR).

Flora Giorgio (DG SANTE, European Commission), along with regulators, industry leaders, and other stakeholders, addressed key challenges and proposed solutions to refine the MDR framework. The event aimed to gather insights from various experts to enhance access and innovation in the medical device sector. Giuditta Callea (SDA Bocconi) presented the EU project on EFS to improve evidence generation, while Rosanna Tarricone (SDA Bocconi) proposed an Accelerated Patients’ Access Program for breakthrough medical devices. Marco Marchetti (AGENAS) discussed integrating the Joint Clinical Assessment (JCA) with MDR, and Flora Giorgio outlined the Commission’s priorities to improve predictability and reduce burdens while safeguarding patient safety. Andrea Rappagliosi (Edwards Lifesciences) highlighted the slow certification processes delaying innovation, and Phil Collis (Patient Advisory Group Representative) emphasized the need for stronger post-market surveillance.

The consortium emphasized the importance of collaboration among all stakeholders to boost efficiency, predictability, and innovation while safeguarding patient safety. The objectives are to improve the MDR to facilitate better access and innovation in the medical device sector, resulting in enhanced regulatory processes, faster certification, and stronger post-market surveillance.

The HEU-EFS project, involving 22 public and private consortium partners, aims to systematize information regarding the regulatory framework and pre-market evidence generation programs, develop and validate a robust methodology, and create a conducive environment for undertaking EFS in the EU.

HEU-EFS Project Featured in the European Heart Journal

We are pleased to announce that the HEU-EFS Project has been featured in a special article in the European Heart Journal, administered by the European Society of Cardiology. This article, part of the Digital Health and Innovation section, discusses the priorities for medical device regulatory approval and highlights our project’s efforts to develop a harmonized framework for early feasibility studies (EFS) in the EU.

Key takeaways:

• EFS can speed the development of innovative devices and investigate initial safety and performance.
• The HEU-EFS Project aims to develop an EU harmonized framework to improve the uptake of EFS.
• The European Society of Cardiology advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices addressing unmet needs and orphan cardiovascular (CV) medical devices in the EU.
• Global regulatory harmonization is essential to streamline CV medical device authorization across selected jurisdictions and enable the reprocessing of single-use devices.

Launched in January 2024, the HEU-EFS Project is a public-private partnership with 22 consortium partners working over the next four years to assess the current status of pre-market evidence generation and develop robust methodologies for EFS in the EU. Our project aims to improve the uptake of EFS and accelerate the development of innovative medical devices.

We invite you to read the whole article and learn more about our project.