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