ISPOR US 2025


At ISPOR US 2025, two sessions addressed critical aspects of pre‑market clinical research for medical devices, with a focus on Early Feasibility Studies (EFS) and the challenges associated with conducting early‑stage investigations in Europe and internationally.

Challenges of Pre‑Market Clinical Investigations of Medical Devices: A Multi‑Stakeholder Perspective

Oral Presentation
Moderator: Giuditta Callea
Speakers: Rosanna Tarricone, Carlo Federici, Helen Banks, Maria Luisa Buzelli, Francesco Benito Malandrini, Franco Luigi Zurlo, Marta Kerstan, Monica Tocchi, Nicolas Martelli, Tess Martin, Ornella Tangila Kayembe, Stephane Piat, Laura Sampietro‑Colom, Andrea Rappagliosi, Claudia Louati, Yasemin Zeisl, Daniel Beltran, Adrián Valledor, Marta Bragagnolo, Marit Erna Austeng, Alexandra Herborg Cornelius Poulsson, Kristian Kidholm, Lise Kvistgaard Jensen, Benedetta Brancadoro, Carmen Furno, Sebastian Kuhn.

This session examined the challenges and barriers involved in pre‑market clinical investigations (CIs) of medical devices and provided evidence to support the development of a harmonized European Early Feasibility Studies (EFS) Program.

Objectives

To gather perspectives from multiple stakeholders—including regulators, HTA bodies, clinical sites, notified bodies, patient associations, and technology developers—to inform future EFS policy and operational frameworks in the EU.

Methods

The work presented included:

  • an online survey for technology developers,
  • open‑ended interviews with stakeholders across Europe,
  • and a focus group with patient advisory group members and patient associations.

Key Findings

  • The EU is viewed as a preferred location for pre‑market CIs due to expertise, site capabilities, and timelines.
  • A major barrier identified was limited dialogue across stakeholders, contributing to complexity and delays.
  • Challenges also included risk–benefit evaluation, device risk assessment, study design, endpoints, enrolment targets, and a lack of clear templates or guidance.
  • Patients identified fragmented information and insufficient time to evaluate participation risks as significant issues.

Conclusions

Stakeholders highlighted the multifaceted hurdles in bringing medical device innovations to market. Strengthening early interaction among all parties involved was identified as essential to improving clarity, reducing delays, and supporting a more efficient environment for pre‑market clinical investigations.

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

Moderator: Giuditta Callea
Speakers: Dorothy Abel, Kevin Drisko

This session examined what the EU and other jurisdictions can learn from the U.S. FDA Early Feasibility Studies (EFS) Program, established to support innovative, significant‑risk medical devices when non‑clinical testing is insufficient.

Topics Addressed

  • the purpose and characteristics of early‑stage clinical investigations for high‑risk devices;
  • challenges faced when non‑clinical testing cannot fully inform device safety or performance;
  • insights from the first decade of the FDA EFS Program, including best practices and oversight mechanisms;
  • implications of Europe’s fragmented pre‑market regulatory landscape for conducting EFS;
  • perspectives from regulators, academia, industry, clinical stakeholders, and findings from the HEU‑EFS project.

The session concluded with a moderated roundtable addressing audience questions, engaging stakeholders such as regulators, healthcare providers, patient associations, CROs, researchers, and technology developers.

Overall Event Perspective

Together, these two sessions demonstrated the growing relevance of Early Feasibility Studies in supporting responsible medical device innovation and highlighted the importance of harmonized frameworks, stakeholder collaboration, and evidence‑based policy development in both the EU and the U.S.

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