We Were There: ISPOR Europe 2025 – Advancing Early Feasibility Studies in Europe 

On 10 November 2025, we led the session “Implementing a Program for Early Feasibility Studies in Europe: Goldmine or Fools Gold?” at ISPOR Europe 2025 in Glasgow. The session brought together key stakeholders to explore how a harmonised Early Feasibility Studies (EFS) programme could support safer, faster, and more efficient medical device development under the EU Medical Device Regulation (MDR). 

Why EFS Matters 

With MDR raising the bar for clinical evidence, traditional feasibility or pivotal trials often face delays or failures due to late-stage design issues. EFS, conducted earlier in the development cycle, can: 

  • Improve patient safety 
  • Enable smarter trial design 
  • Reduce development costs 
  • Accelerate time-to-patient 

The U.S. FDAs EFS programme has already demonstrated these benefits. The HEU-EFS project aims to bring similar value to Europe by proposing a harmonised EU-level framework. 

Session Highlights 

The session featured a dynamic panel of experts: 

  • Tom Melvin, University of Galway
  • Marta Kerstan, Johnson & Johnson MedTech
  • Lucía Feito Allonca, HEU-EFS Patient Advisory Group (PAG)
  • Moderator: Maria Luisa Buzelli, Bocconi University

Key themes included

  • Harmonisation of application processes across EU Member States 
  • Structured early dialogue between sponsors and regulators 
  • R&D support to de-risk innovation 
  • Building awareness and expertise among patients and clinicians 
  • Transparency and open data to build trust 
  • Inclusion of patient voices throughout the study lifecycle 
  • Addressing the specific needs of digital health technologies 

Our Contribution 

We also presented our poster: “National Competent Authorities Experiences with Early Feasibility Study Assessment” 

The poster highlighted

  • The lack of a harmonised EFS approach across NCAs 
  • The importance of early dialogue and sponsor preparedness 
  • The need for standardised templates and improved documentation 
  • Challenges in ethics approval processes 
  • The value of coordinated assessment pilots for shared learning 

What’s Next? 

The HEU-EFS consortium announced a Call for Pilots to test the proposed methodology and a Call for Papers to further the academic and policy dialogue. 

We are excited to continue supporting this important initiative and look forward to collaborating with regulators, HTA bodies, industry, and patient organizations to shape the future of EFS in Europe. 

Learn more: https://heuefs.eu/open-call-for-pilots/ 

#ISPOREurope #HEUEFS #MedicalDevices #MDR #ClinicalResearch #HealthPolicy #MedTech #HTA #Innovation #PatientSafety #RegulatoryScience #EarlyFeasibilityStudies 

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