SPONSOR VIEWS ON HARMONIZING EARLY FEASIBILITY STUDY ASSESSMENT IN THE EU: EARLY INTERACTION, PREDICTABLE TIMELINES, AND STREAMLINED PROCESS FOR SPONSOR AND DECISION-MAKERS
Author(s)
Federico Facciolo, MS, PhD1, Alexandra H. Poulsson, MSc, PhD2, Marit Erna Austeng, MD, PhD2, Fanny van der Loo, MA, LLM3, Giuditta Callea, PhD1;
1Bocconi University SDA Bocconi School of Management, Milan, Italy, 2Norwegian Institute of Public Health, Oslo, Norway, 3Edwards Lifesciences, Dilbeek, Belgium
1Bocconi University SDA Bocconi School of Management, Milan, Italy, 2Norwegian Institute of Public Health, Oslo, Norway, 3Edwards Lifesciences, Dilbeek, Belgium
OBJECTIVES: Early Feasibility Studies (EFS) are early clinical investigations of medical devices conducted to assess the initial clinical safety and performance and to optimize device design and functionality. A dedicated framework for conducting EFS is currently lacking in the European Union (EU). As part of the Harmonised Approach to EFS for Medical Devices in the EU (HEU-EFS) project, this study explored the experiences of sponsors of clinical investigations with EFS assessment to inform the development of an EU-harmonized EFS framework.
METHODS: A focus group was conducted with 11 representatives from five global medical technology companies. Participants held specialist, managerial, or leadership roles and were based in the United States (n=2) or Europe (n=9). Topics included interaction with competent government authorities before and during EFS application assessment, harmonization of EFS assessment in the EU, and interaction with other EU bodies (i.e., Expert Panels). The focus group lasted 90 minutes and was recorded and transcribed via Microsoft Teams. Data were analyzed using thematic analysis using deductive coding based on the focus group topics and questions.
RESULTS: Four themes emerged from the focus group: (1) Dialogue before EFS submission helps sponsors communicate the novelty of their technology and clarify expected evidence and compliance with government authorities, (2) Volume and relevance of questions during EFS assessment are affected by variation in expertise among government authority evaluators, (3) Predictability of the EFS assessment timeline is the priority for sponsors in an EU‑harmonized EFS framework, and (4) Government authorities and ethics committees are the necessary decision makers for EFS, with Expert Panels involvement viewed as slowing EFS assessment.
CONCLUSIONS: Interacting with government authorities before and during EFS assessment, relying on predictable assessment timelines, and a streamlined process for stakeholders and decision makers involved are important aspects for sponsors that can inform the development of an EU‑harmonized EFS framework.
METHODS: A focus group was conducted with 11 representatives from five global medical technology companies. Participants held specialist, managerial, or leadership roles and were based in the United States (n=2) or Europe (n=9). Topics included interaction with competent government authorities before and during EFS application assessment, harmonization of EFS assessment in the EU, and interaction with other EU bodies (i.e., Expert Panels). The focus group lasted 90 minutes and was recorded and transcribed via Microsoft Teams. Data were analyzed using thematic analysis using deductive coding based on the focus group topics and questions.
RESULTS: Four themes emerged from the focus group: (1) Dialogue before EFS submission helps sponsors communicate the novelty of their technology and clarify expected evidence and compliance with government authorities, (2) Volume and relevance of questions during EFS assessment are affected by variation in expertise among government authority evaluators, (3) Predictability of the EFS assessment timeline is the priority for sponsors in an EU‑harmonized EFS framework, and (4) Government authorities and ethics committees are the necessary decision makers for EFS, with Expert Panels involvement viewed as slowing EFS assessment.
CONCLUSIONS: Interacting with government authorities before and during EFS assessment, relying on predictable assessment timelines, and a streamlined process for stakeholders and decision makers involved are important aspects for sponsors that can inform the development of an EU‑harmonized EFS framework.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR58
Topic
Health Policy & Regulatory
Disease
No Additional Disease & Conditions/Specialized Treatment Areas