New Multisite Study Highlights Regulatory Fragmentation, Operational Bottlenecks, and the Critical Role of Investigators.
A new study, led by Hospital Clinic de Barcelona and Fundació de Recerca Clínic Barcelona – Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) in close collaboration with BCCC, examining the operational challenges and site-selection determinants at six European university hospitals when conducting Early Feasibility Studies (EFS) for medical devices has been published in Clinical Therapeutics, under the Special Issue: Early Feasibility Studies for Medical Devices: goldmine or fool’s gold?
The paper, was co-authored by Adrian Valledor from IDIBAPS, supported by the experience of BCCC (Barcelona Clinical Coordinating Center; BCCC), alongside colleagues from Hôpital Européen Georges Pompidou (Paris), in collaboration with other four other European university hospitals from Denmark, Germany, Italy and Ireland. The work was conducted within the HEU-EFS project, which aims to establish an EU methodology for Early Feasibility Studies (EFS) in the EU, supporting the evidence generation pathway for medical device innovators.
Unlike the US, which has run a dedicated FDA EFS program since 2013, the EU has no equivalent harmonized pathway for these early-phase device investigations. To address this gap, the research team interviewed 21 professionals in clinical, regulatory, operational, and ethics roles across six university hospitals between November 2024 and July 2025, using qualitative interviews in combination with a weighted site-selection scoring exercise adapted from the Medical Device Innovation Consortium (MDIC) framework to assess site-selection criteria.
Key Findings
- Six overarching themes were identified, spanning investigator capacity, site readiness, regulatory governance, operational infrastructure and CRO capacity, financial and organizational constraints, and broader ecosystem factors.
- Regulatory fragmentation across Member States, inconsistent ethics committee interactions, and lengthy contract/budget negotiations were recurring bottlenecks.
- Investigator expertise and engagement emerged as the most influential factor in EFS success and site selection, ahead of institutional readiness and operational infrastructure.
- In the site-selection exercise, Investigators’ therapeutic-area expertise scored highest, followed by their availability and personal commitment.
- Several challenges mirrored those previously reported by US EFS sites, despite the US’s more established regulatory framework, suggesting that operational and organizational barriers persist even under more established regulatory frameworks.
The authors conclude that a harmonized EU EFS framework is needed to address these interdependent barriers. Findings will support the development of coordinated guidance and templates, standardized processes and structured stakeholder interactions through the HEU-EFS project, currently being tested via pilot use-cases.
This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101112185. The JU receives support from the European Union’s Horizon Europe research and innovation program and COCIR, EFPIA, Europa Bio, MedTech Eu- rope, and Vaccines Europe and contributing HEU-EFS partners Edwards Lifesciences, Medtronic Bakken Research Center, W.L. Gore & Associati, Philips Medical Systems, Abbott Vascular International, and Synthes.
The full article can be read here: https://doi.org/10.1016/j.clinthera.2026.06.003
