Early Feasibility Studies for Medical Devices: Insights From an Empirical Global Mapping

Early feasibility studies (EFS) are a critical but poorly documented phase of clinical evidence generation for novel medical devices. Despite their growing relevance, no dedicated databases currently exist, limiting transparency and policy learning. This study aims to provide the first comprehensive empirical mapping of EFS studies globally, describing their volume, characteristics, geographical distribution, and key trends, and to derive insights relevant for the development of a dedicated European EFS framework.

A systematic search of major public clinical trial databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, ANZCTR, ISRCTN) was conducted to identify EFS-like studies initiated from 2013 to May 2025. Due to the absence of an explicit EFS classification, an operational definition was applied based on study design features (interventional, sample size ≤30, single-arm, nonrandomized) and EFS-related terminology in studies' title or summary. Additional sources included scientific literature, regulatory documents, and specialized medical news outlets. Extracted variables covered study design, endpoints, clinical area, geography, duration, and status. Records were manually validated by two researchers, resulting in the construction of a dedicated EFS database.

A total of 621 EFS-like studies were identified, with a steady increase over time, peaking in 2024. Forty percent of studies were conducted entirely or partially in the United States (US), 30% in Europe, and 36% involved at least a center from other regions. EFS-like activity was highly concentrated, with 10 centers accounting for nearly one-fifth of all studies, most of them US- based. Cardiovascular devices dominated the landscape, representing 45% of all studies and 68% of multi-country trials. Safety was the most common primary endpoint, reported in 68% of studies. While 42% of studies were completed, early termination occurred in 10% of cases, most often due to recruitment challenges, funding limitations, or business decisions. European studies were more frequently single-center and, on average, involved fewer sites than US studies.

Findings demonstrate that EFS are increasingly used worldwide but remain unevenly implemented, particularly in Europe. The concentration of studies in a small number of experienced centers highlights the importance of site capability and raises concerns about capacity constraints and equitable access to early-stage innovation. The absence of standardized EFS identification in registries hampers transparency, evaluation, and learning. Establishing a harmonized European EFS framework, supported by clearer regulatory guidance, improved data integration, and defined requirements for EFS-capable centers, could enhance innovation efficiency, reduce development risks, and strengthen Europe's competitiveness in medical device research.