OBJECTIVES : Early Feasibility Studies (EFS) are limited exploratory clinical investigations taking place early in the development of devices, in small number of patients, typically before the device design has been finalized, when further non-clinical testing is not possible or meaningful. An EFS program was introduced by the US Food and Drug Administration (FDA) in 2013 to accelerate access of American patients to medical technologies and recoup a leading role in the pre-market research. The aim of this study was to explore perceptions of relevant stakeholders about the desirability and feasibility of an EFS program in Italy and of critical factors favoring or hampering its implementation.

METHODS : Qualitative research methods (i.e., exploratory and confirmatory focus groups) involving an expert panel of clinicians, biomedical engineers, members of ethics committees, academics, and industry representatives were used to collect opinions on the appropriateness and feasibility of an EFS Italian program.

RESULTS : The expert panel agreed that an EFS program would maximize the efficiency of evidence generation process, strengthen competitiveness and attract R&D investments in the biomedical area. Potential challenges relate to the need for a clear legal framework and high level of technical competencies to evaluate studies. A particular attention must be given to ethical aspects, safety and risk analysis. Any device could be eligible, but potential benefits should offset risks, and the use of the device on human subjects should be regarded as the only way to further product development.

CONCLUSIONS : An Italian EFS program is highly desirable, however it requires trust and open dialogue between stakeholders, strong investments in capacity building, and patient protection measures to be successful. If successful, it could be scalable to the European context.