The incremental development of innovative / breakthrough health technologies takes a long time, during which an innovation will have to successfully go through a process of testing and evidence generation before it can be launched.

As part of this process, early feasibility studies provide the opportunity to capture relevant additional information for the intended use from the real-world setting that would not be possible in non-clinical studies (i.e. bench testing and animal studies) at a very early stage. EFS can make it possible to optimise design and gain necessary information before running a large clinical investigation.

The project would entail the following:

• Research & analysis, including a review of existing international, EU and national guidelines, standards and best practice experiences. This would also include a survey of potential current gaps, barriers and challenges to undertaking EFS in the EU, taking into account the interplay between the different relevant current and future EU regulations.
• Development of an EU methodology for EFS
  • The methodological framework would include:i) definition and scope, including legal considerations;ii) the place of EFS in the development pathway of health technologies and when there is an added value for EFS;iii) the type of data required to conduct an EFS (technical data, preclinical data, number of patients, etc.);iv) process evaluation, methods and tools, including statistical tools adapted to the analysis of EFS results, and tailored to the needs and specificities of different health technologies, including digital and mobile health technologies;v) the contribution of EFS to making more patient-centred devices;vi) the contribution of EFS to the development of training plans for healthcare professionals that would in turn improve the use of devices.
  • Recommendations for best practices, addressing also ethical aspects from the outset, and contractual elements.
  • Development of a sustainable, freely-accessible online portal, hosted and maintained by the consortium, which would act as a repository for the methodological framework and the best practices, and which would facilitate interactions between stakeholders with an interest in EFS.
• Facilitate the creation of a sustainable stakeholder network at national and EU level
  • The network would promote the conduct of EFS and continue to gather experience from subsequent studies where appropriate and relevant to inform the EU EFS methodology.
  • Target groups include patient organisations and representatives, healthcare professionals, research institutions and hospitals, health technology developers, including SMEs, regulators, and HTA bodies.
• The selection of dedicated use-cases to inform, refine and validate the framework
  • The purpose of selected use-case technologies will be to undertake an EFS in the EU, whilst applying the methodology developed by the selected project, in order to test the methodological framework and evaluate the benefits for the conformity assessment process and patient access.
  • Learnings acquired on the use-cases will be used to adapt and finalise the methodological framework, and, where necessary, the blueprints and templates.
  • During the project execution, the consortium will define specific criteria and processes to determine which use-cases can be selected. Indicators of success will be developed and defined within each pilot trial, to compare it to other trials, and used as potential stop criteria.