Abstract
ObjectivesTo promote an appreciation of the EU medical device regulatory framework in the biomedical research community and encourage greater levels of clinical engagement to further medical device research innovation, translation and effective clinical trials. MethodsAn interdisciplinary, iterative, needs-based design approach was used to develop medical device regulatory training, information and clinical expertise resources. ResultsA multimedia based self-paced e-Learning course focusing on the ‘Fundamentals of Medical Device Design and Regulation’ was produced in tandem with an interactive online web portal: Medtech Translate. ConclusionsHealth research translation relies on both clinical input and regulation to drive progress and to ensure quality and safety standards from concept development to clinical investigation. A lack of regulatory awareness and access to clinical expertise has the potential to significantly impact on health research translation and ambition for market. Our interdisciplinary academic-regulator-clinical-industry led approach meets the need for a coordinated stakeholder response to support innovation and promote growth in the medical technology sector.
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