A Methodology to Integrate Regulatory Expertise, Research and Education to Accelerate Biomedical Device Translation
The aging population, new healthcare needs, and people living longer are driving an unmet clinical need for biomedical research and development of innovative medical devices. Academic research and development is a key component of biomedical R&D. Academic scientists and engineers have considerable ability to contribute to addressing the unmet clinical need. However, turning basic research into clinical interventions, such as medical devices, that improve the health of individuals, is exceptionally difficult. Device development and/or use of these devices in human clinical studies, even if for early feasibility studies, is highly regulated, requiring a unique knowledge base that is often lacking in academia. For successful regulated device development, and subsequent regulatory approval, researchers need access to tools, expertise and resources that can help simplify and accelerate an often complex and lengthy regulatory pathway while providing for patient safety and regulatory compliance. Therefore, it is necessary to integrate the use of regulatory and quality consulting and expertise into the translational process for taking scientific research into clinical research into usable innovation. Bringing together this type of synergistic relationship to advance research offers value to the researcher, the regulatory consultant, the students, and the patient population for which the technology was developed or will be used. This paper will discuss a model for an integrated biotechnology focused clinical research translational center that integrates research, regulatory, compliance, quality, and academics.