Just-In-Time Education of FDA Regulation and Protection of Intellectual Property for Medical Products: A Course Review After Our First 10 Years

Successful translation of medical devices requires a clear pathway through the business environment, including regulatory obligations and the protection of intellectual property. Introducing these topics can be challenging for biomedical engineering programs, as students prefer hands-on activities and retain concepts best when directly applied to projects or research. To address this challenge, 10 years ago, we created a two-semester course sequence covering these topics, primarily intended for MS students focused on medical device design. Course content is delivered with a “just-in-time” approach to align with ongoing year-long design projects. In the fall semester, our course covers IP and regulatory topics relevant to the selection of an unmet clinical need for further development. The spring course covers topics related to implementation of a business model for a new product, such as licensing, clinical trials, quality systems, and submission of material to the FDA. Over 10 years, we have added numerous special features, including a regulatory science competition, a mock Pre-Submission Project reviewed by regulatory experts, and an IP presentation modeled after industry practices. In this manuscript, we review course content, structure, and outcomes. A survey was used to obtain feedback from graduates now in widely varying positions in the medical innovation space. In addition, we obtained feedback from a sample of external reviewers. With a response rate of ~50%, the survey identified strong support for the courses and identified chosen career paths. The mock Pre-Submission Project was highly valued by students and their employers, as were other assignments that aligned with ongoing design or research activities. Several opportunities for improvement and possible expansion of the course were identified to further enhance this valuable part of our curriculum.