The commercialization of medical products at the university level is a multilayered and challenging process. One barrier to commercialization is the difficulty of meeting Food and Drug Administration (FDA) regulatory requirements. Regulations and standards are undoubtedly necessary to maintain the highest product safety levels, but it creates many obstacles. This paper will analyze how researchers involved with early-stage medical device innovation in a university setting deal with FDA compliance issues and the implications of this engagement for innovation. I conducted an exploratory case study of ten medical product development projects at the Rochester Institute of Technology (RIT). Overall, I found that FDA approval pathways were challenging for project participants to navigate without proper resources; approximately half of the projects indicated a lack of confidence in their knowledge of and/or progress towards meeting FDA requirements based on the resources available. I offer several suggestions regarding how RIT and other universities can reduce barriers to innovation caused by FDA regulation through actions, both internal and external to the university.
Library of Congress Subject Headings
Medical instruments and apparatus--Technological innovations--Government policy--United States; United States--Food and Drug Administration; Medical instruments and apparatus--Research--Law and legislation--United States
Science, Technology and Public Policy (MS)
Department, Program, or Center
Public Policy (CLA)
Fariello, Keyana, "FDA Regulation Impact on Early Stage Medical Device Innovation in Academia" (2020). Thesis. Rochester Institute of Technology. Accessed from
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