Abstract

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

Publication Date

12-14-2020

Document Type

Thesis

Student Type

Graduate

Degree Name

Science, Technology and Public Policy (MS)

Department, Program, or Center

Public Policy (CLA)

Advisor

Sandra Rothenberg

Advisor/Committee Member

Marcos Esterman

Advisor/Committee Member

Ezekiel Leo

Campus

RIT – Main Campus

Plan Codes

STPP-MS

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