Course Description: This course introduces students to the interplay between medical device regulation and product design. Medical device regulations determine the types of testing required for product validation, the associated costs, and the time to market. We examine how these regulations influence product design strategies, with a focus on the US Food and Drug Administration's regulatory framework for medical devices, software, and the use of artificial intelligence (including neural networks, regression, and large language models). The course also covers the regulation of combination products involving both devices and drugs, as well as digital health. Students will learn how to formulate regulatory arguments for new designs in healthcare—whether software, AI, or physical devices—and how to reverse engineer product designs based on regulatory requirements. The course is team-based and includes a major project. 

Estimated Course Enrollment: 50

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