This course teaches students the basic project skills, regulatory principles and best practices for developing a commercial medical device. Lectures and case studies are augmented by real world examples combining both an academic and industrial perspective. Subject matter includes problem identification, product conceptualization, and design, and intellectual property, and formal development including design controls, risk management, FDA regulatory requirements and clinical trials. Student teams will apply their acquired course knowledge and their engineering skills to design and develop a conceptual medical device. This is a required co-requisite to BE465 in the fall for BME Seniors.