The goal of this course is to be able to understand the fundamental theories behind the development of biomedical products from idea to commercial release. At the conclusion of this course, students should be able to: 1) understand the theory behind the development of biomedical products from idea to commercial release; 2) apply the theory to critically analyze the relevant processes; 3) integrate the above knowledge with real world examples and solve practical problems; 4) deliver projects in a team through interactions and group projects; and 5) appreciate the translational link between the fundamental concepts of biomedical engineering knowledge and its practical application in the development of commercial medical products, the processing of such products and the design considerations for clinical use of such products. The main themes of the course are: developing proper requirements; design control; regulatory requirements; IEC 60601 medical device standard; risk management (ISO 14971); verification and validation.

The course will emphasize fundamental engineering principles that will allow students the ability to become productive team members and give them the background necessary to assume leadership roles in product development. Guest experts, case studies, and real world examples augment the learning experience. Each theme incorporates fundamental engineering principles that will allow you to work effectively in a medical device company or to bring your own product to market.