MENG 5363 Introduction to Medical Device Design

This course provides an introduction to the design of medical devices and other medical technologies. It overviews the entire process of producing a commercial medical device from concept to commerce. Topics include problem identification, solution ideation, the FDA and design in a regulated environment, the design process and prototyping, intellectual property, preclinical and clinical testing, and regulatory paths to market. Students will evaluate existing medical technologies and produce a comprehensive technical and commercial feasibility analysis for a medical device.