This course is an introduction to the engineering, clinical, legal and regulatory aspects of medical device performance and failure. Topics covered include phenomenological and mechanistic descriptions of processes such as wear, corrosion fatigue and fretting, in addition to the characterization of bone and other biological materials as it relates to device performance requirements, including biocompatibility. The course also involves case studies of orthopedic fixation devices and prostheses, pacemakers, heart valves and artificial organs. A major portion of the course is a final design project which involves the design of a new medical device or the redesign of an existing device.
