This design course teaches a systematic approach for development of an implantable or injectable medical device to treat a specific and well-defined clinical problem, criteria for preparing applications to the US Food and Drug Administration for approval to conduct clinical trials, and the steps to start a company to make it available to the patient. Students work in teams to develop the design for an FDA Class III medical device or combination product (incorporating drugs and/or biologics). The emphasis is on the science and engineering underlying the design of novel treatments for problems in any one of the 78 organs of the body.Show less