This module of the course is an overview of existing medical devices and discusses methods for development, evaluation, and approval of new medical devices. The course will cover both diagnostic and interventional devices, and cover clinical and pre-clinical testing issues, as well as a discussion of FDA approval processes, funding start-ups, and cost effectiveness analysis. Students will work in teams to analyze requirements in the medical setting and come up with a plan for a new device, and analyze how best to develop it with a new start-up.

CILO-1: Gain ability in problem definition, development and evaluation of creative alternatives, application and methods of technical and economic analysis, identification and application of ethical and legal constraints, and effective presentation of technical information. CILO-2: Design and develop projects from specifications submitted by industry and other organizations. CILO-3: Demonstrate ability in writing proposals and progress reports.