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 startups, and cost effectiveness analysis. The course will involve several case studies as examples. For projects, students will work in teams to analyze needs in the medical setting and come up with a plan for a new device, and analyze how best to develop it with a new startup. Two classes per week, 5 weeks total.
Graduate standing in engineering or business administration.
ENGM 189.2 runs for the second five weeks of the term offered, and is preceded by partner course ENGM 189.1 for the first five weeks of the term offered.
Two classes per week, 5 weeks total.
This course carries .5 credit.
Cannot be used to satisfy any AB degree requirements