Course Description

This course presents the fundamental methods for medical device development. It is designed for students interested in a comprehensive study of the medical device development process, from concept ideation to marketing. It discusses methods that aid completing the procedures of product definition, design, risk management, production planning, and market introduction, in an environment of multiple stakeholders, FDA (Food and Drug Administration) regulations, and intellectual property protections.  The course includes case studies illustrating important considerations to manage the complexities of the development process.