Abstract – A simulation is used to facilitate cooperative and team-based learning to introduce concepts of human factors, risk analysis, and quality control applied to the design of medical devices. We further use a friendly game-based approach to simulate the dynamics between a customer, a regulatory agency, and competitive manufacturers. Students are divided into manufacturing teams/companies and teaching assistants act as the customer and regulator. To promote positive interdependence and individual accountability, each student within a company is assigned roles of CEO, inspector, marketer, and designer. The goal for each company is to design and produce as many eye patch medical devices as possible, which must be approved by the regulator, within a tight deadline. Products are evaluated by the customer, who decides what price to pay for each unit, at the end of production. The most successful company is determined by the greatest amount of money earned after two rounds of production and sales.
Using Role-Playing Simulations to Teach Quality Control in the Design of Medical Devices
