BMDE 655. Biomedical Clinical Trials - Medical Devices.

This course will train biomedical engineers to understand the clinical and business aspects of transferring a medical device idea into a commercial product. This course provides an overview of the pre‐clinical and clinical testing of medical devices, clinical trials, reimbursement systems, market analysis, sales models, and business models, as pertaining to medical devices. This course will also cover the design of randomized trials, including statistical principles, hypothesis postulating, bias minimization, and randomization methods.