Undergraduate Prerequisites: (ENGEK 210) Junior standing. - This four-credit course provides BME students with an in-depth analysis of the design history of specific currently available medical devices, instruments, implants, diagnostics, and drug delivery systems. Students will recreate the clinical and device requirements, the engineering specifications, the regulatory pathways, the intellectual property, the risk management strategies, and the business models that were deployed to bring the product into clinic use. Devices in all areas of medicine are covered with an emphasis on women's health.