Teaching Assistant, Technology Assessment and Regulation of Medical Devices (BIOE/MS&E 256) (Sp26)

Teaching assistant under Dr. Jan Pietzsch. Class of 80 upper-level undergraduates and graduate students. This graduate course gives engineers an introduction to technology assessment methods and the regulation of medical devices. Regulatory approval and reimbursement for new medical technologies are key components of successful product commercialization. This class discusses the regulatory and payer environment in the U.S. and abroad, and common methods of health technology assessment. A framework is presented to identify factors relevant to the value proposition and adoption of new medical devices and the management of those factors in the design and development phases. In addition to lectures and case studies, guest speakers from government (FDA) and industry share their experiences. Students investigate real-world diagnostic and therapeutic technologies in course projects.