HST962 Medical Product Development
Development is the process by which the benefits and risks of a medical product are quantitatively assessed.
A graduate course on medical product development Units: 1-0-3 HST962 is a half-semester course on the translation of basic biomedical science into clinical outcomes and, ultimately, therapies. Topics span pharmaceutical, medical device, and diagnostics development. The course format centers on interviews with nearly forty leading experts in medical product development from many companies and federal agencies. The course concerns development rather than design. Physicians, patients, and regulators need to know the benefits and risks associated with any product before its use. HST962 helps students contemplate the future of their own research projects. We will discuss several important areas that need to be thought about early in the development of medical product. Strategies for establishing who will really benefit from a new medical technology, for example, should be considered very early in a research program. The proof of concept trial must also be envisioned when the technology is still on the bench-top. Quantification of risk impacts design practice. Thus, an upfront understanding of where risks may appear is critical for successful development.