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Medical Product Development


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 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, so understanding upfront where risks could appear is critical for successful development. The course format centers on interviews with nearly forty leading experts in medical product development

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  4. Estimated Effort

    4 hours/week
  5. Requirements