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Unit of study_

BMET9990: Biomedical Product Development

Product development in the biomedical area presents unique challenges that need to be addressed to efficiently satisfy strict regulatory requirements and to successfully advance products to approval for marketing. Biomedical engineers need a broad understanding of these challenges as the main components of product development are complex and interdependent. Development of good manufacturing and quality control processes, preclinical and clinical validation of product safety and efficacy, and regulatory filings, are each progressive and interdependent processes. This UoS will provide a broad understanding of regulatory requirements for biomedical product development, with particular emphasis on the dependence of each component on the development of processes and control systems that conform to Good Manufacturing Practice. This UoS assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development.

Code BMET9990
Academic unit Biomedical Engineering
Credit points 6
BMET3990 or AMME4990 or BMET4990 or AMME5990 or AMME9990
Assumed knowledge:
1000 level chemistry, 2000 level biology, and specific knowledge of cell biology at least at the1000 level, and preferably at the 2000 level

At the completion of this unit, you should be able to:

  • LO1. Understand biomedical product development within the regulatory framework including: developing manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice
  • LO2. Understand the role of progressive preclinical and clinical testing and their dependence on product of increasing quality
  • LO3. Work in a team to develop a plan for progressing a biomedical discovery to initial clinical testing
  • LO4. Understand how to evaluate a case study on a biomedical development failure to determine contributing inadequacies in product testing, design or quality control.
  • LO5. Awareness of the additional challenges associated with entrepreneurship in the realm of biomedical product development