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 unit 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 unit assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development. The objectives are: 1. To gain a broad understanding of biomedical product development within the regulatory framework; 2. To understand the challenges and difficulties of Good Manufacturing Practice; 3. Understand the purpose and conduct of preclinical and clinical testing; 4. To understand how each of these components fit together to support regulatory filings.
Lectures, Tutorials, Project Work - own time
Through semester assessment (100%)
The primary teaching delivery method will be lectures. This unit of study builds on the assumed knowledge of engineering principles and junior and intermediate biology. The purpose of this unit of study is to prepare students for the challenges presented in taking innovative ideas and successfully converting them to valuable products.
Junior level chemistry, intermediate level biology, and specific knowledge of cell biology at least at the junior level, and preferably at the intermediate level.