The objective of this workshop is to identify critical product life cycle issues in biomedical engineering design. The participants include representatives from academia, industry, consulting organizations and providers of health care delivery. Special efforts have been made to engage users, be they consumers, professionals or physicians. The workshop addresses the challenges created by the impact of devices and materials on living systems in the engineering design process. The effective transfer of general design theory and methodology concepts to the domain of biomedical engineering is another motivation for this activity. The ultimate goal is the development of a research agenda that will more fully incorporate issues of safety, process control and efficacy assessment in the life cycle design, manufacturing and deployment of biomedical engineering products.
