Design for reliability in medical devices

The challenges faced by medical device manufacturers in bringing safe, reliable, low overall life-cycle cost products to market in a timely manner is increasing rapidly. The global recession, the increasing complexity and criticality of medical devices and the increasing number of safety recalls is driving the need for a good design for reliability (DFR) program in the medical industry. However, theoretical knowledge of a good DFR is not enough. This paper discusses five DFR paradigms, developed from years of experience; that need to be applied to ensure a successful DFR program in the medical device industry.