Exploring medical device reliability and its relationship to safety and effectiveness

It may seem intuitive that reliability should be essential for modern products that need to be safe and effective, particularly health care and medical devices. It should come as no surprise to find reliability cited in regulations, engineering articles, and consensus standards. Yet typical industrial processes to achieve reliability often do not explicitly provide evidence to support a safety and effectiveness (S&E) argument. The lack of a consistent and standardized framework for achieving reliability tied explicitly to safety and effectiveness undermines the S&E evaluation. Regulators and manufacturers who are unable to take full advantage of the information generated by the reliability engineering process fail to maximize product S&E. This paper explores a reliability engineering framework to provide the arguments, claims and evidence important to product S&E, and the artifacts suitable for integrating reliability to S&E assessments.