Exploring Medical Device Reliability and Its Relationship to Safety and Effectiveness

It may seem intuitive that reliability is essential for modern products that need to be safe and effective, particularly healthcare and medical devices. One would expect to find reliability cited in regulations, engineering articles, and consensus standards. Yet typical industrial processes in which high reliability is needed 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 that is tied explicitly to safety and effectiveness undermines S&E evaluation. Regulators and manufacturers who are unable to take full advantage of the information generated by the reliability engineering processes 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 into S&E assessments.