Contrasting the medical-device and aerospace-industries approach to reliability

Abstract

A comparison is made between the defense driven aerospace industry and the medical device industry with respect to their approach to achieving reliability. The Department of Defense establishment has driven the aerospace industry to consider and analyze reliability through imposing a complex set of standards and specifications that control all aspects of design and analysis. The medical device industry, driven by market forces, safety considerations, and limited government regulation, has typically lagged in the imposition of specific reliability requirements and performance of reliability analyses in the design and development process. This situation is changing, the Department of Defense is adopting more and more commercial standards and the medical device industry is responding to a marketplace that is becoming more demanding, where commercial standards and specifications are becoming more widely imposed, and where the Federal, state, and local governments are becoming more active in exerting influence on the industry. The net result is an increasing similarity in the approach taken by of the aerospace and medical device industries towards achieving reliability.