Reengineering Safety Critical Systems in an Industrial Environment

Abstract

This paper discusses the development of a framework for safety-critical medical devices in an industrial environment. The authors have worked on the development and testing of a cardiac rhythm management system at Guidant Corporation, which is involved in the development of a family of related medical devices such as Pacemakers and Defibrillators. The development and testing process for these systems is expensive because of the stringent safety and reliability requirements of these devices. To leverage the cost involved in this process we take advantage of the overlap in functionality across a family of products. In this paper, we present a domain-specific framework for developing and maintaining these safety-critical software systems. The approach allows easy generation and maintenance of lifecycle artifacts, like code, test requirements, while maximizing reusability. We have demonstrated our technique in the testing of a cardiac pacemaker and have achieved significant improvements in productivity.