Safety case driven development for medical devices

Abstract

Medical devices are safety-critical systems that must comply with standards during their development process because of their intrinsic potential of producing harms. Although the existing trend of an increasing complexity of medical hardware and software components, very little has been done in order to apply more mature safety practices already present on other industrial scenarios. This paper proposes a methodology to enhance the Model-Based System Engineering (MBSE) state-of-art practices from the safety perspective, encouraging the use of safety cases and providing guidance on how to show the correspondent traceability for the development artifacts. We illustrate our methodology and its usage in the context of an industrial Automated External Defibrillator (AED). We suggest that medical device industry could learn from other domains and adapt its development to take into account the hazards and risks along the development, providing more sophisticated justification, as, for example, the impact of design decisions.