The open PCA pump project: an exemplar open source medical device as a community resource

Abstract

Building safe and secure interoperable medical devices with accompanying assurance artifacts is challenging. Many start-up companies have great ideas for innovation, but are not familiar with appropriate safety/security-critical engineering processes, architecture principles, risk management, and assurance techniques. Larger, more experienced, companies may face hurdles in re-engineering their devices for interoperability and greater security. In academia, researchers often have good techniques for addressing some of the issues above, but are not familiar with how a realistic medical device is developed and assured. Building a prototype medical device for a classroom project or research work to validate proposed techniques is often a huge effort. The Open PCA Pump illustrates a full suite of realistic development artifacts including use cases, requirements, architecture models, verified source code, testing and simulation infrastructure, risk management artifacts, and assurance cases that can be used to develop shared understanding of medical device innovations across the academic, industry, and regulatory communities.1