FDA SIR: Compositional Approaches to Safety and Risk Management for Medical Application Platforms

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Modern medical devices increasingly incorporate connectivity mechanisms that offer the potentialto integrate devices via network/middleware technology into larger systems of cooperatingdevices. Initial integration efforts in the industry are focused on streaming device datainto electronic health records and integrating information from multiple devices into single customizable displays. This proposal provides a research foundation for engineering and verificationof these safety critical systems through creating an open source Medical Device Coordination Framework (MDCF) which includes: 1)middleware for integrating medical devices and electronic health records, and 2) a model-based development environment that implements medical device coordinationapplications (apps for short), enabling a systems of systems paradigm for medical devices. The project has substantial broader impact via tools and techniques for verifying the integration of medical systems that are compatible with the Integrated Clinical Environment standard. In addition, the proposer includes extensive interaction with FDA specialists who are looking to transition these methods into their validation and verification processes for their regulatory mission.