An Integrated Development and Certification Environment for a Medical Device Coordination Framework

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Medical devices historically have been monolithic units -- developed, validated, and approved by regulatory authorities as stand-alone entities. Yet modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to integrate devices via network/middleware technology into larger systems of cooperating devices. This NSF-FDA Scholar In Residence research project supports interaction by this NSF-supported academic research team with the FDA Center for Device and Radiological Health (CDRH), as well as with a team from the Center for Integration of Medicine and Technology and a team from the University of Pennsylvania on this problem. The goal is to move beyond early industrial medical device integration efforts that focus on streaming device data into electronic health records and integrating information from multiple devices into single customizable displays. The objective of the project is to support frameworks that coordinate the actions of groups of cooperating devices to potentially realize "closed loop" scenarios. This work is expected to automate clinical workflows by controlling networked devices as they perform cooperative tasks. The project builds on an open source Medical Device Coordination Framework (MDCF) that has been developed under prior NSF funding. The MDCF includes (a) middleware for integrating medical devices and EHRs and (b) a model-based development environment that could be used to quickly implement medical device coordination applications enabling a "systems of systems" paradigm for medical devices as described above. The MDCF already includes support for rapid development of component interfaces for medical devices, displays, coordination logic, and clinical decision support modules. This study extends the MDCF for rapid development of requirements documents, hazard analysis, and correctness claims associated with quality assurance techniques including testing, static analysis, and formal verification of coordination applications and their components. The FDA currently classifies conventional medical devices according to their criticality, but no such scheme exists for device coordination applications. This study is developing a criticality classification scheme for device coordination applications that will provide a structure for regulatory oversight. The study also is providing infrastructure for rapid development of coordination application assurance cases using safety cases an approach that uses semi-formal notations for structured arguments to document and provide evidence that safety claims for a system are satisfied.