FDA SIR: Compositional Approaches to Safety and Risk Management for Medical Application Platforms
Lead PI:
John Hatcliff
Co-PI:
Abstract
Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to integrate devices via network/middleware technology into larger systems of cooperating devices. Initial integration efforts in the industry are focused on streaming device data into electronic health records and integrating information from multiple devices into single customizable displays. This proposal provides a research foundation for engineering and verification of 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 coordination applications (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.
Performance Period: 03/01/2015 - 02/29/2016
Institution: Kansas State University
Sponsor: National Science Foundation
Award Number: 1446544