FDA SIR: Tools, Processes, and Artifacts for Certifiable Clinical Applications in Interoperable Medical Device Frameworks

Kansas State University, Manhattan KS

Investigators

Abstract

This project is a collaboration under the NSF-FDA Scholar-In-Residence (SIR) program. The objective of this research is to advance regulatory science for next generation composite medical systems that are based on the concept of medical application platforms (MAP). A MAP is a safety- and security-critical real-time computing platform for (a) integrating heterogeneous devices, medical IT systems, and information displays via a communication infrastructure and (b) hosting application programs ("apps") that provide medical utility via the ability to both acquire information from and update/control integrated devices, IT systems, and displays. The intellectual merit of the project lies in constructing and evaluating a prototype framework for developing and certifying MAP apps that follow the Integrated Clinical Environment(ICE) architecture standard. The project will study approaches for rigorous requirements and architecture specifications that will enable ICE apps to safely interoperate with other medical devices and other service within ICE. These concepts will be illustrated using mock ICE apps developed during the project. In consultation with engineers from the Food and Drug Administration (FDA), the project will construct model risk management and regulatory artifacts associated with ICE apps. The impact of this work centers around helping FDA engineers understand the architectural and safety issues associated with MAPs and identifying best practices that can lead to high assurance of MAP-based medical systems. Additionally, the project will produce concrete app examples that will provide science-based inputs into the design of a new regulatory approach that supports compositional regulation of heterogeneous multi-vendor ICE systems.