Applying Formal Methods to Improve the Quality of Software in Medical Devices

University Of Pennsylvania, Philadelphia PA

Investigators

Abstract

This award establishes a NSF-FDA Scholar-in-Residence project at the U.S. Food and Drug Administration. With NSF support, a graduate student member of the University of Pennsylvania's formal methods team will participate in a research project for medical device software evaluation at the FDA's Center for Research in Devices and Radiological Health. This effort seeks progress towards technology-supported, rigorous evaluation of software-intensive medical devices, using an infusion pump as case study. The research focuses on establishing the behavioral equivalence of the device software with the specified requirements for devices in this class. The study also explores potential device interactions with operator controls and with changes in the patient's condition. The longer-term goal of this project is to enable a more comprehensive, evidence-based approach for evaluation of medical devices and other safety-critical, software-centric systems.