Compositional, approximate, and quantitative reasoning for medical cyber-physical systems with application to patient-specific cardiac dynamics and devices

Abstract

The design of bug-free and safe medical device software is challenging, especially in complex implantable devices that control and actuate organs who’s response is not fully understood. Safety recalls of pacemakers and implantable cardioverter defibrillators between 1990 and 2000 affected over 600,000 devices. Of these, 200,000 or 41%, were due to firmware issues that continue to increase in frequency. According to the FDA, software failures resulted in 24% of all medical device recalls in 2011. There is currently no formal methodology or open experimental platform to test and verify the correct operation of medicaldevice software within the closed-loop context of the patient. The goal of this effort is to develop the foundations of modeling, synthesis and development of verified medical device software and systems from verified closedloop models of the device and organ(s). Our research spans both implantable medical devices such as cardiac pacemakers and physiological control systems such as drug infusion pumps which have multiple networked medical systems. These devices are physically connected to the body and exert direct control over the physiology and safety of the patient. The focus of this effort is on (a) Extending current binary safety properties to quantitative verification; (b) Development of patient-specific models and therapies; (c) Multi-scale modeling of complex physiological phenomena and compositional reasoning across a range of model abstractions and refinements; and (d) Bridging the formal reasoning and automated generation of safe and effective software for future medical devices.