OP. Model-based Clinical Trials for Software Verification in Implantable Cardiac Devices

Introduction: The software components of implantable medical devices are becoming increasingly complex and are responsible for the majority of life-critical decisions. From 2008-2012, 15% of all the medical device recalls were due to software issues. Research and regulation efforts have largely focused on verifying whether the device satisfies its specification, which can be achieved with open loop testing. However, most safety violations happen when the software specifications of the device fail to meet their intention, which are the physiological requirements. The conformance between the specifications and the requirements requires deep domain knowledge and can only be verified through closed-loop verification. Currently, the only form of closed-loop verification for medical device software is clinical trials, in which the devices are tested on real patients. In terms of identifying and correcting software bugs, clinical trials are not only ineffective due to limited population, but also very.