A platform for implantable medical device validation: demo abstract
WH '10 Wireless Health 2010
On effective testing of health care simulation software
Proceedings of the 3rd Workshop on Software Engineering in Health Care
Digital mockups for the testing of a medical ventilator
Proceedings of the 2nd ACM SIGHIT International Health Informatics Symposium
Formalization of heart models based on the conduction of electrical impulses and cellular automata
FHIES'11 Proceedings of the First international conference on Foundations of Health Informatics Engineering and Systems
A simulink hybrid heart model for quantitative verification of cardiac pacemakers
Proceedings of the 16th international conference on Hybrid systems: computation and control
DATE '12 Proceedings of the Conference on Design, Automation and Test in Europe
From software verification to `everyware' verification
Computer Science - Research and Development
Safety-critical medical device development using the UPP2SF model translation tool
ACM Transactions on Embedded Computing Systems (TECS)
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Designing bug-free medical device software is challenging, especially in complex implantable devices that may be used in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators due to firmware problems between 1990 and 2000 affected over 200, 000 devices. This encompasses 41% of the devices recalled and continues to increase in frequency. There is currently no formal methodology or open experimental platform to validate and verify the correct operation of medical device software. To this effect, a real-time Virtual Heart Model (VHM) has been developed to model the electrophysiological operation of the functioning (i.e. during normal sinus rhythm) and malfunctioning (i.e. during arrhythmia) heart. We present a methodology to construct a timed-automata model by extracting timing properties of the heart. The platform employs functional and formal interfaces for validation and verification of implantable cardiac devices. We demonstrate the VHM is capable of generating clinically-relevant response to intrinsic (i.e. premature stimuli) and external (i.e. artificial pacemaker) signals for a variety of common arrhythmias. By connecting the VHM with a pacemaker model, we are able to pace and synchronize the heart during the onset of irregular heart rhythms. The VHM has also been implemented on a hardware platform for closed-loop experimentation with existing and virtual medical devices. This integrated functional and formal device design approach has potential to help expedite medical device certification for safe operation.