NSF/FDA SIR: Real-Time Simulations of Electrical Activity of the Heart and Augmented/Virtual Reality for Medical Device Applications

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There is a major transformation shift occurring in healthcare resulting from a number of factors including, genome sequencing, patient-specific approaches, and major digital technology advances. The FDA is responsible for the safety and efficacy of all medical products in the US, and its Center for Devices and Radiological Health (CDRH) is responsible for the oversight of ~175,000 devices including nearly 100 novel Pre-Market Approvals (PMAs) per year. FDA, and CDRH in particular, has been pro-active in regard to innovative technology as evident by the release of “Guidance Documents,” Standards, and a major “Digital Health” initiative. The Digital Health initiative includes “Software as a Medical Device, Advanced Analytics, Artificial Intelligence, Cloud Computing, Cybersecurity, Interoperability, Medical Deice Data System, Mobile Medical Aps, and Wireless and Novel Technology. The goal of this one year NSF/FDA Scholar-in-Residence project is to expand these efforts by: 1) catalyzing the ongoing efforts of CDRH regarding Augmented Realty (AR) and Virtual Reality (VR); and 2) develop a novel hardware and software ‘platform’ to address certain devices incorporating BOTH AR/VR and real-time simulations. This new testbed will be housed at FDA and include an “exemplar device” to represent the dynamics within of a “cardiac electrophysiology test” performed in patients. As part of outreach and public dissemination, the software developed for the VR/AR testbed will be made freely available to the public. Developments for the testbed will include an interactive, “walkable” 3D virtual museum and interactive educational simulations about the heart for clinicians, their patients and the public in general to visualize heart dynamics, arrhythmias and existing treatments/therapies. The goal of this project is to help create an infrastructure critically needed by the FDA to evaluate and validate in silico studies and VR/AR systems intended to explore new approaches for visualization and manipulation of cardiovascular anatomies, including electrical wave propagations and strategical planning of invasive procedures used in the clinic as well as anti-arrhythmic drug design. While high performance computer simulations of complex physiological and biological models and VR/AR visualization of biological and medical systems have been done in the past, this is believed to be the first time the two are merged to be simulated and made interactive at the same time. The in-real-time testbed developed will allow the FDA to study interaction of devices and simulations in the loop with patients in the clinic. To achieve this goal, the research plan is organized under three aims: (1) Incorporate interactive real-time simulations of complex mathematical cell models in accurate realistic 3D cardiac structures, and develop a framework for visualization and interaction with these models in VR and AR on a desktop computer to eliminate the need for supercomputer simulations; (2) Develop a large catalogue of electrophysiological and structural models to run under this interactive VR/AR framework from aim 1; and (3) Develop online resources for medical doctors, patients and general public, to explain the heart’s function, heart arrhythmias as some of the methods currently used for control and termination of arrhythmias using the VR/AR testbed. The infrastructure developed will enable the FDA to be proactive and prepared to address the complex regulatory issues introduced by these emergent advanced technologies, which is particularly relevant for cardiac electrophysiological devices because the most dangerous arrhythmias involve complex spatio-temporal patterns that are recorded with limited spatial resolution using cardiac mapping catheters during a cardiac electrophysiological test.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.