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

由于许多因素，包括基因组测序、患者特定的方法和重大的数字技术进步，医疗保健领域正在发生重大变革。FDA负责美国所有医疗产品的安全性和有效性，其设备和放射健康中心(CDRH)负责监督约17.5万台设备，包括每年近100项新的上市前批准(PMAS)。FDA，特别是CDRH，在创新技术方面一直积极主动，发布了“指导文件”、标准和一项重大的“数字健康”倡议。数字健康计划包括“软件即医疗设备、高级分析、人工智能、云计算、网络安全、互操作性、医疗设备数据系统、移动医疗APS以及无线和新颖技术”。这一为期一年的NSF/FDA学者驻留项目的目标是通过以下方式扩大这些努力：1)促进CDRH在增强房地产(AR)和虚拟现实(VR)方面的持续努力；以及2)开发一个新的硬件和软件‘平台’，以满足某些设备的AR/VR和实时模拟。这一新的试验床将被安置在FDA，并包括一个“样本设备”，以表示在患者进行的“心脏电生理测试”中的动态。作为外展和公众宣传的一部分，为VR/AR试验台开发的软件将免费提供给公众。试验床的开发将包括一个交互式的、可步行的3D虚拟博物馆和交互式的心脏教育模拟，供临床医生、他们的患者和一般公众可视化心脏动力学、心律失常和现有的治疗/治疗。该项目的目标是帮助创建FDA迫切需要的基础设施，以评估和验证硅胶研究和VR/AR系统，旨在探索可视化和操作心血管解剖的新方法，包括电波传播和临床使用的侵入性程序的战略规划，以及抗心律失常药物设计。虽然过去已经对复杂的生理和生物模型进行了高性能的计算机模拟，并对生物和医疗系统进行了VR/AR可视化，但这被认为是第一次将两者结合起来进行模拟并同时进行交互。开发的实时试验台将允许FDA研究设备和模拟与临床患者的循环交互。为了实现这一目标，研究计划组织在三个目标下：(1)将复杂数学细胞模型的交互式实时模拟纳入精确逼真的3D心脏结构中，并在台式计算机上开发用于在VR和AR中与这些模型进行可视化和交互的框架，以消除对超级计算机模拟的需要；(2)开发大量的电生理和结构模型，以运行在来自Aim 1的这种交互式VR/AR框架下；以及(3)为医生、患者和普通公众开发在线资源，解释心脏功能、心律失常，作为目前使用VR/AR试验床控制和终止心律失常的一些方法。开发的基础设施将使FDA能够积极主动地准备解决这些新兴先进技术带来的复杂监管问题，这与心脏电生理设备特别相关，因为最危险的心律失常涉及复杂的时空模式，在心脏电生理测试期间使用心脏标测导管以有限的空间分辨率记录这些模式。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.