CAREER: Medical Cyber-Physical Systems

本项目根据器械和器官的经验证闭环模型，为经验证医疗器械软件和系统的建模、合成和开发奠定基础。这项工作涵盖了植入式医疗设备（如心脏起搏器）和生理控制系统（如具有多个联网医疗系统的药物输注泵）。在这两种情况下，器械都与身体物理连接，并直接控制环内患者的生理和安全。目标是确保该设备永远不会将患者带入不安全状态，同时提供有效的治疗。的贡献是在三个领域：闭环患者-设备建模;定量验证优化的患者特定设备;生命关键系统的平台。 开发了集成建模方法，以产生功能生理信号（用于医疗器械的临床相关测试），并生成器械-患者交互的正式时间，用于正式验证。从验证医疗器械软件的安全性和正确性的问题开始，然后使用基于生理数据的概率患者模型来开发定量验证技术以维持治疗？对患者的疗效和器械的操作效率。为了促进CPS社区、美国食品药品监督管理局（FDA）、医生和制造商的参与，开发了器械/患者模型的开源库、用于验证和模型转换的软件工具以及用于测试真实的医疗器械的硬件平台。这里开发的医疗器械软件和患者的闭环设计和验证技术对人类健康以及医疗保健的质量和成本具有直接的潜在益处。 无缺陷和安全的医疗设备软件的设计是具有挑战性的，特别是在复杂的植入式设备，控制和驱动器官的反应是不完全了解。心脏起搏器和植入式心脏起搏器的安全召回？心脏复律器1990年至2000年期间，有60多万台设备受到了影响。其中，200，000起（即41%）是由于固件问题（即软件）造成的，而且频率不断增加。目前没有正式的方法或开放的实验平台来测试和验证医疗器械软件在患者闭环环境中的正确操作。 如果成功，该项目不仅有可能提高此类设备的安全性，而且还可以加快开发和认证过程。 后者可以降低成本，缩短新设备的上市时间。 该项目还包括广泛的教育和推广部分，包括医疗网络物理系统的课程开发，本科生和研究生参与研究，以及与医院，医疗设备制造商和FDA的合作。该项目的跨领域性质汇集了涉及临床医生，电气工程师，计算机科学家和医疗保健安全监管机构的社区。

This project develops the foundations of modeling, synthesis and development of verified medical device software and systems, from verified closed-loop models of the device and organ(s). The effort spans both implantable medical devices such as cardiac pacemakers and physiological control systems such as drug infusion pumps that have multiple networked medical systems. In both cases, the devices are physically connected to the body and exert direct control over the physiology and safety of the patient-in-the-loop. The goal is to ensure the device will never drive the patient into an unsafe state, while providing effective therapy. The contributions of are in three areas: closed-loop patient-device modeling; quantitative verification for optimized patient-specific devices; platforms for life-critical systems. Integrated modeling methodologies are developed to produce both the functional physiological signals, for clinically relevant testing with a medical device, and also generate the formal timing of device-patient interaction for formal verification. Starting with the problem of verifying the safety and correctness of medical device software, probabilistic patient models based on physiological data are then used to develop quantitative verification techniques to maintain the therapy?s efficacy on the patient and operational efficiency of the device. To facilitate participation of the CPS community, the Food and Drug Administration (FDA), physicians and manufacturers, open source libraries of device/patient models, software tools for verification and model translation and hardware platforms for testing with real medical devices are developed. The closed-loop design and verification techniques for medical device software and patients, developed here, have direct potential benefits on human health, and the quality and cost of medical care. 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 (i.e. software) that continue to increase in frequency. There is currently no formal methodology or open experimental platform to test and verify the correct operation of medical device software within the closed-loop context of the patient. If successful, this project has potential to not only increase the safety of such devices, but also to accelerate the development and certification process. The latter could reduce costs, and shorten the time to market for new devices. The project also has an extensive education and outreach component, including curriculum development in medical cyber-physical systems, involvement of undergraduate and graduate students in research, and cooperation with hospitals, makers of medical devices, and the FDA. The cross-cutting nature of the project brings together communities involving clinical physicians, electrical engineers, computer scientists and regulators of health care safety.