CPS: Frontier: Collaborative Research: Compositional, Approximate, and Quantitative Reasoning for Medical Cyber-Physical Systems

该项目代表了跨学科的合作研究努力，旨在开发严格的闭环方法来设计、模拟和验证医疗设备。这项工作将为从根本上加快医疗器械创新的步伐开辟基本的新途径，特别是在心脏装置设计领域。将特别关注开发先进的基于正式方法的方法来分析控制器设计的安全性和有效性；并设计加快监管机构和其他第三方对器械设计的审查的方法。项目团队包括具有计算机科学、电子工程、生物物理学和心脏病学研究背景的成员；pi将使用一种协调的方法来平衡理论，实验和实践问题，以产生旨在改变设备设计实践的结果，同时也促进新的心脏疗法转化为实践。所提出的努力将导致系统验证和心脏治疗基于使用形式方法和闭环控制和验证的艺术状态的重大进展。这项工作的目标是开发一种真正的医疗设备的计算机设计方法，以加快新设备的开发，并提供更大的保证，使其行为符合设计者的意图，并更快地通过监管要求，以便它们可以用于需要护理的患者。提出的科学工作将通过提供数学上可靠的技术来分析和验证医疗设备的行为，建模和模拟心脏动力学，以及对所提出的治疗方法进行闭环验证，从而实现这一愿景。随着更好的诊断和治疗技术更快地进入医学实践，拟议研究所实现的医疗器械创新的加速也将具有长期和持续的社会效益。它也将产生的工具和技术的集合，将适用于其他类型的设备的设计。最后，它将通过广泛的教育和外展计划，包括为本科生提供密集的讲习班经验，为人力资源的开发和进一步纳入代表性不足的群体做出贡献。

This project represents a cross-disciplinary collaborative research effort on developing rigorous, closed-loop approaches for designing, simulating, and verifying medical devices. The work will open fundamental new approaches for radically accelerating the pace of medical device innovation, especially in the sphere of cardiac-device design. Specific attention will be devoted to developing advanced formal methods-based approaches for analyzing controller designs for safety and effectiveness; and devising methods for expediting regulatory and other third-party reviews of device designs. The project team includes members with research backgrounds in computer science, electrical engineering, biophysics, and cardiology; the PIs will use a coordinated approach that balances theoretical, experimental and practical concerns to yield results that are intended to transform the practice of device design while also facilitating the translation of new cardiac therapies into practice.The proposed effort will lead to significant advances in the state of the art for system verification and cardiac therapies based on the use of formal methods and closed-loop control and verification. The animating vision for the work is to enable the development of a true in silico design methodology for medical devices that can be used to speed the development of new devices and to provide greater assurance that their behaviors match designers' intentions, and to pass regulatory muster more quickly so that they can be used on patients needing their care. The scientific work being proposed will serve this vision by providing mathematically robust techniques for analyzing and verifying the behavior of medical devices, for modeling and simulating heart dynamics, and for conducting closed-loop verification of proposed therapeutic approaches. The acceleration in medical device innovation achievable as a result of the proposed research will also have long-term and sustained societal benefits, as better diagnostic and therapeutic technologies enter into the practice of medicine more quickly. It will also yield a collection of tools and techniques that will be applicable in the design of other types of devices. Finally, it will contribute to the development of human resources and the further inclusion of under-represented groups via its extensive education and outreach programs, including intensive workshop experiences for undergraduates.