NSF/FDA SiR: A Nonclinical Testing Tool for Wearable Photoplethysmography-Based Blood Pressure Monitoring Devices

本项目旨在开发并实现一个测试平台，用于评估可穿戴式血压测量设备的准确性。最近，基于可穿戴设备的血压监测技术的发展激增，其中一些已经在市场上商业化。然而，由于可接受的测试程序的限制，在验证这些设备以确保BP测量的准确性方面仍然存在挑战。目前的评估大多基于资源密集型临床试验。因此，该项目的成功完成将使我们能够以低成本和有意义的评估可穿戴式血压监测设备，通过促进我们对以下方面的知识：(I)可穿戴设备测量的生物信号与人体生理和组织生物力学；(Ii)具有时间/成本效益的可穿戴式血压监测设备的台架测试；(Iii)设计和实现一个可以模拟多种生理条件下人体脉动血流的平台。此外，该项目将促进新的血压监测设备的开发，用新技术刺激医疗设备市场，用更准确的血压测量改善人类的生活质量，以及(Iv)培养具有如何开发和评估新型医疗保健设备的知识的下一代科学家。尽管最近基于光体积描记(PPG)的可穿戴血压监测设备的开发和部署激增，但还没有台架测试方法可以客观地评估这些高影响的医疗设备。为了弥补这一差距，该项目将开发一种新型的流动体模电路技术，作为能够对基于PPG的血压监测设备进行台式测试的非临床测试平台。流动体模技术通过模拟模拟循环流动回路和模仿组织的搏动体模，提供了一个低成本、低风险和高效的评估环境。当基于PPG的血压监测设备被物理地放置到电路中时，它与流动模电路一起在动态变化的环境中操作。因此，该平台可以识别设备中传感器和算法元件的变化对血压测量的影响。该平台还可以评估基于PPG的血压测量算法对各种流动和运动条件的敏感度。最后但并非最不重要的一点是，该平台的成熟版本有可能改变各种基于PPG的血流动力学监测设备的设计和测试流程，而不仅仅是血压监测仪。为了实现项目目标，将完成以下任务：(I)将构建一个具有生理相关和可控血压、血流、解剖和光学特性的台式流动体模；(Ii)将开发使用该流动体模来评估基于PPG的血压测量算法对各种流动和运动条件的敏感性的测试方法。该项目的结果最终将把我们引向一个监管科学工具，该工具将加强临床研究，并可能减少为替代传感器-算法组合重复完整临床验证协议的繁琐方法，从而实现更有针对性的临床测试。该奖项反映了NSF的法定使命，并已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。

This project intends to develop and implement a testing platform that can evaluate the accuracy of wearable blood pressure measurement devices. There is a recent surge in the development of wearable-based blood pressure monitoring technologies, and some are commercially available in the market. However, challenges remain in validating these devices to ensure the accuracy in BP measurement due to the limitations in acceptable testing procedures. Current evaluation is mostly based on resource-intensive clinical testing. Hence, successful completion of this project will enable low-cost and meaningful evaluation of wearable blood pressure monitoring devices by advancing our knowledge related to (i) the bio-signal measured by the wearable devices versus human physiology and tissue bio-mechanics; (ii) time-/cost-efficient bench testing of wearable blood pressure monitoring devices; (iii) the design and implementation of a platform that can imitate pulsatile blood flow in the human body under a wide range of physiological conditions. In addition, this project will foster the development of new blood pressure monitoring devices, stimulate medical device market with new technologies, improve the quality of life of humans with more accurate blood pressure measurement, and (iv) creating the next-generation of scientists with the knowledge of how to develop and evaluate novel medical and healthcare devices.Despite the recent surge in the development and deployment of photoplethysmography (PPG)-based wearable blood pressure monitoring devices, there is no bench test method that can objectively evaluate these high-impact healthcare devices. To bridge the gap, this project will develop a novel flow phantom circuit technology as a non-clinical testing platform capable of performing bench testing of PPG-based BP monitoring devices. The flow phantom technology provides a low-cost, low-risk, and highly effective evaluation environment by simulating a mock circulation flow loop and a tissue-mimicking pulsatile phantom. When a PPG-based blood pressure monitoring device is physically placed into the circuit, it operates in a dynamically changing environment with the flow phantom circuit. Hence, the platform can identify the impact of alterations in the sensor and algorithm elements in the device on blood pressure measurements. The platform can also evaluate the sensitivity of PPG-based blood pressure measurement algorithms to various flow and motion conditions. Last but not least, a mature version of this platform has the potential to transform the design and testing processes of a wide variety of PPG-based hemodynamic monitoring devices beyond blood pressure monitors. To achieve the project goal, the following tasks will be accomplished: (i) a bench flow phantom with physiologically relevant and controllable blood pressure, blood flow, anatomical, and optical characteristics will be constructed; and (ii) test methods using the flow phantom to evaluate the sensitivity of PPG-based blood pressure measurement algorithms to various flow and motion conditions will be developed. The result of this project will eventually lead us to a Regulatory Science Tool that will augment clinical studies and potentially reduce the burdensome approach of repeating full clinical validation protocols for alternative sensor-algorithm combinations, enabling more targeted clinical testing.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.