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

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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.