Principal Scientist GE Research Niskayuna, New York, United States
General societal trends across the globe, including a shortage of centralized laboratory and medical facilities, aging populations with increasing incidence of infectious and chronic diseases, earlier diagnosis of diseases, personalized medicine, companion testing for pharmaceutical use, government initiatives and insurance acceptance, are all important factors behind continued demand for reliable, low-cost, wireless, wearable health monitoring and medical devices. In this presentation, we will highlight our recent efforts towards development of two generations of single use Vital Signs Monitoring (VSM) devices, both allowing for continuous measurement of multiple vital sign parameters, including ECG (heart rate), respiration rate, 3-wavelength reflective PPG (pulse oximetry), skin temperature and motion (3-axis accelerometry), for up to 3 days. These patches are designed to measure the vital signs parameters of interest at anatomically relevant locations to achieve clinical relevancy. Robust wireless Bluetooth communications capabilities developed in this program allow for ease of implementation and integration with both mobile (Android based) devices and Cloud platforms. The multi-parameter patch prototypes are fabricated in manufacturing relevant environment, using multiple medical device manufacturing suppliers with GMP certifications, to ensure realistic pathways for low-cost single use devices that can be FDA cleared in the future. In this presentation, we will also provide an overview of algorithms developed for continuous and in-situ monitoring/visualization of vital sign parameters, including continuous non-invasive blood pressure monitoring. Finally, we will present the results of our human subject testing at AFRL to evaluate prototype patch performance under simulated flight/vibration conditions relevant for aeromedical evacuation concepts of operation.