Smart and Connected Nanomembrane Biopatch with AI for Wireless, Continuous Health Monitoring of Pediatric Patients – Towards Immediate Commercialization.

PI’s: Woon-Hong Yeo, Kevin Maher, Christopher Lee, 

Funded by: Imlay Innovation Fund

The use of non-invasive patient monitoring methods is working its way into the adult patient population with advancements in medical and consumer electronic technologies. However, the currently available commercial devices that are bulky, obtrusive, and wired to table-top patient monitors have not been designed for children, much less neonates. For comprehensive health monitoring, the conventional system requires multiple, separate sensors and electronics, which often makes false alarms when one of the wired sensors is detached from a patient due to movements. In addition, the skin-mounted electrodes and adhesives often cause skin irritation and allergic reactions. Thus, there is a significant need for new technologies that will provide a non-invasive, comfortable, accurate, and continuous evaluation and assessment of the clinical status of our smallest patients. Clinicians and families who provide care to infants and neonates should expect that new technologies for cardio-respiratory monitoring will be wireless, gel-free, multifunctional, portable, and easy to use like a Band-Aid. The next generation of a pediatric health monitoring device should work in both hospital and home environment, with a wireless, all-in-one platform with embedded multi-sensors and AI (machine learning) that will offer a warning system to detect and report real-time abnormalities/ deviation from the norm to patient providers. Overall, our project is expected to resolve those issues via a newly developed smart and connected biopatch.

This project aims to demonstrate the functions and performance of a newly developed wearable nanomembrane biopatch (Band-Aid-like device) while collecting much-needed data via in vivo patient study at the Children's Healthcare of Atlanta (CHOA). In 2018, this research team received the Imlay Fund and successfully developed a wireless, nanomembrane pediatric biopatch. We already have a pending US patent (Multifunctional Biopatch for Wireless Monitoring of Health Conditions and Methods Thereof, US Patent (PCT/US2019/036043), 2019) that protects the developed technologies, making an all-in-one, nanomembrane wearable device with an embedded machine learning algorithm for automated data classification and detection of health issues. Thus, in this project for the next 12 months, we aim to fabricate more devices, optimize the predeveloped device manufacturing methods, and collect more patient data at CHOA (IRB and MTA were already approved). Right after the clinical study, we will work on the immediate commercialization of the developed technologies for large-scale manufacturing of wearable devices to help pediatric patients. To support these efforts, we started to collaborate with a commercial industry partner, Huxley Medical Inc (CEO: Dr. Chris Lee, Georgia Tech Alumnus). The device fabrication can be easily scalable to expedite commercialization based on screen-printing and soft material packaging technologies. The project deliverables within 12 months include 1) Over 20 fabricated prototypes to work with multiple patients at CHOA neonatal intensive care unit, 2) Scalable manufacturing recipes - all printing technologies and hard-soft materials integration without cleanroom microfabrication, and 3) All-in-one device platform that measures multiple physiological signals on the chest, along with an embedded deep-learning algorithm for real-time data classification and abnormal signal detection.