WEARABLE PULSED ELECTROMAGNETIC FIELD (PEMF) SENSOR FOR CLINICAL TRIALS COMPLIANCE APPLICATIONS

Abstract

Patient non-compliance in clinical trials is a critical issue that costs clinical trial sponsors money and time. Regenesis Biomedical Inc., a medical device company in Scottsdale, AZ, has an FDA approved device for chronic pain treatment. However, the device turns on and begins treatment without ensuring patient compliance during treatment application. For this purpose, Regenesis Biomedical has asked us to design a device that detects the presence of treatment for patient monitoring. We have prototyped a printed circuit board that detects the presence of treatment, a housing unit for wearability, and Bluetooth functionality that connects to another device and signals if treatment is being applied or not. The device is meant to be worn around the wrist, like a watch, to ensure the patient can monitor compliance in non-clinical environments, such as home or work. Our team also began prototyping a mobile application supported by iOS. While the app does not have full Bluetooth functionality, future plans include ensuring that the printed circuit board can connect to the app and developing the app for Android support as well. Additionally, the next step in prototyping would include adding more capacitance to the detection circuit because the signal to the microcontroller does not hold as well as it could. We will be delivering our prototype, solid works drawings, code, and all other deliverables to Regenesis Biomedical after Design Day on May 2, 2022.