Wearable Pulsed Electromagnetic Field (PEMF) Sensor for Clinical Trials Compliance Applications

Regenesis Biomedical has an FDA-approved pain treatment device in clinical trials. However, the device does not monitor treatment administration for patient compliance. Patient non-compliance can exacerbate an already lengthy and costly trial process.

This project presents a wearable device that senses treatment to increase patient compliance.

The team’s design, worn on a patient’s wrist, consists of multiple components. The device housing – produced with computer-automated design software and printed with biocompatible material on a 3D printer – is similar to a watch. Circuitry on a printed circuit board detects administration of treatment. A microcontroller reads in treatment detection data and uses Bluetooth technology to connect to a downloadable mobile iOS application. In addition to providing treatment information, the app includes account setup and login capabilities. Patient status reports are sent to the trial’s point of contact for compliance monitoring.