Case Study: a leading medical devices company advances overactive bladder treatment approval with ObvioHealth

Leading Medical Devices Company - Customer Case Study

A leading medical devices company engaged ObvioHealth for a clinical trial to evaluate the safety and efficacy of a novel wearable neuromodulation device for treating overactive bladder (OAB). The challenge was to run a 52-week at-home study to test the device and its companion app, seeking FDA approval by demonstrating real-world results superior to the current prescription standard of care.

The solution implemented by ObvioHealth involved a decentralized, virtual study design using their app and platform for eConsent, data capture, and real-time monitoring. The ObvioHealth app collected safety and efficacy data from participants at home, which their team proactively monitored to mitigate compliance and safety concerns. This approach successfully generated the valuable data required for the company's FDA submission to substantiate the device's efficacy.