Case Study
Varian TrueBeam Testing Definition
Designed and implemented a repeatable method, protocol, KPIs, and reporting structure for medical hardware & software human factors testing.
Challenge
Varian Medical Systems was facing new FDA requirements for safety and usability human factors testing for all medical devices and software. Hey
Safety is paramount in Medical Device design. Rigorous, systematic testing with real operators is key to finding and mitigating possible sources of human error.
Approach
EchoUser worked with the Varian team over the course of a year to develop, pilot, and implement an FDA-compliant, rigorous, repeatable process to measure, diagnose, classify, and report on the safety and user experience of its medical products.
The TrueBeam 2.0 radiotherapy machine was the device selected for the initial pilot, which enabled our team to test the process from start to finish on a large, highly complex, safety-critical system encompassing both hardware and software, and both patient and operator considerations. The TrueBeam system treats cancer by delivering powerful, targeted radiation to cancerous cells with pinpoint accuracy, directed by its complex imaging system.
Outcome
The successful pilot of the Safety and User Experience Benchmarking process for the TrueBeam system has now led to the process Echouser developed becoming standardized for use with a wide range of medical devices and software across Varian.