Varian TrueBeam: Defining FDA Human Factors Testing

Varian Medical Systems was facing new FDA requirements for safety and usability human factors testing for all medical devices and software. EchoUser was tasked to develop a new process for testing medical devices and piloted this process through usability tests on the new version of Varian’s TrueBeam radiation cancer treatment machine.

The methodology that EchoUser developed became standardized for testing a wide range of medical devices and software across Varian.


EchoUser worked with the Varian team over the course of one year to develop, pilot, and implement an FDA-compliant, rigorous, repeatable process to measure, diagnose, classify, and report on the use safety and experience of its medical products. We wanted to test how well designed, productive, and safe interfaces were for conducting tasks. We used benchmark usability tests to determine the product’s level of usability and use safety.


The device selected for the initial pilot was the TrueBeam radiotherapy machine which treats cancer by delivering powerful, targeted radiation to cancerous cells with pinpoint accuracy, directed by its complex imaging system. Our team was able 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. Both current and potential users were tested with possible scenarios to gauge the users’ perceptions of the device’s current safety in the usability tests.


We categorized research measures across four basic Key Performance Indicators (KPIs), which we determined to be: Effectiveness, Use Safety, Efficiency, and Satisfaction. Using this testing methodology and measurement classification, the TrueBeam usability test identified areas needing improvement, as well as areas that performed beyond expectations.


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