Cedars-Sinai is routinely acclaimed as one of the best hospital systems in the country. The hospital provides pioneering care to more than 1 million people each year across 40 medical practices. More than 4,500 doctors work for Cedars-Sinai, and the hospital funds 1,500 research projects each year, pushing medical science forward.
Stellar helped the quantitative diagnostics group at Cedars-Sinai pass a regulatory review with the Federal Drug Administration (FDA) for one of its cardiology software programs. This software helps technicians and physicians analyze data from myocardial perfusion studies collected during PET and SPECT scans of the patient’s heart. The primary goal of the project was to identify potential hazardous use scenarios associated with the software and recommend mitigation strategies to help make the software safer and more effective.
Cedars-Sinai needed to quickly conduct a summative evaluation. This required recruiting test subjects, developing a test plan and identifying a way to conduct usability testing remotely. The core challenge: ensure their suite of software was recertified by the FDA.
First, Stellar worked closely with Cedars-Sinai product engineers and other stakeholders to understand how the software was used to understand how medical professionals actually interacted with software when conducting a patient evaluation. Next, the Stellar team leveraged existing product documentation and SMEs provided by Cedars-Sinai to identify a series of hazardous use scenarios that would form the basis for our test plan. Following that, we worked closely with the Cedars team to recruit and screen potential test subjects. Once a representative set of users was identified, the Stellar team crafted a complete test plan, test script and defined all of the requirements for an effective test environment. Over the course of several weeks, Stellar led the summative evaluation test sessions and collected data and insights from the audio and video recorded during those sessions. Finally, the Stellar team analyzed all of the test data and provided Cedars-Sinai with a complete set of analytics and recommendations that helped Cedars prepare for its review with the FDA.
The Stellar team led a summative evaluation of 8 software products to identify hazardous use scenarios and improve product safety to support a Cedars-Sinai 510(K) submission and product review with the FDA. Stellar conducted the testing, analyzed the results and presented Cedars-Sinai with a list of recommendations that helped them improve product safety and ace their audit with the FDA.
engineering review with the FDA.
- Medical Device Usability Testing - Design Test, Plan, Conduct & Synthesize
- Support FDA Submission
- Usability Testing for IEC 62366-1
- Digital Strategy
- User Experience
- Visual Design