Background
A medical device manufacturer was devel-oping a new angiography system, which included a hard- and software update of the previous version.
The study intended to demonstrate that critical use tasks could be performed safely and effectively by the intended users in the intended use environment.
Approach
A summative evaluation was carried out with n=15 intended users in a market research facility, on a partial angiography system.
Use tasks were assessed via simulated use, and warnings in the instruction manual were assessed via a comprehension assessment.
Outcome
Results for the simulated use tasks were categorized and a detailed root causes analysis was performed for non-successful tasks. A residual risk analysis was conducted.
Comprehension of the warnings was also assessed, results were categorized, and a root cause analysis was performed. The final HFE report was used for FDA submission.
Method
Summative usability test
Duration
4 months
Healthcare
Validating Safety & Effectiveness of a New Angiography System
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