Abstract
A literature review was conducted on the topic of sources of simulation bias, as it applies to test design and use scenario creation for simulated-use studies, on medical devices for FDA submission. When it comes to Summative Usability Testing, there isn’t room for simulation bias to impact the data collected. From working with clinicians to design more realistic/appropriate clinical scenarios, to traveling to medical simulation labs to set up a realistic operating room simulation, we, as researchers, are constantly learning and improving our testing designs to ensure that they are as realistic as possible. This poster will look at current research and study logistics to provide best practices for identifying common sources of simulation bias and mitigating those sources during your Summative Evaluation.
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