Usability Engineering Process for Medical Devices

2021 
When designing the innovative technologies for point-of-care medical devices, use errors must be significantly considered, as use-related errors can be very harmful for the patients. Reports stated that about one third of medical device incidents, reported in US Food and Drug Administration, occurred due to use error. The engineers must study usability engineering deeply, to make medical devices effective, for the native use environments and user populations related to medical device. This research uses process methodology, which describes the refining of usability engineering process. Data is gathered in both qualitative and quantitative manner. Literature and used conventions are refined in this process to find an optimized way to perform usability engineering. This modified process employs the usability testing in parallel with the refined process. This increment in the standards of usability engineering will lessen the risk of human errors in medical devices.
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