The UserWise Blog
Training Decay Selection for Usability Validation
When conducting usability validation testing, representative users must use the device in the expected conditions of use in the field. There is usually a period of time—days or weeks—between the point in time a user is trained, and the moment they use the device for the first time. For this reason, the FDA acknowledges the need for “training decay” as part of usability validation testing, but manufacturers face challenges simulating real-time decays. In response to challenges associated with lags of days or weeks between training and usability validation testing, medical device manufacturers typically simulate shortened training decay periods. This paper discusses the theory behind the shapes of various training decay curves and the variables that drive differences between training decay curves. The author proposes to use a task-based approach for defining training decay curves in usability validation studies and sets out generalized training decay curves at a high level. Future research could reveal detailed and generalizable training decay curves. Identifying generalizable training decay curves could standardize the usability testing required for medical devices, and ultimately improve use error identification while avoiding an undue toll on manufacturer resources.
Read the full paper here!
MedTech Frontiers had their largest turnout yet when Shannon Clark spoke about Human Factors. See the full presentation here!
February 3, 2016 was an important date in the history of medical device usability. On this day, the FDA issued the guidance, “Applying Human Factors and Usability Engineering to Medical Devices,” which emphasized the importance of designing usable medical devices. The guidance outlines the FDA’s recommended process for developing usable medical devices.
Shannon Clark’s talk will describe what “Human Factors” means to the FDA, why Human Factors has become such a popular topic in the field of medical device development, and what usability engineering process needs to be followed when developing new medical devices. Shannon will share her experience conducting usability testing for medical devices, and she will discuss how to identify and assess use-related risks for medical devices.
Need to know the process of bringing a device into usability compliance even if it is currently on the market and did not originally follow the usability engineering process? Then take a look at this presentation.
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Having trouble figuring out exactly what to incorporate in your Human Factors Engineering submission to the FDA? Here is a succinct checklist.
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