What does the future of AI hold for medical device usability testing?

[Illustration via Adobe Stock]

Medical device usability testing and the emergence of artificial intelligence

By Nye Canham and Dhanial Salim, Emergo by UL

Usability testing is a mainstay in the application of human factors engineering (HFE) to medical device design. However, while regulatory requirements for usability testing keep developing, the application of usability testing in the medical industry has remained fundamentally unchanged since its adoption.

With the release of generative artificial intelligence (AI) chatbots bringing AI to the forefront of public attention and continued fast-paced technical innovation in the medical industry, current approaches to usability testing may begin to appear antiquated. Furthermore, it brings into question whether traditional usability testing approaches can keep pace and remain effective tools t…

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  • June 29, 2023
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3 critical starting points for medical device design usability research

The future of healthcare lies with the development of devices with designs centered on the safety, needs, desires and challenges of their users. [Photo courtesy of the FDA]

Medical device usability research and human factors engineering starts with device users, the use environment and user interfaces.

Gregory Montalbano, MIDI Medical Product Development

Designing a medical device is not a lighthearted or straightforward task. Every design choice during the development process can influence how the device is used, whether it is effective and if it has the potential to cause its user or intended patient harm.

The vast majority of medical device failures stem from use errors. While this may lead some to believe that the blame lies on the user, the fact is that use errors are frequently the result of unintuitive device design choices.

With this in mind, the FDA and its supporting standards organ…

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  • October 18, 2022
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