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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 to support the human factors research and design (HFR&D) and clinical evaluation of medical devices.
While it should be expected that testing the safe use of medical devices is a perennial need, this may require usability testing to evolve or even be replaced by other forms of validation.
Related: AI breakthroughs in medtech: 7 ways to enhance healthcare
The future of usability testing metrics
Research into the scientific measurement of usability has identified numerous characteristics such as effectiveness, efficiency, satisfaction, ease of use, ease of learning, ease of understanding, fault-tolerance, attractiveness and safety. However, the ease of measuring the difficulties users have with products in comparison to other usability characteristics has led to a focus on identifying and classifying use errors. Usability testing typically involves the observation of a sample of a target population interacting with a product, with the difficulties they have counted and classified. This approach is buoyed by a narrow view of safety and an assumption that these measures will correlate with other unmeasured characteristics of usability.
Future developments could open usability testing up to more dynamic approaches. Advancements in eye-tracking tools for usability testing, facial recognition and brain-computer interfaces could enable researchers to gain deeper insights into user behavior and cognitive processes. Imagine a scenario where a user interacts with a digital application, and AI algorithms capture subtle expressions, eye movements and brainwave patterns in real-time. This wealth of data would provide designers with invaluable feedback, allowing them to refine and optimize user interfaces for enhanced usability. By combining human validation with AI-powered analysis, usability testing will become more accurate, efficient and user-centric than ever before.
Get the full story — including more about novel simulation technologies and automated usability testing — at the Emergo blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.