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A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices



A staggering report was recently released by the International Consortium of Investigative Journalists (ICIJ) indicating that 83,000 deaths and 1.7 million injuries were linked to medical device adverse events reported over the last decade. Furthermore, a 2013 report by McKinsey & Company suggested that such adverse events and associated quality issues cost the medical device industry between $2.5 billion and $5 billion per year on average. There is also indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide a proper methodology for selecting and testing patient populations. This may lead medical devices that pass FDA HFE validation to still exhibit significant use errors when utilized by actual patients in the real world.

As some of you may recall from our previous newsletter or event attendance, our founder and president, Charles L. Mauro CHFP, spoke on this issue at the 2019 HFES in Health Care Symposium on a panel titled FDA Guidance vs. Available Data on Human Capabilities and Limitations. Mr. Mauro’s portion of the talk specifically focused on the current lack of reliable design data for medical devices for the portion of the population that fall below the 2.5th-percentile for the healthy U.S. population.

In succession of that panel discussion, Mr. Mauro, along with Peter Pirolli, Ph.D., a Senior Research Scientist at the Institute for Human and Machine Cognition, and Chris Morley, MSc, a Senior Human Factors Engineer at Mauro Usability Science, conducted a thorough analysis of current Food and Drug Administration (FDA) guidance regarding designing medical devices to accommodate as wide a range of potential users as possible. They recently published their findings in a paper exploring the possible sources of HFE performance problems with medical devices and links potential problems to HFE validation methodologies within the FDA HFE guidance framework. Their paper also examines device design teams’ failure to utilize HFE best practices in the design and testing of medical devices.

Critical conclusions drawn from this analysis suggest that, currently, medical devices may not be designed and validated according to the full percentile range recommended by FDA guidance and HFE best practice. The analysis also indicates that both the FDA and medical device design teams have failed to understand that designing devices to meet a specific range of user needs includes not only physical attributes, but also a wide range of percentile-based cognitive and physiological HFE performance variables. This problem is potentially causing patients who reside at the extremes of percentile distributions (i.e., those with extreme, but acceptable degrees of functional and/or cognitive limitations) to not be able to use devices successfully, which may significantly impact clinical outcomes.

This analysis was just published in a paper titled A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices. The full paper can be downloaded for free through the SSRN eJournal Network by following this link.

If you have any comments or questions regarding the content in this paper, please feel free to email Charles L. Mauro directly. We welcome all feedback.

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