AAMI News January 2018
Human Factors Book Guides Manufacturers on How to Make Devices Safer, One Step at a Time
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It is not enough to develop a medical device and assume that trained users will always use it safely and effectively. The burden is on the manufacturer to consider all of the ways users interact with the product and make sure the potential for use errors is mitigated, according to the authors of the new book Writing Human Factors Plans & Reports for Medical Technology Development.
“It’s not mysterious how to do that. It doesn’t require any magic. You don’t have to cross your fingers,” said lead author Michael Wiklund, general manager of human factors engineering at UL-Wiklund, a consulting firm. “You just need to be dedicated to taking all of the steps.”
The steps he is referring to are the ones found in a human factors engineering (HFE) plan: researching users’ needs and preferences, investigating the ways people interact with a given device, analyzing potential use-related risks, using these results to design the device, and evaluating the user interface.
“By following a structured approach that’s consistent with Food and Drug Administration (FDA) and IEC guidance, you’re increasing the chances that your user interface won’t have any flaws that could induce the kinds of errors that lead to harm,” Wiklund said.
Unfortunately, Wiklund and co-authors Laura Birmingham and Stephanie Alpert Larsen have observed that many companies are not incorporating human factors early enough in the design process or are skipping steps.
“Some companies take an abridged approach to human factors, trying to check off a box rather than doing it fully and completely,” said Birmingham, a managing human factors specialist at UL-Wiklund. “Taking this abridged approach is the same as not doing it at all.”
To help bridge the gap between human factors theory and implementation, Wiklund, Birmingham, and Larsen developed a resource that defines the elements of an HFE project plan and explains how to report usability test results. The book tracks the HFE work performed by a fictitious company and demonstrates how its product improves based on the results of usability testing. The hypothetical design issues and challenges addressed in the work products are similar to those faced by medical device developers every day in their efforts to gain regulatory approval, according to the authors.
The book also includes sample work products and documents, such as formative and summative usability test plans and reports.
“This book provides concrete examples and a jumping off point to help manufacturers consider what would be appropriate for their particular product,” said Larsen, a senior human factors specialist at UL-Wiklund.