You Need Human Factors Folks and Designers: Adventures in Medical Device Usability

Human factors research doesn't involve enough design. Here is why and how to fix it.

March 28, 2012

5 Min Read
You Need Human Factors Folks and Designers: Adventures in Medical Device Usability

juror_Wilcox_web.jpgUsability has been forcefully thrust into the medical device world by, among other things, recent developments at FDA, which, in turn, has meant that more usability experts are working in medical-device development. One thing you may have noticed about my fellow usability folks (i.e., human factors professionals) is that they are prone to whining that they “aren’t involved early and often enough” in the development of medical devices. They have a legitimate point—it’s not ideal to start worrying about usability when you’re doing summative usability testing (i.e., validation research) to prove to the FDA (and TUV and its kin) that your device is adequately safe.


However, not being a whiner, I want to turn this complaint on its head and address the opposite problem—not device design that doesn’t involve enough human factors research, but, rather, human factors research that doesn’t involve enough design.


The problem with human factors professionals is that, if left to their own devices, they are prone to:


  1. Going off on tangents.

  2. Reporting information in a way that’s ugly and inaccessible.


The reason that we suffer from these character flaws, is that we human factors professionals typically have scientific backgrounds. And scientists tend to suffer from certain eccentricities:


  • They don’t like to work on your problems rather than their own.

  • They’re aesthetically challenged (just look at how they dress).

  • They actively avoid making anything accessible, starting with the language they use.


Yeah, I know, this is a cheap stereotype. The problem, though, is that, like many cheap stereotypes, there’s a lot of truth to it.


Which brings me to the antidote that I want to propose for this syndrome—partner human factors professionals with industrial designers. In addition to their more obvious function of designing devices, industrial designers are fully capable of keeping human factors professionals on track and of working with them to present information in a form that actual humans can use. I know it’s ironic that usability experts need help in making their own deliverables usable, but, all you have to do is sit through some of the paper sessions at the annual Human Factors and Ergonomics Society ( meetings to see what I’m talking about.


Just to make sure we’re on the same page, I’ve provided images of a typical human factors professional and a typical industrial designer (photos by iStock). Can you tell which is which?




The first role, then, of the designer, as a member of the human factors research team, is to help the human factors professionals focus on only those issues that have implications for device-design decisions. Without the designer’s help, the human factors effort is at risk of losing this laser-like focus and, thus, wasting time and money. The second role of the designer is to design the way information is presented—to use design tools to make complicated ideas easier to understand (particularly relevant when conducting contextual inquiry (real-world observational research), as mentioned in the FDA Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, 6/22/2011) and to generally make deliverables look better, so that the rest of the team is more inclined to use them.


One interesting thing about designers is that they may be the last renaissance people. While the rest of the world has gotten more and more specialized—something those of us who work in the healthcare world are intimately familiar with—design, as a discipline, has remained resolutely catholic (with a small c). The designer has to know something about engineering, something about marketing, something about users, something about risk analysis, and so on, but not necessarily everything about anything. This makes the designer the “odd man out (sorry, but “odd person out” doesn’t quite work; I’m not implying that designers aren’t also women), the nonspecialist in a specialized world, the seeming amateur among the pros.


Except that now we’re all working in multi-disciplinary teams, and we need someone who can communicate across disciplines, giving the designer a particularly important additional role in device development. It also doesn’t hurt that the designer is the one who can stand up in the brainstorming session (see my previous posting about brainstorming) at the whiteboard and illustrate everyone’s ideas.


In sum, yes, it’s important for human factors researchers to be an integral part of the device design effort, particularly if you want to adequately address FDA requirements. However, it’s also important for designers to be an integral part of the human factors research effort. Based on what I saw this year as a judge in the MDEA awards, I would say that the device world has gotten the message that industrial design has a role to play in device development.


My point here is that designing devices, per se, is not the only thing that the industrial designer can contribute to a device development project (by the way, for a particularly interesting summary of the various roles the designer can play, see Chris Conley’s article in the DMI Review, "Educating Designers for Broad Roles in Organizations".  



Stephen B. Wilcox, is a principal and the founder of Design Science (Philadelphia), a 25-person firm that specializes in optimizing the human interface of products—particularly medical devices. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He has served as a vice president and member of the IDSA Board of Directors, and for several years was chair of the IDSA Human Factors Professional Interest Section. He also serves on the human engineering committee of the Association for the Advancement of Medical Instrumentation (AAMI), which has produced the HE 74 and HE 75 Human Factors standards for medical devices.

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