A recurring theme on the second day of the Human Factors and Ergonomics Society (HFES) Symposium on Healthcare was the tension between the regulated and unregulated components of human factors work.
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Carolyn Johnson, of Daedalus, gave a presentation about a pediatric heart pump project. |
I had made the point on the first day that we human factors professionals seem to be getting so tied up with regulatory issues that I fear we’re neglecting our core functions of ensuring devices are appealing and easy to use, as well as safe. A number of other presenters also addressed this issue—i.e., the tension between the highly structured and systematic methods we need to ensure safety and meet regulatory requirements, on the one hand, and our desire to create great user experiences, on the other. In fact, FDA doesn’t and can’t require pleasant user experiences, per se, so letting the regulatory requirements crowd out a focus on user experience can have the pernicious result of yielding medical devices that are extremely safe but miserable to use.
David Barash, of GE Healthcare, pointed out the irony that all the device alarms systems in, say, an ICU, have been granted FDA approval and CE Marks, but they are still just awful—the vast majority of alarms are false, the alarms are unrelated to each other, so multiple alarms can quickly create chaos, and users are given poor information about what to do. In other words, we are meeting all the regulatory rules, but the result is still terrible usability and an unpleasant environment. Many of us have been raising this issue for years, with no obvious improvement. David said GE is cooking up something that will make a real difference. I hope so.
Carolyn Johnson, of Daedalus, a product development firm in Pittsburgh, described a pediatric heart pump project. She pointed out that one could follow all the rules and still end up with a device that is absolutely miserable for the children who have to use it. She made the distinction between design research that helps one understand what constitutes a good user experience and human factors research, which is more of a regulatory issue. I don’t agree with the distinction because I think it’s all within the realm of human factors, but I certainly agree that it takes more than formative and summative testing to create a product that people actually like to use.
Another example was work described by Arathi of Sethumadhavan, of Medtronic. She talked about the various requirements they have to meet, but it really got interesting when she described research outside of regulatory requirements—observational research in India that found, among other things, a fascinating cultural difference: that nurses work together collaboratively to evaluate the data output from implanted pacemakers/defibrillators, something one rarely sees in the US.
Another theme was the need for dramatic changes as medical devices move out of the hospital—where they’re used by clinicians—to the home—where they’re used by patients and lay caregivers.
Molly Story, of FDA, talked about the importance of defining device users broadly—by considering the range of ages and abilities to be expected, including the various disabilities caused by the conditions we’re designing for, as well as the various comorbidities to be expected. I found it interesting that Molly chose to speak about this topic rather than details of FDA regulatory requirements, which she, as you might expect, also speaks about regularly.
Melissa Lemke, of Human Ability Designs and University of Wisconsin-Milwaukee, pointed out that there’s a tool for those designing for home healthcare—the accessibility section of the standard, HE75.
Linda Harley, of Georgia Tech, described work she and others have been doing that involves empirically studying the lives of older adults, the HomeLab project. According to her, the stereotype of older adults being resistant to new technology is largely true. They’ve put together a fact sheet with various findings that’s available from Dr. Brad Fain.
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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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I generally agree
I generally agree with your comments, Dean. And, just to be clear, I meant no criticism of the various regulations; rather the way they are sometimes applied. I do think we can make a distinction between those things that are hard requirements (e.g., summative testing) and those things that are not hard requirements (e.g., contextual inquiry), and the point of my presentation at the HFES Symposium was that the hard requirements happen to be at the end and the activities that are not hard requirements happen to be at the beginning, so an unintended consequence of focusing too much on the regulations is that less HF work is done up front and more is done toward the end.
The extreme version of this is thinking of HF as a regulatory function with all HF activities supordinated to the goal of regulatory approval. It's a lot better than no HF, which is probably what such a regulatory focus replaces, but it doesn't yield great medical devices.
Is a distinction needed?
There are many distinctions being made for the purpose of partitioning Human Factors work in the healthcare industry into buckets. Things like hard vs soft, regulated vs unregulated, safety vs ease of use, etc. have been thrown around. While I agree with Steve's blog that we are becoming so focused on regulations and guidelines that we, as a discipline, are loosing sight of the general purpose of human factors research (I'm as guilty as the next), Human Factors remains the discipline that provides the conduit between the appropriate end users and product development; period. We ensure that meaningful and valid data become part of the problem space when determining design solutions. All to ensure our products are safe and easy to use. I see no reason to make any distinction. And a correlate; any distinction is arbitrary. Whether this data is observable metrics such as error counts or eye tracks or the result of user interviews or naturalistic observation is of no consequence. Likewise, ease of use and reduction of use error are too intertwined to make a distinction; make a product optimally easy to use and potential for use error is at a minimum.
Steve is right on. We are maybe a little pre-occupied with regulations and standards, but if we look beyond the specifics of, say, the FDA guidelines, we find something that we should have learned in HFE 101:
Test the right things.
Collect meaningful data from appropriate users.
Ensure others can replicate the results.
Sure, the medical device industry is scrambling to catch up to current FDA direction. And a lot of our work is a direct result of this. But once the dust clears, we can begin to promote the notion that a mature, user-centered process will ensure the product is safe, easy to use, accepted by the market, and naturally leads to successful submissions. Unregulated vs regulated human factors becomes meaningless.
Dean Hooper
dhooper@ximedica.com
www.Ximedica.com