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The fatal flaw in medical device design

Norbert Sparrow

May 2, 2016

6 Min Read
The fatal flaw in medical device design

I bought a “smart” TV a couple of years ago. After poking around the controls and skimming the user manual, my eyes began to glaze over and I decided that all I really wanted to do was watch TV and record my favorite shows. All the bells and whistles—and there are more than I can count—remain dormant to this day. When it comes to consumer electronics, that’s not an uncommon experience.

Bryce Rutter, Metaphase Design Group.

“On average, we routinely use 20%—at the very most—of the features available on our smartphones,” says Bryce Rutter, PhD, founder and CEO of Metaphase Design Group (St. Louis, MO). He says that advisedly, having “conducted more than 50,000 man-hours on global research in medical and consumer electronics.”

Feature creep breeds user confusion and frustration, which doesn’t do the brand any favors, but no one is harmed as a result. The same can’t be said of medical devices, where the last thing you want is a confused, frustrated surgeon trying to wrangle a surgical tool. And yet, says Rutter, “I’m amazed by how many fascinating products with exceptional technology get to market where the human factors are so poorly articulated and resolved that the user—be it a surgeon, nurse, anesthesiologist or whomever—has great difficulty accessing the full potency of the technology. Healthcare’s biggest challenge is to tame the technology,” stresses Rutter.

Technology gone wild

Taming the technology has to begin early in the process. A classic scenario that, Rutter says, he has witnessed too many times involves “sitting with a roomful of exceptionally talented engineers, or brand people or marketing people, and they will say, ‘Let’s put this other feature in.’ And someone like myself will ask, ‘Why?’ And they will say, ‘Because so and so has it.' Which begs the next question, ‘Why do they have it?’ But, really, who cares? Does it solve a fundamental need state for the user? A lot of technology features are embedded in a product because they can be and because they’re cool from an engineering standpoint,” says Rutter. But these features are not driven by need, he adds, and as a result “they are noise and create confusion.”

Bryce Rutter will moderate a panel of experts, all of whom, like Rutter, have served as jurors in the Medical Design Excellence Awards, discussing the secrets of successful medical design innovation at the MD&M East conference and trade show. Co-located with PLASTEC East, the event comes to the Jacob K. Javits Convention Center in New York City next month.

Filtering out this noise is an acute concern when Rutter was working on the da Vinci surgical robots early on during the design phase. “The surgeon only has so much cognitive bandwidth,” explains Rutter. “If part of that bandwidth is consumed by doing realtime computations of behavioral control outputs to compensate for poor design, those cognitive resources are unavailable to the surgeon, who needs to focus on the surgical procedure itself,” says Rutter. As they say in business endeavors, that is not a rational use of resources. The guiding principle behind the design of any medical product—whether it is a complicated robotic surgical system, a benchtop analyzer or a wearable auto injector that talks to a smartphone—is to create “a seamless extension of the way the surgeon or other user thinks, feels and behaves . . . achieving synchrony between technology and human factors engineering, which also mitigates user error,” says Rutter.

Ergonomics is one of the touchstones at Metaphase Design, which has achieved international recognition for its work in this area, not just in the medtech space but also in consumer electronics, personal care and food and & beverage packaging, among other sectors. Rutter earned his doctorate in kinesiology—the study of the mechanics of human movement specializing in the hand function— at the University of Illinois at Urbana-Champaign in 1987. Rutter has specialized in the integration of ergonomic and industrial design, and is the leading specialist in handheld product design. “Fitting designs to people’s bodies, behavior and expectations,” as noted in a profile of Rutter in the Wall Street Journal, continues to be a passion. That ethos takes on a profound significance in the context of home care. 

A macro trend in healthcare, says Rutter, is the migration of diagnostic testing and drug delivery from the hospital into the home. Self medication is part of this dynamic. “It used to be that you would go to the doctor if you had MS, for example, and you would get an IV line drip. Because of the cost structure, now you get a kit to take home and you follow the instructions,” says Rutter. In these situations, human factors become tremendously important in product design. “You have an uninformed, often frightened and, in a significant number of cases, uneducated user. These in-home test kits or self injectors are like a chemistry experiment. The instructions are horrible—both intimidating and overcomplicated. They have been engineered for ease of manufacture, shelf stability, and a small pack out-key load for shipping purposes. But [the designer] forgot there’s a human at the end of this who has to figure out how to use the device,” says Rutter.

And then there is the matter of dignity. “The last thing people with a disease state need to be reminded of is that they are sick. When you open one of these kits, everything looks clinical, it reminds you that you really are sick,” says Rutter. As ergonomic design engineers, “we have to be thinking not just about usability and human factors but how we can ensure that the dignity of the user is not eroded day by day.”

The dignity of the patient also takes a hit in healthcare settings. Rutter spent some time in the hospital recently, which tested some of his assumptions. “Having designed medical devices for most of my life, I thought I could empathize with end users, but until you’ve been [in a hospital], you don’t realize how bad it really is. These are inhumane, cold and sterile places that do not inspire an uplifting feeling,” says Rutter.

What can inspire hope, however, is what Rutter calls the potency of great design. “I can manipulate form, materials, colors—user experience design—in everything from a hospital bed to a patient-side test kit to IV therapy pumps so they don’t look like torture devices.”

In part two of this interview, Rutter points to examples of medical device design that offer alternatives to this grim reality and shares his thoughts on some of the promising trends in the healthcare space.

About the Author(s)

Norbert Sparrow

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.


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