As autonomous, intelligent medical devices that effectively manage chronic conditions without constantly reminding patients of their disease become reality, will human factors engineers still be needed?

As patients and caregivers become key stakeholders, human factors engineering and user-focused methods are becoming increasingly important in medical device design. But will these practices soon be rendered obsolete?

During a panel at the MD&M East conference in June, Steve Wilcox, principal and founder of Design Science, made a quip in response to being asked about the future that had a room full of human factors engineers nervously laughing.

“Where things are going is for all of us human factors types to be out of a job because there aren’t any user interfaces,” he said. “I think when we go from insulin pumps to the artificial pancreas, when we go from external renal systems to implanted wearable devices that just act like your organs, that’s where we’re headed. My advice to the human factors community is start planning now for your next job.”

Of course, this statement was intentionally hyperbolic and dramatic: Many medical devices, equipment, and tools will still feature user interfaces and require human factors engineering in the future. But Wilcox did provide some food for thought.

After all, medtech’s Holy Grail is the development of autonomous, intelligent medical devices that effectively manage chronic conditions without constantly reminding patients of their disease. And the realization of such devices is no longer just a pipe dream.

The eventual rise of the closed-loop artificial pancreas, 3-D printed organs, and biological solutions to pacemakers, for instance, will require minimal or no human factors work. That doesn’t mean human factors and industrial design professionals will be out of a job any time soon, however.

On the contrary, they’ll probably be pretty busy, albeit with a whole new set of challenges and users. In particular, the rise of digital health, mHealth, Big Data, and EHRs present new opportunities and challenges alike to human factors and design specialists.

“We’re seeing great expansion in the proportion of medical devices that have a software user interface in place of a physical one, and that creates a world of opportunity for user interactions to go awry,” notes Michael Wiklund, general manager of human factors engineering at UL. “Human factors specialists can steer user-interface designs onto the right track by initially determining user needs and converting those needs into user-interface requirements.”

Bill Evans, president of Bridge Design, echoes the need for human factors work in the changing healthcare landscape. “There are some juicy human factors issues in making sure users are able to make good decisions based on data presentation. This will take some sophisticated human factors analysis upfront, and then some cleverly constructed formative and summative testing to bring to market safe yet impactful informatics systems,” he says. “Sure, this is in the virtual world, rather than the physical. But when done right, its impact will be felt in a very physical way by the patients whose hospital stays are shorter and outcomes better. “

Human factors positions are further secured by the shift in healthcare from the hospital to the home. More than ever before, medical device designers must take such factors as untrained users, potential patient disabilities, multiple users, and nontraditional and varying use environments into account.

This trend of home healthcare, coupled with the rise of the empowered patient, will also result in more stakeholders and, likely, more opinions. “I think users, whether they are patients, providers, or caregivers will ultimately be increasingly involved more directly in the development process,” notes Mary Beth Privitera, director of the Medical Device Engine at the University of Cincinnati. “This may lessen the amount of upfront research that happens. However, human factors engineers and industrial designers have to make sense of the information provided by users and translate this into product criteria and physical form.”

So, perhaps human factors engineers don’t need to start polishing their resumes just yet. But they should be prepared for change as their focus continues to shift to digital user interfaces as well as designing for the layperson.

“While medical technologies are becoming more functionally complex, they still have to match the intended users’ capabilities and limitations,” Wiklund says. “It’s critical to determine what kinds of user interactions are necessary and appropriate for a given medical device, and then make sure that its user interface enables those interactions—ideally while satisfying users’ preferences.”

Shana Leonard is the group editorial director for medical content at UBM Canon, MD+DI's parent company. 

[image courtesy of IDEA GO/FREEDIGITALPHOTOS.NET]