End Users Get a Voice in Device Development

Columbus Dispatch (OH)

September 10, 2012

In late July, four local doctors performed a time-sensitive, high-stakes surgery in a lab on Battelle Memorial Institute’s campus on King Avenue in Columbus, OH.

During the course of the complicated two to three-minute simulated procedure, the surgeons became stumped, and their work ground to a halt. The culprit: a new medical device that replaced a far more familiar tool used for decades in operating rooms

“When we’re developing a device that’s supposed to go into that procedure, we’re disrupting that process,” Battelle’s Reade Harpham said. “We need to know if that disruption’s going to cause a risk to the patient or the caregiver or a surgeon.”

After observing the surgeons’ problems with the device, Battelle decided the risks weren’t acceptable. The likelihood of such problems recurring during a real surgery convinced officials it was time for a redesign. That kind of feedback from end-users—whether they’re surgeons or patients—is the focus of Harpham’s fast-growing design team.

Its technologies have enabled people with severe hand impairments to inject medications using one hand and have helped intensive-care nurses check on patients without entering their rooms.

“You should know what the users are going to do, you should know what the errors could be, what the misuse should be, and (you) should have designed that out of the system as you go,” Harpham said.

Listen and react

The human-centric team’s diverse group of 10 researchers—their specialties range from industrial product design to cognitive psychology—takes feedback from those end-users and incorporates it into their designs early on. That can head off the need for costly adjustments later in the design process.

The approach might seem straightforward, but Harpham said this sort of “human factors” testing in healthcare research has only begun in the past decade or so. “It’s a pretty major shift in the industry,” he said. “The onus is on the manufacturer to understand who’s going to be using the device. It’s becoming a huge liability for manufacturers.”

And it’s a huge opportunity for Battelle to perfect other companies’ devices and also, often as a result of that work, find unmet medical needs for which it can pursue solutions independently.

In some cases, Harpham said, medical-device manufacturers haven’t been able to take a product to market because they haven’t tested it with end-users. One device maker told Battelle such delays cost the company as much as $1 million per day. Through human-factors testing, the idea is to save such manufacturers time and money in the long run.

The U.S. Food and Drug Administration created a human-factors premarket evaluation team in 2008 to ensure new medical devices have been designed to be “reasonably safe and effective” during use. The agency issued draft guidelines that year to clarify its expectations of medical-device manufacturers, according to FDA spokeswoman Michelle Bolek.

“It’s become an area of more-intense FDA focus,” said Bernie Liebler, director of technology and regulatory affairs at AdvaMed, a trade association that represents medical-device manufacturers.

In the past, he said, the agency might have only checked to see if a manufacturer had performed human-factors testing and might not have looked closely at how effective the testing actually was. That’s trouble because people have died through inappropriate use of medical devices, Liebler said. “The best way to address use error is through human factors,” he added.

Wide range

Much of the human-centric group’s work currently focuses on drug delivery and, increasingly, on devices that will ultimately be used at home, not necessarily in a hospital.

Battelle, for example, is taking pipeline techniques honed by the oil-and-gas industry to improve drug injections for patients. That project, by bringing to bear the research giant’s diverse capabilities, is an example of “Battelle at its best,” Harpham said.

Researchers also turn to patients with diseases such as rheumatoid arthritis to gauge how they use products Battelle is testing. The organization has recruited more than 600 subjects for its human-centric, end-user studies in the past 18 months.

The majority live in central Ohio, but Battelle goes farther afield in certain cases, such as when specialty surgeons are in short supply locally or when customers want testing to include a nationwide sample. Because so much of its human-centric research is local, Battelle recently renovated a building on its campus and has used that space for studies twice in the past three months.

In addition to 4,500 square feet it’s already renovating, it might convert 5,000 additional square feet in the building’s basement into part of the user-research lab, commonly called the “U-lab.”

The human-centric team also is expected to expand. The unit, whose revenues were not disclosed, is part of Battelle’s medical-device group, which employs about 75 people. Some of its innovations have included a robotic heart catheter system, a system that detects fluid under the skin, and an insulin pen with dose memory. Its staff holds more than a dozen patents.

The human-centric approach is in keeping with Battelle’s mission to use science to benefit humankind, Harpham said. “It’s the human being at the center of the technology that gets to have a voice.”