Intelligent, automated medical devices are the way of the future, but automation can bring with it some important adjustments for device users.

Marie Thibault

When Medtronics MiniMed 670G was approved by FDA in September 2016, the device received much-deserved fanfare as the first hybrid closed-loop system for insulin delivery. Taking one more step toward an artificial pancreas, the devices SmartGuard HCL algorithm automatically aims to keep patients within their target glucose level range, while requiring limited patient input.

This kind of automation is a big step not only for the medical device industry, but also for users, since it can help reduce the burden of disease management and potentially improve their health. Still, automation in medical devices can be a tricky thing to introduce to some users, according to Steve Vargas, principle human factors design engineer at Medtronic Diabetes.

During a February 7 case study session at MD&M West titled "Deciphering the Diabetes Experience," Vargas noted an important difference in how users interacted with the device. That is, users already adept at managing their diabetes with insulin pumps can be skeptical of automation.

"My biggest challenge hasn't been on the novice side; it's been on the experienced side," Vargas said. "We call them elite users; you'll hear the term 'super users.' Those are the people that understand the system, understand their disease, and act accordingly. These are the [patients] that you have to gain trust from."

Vargas pointed out that until recently, device development and innovation focused on adding new features and improving user interface. "Now I need to do a 180 and take it all away. That's really the basis of automation."

Essentially, while this automation reduces the risk of erroneous patient input, it also reduces user control. With that comes some other interesting challenges, Vargas said. "How do you design for a user interface or how do you do usability testing on a system where the user is not expected to do anythingand on a candid basis?" he asked.

Vargas explained that he and his team kept the patient in mind by cutting down the number of tasks the patient needs to perform and making those interactions with the device meaningful and easy. While patients still need to put in their mealtime carbohydrates because the algorithm doesn't yet allow for fast changes in glucose, all other reactions are undertaken by the system, he said.

Super users of insulin pump systems already feel confident in their use of the technology and don't always see the benefit of switching to an automated system. That's when showing these users examples of such benefits and allowing them to test it with their own experiences comes into play, Vargas told the MD&M West audience. He illustrated the point with an automobile analogy:

The idea of going to automation, especially on a closed-loop system, especially someone that has so much experience with their diabetes, is the equivalent of taking somebody from a GTO Mustang with a manual transmission . . . and giving them something with an automatic . . . if you're somebody used to having a lot of control of the system, it's very difficult to get them."

Vargas added, "That's where you have to go into the trust category, you show them what the algorithm is doing for them, you show them what the burden is that we're removing from them, and get them on board."

Marie Thibault is the managing editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @MedTechMarie.

[Image courtesy of MEDTRONIC PLC]

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What Does Device Automation Mean for Users? - Medical Device and Diagnostics Industry (blog)