'Can't Just Throw AI at Medical Devices' - MedTech Expert

In the fast-paced world of medical technology, the pursuit of innovation often overshadows a critical aspect of medical device development: usability. Roger Mazzella, Global Senior Product Manager for the Medical Industry at Qt Group, argues that manufacturers must prioritise user experience to ensure patient safety and improve healthcare outcomes.

With over two decades of experience in MedTech, Mazzella has witnessed the industry's evolution first-hand. 

"There's more MedTech innovation than I've seen in years," he notes. "But strict regulatory requirements for patient safety make bringing novel products to market challenging."

Qt Group is a cross-platform software framework provider, and has been instrumental in developing intuitive graphical user interfaces for medical devices for the past 20 years. Its technology has been used in various applications, from ultrasound machines in the 1990s to cutting-edge devices today.

Despite technological advancements, Mazzella argues that the healthcare sector often lags behind other industries in terms of user experience. 

"Five years ago, while caring for my father in hospital, an alarm went off on his infusion pump due to a kinked line,” he says. “The nurse struggled to silence it, growing increasingly frustrated with the outdated interface. I saw real fear in my father's eyes.” 

He adds: “This situation clearly showed the relationship between device usability, functionality, and patient safety and comfort."

Medical device user experience affects patients

Mazzella says the incident underscores a crucial point: that user experience affects not only healthcare professionals but also patients and their families. Mazzella cations that, as the industry embraces new technologies such as AI, it’s important healthcare professionals don’t lose sight of “fundamental usability principles”.

"You can't just add AI to a medical device without testing that the UI/UX works as intended," he explains. "We must reframe the conversation so that people are sure that they are taking care of their house at the most basic level? They need to be sure they are building and testing something that's not just cool-looking but intuitive for a human being to use.”

To address these challenges, Mazzella recommends that manufacturers involve healthcare professionals, patients, and caregivers early in the development process. This approach, he says, can help identify issues before formal human factors and clinical testing, potentially saving time and resources.

"Manufacturers should align with the goals of regulatory bodies like the US FDA, which require both pre-market and post-market human factors evaluations for medical devices," Mazzella advises. "By prioritising simplicity and minimising cognitive overload, we can reduce user errors while still driving innovation."

He adds that the importance of user-centric design extends beyond the initial product launch, and emphasises the need for ongoing post-market feedback to drive improvements in future MedTech products.

"You might be creating a product for professional use but it's still people using it,” he says. “The last thing they want is to feel like they're in a hospital."