The importance of good usability in MedTech

Roger Mazzella at Qt Group asks whether MedTech is losing sight of usability, at the expense of safety and productivity

 

There’s more innovative tech in medical devices today than probably the last decade combined. But how usable is that tech?

 

I’ve asked myself that question a lot since my own personal experience with my father in the hospital. A distressingly loud alarm went off on his infusion pump because of a kink in his line. It sounded like there was a fire in the building. The nurse rushed in, cursing and playing around with the pump for what seemed like forever. The alarm just would not turn off. 

 

The user interface on the infusion pump? It looked like something from the 90s. The more she tried to turn the alarm off, the more frustrated she became. It’s not like she had time to pull out a user guide – you never do in hospital settings with hundreds of patients facing a variety of conditions needing attention. 

 

The whole time, I’m seeing fear in my 82-year-old father’s eyes. 

 

This was a microcosm of the frighteningly overlooked relationship between device functionality and a patient’s safety and comfort. And the importance of that relationship gets a little more buried every time someone in the medical sector utters the word ‘AI’. ‘Killer app’ X using Generative AI; medical imaging solution Y using AI. There’s enough innovation and AI to sink a cruise ship….

 

Mind you, innovation is highly welcome, but a bad user experience can render it null and void mighty fast. A bad user experience doesn’t just affect the user of the device (a nurse or a doctor) but the entire user environment, including the most important person: the patient. 

 

In MedTech, usability and safety are the same

It’s not the 90s anymore. Today’s digital health products rely much more on a faster, more intuitive user experience, which needs a modern, dependable and responsive user interface (UI). The phone in people’s pockets is the benchmark – a medical device’s touch screen should be at least that intuitive.

 

But bringing highly performant MedTech devices to market isn’t trivial. Medical devices can get immensely complex with their functionality, needing hefty monetary, resource, and time investment. Throw in regulatory compliance and it extends the runway even more. That’s why medical devices can take from three to seven years to hit the market. In fact, I once worked with a customer who took almost seven years to launch their infusion pump because it was the first that was all-touchscreen controlled and the regulatory process had a heightened scrutiny. 

 

Seven years is a long time. The technology that looked really high-grade in the R&D phase might not be that impressive when it launches. Even if it does – which takes some impressive power of foresight – a clumsy and complex device is unlikely to be widely adopted, no matter how forward-thinking the concept is. 

 

There’s a cost to innovation. The more you shove in, the more complex it becomes. Complexity makes it harder to design a device that reduces user error, fatigue, and unintended bugs or dysfunctionality. The mission-critical nature of many medical applications leaves little wiggle room for fixing or maintenance of programmes and systems.

 

Uncompromised performance and reliability aren’t a nice-to-have but a safety risk. Studies have previously shown the strong link between nurse burnout and low usability scores for health record systems. In another example, patients have reported stress from loud alarms on infusion pumps diverting nurses’ attention away from the patient. 

 

The silver lining? Regulators of medical devices have noticed how interlinked usability and safety are for patient welfare. Regulatory frameworks and guidelines – including directives from the European Medical Device Regulation and US Food and Drug Administration – are now placing much more importance on integrating usability engineering into the development process.

 

Regulatory involvement will no doubt help precipitate design changes that prioritise usability. But MedTech still has catching up to do to sectors like aviation and manufacturing, where human factors have been recognised for longer. 

 

Testing for the human factor

Wearable medical devices, and medical devices used outside of hospitals, have proliferated massively. And what MedTech device manufacturers have to understand is that modern medical device users today aren’t just trained professionals. They’re healthcare workers of all levels of experience. They’re patients. They’ve even the patients’ family members. 

 

What MedTech device manufacturers should do is:

 

1. Engage end users early in error analysis. Before a single line of code is written, design teams should outline exactly who will use the device, and in which environment. That’s essential to understanding the end user’s perspective of the software and device.

 

2. Evaluate prototypes early. You want users identifying bottlenecks in workflows, or potential misunderstandings of instructions or displayed information early on. For this, the end users need a ‘real’ prototype, not a storyboard or wireframe mock-up. There is no substitute for seeing someone interact with a functioning UI.

 

3. Test the usability. Test the user’s ability to execute specific tasks functions in near-real world environments. 

 

4. Do post-market usability studies. Usability concerns never end with a product deployed to the field. Evaluation must continue after release to reveal unmet needs. Post-market feedback surveys are essential to improving design and development processes for future releases.

 

Don’t make it feel like a hospital

A common question I hear lately at tech vendor conferences is, “Where’s the AI in this thing?” 

 

Granted, there’s so much MedTech innovators can do to integrate AI into existing devices to improve patient care. But are enough people answering the question, “how are we building the user interface?” Can they make it not just aesthetically cool but practically intuitive in a way that any human being can engage with the device? 

 

Almost 20 years ago, I helped develop a user interface for a digital platform to be used by clinical and regulatory engineers. My first design was a clean, professional, and clinical look and feel. The  UI layout was very geometrical, using straight lines, sharp angles, and a mostly black, white, and silver palette. The reaction from internal stakeholders and friendly customers wasn’t great. It wasn’t the content they criticised, but the ‘flow’ of the content experience – how disjointed it felt.

 

“I felt like I was working in a hospital,” I was told. Surely, that made sense, right? It’s a professional clinical and regulatory platform! But then the owner of my company said something that has stuck with me ever since…

 

“You might be creating a product for professional use, but it’s still people using it.” 

 

I went back to the drawing board – made significant changes to the layout, using warmer colours, rounded geometries. The geometries became more rounded – the design more visual instead of text-heavy. Suffice to say, it led to better adoption and an extremely successful product launch.

 

The moral of the story for device makers in MedTech is this: people don’t want to feel like they are in a hospital. That’s the last thing they want. They want something warm, inviting and enjoyable. Their desire for a great user experience doesn’t magically switch off when they transition from personal life to work mode. 

 

So, by all means, embrace innovations like AI. But don’t lose sight of making technology straightforward for the end users —especially in those crisis situations where every second counts.

 

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Roger Mazzella is Strategic Partner Manager for the Americas at the Qt Group

 

Main image courtesy of iStockPhoto.com and johan63