The Device Was New. The Problem Wasn’t.

The device was completely new. But the problem that appeared during human factors validation wasn’t.

Several participants hesitated at the same point in the workflow. Some selected the wrong path. A use error occurred during a critical task. Suddenly, the team was discussing redesign, schedule impact, and potentially another validation study.

How did their earlier research and formative testing miss this?

I had never seen their device in the field. It had no field history. Yet when they described what users were doing, the behavior sounded familiar.

I had seen variations of it on other devices used by the same kinds of clinicians, performing similar tasks in similar environments. That familiarity gave me a good idea of where to start looking.

I am not really looking for sticky notes

When I enter a hospital, laboratory, imaging center, or other clinical environment, I am looking for the places where the device and the real work have separated.

A laminated card or sticky note is the easy example because it is visible. More often, the workaround is behavioral: a nurse ignores the obvious button because another path “works better,” calls a technician at one particular step, pulls an unofficial instruction from the bottom drawer, or relies on the one person who knows the trick.

The task still gets completed. The device still appears to work. That is exactly why the difficulty can remain invisible.

The note itself is not the interesting part. The interesting part is why someone needed it—and what happens when it is not there.

Watch what happens between the clicks

Clicks and task completion only tell part of the story. I also watch the subtle changes in a clinician’s face, posture, and pace.

WHAT I WATCH FOR

Frown A visible shift in confidence	Slow down A hand pauses before selecting	Lean in The screen suddenly needs more attention
Reread The same information gets scanned again	Look for help A glance toward a colleague	Take another path The obvious control gets avoided

One of the most revealing moments is when someone who was moving almost automatically suddenly stops and begins studying the screen.

The user has shifted from operating the device to figuring it out.

If I am only recording which feature they selected, I may mark the task as successful and miss the difficulty entirely.

A frown is not a use error, and a hesitation is not automatically a safety problem. But these are clues worth investigating—especially around a critical task or when the same pattern appears more than once.

Over time, we began capturing these moments in what we call an anxiety map. A task flow records what users must do. An anxiety map helps reveal where confidence drops, extra attention appears, or the user begins relying on workarounds and knowledge outside the product.

Other devices may be telling you something

Medical device teams understandably spend most of their time studying their own product. When competitor or legacy devices are reviewed, the discussion often centers on features, technology, workflows, and screen design.

I am often more interested in how clinicians actually use those products. What do they avoid? Where do they slow down? When do they call someone? What have they learned to do differently from the intended workflow?

Users of a new device do not enter validation with a blank slate. They bring years of experience with other products and expectations about how information, controls, alarms, and workflows should behave. Sometimes those expectations come from good design. Sometimes they come from years of adapting to poor design.

That is why observing comparable devices can be so valuable. Not because we want to copy them, but because the behavior around them can reveal where the real work differs from the intended workflow.

But it’s a new device. There are no users yet.

I hear this often:

“This is a completely new device. There are no users for us to study.”

Sometimes there is another reality behind that statement. The team may have limited access to clinicians, a tight development schedule, or simply not have the budget for field research.

No one may have used your exact device yet. But the intended users still exist, and the clinical work already exists.

Ideally, there is a comparable device you can observe. But sometimes there isn’t.

In that case, look at related devices, similar clinical tasks, and the way the same clinicians perform comparable work.

This is also where deep medical-device UX and human factors experience becomes especially valuable.

And I do not mean simply knowing how to organize screens or make a workflow more efficient.

I mean understanding the human behavior behind the workflow.

What is the clinician actually trying to accomplish? What information do they need before making a decision? Where does uncertainty begin?

What causes them to hesitate, slow down, reread a screen, ask another person for help, or develop a workaround?

What happens when they make the wrong selection? Can they recover easily? And where could a seemingly small usability problem become significant because it occurs during a critical task?

After working across many medical devices and clinical environments, you begin to recognize these patterns.

You also develop a deeper understanding of the core usability principles that make medical devices understandable, predictable, efficient, and safe to use.

For complex or high-risk devices, including many Class III systems, that breadth of experience can be especially valuable when there is no obvious competitor or precedent to study.

But experience should never become a substitute for representative-user feedback or formative testing.

It should help the team determine what is already understood, what still needs to be learned, and where limited research time and budget will have the greatest value.

Medical-device experience is not just knowing how to design screens and workflows. It is understanding clinician intent, uncertainty, workarounds, and use-related risk – and recognizing when the design is working against the way people actually perform the task.

Your device may be new. Your users are not.

A new medical device has no field history. But the clinical task does. The environment does. Comparable devices do.

The clinicians who will eventually use the product may have spent years developing habits, expectations, and workarounds around everything that came before it. That history walks into the validation study with them.

So before validation, I want to understand more than whether users can complete the intended workflow. I want to see how they perform that work today: what they avoid, where they slow down, who they call, and what makes them stop and study the screen.

Sometimes the best clue to a new device’s validation problem is not found in the new device at all. It is found in the behavior surrounding the devices that came before it.

The device may be new. The problem may not be.