The definition of ‘medical device’ is wider than many people realise and also heavily regulated. User research with healthcare service users is vital if we want to get it right.
I’ve recently been working as the user researcher on team designing medical devices for a UK healthcare body.
Those devices, primarily in the form of interactive website tools, needed to comply with international standards.
This journey has been an eye-opening learning experience for me. Here's a download of what I learned, and what the team learned collectively.
Define success: clinical risk comes first
We had to start from scratch and rethink what defines a successful test.
Typically, user researchers are taught that empathy is the most powerful tool you have in understanding user needs. While this remains broadly true in medical device development, clinical risk must always take precedence in this context.
So, for example, insight from previous usability studies might be interesting or useful in helping us understand patient needs, motivations and pain points.
But because it was not specific to the devices we were working on we could not rely on it to make decisions where there was any risk of physical or mental harm to patients.
Every design decision needs to be carefully thought through, justified, and evidenced, to meet the needs of both users and clinicians.
Take time and care with summative testing
For those who are less acquainted with testing medical devices here are a couple of definitions:
- Formative tests are initial tests to evaluate the impact of design decisions. They identify additional requirements and any emerging risks.
- Summative tests are a final round of tests that assesses whether all clinical risks have been mitigated, conducted in as realistic conditions as possible.
Summative tests are easy to fail – and that’s a good thing.
Summative testing ensures all clinical risks have been addressed and mitigated. If a summative test reveals any clinical risk whatsoever, the process resets.
That means more formative tests, design tweaks, and further evaluation.
This can add weeks, if not months, to the project.
So, it's vital it’s done right, because rushing could cost you more time in the long run. That means, in practice, that testing happens outside the usual pattern of design sprints, because it’s not about pace.
And also recognising that if it feels like there are gaps in your knowledge, there probably are.
The easiest way of ironing out those creases is early on, in a successful formative test, rather than later, the hard way, with a failed summative test.
In fact, by the time you get to your summative testing, there should be absolutely no surprises.
Bring clinicians into research
The medical device design process is where designers immerse themselves in the clinical landscape, and clinicians step into the world of design.
Clinicians are indispensable in this journey.
Not only are they able to define what clinical risks are in the user journey, but they are also the most likely to spot emerging risks as the project progresses, and as designs evolve.
You can ask them question like:
- "We want to introduce some instructional text, how likely is it to be misunderstood – what are the potential impacts if that were to happen?"
- "We have developed a new field set component – how likely are users to enter inaccurate information causing an inaccurate result?"
They can provide incredible insight along the way and save a lot of time and energy assessing risks after the fact.
I invite clinicians to observe testing whenever possible, to foster collaboration and mutual understanding.
A switch in mindset
Once it becomes clear the product or service you’re working on isn’t just content, or a web page, or an app, but a medical device, everything changes.
What works for user-centred designers and researchers in those other contexts won’t work here.
And the sooner you accept that and switch mindsets, the better.
