Leveraging Regulated UX Design Principles for Success in Non-Regulated Markets
Over the last few decades, from humble, pioneering and sometimes chaotic roots the customer experience (CX) field and user experience (UX) design in particular has evolved into a sophisticated science, with data driving design decisions all the way down to interactions – and a process that is familiar to trained product designers no matter the industry they work in.
That process, when followed correctly, is a source of strength. It allows us to have a method for solving problems we do not yet understand (though in the course of the project we have confidence that we shall get our arms around it). It relies on following all the steps meticulously, talking to all of the types of end users, reviewing documentation, running analysis, and iterating.
All of these activities are time consuming. To an untrained collaborator their value may not be revealed until much later in the project, and sometimes at all. This can be a hidden point of friction – what happens when the client has to make difficult decisions and one of those decisions severely undercuts the process, specifically the research and validation parts?
It’s a well-documented issue, especially for consulting vs. product designers working on the inside. Designers know that this gap exists but often lack the means to compel the client to approve the work, instead prioritizing more “visible” activities such as wireframing and visual design.
The Cost of Eliminating Key UX Activities
So what do designers do when the amount of hours or resources is insufficient to conduct anything but token user research? We turn to technology. The advent of AI has allowed designers and researchers to somewhat bridge that gap when it comes to superficial and readily available information.
Additionally, we conduct competitive research, rely on known best practices and our own experience to come up with a solution. Then we test it however we can, usually via an ad hoc peer or generic user test. As a result, the cracks get papered over – but they remain underneath.
The cost of these cracks is not always immediately visible. On the “safer” end of the spectrum, this could translate some missed opportunities for better UX that is more grounded in the “soul of the problem.” At worst, it can result in dangerous oversimplification of the inherited project and product complexity, leading to UIs and products that are flawed or even unsafe.
Clearly, these are not acceptable outcomes. But what can be done about it? Here’s a look at what happens when the conditions are met for the UX process to be followed as intended (or close to it).
UX Design in Regulated Spaces
One of the things I really enjoy at my job is the ability to work on very varied projects that span the gamut of medical, industrial and personal devices and UIs, encountering new challenges and learning something new each time. By virtue of dissimilarities between our projects, there is always a big chunk of custom knowledge specific to a particular client, use case, user and device that absolutely needs to be ingested in order to have success.
About half of our projects are done in regulated markets where the acceptance criteria is highly defined and any risks are to be avoided or mitigated at all costs. Coincidentally, those are also the types of projects where UX research is understood as an essential necessity and not a ‘nice to have’ – providing designers the tools and the runway to do their best work.
And this is not just limited to initial research, as periodic testing and validation with actual users and user groups is key in uncovering edge cases and issues that may have been in the product team’s blind spot.
The first time I worked on a regulated project, which required consulting IEC 62366 guidelines, it was obvious to me that these guidelines are simply an organizing principle around activities and filters we already have in place. They provide a format to definitively document the feasibility of the product in question and get it to the next stop in the release roadmap.
My true ‘a-ha’ moment was realizing that taking the spirit of the guidelines and making them an active part of the UX process rather than a checklist to consult at the end made our process and our results that much better. We were uncovering edge cases, double and even triple-proofing for errors and faults and actually gaining velocity in our sprints.
Applying Lessons Learned in the Regulated Space
We decided to leverage this discovery by more closely aligning the sequence and flavor of our own activities to it. This led to some small but important changes that have found their way into our standard process since.
It is common sense that being afforded the space to apply a proper, best practices-based process is the optimal way to do things. In our case, getting to do it over and over was invaluable. It gave us the opportunity to observe the process from up close and really understand what works and what doesn’t. We have been able to identify high-value activities – those activities that are indispensable for setting up and running projects correctly versus activities that may or may not be useful on a given project.
And now we apply this approach – identifying and applying those key, indispensable activities – to non-regulated projects to give them a firm foundation and great usability. We think of these indispensable UX activities as building blocks or modules. We know a commercial app for a general audience will not face the same amount of scrutiny, or likely have the same budget, as a connected medical device.
So figuring out a tiered way to apply appropriate activities to any type of project has enabled us to leverage our experience in regulated markets to give all of our clients an unprecedented level of quality and predictability. This process allows us to serve customers no matter where they are on their product design and development roadmap.
Modularizing the UX Design Process Delivers Results
Product design is hard precisely because there are many dimensions and realities to consider. Coordinated release dates, marketing or partner considerations, investment schedules, and other concerns are all part of a product reality. UX designers must take them into account the same way they do with end-user needs. That’s why UX designers must apply a process that is flexible enough to recognize and adapt to different product needs.
For us, modularizing and finetuning UX processes for all clients based on the blueprint for regulated industries (while remaining grounded in Agile and Human-Centered Design principles) allows us to enhance predictability and velocity on projects – something virtually every product owner craves.
For more UX insight, listen to this episode of the UX Growth podcast. I dive into the challenges of balancing the needs of stakeholders, marketing and users.