In nearly every kickoff meeting for a regulated product, the same sentence arrives at some point. Someone on the client side says that regulation is a headache, and that we will have to account for it because there is no choice. The tone is always slightly apologetic, as though they are warning us in advance that the project will be duller than we hoped.
We understand where it comes from. Slow approval cycles, long documents, and requirements that occasionally look entirely arbitrary. But after several years of work on medical and financial products, we have come to see it differently. The best products we have made were made under the tightest constraints, and that was not a coincidence.
Most rules are user research somebody already paid for
A regulatory rule is almost never born in a meeting room full of bored people. It is born after something went wrong for someone. A patient took the wrong dose, a customer could not understand a charge, a person signed something they did not follow and had no way to undo.
Read that way, the requirements stop looking like obstacles and start looking like findings. Someone already did the research, sometimes at a very high price, and the result is sitting in front of us in the form of a rule.
In medical work this is especially visible. The requirement to present dosage information in a particular way, or to demand a second confirmation before an action that cannot be reversed, is exactly what we would have recommended after serious research. The only difference is that we did not have to fund the research.
Constraint settles the boring questions
The most exhausting part of product design is not thinking about the large things. It is the recurring arguments about the small ones. How many steps the flow should have. Whether to preserve what the user entered. Where exactly a warning appears.
In an unregulated product every one of those is open to be relitigated weekly, depending on who is in the room and what they read that morning. In a regulated product a good number of them are simply closed. That is unpleasant the first time, and then it turns out to free an enormous amount of attention for the questions that really are open.
On the app we built for Theranica, which connects to an actual medical device, there was a great deal we were not permitted to change. Precisely because of that, we could put almost all of our attention on a single question, which was how the user understands that the device is genuinely working right now.
What is actually hard
It would be glib to pretend none of this is difficult. Some of it is genuinely hard. It just is not the rules themselves.
The first difficulty is pace. An approval cycle can take weeks, and during that time you cannot simply ship a version and watch what happens. Release fast and fix later does not exist here, and anyone who works as though it does will get stuck.
The second difficulty is larger. You usually cannot put a version in front of real users before it has been approved. Which means the moment of truth, where you learn whether your assumptions held, is pushed to a point where you have already invested heavily in them.
Our way around this is to separate what requires approval from what does not. Onboarding, explanatory screens, navigation and any message that is not clinical can all be tested with people very early. In practice most user confusion lives there anyway, and not in the regulated screens.
What did not work for us
On our first projects in this space we worked in the natural order. First we designed the experience we wanted, then we sat down with the regulatory people to adapt it.
This failed every single time, and it was expensive. Each round surfaced something fundamental in the flow that could not pass, which meant going back and redesigning a screen the team had already signed off internally. Worse, it left everyone with the feeling that regulation was the thing wrecking the work, when in truth we had simply invited it too late.
Today the regulatory lead sits with us at the first sketches, before there is any visual design at all. That has not solved everything, but it moved all the arguments to the stage where they cost very little.
Closing
Nobody enjoys approval cycles, and we are no exception. But looking back over the past few years of work, it is hard to ignore that the products we are proudest of are almost all products where somebody told us no.
A real constraint forces you to decide what matters most, because there is not enough room for everything else. Which is exactly what good design is supposed to do even when nobody is forcing it.