One of the secrets to successful innovation is the ability to work creatively within constraints. Not enough budget? Explore more cost-effective materials and simplify the design where possible. Not enough time? Create a prototype that allows you to test, learn and make the case for greater investment. Are you about to design in a regulated industry? Well . . . this is where a workaround won’t cut it.
Depending on the sector in which you’re operating, the list of regulations can be exhaustive – and daunting. The U.S. Code of Federal Regulations (CFR) alone stands at over 180,000 pages and contains more than a million regulatory restrictions.
There is also great variety in what gets regulated, from workplace safety, the way data is collected and used, the governance around financial relationships and of course rules aimed at protecting the environment. Some regulations will be specific to vertical markets like aerospace, financial services, petroleum and transportation. Others, such as privacy, could apply to almost any kind of business.
Within those organizations, meanwhile, there are always demands to create better experiences that help address critical business, customer, patient or citizen needs. The worst thing that can happen is that regulatory hurdles stifle innovation. That would mean life-saving pharmaceuticals and medical devices don’t get produced, or breakthrough ideas which could improve our daily lives get parked.
Having pushed new products through heavily regulated industries, I can tell you that successfully navigating government and industry requirements is both possible and instructive. When you design something that meets regulations, you’re learning important lessons that will ultimately benefit your organization, your customers, and further your career.
All those “musts” and “shalls” within regulatory documents represent years of careful thinking about the world we live in and how to avoid situations that put people at risk.
Here are 6 key tips to develop a strategy that will achieve regulatory approval and deliver the right outcomes at the same time:
All those “musts” and “shalls” within regulatory documents represent years of careful thinking about the world we live in and how to avoid situations that put people at risk. Governments and regulatory bodies are not adversaries, any more than the legal team within your organization that may be charged with ensuring regulations are followed.
In any kind of user experience (UX) design project, interviewing stakeholders to deepen your understanding of their context and challenges is an established practice. Regulations should be looked at as another way of informing not only UX but every other facet of the design process.
Regulations can sometimes seem like a variety of ways to say “No” to potential product ideas or strategies to improve experiences. It can be tempting to simply avoid the questions regulatory requirements raise of the resources that will be needed to have an idea comply with them.
This is why you should look internally for someone with enough power – and enough vision – to recognize the value your project could offer. Help them to clearly understand the rationale for the proposed innovation and the urgency to make an organizational priority. Regulated industries are often filled with people who have extensive experience that could bring credibility to your idea and evangelize it to gain greater buy-in.
Designing for regulated industries isn’t just about getting other people to say “yes.” It’s about confronting all the biases and assumptions that could jeopardize the result of a project.
Beyond finding an internal champion, you should also consult widely to learn all the reasons an idea might not work. With enough information, it may turn out that killing the project is the right move.
In other situations, the objections you hear might be overcome by retooling your approach. Feedback is always valuable within UX design, and working in regulated industries is no different.
Knowing you’ll likely have to make adjustments to a project or design along the way to comply with industry regulations, make sure you’re doing everything possible to set yourself up for success at the outset.
These are often data-driven kinds of organizations, so doing your homework and having answers to anticipated questions and concerns ready will go a long way towards building trust.
Before bringing an idea forward, for instance, put yourself in the mind of your audience. What are some of the data points that would help inspire them to at least commit to further investigation? Don’t be afraid to be wrong, and be evidence-based in every idea you bring forward.
Leading a design project from conception to completion in a regulated environment may take longer than working in a sector without the same requirements. Part of that extra time might simply be hearing out people who have been working in that industry for decades, who have valid questions and concerns that deserve attention and a thoughtful, comprehensive response.
This is also about practicing the art of the possible, though – helping people to push themselves and their organizations further than they ever would have done otherwise. Drawing upon established case studies can help here: no one in the aerospace industry thought you could recover a first stage rocket until SpaceX did it, for instance.
Instead of labeling this as industry disruption, help people see it as a way of transcending the idea of regulations as a barrier.
Before getting too heads-down on a design project, look up and around. Who else has worked on similar initiatives within your industry, or could bring in experience in adapting to the regulatory constraints? You can continue to own the vision and the overall strategy while also leveraging the skill sets and track record of third parties that ease the overall process of development and execution.
Loft, for example, has a team whose backgrounds span multiple industries and have delivered innovation in compliance with rules affecting health care, aerospace and more.
Connect with us to learn how we work and ensure no opportunity to innovate goes unexplored.
Mar 7, 2023
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Innovation
Regulated Industry
