By Beverley Ferrara, European representative
Growing a business in the United States presents huge opportunities but also poses unique challenges, particularly in the water sector, which is characterized by fragmentation and complexity.
With over 70,000 drinking/wastewater utilities, companies face risk sensitivity, challenging operating environments and complex market channels. But perhaps the trickiest aspect is keeping pace with the dynamic regulatory landscape. As the 2027 building and safety code cycle commences in the United States, I speak to Misty Guard, president of Regulosity, an independent consultancy located in the Global Water Center that specializes in helping companies secure market access for their products globally.
Unlike many consultants who specialize in one or two areas, Misty’s expertise spans regulatory affairs, building and safety codes, standards, regulations and legislative affairs.
Here, Misty shares her expertise and provides an overview of the regulatory landscape along with practical insights to help companies navigate the complexities.
How did you find your way into the world of regulatory affairs? What sparked your interest?
I’ve always believed that regulations and business innovation can and should coexist. However, early in my career, I found myself in a world where businesses were eager to advance innovations beneficial to society but were restrained by rigid regulatory frameworks. As a consultant in those formative years, I often helped businesses navigate these confines. Yet, no matter where my career took me — government agencies, private sector organizations, Fortune 10 corporations, or consulting firms — the same issues persisted. I would ask, “Who’s going to change this?” and I realized that I wanted to be that change maker, the one advocating for reasonable, progressive adjustments in the system. Earning a master’s degree in public policy deepened my understanding of global regulatory frameworks.
“Regulosity is a consultancy built on my conviction that business innovation and regulation can coexist and flourish together.”
The U.S. is a vast country and not a single homogeneous market. What insights can you share with companies looking to establish operations and ensure compliance?
In the U.S., the regulatory landscape is complex and diverse, which can be a significant hurdle for businesses, especially those coming from Europe. Unlike the EU, for example, where a CE mark provides a universal regulatory credential and EU-level directives create a cohesive set of standards, the U.S. has no equivalent system. And each state, county, and city may also have their own regulations, which makes navigating the market more challenging.
Often, there’s a misconception that certifications like NSF are regulatory endorsements, but in reality, they represent a business relationship with an independent organization without regulatory authority. As a professional helping firms enter the U.S. market, my role is to strategize how to use any certifications they have effectively. This involves positioning their credentials in a way that gains acceptance from those with the power to enforce and regulate, ensuring the regulators recognize the value of the “pieces of paper” a business holds.
The water and electrical spaces are two areas under stringent regulations. So that’s why, when entering the U.S. market, converting your EU compliance scheme — like the CE mark — into U.S. market terms is vital. If you don’t, you open yourself up to liability, and revenue generated is at risk of being claimed by others through lawsuits.
How should smaller companies with a limited budget approach regulatory compliance as part of their market entry strategy?
For smaller companies, regulations can be challenging but not impossible. I recommend developing a compliance strategy as part of the broader business strategy in the early stages of funding and organizational development, as it is crucial for understanding the risks to your business as well as helping forecast and protect profits.
In assessing market viability, you must consider both macro- and micro-level trends, including pending legislation that might affect your product. Once you have a timeline for entry, the first step is to determine what you must comply with. In the U.S., there’s a spectrum ranging from minimum requirements to voluntary programs, and where you aim on that spectrum should align with your brand’s values and market strategy.
The key is to start with what’s necessary today to meet your basic compliance requirements, which may include third-party certifications and regular updates to your registrations with various government levels.
“Remember, in the U.S., it’s not just about federal compliance — you will likely have to deal with state, county or city regulations as well.”
I often recommend starting with a focused approach. Instead of aiming to conquer the entire U.S. market at once, target a subset — perhaps three to five states — where you expect to generate revenue quickly. This focused strategy not only aligns with the regulatory framework but also ensures you can cover your expenses and move toward profitability. Every company will have a different path based on their specific products and business outcomes.
Can you take us through the steps of a compliance-centric approach and how it can help a business thrive in the United States?
It begins with a thorough understanding of the market, which involves assessing how attractive the market is from a compliance perspective, determining the best entry strategies, and planning how to sustain your market position. Unlike many data and information providers who stop at giving lists or writing white papers, we take it a step further. We translate information into wisdom with actionable insights.
Continuous adaption is key, both to maintain compliance and to leverage it for business growth. Some companies may only meet the minimum requirements, while others aim to exceed them to align with values like environmental sustainability. Confidence in a product’s compliance can be as compelling to partners and customers as the product itself.
“Because compliance in the U.S. is often a market differentiator, it enables your channels to confidently accept your product, which is crucial in our litigious market.”
Moreover, for those looking to shape the market or introduce innovations, advocacy can be necessary. We can be the voice for our clients in the U.S., from giving testimony at building and safety code hearings to proactively advocating for market changes. At Regulosity, we work to create a playing field that allows our clients’ market differentiators to shine and secure their competitive position.
I founded Regulosity on the idea that business innovation and regulation can coexist and flourish together. If you lay a business strategy on top of a compliance strategy and see them as coexisting instead of adversarial, the world is your oyster!