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Dennis P. Calvert is the CEO of BioLargo, a cleantech company that commercializes technologies for energy and environmental challenges.

gettyHow do you make the trek from breakthrough innovation to real-world impact?

Innovation in healthcare and environmental science is often celebrated for the eureka moments of discovery. But what rarely gets equal attention is the long, difficult journey required to bring that innovation to market, especially when navigating the U.S. regulatory system.

Having spent nearly 20 years advancing technologies through that process, I am not worried about regulators. In fact, I’ve come to view regulatory pathways, such as those from the U.S. Food and Drug Administration (FDA), not as a barrier, but as a proving ground. It’s a gauntlet, no question. But it’s also a process through which real innovation is tested, refined and ultimately validated.

Start with a purpose that outlasts the process.The journey begins by appreciating the regulator’s role. The mission of the FDA is to protect public health by ensuring medical products, foods and drugs are safe, effective and of high quality. The FDA aims to achieve this by balancing the health benefits of a new product against its potential risks before it can be sold to the public.

Understand this upfront: If you’re entering a regulated market, it will probably take longer and cost more than you expect, so your mission must be your anchor. That’s why your mission matters. In our case, for example, the goal has always been to develop technologies that help keep people safe, whether by improving infection control in healthcare or removing harmful contaminants like PFAS (known as “forever chemicals”) from the environment.

When you face years of regulatory back-and-forth, capital constraints and technical hurdles, that purpose becomes essential; it keeps your team aligned and strategy intact. If your innovation doesn’t solve a meaningful problem, it won’t sustain you through the process.​

Treat regulators as partners in safety.​Resistance could show up in slow adoption, skepticism from stakeholders or structural hurdles. Some investors, regulators and analysts along the way might say your innovation is too good to be true.​ It is easy to become frustrated with scrutiny, but I recommend viewing this as an opportunity to do a better job making your case.

In my experience, the most successful approach is to engage regulators as partners by assuming positive intent and recognizing that regulators’ skepticism is a form of responsibility. This partnership is built by providing rigorous, transparent data and working to anticipate questions before they are even asked.

The way through it all is credibility: engaging key opinion leaders, generating peer-reviewed data and demonstrating consistency and reliability over time.​​

Ultimately, you are no longer trying to get through the system; you are helping it do its job.​ So anticipate resistance, and make your case with data, more data and even more data.​​

Build evidence that matters to the entire ecosystem.​In healthcare, innovation alone doesn’t drive adoption; evidence does. I find that providers, payers and regulators evaluate new solutions through a similar lens: improving outcomes, reducing costs and preventing complications. That’s why one of the biggest opportunities in healthcare is to move upstream and find innovative solutions to problems before they become costly complications.

This is particularly true in areas with both human and economic costs. Consider infection control: More than 680,000 healthcare-associated infections occur each year in the U.S. and cause billions in additional healthcare costs, according to the Department of Health and Human Services Office of Disease Prevention and Health Promotion. Preventing infections could have far greater impact and potential to redefine standards of care than simply treating them after they occur.​ Solutions that reduce surgical site infections and, in turn, shorten hospital stays, lower readmissions and reduce reliance on antibiotics deliver outcomes that matter not just clinically, but financially.

The takeaway is simple: Design your validation strategy around real-world impact, not just technical performance, and demonstrate clear economic value. No matter how compelling your technology, it must work within the financial constraints of a system where reimbursement is increasingly tied to outcomes. For innovation to gain traction, it must demonstrate a clear economic value, typically by showing a lower total cost of care.​

Commit to the long game.There’s no shortcut through regulatory clearance processes. In my experience with the FDA’s process, bringing a new medical technology to market can take a decade or more, along with significant capital investment. In our case, the development and regulatory journey for our wound care product from our subsidiary required a 20-year, $25 million quest.

This is where many companies struggle. The pressure to scale quickly can conflict with the need to build a strong technical and regulatory foundation. This requires aligning with long-term capital partners who understand the journey and building robust systems for sustainable growth.

The companies that succeed are the ones that endure. You have to play the long game. Strategic execution, early partnerships and persistence are the key components to building the momentum needed to reach that tipping point toward widespread adoption.

The Bottom LineNavigating regulatory clearance is one of the most demanding challenges a technology leader can face. And that is a good thing. The rigors test not just your innovation but also your resilience, strategy and commitment.

It also serves an important purpose: It ensures that the technologies reaching patients and providers are safe, effective and worthy of trust. For those willing to embrace the process, the reward is more than market entry—it’s the opportunity to create lasting impact at scale.​

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