Getting to Yes with FDA
Think of regulatory approval as just another pitch, only this time, you're not after dollars. Your goal is to convince regulators that your technology has the power to enhance patient care.
Overengineering can wait: Gather insights from all stakeholders and build only what’s essential. Keep it simple, and consider FDA from the start—overengineering can weigh you down more than lift you up.
Involve the right regulatory experts early: Ensure compliance by seeking domain expertise from the start. But remember, while subject matter experts are valuable, rigid, one-size-fits-all strategies may not suit every project.
Balance risk with tradition: In regulatory work, experience and expertise are invaluable, but so is the ability to think outside the box. You get the best of both worlds by hiring a team that balances seasoned pros with creative thinkers who can push boundaries and find creative solutions.
Keep an open dialogue: Think of the FDA as a partner in bringing your technology to patients—initiate contact early, keep communication lines open, and be prepared to adapt your strategy as the regulatory landscape shifts.
Educate when necessary: Work closely with regulators early on and be ready to educate them about the nuanced aspects of your technology—especially when you’re breaking new ground.
Build Only What’s Essential
Derek Herrera was a Marine officer before he got injured in Afghanistan–which left him paralyzed from the chest down. This led him to launch UroDev developers of an innovative bladder management system for men with chronic urinary retention. Today, he’s channeling that same drive at Bright Uro, a startup working on game-changing urology devices that track natural bladder function over time. This new approach replaces the outdated, clinic-bound urodynamics test, which requires patients to be hooked up to large machines.
"Before you invest time in building something, make sure you know what to build," he advises. There’s no room for wishful thinking in Derek’s book. Consult both patients and clinicians to understand if your idea genuinely solves a problem. Once you harness feedback from domain experts, consider reimbursement, investor, and regulatory perspectives as part of your overall strategy. "Before we licensed the technology, I spent a lot of time understanding what are the essential features required for success...and understanding the regulatory path reimbursement as well," Derek shares.
It's vital to keep regulatory requirements in mind when developing your first prototype. Derek knows that medtech is already complex and his strategy is to simplify it. He starts with a minimal, straightforward product that meets immediate regulatory requirements, then iterates. This means simplifying features for initial approval, prioritizing essential functions, and sidestepping anything else that adds complexity to your initial indication. Derek says, “What we are pursuing is a first-generation product with a risk profile suited for a 510(k) process, allowing for quicker market entry and potential qualification for existing reimbursement covering coding, coverage, and payment.
While adding compelling features to your device is alluring, especially when you’re working with top engineering talent, it’s not always to your advantage. Derek shares, “If we were to incorporate new features as they came to us, it would increase complexity from the regulatory, engineering, and manufacturing perspectives.” That’s why Derek believes in being ruthless and judicious when determining the features of Bright Uro’s products, to keep the development process manageable and efficient.
Get the Right Experts on Your Side
Allison London Brown, the former CEO of Luminelle, has been behind over 90 successful products at corporate giants like Johnson & Johnson and GE Healthcare as well as in her own startups. At Luminelle, which was recently acquired, she focused on making gynecological procedures simpler and more accessible by shifting them from the hospital to the office setting.
"Do not underestimate the impact of the FDA. If it’s in contact with patients or if it’s patient decision-making, , the FDA will want to be involved," Allison says. Even if you’re developing an over-the-counter device, make sure you understand the regulations you’re subject to.
Once you lay out your regulatory path, bring in the right people as early as possible. An under-qualified regulatory person can be costly, even devastating. Allison recommends looking for professionals with a broad understanding of the medical device field and a flexible approach to problem-solving. Try to strike a balance between deep domain expertise and strategic adaptability.
Allison emphasizes a tailored approach to launching new medical devices. Instead of relying on a generic rollout, she advises a step-by-step, controlled launch—even after you’ve cleared the FDA’s 510(k) process. This lets you see how the device actually performs in the real world and catch any potential issues early. “We always have a very limited or beta launch,” she says. “Even with something as simple as an endoscope. You think, 'Oh, it’s just a camera,' but you want to confirm that the thing works the way you intended."
Taking these extra steps allows you to adapt your product to meet both real-world needs and your business goals.
Balance Traditional Wisdom with Risk-Taking
Joe Landolina is the co-founder and CEO of Cresilon, a Brooklyn-based biotech company he launched when he was just 17. Joe’s plant-based gel technology stops severe bleeding almost instantly. Recognized on Forbes 30 Under 30 and as a TED Fellow, Joe has raised over $80 million to drive Cresilon’s mission of saving lives through its breakthrough hemostatic products. Their first product, Vetigel, is used by veterinarians on pets to stop traumatic bleeding in seconds. Recently, the company has achieved clearance with their second product Traumagel, which brings this same technology to humans.
For Cresilon, getting FDA approval meant navigating the maze with several agencies and maintaining patience throughout the process. Working with multiple external consultants, Contract Research Organizations (CROs), and legal advisors was crucial but often led to delays. "The biggest X factor is not necessarily the FDA. It's where you have to bring in third parties," Joe explains. His takeaway? Be prepared for extended timelines when collaborating with third-party consultants and CROs.
To move swiftly, Joe likes to have both experienced d and free-thinking professionals on his side. "I always like to pair a Maverick consultant with a larger, more established consultancy. The approach is never living on the extremes but in the compromise," Joe shares. This grants the company the ability to find workable solutions without sacrificing compliance. Joe says, “I find that the best approach is never living on the extremes. It's always a compromise between the two ends. That’s where you get the really good ideas.”
For example, in Cresilon’s case, classifying its gels as medical devices rather than pharmaceutical expedited FDA approval despite the gel’s complex biological makeup. If the team had pursued new drug approval, it would have required more time and resources.
For medical devices, especially ones not requiring new drug approvals, FDA approvals can be faster and involve less-rigorous clinical trials compared to drug or biotech approvals. Crecilon’s products are gels, but Joe’s regulatory team found out that they fell under medical device regulations rather than pharmaceutical ones. Despite the gel’s complex biological makeup, this shortened Vetigel’s regulatory pathway significantly.
Keep the Regulatory Channels Open
Caroline Loew, Ph.D., is the former CEO of Glympse Bio (recently acquired by Sunbird Bio) and current CEO of Mural Oncology. With a background in organic chemistry and an accomplished track record at companies like Merck and Bristol-Myers Squibb, Caroline excels at marrying science, business, and clinical insights to create patient-focused solutions.
When it comes to regulatory approval, Caroline emphasizes a mindset shift: don’t view regulatory agencies as a roadblock. Instead, consider them collaborators in your pursuit to give patients access to life-changing technologies.
Caroline advocates for making contact early and often. “A lot of people have this notion of trepidation when they think about engaging with the agency, particularly as a small company,” she shares. “But my experience has been mainly one of knocking on the door every day. They really want to collaborate…particularly with new technology.” Early engagement with regulatory bodies can bridge gaps in education and compliance, especially for those that are less established.
While frequent, proactive communication with regulatory agencies can streamline the approval process, Caroline cautions that the regulatory pathways aren’t set in stone; they’re subject to shifts due to external factors like changes in political priorities, new guidelines, the fallout from other companies, or even a global pandemic. These transitions can sometimes lead to more stringent requirements or alter the review timelines. That’s why you need to build flexibility into your regulatory strategy.
This means being prepared to adapt on the fly, even if it requires pivoting on timelines, clinical endpoints, or approval strategies. For instance, if regulatory changes demand new data or modifications to your approach, it’s crucial to respond promptly, recalibrating with a focus on compliance—while staying aligned with the company's core objectives.
Simply put, Caroline sees the FDA as a partner to work with, not a hurdle to jump over. She encourages smaller companies to drop the usual hesitation and keep the communication channels open. Still, she’s clear that there’s no “one-size-fits-all” solution for progress. A set plan can fall apart, so staying flexible and ready to adapt is the real key here.
Educate Regulatory Bodies When Necessary
Sina Habibi has a background in fields like nanotechnology, synthetic biology, big data, and fintech. Under his leadership, Cognetivity Neurosciences has developed innovative AI-driven tools for the early detection of cognitive impairments like dementia and Alzheimer’s.
Given the novelty of this field, Sina found himself needing to create a regulatory path from scratch. Because the digital health guidelines are still being shaped, Sina points out the importance of working closely with regulatory bodies from the very start.
For example, Cognetivity's AI-based test didn’t fit into the standard regulatory categories. This meant Sina’s team had to educate FDA to find the right place. “There was not much that we could look at in terms of peers…so we had to do a lot of the work ourselves,” he explains. Staying in active communication with FDA helped them clarify requirements and get the agency’s support. Today, Cognetivity’s platform even serves as an example for others entering the digital health space.
To be able to educate regulatory agencies, you need to do your homework. “What keeps me up at night is staying prepared for what's ahead. It’s exciting, but it’s also a huge responsibility to serve all our customers well. We need a team and an internal organization fully ready to take on the challenge,” says Sina.
It's just as important for you to understand the compliance landscape as it is for regulatory bodies to understand your product. That’s why Sina advocates for consulting regulatory experts frequently throughout the product development lifecycle.
He also advises regularly consulting end-users throughout development to incorporate their feedback along the way. When you have a deep understanding of the regulatory landscape, you can work backward to integrate this feedback. After all, the goal is a final product that meets all guidelines and is fully attuned to its users.