Getting to Yes with FDA: 5 Lessons from Medtech Entrepreneurs


Embarking on a life science startup journey means facing a complex set of rules and regulations that could make or break your venture. In this playbook, trailblazing experts in the field lay out a roadmap for navigating the regulatory landscape.

Key Lessons From This Playbook

  • Plan before you build: Gather insights from all stakeholders to build an informed prototype.
  • Involve regulatory experts early: Ensure compliance by seeking domain expertise from the start.
  • Balance risk with tradition: Pair consultants who push boundaries with those who deeply understand regulatory rules.
  • Keep an open dialogue: Engage frequently and transparently with regulatory bodies.
  • Educate when necessary: Help regulators understand the nuanced aspects of your technology.

Think of regulatory approval as just another pitch. This time, instead of asking for dollars, your job is to convince regulators that your technology has the potential to improve patient care. 

Map Out Your Mission Before Diving In

Derek Herrera was an elite Marine officer before injuries led him down a different path. Now, he’s the founder and CEO of Bright Uro, developing game-changing urology devices. As the head of several healthcare startups and as an ex-military officer, Derek is a pro on planning and execution. 

"Before you invest time in building something, make sure you know what to build," he advises. There’s no room for wishful thinking in his approach. Consult both patients and clinicians to understand if your idea genuinely solves a problem. Once you harness domain expertise, consider reimbursement, investor, and regulatory perspectives as part of your overall strategy. 

Building upon your expertise, it's vital to keep regulatory requirements in mind when developing your first prototype. Focus sharply on the essential features to keep the project streamlined. If you make things more complicated than they need to be, things might get out of hand quickly. 

While overengineering is alluring, especially when you’re working with top talent, it’s not always to your advantage. Derek says, “If we were to incorporate new features as they came to us, it would increase the 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. This way, he ensures the development process remains manageable and efficient.

Build a Regulatory Team Early On

With experience at corporate giants and a background in polymer chemistry, Allison London Brown’s expertise extends to developing and launching products that change how healthcare is delivered. Her current venture, Luminelle, focuses on hysteroscopy systems that are shifting medical procedures from the hospital to the office setting.

Allison underlines the significance of understanding FDA's role in product development as early as possible. Your regulatory team needs to be involved during the initial design process. 

However, finding the right regulatory partner isn’t always straightforward. 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. 

This way, you can move past the generic one-size-fits-all approach to develop a tailored version that works for your product, your company’s capabilities, and your commercial strategy.

Balance Traditional Wisdom with Risk-Taking

Joe Landolina is a young inventor whose innate curiosity has driven him to revolutionize trauma care through his company's plant-based gel technology that stops life-threatening bleeding in seconds.

When it comes to dealing with FDA and other regulatory bodies, Joe points out that the "biggest X factor" is often not the technology or the company, but the involvement of third parties like CROs, consultants, and lawyers. This is where clear communication and contingency planning come into play. 

Joe’s advice is to avoid both heavily relying on conventional wisdom and taking extreme risks. Instead, balance your regulatory strategy by pairing "maverick" consultants who aren't afraid to push boundaries with more conservative partners who understand the intricate details of regulatory guardrails. 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.”

Keep the Regulatory Channels Open

Caroline Loew, Ph.D., is the former CEO of Glympse Bio (recently acquired by Sunbird Bio). With advanced degrees in organic chemistry, she has successfully navigated the challenging crossroads of science, business, and clinical affairs.

When it comes to regulatory approval, Caroline advocates for making contact “early and often” for anyone in the life sciences industry. Early engagement with regulatory bodies can bridge gaps in education and compliance, particularly for those that are less established. In her experience, a proactive stance — regularly initiating contact with FDA — has been met with a willingness to guide and support, especially when new technologies are at play. 

Caroline sees FDA not as an obstacle but as a collaborative partner. She challenges the common hesitation many smaller companies might have toward regulatory agencies, encouraging frequent and open dialogue. She says there’s no "silver bullet" for progression; you must be flexible and adaptable to navigate the regulatory landscape successfully.

Educate Regulatory Bodies When Appropriate

Sina Habibi is the co-founder of Cognetivity Neurosciences, a company at the forefront of detecting cognitive impairment through cutting-edge technology. 

Sina had to forge his own path to regulatory approval because the company’s product was novel and non-traditional. He emphasizes the importance of engaging with regulators to help them understand the nuances of what you’re building. His team took the time to prioritize education, and over time, regulatory agencies started using Cognetivity’s platform as an example for others in the digital health space.

In line with this approach, Sina advocates for consulting regulatory experts frequently throughout the product development lifecycle. It's just as important for you to understand the compliance landscape as it is for regulatory bodies to understand your product. Then, you can work backward to incorporate feedback from the end users. That way, you’re also working toward two critically important goals: a final product that meets regulatory guidelines and is fine-tuned to the needs and expectations of your end-users.

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