Dedicated to design & manufacturing for medical device

September 25-27,2024 | SWEECC H1&H2

EN | 中文

Getting to Yes From FDA

Regulatory Pathway

Regulatory clearance or approval is one of the most challenging hurdles for any medtech startup. But it doesn’t have to be.

As the co-founder and CEO of FastWave Medical and the founder of Medsider, I’ve spoken to entrepreneurs who have found the regulatory journey to be more collaborative than confrontational.

The primary role of any regulatory body, including FDA, is to ensure that new technologies are safe and effective, essentially serving as a gatekeeper for public health. If you’ve done your homework — understanding both your technology and the regulatory requirements — the process can become less of an obstacle course and more of a constructive dialogue.

Read on for some bite-sized, actionable advice from proven medtech entrepreneurs who’ve successfully maneuvered the regulatory gauntlet.

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, Herrera is a pro on planning and execution.

“Before you invest time in building something, make sure you know what to build,” he advised.

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.

“If we were to incorporate new features as they came to us, it would increase complexity from the regulatory, engineering, and manufacturing perspectives,” Herrera said.

That’s why he 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.

She 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. She 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, Landolina 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.

His 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.

“I find that the best approach is never living on the extremes,” Landolina said. “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) and current CEO of Mural Oncology. 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, Loew 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.

Loew 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. 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.

Habibi had to forge his own path to regulatory approval because the company’s product was novel and non-traditional. He emphasizes the importance of proactively communicating 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, Habibi 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.

A summary guide to the regulatory maze

Embarking on a life science startup journey means facing a complex set of rules and regulations that could make or break your venture. While the roadmap varies from one company to another, our trailblazing experts have gifted us with valuable insights that could very well serve as your north star:

  • 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.

Article Source: MDDI