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Preparing to navigate FDA clearance to launch a new medical device

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Heather Underwood, CEO of EvoEndo, talks about the lessons learned navigating through the FDA clearance process, and the preparation work that is required.

Completing an FDA 510(k) submission to launch a new medical device is a complex and challenging task. Thinking proactively about product design, external partnerships, and quality documentation can make it easier for companies to navigate the process successfully. 

Creative clinicians and inventive entrepreneurs continually push the boundaries of what is possible in clinical care. Medical devices play a vital role in the ongoing advancement of modern medicine and have improved outcomes for untold millions of patients.

Healthcare organisations are eager to adopt devices that make it simpler, easier, and more cost-effective to provide high-quality care, allowing new companies to find a profitable niche in the market. 

For every successful medical device company, however, there are many more that don’t make it.

Some stall out in the prototyping phase. Others start off strong but lack the ability to scale. And still more fail at one of the most important hurdles: receiving FDA approval or clearance so they can bring their devices to market and accelerate their growth.

Turning a great idea into a clinically viable, FDA-cleared product is a challenging task that requires the right approach to documentation, testing, and data collection; good relationships; and a structured, proactive plan that encompasses both short-term and long-term goals. Medical device leaders can significantly raise their chances of successfully earning the opportunity to help improve patient outcomes in the real-world clinical setting by considering some of the following best practices.

Turning a promising idea into a viable business venture

EvoEndo was first conceived by a small team of clinicians at Children’s Hospital Colorado to allow an unsedated alternative to upper endoscopy for paediatric patients. EvoEndo has developed a sterile, single-use, ultra-slim, flexible endoscope that is paired with VR-based patient distraction to help reduce the need for general anaesthesia when undergoing a routine diagnostic upper endoscopy, which carries clinical risks and financial burdens. Early debt funding, largely from family offices and individual contributions from patients and their families, made it possible for Dr. Joel Friedlander and his team to start prototyping a system to meet this clinical need. But the young company also needed the administrative and operational infrastructure to start moving toward FDA clearance — and early attempts at putting that framework into place produced mixed results.

When EvoEndo, then “Triple Endoscopy,” first began engaging R&D houses to develop initial prototypes of the system, many vendors lacked an accessible electronic quality management system (eQMS). At the beginning, all EvoEndo’s quality and regulatory documentation existed locally on individual laptops. Sharing files and getting appropriate sign-offs was challenging with these systems given that EvoEndo’s small but growing team was largely remote. COVID-19 compounded the issues as we were unable to work together in person to speed up document review and approvals. 

When we brought our quality management system in-house, we knew we needed a new quality management platform and partner to implement a cloud-based eQMS that enabled full control and visibility into our quality documentation. 

The new system allowed the team easy access to the information they needed when they needed it. With tailored dashboards, design controls, training management, and quality event management tools, we were able to communicate more efficiently, address potential issues before they turn into big problems, and focus on the other key components of a successful regulatory submission.

Working with a team of incredible regulatory consultants and testing partners throughout this process, we further developed our design specification documents, ensured clarity and continuity with our manufacturing partners, and completed a wide range of testing requirements to prepare a successful submission. We achieved FDA 510(k) clearance for our initial product offering in February of 2022 and have since been focused on market adoption and commercialisation.

Lessons learned from achieving 510(k) approval

Navigating an intensive regulatory process is rarely smooth sailing all the way. EvoEndo certainly encountered challenges when working with our partners and the FDA, and we learned some valuable lessons about how to overcome them.

Carefully vet all testing partners

Testing specifications are highly detailed and can be difficult to understand, especially as new devices push the limits of existing standards and specifications. Make sure your testing house is familiar with exactly what the FDA requires for your device — and that they can actually provide the specific services you need in an appropriate manner.  

Communicate early and often with the FDA

If you or your partners are unsure about any aspect of testing, validation, or documentation, ask the FDA. This may be your first submission, but it certainly isn’t the first time for your reviewers. Both parties will benefit from clarity and openness, so don’t hesitate to collaborate on how to do things right the first time.

Start exploring parallel tracks simultaneously 

To conserve limited time and resources, you need to have a comprehensive vision for your product and establish the necessary foundations early in the process. This includes reimbursement mechanisms, marketing and sales, inventory management, and even future iterations of your offerings. Each of these tasks comes with a ramp-up period ranging from months to years, so it pays off to think ahead.

Invest in infrastructure that prepares you for the long haul 

A robust and easy-to-use eQMS can help build a culture of compliance and quality from the very beginning of your company and set the stage for long-term successes that go far beyond 510(k) approval. The clearance is critical, of course, and can make it easier to raise early rounds of capital. But investors are always going to want proof that your products are living up to their potential. The sooner you invest in tools that simplify your quality management, the more likely you are to save time, money, and headaches down the line.

Preparing for a promising future in the medical device market

EvoEndo recently completed its Series A financing round, securing $8.4 million to continue our work. We are currently growing our team and forging new partnerships with clinical customers. 

As we reflect on our successes and look toward our next steps, we know that there will always be new hurdles to overcome. We plan to begin our Series B fundraising this fall, during which time we expect potential investors to carefully scrutinise our quality documentation, compliance activities, and marketing strategies. 

Thanks to our digital quality management infrastructure, exceptional team, and proactive planning, we feel confident in our ability to answer their questions and demonstrate how EvoEndo is evolving single-use unsedated endoscopy for patients and their families.



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