Preparing to navigate FDA clearance to launch a new medical device


Heather UnderwoodCEO of EvoEndotalks about the lessons learned while navigating the FDA clearance process and the preparation work required.

Completing an FDA 510(k) submission to launch a new medical device is a complex and difficult task. Proactively thinking about product design, external partnerships, and quality documentation can help companies successfully navigate the process.

Creative clinicians and inventive entrepreneurs continually push the boundaries of what is possible in clinical care. Medical devices play a vital role in the continued evolution of

modern medicine and have improved outcomes for millions of patients.

Healthcare organizations are eager to adopt devices that simplify, facilitate and cost-effectively deliver high-quality care, allowing new companies to find a profitable niche in the market.

However, for every medical device company that succeeds, there are many more that do not.

Some drop out in the prototyping phase. Others start strong but lack the ability to scale. And even more are failing one of the biggest hurdles: getting FDA clearance so they can bring their devices to market and accelerate their growth.

Turning a great idea into a clinically viable, FDA-approved product is a difficult task that requires the right approach to documentation, testing, and data collection; good relations; and a structured, proactive plan that includes short-term and long-term goals. Medical device leaders can significantly increase their chances of successfully winning the opportunity to help improve patient outcomes in real-world clinical settings by considering some of the following best practices.

Turning a promising idea into a viable business venture

EvoEndo was first designed by a small team of clinicians at Children’s Hospital Colorado to provide a non-sedation alternative to upper endoscopy for pediatric patients. EvoEndo has developed a sterile, single-use, ultra-thin and flexible endoscope that is combined with virtual reality-based patient distraction to help reduce the need for general anesthesia during routine diagnostic upper endoscopy, which involves clinical risks and financial burdens. Initial debt funding, largely from family management offices and individual contributions from patients and their families, enabled Dr. Joel Friedlander and his team to begin prototyping a system to address this need. clinical. But the fledgling company also needed the administrative and operational infrastructure to begin moving toward FDA clearance — and early attempts to put that framework in place produced mixed results.

When EvoEndo, then “triple endoscopy”, began to hire R&D companies to develop the first prototypes of the system, many suppliers did not have an accessible electronic quality management system (eQMS). At first, all EvoEndo quality and regulatory documentation existed locally on individual laptops. Sharing files and getting proper approvals was difficult with these systems as EvoEndo’s small but growing team was largely remote. COVID-19 compounded the issues as we were unable to work together in person to expedite document review and approval.

When we integrated our quality management system, we knew we needed a new quality management platform and partner to implement a cloud-based eQMS that enabled complete control and visibility over our quality documentation.

The new system made it easy for the team to access the information they needed when they needed it. With custom dashboards, design controls, training management, and quality event management tools, we were able to communicate more effectively, resolve potential issues before they turned into big problems, and focus on the other key elements of a successful regulatory submission.

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

Lessons learned from obtaining 510(k) authorization

Navigating an intensive regulatory process is rarely smooth sailing to the end. EvoEndo has certainly encountered challenges when working with our partners and the FDA, and we have learned valuable lessons on how to overcome them.

Carefully review all testing partners

Test specifications are very detailed and can be difficult to understand, especially as new devices push the boundaries of existing standards and specifications. Make sure your test center knows exactly what the FDA requires for your device and can actually provide the specific services you need appropriately.

Communicate with the FDA early and often

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 get it right the first time.

Start exploring parallel tracks simultaneously

To conserve limited time and resources, you need to take a holistic view of your product and establish the necessary foundations early in the process. This includes refund mechanisms, marketing and sales, inventory management, and even future iterations of your offers. Each of these tasks comes with a ramp-up period ranging from a few months to several years, so it pays to think ahead.

Invest in infrastructure that prepares you for the long term

A robust, easy-to-use eQMS can help create a culture of compliance and quality from the start of your business and set the stage for long-term successes that go far beyond 510(k) clearance. Authorization is essential, of course, and can facilitate the raising of initial funding rounds. But investors will always want proof that your products live 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 funding round, securing $8.4 million to continue our work. We are currently expanding our team and forging new partnerships with clinical clients.

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

With our digital quality management infrastructure, exceptional team and proactive planning, we are confident in our ability to answer their questions and demonstrate how EvoEndo is advancing non-sedation single-use endoscopy for patients. and their families.


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