For medical device founders, FDA strategy can feel like something that comes later—after the technology works, after the prototype is built, and only when it’s time to prepare a submission.
Waiting that long can be a costly mistake.
In the first session of a four-part educational series presented by Nucleate Arizona and powered by the Center for Entrepreneurial Innovation (CEI), Kristen Mittal, Co-Founder and CEO of Mittal Consulting, walked founders through the fundamentals of building an FDA regulatory strategy from day one.
The central message was simple: regulatory strategy isn’t solely about getting a device through FDA review. Decisions made throughout product development can influence the testing a company needs, its time to market, the claims it can make, its reimbursement strategy, and ultimately its ability to commercialize successfully.
Start With Risk, Not Just the Technology
The FDA generally categorizes medical devices by risk.
Class I includes many lower-risk devices. Class II represents a broad range of moderate-risk devices and is commonly associated with the 510(k) pathway. Class III covers higher-risk devices and generally requires the more rigorous Premarket Approval (PMA) process.
But classification isn’t simply a label attached to a finished product. How a device is designed and intended to be used can influence its regulatory path.
Mittal illustrated this with wheelchairs. A manual wheelchair has a well-understood risk profile and no electronic circuitry. An electronic wheelchair provides additional ways the device could malfunction. A more complex wheelchair built to navigate stairs presents another level of potential risk.
The lesson for founders goes beyond wheelchairs: seemingly individual product decisions can change the regulatory picture.
That can include a device’s intended use, patient population, whether it will be used at home or in a clinical setting, and even which components or capabilities are included in the first version.
For companies developing products involving emerging technologies such as AI, this raises an important strategic question: does every planned capability need to be part of version one, or could certain features be introduced in a future iteration?
As Mittal explained, those decisions can greatly affect how difficult it is to get a product to market.
Understanding the Major FDA Pathways
The session also introduced several of the pathways medical device companies may encounter.
A 510(k) generally relies on demonstrating that a device is substantially equivalent to an existing legally marketed device, known as a predicate. A De Novo request establishes a pathway for novel devices without a suitable predicate that do not present the risk level associated with Class III. Higher-risk Class III devices generally require a PMA and substantially more evidence demonstrating safety and effectiveness.
The appropriate route depends on the device, its risk, its intended use, existing regulatory precedent, and other considerations.
That’s why understanding the pathway early matters.
Founders aren’t simply choosing paperwork. They are making decisions that can affect the amount of testing required, development timelines, resources, market positioning, and what the company may eventually be able to say about its product.
FDA Engagement Can Be a De-Risking Tool
Another major focus of the session was the FDA Pre-Submission, also called a Q-Submission or Q-Sub.
For novel devices, engaging with the FDA before committing significant resources to testing can allow a company to discuss its device, proposed testing, and regulatory approach.
One of the most fundamental goals, Mittal emphasized, is making sure the FDA actually understands the device and where it fits within the current standard of care.
From there, companies can seek feedback before investing substantial time and money into clinical, nonclinical, bench, or animal testing.
Rather than viewing interaction with the FDA solely as a hurdle at the end of development, early engagement can reduce uncertainty throughout the process.
Regulatory Strategy Starts Earlier Than Many Founders Think
Mittal broke medical device commercialization into stages ranging from initial discovery and concept development through preclinical work, the pathway to approval, FDA review, and post-market monitoring.
A common misconception is that regulatory expertise becomes necessary only at the FDA submission stage.
By then, many important decisions have already been made.
For medical device companies, regulatory considerations can begin as early as product design and prototype development. Bringing that perspective in earlier can help teams understand how today’s technical decisions may affect tomorrow’s testing requirements and commercialization options.
That does not mean designing a product solely around the easiest FDA pathway. In fact, as the session explored, the easiest pathway may not always be the best one.
Regulatory decisions may intersect with competitive strategy, marketing claims, reimbursement, market access, and long-term commercial strategy.
Think Beyond FDA Clearance
Perhaps the most important takeaway from the first session was that FDA clearance or approval isn’t the finish line.
The goal is to successfully bring a useful product to market, achieve adoption, and build a sustainable company around it.
That requires a regulatory strategy that connects with the rest of commercialization rather than existing in isolation.
As Mittal put it near the conclusion of the session, regulatory should be “a flavor throughout the whole process of development.”
For technical founders making the transition from research to commercialization, that mindset can change the question from:
What do we need to do to get through the FDA?
to:
What regulatory strategy gives this technology the strongest path from development to the market?
That is a much bigger question, and one worth asking from day one.
Watch the full webinar here: https://www.youtube.com/watch?v=X2fejYOKxcg
This article is based on the first session of a four-part educational series presented by Nucleate Arizona and powered by the Center for Entrepreneurial Innovation (CEI).
