De Novo: Those Aren’t Great Odds

Are MedTech Startups Prepared for the Process?

Only about 40–45% of De Novo requests historically receive a granting decision. That statistic caught our attention during an FDA presentation at the recent MedTech Conference in Boston. For medical device founders, it deserves a closer look.

De Novo is a pathway to market for certain novel, low- to moderate-risk medical devices that don’t have a suitable legally marketed device to compare against, known as a predicate. A successful request authorizes marketing and establishes a classification that may help future devices follow a more established regulatory path.

That makes it different from a 510(k) submission, which demonstrates substantial equivalence to an existing predicate, and premarket approval, or PMA, generally used for high-risk Class III devices. Being new doesn’t automatically make a device a De Novo candidate. The risks and how they can be managed matter, too.

For a founder developing something novel, De Novo can open an important door.

Getting through it takes careful preparation.

What’s behind the numbers?

The granting rate doesn’t mean every other request was rejected. Some were withdrawn, others administratively closed, and roughly a quarter were formally declined. The presentation also reported that FDA was largely meeting its review timelines.

Still, those aren’t great odds for a startup spending considerable time and money developing a medical device. The reasons behind those decisions are worth understanding before making that investment.

FDA reviewers frequently questioned whether a device’s clinical benefit had been adequately demonstrated. Concerns about mitigating risk were less common. Smaller companies also had lower granting rates than larger ones.

For founders, that’s an important distinction. A device can work as designed and still leave questions about whether the evidence demonstrates its claimed benefit. Does it provide meaningful information for a clinical decision? Does it support the intended use? Does the study actually answer those questions?

At MDM2, we believe these questions belong early in the development process, while a team can still use the answers to shape its plans.

Get the right advice before committing the study budget

Our recommendation is straightforward: bring an experienced regulatory professional into the process early.

For a startup working with limited resources, that can feel like another expense. But the decisions made before a study begins can determine whether that study produces the evidence the company needs.

What clinical evidence will FDA expect? Does the proposed study demonstrate the claimed benefit?

Have the appropriate special controls, the requirements used to address risks specific to that device type, been considered? How much should be worked out with FDA before clinical studies begin?

FDA recommends considering a Pre-Submission to obtain feedback before filing a De Novo request. That gives companies an opportunity to discuss their approach before committing further resources.

An experienced regulatory professional can help a company work through these questions. That means more than preparing documents for submission. It means understanding how FDA evaluates novel devices, anticipating concerns and helping the development team avoid spending time and money answering the wrong questions.

De Novo decisions are never guaranteed. Neither is the success of any regulatory strategy. But waiting until FDA identifies deficiencies to seek experienced help can be an expensive choice.

For early-stage companies, getting qualified advice early deserves serious consideration.

Arizona needs to make that support easier to access

The organization and support surrounding MedTech in Massachusetts, Minnesota and California stood out to him. A conversation with a well-funded, well-connected Boston nonprofit reinforced the point. Founders are competing with companies that have substantial support around them.

At MDM2, we see a clear connection between that observation and the De Novo discussion. If experienced guidance can help founders make better decisions, Arizona needs to make that guidance easier to find and access.

That takes commitment from industry, healthcare organizations, universities, investors and public leadership. Connecting a founder with a qualified regulatory advisor, a clinical partner or funding for critical validation work is a practical contribution to a company’s progress.

Our call to Arizona’s MedTech community is simple: commit expertise, open a connection or help fund the work that moves an early-stage company forward.

The odds are challenging enough. Stronger support should be something Arizona founders can count on.