For a medical device startup, getting through the U.S. Food and Drug Administration is more than another box to check. Until a device receives regulatory clearance, the company can’t market or sell it. And for a young firm burning through investor capital, every extra month matters.

That urgency is at the heart of new research from Foster’s Emily Cox Pahnke, published in Strategic Management Journal. The study asks a simple question: Can startups make choices that speed the regulatory process?

The answer is yes. And the best approach is simpler than entrepreneurs might expect.

Pahnke and her co-authors find that medical device startups seeking FDA clearance tend to move faster when they ask regulators to compare their first product with fewer existing devices. It matters which devices they choose: Startups benefit from pointing regulators toward established, well-known devices in the same category.

Then, when a medical device startup wants to get a second device through the clearance process?

Change the strategy.

Once a company has a regulatory track record, the best device comparison shifts.

A ticking clock for medical device startups

Pahnke studies innovation and entrepreneurship, with a particular interest in a practical question: How can we get meaningful innovations to market faster?

“I’m always interested in research that can help entrepreneurs be successful,” she says.

Medical devices are an especially compelling setting for that work. The category spans everyday products such as bandages and hearing aids as well as life-sustaining technologies such as pacemakers, artificial heart valves, spinal implants, and surgical robots. These products can improve health, make care safer or more accessible, and, in some cases, reduce recovery times, infection risk, and costs. But startups developing them face an extra hurdle entrepreneurs in many industries don’t: They have to pass regulatory scrutiny before they can reach customers.

For startups dependent on outside funding, that creates a ticking clock. Miss a regulatory milestone, and a company may struggle to raise its next round of funding before it can begin selling its product.

Pahnke and her co-authors focused on the FDA’s 510(k) pathway, the most common route to clearance for medical devices. Products cleared through this pathway include digital stethoscopes, soft contact lenses, and catheter guide wires used in vascular procedures. Companies using this pathway must demonstrate that a new device is “substantially equivalent” to at least one device already on the market, known as a predicate device.

Because startups choose which predicate devices to cite in their applications, the researchers could test whether different strategic choices affected how quickly regulators granted clearance.

The researchers analyzed FDA clearance data from 239 venture-backed U.S. medical device startups, focusing on their first and, for the firms that survived, second devices. They also drew on extensive fieldwork and interviews with founders, investors, industry experts, and regulators.

More than 60,000 FDA letters were hand-coded to identify the existing devices that companies chose as comparisons. The researchers then used that dataset to measure different positioning strategies.

When less is more

Entrepreneurs might assume that pointing to several existing products strengthens the argument that their new device belongs in an established category.

The research found the opposite.

The more equivalent devices a startup cited for its first product, the longer clearance tended to take. At 200 days after submission, a device application citing one predicate had more than an 80% chance of clearance. But, when applicants cited eight predicates, they had less than a 55% chance of clearance at 200 days. The likely reason is straightforward: Every additional device gives regulators another comparison to make.

But citing fewer devices makes choosing the right ones more important. For a startup’s first product, clearance moved faster when the company chose a predicate in the same FDA product category and, especially, a familiar “exemplar,” meaning a device that other companies frequently used as a regulatory benchmark.

The finding isn’t about bypassing scrutiny or lowering safety standards. It’s about strategic choices by firms that make the regulator’s job of evaluating compliance clearer and more focused.

After the first success, change course

Once a startup has a cleared device, the advantage of pointing to a well-known device from another company disappears.

Instead, companies seeking clearance for a second product moved significantly faster when they cited their own first device as the predicate.

That finding caught Pahnke’s attention because people naturally tend to repeat strategies that have worked. But once a startup has its first cleared device, its own track record becomes an advantage.

“Once you’re in the club, then you’ll be more successful by telling people you’re in it, rather than saying you’re like other members,” she says.

A first clearance gives regulators evidence that the firm has successfully navigated the process before. Citing that product can make its claims more credible and give reviewers a familiar starting point.

For entrepreneurs, the larger lesson is clear: Don’t assume the strategy that worked at one stage will still be the best strategy at the next.

Regulators as partners, not barriers

Pahnke brings the findings into entrepreneurship courses for students ranging from undergraduates to MBAs and doctoral candidates. That includes Opportunity Recognition and Validation, the kickoff course in Foster’s Master of Science in Entrepreneurship program.

The research reinforces a lesson she teaches across those courses: Regulators are not just obstacles between a startup and the market.

“A lot of the entrepreneurs I’ve talked to, they’re like, ‘No, no, they’re your partner,’” she says. “They’re the ones who can help with this.”

Entrepreneurs who had navigated the process successfully told Pahnke they called and emailed regulators with questions rather than treating the process as a black box.

Pahnke says students also respond to the simplicity of the finding. The switch between the first and second device offers a less obvious version of a familiar startup lesson.

“We say, ‘Startups should be more nimble,’” she says. “But that’s being nimble in a way that isn’t obvious.”

Read the research: “Strategic Positioning and Accelerating Regulatory Clearance for New Ventures,” by Emily Cox Pahnke, Tiona Zuzul, and Michael Howard, Strategic Management Journal (2026).

Emily Cox Pahnke is an Associate Professor of Management and Organization and the Lawrence P. Hughes Endowed Professor of Innovation and Entrepreneurship at the Foster School of Business. Recent and current courses include Opportunity Recognition and Validation, the kickoff course in Foster’s Master of Science in Entrepreneurship program; Foundations of Entrepreneurship for Full-Time MBA and Evening MBA students; Grand Challenges for Entrepreneurs for undergraduate and graduate students; and doctoral seminars.