What happens when an FDA reviewer becomes the person responsible for getting a medical device through approval, securing investment, and bringing it to market?

This week on Trying to Keep Up, hosts Allison Komiyama and Michael Nilo welcome Shreya Mehta, MS BME, President & CEO of Zenflow, for a candid conversation about entrepreneurship, regulatory strategy, and the long road from medical device concept to commercialization.

An engineer by training, Shreya began her career in R&D and manufacturing before spending approximately four years reviewing cardiovascular devices at the FDA. She later joined Stanford's Biodesign Innovation Fellowship, where she helped develop the concept that became Zenflow.

She initially served as Zenflow's Chief Technology Officer, leading technology development and R&D. After becoming CEO, she guided the company through its 2025 PMA approval with support from Michael and the Nilo Medical Consulting Group team.

Now, following a $52 million Series D financing and a commercial partnership with Cook Medical, Zenflow is entering a new chapter focused on expanding access to treatment for benign prostatic hyperplasia (BPH).

Shreya calls the company's journey a "12-year overnight success." Her story illustrates how much work happens between identifying an unmet clinical need and delivering a technology to patients.

From FDA Reviewer to Startup CEO

Shreya didn't initially expect to pursue a regulatory career. Like many engineers, she wanted to solve problems and develop technology. But her experience at the FDA revealed how deeply scientific and engineering-driven regulatory review can be.

That experience later became an asset as she developed Zenflow's technology and navigated the PMA process.

Michael and Shreya discuss the importance of approaching FDA Q-Submissions with focused questions. Although reviewers bring substantial technical expertise, sponsors should not treat the FDA as an extension of their product development team.

For startups, the timing and scope of regulatory engagement can influence development decisions, investor confidence, and future submission strategies.

The Reality of Fundraising

What does it take to convince investors to support a technology that may take years to reach the market?

Shreya describes fundraising as a skill learned through experience. It requires technical knowledge, genuine belief in the opportunity, emotional intelligence, and the ability to understand the risks behind investors' questions.

Early fundraising means selling a vision. Later rounds bring more evidence, but they also introduce new expectations and financial pressures.

For pre-revenue medical device companies, delays can have serious consequences. Every additional month affects cash burn, financing requirements, and the company's ability to reach its next milestone.

Shreya also emphasizes the importance of surrounding yourself with capable people. Building Zenflow required expertise across engineering, clinical research, regulatory affairs, financing, and commercialization.

Pediatric Innovation: The Devices We Need and the Funding They Require

The conversation shifts to the AUTUS Size-Adjustable Valve, a newly approved pediatric pulmonary heart valve that can be expanded as a child grows.

Michael highlights the device's clinical development program, including an initial safety cohort and extended follow-up before broader enrollment.

The approval raises a difficult question: How can developers sustain the long timelines and specialized clinical studies required for pediatric devices when the potential market is relatively small?

Shreya discusses the challenges of securing venture financing for pediatric technologies and highlights Starlight Cardiovascular, a company founded by fellow Stanford Biodesign innovators.

The group also remembers the FDA and NIH's PumpKIN program, which supported the development of circulatory support devices for children, infants, and neonates.

New Medical Devices and TIME's Best Inventions

Michael introduces Argus Cognitive's Neurora, an FDA-cleared diagnostic aid designed to support autism evaluations in young children. The discussion considers how objective assessment tools might complement existing approaches and support earlier access to appropriate services.

The hosts also celebrate three technologies recognized in TIME's Best Inventions of 2026:

• Parcel Health's Tully Tube: A more sustainable alternative to conventional plastic prescription pill bottles.

• Biolinq Shine: A needle-free glucose monitoring technology.

• Essilor Stellest: Spectacle lenses designed to slow the progression of myopia.

The conversation also touches on Vitestro's Aletta robotic blood-draw system and the growing role of robotics in healthcare.

Real-World Evidence, RAPID, and the Reimbursement Gap

An upcoming FDA Grand Rounds presentation leads to a discussion about real-world evidence (RWE), including how data collected during routine healthcare can support medical device regulatory decisions.

Shreya then asks Michael and Allison about RAPID, the proposed Regulatory Alignment for Predictable and Immediate Device Coverage pathway.

All three recognize the importance of addressing the gap between FDA authorization and reimbursement.

Michael questions whether the FDA and CMS have the resources and coordination needed to make the program effective without increasing the burden on manufacturers.

Shreya offers a more optimistic perspective. She believes renewed collaboration and new leadership could create an opportunity to improve a longstanding problem.

The conversation underscores a critical reality for medical device startups: regulatory approval does not automatically translate into coverage, payment, adoption, or commercial success.

What's Next at the FDA?

Allison previews several upcoming events, including the FDA's October 22 Grand Rounds presentation on real-world evidence and the November 10 workshop on transcranial focused ultrasound.

The ultrasound workshop will examine emerging neurological and psychiatric applications, including neuromodulation, blood-brain barrier opening, drug delivery, and safety considerations.

The hosts also discuss the FDA’s December 2-3 workshop on robotic medical devices with autonomous or remote teleoperation capabilities and the broader challenge of international regulatory harmonization.

And because this is Trying to Keep Up, the conversation eventually makes its way to jokes, self-driving cars, anti-choking devices, and the possibility of a medical device holiday gift catalog.

Key Takeaways

• Regulatory experience can strengthen product development and business strategy.

• Successful fundraising requires persistence, preparation, and an understanding of investor risk.

• Pediatric innovation needs sustainable financing and appropriately designed clinical studies.

• Real-world evidence could help inform regulatory decisions when data meet appropriate quality standards.

• The FDA and CMS must coordinate effectively to reduce the gap between regulatory authorization and reimbursement.

• Medical device commercialization depends on strong teams, strategic partnerships, and long-term planning.