From FDA Reviewer to Medtech CEO

Ground Your Device in Unmet Clinical Needs

For Shreya, a key lesson is to focus on genuine patient problems — technology should follow. 

"One of the things I say is always start with the unmet clinical need," Shreya says. "Ground yourself in that. [Technological potential] is really tempting as an engineer, especially. We like toys. We like complex systems.” But if your product isn't addressing a meaningful gap in care, the technical bells and whistles won't matter. “It's already difficult to survive in the startup world," Shreya adds.

This philosophy was tested early in Zenflow's development when the team faced pressure to abandon their flexible delivery system approach in favor of a more technically straightforward rigid design. 

"I was challenged very early on. I started off as CTO at the company, and it's like, Can we just do this through a rigid system?" she recalls. "At the end of the day, the patient friendliness of this approach is what's going to drive the market and adoption. We were persistent — some might call it stubborn — [about sticking] with a flexible approach."

Similarly, the team identified removability — and therefore reversibility of the procedure — as another critical unmet need. This feature addresses a significant psychological barrier for patients contemplating treatment for a sensitive condition.

"When men have BPH issues, it's the first time that something's happening below the belt that isn't pleasure," Shreya observes. "For men, it's a very private decision. It's something that's really meaningful to them."

By allowing patients to try the treatment with the assurance it can be reversed if needed, Zenflow's approach mirrors the familiarity of medication: "It's similar to drugs. If it's not working for you, if you're having a side effect that's not worth the benefit, you can stop taking the drug. Similarly, you can have the implant removed."

When facing technical challenges with the flexible delivery system, Shreya's team could have taken the easier path and limited the product’s flexibility. Instead, they stayed grounded in the patient's perspective. "If that piece of your technology is likely to be the game changer, the difference maker in this space, then lean into it," she advises. "There are always shortcuts and easy ways out. But if you're grounded in what's most important…the patient's decision, then I think you’ve got to stick to your guns."

Zenflow’s commitment to prioritizing patient needs paid off. It gave the team a clear benchmark: every technical decision had to support their ultimate goal of creating a solution patients would willingly choose over existing options.

Firsthand observation played a critical role in identifying real clinical needs and keeping the team aligned. It helped them stay focused, grounded in the belief that they were working from accurate, experience-based insights. Instead of relying solely on physician interviews or market reports, Shreya champions an immersive, in-person approach — one that puts entrepreneurs directly in the clinical environment.

“Any opportunity you have to be alongside key opinion leaders, physicians, or even nurses in the field or operating room — take it,” she advises. “With firsthand observation, you learn far more than what’s conveyed verbally.”

Treat FDA as a True Partner 

Having sat on both sides of the regulatory table — as an FDA reviewer and now as a startup CEO navigating the PMA process — Shreya offers valuable perspective on how to work effectively with regulators. Her central insight: treat regulatory relationships as critical business partnerships, not just bureaucratic obligations.

She highlights a common industry oversight — medical device companies often invest significant effort in building ties with suppliers, vendors, and financial institutions, but neglect to cultivate similar rapport with regulators. This missed opportunity can have real consequences, potentially affecting both approval timelines and outcomes.

While maintaining professional boundaries, Shreya emphasizes the importance of building authentic connections with reviewers. “Yes, they’re regulators, and you have to be thoughtful about what you say — but at the end of the day, it’s still about relationships,” she explains. “You need to invest in building a rapport with your reviewer.”

Companies that take this approach often see tangible benefits. “I was often on a text basis with my best companies,” Shreya recalls of her time at the FDA. “That doesn’t mean it wasn’t professional, but having that relationship and being able to get questions answered quickly — that’s going to be to your company’s benefit.”

While it can be tempting to pursue the least burdensome regulatory path, Shreya is a believer in pursuing a PMA when it makes sense – oftentimes, these are the big and bold unmet needs. 

“Don’t necessarily shy away from a PMA path,” she advises. “Even if you have a Class II device, oftentimes you don’t see the level of adoption you expect until you gather clinical data on that device.”

She points to industry data linking strong clinical evidence with better exit outcomes. “By virtue of pursuing a PMA — you might have to run a randomized controlled trial — but that’s building real value,” she says. “You might feel a little burdened by the regulatory path, but I think it’s okay to pursue that because you’re strengthening the company.”

Shreya’s mindset and focus on the bigger picture helped the Zenflow team navigate the complexities of the PMA process. Rather than viewing regulatory hurdles as setbacks, they treated them as opportunities to improve their product and reinforce their market position. The clinical evidence collected through their pivotal trial has not only supported their submission but also bolstered credibility with physicians and strategic partners.

Shreya underscores that the benefits of clinical data extend well beyond approval. “That clinical evidence is everything — even from a reimbursement standpoint,” she notes.