Insight from engineer and former FDA reviewer turned founder, Shreya Mehta
Shreya Mehta is CTO and co-founder of Zenflow, a medical technology company focused on treating symptoms of benign prostatic hyperplasia (BHP), or enlarged prostate. Before founding Zenflow, Shreya worked as a medical technologies engineer and lead medical device reviewer for the FDA. Shreya holds a master’s degree in biomedical engineering from the University of Pittsburgh and has experience as a Stanford Biodesign Innovation Fellow.
These are highlights from her AMA on Elpha, where women in tech talk candidly online. You can check out the entirety of the conversation on Elpha.
Q: How did you become a reviewer for the FDA? How has that experience changed how you think about medical devices?
Shreya: I was recruited to FDA from someone I met at a lecture. Honestly, I wasn’t thrilled about the idea at first. But then I learned that it was more of a technical job than I had imagined, and I really enjoyed the conversations I had with my interviewers. I realized how important the experience would be for my future career, too. Working there has changed how I think about medical devices, especially in the context of regulatory strategy.
Oftentimes, the medical device industry considers FDA a hostile adversary, which isn’t helpful. I often have to convince colleagues and others to take a more collaborative approach, because I know that’s what worked for companies when I was on the other side of the table.
I also have the perspective of seeing companies behave poorly, too — submitting really poor-quality submissions (my favorite had their test reports in Japanese!), incorrect or false data, and clear attempts to curtail important safety measures for patients.
When you only work on the industry side (assuming you work with good people), you sometimes don’t realize why FDA has to be conservative or so prescriptive. I learned that bad apples certainly exist, and that a few bad apples can ruin it for everyone.
Q: What was the trigger(s) that influenced you to co-found Zenflow and why?
Shreya: I think there were so many influencing factors. First and foremost, the desire to help patients. Then I thought about it from a career perspective. Through the process of considering whether I wanted to be a part of a startup, I remember thinking “I’m not an entrepreneur [imposter syndrome!], but I guess I’ll give this a shot.”
It was in the process of prototyping/building and iterating the design for our pre-clinical studies that I realized how much I inherently just loved creating something from nothing. I wanted to help all these patients we had met, I knew how to work obsessively hard, and I was almost always engrossed in making our ideas work.
We made progress, and it was working. Then the light bulb went off — “Oh, I guess I am an entrepreneur.”
Of course I also realized — it can be just one of the many words that define who I am. I also know that I’m privileged in so many ways, with a support net that would catch me no matter what. I was financially stable enough to spend months without pay, my husband is beyond supportive, and I could always fall back on a secure industry job if we landed on our faces.
Q: How did you transition from being a reviewer for the FDA to becoming a co-founder?
Shreya: After FDA I joined a program at Stanford called the Biodesign Innovation Fellowship (highly recommend you look into it for sometime down the road!). My husband and I wanted to move west to be closer to family and I knew the fellowship would offer me an opportunity to get a more holistic perspective on the industry in general.
Although many people start companies from the projects out of the fellowship, that was never really my primary drive — I really was just there to learn. The program focuses on addressing unmet clinical needs, first and foremost. That year we were introduced to urologists and nephrologists, who we closely observed and shadowed in the clinic and the OR. When our team came up with the idea that is now the basis of Zenflow, we decided to incorporate and see where it led.
My co-founder had started a company before, so I felt I was in good company. And I knew that we could at least get to a feasibility stage where we could convince both ourselves and potential investors that this was worth our time and their investment. When the pre-clinical testing went really well, that’s when we knew we were really onto something!
Q: What made you focus on symptoms of BHP?
Shreya: During the Stanford fellowship, my co-founder and I met patients who were suffering from BPH symptoms every day. They usually started off on some drug therapy. When that failed, we would see them come to the urologist’s office. Usually, the urologist would then present them with the current surgical therapies which are very invasive and come with the risk of side effects, including sexual dysfunction. We saw many patients decline to elect for that type of surgery and just continue to suffer through their symptoms. We knew that if we could provide a truly minimally-invasive therapy that could be done outpatient in an office-based setting, we would provide something of huge value to patients and physicians alike.
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