I'm a medical tech engineer and former FDA reviewer turned CTO & Founder – Shreya MehtaFeatured

I’m CTO and Co-Founder of Zenflow, a medical technology company focused on treating the symptoms of BHP, or enlarged prostate. I’m an experienced medtech engineer, and a former lead reviewer for the FDA. I have an MS in biomedical Engineering from the University of Pittsburgh. Ask me anything about building a medtech startup, working with the FDA, my role as Zenflow’s CTO, or something else!
Hi, Shreya! I'm currently an undergraduate biomedical engineering student. I'd love to hear about how you transitioned from being a reviewer for the FDA to becoming a co-founder.
Hi! 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 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!
I'm a physician and co-founder of HealthSavvy, which is a digital health company for cancer screening. I'd love to get your insight on how much the FDA will regulate going forward for digital health companies.
Thank you, and great question. FDA has, by its own admission, struggled to deal with the speed of development in the digital health space. Simply from a logistics perspective, they're used to changes to medical products happening in a matter of months, not days. Also, now that individuals are taking more independent control of their health, I think FDA is struggling with the fact that the usual gatekeeper of regulated technology (physicians) are sometimes being removed from the health-related decision-making processes. This makes it harder for them to assess the safety and effectiveness of a product because now they have to consider the risk factors associated with the fact that the company/product (especially in the case of AI) or the user are informing or making those decisions. From the user's perspective of course, this is empowering. But from a regulator's perspective, it can be frightening :)
I'm interested in learning what made you decide to focus on symptoms of BHP?
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.
A couple questions from me and the founder of a company I invested in, Ezra, that applies AI for MRI-based prostate cancer screening:- Why Zenflow and not Flomax (often used to treat BPH)?- How long did it take Zenflow to get FDA approval? Which pathway did you use, and any tips for navigating this process?- Do you also help men diagnose BPH?Thank you! 🙏
Hello Sarah! Drugs, including Flomax, often aren't effective enough for patients' symptoms. Mechanical therapies that continue to maintain an open channel over time have, in general, been more effective than drugs for moderate to severe BPH patients. We only work on treating the symptoms, not diagnosing BPH. There are many effective ways of diagnosing BPH, which we use as our screening procedures for potential patients.We are working on FDA approval. For now, we are in the pre-commercial stage and conducting clinical trials so that we can eventually demonstrate that ours is a safe and effective therapy.
Very impressive background you have, what was the trigger(s) that influenced you to join/ co-found Zenflow and why?
Hey Whitney! Thank you. I think there were so many influencing factors. First and foremost, the desire to help patients. The men we met were really suffering (exemplified by the fact that our effectiveness outcome is a "quality of life" measure). It was painful to see, and through the process I also learned that my dad had BPH (something my mom told me -- he still denies he's aging at all ;)) Then I thought about it from a career perspective. Through the process of considering whether I wanted to be a part of a start up, 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. And I wanted to help all these patients we had met. And 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.
Thanks very much for joining us for an AMA, Shreya! As a reminder: this is part of our ongoing series featuring experts from Elpha.
What was the YCombinator process like? How has that program or other VC support influenced your success? Great work, I'm inspired!
Hi Shreya! Thanks for posting this - hopefully I'm not too late!I have been a medical device regulatory professional at a F100 company. I'm now looking into creating a regulatory consulting firm for entrepreneurs in the health and medical space ( My goal is to be able to empower entrepreneurs who are not familiar with regulated environments to make regulatory considerations for their company.What are you thoughts about regulatory consulting groups? What are some struggles you see for entrepreneurs who are looking to develop health and medical solutions?
I have a health tech startup and am desperately looking for a female developer. Do you have any recommendations? We are making women the experts on their body and health and we can't have a man build that!