How can a full-time academic surgeon launch not one, but two successful health tech companies? This episode features one of the leading physician innovators, Dr. Jim Daniero, who shares the real story of how he went from a traditional NIH-funded academic path to a serial entrepreneur. We uncover the "aha" moments and chance encounters that led him to found two startups while maintaining his clinical practice, tackling the core challenge of how to translate medical ideas from the lab to the bedside.
In this deep dive, Dr. Jim Daniero, a practicing laryngologist at the University of Virginia, details his incredible journey and provides a playbook for other doctors with an entrepreneurial itch. He explains how getting involved with the Cville BioHub and angel investment groups provided him with a crucial education in commercialization. We explore the origin story of RefluxRaft, a company born from identifying a gap in the market for effective, accessible non-pharmaceutical solutions to reflux. Dr. Daniero discusses how he built the company around a platform of patient education and trust, creating an over-the-counter alginate product that has resonated with consumers. This story is a masterclass in translating medical research into products with a low regulatory burden. We then shift to his second venture, SonoFx, which takes a more traditional biotech route. Dr. Daniero shares the challenges and long timelines involved in developing novel biomaterials for vocal fold injury, a project that started with university research and NIH funding. Throughout the conversation, Dr. Daniero offers invaluable advice on balancing clinical practice with entrepreneurship, emphasizing the power of building strong teams and finding alignment between his university duties and his founder roles. This is a must-watch for any physician or academic considering a leap into the startup world.
Introduction
Dr. Trevor Royce: Welcome to HealthTech Remedy. You are tuning in to an episode on our bonus series on physician innovators, a special series where we sit down with doctors who stepped beyond the clinic to create new solutions, lead in biotech and health tech, and shape the future of care delivery. While we typically focus on the companies and their stories in health technology, today we're focusing on the individuals that make that happen. I'm Trevor Royce, joined as always by my co-hosts, Tim Showalter and Paul Gerrard.
Dr. Tim Showalter: Hi, I'm Tim Showalter, and I'm excited to learn from our guests and explore how physicians are applying their medical knowledge in unconventional ways, from building companies and products to driving change as investors and ecosystem leaders.
Dr. Paul Gerrard: And I'm Paul Gerrard. We'll be learning how these physician innovators navigated their pivots, what inspired them, and what advice they have for others thinking beyond the bedside.
Dr. Trevor Royce: Today, we're thrilled to kick off the series with Dr. Jim Daniero, practicing laryngologist, medical school faculty member, and serial entrepreneur at the University of Virginia. And I think, Tim, you're probably best suited to introduce him.
Dr. Tim Showalter: I know Jim's track record well, as we're both faculty members at UVA and part of the Charlottesville biotechnology community. Jim is known as a faculty member at UVA based on his medical expertise in voice and swallowing disorders. But he's also a board member of the Cville BioHub and a really important leader within the biotechnology community in Charlottesville.
He's co-founded SonoFx, a company developing hydrogel-based devices to treat vocal fold injury, and RefluxRaft, which is a company focused on non-pharmaceutical solutions to reflux, but I think it's a really interesting example for physician innovators to hear about.
Dr. Paul Gerrard: Jim, welcome to HealthTech Remedy. We're excited to have you.
Dr. Jim Daniero: Thank you for having me. I'm excited to chat about some of these things.
Dr. Trevor Royce: Let's hear a little bit about your story. You've been an academic surgeon, founder, and biotech leader. I think it will be really illustrative for our listeners, as many are physicians thinking about taking the leap into industry and so forth, to hear how you got where you are, what caused you to make the leap, and how you balance that with the clinic side of things as well.
From Academic Surgeon to Biotech Founder: Dr. Daniero's Journey
Dr. Jim Daniero: I started my faculty career as a traditional academic. I built a division within our department. I started a research career in a lab, had the traditional academic success in getting NIH funding and the usual promotion and tenure track.
But then I started thinking about what I got into this in the first place for and on the research side of things, how was that going to impact patients? Because we could have these breakthroughs in technology, but that was all written in order to impact patients' lives. As a care provider myself, I needed to learn a little bit more about the commercialization side of medicine, or how do these ideas translate to the bedside?
I stepped outside that traditional path to engage in the entrepreneurial community, in the startup community. Fortunately, we have such an incredible community in Charlottesville, surrounding the University of Virginia, and extending well beyond Charlottesville into the central Virginia region through the Cville BioHub. It's an incredible organization that supports a lot of the work that I do and that Tim has done here in Charlottesville.
Getting plugged into that community initially looked like doing due diligence and working with CAV Angels, their angel investment group based on UVA alumni. I think they're in the top 25 now of angel investment groups in the country. That was a significant growth opportunity and I learned a lot about startup companies, what made a good company and a bad company, and engaged there so that when it came to my technology that I was looking to develop, I'd have a good understanding of how not to fail by learning from others.
I think failure is the name of the game in the startup community, and how to fail well is how you end up succeeding. Knowing that going into it, I was able to steer in this direction.
Dr. Paul Gerrard: Was there an aha moment or some catalyst that drove you to finally take that final plunge of leaving that traditional academic pathway and start to found companies rather than write papers?
Dr. Jim Daniero: I would say it's "and." I'm still full-time faculty. I think my chair, if they ever listened to this podcast, would want to know that I'm still a dedicated and full-time faculty member.
Dr. Paul Gerrard: We'll make sure we include that.
The Origin of RefluxRaft: A Non-Pharmaceutical Solution for Reflux
Dr. Jim Daniero: Thank you. But I would say it's “and,” and so I stay fairly busy with things. The goal to do something instead of sitting on the sidelines was a chance encounter. These things will never happen if you don't step outside of your comfort zone and outside of your lane in order to have these chance encounters that can lead to very successful companies. I think chance in this whole startup ecosystem is what leads to innovation.
We a lot of times plan innovation and most of the time that leads to failure. Sometimes it's the chance encounters that lead to the breakthroughs and the successes. This is an example of one of those. Through my relationships with this angel group and doing diligence and encountering some entrepreneurs, I came across a trailing spouse. The spouse was recruited as a chair of a department at the University of Virginia.
A trailing spouse happened to be involved in the Silicon Valley biotech startup ecosystem and was coming along following academic recruitment. This individual said, "Hey, you sound like a thoughtful guy and you are involved. You're interested in this ecosystem. We don't get a lot of doctors that engage here. Tell me some things about what you do and what you're interested in."
I told him about my basic science research and the response was, "Okay, we hear a lot of this. It's very early. That's interesting." Then the second idea was about a deficit I see when I talk to patients. There are these commercially available products that I can't get as an easy-to-access and good solution for my patients.
I am sending them all over the world to get things on Amazon to purchase and import into the U.S. There's good data behind it that dates back to the 70s. It seems like a potential opportunity. And oh, by the way, it's over the counter, so it's not regulated by the FDA. This individual said, "That sounds like an interesting opportunity. Let's research that." And it was an alginate, a commercially available product that is designed to relieve the symptoms of reflux.
It's not FDA approved for any specific medical indication, but often is very helpful in symptomatic management of reflux. Huge market, no regulatory burden, and an opportunity for innovation in a space where there was no product available in the U.S. at that point. He said, "We'll do this tomorrow. This is an idea that has legs. Let's go." And that's exactly what happened. We started our company, RefluxRaft. My vision for it was, number one, to make it easy for patients to access. But two, was to help support a platform of education.
Because so much of what I was doing in the clinic was patient education. "Hey, you can manage your reflux without all these potentially toxic drugs that have side effects. If you change your lifestyle around, if you can eat healthier..." We have these conversations as physicians all the time with the ability to change lives through non-medical treatment.
The goal was, let's create a product that's also part of an entire educational platform, building trust with consumers or patients in some cases. But for the most part, as a company, you're reaching out to consumers, building trust and educating them.
You might not need to go down the medical route. Maybe there are things that you can do to help your health, improve your health by making personal changes in your life. This product may be helpful if you want to do that and avoid some medications that potentially have side effects.
That became what resonated with consumers: the honesty, trust, communication. We're not trying to push a product out there. With the company, we're trying to build trust in a relationship with consumers. And that is what allowed this idea to take off.
Dr. Tim Showalter: Jim, it's such an interesting story. I also know that trailing spouse and he's one of my go-tos for a drink after work sometimes, so I follow the story from his perspective.
It's interesting for physicians who might be interested in innovation to think about this example because what you're offering is a product that's partnered with education. They know that the company behind the product has patient impact and quality top of mind. It's helpful for them to know that there's an educational resource available and it's distinctive compared to what else is out there available to them. It's quite an interesting story that I haven't seen other examples like this, to be honest.
Dr. Jim Daniero: Thank you. It's been a fun journey. The most rewarding part of it is it follows the narrative of a physician care provider, looking out for what's best for the patient, what's best for consumers. It makes it easy because our North Star that guides us is always how do we impact people's lives with the least amount of side effects and risk down the road.
These are long-term interventions. Because a predisposition for reflux is part of our culture, as we have American diets, the way we live our lives is always going to be something that we have to manage actively.
Dr. Tim Showalter: This is fulfilled through Amazon, is that correct?
Dr. Jim Daniero: Amazon is approximately—it varies over time—but a good portion of our sales are direct through Amazon. People like Amazon Prime, they like the reliability of the delivery. We also have our website, which is a Shopify-based website, and people can purchase directly through us. We offer various discounts along the way through either platform.
Pivoting to SonoFx: Developing Biomaterials for Vocal Fold Injury
Dr. Tim Showalter: That's great. I love that story. I also wanted to make sure to save time for your other company that you mentioned, SonoFx. This is a great story to hear—a UVA spin-out based on some clinical insights and work that you had done at UVA. Can you share a little bit about that origin story? My understanding is there may be some NIH grant funding associated with it. Can you catch our listeners up on what that process has been like?
Dr. Jim Daniero: That has been a more traditional route. We had intramural funding that allowed us to get some pilot data in collaboration with biomedical engineering at the University of Virginia, developing an electrical property that UVA controlled. The timeline for those things is pretty long when you develop things through the university. I was interested in, number one, meeting a patient need—again, getting back to that same patient-driven problem that we're trying to solve. We have a lack of appropriate biomaterials for restoring voice and speech. Right now, we borrow them mostly from plastic surgery.
We were developing technology that takes about seven or eight years to go through the process, get NIH funding, fund the research and development that leads to something that's potentially commercializable, redesign then for scale-up and commercial applications, and continue to refine. That's a potentially 10-year process.
One of the things that we're interested in now is how to condense that timeline. We have so much more data, inference, and interpretation through AI now that we have the capability of doing high-throughput screening that we use for drug development. But now we have the capability for doing that for polymer and polymer design and development.
That's an exciting new avenue and new spin on some of the research that we've been involved with over the last 8 to 10 years at the university. We're excited to take that next step with SonoFx.
Dr. Tim Showalter: Where are you guys at in terms of product development and regulatory pathway steps?
Dr. Jim Daniero: Super, super early. We're still in the R&D phase and accumulating talent. If anyone out there is a biomaterials researcher who wants to reach out, please do. We're looking for folks to continue to build the R&D side and scale up from there.
Dr. Trevor Royce: Nice thing about being in a college town is there's a lot of talent nearby.
Dr. Jim Daniero: It's one of the things that's unique in Charlottesville. A lot of folks are looking for something to do because the job market may not be as diverse as where they came from. There are a lot of interesting pivots. One of them is the CEO of RefluxRaft, who is one of those trailing spouses that was interested in the conversation initially, and now he's running our company.
Dr. Trevor Royce: We'll probably come back to this theme later, but it's interesting to think about in the era of modern medicine, where it's certainly on the subspecialty level, but even beyond that, it's so much harder to hang up your own shingle. For this entrepreneurial itch, we need an outlet for this type of thing. The story that you're telling is a good reflection of that.
Balancing Clinical Practice with the Demands of Entrepreneurship
We've covered a lot, and I've even lost count of the number of hats you're wearing. If we think of the three pillars of an academic doc—research, clinic, teaching responsibilities—we've got that. We've got founder now of two companies, along with all the faculty responsibilities. And then my understanding is you're also involved on the investment side in the ecosystem in Charlottesville and the greater central Virginia area.
So how do you balance all that? How do you stay grounded in the patient care side of things while doing all this other stuff, including building two successful companies?
Dr. Jim Daniero: It's a lot of good partnerships, good relationships. If I'm good at one thing, it's trying to put together teams that can execute. There's no way I could do all this on my own. As you alluded to, there's not enough time in the day to do all that in a successful way.
It's finding good people that can execute and convincing them that your idea is one that they should spend their time on. I've ridden on the coattails of some other folks to be successful, but it is this diverse group of successful individuals that have helped sustain a lot of the different things that I'm involved with now.
And then to come full circle, I would say I started as a faculty member, have spun outside of the university. And one of the interesting things is I'm coming full circle back into the university for better alignment in all those things and saying I don't want to be pulled too far away from a job where I'm full-time.
Through some of these relationships, I've now been asked to be a faculty advisor—a venture advisor in the innovation portion of UVA called UVA Innovates—and lead other faculty members through the founder process. That's been incredibly rewarding and fun. That gives me a lot of energy.
It allows me to share some of this knowledge with potential founders, what that may look like for them, but also to do it in a way that I'm also fulfilling the duties of my day job. That has been something that has been relieving to come back to and not be spread so thin. I can spend a lot of time doing that for the university.
Final Advice for Aspiring Physician Innovators
Dr. Paul Gerrard: In all these things that you've done, what lessons have you learned and what advice would you pass on to physicians who want to make that leap from going to their comfortable, routine lives as physicians to trying to do something different in the space of innovation, either working for a startup or launching their own?
Dr. Jim Daniero: Physicians—and I'll speak a little more specifically about surgeons, being a surgeon myself—are all great innovators. We have to be. We solve problems for a living. That's all we do. All day long, we solve problems and help people solve problems for their lives, help people solve problems in team building within the healthcare infrastructure. We don't give ourselves enough credit for that constant, constant problem-solving.
We're good at that portion. If you step outside of what we are doing on a daily basis for patient care and put yourself in another environment, it gives us the opportunity to excel in a parallel lane with healthcare. Those relationships will be developed through those different interactions that we have that are outside our normal ecosystems.
That's where the spark turns into a blazing fire, because we are able to be in a different lane. A lot of those talents and resources are realized and can turn into something special.
Dr. Tim Showalter: That's great. Then there's one important thing we did not cover, which is what is a Wahoo, for our listeners?
Dr. Jim Daniero: I am not a UVA alumnus, but being a faculty member, I've learned this through osmosis. A Wahoo is a fish that can apparently drink its weight in water. I don't understand the analogy. I have a lot of questions there because fish live in water and drinking water doesn't make any sense.
But that is the word on the street. Therefore, a Wahoo in the UVA analogy is a student that can also drink their weight in certain beverages. That's where that comes from. At least that's the lore.
Dr. Tim Showalter: That's a great answer. And I should have shared with you, we had a secret hidden judge among the podcast co-hosts, which is Trevor, because Trevor's an alum of UVA for undergrad. It sounds right to me.
Dr. Trevor Royce: There you have it. Go 'Hoos.
Dr. Jim Daniero: Go 'Hoos. I love it.
Dr. Tim Showalter: Thanks for giving so much of your time today and sharing your experiences with us.
Dr. Jim Daniero: Thank you for having me. It was fun talking.
Dr. Trevor Royce: That's it for this episode of HealthTech Remedy Physician Innovators. Be sure to subscribe and follow us on your favorite podcast platform. And if you know of a physician innovator we should feature, reach out. We'd love to hear their story. Thanks for joining us.
