Alumni Entrepreneur of the Year: Don Gonzales ’95 on Solving Problems That Change Lives

Since launching ENTrigue Surgical, Gonzales has founded two other medical technology companies. His latest, Cryosa, is developing a minimally invasive, incisionless treatment for obstructive sleep apnea and is currently undergoing clinical trials.

This fall, Gonzales will return to Gordon College to receive the College’s Entrepreneur of the Year Alumni Award at Homecoming. In this conversation, he reflects on the physician-entrepreneur mindset, how to recognize an opportunity worth pursuing, and why persistence, humility, and a willingness to learn from failure are essential to entrepreneurship.

How did you first know the medical field was for you, and how did your interests in medicine and entrepreneurship ultimately come together as a vocation and calling?

I always had an interest in science, so when I was at Gordon, I became a biology major. At the time, I thought I would probably go into research. I loved reading the textbooks, oddly enough. I just found it all incredibly interesting.

While I was at Gordon, I needed a part-time job on the weekends, so I worked as a phlebotomist at a hospital. That was actually quite incredible. I loved just being around the treatment of patients and seeing patient care firsthand. It seemed like such a great use of the knowledge I was gaining through studying biology.

I think the combination of that interest in biology and the patient care I was seeing around me made me want to bring those two things together. It just made the most sense.

Interestingly, when I look at what I’m doing now, it’s still very much research. It’s just translational research, where I’m taking that science and using it to create something that can directly impact patients.

Was there a professor, mentor, class, or experience from your time at Gordon that influenced you the most?

Professor Russell Camp was fantastic. He became my mentor during my junior and senior years at Gordon, and he actually allowed me to do basic science research and create my own project. I created a polyclonal antibody from rabbits and developed a way to detect estrogen mimics in water samples, looking for pollutants that were linked to breast cancer.

Because of that research, I was able to apply to the American Cancer Society for a Fuller Fellowship, and I received the top Fuller Fellowship in the country, the Ingle Fellowship. They placed me in a lab at Mass General for the summer and funded me to work there.

After the summer was over, they asked me to stay on, so I continued working in the lab during my senior year at Gordon as a fellow.

I think that was probably the main experience that shaped me. Dr. Camp and the rest of the biology department had never really done anything like that before, allowing a student to go off on their own, create their own project, and do something significant with the research in such a self-directed way. For him to work with me and allow me to do that was really incredible.

You’re both a physician—an otolaryngologist—and an entrepreneur. How do those two roles shape one another?

I needed to be an otolaryngologist to understand the needs of the field and the limitations of our current treatments. As a practicing physician, I experienced firsthand where the problems were. That also gave me the knowledge base to understand how things are currently done.

Being an entrepreneur helps me see problems that are usually taken for granted. As a physician, you’re taught to do things a certain way, and you do them that way every time. There are a lot of issues you might not pay attention to because looking for them isn’t necessarily part of your training.

Being an entrepreneur helps you look beyond that—to step outside of the way things are currently done and pay attention to the problems you encounter day to day. Are there problems with diagnosing a patient? With treating a patient? With the surgery itself? It makes you pay attention to those issues. So, I think the combination of the two is really a perfect combination.

I think being a physician helps me focus our efforts on the ease process and the specific problems we’re trying to solve. It also helps me work with engineers to create things that will actually work within the normal flow of an otolaryngologist’s practice.

Being a physician helps me think about whether we’re creating something that can realistically be made, incorporated into clinical practice, and ultimately, used.

You started your first company while you were still a third-year resident at Tulane, after challenging yourself to submit one new idea a week to the technology transfer office. Where did that entrepreneurial drive come from? What made you decide, at that point in your medical training, that you wanted to start creating solutions rather than simply practicing medicine?

As a resident, even though I really enjoyed patient care, I missed the excitement of research. I had seriously considered a career in research before deciding to become a physician, and I knew I’d be more satisfied if I could find a way to incorporate that excitement into my medical career. When I realized that many of our procedures are performed in a specific way only because they’ve always been done that way, and that ENT at the time was behind the curve for innovation compared to other surgical subspecialties like urology and orthopedics, that created the perfect situation to look for problems to solve. I started to pay attention to difficulties, both in surgery and in clinic to see if I could come up with solutions that would either be more efficient or change outcomes. At the time, I had no plans to leave medicine, but I greatly enjoyed researching the issues. The third idea I sent to the technology transfer office became the basis for my first startup company.

After residency, I became staff at Tulane for head and neck surgery for a year, then moved to Gloucester, Massachusetts for private practice for another year. In 2007, I was able to get venture capital funding for my company, which became ENTrigue Surgical. At that time, I decided that I needed to fully devote myself to the company and, to give it the best chance to succeed, to stop clinical practice. I’ve been inventing medical devices as a career since then.

You’ve built multiple companies at the intersection of medicine and innovation. What is it about that intersection that keeps drawing you back, and what impact have you always hoped that combination would have?

I feel like this is the best area in which to be an entrepreneur because the solutions you create can have such a significant impact on patients’ lives.

There are incredible things being created by entrepreneurs in technology and other fields, but as a med-tech entrepreneur, it’s really incredible to imagine that something you’ve created could help someone live a longer, better life.

Entrepreneurs often have a unique ability to spot problems worth solving, which you’ve demonstrated throughout your career. How do you know when an opportunity is truly worth pursuing—and when to walk away from one that isn’t?

Before starting a project, I do the research to determine whether this is a true problem. Most of the time, finding the problem that needs to be solved is harder than finding the solution.

Once I determine that the problem exists, I work backwards. Will this product be something that could eventually be acquired, or could it become a standalone company? How much money will be required to get to those outcomes? Will the potential acquisition price give investors a return?

Bringing a product to market is incredibly expensive, so you have to be solving a pretty significant problem to get the funding necessary to make it all the way through development and into the clinic.

If all of those questions have positive answers, then I do diligence on the patents. I’ll dive into the U.S. Patent and Trademark Office database to make sure someone else hasn’t already patented a good solution that’s out there.

Once I’ve done all that groundwork, I feel like it could be something worth tackling. If any of those pieces don’t work, then I don’t do it.

How has your definition of success as an entrepreneur changed from your first company to today?

With my first company, success was simply bringing a product to market that could be used in an existing procedure. My first company was Entrigue Surgical, and the product was a stapler for septoplasty that used bioabsorbable staples. It didn’t create a new procedure; it was a tool that could be used within an existing one. My first goal was really just to create something useful within the procedures I already knew.

Since then, my definition of success has progressed toward creating new procedures that can improve and prolong life.

The second company I co-founded was Spirox, which developed an absorbable implant for nasal valve collapse. We took an existing procedure called a batten-graft, which was difficult and tedious to perform and generally limited to facial plastic surgeons, and developed a way for any ENT to perform it. So we took an existing procedure and made it easier and more accessible.

That was one step beyond creating a device for an existing procedure. And now, with Cryosa, we’re taking it another step further: creating a brand-new procedure to treat a patient population that is currently undertreated.

Ultimately, that’s what success means to me. It’s building something that changes lives and maybe makes the world just a little bit better. Changing the life of even one person makes all of this worthwhile. I hope that through these inventions and companies, patients are living longer and better lives.

Many people dream of starting a business or becoming entrepreneurs someday, but the path can feel uncertain. What advice would you give them, and what qualities do you think matter most?

I think it’s important to understand what being an entrepreneur really is. Talk to as many entrepreneurs in your field as possible. I read stories about companies that were successful and also those that weren’t because I wanted to understand what that process actually looks like. It’s really hard to know what it means and what it takes to create a successful company until you’ve experienced it.

There are books out there about entrepreneurship, but I’ve found that most of them aren’t very accurate. There really is nothing like experiential learning. So trying is incredibly important. If it doesn’t work, that’s okay. Try again. Learn from your mistakes. It may take several tries to build a successful company.

I think the most important thing is understanding what that pathway really looks like, whether that comes from your own experience or from talking with people who have both succeeded and failed.

As for qualities that matter most, I think it’s relentless persistence. You have to be okay with hearing a lot of “no”s because you’re going to get so many of them—from the patent office, from funders, from people in the field.

With my second company, Spirox, I had to convince the field that nasal valve collapse was a significant cause of nasal obstruction. Many of the key opinion leaders in the field did not agree. I believe their reluctance was due to the fact that there was no good treatment. This opinion changed once Latera hit the market. Nasal valve collapse is now considered a major cause of obstruction. You have to be persistent enough to keep going through that resistance.

On the flip side, you also can’t drink your own Kool-Aid. When I was just starting out I didn’t leave myself very much room for failure, which I guess can be both a positive and a negative.

You have to recognize when something simply isn’t a good idea. That’s incredibly important, too. And along with that comes recognizing your own strengths and weaknesses. Most physicians don’t make good CEOs. You have to understand when it’s time to bring in someone who knows more than you do about a particular part of the business, whether that’s a CEO, a vice president of R&D, or someone else. Knowing what you’re good at, what you’re not good at, and when you need help is really important.

I’d love to hear the origin story of Cryosa. What convinced you that there had to be a better way to treat obstructive sleep apnea and ultimately led you to found Cryosa?

Thinking back, it actually started in Gloucester, when I was in private practice there. I had a large population of Italian fishermen with sleep apnea. Because they were fishermen, they couldn’t take CPAP out on their boats, so they were looking for a surgical treatment or some other type of treatment.

That was the one population where I had nothing I could offer them. I saw them day in and day out. Almost every day, I saw at least one person I had to tell, “I have nothing for you.” It’s hard for a physician to tell somebody that. That’s when I realized just how large the unmet need was in sleep apnea.

At that point, I had already started my first company, Entrigue Surgical, and what Entrigue did for me was hone my skills in looking for problems. So I started looking for similarities among these patients.

I looked at their tongues and their palates, and that led me to the hypothesis that there was a link between fat accumulation in that area and sleep apnea—or potentially a root cause of sleep apnea.

Once I had identified what I believed to be the problem, I started looking for solutions: a minimally invasive way to selectively reduce that fat.

Why do you believe Cryosa’s approach has the potential to change the lives of patients with obstructive sleep apnea?

Right now, there are very few treatments that work well for sleep apnea patients. CPAP, which uses a mask to provide positive airway pressure at night, works well, but it has a very low compliance rate. People just don’t use it because it can be very uncomfortable. And it doesn’t actually treat the underlying cause of their sleep apnea.

One of the surgical procedures performed now involves removing tissue from the base of the tongue using a robotic surgical system. But that procedure isn’t selective. When you non-selectively remove tissue, you’re also affecting important structures like muscle, nerves and blood vessels. It can have significant morbidity, including bleeding and scarring, and it can be a very difficult procedure for patients to tolerate. Because of that, it isn’t done very often.

The challenge with fat in the tongue is that you can’t simply go in and do something like liposuction. The fat is interspersed within and around the muscle; it isn’t concentrated in one place. It’s scattered throughout the tongue. So there really isn’t another surgical procedure that can selectively remove it.

With Cryosa, it’s incisionless. There’s no cutting involved. We use a specific temperature to cool the oropharynx (the base of the tongue and the palate) to a temperature that causes fat cells to die selectively without harming the surrounding tissues. So, through a minimally invasive surface treatment, we can remove fat without damaging the other structures.

Our approach is probably most comparable to removing tissue at the base of the tongue, but without cutting into and removing those other important structures.

How does your faith influence the work you do?

I think my faith makes it all more worthwhile. Saving lives and making people’s lives better, while also working within science and continuing to build our knowledge and understanding is where it all comes together for me.

It goes back to a quote attributed to Louis Pasteur: “A little science takes you away from God, but a lot of science brings you back to Him.” The idea of understanding these problems, striving for knowledge, and then using that knowledge to find solutions. I feel like that is the most godly thing I could do.