Many otolaryngologists have ventured into the realm of entrepreneurship, developing products to improve patient care or make the lives of physicians easier, or both. But in the background, there are legions more who have ideas and wonder whether or not to launch them commercially.
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December 2019ENTtoday talked with four otolaryngologists who have taken the leap to get their thoughts on figuring out the right idea and determining the right timing for taking the plunge. They also shared headaches and successes they’ve had along the way.
A Learning Experience
Patrick Byrne, MD, MBA, director of facial plastic and reconstructive surgery at Johns Hopkins, was an early investor in and is chief medical officer at AEGERIA, which is centered around an acellular adipose tissue designed to be a regenerative matrix that can be injected to restore and help regenerate soft tissue. It is now in phase 2 trials. He also helped found HALE, an internal nasal device that is also in a second phase of clinical trials. Additionally, he co-founded a company that owns and consolidates eye care practices.
ENTtoday: Two of your ventures are still in the development process. What hurdles have you run into?
Dr. Byrne: When we first started the process [with AEGERIA], we anticipated that the material would be classified as a “tissue” by the FDA, and we registered with the FDA as we went through the clinical trial process and development phase. They came back and said that we don’t qualify as a tissue; we qualify as a biologic, which is the same level that a vaccine, for example, is considered. It was an enormous hurdle, actually, and set us back several years of having to go back and do more pre-clinical animal work and documentation, and go through a much, much, much more complex and expensive process to get approval. So we calibrated and probably took an extra four years, to be honest…. That was just an incredibly humbling learning experience, for sure. That’s part of entrepreneurship; that’s the way it goes.
ENTtoday: How critical was the decision to get an MBA, and would you recommend other otolaryngologists do the same if they’re serious about entrepreneurship?
PB: For me, it was key. I felt like my understanding and confidence were insufficient, despite my interest for many years in doing something entrepreneurial. I needed that confidence boost and knowledge. For me, it was a good investment of time. I’m appreciative that I went through a top-tier program because the network that people talk about is pretty powerful. And everybody’s life situation is different. For me, having gone to Wharton was really a boost because I was so quickly and easily able to tap into partners for each of these ventures.
It wasn’t really, in the end, a strategic decision with a specific end in mind. And my entrepreneurial interests aren’t either, really. I don’t have any master plans. Certainly, it’s not around economic gain, whatsoever. I just like building cool things. I like the creative process. I like the intellectual challenge.
If you really believe that your idea might become very valuable to society and make medical care better, then every time is a good time to do it —Subinoy Das, MD
ENTtoday: How do you balance your entrepreneurship and academic medicine life?
PB: The partners you have in any venture are critical. Before I landed on these two start-ups, for example, I looked into other things. And some proved impossible …. If you don’t have a business partner who is a great fit, who is capable of moving the project forward independently—for me, this is just my experience—it would be impossible because I have not quit my day job. So that’s unbelievably important.
The other thing, to be able to contribute my fair share, I think there’s a lot of management stuff out there that’s helpful. I like David Allen’s [book] Getting Things Done (Viking, 2001), and the whole idea of chunking your time. You really have to exert discipline on your calendar, especially if you’re a busy clinical person, and block out time every single week in which you are completely free and devoted to your projects.
Leap of Courage
Subinoy Das, MD, chief medical officer with Tivic Health, first ventured into entrepreneurship as a consultant with Medtronic shortly after he finished fellowship. There, he worked on a biomaterial to be used as a sinus sealant. With an NIH grant at Ohio State University, he conducted research that became the groundwork for Sinu-Test, a test still in clinical testing that includes an optical reader and is designed to tell whether a sinus infection is viral or bacterial. He also works with the company VedaJag, which developed AGADA, a wound-healing product made of chitosan—a biomaterial made of insects’ and crustaceans’ exoskeletons that prevents bleeding and is highly anti-microbial. Tivic markets a microcurrent device for treating sinus and headache pain. Dr. Das also works with a company, along with two pediatric surgeons, on a disposable silicone mouth guard designed to reduce injury during tonsillectomy procedures.
ENTtoday: How do you know when an idea or a scientific finding is worth taking a shot at commercially?
Dr. Das: It really requires a leap of courage and a lot of passion that your idea is going to be helpful and valuable to society. You, by doing so, are taking tremendous risk and are going to be forgoing a lot of income for many, many years. It can’t be done as a financial decision because it doesn’t make sense from a risk perspective to do this for any financial reason. But, if you really believe that your idea might become very valuable to society and make medical care better, then every time is a good time to do it. And then you can work it around where you can find ways to support yourself financially while you work on this idea.
ENTtoday: How did you decide to leave academic medicine?
SD: It was a very difficult decision. It was coming at a time when I would be forgoing a significant amount of income, and what was helpful was that it occurred five to six years after I had left medical school. So, in some ways I was very concerned that I had paid off all of my medical school debt and I had paid off my house. My wife is a physician also, and we had paid off enough debt where my family—my two children at the time and my wife—could survive even if I was not making any income. That was a difficult choice, but I thought I would be much happier in trying to develop a medical device that could treat maybe millions of people as opposed to just solely working one patient at a time.
ENTtoday: You’ve said that in business ventures it’s easy to create a win–lose relationship, but the challenge is creating a win–win. How do you create this dynamic?
SD: There are a lot of situations where you can, for example, bill for your time in kind of a monopoly type of setting where either your patients or your business partners are forced to utilize you as a resource in a way that is very expensive to the patient and where you have asymmetric knowledge and you realize the value of what they’re paying for is not the value of what they’re getting. I would say that’s a win–lose situation.
Then there are lose–win situations where companies are exploiting you for your knowledge by asking you for your intellectual property—for free, basically. There are also lose–lose situations where you and business partners fight over equity or resources or who gets credit for a paper or who’s going to be right or wrong, and the two of you can’t come to an agreement, and as a result the relationship is destroyed.
The time commitment to many may seem insurmountable, but when we really work together in a team environment, it’s very doable on nights and weekends. —Peter Belafsky, MD, MPH, PhD
The win–win situations are really what you have to build on and continue to grow, where two people engage in an endeavor, and both people benefit from that engagement, and it makes both people stronger. It’s developing a way to share equity fairly between two partners or to make sure everybody gets the appropriate amount of credit when they work on a project, or everybody’s up front and everyone knows that the time that they’re spending, they’re all going to get something that gives everybody a return on investment.
Team Effort
Peter Belafsky, MD, MPH, PhD, director of the Center for Voice & Swallowing at the University of California, Davis, is chief medical officer with VisiTube, which is developing a way to use endoscopy to place feeding tubes more safely and prevent deaths from misplacement in the lungs. The company is also developing a pump to help patients with PEG tubes deliver nutrition to themselves more easily and discreetly. He is also a co-founder of Reflux Gourmet, which has developed an all-natural alginate product to prevent and help with symptoms of acid reflux. In that venture, he has partnered with Ken Frank, a chef and also a reflux patient, and Ramon Franco, MD.
ENTtoday: Would you have become involved in entrepreneurship if not for the personal clinical observations that you felt would really help patients?
Dr. Belafsky: There’s no way. My passion in life is to treat patients and improve their health, well-being, and quality of life, and I just feel very fortunate to be in a part of the world where innovation is encouraged and promoted and supported…. I’m at an institution in a part of the country that says, ‘What do you need to see your idea through to completion?’ ‘What can we do to help?’”
ENTtoday: How have you been able to balance your clinical work with your entrepreneurial projects?
PB: We have the world’s knowledge base at our fingertips, immediately available on our mobile devices. So all of the time that would be spent on acquiring knowledge is now freed up for us to pursue other projects. If I see something in the clinic for a patient I’m not sure of, I can research that on the Internet in three minutes—whereas my parents’ generation would be in the library trying to pull articles and figure out how to help this person. Really, for us to succeed, our generation and our kids’ generation, it’s all about innovation and working in teams. So we’ve been able to develop these teams, and when we work together, the individual work is dramatically amplified by the productivity of the team.
The time commitment to many may seem insurmountable, but when we really work together in a team environment, it’s very doable on nights and weekends.
ENTtoday: How do you go about assessing the risk–benefit in these kinds of projects? How do you know when it’s worth going for it?
PB: I think there are a couple ways to evaluate this. The first is, what’s the risk to the patient for not doing it? Is somebody else going to do this? With our feeding tube company, I mean literally there are four people dying every year at every major medical center because a feeding tube is put blindly into their lung, and nutrition is being administered through that. The risk to the patient if we do nothing is death. So I’ve been fighting like heck to get this device to market because we can save somebody’s husband or save somebody’s child.
With regard to finances, it’s really just a matter of what resources you can devote to this, and I think that’s just an individualized notion. I’ve taken money out of my retirement on both (VisiTube) projects and haven’t earned a penny from either. I luckily have been pretty diligent about saving for my children’s college funds, but my retirement is definitely a risk. You just have to have faith in your mission and your team.
ENTtoday: What are some factors that might work against pursuing an entrepreneurial venture?
PB: Innovation is, in general, a game of the young. As you get older, your creativity persists and can even become more creative, and you can teach and promote creativity as you get older. But experience breeds out risk. So people come a long way to see me to take care of their swallowing problem because of my experience. They know that they’re going to expect a certain outcome, and I know what works, I know what doesn’t work. That experience leads me to be risk averse. When you’re earlier in your career, you don’t know what works and what doesn’t work, and a crazy idea is only crazy until it works. So you’re much more likely to try new things earlier in your career. As you get older, you need to force yourself to continuously innovate, and not just reinvent yourself, but to continuously reinvent the healthcare you’re delivering to improve outcomes and improve health.
Just Say ‘Yes’
Thomas Carroll, MD, is director of the Brigham and Women’s Voice Program and is on the Scientific Advisory Board of Sofregen Medical, which has developed Silk Voice, a product that uses silk protein for vocal fold augmentation and recently gained FDA clearance. He connected with the company through basic science work he was conducting with scientists at Tufts University’s biomechanical engineering department. He also worked with Sofregen on a catheter-based delivery system, on which he shares the patent. The device, still in development, is designed to allow physicians to deliver injectables to the vocal fold through the working channel of a flexible laryngoscope, allowing one surgeon to perform procedures that otherwise require two people.
ENTtoday: How do you pursue ideas without knowing the end goal ahead of time?
Dr. Carroll: I think everybody’s ultimate goal is to make something that will benefit patients and other physicians. My personal take on it is that I really don’t know what is going to become of an idea or a product until it gets further down the line, and usually the ultimate decision by a company to continue a project is financial. And I’ve tried to—at least I hope I’ve gotten smarter over the years—[be able to say], ‘That will be great for about 20 people, but it’s never going to be something that would sell.’ But you have to think like that, unfortunately.
I know that any good idea can be the launching pad for another good idea, etc., and I hope that I still can put some mental energy into even smaller projects, knowing that they may not come to fruition just from a financial and marketing standpoint, but it may give me some room to think in a different way about another approach or another product or another idea.
I think the principle is learning that even if you have a great idea as an inventor or physician–scientist, it’s got to make money for a company, or it’s got to become a company that’s successful and there has to be market for it. In otolaryngology, it’s got to be something that’s universal to a lot of people who don’t already have it or use it, and there [has to be] room in the particular space.
With the silk product, for example, there are already good injectables out there that I use every day. We just are hoping to produce something that checks a few more boxes for the physician–user as well as for the patient.
If you’re given the opportunity to do something you’ve never done before and your personal knowledge can help in developing the product or idea, I would say ‘yes’ to the project. You never know what’s going
to work. —Thomas Carroll, MD
ENTtoday: If you had known at the beginning of the process what you know now, what would you have done differently?
TC: I think I would have been more on top of the patent for the material itself.… I probably could have done more to protect myself from that standpoint. But, in some ways, I don’t regret it because it really was a learning experience, and it was just a great opportunity for me to learn how entrepreneurship works.… As I went through the catheter development process, I was much more on top of that aspect of things.
ENTtoday: What’s the biggest hurdle you’ve had to overcome with Silk Voice?
TC: There was a slowdown for a period of time in terms of funding. Sofregen was waiting for some capital, and they had to do their part to ensure their success.
Honestly, I’m more worried about the next steps, which are more on me in some ways, because I feel like the application of material in humans is going to be the biggest hurdle. We have FDA clearance, but that doesn’t mean it’s going to be a successful product necessarily. It means that we have to see safety and efficacy in humans; then we have to see how long the product effects last in humans. Hopefully, the catheter that I helped develop really does what we want it to do. There are highly respected colleagues of mine coming out of the woodwork saying, ‘You know I tried something like this years ago, and I don’t think it’s going to work as well as you think it will.’ It just puts a little bit of doubt out there that it’s not going to do all that we want it to do despite improvements in older designs. I just stay positive and continue to work toward a better design.
ENTtoday: What’s the most strategic point in a career to try a venture like yours?
TC: No matter when you jump in, it’s going to be a learning process because you’ve never done it before. And I decided to just jump in right at the beginning.
I don’t regret much of starting early because I’ve learned some of the terminology and what the entrepreneur and the inventor side, as opposed to the physicians, are going to deal with or have questions about. So my personal take is: Go for it. If you’re given the opportunity to do something you’ve never done before and your personal knowledge can help in developing the product or idea, I would say ‘yes’ to the project. You never know what’s going to work.
Thomas R. Collins is a freelance medical writer based in Florida.