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Ophthalmologist-entrepreneurs need a thick skin and plenty of patience to succeed
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Coming up with an idea is easy. Developing the idea into a product and full-fledged company is a difficult but ultimately rewarding process for ophthalmologists looking to branch out as entrepreneurs.
Every product or company starts out as a singular initial idea that someone chooses to either pursue or ignore, Gary N. Wörtz, MD, founder of Omega Ophthalmics, said.
Anyone can have an idea because ideas are easy, but to be willing to put in the hard work and focus on an end goal is ultimately what will determine the idea’s success, he said.
“If you have a great idea, recognize you are going to have to say ‘no’ to a lot of other good ideas that will come to your mind while you are developing this one. If you do not do that, it will be at the risk of this one actually making it. Turn off your innovative creativity for other things and put that on hold while you are developing that one idea,” Wörtz said.
Frustration begets progress
Wörtz developed, founded and currently leads Omega Ophthalmics as its chief medical officer. Wörtz and the company developed an IOL called the Omega Gemini Refractive Capsule, which is specifically designed to reduce variables that have hamstrung traditional IOL designs and ultimately improve outcomes in patients. The design of the lens is a departure from past IOLs and constitutes a new category that keeps the capsular bag open, according to Wörtz.
Image: Wortz GN
The genesis of the company, Wörtz said, started with a personal frustration that he was not doing well enough for his patients and the available technology did not support the outcomes he desired.
“The problem was, we had a difficult time estimating where the lens would sit inside the eye. Because of that, we had a lot of variability. I hated it. I hated walking into a room after a cataract surgery was done on a patient; all the measurements looked correct, the surgery went beautifully, but the patient did not have the outcomes that they wanted or I wanted,” Wörtz said.
Bet on yourself
That frustration evolved into an idea for a new IOL technology that Wörtz researched and designed himself and, most importantly, found had not yet been patented by another ophthalmologist or company.
Wörtz decided to make a “$10,000 bet” on himself and register the intellectual property as his own.
“I went ahead, self-funded the project and got a patent written. That took some time — it actually takes years to hear back. After I had my patent submitted, that is when I had the patent attorneys draw up a non-disclosure form I could use when I was trying to talk to others about it. I was 3 years out of residency. I needed folks around this idea that could give me perspective from years and decades of product development. I knew that I did not have the skill set or experience to develop this all by myself,” he said.
Collaboration is key
Rarely can one do everything himself or herself, John Berdahl, MD, founder of Equinox and co-developer of Imprimis Pharmaceuticals’ MKO Melt, told Ocular Surgery News. Fostering an open attitude of collaboration with peers, mentors and colleagues is a crucial aspect of getting your idea off the ground and onto the market.
Berdahl said he began to formulate an idea for a new product to better regulate the pressure inside of the eye after his research led him to conclude that glaucoma is a “two-pressure disease.”
“We studied it and found it is not really the absolute pressure inside the eye that matters, but the balance between eye pressure and CSF pressure that matters. With that fundamental new belief that glaucoma is a two-pressure disease, we started to think about how could we use that new knowledge to help our patients,” he said.
Protect intellectual property
Using his research, Berdahl collaborated with his colleagues and developed a specialized pair of goggles for patients to wear that would change the pressure in the eye but not the pressure applied to the brain. Equinox was born from this idea and this product, he said.
Sharing ideas with friends and colleagues, all while being mindful of intellectual property, helps one focus that initial idea and perhaps take it in directions not thought of before. Without collaborating with his mentors and colleagues, Berdahl said Equinox would not have been possible.
“You want to do as much as you are capable of by yourself with some advice by key colleagues. Do you really love this enough? Do you really believe in this and want to put your heart and soul, time and treasure, into it? Once you have convinced yourself that it is no longer an idea but it is a viable product, at that point there is no way you can go forward on your own. I do not know if there is anybody that has all of the skills and bandwidth necessary to do so. You start working with consultants and engineers and start moving the project forward. The moment you get that first person, you start to have a company that needs to be managed,” Berdahl said.
Do your research
Once a physician has an idea, it is his or her responsibility to complete the research to see if the product is already on the market or if the technology has been patented by another party, Malik Y. Kahook, MD, an OSN Glaucoma Board Member who has filed more than 40 patents for medical devices, said.
When first developing the Harmoni modular IOL (ClarVista Medical), Kahook said he came up with the two-piece design for the lens, sketched the concept and completed a patent review to explore the novelty of the idea.
“The patent search is an important part of the process in the early phases. Any physician can do this by looking at the [United States Patent and Trademark Office] portals or even Google patents. Once I felt the concept was truly novel, I partnered with a team of engineers and medical device professionals at Prospex, which is a medical device incubator. We were able to refine the concept and obtain funding to create ClarVista Medical, which is now a commercial-stage company with hundreds of implants globally,” he said.
In addition to completing initial literature and patent searches, Kahook strongly suggested keeping detailed written records to refer back to when needed. If the concept can also be modeled, he suggested creating a rudimentary proof-of-concept device that the development team can use to refine future design iterations and to help communicate with potential investors.
Do not skimp on design
For those without engineering skills, Kahook said there are many contract manufacturer shops that can help an ophthalmologist sketch and create a simple model device. However, if this route is taken, it is important to sign a confidentiality agreement with the group.
“Also, file a provisional application to secure the novelty of the idea in a legal document. This starts the clock ticking toward the need to file for a patent but gives you further protection, and you can seek help in advancing your idea. Partner with colleagues who have the skill sets needed to further advance your idea. In the early stages, this might be as simple as hiring a manufacturing contractor and refining your concept, or you could partner with engineers and others at local universities or within your community. Networking is key to make sure you can find likeminded people or a manufacturing contractor that is responsive and professional,” he said.
Bring in those with experience
Speaking with a mentor and bringing in others with experience in the business world are key to getting a company off the ground, John A. Hovanesian, MD, FACS, OSN Cataract Surgery Section Editor and founder of MDbackline, said.
Nobody is an expert in all areas, so bringing in people who know how to launch a business is the perfect starting point when an idea or product concept is thought to be marketable, according to Hovanesian.
“It is always good to start with good advice from smart people. I spoke to folks I knew and trusted in the industry, with other physicians, patients, those who are forward-thinking, smart people. How would this work best for you? I got a lot of great advice with how to help shape my thinking and form my product. From there it was a matter of finding the right people, and I am really lucky to have been connected with successful developers to write the software and successful business development people,” he said.
The website MDbackline went online in 2013 with a beta version of its product and became fully functional almost a year later. The website’s cloud-based software utilizes a patent-pending algorithm to analyze patient experiences to streamline follow-up care, increase patient safety and improve business performance, he said.
Know when to bring in capital
Hovanesian said the initial idea for the software came to him in 2010, but it took several years of development to bring the site to fruition. Now, the website is connected to 125 doctors and has been installed in five ophthalmology practices, he said.
“It takes capital. It takes money to pay people. For us, we were fortunate because the information our system develops is of great interest for research. The drug and medical device industry has conducted studies with us for their products, and that has generated revenue to support our development and the people that work with us completely to date. We have not had to accept any investments from the outside so far. But now we are at a stage where we have a working product, a growing customer base that we need to scale more quickly, and that will require capital investment to take that leap. We are ready for capital now,” he said.
Another path to the market
Developing a medical product or new company from scratch can take years. However, there are certain strategies and different routes that can advance the process if an ophthalmologist is willing to partner with a company and share the idea. William F. Wiley, MD, a co-developer of MKO Melt and developer of the LessDrops formulations for cataract surgery, worked with Imprimis Pharmaceuticals to develop his ideas and get them to market faster than by doing it alone.
Wiley said he was inspired by Imprimis Pharmaceuticals’ concept of DropLess surgery, which utilizes no eye drops during cataract surgery, to develop a triple combination eye drop to reduce the number of drops patients need during cataract surgery.
“I met with Imprimis and wanted to develop something similar to DropLess, providing something easier and more affordable for patients. I worked with Imprimis to take the three most common medications that are used around cataract surgery and combine them together for one compounded medication,” he said.
Wiley said he signed a non-disclosure agreement with Imprimis to design and develop the product and to determine the best formulation.
“To get a triple combination drop approved by the FDA is very hard. A double combination is almost never approved. You have to show efficacy better than the individual drops alone; it is hard to do that when it is the same medication. But with a compounding company you can do that relatively straightforward,” he said.
Because of his relationship with Imprimis, Wiley suggested going to the company first when he and Berdahl were shopping their idea for MKO Melt. Berdahl was successfully using sublingual Versed (midazolam, Roche), while Wiley was using ketamine with a midazolam intravenous formulation for anesthesia during cataract surgery.
The two came up with a formulation to combine ketamine and midazolam in a sublingual form, Wiley said, and they needed a way to bring it to market, leading them to Imprimis.
Wiley and Berdahl, along with Imprimis, successfully developed the sublingual sedative for cataract surgery and brought it to market faster than they would have been able to do without the company.
“We have a patent that is being filed for that medication. It is a win for Imprimis because they will do well if it succeeds nationwide, and contractually we have worked out a favorable agreement for those of us that helped develop it. What is nice with a company like Imprimis, a compounding pharmaceutical company, it is much easier to come up with an idea, pitch an idea, and develop a product and get it to market, or at least to patient use and patient care, very quickly,” Wiley said.
If the two had gone a traditional route to develop the product and get it approved by the FDA, it would have taken years and millions of dollars, Wiley said.
“I think it is a 5- to 7-year cycle. It takes $200 million to $300 million to get a product from point A to point B,” he said.
Expect frustrations
Despite which path an ophthalmologist takes to get his or her product or company off the ground, the process will certainly “test your mettle,” Wörtz said.
Wörtz advised potential entrepreneurs to resist the urge to move on to something else while developing the original idea.
“Turn off your innovative creativity for other things. Put that on hold while you’re developing that one thing,” he said. “Be careful, protect your ideas, but at the same time do not be so overly cautious that you are not willing to speak to people who can help forward your ideas and help connect you with others who can actually help you make that idea happen. It is a delicate dance.” – by Robert Linnehan
- References:
- Getting started with patents. United States Patent and Trademark Office. http://www.uspto.gov/patent.
- Harmoni modular IOL. ClarVista Medical. http://www.clarvistamedical.com/harmoni.htm.
- MKO Melt (midazolam/ketamine HCI/ondansetron), lemon. Imprimis Rx. http://www.imprimisrx.com/formulation/midazolamketamine-hclondansetron-lemon-controlled/.
- The Omega lens. Omega Ophthalmics. http://omegaophthalmics.com/lens.
- For more information:
- John Berdahl, MD, can be reached at Vance Thompson Vision, 3101 W. 57th St., Sioux Falls, SD 57108; email: johnberdahl@gmail.com.
- John A. Hovanesian, MD, FACS, can be reached at Harvard Eye Associates, 24401 Calle De La Louisa, Suite 300, Laguna Hills, CA 92653; email: drhovanesian@harvardeye.com.
- Malik Y. Kahook, MD, can be reached at Department of Ophthalmology, University of Colorado School of Medicine, Rocky Mountain Lions Eye Institute, 1675 Aurora Court, P.O. Box 6510, Aurora, CO 80045; email: malik.kahook@ucdenver.edu.
- William F. Wiley, MD, can be reached at Cleveland Eye Clinic, 2740 Carnegie Ave., Cleveland, OH 44115; email: wiley@cle2020.com.
- Gary N. Wörtz, MD, can be reached at Omega Ophthalmics, 333 W. Vine St., Suite 1550, Lexington, KY 40507; email: 2020md@gmail.com.
Disclosures: Berdahl reports he is the founder, CEO and a board member of Equinox LLC, and a consultant with Imprimis and Ocular Surgical Data, LLC. Hovanesian reports he is the founder and has an equity interest in MDbackline. Kahook reports he is a consultant with Alcon, Allergan, ClarVista Medical, New World Medical, Shire and ForSight Vision5, and he has patent interests in Abbott Medical Optics, New World Medical, ClarVista Medical, ShapeTech and Mile High Ophthalmics. Wiley reports he has financial interests in Imprimis as a consultant, has license agreements with LessDrops and MKO Melt, and is a consultant for Bausch + Lomb. Wörtz reports he is the co-majority shareholder of Omega Ophthalmics.
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