Inventions In Retina
At the 2015 meeting of the Vit-Buckle Society, I had the pleasure of hosting a roundtable discussion titled “Bench to Bedside.” Steve Charles, MD; Samir Patel, MD; and David N. Zacks, MD, PhD, all of whom are leaders in the fields of innovation and invention, discussed how young retina doctors interested in product development can maximize the potential of their inventions.
The Vit-Buckle Society’s outside-the-box approach to retina meetings mirrors the inventive thinking of leaders in retina responsible for many innovations. The future of retina—that is, the young retina doctors at the forefront of launching our field into the next wave of breakthrough technologies—relies on the wisdom of experienced retina innovators. Surely those future leaders can glean something from this discussion among current leaders.
—Derek Kunimoto, MD, JD
Derek Kunimoto, MD, JD: Patenting a product is an important step in protecting intellectual property. Dr. Charles, what challenges might someone encounter when trying to patent a product?
Steve Charles, MD: I see a couple of problems with patents. One is failure to find patent lawyers who specialize in your area to draft and defend the patent. There’s no such thing as a family practitioner or a primary care doctor of intellectual property. Very likely, any product worth patenting in a field as narrow as retina is so technically complex that an enormous amount of expertise is required by the US Patent and Trademark Office to understand the product. After all, if the product is not technically complex, it likely is not worth patenting, and it certainly is not marketable or useful. Hiring a firm to thoroughly understand your product will always be expensive, and the likelihood of failure is high even in the best of circumstances. If you are going to spend money, you may as well do so at a firm with a high level of expertise in the field in question, even if they end up being the most expensive option.
Dr. Kunimoto: How do you find specialists other than by going to a big firm with a large number of employees?
Dr. Charles: You have to do a lot of research. Part of the process involves looking at the credentials of employees at a firm. At one patent law firm, we found a patent lawyer with a PhD in optical science. Credentials aren’t everything, though: Trying to teach a PhD electrical engineer complex optical designs will prove frustrating.
Dr. Kunimoto: What role does money play in all of this?
Dr. Charles: A lot of this comes down to money. If you are not going to have enough money to defend a patent, it is a worthless patent. So many physicians have been granted patents that generated no revenue. A patent is not something to hang on your wall or put on your CV. Rather, it is an investment, and you’d better be ready to spend money to protect it.
Remember also to consider the international scope of your market when filing patents. If you choose not to file in Europe or Japan, you are forfeiting a large share of the market. Filing in those markets is an obvious (though expensive) way to ensure that your product is protected. You have to defend, and you have to maintain, patents. It is an extravagantly complex effort. But without intellectual property, what do you have to sell to interested people? What is the likelihood of going public? In medical devices, the likelihood is zero.
Dr. Kunimoto: What types of discipline are most important vis-à-vis the business of invention?
Samir Patel, MD: The importance of patent-related filing should be the first priority, followed closely by the discipline of writing a thoughtful and integrated business plan. I always remind myself that if a particular invention or innovation cannot be translated into a clinically meaningful impact, be cost-effective, and be differentiated from similar existing products, it is probably not worth the time, effort, or risk. The same can be said for a technology that doesn’t result in the alignment of interests of key relevant groups. These include the regulatory agencies, care providers, shareholders, and, most important, patients. But, if one can identify a product or technology that may successfully result in addressing these issues, coupled with the required passion and relentless drive to pursue it, you will likely be successful in the market.
Dr. Charles: I want to comment on your use of the word relentless, Dr. Patel. If you lack an appetite to work on your product during nights, holidays, and weekends, or lack the capacity to let people go and get new partners and raise money and talk to people you normally do not want to talk to, then your invention is unlikely to live up to its potential. The process involves an endless amount of energy. The process involves 16 to 18 hours a day on Christmas Eve and Christmas Day, writing documents, reviewing documents, working on materials that have to get out first thing in the morning. If you do this work casually, you will have casual results, which basically amounts to a failed product.
Dr. Kunimoto: Given the amount of time you must spend on this process, how flexible must you be?
Dr. Charles: I have made numerous business mistakes. However, I have always recovered. When things went wrong, instead of inventing an excuse such as, “I would have done this were it not for all of those stupid venture capitalists who don’t understand,” I said, “No, this needs to happen, and I will make it happen by figuring out another way.”
Let’s say you have an issue with funding. There are a variety of mechanisms for obtaining funding; government funding and university grants are two examples. You should use these sources even if they were not in your original plan. No matter what your plan, things will never go according to it, so you must keep fighting and adjusting. You must have a plan A, plan B, plan C, etc., and just keep pushing, pushing, pushing.
You must be willing to change gears and must recognize that you will eventually outgrow people. Also, you must know your strengths and weaknesses. I, for example, am clearly not a manager, and I have no business being a CEO. My VP of business development put me in that role for while, but it was not what I wanted, nor was it what I was good at. I am a chief scientist, not a manager. Many of my colleagues have made the transition from the science side to management or finance, but I did not. Although you have to be flexible with your business plans, you must do so within your limitations.
Dr. Kunimoto: Your point about flexibility is a good one, Dr. Charles. Finding a team whose strengths complement yours can be very important in the business development process. Dr. Zacks, can you speak about the importance of collaboration when it comes to business structures? Tell us about how you split the responsibilities based on skill set or experience.
David N. Zacks, MD, PhD: I am trained as a doctor and a scientist. I am not trained, however, in starting a company. For that, I rely on my team. Luck and a confluence of factors brought my business team together. I was fortunate to work at the University of Michigan; Ann Arbor has a rich history of pharmaceutical companies, meaning that many of the people in the city are qualified as scientists or business leaders in very specific spheres. Your business partners will introduce you to innovative ways of thinking. One of my partners, for example, has a PhD in electrophysiology, so he knows the eye. He helped me construct experiments and taught me how to think about the invention process in a fresh and exciting way.
Dr. Kunimoto: The space of innovation changes quickly, and in a field such as retina, where your competitors are highly trained, innovative thinkers, you need to find every advantage available to make your product successful. How do you find those advantages?
Dr. Charles: It is simple: You must beat your competition to market; first-mover advantage is critical. The company that first launches a product has über-advantage. This means that funding is critical. If you are underfunded, then you cannot move fast enough to beat your competition. Everything you can possibly do to expedite the time to market helps your advantage, and it is more useful to, say, secure funding than to stay up all night worrying about what other people are doing.
Dr. Patel: I have changed almost 180° on this topic. I used to be overly concerned about protecting intellectual capital. But I believe we live in a world of transparency and speed, and collaboration with key individuals with proper skill sets is critical. For example, the more transparent you are with the regulatory agencies, the quicker you can bring worthy products to the market and potentially in a more cost-effective manner.
Dr. Zacks: Just a quick comment about competition. My PhD advisor gave me advice early in my career: Find a subject on which you can read all the papers in one afternoon, and then spend the rest of your life writing the rest of the papers. I think that is a common theme in retina. If you are focusing on solid science, you are going to be so far ahead of the competition that you will be the first to market, thus giving yourself the greatest possible advantage.
Dr. Kunimoto: That’s a sound point, Dr. Zacks. In the end, business considerations aside, the science must always be first if a product is to have a reasonable chance at success. n
Steve Charles, MD, is founder of the Charles Retina Institute in Memphis, Tennessee, and is a clinical professor in the department of ophthalmology at the University of Tennessee College of Medicine. He is a consultant for Alcon Laboratories. Dr. Charles can be reached at firstname.lastname@example.org.
Derek Kunimoto, MD, JD, is a co-managing partner at Retinal Consultants of Arizona and a director at Scottsdale Eye Surgery Center in Scottsdale, Arizona. Dr. Kunimoto may be reached at email@example.com.
Samir Patel, MD, is the cofounder, president, and CEO of Ophthotech.
David N. Zacks, MD, PhD, is an associate professor of ophthalmology and visual sciences at the University of Michigan’s Kellogg Eye Center, Ann Arbor. Dr. Zacks may be reached at firstname.lastname@example.org.