Support needed for clinician innovators
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Roy Rubinfeld’s description of his experience as a clinician innovator is typical of those who attempt to bring a new drug, device or diagnostic from the bench to the bedside.
I was a small part of Roy’s journey in the early days of CXLO, and our group of corneal surgeons at Minnesota Eye Consultants participated in the CXLUSA epithelium-on corneal cross-linking for progressive keratoconus clinical trial. Our results were excellent, and we look forward to seeing his innovation, now advancing through FDA clinical trials under the direction of the team at Epion Therapeutics, navigate the daunting and expensive pathway to a marketed product in the United States and become available to our patients.
I am a passionate supporter of investment, innovation and education in eye care and will share a few thoughts. Many of the great innovations in ophthalmology have originated in the minds of practicing clinicians and surgeons, both academic center-based and private practitioners. Disruptive innovations conceptualized by practicing ophthalmologists that have changed the course of our field include phacoemulsification, IOLs, laser therapy for glaucoma and retinal diseases, laser corneal refractive surgery, femtosecond laser-assisted cataract surgery, minimally invasive glaucoma surgery and anti-VEGF therapy for retinal diseases, to name a few.
A practicing ophthalmologist’s primary duty is to deliver quality, compassionate, cost-effective care to preserve, restore and enhance their patients’ vision. I believe there is also a duty to recognize our patients’ unmet needs and develop or encourage development of useful solutions. Once a new treatment or diagnostic device is developed, we who helped develop it and know the most about it also have a duty to teach our peers how to properly employ these innovations to achieve maximum benefit for patients, eye care professionals and society.
Innovation is not just an idea — it is a process that results in the creation of something new. Research is not innovation. Research applied to an unmet need that results in something clinically useful is innovation. The distance between research and innovation is called the “translational gap.” The innovation cycle is what takes ideas from the research bench to the clinical bedside. Innovation can be disruptive or incremental. Disruptive innovations induce change that significantly modifies how eye care is delivered and can topple current practice or industry leaders and create new ones.
For the innovation cycle to work its magic, there must be investment of human and financial capital. Usually, the cost and time required are far greater than initially expected. For this reason, careful thought is required before investing the time and money required to innovate. The innovation worth pursuing must meet many criteria. These include targeting an unmet or poorly met clinical need, a commercial market size that is adequate, access to a delivery channel, IP or proprietary know-how that creates a protective moat and stifles competition, access to quality manufacturing at a reasonable price, minimal current competition, finding an industry partner or recruiting the talent to go it alone, finding investors, a regulatory barrier that is surmountable, and a probable exit strategy through sale to a strategic or an initial public offering so that investors and innovators can monetize their efforts.
Once initiated, the innovation cycle advances from an idea to laboratory bench or animal testing. There are usually many early failures that result in learnings that require pivots, persistence, perseverance and patience to overcome. Eventually, clinical trials are performed that, if properly conducted, can lead to regulatory approval. The entire process can extend for a decade or more. Then, even if a product is approved for marketing, it must complete a successful commercial launch and achieve reimbursement, which can cost many more millions of dollars and add another 5 to 6 years to the process. Only 10% to 15% of innovations that are initially funded eventually achieve regulatory approval, and many of them are not commercially successful in the marketplace. Statistically, it is a daunting task to commit to the development and commercialization of an innovation. Fortunately, ophthalmology still supports and rewards innovation, attracting entrepreneurs and investors including angel investing individuals, venture capital firms, private equity firms, established strategic companies and government funding agencies such as the National Institutes of Health/National Eye Institute and Department of Defense.
Ophthalmology has produced some of the leading clinician innovators in all of medicine, generating great value for patients, eye care professionals and society. Many of our innovators have been disparaged and discouraged by their colleagues during their journey through the innovation cycle. At present, there are unprecedented and increasing barriers to innovation, and I encourage all of us to be thoughtful and support our colleagues who commit to develop a new drug, device or diagnostic and transform an idea into a technology or treatment that can benefit us all. The innovation cycle can only work its magic when properly supported.
- For more information:
- Richard L. Lindstrom, MD, can be reached at rllindstrom@mneye.com.
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