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Innovation journey in ophthalmology takes many pathways
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Taking an idea from inception to completion as a product or device sold on the ophthalmology market can follow many different paths. No one path is correct, but burgeoning innovators need to realize which one is appropriate for them and their goals for the idea.
The innovation process can take many pathways depending on the idea and how it will affect the field of ophthalmology, according to Malik Y. Kahook, MD, an OSN Glaucoma Board Member who holds more than 20 granted patents for medical devices.
Exploring an unmet need identified in clinic or surgery is the originating moment for Kahook’s developmental process. An idea that appears interesting on an intellectual level and, more importantly, is a specific health care need that can improve patient care outcomes can be the seed for a successful device, he said.
Once a new area for exploration is identified, Kahook will discuss the idea with colleagues he has worked with over the past 15 years at the University of Colorado.
“Speaking freely with trusted collaborators can help me tease out what might be an idea with legs vs. an idea that appeared interesting while in the heat of clinical or surgical care but that lacks potential for financing and marketability. Identifying a ‘cool idea’ vs. something that will eventually reach patients is one of the biggest early steps. The inventor mind frame by nature is geared toward running an idea down to proof of concept and may be clouded by the pursuit of the novel rather than the practical. This is why early conversations with close friends can help check my enthusiasm and force me to convey ideas in a way that gives me an early ‘go, no-go’ signal,” he said.
Source: Malik Y. Kahook, MD
Protecting intellectual property
For most ideas or inventions to have value, especially in health sciences, they must have intellectual property protection, OSN Retina/Vitreous Board Member and managing director of Clarus LLC Emmett T. Cunningham Jr., MD, PhD, MPH, said.
“The first thing when you have an idea is to think about working with an attorney or your intellectual property office at your institution if you’re in academics to protect that intellectual property,” Cunningham said.
Previously, if an inventor documented an idea in a notebook and could prove a date of conception, the idea was credited to him or her. Now, the process is “first to file,” Cunningham said, so ownership depends on when the idea is filed at a patent office.
It is also important to remember that an idea can only be patented if it has not been publicly disclosed. If an inventor presents the idea in a paper or presentation, it can no longer be patented, Cunningham said.
“Once you have filed an intellectual property, in the U.S. at a minimum, but some people would say in the U.S. and the major global markets, then you can decide how to advance it,” he said.
Vetting ideas
Vetting an idea is an important early process that can garner invaluable direction for the product, Gary N. Wörtz, MD, OSN Technology Board Member and chief medical officer of Omega Ophthalmics, said.
Before discussing the product with colleagues, Wörtz said creating a nondisclosure agreement is a necessity to protect an idea. After he created a nondisclosure agreement, Wörtz discussed his idea for a new IOL with well-established key opinion leaders in ophthalmology, Stephen Slade, MD, William B. Trattler, MD, George O. Waring IV, MD, FACS, and Richard L. Lindstrom, MD, to decide if the product had merit.
All potential ideas should also be looked at through the “real, win, worth it” framework of innovation, he said, a scenario that can force an inventor to accurately assess a potential need for a new device or idea.
“MIT has a framework that they call ‘real, win, worth it’ for evaluating ideas. There are basically three hurdles any good idea has to get through for MIT to decide to move forward on an innovative new idea. It’s very simple. Does this solution solve a real problem? Is there a real need in the world for whatever this solution is, or is it an invention looking for a problem? It has to solve a true need in the marketplace. The second hurdle is, can you win? Just because you developed a great idea, do you have a team of people surrounding this idea that can take the project from start to finish and get through the requisite challenges that will be presented? That is a very important piece of it,” he said.
Does the potential product have a market and a use in the field? A product needs to post enough of a return on investment to justify the time and effort it will take to develop, Wörtz said.
“You don’t want to create the world’s most innovative trombone oil because there isn’t much of a potential market even though it may be a great product and you have a great team. If the potential market is for high-end trombone players, you’re probably not going to make a lot of money on that innovation,” he said.
Pathways to completion
Once the idea is vetted and intellectual property protection has been achieved, the inventor needs to decide on how to advance it. For his new IOL, which would later become the Gemini Refractive Capsule, Wörtz chose to create his own company, Omega Ophthalmics, in 2013.
There are several alternative pathways an entrepreneur can take to realize the creation of their idea, Cunningham said.
“That can be anywhere from selling that intellectual property as it stands, which is difficult. If it’s valuable or useful, you might be able to do that, but it’s hard. Or you can advance it to a prototype or advance it to a lead compound in the case of drugs, so you can move from there. You can sell the intellectual property, you can advance to a prototype and sell it there, advance it into human clinical studies proof of concept and sell it there, or advance it then to registration trials and sell it there, or you can commercialize it and sell it there, or you can commercialize it and keep it going,” he said.
An ophthalmic tool or instrument can take 1 year of development and $500,000 or less in funding to bring to market. A 510(k) device can take 3 to 5 years and $5 million to $50 million to develop, and a brand new device or drug can take between 5 and 10 years and $50 million to $200 million to develop, Cunningham said.
“It really depends on how much bandwidth the inventor or entrepreneur has, how much interest they have. If you’re a full-time vitreoretinal surgeon or a cataract surgeon, it’s very hard to develop a company. You can work with professionals to do that. You can be a contributing co-founder, but even that takes time and some amount of focus. The amount of time and focus you’re willing to contribute to the enterprise really determines whether you sell early, in the middle of that arc or later,” he said.
Academia as a path
Academia offers its own pathway that allows a clinician or educator the opportunity to develop an idea while maintaining time in education or seeing patients in clinic, Mark S. Humayun, MD, PhD, a professor of ophthalmology at USC Roski Eye Institute and a National Medal of Technology and Innovation winner, said.
Humayun, the inventor of the Argus II (Second Sight) retinal implant and holder of more than 110 patents, noted that the three most important aspects any potential developer needs to have are time to dedicate to a project, perseverance if things do not go according to plan, and an idea that will “make a difference in a patient’s life.”
“Medical devices, medical drugs, biologics — this is not a cell phone industry. We live in a very regulated space, and you have to have the funds to get through the regulatory approval,” Humayun said. “But if you have the time, the patient’s best interest and perseverance, then you can get up and do it again if things don’t go right. These are the things that I’ve found out are most important.”
Innovation in the academic setting allows Humayun to remain in the classroom to teach residents and fellows while also allowing him to remain in clinic and see patients, all while spending time in research and development for new design ideas. However, the academic setting renders less funding for projects.
“You don’t have $2 million or $3 million per project. You have a few thousand dollars per project. You have to de-risk that project by getting grants from the federal government, state government or foundations,” he said, adding that grant funding plays a large role in de-risking an idea.
By procuring funding, an innovator can further develop an idea to the point at which additional strategic partners or a health care investment firm can be brought for the next stage of gathering human clinical data, he said.
An academic setting can be used to de-risk projects and get the initial proof of science, but often someone in the venture capital world or a strategic partner is needed to arrive at the ultimate proof of concept, Humayun said.
“That’s where things really transition. You can do a lot of things in academia where you can develop things on the benchtop or preclinically, but to step into that human testing phase, that brings in the regulatory aspects and other things. You need to make the product such that it is done in accordance with rules and regulations for human use,” he said.
Know what you have
Physicians with ideas are common, but those who act on these ideas are uncommon, OSN Refractive Surgery Section Editor John P. Berdahl, MD, said. Berdahl is co-founder of Equinox and co-inventor of the MKO Melt (midazolam, ketamine and ondansetron, Imprimis Pharmaceuticals).
“That’s because it’s so much time and so much risk, so if you have a really big idea, you want to take an approach to get intellectual property around it, partner with people who understand the business side, and secure a passable structure where you hopefully won’t run out of money when you meet milestones. That’s not natural for doctors to do. It’s a skill set we don’t have naturally. It can be taught, but it’s work. You go after it, try to find a way to get to the next milestone honestly, look at the data and let the data guide you,” Berdahl said.
Berdahl created Equinox LLC, a medical device company centered around Balance Goggles, a product he and several colleagues designed to add a vacuum around the eye to normalize the pressure differential in optic nerve diseases. The product was robust enough to center a company around, Berdahl said, while the MKO Melt, a sublingual sedative for cataract surgery, was more appropriate to sell to an already established pharmaceutical company.
“It wasn’t easy, but it was easier than starting your own company. Imprimis formulated it, we tried it, liked it and they commercialized it, and now it’s being used frequently. That being combined with the opioid crisis and people looking for non-opioid ways to sedate patients, it’s really gained a lot of traction. It makes the flow easier for patient and doctors, and they don’t have to get an IV stick. Ultimately, there is always more work than you think there’s going to be when you undertake any project, but partnering with a company that can do the marketing, the distribution, the sales and the manufacturing is a way easier approach than starting a company from scratch,” he said.
Realizing the limitations of an idea is important, Berdahl said. Is an idea a new feature, a new product or the cornerstone of a potential company?
Most products cannot support a stand-alone company. If a product fits into an existing company portfolio, Berdahl suggested trying to partner with that company as early as possible.
Form partnerships
Kahook said it was evident that the appropriate pathway for the Kahook Dual Blade (New World Medical) was to partner with an established company. The concept was first born on the campus of the University of Colorado, and it was clear that it was a product concept and not a startup company concept.
Kahook sought a partnership with New World Medical, and the device became an important part of its portfolio since launching in 2015.
ClarVista Medical, a startup based on novel IOL patents licensed from the University of Colorado, was clearly a stand-alone company from the start, Kahook said.
“The platform technology was robust and sustainable from a fundraising standpoint. An entire team was built around ClarVista, eventually leading to a novel platform with compelling clinical data and subsequent exit to a strategic acquirer. It is important to know where a particular device is headed with formal mapping of the pathway so that appropriate decisions can be made to ensure success,” he said.
Choose like-minded partners
Besides understanding the best pathway to bring an idea to fruition, the mechanics of patenting and the manufacture of devices, Kahook also emphasized the importance of working with like-minded people who focus on treating patients and have a passion for making a real difference in treating disease.
“I have been lucky to work with some great people but have also worked with others who were more focused on aspects not aligned with my own values. Cultivating relationships with colleagues who have worked with me on several projects throughout the years has been one of the most rewarding aspects of my life in translational research. In many cases, the same team members have worked together on multiple projects, and we gain team members along the way. It is very much like a family atmosphere and makes work very enjoyable,” he said. – by Robert Linnehan
- References:
- Acquisition of ClarVista Medical. Clinical stage intraocular lens spinout company acquired by Alcon. http://www.ucdenver.edu/anschutz/about/cuinnovations/MID/Pages/Acquisition-of-ClarVista-Medical.aspx. Published Dec. 15, 2017. Accessed March. 22, 2018.
- Cunningham ET. Helpful tips for the aspiring entrepreneur – a venture capital perspective. Presented at: American Academy of Ophthalmology meeting. Oct. 18 to 21, 2014; Chicago.
- Equinox Balance Goggles: The effects of local orbital pressure changes on intraocular pressure. http://nsbri.org/researches/equinox-balance-goggles-the-effects-of-local-orbital-pressure-changes-on-intraocular-pressure/. Accessed March 27, 2018.
- Masatani M. Mark Humayun receives the National Medal from President Obama. https://keck.usc.edu/mark-humayun-receives-the-national-medal-from-president-obama/. Accessed March 22, 2018.
- Omega Ophthalmics receives issuance of 2nd continuation alpha patent from USPTO. https://www.omegaophthalmics.com/omega-receives-issuance-2nd-continuation-alpha-patent/#more-274. Published Sept. 13, 2016. Accessed March 23, 2018.
- For more information:
- John P. Berdahl, MD, can be reached at Vance Thompson Vision, 3101 W. 57th St., Sioux Falls SD 57108; email: john.berdahl@vancethompsonvision.com.
- Emmett T. Cunningham Jr., MD, PhD, MPH, can be reached at Clarus Ventures, 601 Gateway Blvd., Suite 1270, South San Francisco, CA 94080; email: ecunningham@clarusfunds.com.
- Mark S. Humayun, MD, PhD, can be reached at USC Roski Eye Institute, 1450 San Pablo St., 4th Floor, Los Angeles, CA 90033; email: humayun@med.usc.edu.
- Malik Y. Kahook, MD, can be reached at University of Colorado, Anschutz Medical Campus, Department of Ophthalmology, 1675 Aurora Court, Aurora, CO 80045; email: malik.kahook@ucdenver.edu.
- Gary N. Wörtz, MD, can be reached at Commonwealth Eye Surgery, 2353 Alexandria Drive, Suite 260, Lexington, KY 40504; 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. Cunningham reports he represents Clarus on the board of directors of Annexon Biosciences, Graybug Vision, Restoration Robotics and SFJ Pharmaceuticals Group; is a board observer for Lumos Pharma; and is on the scientific advisory board of Aerie Pharmaceuticals. Humayun reports no relevant financial disclosures. Kahook reports he is a consultant with Alcon, Allergan, New World Medical and Equinox; has ownership interest in Ivantis; and has patent royalty interests in J&J Vision, New World Medical, Alcon and Iantech Medical. Wörtz reports he is the chief medical officer and general partner of Omega Ophthalmics.
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