Successful innovators often become that way by first becoming careful witnesses in the clinic.

Innovators, at their essence, are problem solvers. An observant person, regardless of profession, sees the same issue come up time and again among his customers or patients. He recognizes that those customers would buy a product to satisfy that issue, so this observant individual devises a plan to bring that product or service to fruition. When that inchoate product is ready for public viewing, our observant individual might go to a financial professional, if necessary, who can help convert that idea into a sellable entity.

In our business, innovators have solved many issues. From Sir Harold Ridley to Jose I. Barraquer to Charles Kelman to Graham Barrett — and too many others to mention here — these innovators have advanced science, medicine and patient care, all in one.

Ophthalmologists are in a singular situation to become successful, patient-serving entrepreneurs. Most are astute business people, with a keen sense of how to advance a practice.

And the larger practices — I refer to them as academic private practices — are perfectly positioned to observe first-hand any unmet needs. Physicians can verify their observations with colleagues, and, should the innovation get to the point of a clinical trial, they have the patient base necessary for enrollment.

But let’s step back a bit.

THE INNOVATION WAVE

Any innovation will need money for fulfillment to market, and ophthalmologists today have plenty of opportunity in that area. Venture capital investing in the ophthalmic sector was minimal until the late 1990s, which, not coincidentally, came a few years after the seminal Science paper that introduced the world to OCT.¹

We’ve seen an acceleration of venture investments this decade in the ophthalmic sector.

Since 1999, venture capital investments have helped more than 47 ophthalmic start-ups. A handful of organizations dedicated to financially helping those whose ideas hold promise have also sprung up in the last few years.

Between 2012 and 2018, the worldwide ophthalmic device market was expected to have a market share of between 5% and 9%, and sales growth (CAGR) of 5.5% to 5.9%. While its market share was smaller, its sales growth was larger than any other of the medtech categories, including in vitro diagnostics. In the 2015-2022 analysis, ophthalmics drops slightly in market share but rises slightly, 5.7% to 6.2%, in sales growth.²

TIME THIEF

This is what you are facing.

After you have made your critical observations, developed the invention and produced a product development plan, then comes animal experimentation, if needed. You will need the FDA’s approval for this preclinical experimentation. Be prepared for endpoint failurs, and be prepared for FDA rejection, regardless of the preclinical outcomes.

If you get past the preclinical and move to phase 1, your life will not be your own for a long time. How long? Start to finish of device/drug development, eight to 15 years. How much money? The low end for a device is $50 million, high is $150 million. For drugs, low ball is $.5 billion.

OTHER POINTS TO CONSIDER

It certainly saves you interest if friends and family can lend you the money for your project and you prefer to go that financial route, but it’s always risky on a personal front. The one thing you must do is protect your idea from others: either obtain a patent or at least register the idea.

And, don’t think you can get your idea off the ground without help. Contract research organizations and other professionals trained in running clinical trials are invaluable. And so are good, like-minded friends. Call them. OM

REFERENCES

1. Huang D, Swanson EA, Lin CP, et al. Optical Coherence Tomography. Science. 1991; Nov 22; 254(5035):1178-1181.
2. EvaluateMedTech. http://info.evaluategroup.com/rs/607-YGS-364/images/mt-wp16.pdf . Last accessed Nov. 15, 2017.

Richard L. Lindstrom, MD, is founder and attending surgeon at Minnesota Eye Consultants. He is an adjunct professor emeritus at the University of Minnesota, Department of Ophthalmology, and a visiting professor at the University of California, Irvine, Gavin Herbert Eye Institute. He can be reached at rllindstrom@mneye.com.