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Business & Profession Business and Innovation, Comprehensive, Professional Development, Health Economics and Policy

ROI: Return on Innovation

Innovation is non-linear, experiential, elusive, difficult to teach didactically, and rarely meeting the ROI objectives of the aspiring investors and innovators. The cycle today from creative ideation, finding solutions, clinical validation, and ultimate commercialization can short-circuit at any point along the way and turn a setback into failure. But what I have learned is that breakdowns can be more important than incremental gains and learning from them – from the unexpected outlier or glitch – can turn a breakdown into a breakthrough, with the right team and the right attitude at the helm of the innovation  process. For the healthcare entrepreneurs and innovators, this can change not only the outcome, but the entire ROI – “return on investment” and “return on innovation.”

My beginnings
 

I started on the tracks of innovation early in my career, during my residency training, when I saw a new emerging problem in some of my cataract surgeries – post-LASIK patients undergoing cataract surgery a decade later had major post-surgical errors in their IOL power prediction. All of the conventional IOL power formulas failed in the setting of prior LASIK. This is when I came up with the idea of performing intraoperative biometry to calculate the IOL power and along with several colleagues and fellow resident surgeons, we conducted and published the first investigation of intraoperative biometry. I patented this innovation, which was later developed and commercialized by Wavetech and ultimately  acquired by Alcon. Almost a decade in the making and after more than US$50 million of venture investment, the technology, which had its fair share of breakdowns and near death experiences, made it through and is now being used in millions of patients worldwide.

My second idea – developed around the same time – was also influenced by cases I was seeing in the hospital where I did my training; this time – large numbers of glaucoma patients  who were often waiting for weeks to have their perimetry diagnostics done at the county hospital. Peter Pham – inventor and ophthalmologist – and I came up with a solution and developed the first virtual perimetry in ophthalmology in 2002 (two decades ago), which may have been one of the first virtual diagnostic medical devices. It had no hardware, and was an exponentially scalable, on-demand software-as-a-device application for remote monitoring and testing of visual function.

As both of those innovations were conceived when I was still in training, I make the point of telling my residents that they don’t have to focus solely on patient care, but they can start innovating early and come up with technologies that can transform that care in the future. I am currently mentoring a couple of innovators  who have had great ideas and are trying to turn them into reality by setting up new ventures.

The commercialization process
 

I started commercializing my innovations from just pursuing an idea and following a natural thread of speaking to people who could guide me through the process, assembling the right teams, and raising funds. I have compared starting a company to building a car: you need all elements to function properly independently – with different people having expertise in different fields – but you also need everything to work well together. When asked by other physicians who want to innovate about setting up a company, I try to make it clear that it isn’t a linear process, and it certainly isn’t easy – so sometimes licensing your idea may work better! However, I have found that people get so passionate about their ideas and products that they prefer to pursue the pathway of capitalization and venturization and set up their own companies. Unfortunately, most physicians don’t have the skills or experience to commercialize products or technologies. It’s also not easy to do it part time and combine it with a busy surgical or clinical practice; it’s often an all-consuming affair. In the past, and with simpler technologies, it was much easier, with no complicated research and development processes needed, and no requirements of clinical trials, but the process has changed a lot.

These days, to develop a new medical solution, you have to go through a very sophisticated cross-functional matrix process, taking people and resources into account. The process can last between five and 10 years, and cost millions. Doing that on your own from scratch and on a shoestring budget is almost impossible, and surrounding yourself with the right mentors is absolutely critical. There comes a point where you have to consider deploying capital, hiring regulatory and manufacturing experts. You have to be able to lead and manage people efficiently, and inspire them to follow a common goal, as they may be used to working for a big corporation, but you need to get the best out of them in a tiny start-up setting. You also have to be able to articulate your vision to “sell it” to investors.

Inspiring investors
 

I have learned that dealing with investors is like dealing with patients: like the patients, they have a real problem – how to put their money to work and achieve meaningful return, both financial and on the innovation curve. Doctors and innovators alike are the experts and the guides who know the technology inside out, who understand the science, and who can explain it well. Similar to the patient care paradigm, when an intervention is at stake, one has to be transparent with the risks involved and hold their hand through the journey. You need to develop an almost paternalistic approach, where you address their questions and concerns, articulate the risk and provide a mitigation plan. Remember that most investors understand that returns involve risks, especially with medical innovation. They want to see that we as innovators understand this as well and collateralize our passion for innovation with a thoughtful risk mitigation plan and calculated risk taking. Investors usually are passionate for healthcare and life sciences innovations, and they do get more satisfaction from a successful life or sight saving technology than a strip mall project in the latest opportunity zone.

It all becomes easier once you have developed a track record of successful projects. If you are a new innovator who doesn’t yet have a proven track record, make sure you surround yourself with people who do – invite them to your board and get them involved in your vision. These are the people who can vouch for you.

Remember that succeeding at innovation also depends on where you are based. I immigrated to the US from Bulgaria, which opened a lot of possibilities for me. If I was an ophthalmologist in Bulgaria, I may have played it safe and just focused on clinical practice. If you’re in an environment that doesn’t support innovation and you are passionate about it, it may be worth considering a move.

Failing to succeed – or succeeding to fail?
 

It is so easy for a success to become a failure, and vice versa. I see almost every failure as a success in the making, and most finished products have once been a string of failures that have been overcome, as developing new technologies is anything but straightforward. What I tend to remember about a commercialized idea is not the day I knew it succeeded, but all the hard work throughout the years previous to that.

A good question for a budding innovator to ask is: “What does success mean?” For me – speaking as a clinician – it’s less about the return on investment, and more about the return on innovation. The sense of achievement that comes with seeing a specific product or technology that you helped develop used by your peers is unparalleled. Recently, my team went to Panama on a humanitarian mission with SEE International. We did around 200 cataract surgeries and donated miLOOPs – lens fragmentation devices I developed that got acquired by ZEISS – to the local surgical team. They told us they couldn’t do without them; they use them for almost every case.

Twists and turns
 

Some innovations – and CyPass may serve as a good example here – bring a great return on investment and financial success for investors, meaning high financial ROI, but if the technology does not ultimately serve patients to advance care – the return on innovation may not match the financial one. Innovation for the CyPass® product took in total more than 100+ investigator years to bring through the R&D process, and thousands of patient years when you consider clinical trial participation. But it is not all for naught – we learned about the clinical performance and pathophysiology of suprachoroidal innovation and we are now smarter and more prepared as we approach the space with a new micro-interventional technology for biostenting – the first 100 percent bio-tissue, hardware-free stenting in medicine. We know that the suprachoroidal space hides enormous potential for IOP lowering that needs to be unlocked. And we need to do this for the sake of patients and for the sake of innovation itself.

Times and circumstances change and you may end up revisiting a failed project several years later. A good example of this is the virtual remote monitoring and perimetry testing for glaucoma that I mentioned earlier. When we developed it 20 years ago, we registered it with the FDA, but found that it wasn’t easy to commercialize it at the time; Medicare ruled that physicians weren’t allowed to bill for any diagnostic tests that weren’t conducted in a doctor’s office, with the patient physically present at the clinic. This killed any hope of securing reimbursement for our solution, and we shelved this technology for commercial use in the US, but we didn’t stop supporting it and even invented a second test for macular degeneration patients, which we deployed for global health outreach.

Fast forward to 2020 and the COVID-19 pandemic, and we began receiving a lot of calls from clinicians asking about the online perimetry and macular degeneration tests! Glaucoma and wet AMD patients were losing vision, and doctors didn’t know which patients to prioritize and see in person. Peter Pham and I decided to revisit this innovation, put the team back together, invested more funds, and – of course – it helped that reimbursement rules for telehealth changed. This is how KYS Vision (for “Keep Your Sight,” kysvision.com) came to life. It is now a platform for remote care and patient monitoring, with on-demand vision tests virtually delivered to practices and patients. It is capable of monitoring, screening, and testing millions of patients at the same time, in a scalable way.

My current projects
 

I have been working closely with a Dutch team developing a surgical ophthalmic robot that already has a CE Mark for use in the European Union, but we are working on getting it approved in the US, with clinical trials starting here. This project was recently acquired by ZEISS, and I look forward to bringing robotics to ocular surgery.

I am also involved with a new MIGS venture, Iantrek, which uses a micro interventional technology, creating bio tissue stents that use the suprachoroidal approach. We already have registered devices, which we have been rolling out in selected US-based centers.

I have also been continuing work with the publicly traded company I founded, Eyenovia, developing smart drug delivery devices – essentially an “inkject” printer. We are running multiple Phase III trials in progressive myopia and presbyopia and just this month the company submitted the NDA for our mydriasis program. We hope, if approved in 2023, this will be the first topical delivery system other than the century old legacy eyedropper, with smart monitoring functions, horizontal delivery and micro-dosing – all breakthroughs that can change the paradigm of topical therapies.

More recently, I have worked with a company developing a technology for AI-based non-mydriatic screening for diabetic retinopathy. I’m an investor and on the board, and also working with the team on the clinical validation. We just announced  the FDA approval of  a autonomous diabetic retinopathy screening system with best-in-class efficacy exceeding 93 percent, virtually surpassing the human expert paradigm.

What’s out there…
 

When I was at Genentech, I was very involved in programs focusing on bispecific antibodies, and this field still fascinates and excites me. I see targeted therapies as bringing great opportunities to ophthalmology. In the gene therapy sphere, companies such as REGENXBIO are really shaping the landscape, aiming to solve the issue of sustained delivery. I see bio-engineered tissue approaches – including 3D printing – as able to replace some hardware solutions. Being able to 3D print collagen, and perhaps even corneas, will remove the great burden of harvesting corneal tissue from donors. There is a lot of great innovation coming from outside the US – countries like Israel and the Netherlands are a hotbed of innovation, so it is worth keeping an eye on technologies coming from there.

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About the Author
Sean Ianchulev

Sean Ianchulev is Professor of Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, USA; Founder of Eyenovia, Iantech, Iantrek, KYS Vision, PME ventures.

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