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OptiMedica CEO examines development process of femtosecond laser cataract system
The U.S. FDA recently cleared the remaining femtosecond laser cataract surgery system indications of single- and multi-plane corneal incisions.
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Ocular Surgery News: What do these clearances mean for OptiMedica?
Mark J. Forchette: Now we have our complete portfolio of clearances for all the capabilities of the system that lets physicians and patients access what we designed the system to deliver. That is an immensely rewarding accomplishment for the company, to be able to go to market with a fully cleared system.
The other thing is that our system does what we say it does when it is in the hands of customers. It is a really fast learning curve, with a high ease of use. It is very confidence-inspiring and extremely effective. It is great to get the clearances but then the system has to deliver when it is in their hands and it absolutely does, and we are really excited about that.
Mark J. Forchette
OSN: What would you say is the biggest differentiator for your system between the other systems that are available?
Forchette: I think there are probably five key elements when you look at the design decisions we made: the advanced graphical user interface for smooth and efficient workflow and the Liquid Optics interface — the way it eliminates corneal folds and the way its minimal IOP rise contributes to safety and precision. The on-board OCT guidance is very sophisticated and automatic in surface identification. We made some different decisions about the femtosecond laser, resulting in fewer gas bubbles, and then we integrated the bed into our system, leaving nothing to chance. So those are all differentiators by themselves, but when you take them and put them together holistically, there is a kind of synergistic element that delivers the precision and accuracy that we have committed to every step of the way. We are very proud of our clinical data because it is clinical data to be proud of.
OSN: Having gone through such a long process to receive all of your clearances and to come to market, could you describe anything that you have learned along the way?
Forchette: During that whole process and through our company history, there have been various pivot points and various decision points that have really stacked up to contribute to the position that we are in today. I had the unique experience recently to hear Jim Collins, who wrote “Good to Great” and “Built to Last,” and he was talking about times for a company to go fast and times to go slow. And I look at the kind of decisions we made in the product, and there were times where we absolutely slowed down because we were in that very important innovation segment of time. I am thinking particularly about the Liquid Optics interface and its remarkable development story. We were doing our clinical trial, and we initially had a solid curved patient interface that was used to dock to patients, and we saw issues with it. We saw corneal folds; we saw things that we believed we could do better. So we slammed on the brakes and said, “We can do this better. Patients deserve that.” And so, we brought all of our engineers, all of our physicians together. There is a great Louis Pasteur quote that says a well-defined problem is nearly solved. We defined the issues that were creating corneal folds, and it was that curved interface, and we invented the Liquid Optics, put it into the clinic and now it is part of our commercial system. So that is one thing I learned very acutely in this process about that time to go slow and time to go fast.
If you look at the system we iterated to get to the system that we have right now, this is probably a fourth-generation system on the market today. If you go through all the iterations and the development process, you will see this is a very refined system that we have launched, and you can tell that because of the ease of use and simplicity. Think about the stages of learning, where you ultimately get to a state of being unconsciously competent … a really advanced stage where things feel simple. When I say, “It does what we say it does,” that is no small feat. Customers have high expectations when they spend the kind of money they do when they invest in a laser cataract surgery system, and we have been very focused on meeting and exceeding these expectations. I think the refinements in Catalys are a tribute to that.
OSN: What is the key going to be to have ophthalmologists adopt femto cataract systems?
Forchette: I think that, No. 1, the key is that moment when a physician is directly interacting with a patient. Is the physician convinced that this technology is the best that there is and it is worthy of telling patients about it and creating a desire in the patients for it? I feel very confident, and Catalys customers are very passionate and enthusiastic in those discussions because of clinical performances, like our 99% free-floating capsulotomy rates, precision within 27 µm of the intended diameter capsulotomy, and our ability, in the vast majority of cases, to eliminate use of ultrasound in the procedure. If physicians experience that, it makes them really enthusiastic and passionate about it and they believe that this is the future. Catalys is the standard. If they can say that, it contributes heavily to adoption.
The next piece is for them to say, “Is there a workable business model that allows me to integrate this and make this available to patients?” With our corneal incisions capability, unquestionably there is a high access to availability for patients through a patient-shared billing model.
The last important factor is just having a reliable system, an easy-to-use system that can smoothly integrate into practice, and we deliver that at a really high level. Our rigorous development process has ensured that Catalys is really smooth and efficient for surgeons to use.
OSN: How many units do you have in place now?
Forchette: We are 25+ globally. We are in eight countries, four continents and rapidly growing. We have done more than 4,500 procedures now globally, and that number is rapidly ramping up. The fact that our corneal cuts are now market cleared in the U.S. is making a big impact for us, so watch this space. It will continue to grow at a really fast clip.
OSN: What do you think is most important for ophthalmologists to know about OptiMedica and the Catalys system?
Forchette: I think one thing is this is an emerging category and ophthalmologists who are moving to adopt this technology have decisions to make. It is really important that they understand that all systems are not created equal. Catalys does what we say it does, and what we set our target on is to be the best technology available. That is a high, lofty goal, but we have an amazing group of really bright engineers, physicians and nurses that participated in the development of Catalys, and they poured their hearts into it. That is what you get in a Silicon Valley-based company that does only this. We are not going to do anything less than fantastic. Catalys represents breakthrough technology, and I would just encourage surgeons to look at this system because it has changed the technology standard so dramatically. No matter what their predisposal was previously, Catalys represents an important new technology alternative that is worthy of very serious consideration.