Industry Insider is a timely chat with an ophthalmic industry thought leader.

James Crutchlow has almost 10 years of experience at U.K.-based Rayner, manufacturer of the first IOL. After managerial positions in European and Latin American markets, he was named director of Rayner’s new U.S. subsidiary, Rayner Surgical Inc., in September.

Ophthalmology Management: What motivated Rayner to create a U.S. subsidiary?

James Crutchlow: The investment in Rayner Surgical Inc. is a milestone in our global strategy. In our previous business model, we were essentially exporting from the United Kingdom to the United States whilst providing marketing and regulatory support from U.K. HQ. While that was successful, we realized it was difficult to work collaboratively with American ophthalmologists and industry members without investing in a local, strategic asset.

One of our goals with Rayner Surgical Inc. is to strengthen our collaboration with hospitals and ASCs, universities, doctors and KOLs, with a view to accelerating new product development.

OM: Rayner Surgical’s current focus is IOLs and IOL delivery systems. Why start there for the U.S. branch?

JC: Rayner manufactured the worlds’ first IOL in 1949, and that continues to be our primary business. It makes absolute sense to focus on this in a market that will see 4.3 million lenses implanted in 2018 and over 5 million lenses by 2023.

Of course, we will consider expanding into areas outside of that, including products already offered by Rayner’s global branch. Outside the United States, Rayner has a wide portfolio, including pharmaceuticals and viscoelastic, and I can see Rayner Surgical operating in those spaces.

OM: What other Rayner products are in the pipeline?

JC: In the last two years, we’ve released several new products in markets outside the United States. Our decision, then, is which to introduce here. Our flagship monofocal lens, the 600C Aspheric, was recently approved by the FDA and will be commercially available in September. Its 6-mm lens allows a sub 2.2-mm incision, which opens us up to a larger percentage of the U.S. market. We are now waiting on the FDA’s decision on our RayOne Aspheric monofocal, a fully preloaded micro-incision IOL.

Longer term, we intend to bring our RayOne Trifocal, and will sit down with the FDA soon to discuss that process. While we don’t have data from U.S. trials yet, the RayOne line was included in a U.K. study comparing six preloaded IOL injection systems. That study, published in 2017 in the Journal of Cataract Refractive Surgery, found that the RayOne system had the fastest IOL delivery and was in a two-way tie for easiest to use.

OM: What do you bring to Rayner Surgical from your prior experience in European and Latin American markets?

JC: I’ve learned a lot from those experiences, particularly around the internationalization process. First, it’s surprising how much markets vary in the time taken to put basic infrastructure in place. For elements such as incorporation, securing tax identification numbers and local bank accounts, it can take from just one month to 18 months based on location, so this needs factoring into the internationalizing firm’s plan.

From my experience in four similar Rayner projects, I’ve found it’s better to hire people who have an entrepreneurial mindset and their own experience with start-ups, as opposed to bringing in people with multinational enterprise experience. Of course, there are many more competitors in markets outside America, due to the FDA’s stricter requirements. OM