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Navigating uncharted waters

KYLEE HALL provides a glimpse into the major task of bringing Cylite’s homegrown OCT to market, and opens up on the unique challenges she faces as CEO.

When building incredibly complex technology from the ground up, at-scale, each day can present new challenges – some known and others unexpected. Adapting to this and making tough calls for the sake of progress is often how a company successfully transitions from a start-up to fully-fledged business.

This knife’s edge – teetering on excitement and uncertainty – is one that Cylite CEO Ms Kylee Hall finds herself balancing on daily as the company moves closer to the anticipated market launch of its Hyperparallel OCT (HP-OCT), quietly clearing major hurdles over the past 12 months that few would realise are necessary when bringing a new type of OCT to market from Australia.

Kylee Hall.

“I’m constantly assessing what we need to deliver on a quarter-to-quarter basis and even down to a more granular week-by-week basis, and i’m having to make some tough decisions.”

Since Hall last spoke with Insight in July 2022, Cylite’s significant milestones include moving into a new facility that has tripled its production capability and received the all-important ISO:13485 certification to ensure the quality of its production systems and processes. The company has also received validation of its Focus software for CE and subsequent ARTG listing, and has streamlined some of the time-consuming, manual manufacturing processes.

Some challenges remain, but when highlighting these, Hall is hoping the industry can appreciate the incredible work occurring in Cylite’s suburban Melbourne facility. Although it’s been slated for some time, the official launch isn’t far away, scheduled for the combined O=MEGA23 and World Congress of Optometry in Melbourne in September 2023.

“This is an extremely intricate piece of optical technology the team are building. There is a huge focus at the moment to dive deeply into the system and look for opportunities to streamline the complex engineering. We are transitioning and making improvements each day,” she says.

“For me as CEO, it’s about challenging the thinking to ensure people have the longer term in mind. We’re going from the mindset of a company focused on R&D to something that needs to be mass produced the same every time, every day, with the same quality and reproducibility – that’s the ultimate aim.”

The reason there’s so much excitement around Cylite’s HP-OCT doesn’t simply come down to the fact there’s an Australian company designing and manufacturing an OCT machine on home soil.

Most people assume it’s a retinal OCT first and foremost, but the opposite is more accurate – it’s primarily an anterior segment OCT with the main goal of using the precision of OCT for corneal tomography and measuring axial length. Cylite has also developed a retinal lens and is currently funnelling a lot of energy into its retinal capabilities.

What makes the technology unique is its ability to obtain true volumetric, or 3D, images of anterior segment and posterior structures in a series of snapshot captures. Users can then take a B-scan slice of the eye in any direction, X, Y or Z (enface) axis while obtaining precise measurements of the various ocular surfaces. Industry-leading rates of more than 300,000 A-scans per second allow it to capture a full biometry scan in seconds without the need for eye tracking software for motion artefact-free scans.

“We have several other exciting projects in the R&D pipeline, but they are a little way off being ready to discuss at any length,” Hall adds.

Challenges and opportunities

OCT is one of the more complex instruments in modern day eyecare – and it’s fair to say the average user may never fully appreciate what’s involved in bringing one to market, especially without the backing of a large multinational.

“To give you an example, one challenge that all equipment manufacturers face, is part obsolescence. If a part reaches end-of-life, we are usually given 12-18 months warning, so that we have time to make alternative plans. Ideally, you’d just replace it, but many components can’t be purchased off-the-shelf, and this can have a flow-on effect for the engineering of the system,” Hall says.

“But on the other hand, when you look at our progress from the past year, the improvements and iterations have been incredible. For example, there was a process (optical alignment) that used to take a team member up to two days to complete, it now takes only five to 10 minutes thanks to the work of our mechatronics team who have introduced robotics into the process.”

On the ISO:13485 certification of Cylite’s new facility, Hall says it was a significant undertaking. The team needed to build three HP-OCTs from scratch over several days under the watchful eye of an external audit team. Safety and quality are non-negotiables when it comes to developing medical devices.

“You’ve got to show your work instructions, and how you have followed them, as well as the calibrated equipment used, then they audit the build and the build quality of the product itself. They audit your entire quality systems, so it’s quite a milestone achievement for the whole team, especially our production, NPI (new product introduction), regulatory and quality departments, who led the multi-day audit.”

Inside Cylite’s clean room where the vital assembly stage is performed under strictly controlled conditions.

The company has also seen improvements in the supply chain, but ongoing freight costs, as a result of COVID, have made budgeting difficult.

“Supply chain impacts with regards to both delivery timelines and freight costs continue to greatly impact the ability to accurately plan and budget,” Hall says. “We’ve only recently had some electronic components come down from 80+ week lead times to around 40 weeks, which has helped, and our operations team are doing a great job ensuring we have a plentiful supply of the components we need.”

In terms of Cylite’s Focus software in the HP-OCT, Hall says senior product manager Mr Matthew Wensor has led a huge effort to ensure it is suitable for the end user.

The software is driving the user interface, and is what many eyecare professionals will arguably judge the company for. There’s been a significant emphasis on continuing to evolve the software, while ensuring it is ready for action, particularly for optometrists wanting to conduct scleral lens fitting, other advanced contact lenses and myopia management.

“Our Focus software had to go through a stringent verification and validation process to receive CE MDR approval . This involved a significant evaluation showing 15 individual professionals how to use the system, before they then attempt to drive it and then give you feedback,” Hall says.

“That was a huge process and ultimately we received the validation we needed to say that what we’d created was intuitive and easy-to-use for the operator.”

Making tough decisions

Hall has a wealth of experience in the ophthalmic industry, serving in senior roles within ZEISS and Device Technologies. While this has served her well, transitioning to a company like Cylite – which is going from an R&D-heavy business to one focused on large scale manufacturing, sales and marketing – is a unique challenge.

Making tough strategic calls, vital recruitment decisions and dealing with unexpected challenges are all part of life as a CEO.

However, she has found comfort in a quote from Mr Jim Fader, the co-founder of animal-free milk company and Australian start-up Eden Brew: “Dream big, run hard, consult broadly, stay positive. It’s a roller coaster, so if you are in a down, an up is around the corner, and vice versa. Celebrate your successes but keep some energy for tomorrow. Prioritise yourself – founders feed last and give everything to the business. If you aren’t at your best, the business feels it.”

Hall acknowledges the role of CEO of Cylite differs from those at more established OCT companies. The unknown of tomorrow and the excitement around the unique technology they’re producing only serve as fuel.

“Sometimes you’re making decisions and haven’t necessarily got all the information you would like, but a decision is required to move things forward. I’m constantly assessing what we need to deliver on a quarter-to-quarter basis and even down to a more granular week-by-week basis, and I’m having to make some tough decisions. Sometimes that’s saying ‘no we’re not going down that path’ because it will blow out the timeline, especially now that we are at the pointy end of bringing our HP-OCT to market,” she says.

“What I’ve found tough is that we’ve been saying we’re coming to market for some time now, but there’s some exciting development projects in the pipeline as to why that hasn’t occurred yet, and it’ll all make sense soon enough.”

In other company updates, Cylite’s staff count has almost tipped 90, but this will increase dramatically over the next few years as it ramps up production and exporting capabilities. Several new roles become available each quarter, and these are mainly focused within the software and production teams but soon the company will build out its local sales and marketing team.

Internationally, distributors have travelled from Europe to visit Cylite for some hands-on time with the HP-OCT. Hall says the attention has been flattering.

“But a big priority is ensuring the most robust leadership team possible that will help the company transition seamlessly through this next growth phase. Of course, we have a long-term five-plus-year strategy, but five years is a long way off, so I also have a 12- to 18-month strategy and plan that outlines quarterly goals and deliverables,” she says.

The HP-OCT is also the focus of several large studies, some of which are to validate the technology and improvements made, and others are to help Cylite gain entry into more international markets.

The system was on display at ARVO 2023 in New Orleans, a popular event among ophthalmic academics.

“The quality of our imaging and amount of data we are capturing in one biometry scan is what always garners the most interest from eyecare professionals,” Hall says. “We were recently in London at 100% Optical with both optometrists and ophthalmologists visiting us. The feedback was overwhelmingly positive.”

More reading

Cylite’s Melbourne production site granted ISO certification

Cylite embarks on crucial scale-up

Cylite HP-OCT’s presence felt on international research stage

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