Given the precision required for ophthalmic laser procedures, ophthalmologists expect the same from their manufacturer. But that’s easier said than done, as South Australian-based Ellex Medical can attest to, as one of few firms globally with the technical ability to make their entire units in-house.
In ophthalmology rooms and hospitals across the world are 38,300 medical instruments branding the Ellex name. Most are ophthalmic laser units; incredibly intricate, high precision pieces of kit the Australian business has built a reputation on for more than three decades.
Given that ophthalmologists are firing lasers into delicate ocular tissues for glaucoma, retinal conditions and posterior capsulotomies, it’s no surprise the expertise to build such instrumentation is limited to few manufacturers globally.
What many may not appreciate is the bulk of these units involve hundreds of components largely assembled by hand. But the other thing they may not realise is that 100% of Ellex Medical lasers are built in Mawson Lakes, a suburb 12km north of Adelaide’s centre, where it employs around 130 staff.
It’s part of the Technology Park precinct alongside more than 100 other like-minded companies in defence and aerospace, advanced electronics and IT. Some of them are global firms, and it would be fair to count Ellex among them.
The company is highly self-sufficient, machining many of its own parts and building the highly complex laser cavities at the heart of its instrumentation. It’s something it’s proud of given there’s limited companies globally with this technical know-how (more on this later).
Insight recently toured the headquarters of Ellex that lives on as an Australian success story, buoyed by the backing of its relatively new European parent company Lumibird.
Today, the company produces around 100 laser systems per month, with each individual unit taking three to four weeks to complete, on average. Around 95% are exported to international markets, Europe and Japan the largest.
It’s remarkable when you consider how it all began – back in the 1980s with an Australian scientific laser company called Quentron.
It was a government grant that paved the way for Quentron to expand into ophthalmic lasers. The first of those was a YAG laser photodisruptor, a device that stood at the intersection of function, ergonomics and aesthetic design.
Later, Quentron was acquired by venture capitalists who rebranded as Laserex. At this vital juncture in 1990, a management buy-out saw Ellex emerge as an independent company with its ophthalmic laser technology.
There’s been many highlights along the way.
As it continued to produce proprietary lasers, Ellex also signed original equipment manufacturer (OEM) deals with companies like Alcon and Lumenis. In 2000, it entered the photocoagulator market with Laserex Integre, then expanded further in 2006 by acquiring ophthalmic ultrasound technology.
As the company grew, so did expectations by going public on the ASX in 2001. It outsized its premises multiple times, moving into Technology Park in 2017.
It also had forays into other areas such as its 2RT system for intermediate-stage disease, and minimally invasive glaucoma surgery (MIGS) with the iTrack canaloplasty. Both of these products would be separated from the business to form Nova Eye Medical in 2020.
That’s because Ellex – and its laser and ultrasound products – were acquired by Lumibird, a European technology company whose subsidiary, Quantel Medical, was competing with Ellex in the market.
The Lumibird Medical division now comprises three complementary divisions: Ellex (Australia), Quantel (France) and Optotek (Slovenia).
Ellex continues to flourish under the synergistic effect of joining a group with similar expertise. Together, the group has more than 200 patents and launches two to three new instruments a year. Ellex is a strong contributor with equipment like the Neo premium laser range (Ultra Q Reflex Neo, Tango Neo and Tango Reflex Neo) in 2022.
But what’s also pleasing for Ellex customers is they now have access to more technology. For instance, Ellex has divested its own ultrasound technology and now is supplying the superior ABSOLU system from Quantel. There’s also the PROcap (Premium Refractive Outcome Capsulotomy) YAG capsulotomy platform available in Ellex systems, and the ability to now reach customer bases it never envisaged such as in dry eye diagnosis (C.DIAG) and intense pulsed light treatment (C.STIM).
Keeping it in-house
Ellex’s Technology Park site is how you’d expect – a factory with a real clinical edge. It’s spacious, highly organised and the production teams go about their work diligently. There’s half-built laser units, each clearly labelled with a model and serial number, and signs above some doors warning “laser firing” might be in session.
Each Ellex laser goes through a four-step process overseen by an expert workforce. It’s difficult enough manufacturing medical equipment, but even harder when it involves a laser.
As Ms Angela Standing, Ellex general manager, explains, this is why the process requires an incredible level of detail and tight control.
“A laser has an intricate optical path generating differing laser wavelengths that flow through to a delivery path to the end patient,” she says. “This involves fine alignment of many optical and mechanical elements and thorough calibration/testing at each process, including quality specifications at each stage of product realisation, to ensure end product requirements are met.”
But before they even begin assembly, they need to validate each part is manufactured as intended. It’s a big job when you consider more than 5,000 unique parts go into Ellex lasers, most of those produced internally.
The four key areas that go into manufacturing an Ellex laser are: optical assembly, mechanical assembly, the all-important laser cavity build, and integration.
The optical and mechanical assembly teams are responsible for crafting all optical and mechanical assemblies. Depending on the complexity involved, assemblies can take anywhere from a few minutes to several hours to complete.
“As an example, our Tango SLT laser has 40 sub-assemblies comprising more than 500 unique parts,” Standing says.
The company’s team of laser cavity builders is responsible for just that.
To understand why few companies possess this technical capability, Ellex says it comes down to the complicated nature of ophthalmic laser production. Given the wavelengths involved – and the need to ensure accuracy “within excruciatingly tight tolerances” – ophthalmic laser cavities are inherently complex to manufacture.
Further exemplifying this, all laser cavities have a mixture of optical, mechanical and electronic elements that are built as small sub-assemblies before being brought to life by being placed, aligned, calibrated and tested in the laser cavity housing. In the case of Ellex’s Yttrium Aluminum Garnett (YAG) laser cavity, the YAG crystal involved is doped with a rare-earth element – typically neodymium (Nd) – to create the laser active medium. The cavity ensures the light remains coherent and focussed.
Bringing together the various assemblies during the laser cavity build generally takes several days. Which is remarkable when you consider the cavity is not much larger than a tennis ball.
“The majority of our competitors outsource the manufacture of their laser cavities. In contrast, we have a strong IP platform and equally skilled manufacturing teams which enables us to conduct the manufacture of our laser cavities in-house,” Standing says.
It all occurs in a sealed off area, known as its Controlled Environment Room (CER). Air in this room is “scrubbed” by high velocity HEPA-filters to control airborne particles that also control temperature and humidity controls. All who enter must move through an “air shower” to minimise particulate matter, and wear clothing coverings.
“Any pollutants, such as dust, can lessen the product life of a laser which is heavily reliant on clean optical paths,” Standing says.
Use of specialised test equipment and software also take place in the CER. This is part of the laser cavity build test qualification process to ensure correct alignment, calibration and the relevant power specifications.
Once the laser cavity build is completed, the system is passed on to the integration team that brings everything together to create the finished product.
They follow a precise procedures and a commissioning book of detailed full system alignment and calibration specifications to ensure all Ellex systems meet quality requirements. From testing output power on power meters, electronic specifications on oscilloscopes, through to checking micron size laser beam parameters on a beam view camera, these are all vital steps to ensure the lasers work as intended the moment they’re unboxed by the ophthalmologist.
Tooling its own parts
Another way Ellex has been able to keep its edge is through the Ellex Machine Shop (EMS), which it started in 2001.
Given the need for high-precision components, EMS is responsible for machining some components used in the sub-assemblies and system parts. Again, it’s all about achieving more consistency and quality control.
“The establishment of EMS has enabled a higher level of consistency and quality in system components than was previously possible with external suppliers, which is paramount in ensuring that the lasers produced deliver the intended treatment effect,” Standing says.
EMS also supplies to several other third-party customers. But equally, Ellex does outsource some components to some local, interstate and international suppliers. This includes the low-value, low-complexity components, as well as small number of highly specialised components, such as cable assemblies.
Thanks to Adelaide’s reputation as in defense technology, this proximity has given Ellex easy access to world-class laser and optical resources.
“Maintaining the SA-based manufacture of our products is also important from an IP standpoint,” Standing says.
“We hold several patents with respect to our laser cavity design, but it also enables us to closely align the activities of our engineering and manufacturing teams, which ensures improved efficiency across both teams and helps us maintain the highest standards of quality.”
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