When telecommunications R&D crossed the boundaries of ophthalmic research, it led to the Australian design and manufacture of a revolutionary new whole-eye imaging system. AMT Editor Paul Hellard reports
Brothers Steve and Grant Frisken used to have regular phone hookups on Sundays. Steve, an optical physicist, worked in the telecommunications industry, and Grant led the software development for a corneal topographer (using reflectance light to measure the front surface of the eye).
Grant knew that if you could find a way to keep the eye perfectly still, then optical coherence tomography (OCT) would have a whole new life in the ophthalmic field, beyond imaging the back of the eye. If you could remove motion artefacts (caused by the eye’s movement), then the micron-level accuracy of OCT could be used to measure the critical surfaces at the front of the eye. These are the measurements you need for the precision of cataract and refractive surgery and monitoring other important ophthalmic eye diseases such as myopia and keratoconus. Grant challenged Steve to devise a new way of using OCT to image the eye, knowing that eye movement will always be present. They just needed the time, the people and the space to prove the concept. They rode the dot com dragon and fought to gather the right brains for their dream company, Cylite.
Fast forward to today, and Cylite is a high-precision engineering and medical manufacturing company in Melbourne, which has designed and produced a revolutionary whole-eye imaging system. The Hyperparallel OCT, or HP-OCT, is a diagnostic ophthalmic and optometric device that uses world-first 3D imaging to provide micron-accurate measurements of the eye and monitor conditions such as keratoconus, closed-angle glaucoma, presbyopia, cataracts, corneal infections and biomechanics. This cutting-edge optomechanical design, high-speed image acquisition and advanced parallel software processing integrate the functions of more than four existing instruments into a single, automated platform.
From its beginnings in 2013, the Frisken brothers gathered two further experts in their fields to found the company and guide the vision of the Hyperparallel OCT. Cylite now has an office and scalable clean room facility close to Monash University, over 100 employees and many orders to fill. The new CEO, Kylee Hall, spoke about the mechanical and metallic parts manufacturing by local Australian companies like Formero, Computool, Markerry and Guhring (many others) and the electronics were built here in Australia by SRX Global Australia. “Unfortunately, nobody in Australia manufactures the high-end optics we need in the HP-OCT,” Hall says. “These are extremely speciality lenses that need to be imported from countries such as Germany, Switzerland, China and the USA.” With over 2,000 individual parts in the Cylite HP-OCT, everything is assembled in their facility in Mulgrave. “We are just over 10 years into this and only now preparing for commercialisation,” Cylite CEO Hall said. Doing it right has been very important for Cylite. “ISO-13485 Certification is one of the many standards we must adhere to for Medical Equipment of our Class, ten years is how long it takes to tick all the regulatory boxes. It’s a long and costly process.”
Design
Cylite engaged Cobalt Design as a key collaboration partner to assist with the design and development of the HP-OCT device. AMT spoke with Kynan Taylor, Associate Principal at the North Melbourne studio. “Cobalt developed the device industrial design for Cylite,” said Taylor, “along with detailed engineering and design for the manufacture of the device enclosure, including integration to the functional internal elements.”
Working closely with the Cylite team, we transformed a unique, novel technology into a refined, world-class product that meets user needs, functional requirements, and global market expectations.
“Cobalt also supported the development and testing of device prototypes, and provided technical support during the transfer to manufacture phase of the project,” Taylor added. While a fair proportion of the metal componentry was die-cast, and fabricated in Australia, some was manufactured in Singapore and China. All assembly stages in the optical blocks and final product tests are done locally.
“User-centred design is a fundamental principle in our approach to product development, especially medical device design,” Kynan Taylor said. “Ensuring that products are safe and effective necessitates a focus on the user and their needs, which is why usability and human factors engineering (HFE) is integral to ISO-13485, the international standard for medical device design and manufacture.”
Patients undergoing medical procedures, such as ocular diagnosis, often feel a level of apprehension. A product’s appearance and the way the patients interact with the device play an important role in alleviating these concerns. By combining appropriate manufactured materials, forms and colours, and ensuring the product is easy and comfortable to use by both patients and clinicians will often lead to better health outcomes.
“Our approach to the development of the HP-OCT was to create a product that improved patient experience by creating an approachable, integrated form combined with soft-touch patient contact points,” explained Taylor. “This design accommodates a wide range of patient demographics, considering variations in height, face size, and shape. Features such as a forward-angled chin and headrest, along with an auto-height adjustable chinrest, enable patients to intuitively and accurately position their head, allowing the HP-OCT to align with the patient’s eye automatically.”
The tech
The technology shares some of the key components of a spectral-domain OCT (SD-OCT) but adds a micro-lens array to split the light source into 1,008 individual beamlets. Each beamlet is imaged onto the eye and simultaneously measured in a single ‘snapshot’ capture (which Cylite terms a frame).
The HP-OCT captures 300 frames per second, each containing 1,008 A-scans, to give an A-scan rate of 302,400 A-scans per second. Although the A-scan rate is very high, the HP-OCT’s patented simultaneous measurement technique does not impact the dwell time for acquiring data at each point. The signal-to-noise ratio at each of the beamlets is typically more than 100dB, allowing very high-quality images to be acquired at high acquisition speeds and removing motion artefacts.
Upgrades
Since its long-awaited public launch in 2023, Cylite has recently released a new software upgrade, which has expanded its optical scanning capabilities from a 9mm zone to 16.6mm. This new scan allows sagittal height and elevation maps beyond the cornea and onto the sclera, extending its application to cover all contact lenses.
The OCT market is worth around US$2.5bn and is expected to grow to US$7.76bn by 2030, largely dominated by multinationals from the United States, Europe and Japan.
Three years ago, Cobalt Design, Cylite’s industrial design partner, and Cylite itself received the Victorian Premier’s Design Award of the Year and Best in Category. This was after winning Engineer Australia’s Sir William Hudson Award in 2020. They also won the Good Design Gold Award with the HP-OCT the following year.