Nidek Technologies (Nidek), located in Padova, Italy, specializes in the development and prototyping of high-technology ophthalmological diagnostic systems. With all of its products having direct contact with patients, it’s crucial that Nidek produces fully-functional prototypes that precisely replicate the final product. This enables a comprehensive evaluation of the fit, form, and function of new devices before investing in expensive clinical trials and moving to final production. As this process often proved costly in terms of lead-time and capital, Nidek Technologies turned to 3D printing in a bid to optimise its prototyping process and, as a result, accelerate its clinical validation.
One such project involved the production of a new automatic Gonioscope®, a device designed to observe the space between the iris and cornea. Typically, the R&D team would create the prototypes using traditional manufacturing with expensive injection moulds or use CNC machines to create the individual components. This led to escalating lead-times and substantially increased prototyping costs if iterations were required.
According to Tanassi, waiting for production parts to conduct clinical evaluations creates costly delays. “Previously we were constrained by the time restrictions associated with traditional manufacturing. 3D printing overcomes these bottlenecks and permits us to quickly enter our devices into clinical trials. As you can imagine, fully verifying our products is crucial to ensuring that premium healthcare is maintained,” he explains. “In the case of the Gonioscope®, the quality of the 3D printed components saw the device pass a year-long clinical trial where eight global medical centres examined it.” As a result, Nidek’s Gonioscope®, accelerated to market with 3D printing, will contribute a novel way to diagnose glaucoma.
Beyond the Gonioscope, the benefits of 3D printing are impacting numerous other products. According to Federico Carraro, Nidek’s mechanical division manager, this occurred when developing the company’s microperimeter, a device used to determine the level of light perceived by specific areas of the retina.
Previously Nidek used metal fabrication for this device, which took around two months to create and dramatically delayed the prototyping cycle. With its multi-material printer, Nidek can combine a wide range of 3D printed materials with contrasting mechanical characteristics. “This allows us to accurately emulate final parts, including threads, seals, rubber and transparent components. In this case, we achieved the same functional result within 24 hours by replacing metal parts with robust 3D printed components,” explains Carraro.
Tanassi concurs: “In the case of the Gonioscope, utilising the tough flexibility and snap-fit characteristic of the Rigur™ 3D printing material, we could replace several aluminum parts with a single 3D printed component. The ability to quickly 3D print high-quality parts that require no post-processing has proven instrumental in cutting our iterations and directly reducing our product development cycle. In fact, since introducing 3D printing, we have slashed our prototyping costs by 75% and accelerated our development time by 50%.”
Nidek Technologies is now pioneering a new proprietary polishing process for its prototype illumination lenses. Traditionally the development of lenses requires several months of build time and cost thousands of Euros per lens. Concludes Tanassi, “In the future, with the VeroClear material, we may quickly 3D print prototype lenses with high clarity and smooth surface finish devoted to our illumination optics. We used a proprietary robotic polishing process for our 3D printed lenses.”
The versatility of the Stratasys Connex3 multi-material printer and PolyJet materials gives Nidek Technologies the tools to quickly overcome multiple challenges throughout the product development process. From ideation to iterating prototypes, to clinical evaluation, 3D printing drives innovation, improves product design, saves cost and reduces product development time.
