Italian surgical eye equipment manufacturer, NIDEK Technologies has been using Stratasys’ Objet 500 Connex3 3D printing platform to accelerate clinical trial evaluations of it vision diagnostics systems.
These systems, often called ophthalmological devices, have first been prototyped with Stratasys’ multi-material, colour 3D printer. NIDEK’s research and development division reports a 75% reduction in prototyping costs and a 50% reduction in lead times compared to previous methods.
NIDEK Technologies Managing Director, Cesare Tenassi, says the company’s prototyping process has been transformed since the adoption of the Objet 500 Connex3. The Stratasys 3D printing technology enables NIDEK to quickly evaluate the fit, form and function of the device, accelerating the time to market. And since ophthalmological devices come into direct contact with patients, it is of upmost importance that NIDEK produces prototypes that precisely replicate the final product.
“Our prototyping process has become much more accurate and streamlined since incorporating Stratasys 3D printing into our workflow,” said Tenassi. “Previously, we were constrained by the prototyping restrictions associated with traditional methods. This proved costly in terms of lead-times and capital, particularly with moulds and CNC machining. We found that we had limited flexibility over our prototypes and, should iterations be required, this resulted in escalating costs.
“3D printing overcomes these bottlenecks by permitting us to quickly validate designs before entering our prototypes into clinical trial validation. As you can imagine, fully verifying our products is crucial to ensuring that premium quality is maintained.”
The first NIDEK product to benefit from 3D printing’s influence was the Gonioscope, a system designed to observe the space between the patient’s iris and cornea. Gonioscope is deployed for the early diagnosis of glaucoma. Thanks to the Connex3, NIDEK have been able to replace a number of aluminium parts with single 3D printed Rigur components. Rigur is a Stratasys advanced, simulated polypropylene material, which boasts toughness, excellent dimensional stability and surface quality.
Tanassi has been encouraged by the performance of Rigur, and in particular the Connex3. It gives NIDEK the ability to incorporate 3D printed materials that match the performance of their metal counterparts is crucial to accelerating the development cycle for clinical trial evaluation.
“In the case of the Gonioscope, utilising the toughness flexibility and snap-fit characteristics of the Stratasys Rigur 3D printing material, we replaced several aluminium parts with a single 3D printed components,” Tanassi added. “This saw the device pass a year-long clinical trial where eight global medial centres examined it.”
The adoption of the Stratasys Objet 500 Connex3 is being championed across the whole company. Federico Carraro, Mechanical Division Manager at NIDEK, has been overwhelmed with the time-saving benefits, as well as the Connex3’s scope for an array of materials.
“Previously, we used metal fabrication when developing the micro perimeter, which took around two months,” Carraro said. “With our Objet 500 Connex3 3D printer, we 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.”