“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 Stratasys 3D printing, we have slashed our prototyping costs by 75% and accelerated our development time by 50%,” says Cesare Tanassi, managing director at Nidek Technologies
Faced with high costs and lengthy lead-times associated with traditional prototyping, Nidek Technologies required an alternative prototyping solution to overcome these barriers, while maintaining the quality and functionality of its devices for clinical trials. With the integration of a Stratasys Objet500 Connex3 3D printer, the division has optimised its prototyping process, replacing metal component prototypes with more complex, high-performance 3D printed polymer parts, while producing intricate geometries previously unattainable.
As a result, Nidek Technologies can develop functional prototypes of its vision diagnostic systems 75% cheaper and enter these into clinical trials 50% faster.
Nidek Corporation was founded in 1971, Japan, as a medical diagnostic and surgical eye equipment. The company has since established itself as a global producer of ophthalmology products.
Located in Padova, Italy, Nidek Technologies specialises in the development of high-technology diagnostic systems. With all of its products having direct contact with patients, it’s crucial that the division can develop 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 the company turned to 3D printing in a bid to optimise its prototyping process.
Accelerating time-to-market with 3D printing
This was exemplified in a recent project which saw Nidek Technologies develop a working 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. This would often require them to either produce expensive injection molds or use CNC machines to create the individual device components. This led to escalating lead-times and, should iterations be required, substantially increased prototyping costs.
“Our prototyping process has become much more streamlined since incorporating Stratasys 3D printing into our workflow,” said Tanassi.
“The technology enables us to develop complex parts with intricate geometries on-demand. The ability to validate designs early in the product development cycle helps us eliminate costly iterations during manufacturing, as well significantly reducing our time-to-market compared to traditional prototyping methods.”
Using 3D printed devices in clinical trials
According to Tanassi, waiting for prototype parts to conduct clinical evaluations created costly delays. “Previously we were constrained by the time restrictions associated with traditional prototyping. 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 quality is maintained.”
Tanassi explained, “In the case of the Gonioscope, the quality and accuracy of the 3D printed components to withstand rigorous use in clinical settings were critical to accelerating the clinical trial. In fact, this saw the device pass a year-long clinical trial where eight global medical centers examined it.”
Replacing metal parts with photopolymers
Beyond the Gonioscope, the benefits of 3D printing are impacting other products. According to Federico Carraro, mechanical division manager at Nidek Technologies, this is particularly the case when developing the company’s micro perimeter, a device used to determine the level of light perceived by specific areas of the retina.
“Previously we used metal fabrication for this device that took around two months to create. This method dramatically delayed our prototyping cycle and the speed at which we could validate designs before entering our prototypes into clinical trial validation,” explains Carraro. “With our Stratasys printer, we can combine a 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.”
Tanassi added: “In the case of the Gonioscope, using the tough flexibility and snap-fit characteristic of the Stratasys Rigur 3D printing material, we could replace several aluminium 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%.”