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The Nikon Metrology iNexiv system generates high-quality images of difficult-to-measure silicon samples.


also included wall thickness measurements, a unique capabil- ity offered as part of the Nikon AutoMeasure soſtware. Tanks to automatic iNexiv inspection using fast stage controls, we were able to reduce the start-to-shelf time for the pacemaker header part from four days to a day and a half.” Sant says that pre-production and production operations at


FMI probably benefit even more from automatic inspection. “iNexiv proves to be a major timesaver, considering the mil- lions of silicone parts we produce every year. Te shiſt from manual to automatic inspection led to a three-month payback time for our system, just in labor alone.”


High-Precision Measurements Te complexity of the parts has increased tremendously.


FMI invests in state-of-the-art processes and equipment to deliver the sophisticated ultra-clean silicone product required for surgical implantation. Based on expertise built up over the years, FMI is recognized as a leader in insert molding and bonding of silicone to various substrates. “High precision and process validation is key in the medi-


cal device business, to make sure critical silicone parts can be confidently incorporated into lifesaving medical devices and


state-of-the-art laboratory equipment,” explains Sant. “Te iNexiv system is ideal to measure any of our silicone molded parts, including microprecision parts manufactured to the tightest tolerances. It outperforms our previous manual video measuring system in terms of measuring accuracy and speed as well as repeatability and reproducibility. We notice that leading medical device manufacturing firms trust our inspec- tion qualification and validation reports better, because the majority of them are Nikon users themselves who know the system we are using.” FMI is also a long time user of many stereomicroscopes


from Nikon and NIS Elements soſtware to characterize the detailed features of molding tools. Te iNexiv CNC video measuring system was purchased aſter concluding a detailed comparison study including demos and benchmarks involving different brands. “All along, we felt that Nikon better under- stands our business, and that iNexiv hardware and soſtware are better aligned for inspecting medical device components,” Sant clarified.


Edited by Yearbook Editor Michael C. Anderson from information supplied by Nikon Metrology.


Medical Manufacturing 2013 73


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