Contract medical device parts manufacturer Metal Craft (Elk River, MN) recently installed two LASF Series fiber laser marking systems from LNA Laser Technology (Pawtucket, RI). The fiber laser markers use the company's SuperSmooth rotary laser marking technology.
A challenge facing medical device manufacturers is the need to meet new regulatory requirements. The Food and Drug Administration (FDA) is in the midst of a three-year rollout of regulations regarding labeling of medical devices. The new rule will be fully enacted by September 24, 2018. The final regulation requires that devices have a unique device identifier (UDI), which is both in human-readable plain text and machine-readable 1D barcode or 2D data matrix. The UDI consists of a fixed portion that details the labeler and model number, and a variable portion that may include batch number, serial number, date of manufacture, etc.
Additionally, devices intended for more than one use and reprocessed must have a UDI directly on the device. Lasers are ideal for this application and for implantable devices where the laser can discolor the surface with no tactile change to the surface smoothness. The mark is permanent and can be easily scaled to match the device dimensions.
Catheters, lumens, and extrusions can be tricky to laser-mark. Typical laser marking of cylindrical parts is done by covering a 10-15° angle, rotating the part, and repeating until the full circumference of the mark is complete. This can result in voids, overlaps, and indexing lines within the finished mark. Additionally, as the laser beam reaches the edges of the scan, it is slightly out of focus, resulting in a mark with potential intensity variations.
As the majority of parts that Metal Craft manufactures are laser-marked, the company needed a new laser marking system that does not require routine flashlamp maintenance and revalidation, according to Jon Hillstrom, Finishing and Laser Marking Lead at Metal Craft. The LASF Series fiber laser marker is essentially maintenance-free, he says.
LNA Laser, working with Metal Craft's engineers, pioneered the SuperSmooth spindle laser marking technique. This new feature allows the graphic or text to be marked at a constant spindle speed, where each line is marked at the precise laser focal point. This “Turn and Burn” technique results in seamless marks with each laser pulse delivered at the ideal focus for high resolution, consistency, and accuracy.
This development is of particular importance for instruments and devices requiring high-contrast gradations, regardless of the substrate’s composition (metal, plastic, etc.). It has also been shown to have aesthetic value in creating seamless, intricate rotary patterns for decorative applications.
To view a video of the laser process, please visit http://lnalaser.com/site/supersmooth-spindle-laser-marking.