Lasers get more powerful, accurate and affordable, improving productivity of laser marking and cutting
Lasers are superior for marking medical tools and devices because the marks they make are flat, which is crucial: Any crevice, no matter how small, can provide a home for germs to congregate and reproduce.
So an impending new rule expected from Washington may help companies that sell laser marking systems to medical device manufacturers fatten up their bottom line.
In 2012 the Food and Drug Administration proposed the new rule requiring the more than 5000 domestic medical device manufacturers and their foreign counterparts to add a unique device identification—a numeric or alphanumeric identifier—to some of the 1700 different types of devices used in the US. Examples of devices that would have to bear a UDI are implants and multi-use surgical instruments.
A final rule isn’t expected until June. But if implemented, the rule could mean much more business for medical device makers, even if it means $132–$176 million a year in extra costs for the domestic and foreign medical device industry.
The rule is designed to help improve device safety and the reporting of device-related adverse events.
“It will improve how tools and devices are used and help define the life cycle of a device,” said Alex Boffi, key account manager for Technifor, a GravoTech Inc. company (Duluth, GA). His company offers a wide range of laser and other solutions for medical application UDI marking compliance. “At the end of the day, it comes down to safety.”
But even as the FDA creates additional costs for medical device manufacturers, insurance companies and the Centers for Medicare & Medicaid Services—who pay for their products, which are often cut with lasers—are forcing them to do more with less.
“Produce more in less time for a lower cost per part” is what customers want from lasers and laser systems from Trumpf Inc. (Farmington, CT), said Sascha Weiler, micro-processing product manager.
Geoff Shannon, laser technology manager at Miyachi Unitek Corporation (Los Angeles), agrees. He’s noticed a big cost-reduction drive among manufacturers who now operate smarter and leaner, compared with 10–15 years ago when money was no object.
Part of operating smarter may mean making more powerful lasers. “We are always working on increasing the laser’s power,” said Weiler, “but still maintaining high efficiency. The tricky part is how to use this power, and merge it with the capabilities of motion control.”
That’s where Aerotech Inc. (Pittsburgh) comes in. Aerotech manufactures extremely precise motion control systems for laser processing and micromachining.
“Capabilities 10 years ago were normally limited to micron-level resolutions and accuracies,” said Scott Schmidt, laser processing and micromachining group manager. “Today we already offer standard products that function in the nanometer range, and we fully expect that 10 years from now many standard systems will be capable of picometer resolutions and accuracies.”
Making Their Mark
G.T. Schmidt Marking Systems (Niles, IL) has several marking product lines, but since the turn of the century lasers have taken over.
“We do see lasers as truly the future for GTS,” said Dave Noonan, product manager. Growth in Schmidt’s laser marking sales grew by about 50% in 2011 and 40% in 2012.
Not only are lasers the future for Schmidt, the company will likely expand into systems for cutting and ablating as well as for marking, Noonan said.
Schmidt’s laser systems include the scanning head, software and programmable controller in addition to the laser itself. Medical device makers use the system to add their corporate identifying names and logos, as well as serial numbers and 2D matrices to artificial joints, pacemakers and their nerve-stimulating cousins, catheters, tubing, and surgical tools.
“About anything steel or plastic that needs to be marked, our lasers are marking,” said Noonan, whose customer base is mainly in the United States and Canada, with a few clients in South America, Europe, China and India. “Most of our customers are opting for the fiber laser these days due to its price and durability. The sources are rock solid and the design is well proven.
“I think durability speaks for itself by simply looking at the expected life of the lasers,” Noonan said. “The fiber laser sources are projected to have a 100,000-hour life cycle while the diode laser sources are rated for 30,000 hours.”
Fiber lasers are also becoming more powerful, up to 70 W, and are more environmentally friendly because they’re air-cooled vs. water-cooled like CO2 or YAG lasers. But they also have another distinctive advantage.
“The nice thing about a fiber laser is that it’s compact,” said Bob Henry, product manager for Epilog Laser, (Golden, CO).
It’s not uncommon for visitors at medical device trade shows to approach Epilog’s booth and hand over a bag of jangling metal parts to mark, said Henry.
“We love the challenge when people bring us materials,” said Henry. “We haven’t seen a metal yet that we can’t get a good mark on.
“The trick is to get a nice, thick oxide layer that can stand up to passivation [a cleaning process] and autoclaving,” said Henry.
Epilog’s latest products include the Fusion FiberMark Laser System. The FiberMark’s work area, at 640 in.2 (4129 cm2), is more than double that of its predecessor, which has a 288-in.2 (1858-cm2) work area. It also features bigger motors, an enhanced motion control system, a central processing unit on the laser motors, an all-new bearing assembly and steel-reinforced belts, and bidirectional communication between the computer and laser. The two-way communications, along with the operator’s ability to pause the system’s operations, make it handy for prototyping.
Another handy feature for job shops is the Epilog systems’ time estimator, which is activated after an image is uploaded to its programmable logic controller.
Epilog’s open-source software, along with off-the-shelf writing or graphics software, such as Microsoft Word, Adobe Illustrator, CorelDRAW or BarTender, control the system.
“With our approach, you can use so many different approaches for printing,” said Henry.
Device manufacturers intent on cutting production costs not only want options, they want the process to be fast as well.
Technifor’s TC 500 35-W CO2 laser is fast enough to keep up with production of plastic-molded parts, said Boffi. Just out this year, the TC 500 is galvonometric-steered vs. gantry-based, easy to integrate, cost-competitive and extremely powerful. As a result, it offers a low cycle time and increases throughput.
“We anticipate it’s going to be popular in the food and beverage industry, automotive, and for medical devices,” said key account manager Boffi.
Also innovating to increase speed is Miyachi Unitek.
“To make the commonly required dark, or so-called annealed mark, on stainless steel faster is a challenge, as it’s very easy to overheat the part,” said Shannon. “However, using the correct laser technology, this is possible, resulting in significant throughput gains.”
Shannon said his firm’s new LMF 3500-HP laser marker cuts this type of marking time by up to half, compared with its previous technology.
Cutting Into the Business
Faster marking is not the only innovation Miyachi Unitek has to offer. The company’s as-yet unnamed tooling option for its Sigma Tube Cutter can cut features in small-diameter nitinol tubing for neurovascular applications. Not only will the new technology cut tubing as small as 254 µm in diameter, it will immerse the part in an ultrasound bath that eliminates the need for electro-polish finishing.
“If you can provide a cutting process that produces minimal need for postprocessing you can shave time off the manufacturing process and save money,” said Shannon. “We think we’ve come up with a nice, elegant solution.”
For this particular application the Miyachi Unitek technology—with an estimated cost of $20,000–$25,000—can be used with a system that includes a $40,000 fiber laser to make acceptable cuts. Previously the process required a $250,000 ultra-fast laser, Shannon said.
Joining Miyachi Unitek with new technology is Trumpf, with the second generation of its TruMicro Series, which was first offered in 2008. The TruMicro Series 5000 uses a hybrid design for laser-cutting metals and polymers. A fiber laser is amplified by a disk laser and uses six pico-second pulses for cutting polymer stents and other materials that are sensitive and react to heat affect.
Also offering revamped technology—and making it price competitive in the medical device market—is Prima Power Laserdyne LLC (Champlin, MN). Prima started selling its Laserdyne 430 just this year, but it’s based on laser system designs initially created 20 years ago and used since then primarily in the aerospace industry.
Prima reduced the Laserdyne 430’s price by modifying its design: For example, the work area has been reduced to a cube that measures 23 × 16 × 20″ (584 × 406 × 508 mm), a work envelope compatible with the size of medical device components to be laser processed. The cost of the control system has decreased as, for example, industrial computers have become less expensive, explains Terry VanderWert, company president.
Also multi-generational is the system’s BeamDirector, a rotary and tilt axes laser beam positioning device that gives the 430 full 3D cutting capability.
“It’s the cleanest head on the market today, without external cables and hoses that can interfere with parts being laser processed,” said VanderWert, who sees great potential for using the Laserdyne 430 to make orthopedic implants and process-formed and tube-based medical instruments.
He also points out that his new technology can be used for laser drilling and welding as well as cutting, and promises quick company responses to users’ changing needs for the 430’s operating program as the marketplace evolves.
Essential to many cutting jobs is motion control that controls chattering, and that’s exactly what Aerotech focuses on with its VascuLathe Stent Manufacturing System and its Toric Lens Generator.
“Potential users of the VascuLathe get the benefits of better quality stents, produced more quickly, with easier and quicker system start-up,” said Scott Schmidt, laser processing and micromachining group manager. He promises a two- to five-fold increase in vascular and neural stent throughput with VascuLathe.
That’s because Aerotech, Schmidt explains, integrates VascuLathe’s linear-rotary system with material handling and wet-cutting capability.
“Aerotech’s direct-drive and advanced control architecture also means better quality output,” Schmidt said.
The Toric Lens Generator is designed specifically to create toric lens profiles (that correct for astigmatism as well as near and farsightedness) to manufacture contact lenses and intra-ocular (implantable) lenses.
“By limiting the application scope of the product, the TLG provides a smaller, less costly solution than competitive products,” Schmidt said. ME
This article was first published in the May 2013 edition of Manufacturing Engineering magazine. Click here for PDF.
Published Date : 5/1/2013