Exponential Growth of Medical Laser Applications in the U.S.

By Geoff Giordano

At the second-annual Lasers for Manufacturing Event (LME®) in October, past LIA President David Belforte gave a riveting account of some of the more economically robust segments of the laser industry. Ultimately, it was the medical sector that “kept us alive through the recession,” he asserted.

Laser applications in the manufacture of stents, catheters and implantable devices “continue to grow,” Belforte said, noting the value of their respective niches.

For instance, “Stent cutting is one of the major success stories in laser precision cutting, going back 25 years,” he said. “As stents are getting more and more sophisticated, they have to be processed by lasers, and lasers are doing well every single year in expanding this particular market,” which he says is worth $2.8 billion in the U.S.

Meanwhile, in the $11.5 billion catheter market in the U.S., most makers use lasers in various assembly functions, including marking, drilling and welding balloons onto the devices. Even bigger is the U.S. market for implantable devices, where lasers play a vital role in the production of drug-delivery units, pacemakers and defibrillators — the latter a $106 billion sector.

A survey of some key players in these areas substantiates Belforte’s assertions that lasers will continue to offer a profitable avenue for contract manufacturers.

Laserage in Waukegan, IL, has been doing precision tube processing since 1997, according to Dan Capp, vice president of sales development. Since the Great Recession of 2008, the firm has grown from about eight precision tube cutters to 15, he says.

“Laserage is a production organization, but we’re also a prototyping organization,” Capp explains. “We do tons of prototypes. Engineers from all kinds of companies —big OEMs as well as startup companies — send us drawings daily. We (are receiving) well over 5,000 different designs for implant scaffolds and producing anywhere from two to millions of their designs.”

In terms of materials Laserage can process, “our forte would be nickel titanium components; however, we produce lots of stainless steel, cobalt chrome and many other alloys that people send in — the other alloys in much smaller volumes, of course. We are also in the realm of bioabsorbable materials,” both plastic and metal.

Laserage offers its clients a variety of capabilities depending on the application.

“If we were talking about a really thick-walled tube — say a half a millimeter or more — depending on the design, a disc laser can approach that requirement very well,” Capp says. A lot depends on how densely packed the laser cuts are.

In the meantime, “if we’re talking about a really small diameter tube and heat effect is going to be a problem when it comes to putting a fiber or a YAG laser on this tube — there are lots of little cutouts but the tube’s only a fraction of a millimeter in diameter — we would approach that with an ultrafast pulsed laser.” In that instance, “there’s not any room to do post-processing. If we put heat into it, we’re going to change the metallurgy of the tube. What comes out is a part ready to finish.”

While medical products come in and out of favor, affecting the growth curve for shops like Laserage, the future grows brighter with each advance in ultrafast lasers.

“No-heat processing (is) going to continue to develop, and that will be required more and more as parts get smaller,” Capp asserts. “I would expect the guys out there developing lasers to focus on this area — make the lasers more productive, make the cost of running lasers come down and the cost to purchase the lasers come down. There are going to be more and more applications that use that type of laser processing.”

At PhotoMachining in Pelham, NH, founder and CEO Ron Schaeffer says “we had some of our best years in 2008, 2009, because we were heavily entrenched in the medical device market.”

Over the years, he says, “we’ve seen all kinds of things for catheters; we’ve seen lasers being used for tipping applications (and) what we primarily do, drill holes in them for drug delivery. We’ve seen all kinds of other things, too. There’s a lot of welding involved within the catheters. We do the ablation: hole cutting, drilling, slicing, tipping.”

At present, he says, about half of all the disposable medical devices used worldwide are made in the U.S. “The corollary is that approximately 50 percent of that is outsourced to smaller companies. So you get the big guys — the Johnson & Johnsons, the C.R. Bards, the Boston Scientifics — shopping out a lot of work to companies like ours.”

That means the medical device industry “can be highly profitable, and it can be high volume. And it’s sustaining.” After all the upfront engineering, capital expenditure and regulatory hurdles, a product embraced long-term can be quite lucrative. “And if you’re working with the company from the beginning, you are locked in as a vendor because larger companies don’t want to have to go out and qualify a whole bunch of vendors if they don’t need to. They’re usually going to qualify at least another one so they have a backup. But as long as you’re the prime vendor and you are not screwing up, you are probably going to continue to get that business.”

Schaeffer, like Capp, is excited about the prospects of ultrashort-pulse lasers. About 15 years ago, when PhotoMachining opened for business, the firm looked to diode-pumped solid state lasers to replace UV excimer units. Now, with picosecond and femtosecond devices, “the pulse length is so short you can get really good processing quality” without UV lasers.

The importance of processing quality in the medical device field can’t be stressed enough. As Schaeffer relates, lasers fill the bill with ease.

“We have a big customer, and we built about a dozen systems for them for marking catheters,” he begins. “You want to stick these catheters in a body and you want to know how far you’re sticking them in, so you mark graduations on them. This could be done with printing, but a lot of times the inks do not stick very well to some of these plastics.

“Our customer initially was using a YAG laser to mark these parts. The marks looked good to the eye — very high contrast — but if you looked at them up close, you could see that they were burned in, which you would expect from a red laser. You could run your hand over it and feel the mark — and where they stick these things you don’t really want to be feeling (imperfections). We came in with a UV laser, which just marks the surface, doesn’t impart any heat (and creates) an indelible mark. You can’t feel it.”

Steve Weiss, one of the primary owners of Innovative Laser Technologies (ILT) in Minneapolis, MN, echoes the importance of the quality of lasers and ILT systems bring to the table — especially the operating table.

“One of our customers communicated to us recently that a doctor in an operating room will look at that (implantable) device, and if that laser weld doesn’t look good, he won’t hesitate a second to set that device aside and grab another one — one that might even be a competitor’s device — even though it costs tens of thousands of dollars.”

ILT, founded in 1998, benefits by being in the backyard of many medical device firms. “We have had pretty much continual growth since then,” he says, largely due to the firm’s emphasis on being a laser integrator. By employing a broad variety of lasers — including Nd-YAG, fiber and more recently ultrafast — in various wavelengths and powers, “we continue to grow technically and as a business.”

While ILT’s decades of in-house laser systems experience for the implantable medical market has contributed to yet another record year in 2012, the burdens of Obamacare’s tax on medical device manufacturers presents a significant unknown to the market’s future. But as Baby Boomers age — “there are approximately 10,000 people a day turning 65” — the demand for laser-based hermetic welding of drug pumps, defibrillators, neurostimulators and other devices that enhance quality of life seems unending. Those units also require laser-based welding of sub-assembly components such as batteries, capacitors and leads.

“A lot of what has been developed over the years assists our customers in meeting the needs of the medical implantable device market with process control, process monitoring and part-to-part traceability to help take the operator variability out of the process and make it more repeatable,” Weiss explains. For example, “the processes developed and qualified by the customer for a laser weld need to meet a strict set of requirements. ILT developed systems provide the necessary functionality so if that process deviates from those required parameters, we stop and raise a flag.”

In short, the principals at ILT, PhotoMachining and Laserage are unanimous in their confidence that the use of lasers to produce high-quality, high-value medical components is sure to remain a profitable enterprise.

As more opportunities for laser-based manufacture present themselves in the medical sector, training laser operators is paramount. Toward that end, the Laser Institute of America continues to expand its safety resources, from the ANSI Z136 standards to an always-evolving range of classroom and online courses. View the full range of LIA’s educational materials online at www.lia.org/store.