Despite its price, nitinol— shown here in a clip manufactured by Fotofab— is gaining popularity in medical applications.
In recent years, trends such as the rise of competing materials, the popularization of certain metals, the miniaturization of devices, and vanishing lead times have all played a part in altering the interests and capabilities of metal fabricators. Luckily, the gradual pace at which these trends have emerged has enabled many fabricators to readily adapt to and prepare for these industry shifts. And while the metal fabrication industry remains a profitable one, changing requirements continue to put these service providers to the test.
Threats to the Industry
Metal alloys have long been a staple in the medical industry, employed in everything from devices to instruments. Recently, however, ceramics and polymers have supplanted metal in numerous applications, primarily in the orthopedic and implantable sectors. Plastics are often considered more economical and flexible than metals and do not present problems in imaging environments. Meanwhile, OEMs champion ceramics for their wear resistance and biocompatibility in implants.
In light of this changing material landscape, the question remains: Will the rise of ceramics and polymers ultimately spell the demise of metal in the medical industry? Metal fabricators aren’t fretting just yet. Ceramics can be expensive and are often used along with metal, as is the case with common ceramic-on-metal implants or ceramic-coated metal products. Jamie Howton, president of Fotofab (Chicago; www.fotofab.com), says that his company has not experienced a decline in business resulting from this trend and affirms that many parts are constructed from metal simply because it is the best fit for the application at hand.
Patrick Pickerell, president of Peridot Corp. (Pleasanton, CA; www.peridotcorp.com), agrees that some properties of metal are unmatched by competing materials and will save it from becoming obsolete. But Pickerell also acknowledges that polymers and ceramics may be cutting into the metal fabrication business. However, since Peridot began offering device manufacturing, its outlook on these encroaching nonmetal materials is changing.
“Rather than obsess over the dent that those materials will make in my marketplace, my approach is how to determine how I can integrate those materials into a finished device,” he says. “Because we’ve decided to step up a level to device manufacturing, we are now heavily involved with selecting and evaluating some of these new performance materials. Really, on the face of it, I embrace those new developments.”
Metals Moving to the Forefront
Metal fabricators have been forced to embrace new developments and changes within the metal industry as well. Raw material prices continue to steadily climb with no sign of relief, according to Howton. Furthermore, a popularity shift in the types of metals used by the medical industry is occurring.
Laser machining capabilities have enabled Peridot to expand its metal fabrication offerings within a competitive marketplace.
Although stainless steel continues to dominate the market, titanium and nitinol are quickly gaining momentum. Titanium is experiencing a significant surge in the orthopedics market owing to its corrosion resistance, biocompatibility, and strength. In response to this growth, Fotofab has taken the necessary steps to stay ahead of the competition. “We’ve actually pioneered a new etching solution that we use for titanium that is faster, cleaner, and more environmentally responsible than chemicals that have been used traditionally,” Howton says.
Like titanium, nitinol is not a new material; however, its use in medical devices has similarly ballooned in recent years. Suited for such applications as implants and instruments for minimally invasive surgery (MIS), the shape-memory alloy boasts a host of properties desirable to the medical industry. Unfortunately, it also comes equipped with a hefty price tag.
“We are seeing lots of start-up device manufacturers wanting components manufactured from nitinol,” observes Pickerell. “We actually spend a lot of time pushing customers to explore less-expensive materials that have adequate performance, but we cannot turn a blind eye to that nitinol market.”
And Peridot hasn’t. To prepare for the thriving nitinol market, the company has adapted its training, education, and equipment in order to effectively serve nitinol needs. Fotofab is also attempting to anticipate industry needs by investing heavily in materials R&D and even offers nitinol etching.
Miniaturization of Devices
While competing materials and developments in the metal industry have required some attention from metal fabricators, most of their energy has been focused on the trend toward miniaturization. Shrinking medical devices have caused big headaches for service providers.
Characterized by shorter recovery times and less trauma than conventional procedures, MIS is ideal for patients, surgeons, and insurance companies—but it’s a nightmare for metal fabricators, says Pickerell.
Howton concurs. “Feature sizes that we rarely saw 10 years ago are now sort of the norm. People are asking for things in some medical applications that are almost not manufacturable by any method,” he says. “At that point, it’s a challenge to either try to educate these young engineers as to what really can be made in the real world or struggle through yield and quality issues to make what they [OEMs] want.”
Fotofab’s fabrication process can machine hole diameters and slot widths as small as 0.005 in., while the minimum hole diameter and slot width that can be produced is typically 1.2× the metal thickness.
Though there are limitations on metal fabrication, companies are trying their best to meet the requests of their customers. To do so and to stay ahead of competition, the fabricators must keep investing in new equipment and adapting to the dynamic market, experts say.
Diminishing Lead Times
Unfortunately for metal fabricators, devices aren’t the only things getting smaller. Lead times are rapidly reducing as companies find themselves under the gun to get products to market as quickly as possible. Pickerell attributes much of this increased pressure to the influx of venture capital (VC) firms jumping on the MIS bandwagon while it’s at the height of profitability. Companies backed by VC funding must make their first deadline or run the risk of losing future funds. Consequently, companies desperate to hit a deadline are willing to pay more for expedited operations, Pickerell says.
“Lead times to a company like ours are evaporating and we do not have the luxury of weeks and weeks to get things done any more,” he explains. “There is so much demand now for quick turn; a smart person can make a lot of money off of that category by setting up an operation in a flexible fashion so that rapid changeover from one process or one project to another can be achieved.”
Peridot aims to save OEMs time by housing a variety of metal fabrication machines under one roof, which eliminates the need to spend time on contracting multiple vendors to get the necessary processes completed. The specialized facility includes CNC Swiss screw, laser, EDM, CNC wire-forming and -machining, metal-stamping, and sheet-metal fabrication equipment.
Flexibility is also exercised by Fotofab. Though its forte is chemical etching, the company also offers laser cutting, machining, finishing, and metal-forming and -bending services. For those services it cannot provide, Fotofab will subcontract the work.
But the competition isn’t just fierce among U.S. manufacturers. Regardless of quick turnaround capabilities, the metal fabrication industry faces ominous competition from Asia, according to Howton. He cites price pressure from Asia as a concern for U.S. manufacturers, but states that the life cycle of this trend could be limited. “As a positive, we’re able to compete with China very effectively... because we’re able to offer faster lead times, are still ahead of them in manufacturing technology, and are able to hold tighter tolerances as a result,” Howton muses. “So, we’re able to hold our own, but it’s what keeps me awake at night.”