Pinpointing Perfection

Pinpointing Perfection

As OEMs Drive Innovation With Smaller, More Precise Components, Suppliers Aim to Deliver Complex Solutions Faster

Jennifer Whitney
Editor

In the medical device industry, companies often play the roles of competitor, customer and supplier concurrently. In the machining and laser processing industries, greater demands from OEMs are requiring that suppliers step up their efforts to meet newer, pressing needs—regardless of their role.

Criterion uses technology such as the H-T20 CNC Lathe, shown here with a machine operator. Photo courtesy of Criterion Instrument, Inc.

As demands for smaller, more precise parts and faster turnaround times dominate the industry, suppliers are finding that they must machine parts with ever-tighter tolerances while ensuring that safety, utility and quality aren’t compromised. Fortunately, advances in equipment and technology are making gains in all areas possible.

Many suppliers are finding that their expertise is being rewarded; outsourcing is becoming increasingly popular. It appears that OEMs are focusing heavily on their core competencies and are turning toward contract manufacturers and other suppliers to handle product development.

“Three or four years ago, large medical device companies would come to us and say, ‘We’re going to want you to do this part for the next year, but our intention is to [eventually] bring this in-house,’” said John O’Brien, executive vice president for Point Technologies in Boulder, CO. “Now, for the past year or two, they’re not doing that. The trend really is toward outsourcing—there’s no question about it.”

Evolution of Machining

As the outsourcing industry grows and evolves, so, too, are the machines and processes being used to create medical components. Just as the home computer you bought a year ago can soon feel outdated when the market introduces a more powerful, faster system, so, too, can the machinery being used to create medical parts. Therefore, industry experts are constantly evaluating the need to invest in new technology to serve customers’ more complex needs.

The latest technology offers plenty of benefits to both OEMs and suppliers. Today’s machinery is more user friendly, with features such as help screens that guide operators. Personnel operating the equipment can also be more easily trained and, in some cases, do not need to have the kind of expertise required to operate past machinery. In addition, the machines themselves are much more powerful, allowing for faster production runs.

“You’re going to see a drastic reduction in cycle times compared with the older technology, by as much as 50%,” said Tim Hoklas, director of operations for Accellent Endoscopy in Wheeling, IL.

As the equipment becomes more sophisticated, complex systems often enable suppliers to expand and customize machinery to better meet customers’ needs. Technical Innovations, based in Brazoria, TX, uses a base platform for its equipment to enable customization. The machinery can be expanded or have tools added to meet a product’s particular challenges.  

“That’s a big part of our business,” said Scott Thompson, manager of sales and business development for Technical Innovations. “Our customers come to us when they have a development or production requirement that is not in their business competency.”

Much of today’s machinery can perform functions that were not previously possible. For instance, Technical Innovations recently developed a “cutter technology” that can create holes in braided tubing, since lasers can’t perform this function.

While high-speed machining is not new to the medical device industry, suppliers are increasingly realizing the benefits of the technology. “High-speed spindles allow you to machine parts a whole lot faster than older technology does,” said Hoklas.

He has found that spindle speeds in particular enable use of smaller tools, give better surface finishes and offer more accuracy. Programmers, however, must alter their methods to fully utilize the high-machining speeds, which can be difficult, since older programming systems have canned cycles that do not take advantage of the machine’s complete capabilities.

Jack Fulton, vice president of sales and marketing at Specialized Medical Devices in Lancaster, PA, acknowledged the unique issues related to using the proper machinery: “You constantly have to reevaluate and make sure that the equipment you maintain is state of the art.”

Laser Technology

Advances in laser technology also offer many solutions to OEM challenges. Debra Van Sickle, vice president of Peridot Corp. in Pleasanton, CA, described the industry as “pioneering, because we’re doing things today that even months ago weren’t possible.”

Indeed, some of this innovation is due to the equipment itself.

Today’s lasers provide a lot more power than former iterations, and they’re becoming cheaper to acquire. In some instances, laser technology can actually save OEMs money when machinery falls short. The ability to weld parts together is sometimes a less expensive way to make a component, compared with spending extra money to form one solid part. The move literally pays off: A device maker can contain costs and still offer a technologically advanced component.

“We’re always trying to get the product to market at the cheapest price possible,” said Hoklas. “It’s a win-win situation. The customer gets a cost reduction, [and] they build confidence in our business because they know we’re looking out for their best interest.”

Today’s lasers also are able to cut longer lengths and cut very precise measurements in the tiniest of parts. Many suppliers have been perfecting the art of focusing the beam and using different wattages to enhance their capabilities.

The types of lasers being used are as vast as the product components they help create. Solid-State lasers are becoming more popular, because they are very stable, operate at high repetition rates and are coming down in price. However, Excimer lasers continue to be useful in ablating certain materials. “They’re very effective in processing heat-sensitive materials because they have limited thermal effects, especially polymer materials,” said Mike Adelstein, vice president of Potomac Photonics in Lanham, MD.

Yet another trend is the conversion from CO2 to Yag lasers, which suppliers say offer more precision and control.

As requests increase for smaller parts, many companies are trying to stay ahead of the curve by anticipating OEMs’ needs. Just over a year ago, Peridot Corp. invested in a highly specialized laser that enables very narrow kerf widths—as small as 20 microns—and much higher cutting speeds than the technology it replaced. “We are in the infancy stages of it,” Van Sickle said, noting that only four other companies in the world have this technology on hand.

“Laser technology is still in its infancy,” Van Sickle said. “It will grow phenomenally—there’s no question about it.”

Smaller All the Time

Since size parameters often dictate that it’s difficult—if not impossible—to physically machine a part, the role of suppliers in developing technologically complex solutions has grown exponentially.

“We are seeing requests for smaller and smaller components,” said Rick Desrosiers, sales manager for New England Precision Grinding in Holliston, MA. “Equipment readily available in the industry today is only beginning to address the needs of miniature components.”  

Many suppliers said they now accommodate needs for parts that are anywhere from thousandths to ten-thousandths of an inch. Some of the mechanisms being used to perform these operations include Swiss lathes and centerless grinding, since these methods offer the ability to effect very intricate shapes and cuts in metal.

Electrochemical machining—while not a new technology—is yet another mechanism that is capable of manufacturing wire to parameters such as a quarter of the size of a human hair.

“You’ll find that, on the whole, everything is getting smaller all the time,” said O’Brien.

“The precision and strict tolerances for the things being made afford the medical device company a competitive edge,” added Lori Beer, president of Potomac Photonics.

The trend toward increasingly tiny components has spurred some suppliers to develop creative, value-added services to serve OEM needs. New England Precision Grinding has advanced its ability to machine smaller parts by creating its Micro-Precision Grinding Center. This center was developed to assist in scaling down the tiny devices needed to reach certain parts of the body.

The Micro Group, based in Medway, MA, solved the make-it-tiny dilemma by developing an in-house tool-making staff, because, as Vice President, Business Development, Bob Lamson said, “we realize a lot of the time that it’s not the machine, but how you move the part within the machine while it’s being processed.”

Faster Turnaround

In addition to the aforementioned challenges, an even greater worry can be meeting increasingly tight deadlines.    

“I joke that we need a drive-up window, because it’s moving that fast,” said Steve Iemma, president and owner of Accu-Met Laser in Cranston, RI.

Most commonly, time constraints are connected with the research and development phase for devices. Whereas in years past a medical device could take years to come to market, products are now getting there in an average of about 18 months. OEMs and vendors alike understand the simple business tenet that being the first product to market can be a huge advantage.

To meet this goal, suppliers try to complete the prototype phase for OEMs as quickly as possible—without compromising the end result. “We provide expedited services as much as possible,” said Mario Vaenberg, business director for Gateway Laser Services in St. Louis. “However, we will not sacrifice quality.”

Some companies have created programs and divisions that are solely dedicated to meeting their customers’ needs at the prototype stage. New England Precision Grinding developed its Rapid Prototype Center to enhance service, because customers want their outsourcing partner to deliver results quickly—even more so in recent years.

Lasers enable a wide variety of cutting patterns and options. Photo courtesy of Accu-Met Laser in Cranston, RI.

“We understand that the sooner customers can get their products to market, the better the chance of capturing market share and winning the race,” Desrosiers explained. “If they don’t win, we don’t win.”

Potomac Photonics also realized the need to better meet quick turnaround times and created its First 2 Market Program. Starting with a “back-of-envelope product design,” the company works with the OEM from concept to production. Adelstein said his company can transfer a drawing to its machinery and complete a design within 24 hours, handily beating the former lead time of six or seven weeks.  

Beer said this type of service enables his company to better work with the OEM during all phases of development. By being so involved in the prototype stage and helping the OEM determine what needs (eg, costs, components) must be addressed during certain phases of development, he said, “they like that we’re thinking about commercialization from the beginning.”    

Ironically, the fast turnaround associated with prototyping doesn’t necessarily extend to the rest of the research and development phase. Suppliers empathize with OEMs’ frustration to get a product to market. “I think everyone would like it to be quicker, and that’s what we have organized, planned and capitalized to do,” said O’Brien.

Maintaining Satisfaction

As suppliers compete for outsourcing business, they are learning that certain investments can give them an edge when OEMs select a partner.

Van Sickle said her company decided to obtain ISO certification in response to pressure from one client to do so. “It required more overhead and personnel, but we did it,” she said. “We’ve seen a lot of our competitors dissipate because they don’t keep up with changes in the industry, but more companies are evolving,” said Van Sickle.

Overall, suppliers are excited by the advances OEMs are developing in the medical device industry and want to ensure customers succeed.

Lamson offered OEMs some practical advice in working with machining and laser processing specialists: “If you are developing a new component, work closely with your supplier, because they understand the capabilities of the manufacturing process. [OEMs] need to leverage that relationship.”

Suppliers agree that the outlook for machining and laser processing is quite good. As machining and laser companies continue to develop complex capabilities to produce ever-smaller parts faster, expect these pioneering companies to make yet more great strides in the months and years to come.