Continually looking to produce smaller and more intricate metal parts in less time, metal processing shops are trying to keep up with the ever-increasing demands of OEMs. In what had been at one time a market dominated by machining companies, medical OEMs are increasingly turning to partners with laser processing capabilities for better parts.
To keep up with customer demands, metal processing firms such as Marox Corp. employ a spectrum of precision tools such as this Citizen M20 Swiss screw machine to manufacture small-diameter turn parts including bone screws. Photo courtesy of Marox. |
Not only is the number of laser processing companies growing, but machining companies have added laser processing capabilities to their offerings as well. This is in response to demand for tighter tolerances, faster turnaround and growing use in new materials.
Be it machining or laser processing, contract manufacturers say OEMs’ most pressing demand is for shorter processing time. With a domino effect stemming from medical device company stockholders, the pressure to deliver product more quickly has trickled down to the contract manufacturers.
“The biggest challenge is time,” said Joe Popper, president and CEO of Popper and Sons of New Hyde Park, NY. “Everybody is looking for parts super fast.”
Precious Time
With time to market growing more critical these days, medical OEMs are giving their outsourcing partners less time and advanced notice to complete projects. Demand for shorter turnaround times has led service providers to invest in new technology and set up systems that enable a more rapid response. Potomac Photonics of Lanham, MD, for example, boasts that it can complete prototypes within 48 hours.
“We put technology in place so that we are able to do that because everybody is looking for their parts yesterday,” said Mike Adelstein, vice president of Potomac Photonics. “We tried to set up systems that are capable of doing that. We get their software file, run them and get (the parts) to them quickly.”
Brad Rosenkranz, vice president of sales and marketing for Marox in Holyoke, MA, said OEM customers might shelve a product for some time and then unexpectedly ask for it to be built within a short time period.
“All of a sudden the green light is on and the buyers says ‘I knew that you have looked at this project seven months ago, but we need the project right now,’” said Rosenkranz.
Time is especially important in the production of prototypes, said Al LaVezzi, president of LaVezzi Precision, Inc. in Glendale Heights, IL.
“They want to see it right away,” he said. “The main thing is that once you get into production, you meet the schedule they ask for.”
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Hip implant parts are manufactured with the Mori Seiki MT 2000 turn mill machine at Marxo. With customers demanding more precision in less times, machining shops are making more investments in capital equipment. Photo courtesy of Marox Corp. |
Tighter Tolerances
At the same time that medical device manufacturers are demanding faster responses from their machining service providers, they are also insisting on tighter tolerances, reaching as low as .0001 inch. Despite steady progress in machining capabilities, some contract manufacturers say the tightening of tolerances may have peaked.
“It almost seems like we [have reached the lowest tolerance level]at the moment with the equipment that we have available,” said Bob Elliott, cell manager of MicroGroup in Medway, MA.
Adelstein pointed out that the industry has reached the one-micron level, which for now, seems to be adequate for most applications.
“We just got down to that a couple of years ago,” added Adelstein. “We’re pretty comfortable with that, and the technology is still ahead of the curve of what most people are asking for. We do have some bio-tech companies that are asking for that level.”
Micromachining has leveled off in areas such as orthopedics, but demand for finer parts continues to grow in the heart surgery area. “It is still trying to get smaller and smaller because they are trying to get into a smaller opening all the time and make it less invasive,” said David Ehlers, director of business development for Metal Craft Machine and Engineering in Elk River, MN.
But future trends could lead to sub-micron specifications.
“There are new laser systems coming out in the picosecond (one millionth of one millionth inch) and nanosecond (one billionth of a second) pulse regime that will allow us to do features sizes that will be submicron going into the nanometer scale,” said Kevin Hartke, manager of sales and marketing for Mound Laser and Photonics of Miamisburg, OH. “There is a defraction limit in how small you can focus a laser. Also with new pulse technology that’s available, you can use a small portion of the beam to do the processing. It allows you to get and gain feature sizes that are below a submicron.”
Mound Laser and Photonics has been involved with medical devices for the past five years, but half of its business is with the U.S. Department of Defense. Hartke said the company is increasingly shifting its R&D work with the defense department to the medical device field.
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Increasing Complexity
While meeting time mandates and tighter specifications pose a big challenge, some contract manufacturers see another hurdle as machinery becomes more complex: finding qualified operators to man their operations.
The machines “have become more sophisticated,” said LaVezzi. “An educated workforce is the biggest challenge for the coming years. Schools are just not stressing the occupation like they do with others.”
Related to the challenges of staffing is the contract manufacturer’s ability to stay current with the technology. Popper said his company must “continually stay up-to-date with the latest equipment that’s available because parts seem to be getting smaller and smaller,” he said. “It’s having up-to-date equipment. We have a big program for equipment reinvestment and staying on top of new technology.”
Another problem that machine shops often encounter is demand for parts that are impractical to make. “The biggest challenge in machining is often trying to make parts that have been designed with no thought given to the feasibility of being able to manufacture the part,” said Kevin Noble, vice president of Norman Noble Inc. in Cleveland.
Laser processing manufacturers say they are especially hard hit by unrealistic expectations.
“They (OEMs) don’t always realize that what they are designing may not always be possible,” said Mario Vaenberg, business director and partner of Gateway Laser Services in St. Louis. “Just because they think you have a laser, it doesn’t mean you can put a hole through anything. You always have to take into account your thickness of the feature material to what you want done.”
Increasingly, OEMs are expressing preference for service providers with broader capabilities than just one specialty. In part, this trend is driven by procurement managers wanting to consolidate the number of vendors they use. Machining shops are responding by investing in more products and services.
“They (OEMs) are looking to partner with companies that can do vertical integration, that have multiple machining capabilities in there,” said Jack Fulton, vice president of sales and marketing of Specialized Medical Devices in Lancaster, PA. “They aren’t strictly looking for a turning house or milling house or wire Electrical Discharge Machining (EDM). They are looking for somebody who can do all of it at one facility. The challenge is making sure that you have all those services under one roof, which we do.”
Adelstein, however, believes companies will always make sure they have a second source.
“Most companies, when it (a product) gets to production, will find a second source to protect themselves,” added Adelstein.
Tanya DiSalvo, operations manager for Criterion Tool of Brook Park, OH, said that while OEMs want a one-stop shop, they are tentative to use it. “I think in theory it’s nice to have a one-stop shop to have all the pull and problem solving and understanding all the requirements,” said DiSalvo. “But when we have been a one-stop shop, we have been told that ‘You are doing an outstanding job, but we can’t afford to have all of our eggs in one basket.’”
LaVezzi, however, disagreed, saying that he sees OEMs wanting a manufacturer that does it all.
“They don’t want to receive a part that they have to in turn send out for plating or laser marking,” he said. “The bigger manufacturers like Medtronic and Bausch & Lomb, they don’t want to have two sources on a product as far as getting anything complete. They want one source complete.”
Be it one or multiple sources, OEMs tend to be demanding on all of their vendors.
“Lead times are definitely always a challenge, especially when the industry gets loaded up like now,” said Rosenkranz.
One trend that might enable a single contract manufacturer to produce a complete part is the continuing development of multi-function equipment capable of performing various machining tasks.
“That’s the biggest thing I see today,” said Bob Elliott, cell manager of MicroGroup in Medway, MA. “You are trying to constantly drop a part off that is complete. The next step is to go to cleaning it, ship it or weld it to something. More and more of this stuff we do are multiple operations that are done within that operation because you have a multiple axis working.”
One of the services demanded by OEMs in the past few years is EDM. It is considered to be one of the most accurate manufacturing processes available for creating complex or simple shapes and geometries within parts and assemblies. There are two types of EDM: wirecut and die sinking. Ehlers said the demand for EDM is growing.
“It’s still the most accurate thing that you can do for a tight tolerance,” said Ehlers. “In the last six months we’ve added three EDMs to our capacity because there is so much [demand for] EDM going on in the work that we are doing.”
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Laser Processing
While EDM is one process in hot demand, the growth in laser processing is even hotter, be it cutting, marking or welding, according to Elliott, whose company offers both processes.
“EDM has been a steady increase for us, but laser over the last two years has been going crazy,” said Elliott. “We’ve been buying all kinds of equipment and running 24 hours a day in the laser area.”
There are several advantages to laser processing, including intricacies of designs, decreased manufacturing times and lower manufacturing costs. While the lasers are costly, it can process some parts more cost effectively than traditional machine tools.
“You get a nice clean [cut],” said Elliott. “When you do the cutting, there are no burrs. You can get down super small. When you look at the welding, you can’t even tell that there is a weld there. It does such a beautiful job.”
Another advantage for laser processing is in performing R&D work and rapid turnaround prototyping.
“The customer can call up the day after [delivering the design file] and change the part completely, and it’s not like a tool becomes obsolete,” said Patrick Pickerell, president of Peridot Corporation in Pleasanton, CA.
In the future, many laser processing service providers are expecting the technology to become cheaper, more precise and simpler to use.
Despite having been used in medical device manufacturing for several decades, laser processing remains shrouded in misconceptions.
“There are guys out there who think it is a magical tool and they don’t understand that it is just another cutting or joining technology and that you still need to use good engineering practices,” said Steve Iemma, president of Accu-Met Laser, Inc. of Cranston, RI. “You need to validate and test your device and quantify the process. You can’t just say, ‘Well, you are using a laser, make it real strong in terms of a weld.’”
Another misconception is that heat from the laser will negatively affect the material. “Many people don’t realize that the heat-affected zone in laser processing is extremely small and very controlled so people sometimes worry that you are going to burn up the part or soften it,” said Pickerell.
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Material Trends
Even as machining and laser shops focus on process improvements, their customers are looking to new materials that offer greater strength, cost efficiencies and better manufacturability. The current trend in materials includes a movement toward plastics such as polyethylene, ceramics and more exotic materials such as Ultem and nitinol, a super-elastic, shape-memory alloy. As the implantable market experiences strong growth, product developers are looking for new materials to improve biocompatibility and comfort to patients.
“The body does not want to have a piece of metal in it,” said Fulton. “Imagine you carrying around a bar of stainless steel or a bar of titanium. Titanium is much lighter, so if you are going to have something in you, you want it to be lighter.”
Similarly, nitinol is used extensively in the industry for stents, dental implants and endoscopic devices.
With OEMs turning to a variety of new and existing materials to help them improve device performance, they are increasingly relying on machine and laser shops to help process these parts. At the same time, they are imposing the same demands on manufacturers that they have for years: quick turnaround times, an ever-tightening tolerance and the flexibility work with a broad range of materials. Service providers investing in capabilities, equipment and training find that they are able to keep up with their customers’ requests.