Positioning for Precision

Manpower, tougher materials top challenges among precision machinists and toolers.

Frank Celia
Contributing Writer

Shown above is a WU-305 Linear, Schütte 5-Axis CNC tool and Cutter Grinder. Photo courtesy of Schütte LLC.

A staple offering of consumer media outlets is the “declining number of manufacturing jobs” story. Once a year or so, a think tank or government agency releases figures bemoaning the shrinking manufacturing job sector, juxtaposed against the growing services economy, and newspapers from coast to coast dutifully report this information, usually on or near the front page. These stories project an air of gloom, suggesting directly or indirectly that most of these jobs are being shipped overseas to foreign countries with negligible labor standards.

While such reports and data certainly are accurate—and unemployment at home and slave labor abroad are genuine problems not to be scoffed at—they almost invariably ignore a few highly salient facts. A significant percentage of the manufacturing jobs that have been phased out in the last half century are gone because factories and shops today are far more efficient than ever before. Furthermore, these efficiencies, while the cause of lamentable job loss, also have an upside.

As anyone older than the age of 35 can tell you, the prices of menu items at McDonald’s have not risen significantly since mid-1980s. Nor has the price of a DVD rental. Ditto a pair of name-brand sneakers. The list goes on. Why? In last 20 years, there has been a veritable revolution in manufacturing cost effectiveness, and these savings have been passed along to consumers.

But what is good news for the consumer can be a headache for a plant manager. Advances such as automation, robotics, computers, CAD software, outsourcing, etc. help to boost the bottom line, but they also can create a challenge to find employees qualified enough to implement and maintain such complex tools.

Thus, we have the paradox of an undersized qualified labor pool being a perennial complaint among medical device manufacturers and their contractors in a world constantly mourning the loss high-paying manufacturing jobs. The problem seems especially acute among precision machining and tooling shops, where a company’s reputation largely sinks or swims based on the expertise of its personnel. In the orthopedic field, companies bear the additional burden of materials that are getting harder and more durable (to resist wear and remain in the body longer) and product and component shapes that are becoming more complex (as is the case with rod and shaft-locking methods in spinal implants, which grow ever more convoluted).

Following is a look at how these forces have shaped companies that provide precision machining and tooling for the orthopedic industry.

Manpower

Micro Precision Swiss, located in Rancho Santa Margarita, CA, provides precision machining for biomedical implants. About half its business derives from orthopedic clients. As with many companies in this field, it is undergoing considerable growth. In the last two years, its machining capacity has increased by 30% and its staff size has increased by 20%. It also recently purchased three other companies. President Andy Mead said managing this type of rapid growth is a major challenge, especially in terms of staffing.

“Finding really qualified employees is tough,” Mead said. “Finding them at a rate that we can absorb them and train them and upgrade their skills is a challenge. So we are constantly looking for employees. If we find a good one, we are going to put that person on staff, whether there is a need that day or not—just so we are continuing to grow.”

Not surprisingly, when a company does manage to put together a highly qualified staff, that fact alone becomes a significant marketing strategy. At Miltronics & Skye, based in Mentor, OH, customers are offered state-of-the-art manufacturing equipment, the most recent including 13-axis Swiss CNC machines, multi-axis, high-speed mills and 5-axis machining centers that can handle the most complex medical devices. But according to Sales Manager Chris Rawlins, it is the company’s employees that set the company apart.

“We employ very technically sound people, from our engineering department to our shop floor,” he said. “I believe it’s our people and their skills that separate us from the pack. The combination of high-tech equipment and highly skilled operators allows us to be very competitive in a market where other contract manufacturers may find it difficult to survive.”

A company’s longevity, history and culture also can help it distinguish itself. In existence since 1948, Oberg Industries, of Freeport, PA, was founded by Donald E. Oberg, who pioneered the use of tungsten carbide components in the manufacture of high-speed stamping dies. Carbide revolutionized the tool and die industry because it offers about 10 times the wear resistance of high-carbon, high-chrome tool steels. This kind of extensive history gives the employees there a unique perspective on the industry, said Shawn E. Schafer, director of marketing and strategic planning at Oberg. It is a variety of what he calls “tribal knowledge” that cannot be matched by shops that have been in existence for only 10 or 20 years.

For example, Oberg offers all the traditional services of a precision machining shop: 3- and 5-axis machining, wire EDM, precision turning, etc. But for some jobs, precision metal stamping might be more efficient than machining. “Stamping is something that most designers out there are not familiar with,” Schafer said. “Most of the folks that are in this business have been around since maybe ’85 or ’95 and above. They are not going to have access to our kind of tribal knowledge. So everything in the market gets designed around available technology, and they might not even consider an option like stamping. To me, this kind of background a big differentiator at Oberg.”

So great is the value placed on personnel that some companies actually offer contract staffing as a service to their clients. Mahar Tool Supply Company, headquartered in Saginaw, MI, provides tooling to a wide variety of industries. It does a small but growing percentage of its business in the medical manufacturing field, mostly orthopedics. As a value-added service, it also furnishes staffing to its clients in the fields of purchasing, technical and logistical positions, according to Mike Kovaleski, president of the company.        

“Most of our customers, their core competency is the design and manufacture of instruments,” he said. “They are experts at that, and also they are experts at the outbound logistics of their products—that is, getting the right implants and instruments to the operating room on time…But the inbound stuff, the tooling, the different things they need to get a manufacturing job done that need to be brought into the plant—sometimes they struggle with this stuff. We can do a great job at it. We focus and specialize in that.”

Harder Materials

As the market for orthopedic implants grows, more companies enter the field and more products are introduced. When a field grows crowed with competitors, slight differences among the products take on greater importance and are touted in advertisements and marketing campaigns. Currently, this can be seen occurring in the field of primary total knee replacement, which by 2011 financial experts predict will be a market worth more than $5 billion in the United State alone. Patients themselves now are being targeted. In 2006, industry leaders such as Stryker and Zimmer began promoting gender specific knees, which are specifically designed to fit the unique anatomy of women. Network television routinely airs commercials publicizing knee implants, and celebrity endorsers Angela Lansbury and Jack Nicklaus have been enlisted to add luster to brand identities.

A significant area of competition among these products is expected to be an implant’s lifespan. The generation in middle age today can expect to live longer than any one before it, and because implant surgery tends to be very invasive, no one wants to undergo this surgery more than once if possible. That is why OEMs are pushing their contractors to work with harder, more durable materials that will last longer in the body.

“Changes in the orthopedic field that we as a manufacturer have seen involve the materials used…an increase in the wear resistance and yield strength are foremost,” said Al LaVezzi, president of LaVezzi Precision, Inc., based in Glendale Heights, IL. “One notices for the first time that the major players in the hip and knee implant business are actively advertising in all media, especially on television. As the population ages (and grows more obese) this market will expand from a few hundred thousand to millions per year. The requirement for new materials, which will alleviate the need for replacing these implants due to wear, is tremendous.”

Also, the growth in spinal fixation systems has caused the development of new, stronger materials and a number of unique methods for the fixing of the rods to the sleeves or brackets, through which a vertebra bone screw passes, LaVezzi noted.

“The design of these sleeves, brackets and screws, due to the material and the part geometry, presents a challenge to the manufacturer,” he said. “Multiple axis Swiss lathes, with the capability to do internal and external thread whirling, are mandatory.”

The companies that flourish will be the ones can handle these tougher materials, noted Oberg’s Schafer. “Oberg has experience with very hard materials like ceramics, like tungsten-carbide, and carbides in general. As we see implants going into these very hard, longer lasting materials, the play that we have is we have been working with these very difficult to grind and machine materials for nearly 60 years. That brings a whole new level to our expertise,” Schafer said.

In addition to its traditional and broad knowledge base, Oberg is taking steps to develop new technologies. The 700-employee company has an advanced operations group whose sole responsibility is developing new machining and turning technologies to cut and form materials. One area of study is to develop ways of removing material while minimizing stress on the part. “There are a lot of benefits to being able to machine something without inducing stress,” Schafer said, adding that the company is very close to unveiling a process which will do just that, though for proprietary reasons he could not discuss it in much detail.

“What I would call it is a reverse plating process,” he explained. “Plating adds material to a substrate. With this process, we are actually removing material from the surface. And there is no stress involved, and very limited physical contact. It’s something we have in the works. A lot of orthopedics folks we have talked to are excited about this technology; I just can’t get into much detail.”

 The much increased use of surgical plates, having a myriad of shapes and sizes, requires that the manufacturer have the capability to perform simultaneous 5-axis machining on the toughest implantable alloys, according to LaVezzi.
    
“As with most implants, this requires the ability to move the designer’s ideas from his file to your CAM program. Also, a Coordinate Measuring Machine with an articulating probe and scanning capabilities helps to deliver parts that meet specification,” he said.

The powered hand tools used in today’s operating rooms, whether for minimally invasive or open surgical procedures, are constantly evolving to accommodate the surgeon’s needs, added LaVezzi. “They are light in weight, machined to ensure a good grip yet not tear a glove, finished to ensure a non-reflective surface. The cutting tools (drill and burs) are now made of steels able to reach a higher hardness while still being autoclavable. More attention is paid to the geometry of the cutting edge of these tools, to ensure that cutting action is smooth, with no heat buildup,” he said.

Tooling

Quality precision machining on very hard surfaces cannot occur without quality tooling. The Schütte WU 305 Linear Universal Tool and Cutter Grinder is gaining a reputation for quality work in the orthopedics manufacturing world. The machine is not cheap but is considered worth the cost because it delivers true 5-axis capability and the high level of precision necessary for medical implants.

One of the keys to the machine’s speed and the extremely fine finish it can deliver is the fact that it employs linear motors, as opposed to the ball screw mechanism used in older versions of the WU 305. David W. Brigham, director of the grinding division at Schütte TGM LLC, based in Jackson, MI, explained the difference.

“With a linear motor the speeds and feeds are a lot faster,” he said. “But the key advantage is you can obtain a lot better finishes. There are no herky jerky movements, like the kind you get with ball screw technology.”

Brigham added that another advantage of the WU 305 is its unique coolant system that can handle grinding dust, milling chips, sandpaper grit and the ruby rouge generated by various machining operations.

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As the companies in this field adapt to a diversifying market, a constant refrain among their leaders is the need to differentiate themselves from the pack, to offer something no other company can offer. “We try to position ourselves as a little bit of a different player,” noted Schafer. “That’s our main strategy.”

Frank Celia is a freelance healthcare writer based in the Philadelphia area.