Modernizing Machines

Updating equipment can help foster change and drive new technology.

Michael Barbella

Machines are the lifeblood of manufacturing. They have been the driving force behind modern progress, enabling inventions such as the automobile, telephone and computer to be mass produced and consumed on a global level. Throughout history, machines have been the facilitators of change, turning agricultural-based societies into industrial powerhouses and creating a global marketplace that is instantly accessible.
  
To be true facilitators of change, however, the machines themselves have had to change. One of the reasons the Industrial Revolution was so successful was because the manufacturing machines of that period kept adapting to new technology. The textile industry is a perfect example.
   
The earliest textile machines were hand-powered and only could spin eight threads at once. The first improvement to these machines—called a Spinning Jenny—allowed the operator to spin 80 threads at once, while further enhancements enabled the machine (renamed a Spinning Mule) to spin 400 threads at once and be powered by steam engines. Later incantations led to the development of the power loom, the cotton gin, the automatic weaving loom and other mechanisms that contribute to the process used today to manufacture textiles.
   
The machining and tooling industry serving orthopedic companies has experienced the same kind of evolution. Suppliers and contract manufacturers in this sector continuously upgrade their equipment to satisfy customers and remain competitive.
   
“Most of us supplying the industry are constantly upgrading our CNC milling and turning equipment as well as any inspection equipment based on our customers’ requirements,” said Sean M. Stowik, sales and marketing manager for Preferred Tool & Die Inc./Preferred Precision, a Shelton, CT-based manufacturer of stamped and machined parts and subassemblies.
   

Swiss turning machines such as the one pictured above enable manufacturers of orthopedic device components to perform several operations at once, saving time and money. Swiss turning is used to make small, slender, precision components. Photo courtesy of Metal Craft.

“Tooling continues to evolve, affording us the ability to machine harder materials and some of the newer materials. Our manufacturing team regularly meets with machine tool representatives to keep up with new tooling and material technologies,” he added.
   
Preferred Tool uses multi-axis machining centers and Swiss-type turning centers to make close-tolerance CNC-machined medical components, surgical implants and parts with scientific applications. Several months ago, the company purchased several new high-speed machining centers that offer milling capacity comparable to a 40-taper machine.
   
The machining centers were purchased as part of a program Preferred Tool instituted to replace aging equipment. But the machines also were chosen for their ability to meet customer tolerance and quality requirements, save the company time in manufacturing parts and because they were a “perfect fit” for a project that has been in development for several years, Stowik said.
   
The decision to purchase the new equipment was a relatively easy one for Preferred Tool. Usually, these choices are not so clear cut. Stowik noted that various factors are taken into consideration before the company determines whether to upgrade its equipment. Naturally, the most important of these factors is the evolution of customers’ requirements followed closely by cost.
   
“Our decision is based on the scope of the project we are looking at,” Stowik said. “It may require that we purchase new equipment, or it could be developing an innovative approach in-house utilizing the expertise of our tool and die facility to develop specific fixturing that allows use of our existing equipment. In most circumstances, we will sit down with our engineering and tooling group and decide what the best approach is for both our customer and Preferred. Each project may have unique circumstances in which we need to make the decision between utilizing existing equipment or purchasing new.”   

Sometimes, the executives at Preferred Tool contact the machine’s manufacturer to help them decide about upgrading equipment. “It’s an internal investigation initially. Sometimes we can develop an approach to make the part internally, but if we can’t come up with a robust process that we’re comfortable with, we’ll seek the support of the machine’s manufacturer,” Stowik explained. “We’ll contact the machine manufacturer and say, ‘this is what we’re looking to accomplish. Can we make it with your machines?’”

Executives at LaVezzi Precision Inc., a Glendale Heights, IL-based manufacturer of components for the medical industry and various other sectors, have a different approach: They don’t let equipment manufacturers help dictate any upgrades but, instead, let customer needs justify decisions to make upgrades. President Al LaVezzi said his company has had to regularly upgrade its machines to make more complex components and keep up with customers’ expectations.

“Obviously, [customers] want to see that their supplier has the latest equipment, is able to maintain the production flow and has inspection equipment that meets or exceeds their in-house systems,” he noted. “You always have to look for better methods of manufacturing, and that doesn’t always mean new equipment. It could mean different accessory tools. It’s something you have to keep on top of to keep your costs down and make the process less labor intensive.”

Complex Parts

Customers also expect manufacturers to be able to produce orthopedic device components that are more complex. While there is no doubt that components have become more complex in recent years, industry experts are divided on the reasons for it. Stowik of Preferred Tool speculated that the penchant for more complex parts is driven by a desire among medical device companies to continually improve their products’ safety and performance. Or, it could just be part of a product’s natural evolution.
   
“With new innovations, our customers are always looking at current designs and evaluating opportunities to improve the design, functionality, and safety,” Stowik noted. “Utilizing surgeon and patient feedback, they’re building upon existing designs and as a result, they’re developing products that are more innovative and complex. The new shapes and features that are developed provide additional functionality to patients.”

David W. Brigham, vice president of Schütte TGM LLC in Jackson, MI, offered another reason for the increasing complexity of orthopedic device components: the ability to produce parts—particularly those for the spine and smaller joints—from manmade or natural materials. 

To achieve the requirements of a complex device component, companies often must upgrade their existing equipment or buy new machines. LaVezzi, for example, said his company recently installed its third Willemin-Macodel 5-axis mill to stay abreast of the demand for more complex parts.

Willemin-Macodel mills machine parts such as spinal and extremity implants by milling and turning them in one cycle, eliminating the extra steps that are required in other machining processes. These mills simplify the manufacturing process and reduce the costs associated with manufacturing medical components, according to LaVezzi.

“Components have become more complex with more facets,” said LaVezzi. “To meet the challenge, we must constantly upgrade our manufacturing capability, [such as] more axis on the Swiss [turning] equipment and multi-form grinders. The small size of many of the components we manufacture makes it almost impossible to fixture to perform secondary operations, so it is imperative to do the work in one operation whenever possible.”

The demand for more complex orthopedic device components prompted Metal Craft, based in Elk River, MN, to buy several new Swiss turning machines in the last year. The move enabled the company to perform several operations on one machine rather than three separate ones.
     

The Cost of Upgrading Equipment

Besides simplifying manufacturing operations and enabling them to produce more complex parts, suppliers and manufacturers of orthopedic device components are finding that regular upgrades to their machines can reduce product cycle times and cut costs.

Brigham said he has noticed an increasing number of customers are looking to reduce costs by combining several manufacturing steps. To meet the demand, Schütte’s parent company—Alfred H. Schütte GmbH in Cologne, Germany—makes machines that can grind, mill, belt sand and polish in one step. “We have experienced more and more customers looking for this type of machine because of the demands for lower prices for the parts they manufacture,” he explained.

In addition to reducing product cycle times, new equipment can perform more accurate work, which helps cut down on the amount of rejected products. New or upgraded equipment also can help companies increase their manufacturing capacity and reduce cycle times, which ultimately leads to a cost savings. And fewer rejected products mean fewer customer returns.

This piece of equipment has both probe and laser capacity that allows manufacturers to inspect complex shapes and features of orthopedic devices. Photo courtesy of Preferred Tool & Die Inc./Preferred Precision.

New equipment, however, does have its limitations. Machining companies that produce prototypes for startup orthopedic firms can find it challenging to keep costs down and reduce cycle times when the part they are contracted to produce constantly is undergoing changes. These changes not only can be costly, they also can be frustrating, particularly when the plans for these prototyped parts change as quickly as a company can make the parts. One  manufacturer of orthopedic device components told ODT that it is not uncommon for plans to change overnight, rendering all work done in the previous day useless.

To avoid any misunderstandings, some companies warn customers in advance about the possibility of incurring additional costs when making prototypes. In many cases, the extra charges are unavoidable.

Industry experts said most companies understand the reasons for  additional charges for raw materials and time. Past experience has taught them that constant changes are going to increase the amount of scrap involved, drive up costs and extend product cycle times.

Though it is the goal of every company to reduce costs whenever possible, it is not always easy to do, particularly when the price of materials rises. With fuel costs up 80% compared with last year, companies such as LaVezzi have had no choice but to pass on the increase to customers. LaVezzi, however, pointed out that fuel and materials costs comprise a “very small percentage” of the final cost of the products his company manufactures.

Most machining and tooling executives admitted that ballooning fuel and materials costs have driven up the price of manufacturing orthopedic device components. However, other factors are driving up the price as well, they noted, including engineering services, programming services and inspections. Rising prices have forced many manufacturers to come up with innovative ways to reduce product cycle times and increase accuracy. But with Lean manufacturing initiatives already in place, it can be difficult to find areas that warrant further cuts, which has left companies facing a grim choice of either absorbing the price increase or passing it on to customers.

At Metal Craft, a company that supplies various parts for the medical device industry, executives have dealt with skyrocketing fuel and materials costs by determining whether the orthopedic components it manufactures can be produced at a lower cost without compromising quality. “The real challenge has been that every one of our suppliers has been trying to get us to shave costs off the parts,” said Shawn D. Peck, sales and marketing director for Metal Craft. “Our suppliers are not going to reduce the cost of materials when those costs are rising. So what you have to do is use your expertise in manufacturing to look at the part and figure out in the manufacturing process how you can make the part better or less expensive without compromising the quality.”

Schütte has experienced the same rise in manufacturing costs as most other companies but also has had to deal a challenge US-based businesses don’t necessarily have to contend with: the decline of the US dollar. “The euro to US dollar has been our biggest challenge,” Brigham noted. “Our machines have increased in price to our US customers due to the fluctuation in the currency.”

Striving for Perfection

Perhaps one of the most vexing challenges currently facing manufacturers of orthopedic devices is meeting OEMs’ demands to make parts quickly and flawlessly. Device makers said they have noticed an increasing number of customers asking for parts that are both dimensionally and visually appealing. In response to this demand, companies must invest in new equipment that provides the kinds of textures customers want. Preferred Tool, for example, recently bought new finishing equipment to make its parts picture-perfect.

“As parts are processed off of machining equipment, some burrs may remain or it might have some slight milling marks,” Stowik noted. “Our process is to put it through our tumbling process to remove any imperfections and clean up any potential tooling marks, so before the parts get sent out for any special finishing or anodizing process, they look as good as they can. All the anodizing will do is highlight any imperfections of the parts, so the parts have to look as good as they can before they leave our facility.”

Though the reasons for this penchant for perfection are numerous, industry experts speculated that it is related to the more complex shapes and features of today’s orthopedic device components. It also could be related to a perception among medical personnel to use medical devices that are the most visually appealing.

Greater Process Validation

Besides being asked to make unblemished parts, companies also are expected to more closely validate their manufacturing processes and facilities. Industry experts attribute this trend to the increased pressure OEMs face from the FDA regarding quality standards.

Facing pressure from federal lawmakers to improve its quality standards, the FDA has begun to hold OEMs more accountable for the quality of the products they want to market. And the OEMs, in turn, are raising the process validation and inspection standards for the contract manufacturers that support them.

With process validation playing a more important role in the quality of manufactured products, a much greater emphasis also is being placed on inspections, manufacturers said. This focus on inspections forces companies to spend more time inspecting parts, which ultimately adds to product cycle times. Plus, the complexity of parts has made inspections more difficult, and that difficulty can contribute to longer cycle times, industry experts noted. 

Besides prompting a more thorough inspection process, the focus on higher quality standards also has caused customers to become more interested in process changes than about the way their product is made. “For the most part, customers are not that interested in how the part is manufactured as much as they want to know of any process changes made once the component is in production,” LaVezzi noted. “Once they receive approval for a product, they don’t want to make any changes because they’ll have to go back to the FDA and go through another approval process. Once you get approval for a product, you are not going to want to go back and change it.”

The trickle-down process of raising quality standards has prompted many companies to attain ISO 13485 certification. While orthopedic device makers are not required to have such certification, some companies are willing to go the extra mile to obtain it because they know it will help improve their quality standards. It also helps to reassure customers about the stability of their manufacturing processes and practices.  

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Certainly, machining companies that upgrade and regularly replace their equipment can keep costs down and reduce product cycle times. But the upgrades also help drive the technology that has enabled firms to manufacture products with complex shapes and parts as small as 1 mm (or even smaller).

Most important, though, by continuously upgrading equipment, machining and tooling companies are promulgating the kind of change that rapidly is transforming the industry and enabling them to stay competitive in the global marketplace.        

SIDEBAR:

Demand for Spinal Products Is Skyrocketing, Benefiting Machinists

The spine is one of the most important parts of the human body.

Besides providing support, the spine houses part of the central nervous system, where thought processes and motor skills originate.

Comprised of vertebrae that are separated by discs and supported by muscles and ligaments, the spine is built to be flexible. That agility, however, can also lead to trouble.

Back pain affects an estimated eight out of 10 people, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The prevalence of back pain has helped contribute to an increase in treatments and to the need for medical devices to help rectify the condition and other spinal disorders. The demand for spinal devices has risen faster in recent years than any other sector of the orthopedic device market.

Shawn D. Peck, sales and marketing director for Metal Craft, an Elk River, MN-based supplier of various parts for the medical device industry, said he has noticed an increased number of foreign companies attending medical device trade shows in the United States to find American manufacturers of orthopedic components, particularly those for the spine.

“The spinal orthopedic market is showing an increase for sure,” Peck said. “The lead times [for products] are three or four weeks further out than they ever used to be because the orders are growing so much.”

The global orthopedic spinal device market is a multibillion-dollar industry that is expected to achieve double-digit growth annually through 2011. In 2006, the market was worth an estimated $5.3 billion—more than the knee implant sector—and is one of the fastest-growing markets in orthopedics, according to the World Orthopaedic Market Report 2008 released by Espicom Business Intelligence in December.

David W. Brigham, vice president of Schütte TGM LLC in Jackson, MI,  attributed the explosive growth in the spinal orthopedic device market to the availability and decreasing cost of 5-axis machines that enable companies to produce parts quicker and more accurately. He also cited the greater availability of machines and tooling for miniature parts as reasons for the increase.

Sean M. Stowik, however, drew a correlation between the growing demand for spinal devices and the benefits of back surgery.

“We have been making spinal implants for several years now, and we do see an increase in activity,” said Stowik, sales and marketing manager for Preferred Tool & Die Inc./Preferred Precision, a Shelton, CT-based manufacturer of stamped and machined parts and subassemblies. “I think people are more willing to explore the possible benefits of surgery, and making the decision to move forward has become easier due to less invasive procedures and the documented results. The population of people with chronic back pain continues to grow, and surgery has become a more accepted and accessible approach. And the results of the new technologies have proven to be extremely beneficial.”

Stowik said he also has noticed an increased demand for components used in products for smaller extremities such as fingers, toes and ankles. This is a fast growing market—and although not nearly as large as the other orthopedic implant sectors, it is a future growth opportunity for Preferred, he added.