IMPLANT PROTOTYPES WHILE YOU WAIT

The time is midmorning. The place is a modern, fully-equipped operating room, located on-site in Logan, Utah's IMDS Co-Innovation facility. Three masked orthopedic surgeons are bent in concentration over a test specimen while one of them attempts a delicate spinal implant.

Behind them, several other surgeons and engineers watch the proceedings with interest. Finally, the surgeon performing the operation shakes his head, backs away and holds up the cobalt chrome facet he has been trying to implant.

"This is slightly oversized," he says.

"We have to modify it." An IMDS Co-Innovation engineer, one of the men who helped the doctor design the new implant, steps forward.

"We can take care of that while you wait, doctor," he says. "If you will come with me, we will discuss your modifications with Carlyle Creger, our prototype shop manager." The doctor nods, peels off his mask and follows the engineer, while the onlookers relax.

An hour later, with the modification made, the implant is successful. The doctors depart, satisfied that a new, improved spinal facet implant has been satisfactorily tested.

Prototypes Under Pressure

"That scenario is fairly typical for us," says Creger, who joined IMDS in 2001, shortly after its founding. "That is what we do here. Surgeon-inventors or medical device companies come to us with their ideas for new implants, surgical tools or other products. Medical devices and new implants are highly competitive, so time to market can make the difference between success and failure; which is why we have engineers, doctors, patent attorneys, and manufacturing and marketing specialists available to help them create and take their products to market fast. Once a new product has been designed, tested and approved, if a customer needs it, our IMDS Product Sourcing facilities can manufacture any quantity required from small lots to high volume, but that is totally separate from what we do. Our service area maintains secrecy to protect the new ideas that come to us.

"Often the surgical test lab is reserved months in advance, long before a product design has been completed," Creger explains. "Doctors and other interested parties make their flight reservations, and then, at the last minute, the prototype design comes to us for fabrication. We really do not have the choice to say, ‘Sorry, you did not give us enough time.' We have to have that prototype ready and waiting when the doctors arrive for the test." Although modifications while you wait usually require only a little grinding or other touch up, the prototype shop has the capability to make even more extensive modifications by reprogramming its CNC equipment and producing an entirely new prototype with very short turnaround time.

"About two years ago they spun off our prototype shop," Creger says. "At the same time, they gave us their older machine tools, a 3-axis mill, a lathe and a Sodick Wire EDM. The problem was that many of our prototypes required numerous set-ups to complete, so I requested and got permission to buy a system that would allow us to build our prototypes in one set up." In June 2008, Creger purchased a Mazak Quick Turn Nexus 100MY with a 6" chuck. "That is a good machine," he says. "It is basically a lathe with live tooling, and it produces high-quality parts for us, but it does not have a sub-spindle, and it only has 12 tools.

A prototype part is being set up for production on the Integrex i-150.

We quickly realized we needed a larger capacity of tools and the ability to do 5-axis machining, so we went looking again." In September 2008, IMDS Co-Innovation added Mazak's Integrex i-150 multitasking machining center, which was designed and built specifically for the medical device industry.

"The i-150 was exactly what we needed," Creger says. "First, it comes standard with a 36-tool magazine, with an option for 72 if needed, though 36 works well for us. Second, it has 5-axis machining capability. It has a 12,000rpm milling spindle with 120° Baxis control. The machine is extremely rigid for its size, which we needed because the materials we machine for implants are very hard. Yet, because of our industry, we really need highquality surface finishes too." The thing about the i-150 that pleased Creger most was that with all its capabilities, the machine came in a very small package.

"What surprised me was that the machine delivered the quality parts and the 5-axis done-in-one-setup capability we needed, and it did it all in such a small footprint," Creger says.

Productivity Increase

Another feature that sold Creger on the i-150 was its ability to pick off a part, turn it and hold it for additional operations.

"Not only does this machine have the fifth-axis machining capability on the first op [operation], it also has 15hp, 5,000rpm turning spindle with C-axis control," Creger explains. "So we can turn and rough out a part, do the fifth-axis program that we need, and then the machine actually has a workholding unit with jaws, like a vise.

Clockwise from top-left, a look at the breadth of IMDS' work, showcasing hip, shoulder, spinal and trauma implants.

You can program it to come in pick off the part, take it down and orient it to do a second op. We have found that this is one of the most valuable features on the machine. It saves us a lot of time." Creger uses an inverse of the part geometry to create what he calls soft jaws for the pick-off unit. "We already know the profile that we are going to create on the first operation, so it is easy to create a shape in the soft jaws to pick off and hold the part for final ops [operations]," he explains. "Sometimes orientation is critical for machining the final operations, and this capability makes it fast and easy." According to Creger, the i-150 also delivers all the precision he needs for producing his prototypes. "We commonly get parts in that require tolerances of ±0.001", and often ±0.0005"," he says.

"Mazak Integrex i-150 has given us a tremendous productivity increase," Creger says. "On average, instead of doing 40 different components in a two-week period, we are now doing 60 or 70. Even with that increase, we need more productivity. At the moment we are trying to find enough room in the shop to add a second i-150." In order to maintain separation between IMDS Co-Innovation Logan and IMDS Product Sourcing Logan, IMDS Product Sourcing Logan operates in a 50,000ft2 facility about a mile away from the prototype group.

"We serve a lot of large OEMs that come to us when they want just prototyping services," says Chris Vance, IMDS Product Sourcing Logan director of operations. They are very secretive about their designs and need to feel totally confident that there will not be any cross pollination with the released products we produce here. They have to know that no one else will see their product before patents are issued." At the IMDS Product Sourcing facilities, IMDS produces a broad variety of medical devices and products for major medical device OEMs and private individuals.

"When we started nine years ago as MedicineLodge, we were strictly a prototype shop," Vance says. "But over the years, the company's services and capabilities grew, and today IMDS is an ISO 13485-certified company with more than 400 employees between all our facilities. We operate some of the most advanced equipment available, most of it Mazak. Today, IMDS Co-Innovation is about 35% to 40% of our total sales. IMDS is a growing company determined to stay at the cutting edge of medical device manufacturing. It is going to be exciting to see where we will be tomorrow."

Mazak Corp.
Florence, KY
mazakusa.com