Medical device manufacturing returns to its German roots: bucking worldwide manufacturing trends, CM Instrumente GmbH has recalled manufacturing operations from abroad to its German facilities, using new machine tool investments to regain production control of its range of innovative medical instruments.

Based in Tuttlingen, Germany, home to a cluster of literally hundreds of medical device-related companies, CM Instrumente GmbH has made a strategic move to which many manufacturing people in Western Europe will no doubt raise their eyebrows. But CM's leader, Thomas Bacher, is not like many manufacturers. He is young and ambitious and has resolute ideas about how to recapture market share in potentially the company's biggest market--the United States.

CM is the production arm of sister company, Dimeda, a world-renowned manufacturing brand with more than 15,000 standard instruments to its name, covering human, dental, and veterinary applications, with specific focus on orthopaedics, osteosynthesis, ophthalmology, endoscopy, and urology. CM also specialises in its own line of instruments for cardiovascular surgery, such as aluminium rib spreaders, as well as parts for surgical machines, such as bone-bending presses and drills. The co-located companies have an intertwined history, as does Bacher, who is both the quality manager for Dimeda and the managing director of CM Instrumente.

The turning point in recent company history arrived in 2000, when the new shareholders of Dimeda decided to repatriate the company's manufacturing operations, bestowing the project on sister company CM.

"Before our new shareholders arrived, we used to buy forgings and subcontract the machining out of Germany, but we wanted to pull it back in-house because of issues concerning quality and process control," says Bacher. "If we were going to achieve the kind of quality required to win market share in countries such as the U.S., we were going to have to take control, particularly regarding our cardiovascular range. The shareholders approached me and asked me to build a production unit for these products. We knew that if we produced the components on our own machine tools, we would be able to guarantee the quality--that every item would have the same finish."

The question was, which machine tools?

"We first came across Haas machines 18 months ago, after being invited to an open house at a company called Tontarra in Florida," explains Bacher. "Beforehand, we were contemplating using local machine tool companies--there are two prominent European brand suppliers based near Tuttlingen. However, I knew Tontarra as a company, and I knew how satisfied they were with their Haas machines, so we made some further enquiries. We spoke in detail to the local Haas distributor--Thomas Weber at Tuttlingen based Weber Machines--and to the two local machine tool builders and, to be honest, Haas won on three accounts. First, the price of the Haas machines was unbeatable; second, they provided excellent responses to all of our questions; and last, our production manager had previous experience programming Haas machine tools and liked the control.

"Some of our customers also employed Haas machines, and it seemed that everyone was speaking of them in high regard, particularly on a price-versus-performance basis."

CM subsequently ordered two Haas machining centers: a VF-1 and a VF-2. Ten weeks later the machines arrived and production parts were being produced. The VF-1 at CM is configured with a fourth axis, while the VF-2 is permanently set with dual fixtures to boost throughput. Both have 10,000-rpm spindles. The success of the machines is ratified by CM's decision to buy another VF-1--to be delivered shortly--also with a fourth axis, and this time featuring a 7,500-rpm spindle.

CM's VF-1 is being used to machine a variety of specially designed medical devices, such as "mosquito clamps," which are used to clamp veins behind the heart during by-pass surgery. The VF-1 is able to take a forging and perform all of the machining in a single setup, including a section of tricky-to-machine serrations.

"The success of the machines is apparent when you consider how many machines Haas has sold in a town like Tuttlingen, which is well served by regional machine tool vendors. It highlights the fact that people want choice --if they can buy equable technology for a better price, then they will."

Bacher light-heartedly refers to these previously dominant companies as the machine tool "mafia."

"One of the biggest advantages Haas has provided for us is our independence --we are no longer reliant on external contract manufacturers. We also have total flexibility--able to produce a wide range of different components and products--and we are very well supported by the local Haas distributor," says Bacher. "These machines will help us regain market share in the U.S. As recently as five years ago, 90 percent of our products went to the US, but some of this has been lost, and the new shareholders are keen for the situation to be rectified. The U.S. medical market is the biggest--if a company sells well in the U.S., it will sell well in the rest of the world."

Bacher wryly adds that owning and using U. S.-manufactured machine tools might also be influential in winning new customers from across the Atlantic. In reality, however, quality is the chief factor in the medical industry. With component limits on the Haas machines tied to within [+ or -] 0.02mm, accuracy is key to the success of these products, and with production firmly re-established in Germany, CM, which is FDA approved, is in control. "We were so keen on having the critical working steps take place here, in-house. With the help of the Haas machines we have been able to achieve this," adds Bather.

A single operator, who will soon also be overseeing the third Haas machine, operates both Haas machining centers at CM. This person works a 12-hour shift and is responsible for the programming (using Esprit CAM software) and scheduling of the machines (batch sizes range up to 1,500). As he already had Haas programming experience, the only training required was in relation to the on-board Renishaw TS-27 tool measurement system.

The machines also allow CM to monitor its material, a critical factor in the manufacture of medical devices. When previously subcontracting, CM would sometimes find that the material free-issued to the contractor was being substituted for inferior material, whereas now the company can keep much tighter reins on all of its stock.

The experience that CM enjoyed purchasing and using Haas machines has led company shareholders to insist that Dimeda products are also manufactured using these useful tools.

"The shareholders soon realized the benefits being realized using the Haas machines--and we haven't had a single problem with them," concludes Bather. "Once they are set and running, the quality is consistently good. We use a random sampling plan to check conformance, but they don't deviate. We have successfully been able to bring manufacturing back to Germany because we were able to buy good quality, reasonably priced machine tools." Haas Automation Inc., www.rsleads.com/705tp-152