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This progressive die (with strippers removed for clarity) was developed by Oberg Industries and runs at its plant in Sarver, PA, to produce five different sizes (four shown here, above) of frame stampings for a Covidien TA DST Series open surgical stapler. Oberg developed two dies for the stapler, one to make right-hand frames and the second to make left-hand frames. Each die comprises 19 stations and runs at 70 strokes/min. in a 300-ton Minster E2-300 Hevi-Stamper mechanical press. Material is fed through a Herr-Voss precision leveler to help maintain part-flatness tolerances of ±0.002 in./1.000 in. Also critical is true hole position, to ±0.002 in.; maximum burr height is 0.002 in. Shown in the close-up photo is the punch shoe, with stripper removed.

Trends governing the growth of this lucrative industry? There are more doctors and dentists than ever before. And, more and more patients expect portability from their devices, to deliver care at the bedside or even away from home. Examples (offered up by Phil Salditt, director of customer development for Plexus Corp., a manufacturer of printed circuit boards for the medical-device and other industries, in his paper titled, Trends in Medical Device Design and Manufacturing) include products for cardiac pacing, pain management, drug delivery, and blood-chemistry monitoring. All of these new products require a fresh approach to design and functionality, including ruggedness, wireless connectivity and a user-friendly control interface. And, manufacturing volumes, particularly for disposable medical products, have risen exponentially in some cases, forcing manufacturers and suppliers to add automation to their production and assembly lines.

New Quality Standard Gaining a Foothold

Critical to tier manufacturers along the medical-industry supply chain is diligent attention to quality, governed up and down the supply chain by ISO 13485—Medical Devices—Quality management systems—Requirements for regulatory purposes. While still not widespread, more and more suppliers have recently begun to work toward becoming certified to this standard, which underwent a significant upgrade in 2003.

The Weiss-Aug pressroom features Bruderer high-speed presses from 20 to 90 tons. The firm’s expansion in the medical arena has focused on developing strategic customers—those that would generate at least $1 million in annual sales. Weiss-Aug specializes in new-program development, assisting OEMs early in the design stage of products such as the surgical disposables shown here, to ensure quality and manufacturability and at the same time help control costs and prevent overruns.

Frank Nisco, director of global sourcing for medical-device manufacturer Covidien, tells MetalForming that, “I can’t emphasize quality enough, and nothing else comes close as being so important when we rate our suppliers. Quality accounts for 50 percent of our supplier scorecard (with price and on-time delivery performance each accounting for 25 percent). And while today we expect ISO 9001 registration at a minimum from our suppliers, we are moving quickly toward expecting all of our suppliers to also comply with ISO 13485.” All of the firm’s stamping suppliers also have TS 16949 registration. Covidien, based in Dublin, Ireland, maintains U.S. headquarters in Mansfield, MA, and has product lines in medical devices, imaging solutions, pharmaceutical products and medical supplies.

What’s unique to ISO 13485? According to an article in Quality Digest, the standard adds requirements related to design, traceability and environmental control. It expects manufacturers to engineer controls in the work environment to ensure product safety and to focus on risk management, and contains specific requirements for inspection, traceability and validation of processes for sterile medical devices. The article quotes a regulatory services manager, who says that, “If a medical-device manufacturer gets audited, the auditor looks back on the supply chain. When auditors ask how the company controls that supplier and whether they hold a registration (to ISO 13485), that’s a good start in showing control over production of components or subassemblies.”

A recent survey from Crimson Life Sciences finds that, from the standpoint of risk management, the device manufacturer and its contracted suppliers are considered one and the same, so suppliers must be held to the same standards as the OEM. More than one third of the total supplier base to the medical-device industry has ISO 13485 certification, according to the survey (and more than 50 percent when looking at nonexempt suppliers, or those suppliers of components such as springs and other metalformed parts that are not exempt from destructive and incoming inspection).

Covidien Helping to Fortify its Supply Chain

Covidien’s Nisco says that to help its supply base improve and more consistently achieve its required minimum CpK of 1.33, the firm has increased its focus on supplier training, in areas such as six sigma and lean initiatives.

“Our suppliers are an extension of our business and we need the best of the best,” says Nisco. “And although we do not require six-sigma blackbelt certification from our suppliers, we do prefer to see our suppliers working toward achieving that level of excellence. As we look down the road at our supply chain, those are the types of suppliers we will require.”

Nisco explains that, “within Covidien, we don’t manufacture very much of the metallic components for our product. More than 95 percent of our metals-related purchases—raw materials and components—are done on the outside, primarily from about 50 core suppliers. We design here, and then rely on our suppliers to lend their expertise in manufacturability and methodology, to keep costs low and quality high.”

Covidien recently conducted a two-course training program in lean supply-chain management, attended by 25 employees from 13 Connecticut companies. According to an article in The Herald (published June 21, 2009), the training program was designed to “make the industry’s supply chain leaner and eliminate wasteful nonvalue-added activities… Participants focused on quality tools, evaluation and auditing, scorecards, metrics and organizational culture.”

Among the attendees at the Covidien training program was Allen Nadeau, supervisor of shipping, receiving and finishing from metalforming company Southington Tool & Manufacturing Corp., Southington, CT. The firm produces stampings, springs and wireforms from presses with capacity to 100 tons, as well as from fourslide stamping equipment and CNC wireforming equipment. Among the medical products it supplies are ligating clips, medulary pins, surgical staples and sutures, and stents.

Describing how the course helped him focus on ways to identify bottlenecks that slow down the manufacturing process, Nadeau said: “On a skin staple, we discovered how to perform 100-percent mechanical inspection while increasing product quality… though we only have 40 employees, we’re expected [by our customers] to turn out work done by 100 people.”

How One High-Speed Stamper Made the Move to Medical

Southington Tool & Manufacturing’s successful migration into the medical-product industry exemplifies that of numerous metalforming companies. The common thread weaving the successful formula for most: The development of the engineering and design know-how to help medical-product OEMs such as Covidien develop those perfect partnerships, where designs are turned into reality by creative process-development engineers.

Case in point: Weiss-Aug Co., Inc., East Hanover, NJ, which manufactures surgical and drug-delivery devices. The firm specializes in new-program development, assisting OEMs early in the design stage to ensure quality and manufacturability and at the same time help control costs and prevent overruns.

Weiss-Aug is a high-speed stamper and injection molder, with Bruderer presses from 20 to 90 tons. Born in 1972, the firm was raised on supplying primarily the telecommunications and automotive industries, until it retrenched itself in the medical marketplace about five years ago.

“In 2001, to help us set our course in the medical industry, we hired someone from the industry to help us develop our sales team and make the proper contacts in the industry,” says Weiss-Aug president Dieter Weissenrieder. “We already had the quality track record the OEMs look for, with expertise in high-volume manufacturing and 100-percent parts inspection, to achieve PPM levels in the single digits. Any operational changes were minimal. But it did take us about five years to get a strong foothold in the industry and convince the customers to trust our ability to develop prototypes, consult on engineering changes and move into high-volume production.”