Page 21 - MetalForming July 2009

the bedside or even away from home. Examples (offered up by Phil Salditt, director of customer development for Plexus Corp., a manufacturer of print- ed 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 moni- toring. All of these new products require a fresh approach to design and functionality, including ruggedness, wireless connectivity and a user-friend- ly control interface. And, manufactur- ing volumes, particularly for dispos- able 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 man- agement systems—Requirements for reg- ulatory purposes. While still not wide- spread, more and more suppliers have recently begun to work toward becom- ing certified to this standard, which underwent a significant upgrade in 2003.
Frank Nisco, director of global sourc- ing 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 account- ing for 25 percent). And while today we expect ISO 9001 registration at a min- imum from our suppliers, we are moving quickly toward expecting all of our sup- pliers 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,
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 cus-
tomers—those that would
generate at least $1 million in
annual sales. Weiss-Aug spe-
cializes in new-program develop-
ment, 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.
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 environ- mental control. It expects manufactur- ers 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 sub- assemblies.”
A recent survey from Crimson Life Sciences finds that, from the standpoint
of risk management, the device manu- facturer and its contracted suppliers are considered one and the same, so suppliers must be held to the same stan- dards as the OEM. More than one third of the total supplier base to the medical- device industry has ISO 13485 certifi- cation, 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 incom- ing inspection).
Covidien Helping
to Fortify its Supply Chain
Covidien’s Nisco says that to help its supply base improve and more con- sistently 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
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