Originally Published MDDI March 2005
EMS Facility Certified for Medical Device Manufacturing
|A new building that houses TFS's EMS could have 21 CFR 820 certification soon.|
After receiving ISO 13485 certification of its new facility, Three Five Systems (TFS; Tempe, AZ) opened its doors in Redmond, WA, to focus on medical device manufacturing. The 140,000-sq-ft facility began operations in December 2004. Dave Prunier, senior director and general manager of the Redmond facility, said the certifi- cation is a milestone for the company as it ramps up its electronics manufacturing services (EMS) for the medical device market. Prunier made the announcement during the MD&M West Conference in Anaheim, CA.
TFS, which has its roots in the display manufacturing business, began the shift toward becoming a full-service EMS provider in 2002. It began the transformation by broadening its display offerings to include AVT (Marlboro, MA) for large displays. TFS then purchased existing EMS companies ETMA (Redmond, WA), Unico Technology Bhd. (Penang, Malaysia), and Integrex (Bothell, WA). Spinning off its microdisplay unit enabled the company to focus on expanding its EMS services.
The opening of the Redmond facility follows the company's yearlong effort to achieve ISO 9000:2000 certification as well. “We expect to be ready for an FDA 21 CFR 820 audit [of the facility] by midyear,” said Prunier. He said the company is “courting prospective OEMs” so that it can begin production as soon as it passes the audit and is registered to manufacture Class III devices. The facility is currently registered to manufacture Class I and Class II devices.
The facility will specialize in prototyping and new product introduction of low- to medium-volume production runs. Medical device manufacturing services include high-level assembly and box build as well as final and system assembly. The facility features four surface-mount-technology production lines and a fifth line dedicated to prototype runs. TFS bills itself as a Tier 3 manufacturing partner with Tier 1 capabilities. It provides central commodity management with domestic purchasing and change control.
“The medical device manufacturing market is a key area we have identified where we can deliver a significant value to customers,” said Van H. Potter, senior vice president of electronics manufacturing services. “We have a history of producing a variety of medical OEM products such as defibrillators as well as subassemblies for medical OEM products such as glucometers.” Potter said the Class III certification will allow the company to deliver a broader range of services to its medical device OEM customers.
Potter and Prunier both noted that the medical market has always been a focus for the company. TFS plans to capitalize on its expertise in display technology, said Prunier. “About 90% of medical devices employ a display, which TFS can provide without outsourcing that critical step to others.”
|Senior VP Van H. Potter says TFS will focus on medical OEM's specific needs for display panels.|
“We are vertically integrated to offer the displays that others would outsource,” said Potter. “LCDs are a top-five cost driver. We are the only U.S.-based EMS provider to offer displays, which we have specialized in for 20 years,” he said. “Displays are difficult. Many display manufacturers don't understand the medical device arena and don't focus on it because the volumes aren't there,” Potter said. “We provide the attention and the total solution. We hope to become a stronger player in the marketplace because of that.”
Prunier said TFS will focus particularly on high-level assembly that incorporates displays. “That will be our niche. We will do the PCB, test, design, final test, validation. The process will be 99% turnkey,” he said.
TFS also has a medical device manufacturing facility in Penang, and Prunier said that facility also has a “roadmap” for certification. “We've made a significant investment in offshore capabilities,” said Potter. He noted that the company's global footprint gives it the flexibility of a Tier I manufacturer that has a presence in Asia. He also said the company has many design-for-manufacturability resources at its Asia facility that can be tapped remotely. “As a medical device company's volume grows, TFS offers high-volume facilities in Penang to continue to serve that customer's needs,” Potter said.
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