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CAROL STREAM, ILLINOIS – The demand has never been greater for specialized supply chains that deliver medical materials to meet the production demands of OEM’s. These businesses are acutely aware of the need to use quality metals and materials in their products to assure performance, durability and long-term reliability. Due to the recent revisions to ASTM standards F136 and F138, Banner Medical has installed a multi-axis, computer controlled Ultrasonic Inspection System designed and built by Matec Inspection Companies, Inc., for precision ground bars.
ASTM F136 and ASTM F138 are commonly specified standards in the design of titanium and stainless steel surgical implants; and recent revisions to each standard call for ultrasonic testing at final diameter for all centerless ground, or peeled and polished bars, which are greater than or equal to .375” in diameter.
“The decision to purchase this highly versatile inspection system was driven by the current and future needs of our customers. We are experiencing greater demand for ultrasonic testing of medical grade raw materials and the recent changes to ASTM standards F136 and F138 will increase demand even further in the very near term,” said Bob Khin, Vice President of Quality Assurance, Banner Medical.
“We recognize the impact these revisions will have on our customers. Ultrasonic testing at final diameter has the potential to add significant delays and cost to the supply chain. Our new ultrasonic inspection unit allows us to ensure the precision of centerless grinding and testing under one roof. We are providing our customers with a cost effective, time saving solution to the problems which could arise as manufacturers begin to comply with these changes. We will maintain the inventory, production capability, and testing equipment in a medical focused factory,” said Dan Stoettner, Executive Vice President and Chief Operating Officer.
To fully comply with industry testing standards, Banner Medical has hired additional qualified personnel to operate the equipment and implement the proper management systems including Rick Wallen, Director of Technical Services. He will assume full responsibility for the ultrasonic testing program. Rick was employed at Zimmer Inc. for 34 years in various roles and most recently served as Principal Engineer, Quality. He was responsible for all nondestructive testing requirements company-wide.
“We feel very fortunate to have Rick join our team. He is an industry recognized expert in ultrasonic testing and Quality Management Systems, and we are certain he will make an immediate impact within our organization. Rick is an ASTM certified Level III Engineer and an ASQ certified Quality Auditor. He is going to help us provide the very best service to our customers,” said Bob Khin.
Banner Medical serves the medical device, implant, and instrument industry with medical-grade metal materials; Banner Medical is ISO 13485 and ISO 9001 certified, and FDA CFR part 820 compliant.
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Fourth annual event to include Banner and Pioneer executives, presenting how to effectively address FDA supplier control concerns through strategic OEM/Supplier partnerships
Carol Stream, Illinois – Banner Medical executives Vince Adams, Vice-President of Sales, Marketing & Strategic Planning, and Bob Khin, Quality Assurance Director, along with Peter Johns, Supplier Quality Manager for Pioneer Surgical, will participate on a faculty panel at the upcoming Supplier Quality Management Congress sponsored by FDAnews, to be held at the Bethesda North Marriott Hotel & Conference Center in Bethesda, Maryland from July 31-August 2, 2012. The Banner Medical / Pioneer Surgical alliance has long been recognized in the industry as a successful strategic OEM / Supplier partnership formed to address the challenging supplier and raw material control issues which has been a focus of the FDA and of the Industry itself for the past decade. The partnership model, which the two companies have developed together, has produced positive results and yielded best practices that have been recognized by many and already adopted by some within the Medical Device industry.
This year’s Supplier Management Congress mark’s the fourth annual event and is designed to bring together suppliers, producers, top regulators / policy makers, legal and advisory consultants to the industry, for the purpose of assuring the integrity of Device raw materials and supply chains. FDA representatives as well a dozen other OEM and Supplier executives will participate as the faculty for this three-day event.
Attendees will include various manufacturers and suppliers to the industry, who will learn about risk management, recalls, liability issues and the new regulations recently instituted by FDA to better control the international drug and device supply chain to the medical markets.
Banner supplies medical and orthopedic device manufacturers with medical-grade materials to meet the highest quality standards. It operates two ISO 13485 and ISO 9001 certified, FDA CFR part 820 compliant facilities in Carol Stream, Illinois and Charlotte, North Carolina. The company provides its GuardiaNTM customer support solution program for supply chain management and medical materials stocking, plus its AssuraNce® protocol that assures all products made for the medical market are produced on equipment validated per the FDA requirements. Banner’s EsseNtial Quality SystemsTM is a patent-pending IT-based quality program that manages the company’s materials selection and production processes to deliver medical-grade bar and plate stock.
Banner Medical is a strategic business unit of Banner Services Corporation, a provider of precision ground bar as well as centerless grinding, turning and straightening, among other machining services.
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