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Market Report: Medical Devices Step Up to Regulatory Challenges

While vigorous in the United States, the medical device industry is preparing for regulatory changes.

March 2011
(page 2 of 2)
Suppliers Pitching In
Zeus, Inc., specializing in material science and high-performance polymer extrusions, recently announced that it has expanded its capabilities and is now able to process Aeos®ePTFE and Electrospun Polymers in a new 5,000-square-foot Class-7 manufacturing environment. This expansion allows for the processing of these advanced materials in a more controlled environment, resulting in compliance with stricter regulatory standards.

"Medical regulatory bodies are raising the bar on standards for devices in the industry and Zeus is committed to meeting this challenge," according to Bob Jennings, Zeus' vice president of Sales and Marketing. "The processing of these advanced materials in a tightly controlled environment ensures that customer products meet the strictest regulatory requirements in the medical device industry," he explains.

Zeus, with headquarters in Orangeburg, South Carolina, is also equipped with a Class-7 Certified, 5,000-square-foot biomaterials facility dedicated exclusively to the extrusion, analysis, and characterization of bioabsorbable polymers and other advanced materials, for a total of 10,000 square feet of controlled environment operating under ISO 13485 guidelines.

Mack Medical has also added capacity to its medical molding at its headquarters facility in Arlington, Vermont, with three new electric molding machines from Toshiba Machine Co., Ltd. All are 110-ton, 3.4-oz. high-precision machines from Toshiba's EC Servo Electric Series. The company also replaced one of its older presses in the Arlington facility with a new 1650-ton hydraulic from Engel.

"This new equipment purchase represents another investment in our medical manufacturing strategy, which we originally embarked upon 10 years ago and today represents a full third our business," says Jeff Somple, president of the company's Northern Operations. "These presses have been brought on line to support the rapidly growing orthopedic segment of that business," he says. The purchase takes Mack's Northern Operations, which consist of four plants in Vermont and Massachusetts, to a total of 82 presses ranging from 28 to 2,000 tons. Expect more upgrades as medical device suppliers step up to regulatory challenges.

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