Whitford Corp. Forms Medical Device Coatings Division

Whitford Corp., based in Elverson, Pa., a manufacturer of fluoropolymer coatings for industrial and consumer industries, has formed a new group dedicated to supporting the use of its coatings on medical devices.

Historically, the use of fluoropolymer coatings on medical devices have been dependable and offer benefits, despite a select few localized application issues that recently lead to U.S. Food and Drug Administration device recalls, according to a statement from the company.

Whitford’s medical coatings group is now in development, based at the company’s headquarters. The operation will occupy a newly constructed facility that is expected to be fully operational by the third quarter of this year.

“As a raw material supplier for catheter guide wire manufacturers and coaters, as well as countless biocompatible devices, we understand the benefits of our coatings in medical applications. Our decision to establish a dedicated medical coatings group will enable us to support the use of our coatings in medical applications, and to safely be a key supplier to medical device manufacturers,” said Dave Willis, founder and CEO of Whitford Corp.

In order to serve all global tiers of the medical supply chain, Whitford will implement an ISO 13485-compliant quality system; validate all levels of manufacturing and enhance quality control testing to ensure product quality and performance.

“ISO 13485 outlines the standard quality management system in the medical device supply chain,” said Greg Lundell, Whitford’s industry manager of medical coatings. “Complying with this international standard will allow us to meet global regulatory requirements.”

Investment in the new facility includes dedicated equipment, a new quality control laboratory with additional management and operations personnel.

“Our aim is to establish ourselves as a global leader in medical coating supply,” said Lundell. “Having a dedicated facility reinforces our policy of providing exceptional quality and security of supply at a time when many other coating manufacturers are struggling to meet rising regulatory demands of the medical industry.”