Approximately 2% of Whitford's global sales currently involve medical coatings, Dave Willis, founder and CEO, told PlasticsToday, but he sees opportunities in that market that he hopes to tap into with the establishment of this group. "Though our coatings have been used on medical devices for many years, it was never a core business, and not one we aggressively pursued," said Willis. "We are changing our handling of medical coatings to provide a higher standard of service and quality controls and will now directly support medical device manufacturers with product development activities and specific quality control tests and certifications."
As part of this program, Whitford will implement an ISO 13485–compliant quality system, validating all levels of manufacturing and enhancing quality control testing to ensure product quality and performance. "ISO 13485 outlines the standard quality management system in the medical device supply chain," explained Greg Lundell, 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 and 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 the rising regulatory demands of the medical industry."
"Double-digit sales growth [in medical coatings] is the expectation in the short term and into the foreseeable future" for Whitford, says Willis.
Some of you may recall that PTFE-coated guidewires made unwanted headlines in 2013 and early 2014, when several medical device manufacturers, including Medtronic and Covidien, recalled devices because the coating was flaking off. It was a rare adhesion issue for this material, which is often called a gold-standard coating, that was indirectly caused by the U.S. Environmental Protection Agency (EPA) requiring manufacturers to cease using perfluorooctanoic acid (PFOA) in the coating process by 2015. EPA classified PFOA, which was used as a processing aid for the polymerization of PTFE, as a suspected carcinogen. In their haste to eliminate the material, some coatings applicators and device manufacturers did not perform sufficient due diligence to ensure that all potential problems had been anticipated and resolved, according to experts. (For more on this, read "How to Prevent Guidewire Coatings from Flaking" on Qmed.com.)
This episode is a rare misstep involving fluoropolymer coatings in medical applications, and should not tarnish its image as a gold-standard coating material, says Whitford. The use of fluoropolymer coatings on medical devices has been historically dependable and offers many great benefits, despite a select few localized application issues that recently led to FDA device recalls, says the company.