Whitford have it covered with ISO 13485 medical coatings

Greg Lundell, Whitford Corporation, announces the creation of a new medical coatings group to be certified to ISO 13485

Founded in 1969, Whitford Corporation’s early focus on solving problems for customers rather than merely selling coatings resulted in the company’s becoming the manufacturer of the world’s largest, most complete line of fluoropolymer coatings. Today, Whitford offers thousands of products from nine manufacturing facilities and operates in more than 50 countries globally. 

Always focusing on solving customers’ problems, Whitford’s emphasis on product development is an important core value. Along with the development of new products has come the development of new industry sectors served by its growing product portfolio.  

Initially, Whitford focused on niches in the industrial market, later moving to the consumer market.  Frying pans, irons, and other household nonstick-coated items allowed Whitford to grow its business. Specifications for more industrial applications came as a matter of course when companies realised coating critical parts would offer a variety of benefits over their uncoated counterparts. Corrosion resistance for parts in contact with sea water, lubricity for fasteners and ease of cutting, release for molds, and friction reduction in constant wear situations have all been the cost and timesaving benefits offered by Whitford coatings. 

Along the way, the company’s high-performance coatings were sought out by the medical-device industry. Such devices, though highly specialised and often small and delicate, are susceptible to a number of extremes within the human body that mimic those faced in other industrial applications.

Take the example of medical catheter guide wires, for instance. They are thin, flexible, and perform in relatively small spaces (blood vessels). In this example, lubricity prevents the wire from catching on vessel walls and ensures smooth catheter insertion. Another example is coated electrosurgical instrument tips. The release characteristics of non-stick coatings similar to those needed for industrial molds prevent tissue adhesion during operation. 

Coatings can also be used as a protective barrier on caps for drug and sample vials. Typically, vial caps are made of formed rubber or a rubber disk inside a plastic screw-cap.  The rubber allows for proper seal formation, but are porous and can both leach components into the drug formulation and bind the drug they are meant to contain. Fluoropolymer non-stick coatings solve both of these problems.

To provide maximum service to the medical-device market, Whitford Corporation recently decided to form a medical coatings group to be headquartered at the company’s worldwide headquarters in Elverson, Pennsylvania. This move should have both immediate and long-term effects on the medical coatings / device industry. 

Establishing the group has been an important project for the company over the past year. A dedicated manufacturing and QC facility was designed, and construction is currently underway. This includes new equipment for both the manufacture and quality control of products as well as office space for quality assurance and administrative personnel. 

Once complete, the group will be certified to the ISO 13485 standard. By implementing the stringent quality-system standards to achieve this certification, Whitford aims to ensure that the quality of its coating products is second to none. Medical-device companies searching for solutions that coatings can solve for them will be able to rest assured that Whitford understands the market, and will be a viable global supplier to the industry for years to come. 

Initially, the manufacture of coatings for medical devices will be relocated to the new facility following a full validation program. The coating formulations will remain the same to ensure regulatory compliance for the end user. As the group becomes further established, co-development programs will be initiated. We know there are certain coating specifications needed in the medical-device markets that are currently not available. Nitinol substrates, for instance, can’t withstand the high coating cure temperatures that traditional stainless steel substrates can; we’re looking to solve that, and make other improvements along the way.

Currently, high-performance fluoropolymer coatings are used on catheter guide wires, electrosurgical scalpel blades, stents, mandrels, needles and probes, biologic processing equipment, and a variety of other devices. As it evolves, the medical-device industry will require more coatings for an even wider application base, and Whitford plans on being a partner with device companies for their development. 

The future of our business includes biocompatibility and plastics class testing, generating information and data for customer device master files, regulatory support, and establishing full design control projects. It’s a different business model from supplying a coating for frying pans, but we can easily leverage our deep technical knowledge and second-to-none customer support in this venture. It’s a very exciting proposition for us and our customers.