Charles Fields: Whitford is a leading manufacturer of non-stick and low-friction coatings. It was founded by David P Willis Jr more than 50 years ago. Having come from the plastic compounding industry, Willis recognised a market need to apply the principles of polymer compounds to thin films, combining a thin layer of engineering plastics with a metallic substrate to impart polymer properties to the metal surface. Through many innovations, Whitford developed thousands of different coating formulas for applications ranging from frying pans to aircraft, and oil rigs to medical devices. Today, Whitford operates around the globe.
By chance: Whitford sells its products to coating applicators that specialise in applying many different types of surface-finishing processes, such as plating, painting and chemical-conversion coatings. A few decades ago, an engineer at a medical device company approached an applicator, wanting to improve the performance of a catheter guidewire, and a market was born. The properties of PTFE coatings were ideal for the issues that device designers faced, such as easing the insertion of an invasive device into the body, or releasing blood and tissue that might accumulate on a surface.
Regulatory issues forced change on the entire PTFE coating industry. The first change was the removal of perfluorooctanoic acid, or PFOA, from the manufacturing of fluoropolymers. The most commonly used PTFE coatings relied on an old, basic formula that included PFOA, which was later a subject of concerns raised by the EPA. Many know that PTFE coating delamination also became a significant issue. The removal of PFOA had some unforeseen impact on the application of coatings, especially to catheter components. Whitford notified its direct customers of the pending changes, and offered alternatives, but was not exposed to their customers. As a supplier of industrial products, it was unaware of the implications of raw material changes in medical device. The company spent time and money working with customers to offer assistance. We realised that, if we were going to sell to this industry, we would have to improve focus, and offer customers and end users improved support.
The company had to change its business model. Whitford, up to that point, had been an industrial manufacturer operating under an ISO 9001 quality standard. While this was perfect for typical customers, it was insufficient for medical customers. The company started a new medical division, building a separate manufacturing area at its global headquarters that was dedicated solely to medical coatings and related technology. It hired staff from the medical industry to design processes and implement an ISO 13485 QMS. It began monitoring vendors better and put much tighter controls in place. We made a significant investment in what then represented less than 2% of our business. It's been a good investment.
Regulatory pressures regarding chemicals are tougher every day. Whitford has a global regulatory team that keeps the firm up to date, addressing chemicals on the EU's SVHC list, such as hexavalent chromium and NMP. We've developed a new range of products just for invasive medical devices. We are now able to offer our medical customers alternatives before change is mandated. We work directly with medical device designers. We tailor coatings to specific requirements. It's a whole new and exciting ball game.