Whitford’s Medical Coatings Group Addressing Rapidly Expanding Market in Medical Devices
Date: 21st September 2018
Recent analyses place the global medical devices market in excess of $325 billion, with a continuing growth curve driven by expanding healthcare coverage; an increase in the construction of hospitals, clinics and other healthcare facilities; and the medical needs of an aging population. The coatings element of this growth market is expected to reach more than $15 billion by 2021.
“Rising demand for the product, as it reduces friction between the devices and tissues and provides wetting, surface coverage, and coating homogeneity will augment its demand,” according to San Francisco-based Grand View Research. “These coatings enhance the durability of the equipment and offer excellent dielectric properties, dry-film lubricity, and thermal stability, which is likely to create immense market potential.”
Addressing this burgeoning market is Whitford Worldwide’s Medical Coatings Group, housed in a completely renovated area at the company’s headquarters and manufacturing facility in Elverson, PA. The group is set apart from the bustle of the building’s other manufacturing areas and conveys the feeling of a new wing at a hospital. Investment in the facility included equipment specific to the requirements of medical device manufacturers, as well as a separate quality control laboratory. Experienced management and operations personnel were hired specifically to address this aspect of Whitford’s business.
With thousands of coating formulas, developed over more than 50 years, many of them designed to meet specific needs for individual clients, Whitford is in a unique position to supply a market as diverse as medical devices.
“We coat catheters, stents, guide wires, syringes, hypo tubes, and mandrels,” explains Charlie Fields, Whitford’s global business manager-medical device coatings. “Activity is really heating up. We are currently growing at 18% year-over-year.”
Strong Ties to Catheter Market
Whitford has particularly strong ties to the $8.9 billion catheter market, which is also experiencing dramatic growth. “We serve this minimally invasive medical device market, which is heavily influenced by the insurance companies,” Fields explains. “The procedures are very safe, efficient, have much lower side effects and better recovery rates than traditional procedures.”
Whitford’s Medical Coatings Group is certified by the International Organization for Standardization, based in Geneva, Switzerland.
“This ISO 13485 certification reassures customers when ordering Whitford coatings,” Fields says. “Whether the products are catheter guide-wires, scalpel blades or other devices that benefit from a PTFE, FEP or other fluoropolymer coatings, customers know that this coating is reproducible and they will receive the same formula every time. This guarantee is vital with medical coatings. It’s important to note that all of our processes are reviewed on a regular basis. ISO 13485 tells customers that we will be a strong, reliable link in their supply chain, able to support them with documentation above and beyond what ISO requires.”
The ISO certification adds value to the group’s entire product portfolio. While Whitford has invested a large amount of time and money into building its dedicated medical facility, additional time was invested in standardizing and documenting processes in order to be certified. As a result, customers are now able to save time and money by eliminating certain steps from their supplier search process.
“Customers know that we have been audited to the full ISO extent and they no longer need to invest their own time into an additional audit,” Fields says. “Many of them will be able to set us up as a critical supplier due to the quality system certificate that we now possess. Customers can trust that we will provide support should they decide to submit to the FDA. Overall, ISO 13485 improves the customer experience and ensures that the Whitford Medical Coatings Group continuously works to advance our products and processes.”
From Generally Industrial to Specifically Medical
In order to take on already-established competition, an ability to concentrate on the challenges at hand, with the fewest distractions, is paramount when building a new business in high-performance fluoropolymer coatings on medical devices. Nonetheless, fluoropolymer coatings have been successfully used on medical devices for many years, offering a variety of important benefits and Whitford has a long tradition of taking on established competition in diverse business genres. A logical starting point, however, was repositioning some existing business.
“The initial push has been to convert current medical device customers from ordering our industrial material to specifying the material made specifically in the medical coatings facility,” explains Darlee Alexander, the medical group’s quality assurance and analytical development manager. “Our aim is to become a global leader in medical-coating supply. 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. The goal is to have our coating specified by original equipment manufacturers. Then, whether they apply the coating themselves or contract the application process out, we will still gain the business. The challenge lies in ensuring these companies know that we understand the medical device market, we know the documentation and level of manufacturing excellence they require and are not just a commodity supplier.”
Once you have customers on board, keeping them becomes a matter of maintaining a lasting relationship built upon service, according to Fields. That ongoing product support is a key element to maintaining market share. “We sell a lot of systems, reliability and services to support the product,” he says. “The products require stewardship and the customers require mechanisms to reduce risk.”
Whitford is the manufacturer of the most diverse line of fluoropolymer coatings for both consumer and industrial applications. Founded more than 50 years ago, the company is based in Elverson, Pennsylvania, with sales and manufacturing operations throughout the world.
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