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Company insight


ince different coatings require different techniques and application practices, this company has been able to blend its approaches and technologies into unique offerings driven to solve each customer’s individual needs.


Time-saving, solution-based coating services


“Our ‘solution’ approach centres around one simple idea: ‘What do you want and why?’” states Mark Gross, CEO and founder of Formacoat. It’s called the ‘Formacoat Formula’. “While this may seem like a basic concept, it is one that often can be overly complicated and even missed altogether,” say Gross. “We are continually amazed at how important the answers are to this seemingly simple question. Before we offer solutions to your coating challenges, we want to know what you care about; what the customer who uses your device cares about. By digging deeper and listening to our customer’s needs, we gain a better understanding of what you need and that leads to improved results in a much shorter time frame.” “In real estate, they say it is all about location, location and location, but in medical device coating it is all about coating, coating and coating,” says Todd Paulsen, vice-president of sales and marketing. “With over 18 years of experience and 90 different coatings from 45 vendors to choose from, a customer can evaluate multiple coatings all at the same time. This eliminates the lengthy research and qualification process, saving our customers not only financially, but also in their most valuable commodity: time.”


A variety of coatings under one roof Formacoat has a variety of different technologies from different vendors to choose from, including hydrophilic,


The right coating solution S


Formacoat has been on the leading edge of coating technologies for the past 18 years. From the start, it has always partnered with its coating vendors to develop custom coating solutions for its customer’s unique application needs. Through these partnerships and its medical device coating-centered skill set, the company can focus on finding the right solution for its customers by diving into the real issues its customers experience and have come to Formacoat to solve.


hydrophobic, surface-blocking and anti- fouling, anti-microbial, heparin, collagen, and PSA/adhesive coatings. It has thermal cure, UV cure and grafting technologies as well. “By working with Formacoat, our knowledge of your device’s needs and our catalogue of coatings help us to get through several options, and slide into the perfect one for your device. Even if you have your own coating that you would prefer to work with, that is okay,” states Gross. “We have over 18 years of experience applying a variety of coatings to medical devices. We have the knowledge to make it work. As long as you are happy with it, so are we. At Formacoat, it is all about finding and applying the perfect solution and getting your device to market.”


And its experience does not just relate to coatings and application techniques. It has the expertise to take its customers from concept to production all under one roof. “We have a brand new, 38,000ft2 facility in Chaska, Minnesota with three level 7 cleanrooms totalling 8,400ft2 of cleanroom space. We are ISO 13485-certified and are intimately familiar with the necessary documentation needed for the approval process and to get your product to market,” states Paulsen. Along with its full-scale research and development lab, and seasoned staff of engineers and chemists, this means that Formacoat is prepared to help its customers get to the finish line with its devices and start generating revenue.


Onwards and upwards With the expansion of its new facility and greatly expanded production floor, Formacoat has invested a large amount of time, energy and resources necessary for getting into the drug coating market. “Our coating capabilities now include drug coatings – DES (drug eluting stents) – for coronary, peripheral stents, neuro devices


Medical Device Developments / www.nsmedicaldevices.com


and balloon catheters, as well as the contract manufacturing service applied to those devices. We offer coatings from the full range of polymeric materials and chemistries for specific customer needs and indications,” states Gross, “with many ways to apply coatings to different kinds of devices, substrates and materials – and the commercial-scale equipment to do so at any level of production.” One of its newest vendor offerings, a grafting technology, has been in commercial development at Formacoat for the past couple of years. This revolutionary technology allows it to graft to select substrates in such a fashion that it creates a durable, lubricious layer that is tunable for its customer’s specific requirements. “Imagine this coating like a field of grass; we can configure the parameters in such a fashion that we can not only have the grass sprout up wherever we would like, but also as thick or thin as possible. This allows us to tune the lubricity and durability, and is excellent for the smallest of IDs where traditional hydrophilic coatings are unable to be functionally applied,” says Paulsen. “This process can offer pricing that is lower than other coatings.” Formacoat is family owned, and its second-generation members are invested in maintaining the quality and consistency that comes from sustaining long-term relationships with employees, customers and vendors. Formacoat’s family owners are committed only to the success of the business, without the short-term monetary pressure and the sudden upsets in culture that often comes with private equity and venture capital types of ownerships. This means that the Formacoat family will continue to work for its customers, providing the coating expertise they need. ●


www.formacoat.com 111


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