According to Mark Gross, Formacoat's CEO, the company's business proposition is refreshingly straightforward: "We focus only on coatings," he says. Their applications, however, are myriad. Formacoat applies coatings for everything from vascular and ophthalmic implant delivery, to guide wires, catheters, films and screen mesh. "There are as wide an array of coatings as there are different things people need to do with their medical devices to make them work," he adds.
Demand for more coatings in increasingly complex applications is rising. As Gross says, "Formacoat's investments in more and varied coating technologies is increasing, and the company is expanding to a new 38,000ft² facility during the next year to make room for these new product lines and to increase capacities."
The company has always aimed to be the primary source for medical OEMs in satisfying their commercial coating needs, whether it is for instruments used in cardiovascular or implant delivery, or guide wires and catheters.
From a coating-technology standpoint, the company added several different haeomocompatible coatings, with different types of chemistries, that are useful for a wider range, and different types, of devices and markets. It has also added variants that prevent wound adhesion, scar tissue formation, protein absorption and biofouling. The latter two have proved especially popular. "We've several projects running right now that fit these product niches," says Gross.
The company has also begun to work on making a controlled-timing, super-swelling hydrophilic material for a specific customer need, by modifying an existing technology. By bringing other coating technologies in-house, the company can find or work to adapt new technology types in order to meet unique needs. In the past year, Formacoat worked to find ways to use a grafting technology on metals that were previously only working on some polymers.
"It's a chemical-assembly grafting technology that's capable of coating the IDs at a finer diameter than other coating technologies, as well as providing excellent lubricity and durability on select substrates," Gross explains.
The company has emerged as a leading player in the coatings market since its foundation in a basement in 2002. It has always aimed to be the primary source for medical OEMs in satisfying their commercial coating needs, whether it is for instruments used in cardiovascular or implant delivery, or guide wires and catheters. The increasing range of products that need coating, and different types of coatings, means the company is outgrowing its current facility and equipment.
Its new facility will allow fourfold expansion in its core catheter processes (including a new coating system that works well for small-volume research and development runs at less cost, and, for some products, 'unlimited' lot sizes - larger than its batching production lines can do); film and mesh coating by twofold; sixfold increase in ISO Class 7 cleanroom; and space for other work by increasing by threefold the square feet of its current facility.
Fundamentally, what customers get with Formacoat is a company devoted wholeheartedly to finding the right coating for their medical device.
And if the first formulation does not succeed, Gross and his colleagues will persevere until they find the most suitable coating for the assigned application. It's a focus that can sometimes be missing from the company's competitors in the marketplace.
"They're manufacturers of catheters and tubing extruders," says Gross. "Their core focus is on things that we don't do, and we don't care to do, because this field is engaging enough in terms of what it takes to work through all the needs of a customer and, certainly, the more challenging applications."
