From its Minnesota base, Formacoat has grown into a formidable contender within the medical-device coating market. Medical Device Developments talks to Mark Gross, the company's founder and CEO, about how its willingness to adapt its products to new shapes and devices will put it in good stead for years to come.
"I started Formacoat with my own money, in a friend's basement," says Mark Gross, recalling how he founded Formacoat, a leading Minnesota-based coatings service. Since its foundation in 2002, the firm has grown into a formidable player in the US market for medical-coating manufacturing services, offering a wide range of medical uses for existing hydrophilic, hydrophobic and other speciality biomedical coatings.
Although Gross is not inclined to be romantic about the origins of Formacoat, he probably should be. Thanks to his expertise in biology, chemistry and team engineering, Formacoat's objective has been to provide an effective one-stop shop for small to large-scale commercial coating applications for a range of uses, including in vascular, cardiovascular and implant delivery, as well as catheters, guide wires and roll-to-roll applications.
Early on, Gross received an offer of a contract to coat special-function tubing from Becton, Dickinson & Company.
"It took me about four months to figure out how to meet the unique needs of that particular device," says Gross, "but I worked it out, and Formacoat has been doing manufacturing for that device - and many more - ever since. There are still times when a particular coating does not work, but, having conducted numerous experiments, we can easily apply what we've learned in the first set of experiments with different types of coatings from other vendors. That means that the customer doesn't need to teach someone about their device multiple times, as they might if they were going directly to coating vendors.
"We recently conducted one project for a customer where testing ended up with 14 different coating solutions and ways of putting it on, all in one experiment. Success came with composite layers of different vendors' materials with modified solvents. We're always adding new coatings. It's always wise to remember how specialised coatings can be in terms of what an individual substrate can attach well to, in addition to their durability characteristics."
Gross and his colleagues are also building abundant experience in the coating of objects of unusual shapes - ones that would usually defy conventional coating approaches. One of the most challenging of these projects, Gross says, was Formacoat's task was to waterproof an egg-shaped foam object for application in urology.
"We had to learn how to skin the foam with something that would allow the coating to be applied so that there was no solvent intrusion into the foam," he says. "Then we had to cover that skinned area with a hydrophobic coating that prevented water intrusion. That foam piece possessed exposed interior components that needed to be protected from the coating, while the exterior areas needed to be coated.
"We are eager to find the best coating for your particular situation," he finishes.
While Formacoat retains significant expertise in conventional coating techniques in its routine manufacturing of typical medical devices (such as catheters and guide wires), it's expanding into new application areas as well, of which topography jacketing is just one.
"It's allowing us to build a polymer topography upon guide wires, for example, that's different from the underlying substrate," explains Gross. "We're also interested in expanding further into coating films. Our first film project started as a generation-one product - a 3D shape with a cloth substrate that used too much coating to be cost-effective.
"When were done, we were coating rolls of film - the substrate that the customer originally wanted but no one else could coat - with formation of the 3D shape after coating. This greatly increased quality, performance and capacity while dramatically decreasing costs. We already conduct routine production for that film and new variants, and we're also in dialogue with a client for a new miniature application of a biopolymer solvent cast film."
Formacoat's work in these kinds of areas is symbolic of a much larger commitment to innovation - one that the firm intends to showcase at the MEDICA trade fair in Düsseldorf in November 2016.