Coatings are vital for many medical devices. Rarely, though, is the process of adding a coating to a device as straightforward as initial conceptualisation would have it seem.
As medical devices become more advanced to meet increasingly targeted needs, the expectations of coating capabilities and performance have greatly increased. For experimental and proof-of-concept and novel, leading-edge medical devices, there is often no established coating path that meets every design requirement. This is where Formacoat comes in. The company has a reputation for its willingness to take on almost any coatings challenge.
Formacoat is an independent, family-run business based in Minnesota, US. The company was founded almost 19 years ago by its CEO Mark Gross, based on his experience with hyaluronic acid. Much of Formacoat’s long term business is in the application of hydrophilic and hydrophobic coatings. Yet the company has also evolved into a more diverse R&D operation, with a wide variety of customers who are at all stages from device development to production scaling.
To find out more, we talk to Mark Gross and his sons Brecon Gross – Formacoat’s manager of manufacturing engineering – and Brontë Gross, the company’s marketing engineer.
How would you best describe the work of Formacoat?
Brontë Gross: “Hah, you know, it really depends on who is asking. When it comes to new clients, we like to see ourselves as problem-solvers. When you make a medical device, you can run into any number of different issues. Some of them might be trying to meet the fundamental design requirements or to add in a certain quality – one that you only find you need at the end of a year of development.
“At other times, maybe you have a device that’s already gone through all the hurdles of testing, it’s just an issue with trying to build a production scale process that includes coating. Sometimes the customer won’t realise their product even needed a coating until the final device has been made. We have enough experience to either have dealt with specific issues before, or we have the people who can work with our clients to figure it out. The beauty of it is that we don’t make our own products – it’s hard to stress that enough. We have a niche. What gives us our best advantages is the fact that we exist in this middle space between device developer and coating vendor.”
Brecon Gross: “When it comes to the day-to-day operations, we describe ourselves as a contract manufacturer. That middle space that Brontë was talking about leaves us the ability to work with countless vendors. On-site, we have up to 60 or 70 different coatings, each different enough that they may be the correct solution to each individual device’s design or clients requirements, whether that’s quality, price point, or some other factor. And that’s not even mentioning the modifications that can provide all kinds of different qualities.
“Depending on the customer requirements, we could be running upwards of five or six different products with different chemistries and different application methods every day, to meet whatever the customer’s requirements are.
“We work with companies of all sizes, from PhD’s with new ideas in a chemistry lab to the largest medical device companies that you could name. It’s all about our ability to scale. We can do anything from batch sizes of 12 units, to scheduling throughput for potentially thousands of devices a week. It’s the flexibility of being in contract manufacturing that allows us to work with multiple coating vendors and many customers. A lot of other companies don’t function with this much flexibility.
Mark Gross: “We provide a hugely vital service that allows customers to use high technology without having to invest in all the facilities, equipment and staff necessary to perform the types of processes that we do.”
What have been some of the biggest changes to the company operations over time?
Mark: “Probably in year six, out of our 18 going on 19 years, back when we only bought from one coating vendor, I learned that they kept running into situations where a coating couldn’t do the job. Yet I knew there were ways to adjust it to make it work, which the vendor didn’t want to or didn’t know how to do.
“And I realised that there were other coatings out there that could be more effective than that particular one. At the time, I was thinking of partnering with or even buying that particular coating vendor.
“Then I realised, no, I don’t ever want to do that. Because, really, I don’t want to be beholden to one brand, even if it was my own. Ultimately, that would limit our ability to offer the huge spectrum of technologies and chemistries and creativity that comes from individuals working on their own specialties to come up with coatings.
“Our positioning as a contract manufacturer wasn’t a random thing, it was a clear decision. I realised we had to play the field here so we can always find the best match for any given customer and each device’s substrate.”
Brecon: “One thing that is different in the last four years, compared with the previous 15, is that while we do not offer design services and we don’t design products for people, the amount of guidance and influence that we usually end up having in a final product is more than that of just a coating company.
“Our experience helps us with customers that don’t know exactly what they’re looking for or need in a coating for their end device. We help build up that design phase you would more often find in a mechanical engineering or design firm. That’s something we do not usually associate with coating manufacturing or coating applications.
“Obviously, in our opinion, a lot of designs benefit when the coating is taken into account in the early design phases. Most clients know how they want a coating to perform. But the interaction between their device, be it substrate, the chemistry of the coating, and the end-design requirements are not something that you can always predict without testing. That is unless you have that specific chemistry experience on your staff, which a lot of design firms don’t. They come to us with a mechanical design, and they just assume that you can put anything on it. Rarely is it ever that easy.”
What are some of the other industry trends you’ve been dealing with recently?
Mark: “Some vendors are trying to broaden their horizons, while others are still very content with the chemistry that they’ve been working with for years and years. What Formacoat has been about since very early on in the company is the diversification of offerings in regards to our coatings and services. What we have seen from our customers is a need for this type of diversity with their current projects. They want to have the multiple options and functions that Formacoat can apply. Their devices have gotten much more complex; so have their coating needs.”
Brecon: “During just the last eight months, every single project I worked on was a different coating with a different product and a different design expectation for that coating.
“A lot of the smaller scale customers that are approaching us are looking for not just hydrophilic coating, but coatings that have more interactions with whatever their specific goal is. There are a lot of more advanced chemistries, and more specifically tailored formulas that require a lot more expertise to get right. But people seem to be venturing into assessing the potential of what else a coating can do other than just its hydrophilic or hydrophobic properties. The off-the-shelf options aren’t as attractive as they used to be.
“And, of course, this can also bring new challenges in sourcing and procurement, storage and distribution, and logistics management.”
What do you feel gives Formacoat an edge over competitors?
Mark: “Part of what gives us an edge over competitors is that we are not beholden to any one coating. Because we don’t make coatings, we don’t sell coatings, we are focused on this arena in ways of supplying coating services and also ways that many of our vendors don’t focus on.
“Some vendors are trying to do both contract manufacturing and sell coatings. For some customers, that may well be fine. But if you’re looking for a truly insightful understanding of the best way to coat your device without spending a whole lot of staff time and effort looking for the right coating, then we have an edge over all coating vendors that try to both sell and do contract manufacturing.”
Brontë: “Our whole system is built on a core of trust and reliability. We work for the customer, and we do it well. Other companies have their ‘secret sauces’, as Mark puts it, but a lot of what drives us forward is the staff. The people who work at Formacoat are beyond brilliant at their jobs and committed to quality. Mark is a great CEO because he really puts time and effort into his staff, and that creates an environment where true expertise thrives.
“We’re in the middle of this network, we know people on all sides of the industry. And when we’re at trade shows or talking with others, we’re always finding out what’s new. Because we are already so deeply embedded in these networks, we’re always making new connections. So, in part, it is those connections that are helping drive ours and our customers’ innovations.”
Mark: “We’re interested in investing time and energy in solving customers’ problems, whether it’s with the oldest technology or the newer types that may be available to help in ways that weren’t possible before. Even if they have their own coating solution and need help in the application. With almost 19 years of experience with a wide variety of coatings and our experience and know-how, we are a one-stop-shop for our customers’ coating solutions. This saves our customers money but more importantly, time.
“We help customers in all stages of production. Whether it’s trying out early-stage coating ideas, late in the game coating needs or even device improvement coating. Alongside that, we can provide more standard methodologies or technologies or chemistries, so that we can be looking for the next big thing to help our customers with their marketing, sales, and product needs. Our experience helps our customers to parts of the picture that they haven’t seen before, which in the end saves them time and money.”