Continual development and innovation of medical devices is crucial to ensuring and safeguarding the wellbeing of an increasingly health-aware population. Producing efficient, cost-effective, and durable devices is difficult enough, but when paired with the sanitary and biocompatibility considerations necessary for functional medical equipment, the challenge increases manifold. There is always a risk of contamination when implanting any foreign device, such as implants in the human body. As medical device coatings come into direct contact with a patient’s body, it becomes crucial for device manufacturers to choose wisely from an extensive range of coatings and technologies to avoid any complications, such as bacterial infection, blood clots, and tissue trauma. It is safe to say that the coatings applied to these devices are as important as the design and sophistication of the device. The right coating not only enhances the performance, durability, and maneuverability of medical devices but also protects them and the humans they are in from microbial infection and subsequent and related immune response.
However, applying coatings to medical devices is a multifaceted process that requires exceptional skills and careful thinking. Achieving the desired coating specifications and results starts with selecting the right coating material and supplier. While this is no easy undertaking, Formacoat—an innovative and leading provider of contract medical device coating services—offers a simple solution to the problem. As a one-stop shop for all biomedical coating requirements, Formacoat collaborates with many and varied coatings and vendors to bring its customer’s custom coating solutions to life. The company leverages its commercial device coating expertise and an array of different technologies to help its customers select the best quality, cost-efficient, and technologically appropriate coating for their application. “We don’t make or sell coatings, but we work with different coating suppliers and harness their unique technologies, such as thermal cure and UV cure, and now grafting technologies for the benefit of our customers. One of our key differentiators is our specificity on coatings services we can parse the diverse field of coatings to help find the right coating for our client and their medical device challenge,” says Mark Gross, Founder and CEO of Formacoat.
From Humble Beginnings to Becoming an Undisputed Leader
The journey of Formacoat began in 2002 when Gross bagged his first contract from Becton, Dickinson and Company (BD), a leading American multinational medical technology company that had specific coating requirements for one of its products. Gross started the company in his friend’s garage yet successfully met those needs, and BD remains one of the company’s major customers to date. “I made a cleanroom in the garage with HEPA filters to meet the product-specific (medical but non-human use) needs. From there, we formally moved to a place where we ended up staying for 17 years and established our presence as a leading boutique family-owned business,” mentions Gross.
With roots entrenched in the medical device world in Minneapolis-Saint Paul (the Twin Cities)—a world center for the medical device and life science industries—Formacoat is uniquely positioned as a medical device coating services contract manufacturer. The company specializes in the commercial-production application of liquid applied medical device coatings, including hydrophilic, hydrophobic, Anti-Microbial, Surface-blocking/Anti-fouling, Heparin, and PSA/Adhesive coatings with thermal, UV cure, and grafted coatings.
All Coating Needs Covered
Formacoat is renowned for providing coating-engineered application solutions utilized in sophisticated medical device design and development for scalable and dependable production. The company’s array of coatings entails a complete range of polymeric materials and chemistries for specific customer requirements and indications, which enhance the capabilities of a variety of devices/parts, including catheters, introducers, guide wires, balloons, tubing, and wire.
One of our key differentiators is our specificity as we can parse the diverse field of coatings to help find the right coating for our client and their medical device challenge
As an expert in the industry, Formacoat has the flexibility to respond to its client’s coating needs, regardless of their device type or substrate. Be it coating the inner/outer diameters or complex part shapes of medical devices, Formacoat can effortlessly do it all.
Formacoat has distinguished itself in the market by adopting a dynamic business model. The company takes great pride in its collective effort to quickly take products from concept to cash flow by effectively solving each device’s issues as early as possible in the development cycle. Clients can simply bring an idea, and the company’s experts can figure out their needs and accordingly make recommendations to help them dial in the right coating. Formacoat makes this possible through its “problem-solving mindset” centered on one simple question: “What do you want and why?” “We call this the ‘Formacoat Formula,’ and even though this seems like a basic concept, it is oftentimes overlooked by manufacturers in the complicated process of dealing with the medical devices. By asking customers these simple questions, we can really jump ahead in our thought process and make recommendations to help them market their product faster,” states Gross. Crediting Gross for infusing his problem-solving attitude into Formacoat’s work culture, Todd Paulsen, Sales and Marketing Manager at Formacoat, emphasizes that over the years, Gross has assembled a team of experts with the same mindset. “Our growth from the beginning has been revolving around our desire as a company to solve problems for our customers,” he asserts.
No Stopping with COVID
Paulsen mentions that medical devices and implants have to meet stringent FDA regulations and expectations of quality, safety, and consistency. To deliver high-quality products with the desired finish, medical OEMs often approach several coating solution providers to find the optimal long-lasting coating with superior properties at the lowest possible price. This challenge is now compounded by the ongoing COVID-19 crisis. The pandemic has almost quintupled the lead times for medical device coating projects, making it a cumbersome process for device manufacturers to communicate with vendors, line up lab time, develop an R&D team, and so on. Besides, individually visiting multiple vendors and coating suppliers and finding the right coating for the product that matches the needs of the substrate and the device is a huge undertaking amidst this crisis, from both a time and financial perspective. But this is barely a problem for manufacturers when they partner with Formacoat as they find all the appropriate coating solutions in one place. “Our 18 years of extensive coating and device experience and expertise enable us to seamlessly find the best coating for our clients’ needs, as we have so many options to choose from. We do everything for our clients, right from proof of concept, initial trials through FDA approvals to helping them move into production quickly. All their coating requirements are fulfilled under one roof,” comments Paulsen.
In just a year, Formacoat added nine different coatings to its solution suite and currently provides a wide selection of 90 different types of coatings from 45 different vendors. The company also finalized its move to a new 38,000 square foot facility in Chaska, MN, last year, quadrupling its previous space.
The fully equipped, state-of-the-art facility with three different purpose-built ISO Class 7 cleanrooms totaling 8,400 square feet is eight times the cleanroom space in Formacoat’s old facility. Due to the huge space available, customers can visit the facility while strictly following the social distancing norms. With the expansion of its production floor, the company has invested heavily in the equipment, added experienced staff, including a dedicated cleanroom to supply the drug coating market, specifically stents and balloon catheters.
Delivering Improved Efficiencies
Committed to innovation, Formacoat works closely with its customers to make the tools of medicine run smoother. To provide customers with the ultimate coating solution, the company follows a two-pronged sales strategy—reaching out to either the customers that make devices or vendors with coating systems who don’t do contract manufacturing. “We are able to provide a whole new genre of assistance to those coating suppliers and their customers,” explains Paulsen. Formacoat partners with customers who understand the value of focusing on their core strengths and want to minimize the internal expense associated with coating operations. “As I said, coating vendors often reach out to us with their own clients, which opens up another vast marketing arm for us,” Paulsen notes. Formacoat functions as an honest broker with regard to how it processes referrals and works with the customers referred by the coating vendors until the product is commercialized. If the customer is unsatisfied, Formacoat can either quickly switch to a different solution that meets their needs or provide feedback to the vendor to give them a good shot at getting to completion.
Integrating years of expertise and an impeccable reputation in the industry, Formacoat has carved a unique niche in the market with several notable client success stories. In one such instance, Formacoat successfully helped one of its clients zero in on the most appropriate coating solution. Formacoat conducted a coating survey using six coatings that appeared to meet the customer’s criteria and then, through functional testing, dialed the coating that best met the customer needs. Despite the unprecedented challenges presented by the COVID-19, the lead time for their project went from a year’s worth of development to two months. Formacoat then continued to proceed down the road, getting the client’s product to market, leading to cash flow in their new accounts.
Soaring into the Future
Under Gross’ leadership, Formacoat has been on a remarkable journey of helping medical device manufacturers improve device functionality and performance while minimizing coating operation costs. Shedding light on plans, Gross mentions that he intends to continue operating Formacoat as an independent company, passing on the baton to his second generation.
Over the years, Formacoat has garnered huge traction in the market, and its customer base continues to grow in the San Francisco Bay Area, Southern California, Boston, and across parts of Europe. “The COVID-19 pandemic compelled us to change our business practices, like so many of us in the pandemic, with new technologies like video conferences and calls, which has allowed us to take our business philosophy across the world. And being able to do that brings everybody to their neighborhood coating service provider,” notes Gross. Formacoat plans to upgrade its selling approach for attracting customers all around the world and across town. “We are consistent with our unwavering focus on liquid applied coating. Our core goal is to keep excelling in the coatings world,” concludes Gross.