Formacoat: A World-Class Leader in Coating Devices, making the Tools of Medicine Run Smoother 

Formacoat: Leader in Coating Device | Mark Gross | The Lifesciences Magazine

Established in 2002, Formacoat is a specialist in providing coating-engineered application solutions utilized in sophisticated medical device design and development for scalable, dependable production. The company is located in the southwest suburbs of Minneapolis, MN. 

As an industry leader in the medical device coating services field, Formacoat strives to assist customers with getting their medical devices to perform as they need them, with coatings, which can do things that bulk medical device materials cannot do. Further, the company takes the developed coating processes and materials and provides full-scale coating production for the device. 

Formacoat is dedicated to providing value to its customers around the world by improving the design, functionality, and performance of its clients’ medical devices. Formacoat’s commitment to quality is highlighted by its ISO 13485:2016 certification.

Spearheading the CEO Role with Utmost Dedication

An exemplary leader, Mark has an educational and industrial background that spans the fields of biology, chemistry, and engineering. This includes wide-ranging and varied functional roles in the development, manufacture, and commercial uses of hydrophilic and hydrophobic coating materials. With his expertise, passion, vision, and resources, he continues to drive Formacoat toward excellence in serving customer coating needs, solving unique challenges, and providing an excellent value-added service at an efficient price.

Mark’s job is to ensure that his second-generation family members are trained and taught how to be skilled, engaged, and invested owners and operators, and develop all its managers to think in terms of long-term development while meeting customer’s needs to get them as Formacoat’s VP, Todd Paulsen, states “from concept to cash flow” as quickly as possible. 

Todd states, “Gross often says he is not a manager.He is a cultivator, a collector of misfit toys if you will. This applies to how he runs his company. From what they do, to the staff they employ, Formacoat is not your typical medical device company. Due to that, one of Gross’s many responsibilities as the company grows is to keep it as close to his successful roots as possible.

A First-Class Suite of Offerings 

In their offerings from different coating vendors, Formacoat has a variety of different technologies to choose from which include Hydrophilic, Hydrophobic, Surface-blocking and Anti-fouling, Anti-Microbial, Heparin, Collagen, and PSA/Adhesive. It has  thermal cure, UV cure, and grafting coating technologies as well. And with its vast array of equipment and technology, the company is the expert in its field when it comes to coating Stents, Catheters, Guidewires, Mesh, and Films. You name it, Formacoat can coat it!

Todd states, “We don’t make or sell coatings, so when a customer asks us to figure out what will work best for their device, we can survey the marketplace for the best fit for each customer’s product-specific needs. And we can provide coated samples in a blind survey with several different coatings from different vendors, all in one experiment. This saves time and money.” 

As a future-driven organization, Formacoat highly emphasizes improving its offerings and fulfilling its customers’ needs. It responds to customers’ and suppliers’ needs and requests for technologies. Since Formacoat is agnostic about what coatings to use on any given device (because as previously mentioned it doesn’t make or sell coatings), it is an honest broker for coating manufacturers to make referrals to them. Mark adds, “We always honor our referrals until a customer says, this isn’t working for us.” 

Formacoat will continue to expand its coating selections and its skills in the application of coatings. It has a full team of chemists and engineers ready to take on any device, no matter how challenging.

Churning Out Constant Success

Formacoat has been in the business for over 20 years, it is a significant amount of time for a business to gain credibility and mark its presence as an industry leader. And Formacoat has aced its game by offering state-of-the-art services and a striking ongoing success rate. 

Formacoat’s success is mainly a result of Mark’s organic growth of the company. Nothing was ever forced in a certain direction, but instead pursued opportunities as they presented themselves.

Its long-standing success is a measure of hitting the trifecta of Quality, Service, and Technology or Quality, Speed, and Price. Formacoat has successfully hit all these points and Mark believes it has achieved these standards because of its nature of being a family-owned and operated business.

Unlike others, Formacoat has seen the long-range vision for each customer’s product, not just next quarter’s numbers, let alone Private Equity’s artificial 3-5 years’ time horizons, and yet it is a small, nimble, skilled, and focused enough that it can make projects happen fast. 

The Roadblocks

Mark was inspired by a college professor to pursue chemistry and it has been a passion ever since. After college, his main focus was hyaluronic acid and its application to medical devices. From there, Mark expanded Formacoat’s capabilities by focusing on the application of coating. Formacoat does not make the coating, but instead, it has partnerships with over 45 vendors all over the globe to be able to provide the perfect coating solution.

Twenty-plus years ago, as a chemist, it took a few years and customers to get the basic balance of Formacoat’s business plan figured out: How much to invest in customers vs. how much to charge them. Mark concludes, “When you add value, you should be getting paid fairly, but helping customers get to the commercial stage tends to mean that we just cover our early R&D costs.” 

Surpassing Competition with Exclusivity

Since Formacoat’s niche is coating medical devices, it can focus on that skill set exclusively. This provides them with the ability to creatively coat extremely unusual products, but the equipment to also coat more regular products. Its technical depth includes Chemists and Mechanical, Process, Automation, Medical Device, Quality, and Industrial Engineers

Formacoat has a wide array of coating equipment to tackle any need, including industrial-scale catheter-sized plasma chambers. If it doesn’t have unique and specific products, and their specific processes, the company will design and build the coating equipment and production line. 

There is no one “best” medical device coating. Some are good in some situations, and not so in others. Some may work better than one situation needs and end up costing that way too. Medical device performance requirements have become progressively more demanding over time. 

Formacoat works with over 45 different coating formulators that offer over 90 different coating chemistries and technologies. It uses these different technologies to address the specific needs and challenges of each device in creative, robust, and cost-efficient ways. Formacoat’s expertise provides a powerful partner in this niche area of medical device coatings.

A One-Stop Shop 

Time is now the most valuable commodity out there. With Formacoat’s access to so many different coating options, it has become an ultimate one-stop shop for selecting a coating for every customer’s device. It carries all varieties of coating and can help a customer choose one based on whatever criteria they bring to the table, instead of having to spend a variety of time and money working through different options with different vendors.

The march of time for science, technology, and creativity makes new opportunities for solving device problems with coatings ever more challenging. In this ever-evolving marketplace, Formacoat continues to evolve and grow its knowledge and capabilities to help leading-edge-idea customers with the solutions they need for their envisioned products. It aims to keep up with the latest demographics adapting to the changing needs of the customers and market.  

With advancements in technology, Formacoat always strives to find answers to the new and challenging opportunities its customers bring them. As the healthcare industry continues to grow exponentially, it believes that these three trends will drive the future of the healthcare industry- Miniaturization, Functionalization, and Ideation. 

Serving a Holistic Audience Base

Formacoat is here for any customer in need of a coating. Of course, the company will prefer to be brought on early in the project, but there have been plenty of times when customers didn’t know they needed coating until they were well into the project.

Mark concludes, “Anyone that needs medical device coatings, and who is interested in a coating service. Customer feedback is essential to tuning to what each customer needs since so much of what we do for customers is custom work. Every device is different.” 

Unveiling Leadership 

Mark has worked his entire adult life with the  medical device material, Hyaluronic acid (HA). Finding that first job as a production worker fermenting and purifying HA was pure luck; plucking a name out of the phone book, Yellow Pages, if anyone remembers those! 

Currently, Formacoat works with HA every day, but also a hundred other materials as coatings. Those humble beginnings ignited a spark and fueled his inner passion to pursue his career in the field of medical devices.

Mark detests what Private Equity does to companies that it buys, no matter the industry. He operates and leads Formacoat to be a company that strives for fair balance among all parties, Owners, Employees, Customers, Vendors, and Suppliers

He believes that innovation is key to success and longevity. Formacoat has always been an out-of-the-box thinker when it comes to the application process and due to that it is not afraid to say yes when others say no.

Fostering a Unique Team Culture

As opposed to a Private Equity path, Formacoat as a family-owned business, with a second generation is well engaged. So, as a business that intends to stay family-owned, the dynamics of making a team and motivating them are more elemental. With respect and a fair and reasonable share of the fruits of its communal labors, the company has beautifully yielded a remarkable team culture. 

Mark has been busy ensuring the future of Formacoat through training the next generation of owners. Brecon is currently the Manufacturing Engineering Manager and is working with his team to continue to revolutionize the processes and capabilities of Formacoat. Bronte is the Marketing Engineer who is focusing on marketing strategies as unique and creative as Formacoat’s business model. Both of these young men have grown up with the company and under Mark’s careful tutelage will be ready to take Formacoat into its next phase.

Formacoat has always been for those with a curious mind and a desire to find answers. The company states, “We have found that if you begin by bringing in folks that have these qualities to start with, and we are always on the cutting edge of something new and exciting, productivity and motivation take care of themselves.

The Mantra, The Mission, and the Magic

For our customers, we ask: “What do you want, and why?”

For Formacoat, and our customer’s unique needs: “What cool problems can we solve!” 

The company fondly calls this the “Formacoat Formula” and it’s a simple idea: What do you want and why? While this may seem like a basic concept, it is one that oftentimes can be overly complicated and even missed altogether. The company is continually amazed at how important the answers are to those seemingly simple questions. Before it offers answers to its coating challenges, it wants to know what the customer cares about, even what the customer who uses the device cares about. By digging deeper and listening to its customer’s needs, the company gains a better understanding of what it needs which leads to improved results, sooner.

Notable Testimonials

  • Jennifer Arnold, Chief Operating Officer, Transit Scientific

As a fast-paced, innovative medical device startup, we work with a variety of contract manufacturers. Formacoat is the contract manufacturer partnership that sets the bar in all aspects. They consistently exceed expectations in product quality, communication, innovation, and speed. Thank you Formacoat for being a critical part of our commercial supply chain! 

  • Andrew Kiezulas, CEO, Coatings2Go, LLC

A merry band of wizards, blending new and trusted technologies with cutting-edge ideas. From understanding the problem to finding multiple-option solutions, Formacoat is our go-to for any contract manufacturing, engineering, and design work inquiries that come our way. Save time, go to Formacoat. 

  • Kristian Erik KillianBusiness Development, Isurtec

The Formacoat team are experts in discovering, and optimizing, the desired Coating Solution as well as providing an efficient application process. Additionally, the Formacoat team provides unmatched service in concert with industry expertise that will exceed expectations and satisfy your project requirements by delivering valuable solutions. – 

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