Formacoat
The Agnostic Outlook Redefining Medical Device Coating

What foundational considerations guide initial coating discussions for medical device requirements?

When a medical device company brings a coating challenge to Formacoat, the first question is never about materials. It is about the device, its composition, functional requirements, and the constraints the customer is working within. That starting point is not always how coating decisions are approached. Across much of the contract coating space, recommendations are often influenced by existing capabilities rather than what the device specifically requires. A decade of consolidation has made that more challenging, narrowing choices and pushing costs beyond the reach of many smaller companies.

How does Formacoat structure its infrastructure to support customer-centered coating evaluations?

Formacoat, a contract coating application company focused exclusively on medical devices, was founded to work the other way around and has spent nearly 25 years building the infrastructure to support that approach.

That infrastructure centers on one core principle: the customer should be able to evaluate every viable option in a single engagement. Where most device companies navigate a fragmented landscape of vendors, separate conversations, and data gathered under different conditions, Formacoat consolidates the selection process into one place.

Customers evaluate multiple coating options using comparative data generated on the same equipment, eliminating variability and significantly reducing the time, effort, and operational complexity typically required to arrive at a decision. Instead of spending months coordinating across suppliers, customers can move through selection, validation, and decision-making within a structured, unified process. The evaluation is structured around the device's requirements and the customer's budget, producing a decision they can stand behind.

“We just want to find the right coating for our customers' devices that fits both their needs and wallet,” says Todd Michael Paulsen, vice president.

A Catalog Built around Customer Choice

Why did Formacoat expand its coating catalog beyond a single vendor approach?

The agnostic model did not happen by accident. When Mark Gross founded Formacoat, he deliberately chose to build outside the boundaries of a standardized corporate structure. The company started with a small set of coating solutions from a single vendor. It became clear early on that a single coating technology could not serve the full range of devices, substrates, and performance requirements that customers were bringing through the door. Gross responded by expanding the company’s access to coatings, building a catalog broad enough to give every customer a genuinely open field of options.

Today, that catalog spans over 90 coatings from 45 vendors worldwide. When a customer comes to Formacoat, they go through an open-coating survey, with comparative data gathered on the same equipment across viable options. The process removes the fragmentation that typically defines coating selection, eliminating the need to manage multiple vendors, separate NDAs, and inconsistent data sets.

The evaluation remains anchored to the device and the budget, allowing customers to complete the selection process within a single engagement and move forward with confidence before production begins.

The People Behind the Process

In what way does Formacoat’s team structure enable broader coating solution development?

From the beginning, Formacoat has attracted a particular kind of talent: scientists and engineers who are exceptionally capable but do not fit the mould of a conventional corporate environment. The company employs five full-time chemists and a dedicated engineering team. This structure allows the company to move beyond the limitations of a single coating technology.

Where many coating houses decline work that falls outside a narrow device profile, Formacoat takes on catheters with multiple substrates, complex geometries, drug release coatings, stents, meshes, and films. Each of these requires a deep understanding of how coating chemistry interacts with different materials. A provider built around one proprietary technology typically lacks the flexibility to address that complexity. Formacoat’s team is structured specifically to do so.

“Our team is brilliant, but they don't necessarily fit into the typical corporate mold. They think outside the box, and that is what allows us to be incredibly nimble,” says Paulsen.

This unconventional talent model allows Formacoat to approach coating challenges differently. Rather than limiting solutions to predefined use cases, the team actively explores how coating chemistries can be adapted beyond their original intent, opening up alternative pathways that would typically be overlooked in more rigid development environments.

That flexibility extends beyond early development. Formacoat supports customers from an initial napkin sketch concept through to full-scale production, with coating processes engineered for scalability and repeatability. Core coating equipment is designed, built, and maintained in-house, allowing the team to tailor processes to each device while maintaining consistency and cost efficiency at production volumes.

Vendor Relationships that Expand the Possible

The partnerships Formacoat has built with coating vendors over 25 years are not transactional. They are working relationships built on a shared interest in extending the practical use of coating technologies.

Many coatings are originally developed for a specific application. Formacoat’s chemists evaluate their underlying properties to identify additional use cases beyond their initial intent. This approach creates value on both sides. Customers gain access to solutions that would not typically surface in a standard vendor interaction, while vendors benefit from broader adoption of their products across different device categories.

This dynamic has enabled Formacoat to build relationships with major coating suppliers across the industry, creating a network that continually expands the range of viable solutions available to customers.

From Zero Hour to Market

The real test of any coating partner is how it performs under pressure. One client approached Formacoat just four weeks before a planned market launch. The device, an implantable delivery system, had received regulatory approval but failed during initial field testing due to insufficient lubricity.

Formacoat evaluated the issue and presented multiple solutions, including one that involved no coating. When the substrate itself was identified as a contributing factor, the team clearly communicated that, even though it was not a practical option at that stage. A compatible coating solution was then identified, applied at production scale, and the device successfully reached the market.

Within a year, the company was acquired. The individuals involved in that project have since returned to Formacoat multiple times, bringing new devices from different organizations.

Due to similar outcomes across multiple engagements, Formacoat has been recognized as a Top Medical Device Contract Manufacturing Coating Solutions provider, reflecting its ability to deliver consistently under complex and time-sensitive conditions.

Expanding Access through Internal Development

Formacoat’s decision to develop its own coating platform was a direct response to market changes. Consolidation across coating suppliers has driven prices upward without corresponding advances in underlying technology, limiting access for startups and mid-sized companies.

HydroMark, launched at MD&M West, was developed to address that gap and ensure more consistent access for customers. Currently offering hydrophilic thermally cured coatings, with additional formats in development, it delivers performance aligned with industry standards while remaining cost-effective. Formacoat positions HydroMark as one option within its broader portfolio rather than a replacement for its agnostic model. The platform is evaluated alongside other coating solutions based on device-specific requirements, ensuring that recommendations remain driven by performance, compatibility, and cost rather than internal preference.

The company is also expanding access to coated materials earlier in the development cycle. By working with OEM partners and distributors, Formacoat aims to provide pre-coated substrates to R&D teams, allowing engineers to incorporate coating compatibility, performance, and cost into designs from the outset rather than addressing them late in development.

Nearly 25 years of experience solving complex coating challenges has given Formacoat a clear understanding of common challenges in device development. By engaging earlier and providing broader access to coating solutions, the company continues to help customers reduce risk and support more efficient development from concept to market.