Formacoat, a medical device contract manufacturer, has won three awards in the 2025 Medical Device Network Excellence Awards for its strategic pivot from a pure services model to a full-solution coatings partner, underpinned by a targeted technology acquisition, thoughtful capacity investments, and a disciplined product relaunch.
Formacoat won the M&A award for acquiring VitroStealth, a proven coating technology, and ensuring a smooth transition for existing users. The company won the Business Expansion award for advancing flexible, scale-ready manufacturing with enhanced verification and standardization. It additionally won the Product Launches award for relaunching VitroStealth with clear adoption pathways and quality-focused support.
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VitroStealth integration and market expansion recognized with M&A award
Formacoat’s acquisition of VitroStealth from DSM Biomedical is notable for both scope and execution. For more than two decades, the company operated with an agnostic sourcing model, building a library of coatings from dozens of vendors and avoiding ownership of a specific chemistry. Taking on a proprietary product marked a deliberate shift. The decision followed technical due diligence by Formacoat’s chemists and engineers, who concluded that VitroStealth’s non-biofouling behavior, hydrophilicity, durability, and fast ultraviolet (UV) curing filled a distinct gap without displacing existing supplier options.
The handover also prioritized continuity for DSM’s established customers. Formacoat assumed responsibility for ongoing support, signaling a low-friction transition rather than a disruptive change of supplier. That continuity matters in regulated device programs, where changes to materials or processes can trigger revalidation. By integrating VitroStealth into its offering while affirming long-standing vendor relationships, the company maintained its “best-fit” ethos—now with an additional in-house option when it serves the device brief.
VitroStealth’s attributes align with specific device needs. In biosensors and capillary-driven systems, for example, analyte permeability that supports glucose and oxygen transport is essential to signal fidelity, while non-biofouling surfaces reduce protein adsorption or cellular adhesion that can undermine performance. Hydrophilicity helps wetting and flow, and scratch resistance supports durability during handling or assembly. The ability to apply the coating via dip, spray, spin, or roll methods and to cure rapidly under UV also compresses processing time. The acquisition opens incremental revenue streams—moving Formacoat from “services only” to “services plus product”—and broadens its role as a coatings partner that can supply technology, application, and support across multiple device types.
Capacity scaling: Flexible equipment and quality verification
Formacoat’s capacity strategy centers on enabling scale without forcing device makers to rework processes as volumes rise. Adding dual-cure capability—thermal and UV—on shared equipment means the same hardware can accommodate different chemistries, helping programs progress from engineering runs to commercial production without wholesale equipment changes. Standardization of recipes, fixtures, and quality assurance (QA) checkpoints supports repeatability, which is critical when shifting from small pilots to sustained manufacturing.
Breadth in application methods is another lever. Supporting dip, spray, spin, and roll allows Formacoat to match the coating route to a device’s geometry and substrate—fine wires and tubulars may favor dip or spray; thin films, meshes, and continuous web materials align with roll coating. This flexibility reduces the need for retooling or route changes as specifications are refined, helping teams preserve validation work while scaling lots from small batches to high-volume orders.
Upgrades to the Gen 3 roll coater illustrate the emphasis on measurable quality. The addition of inline camera verification offers objective evidence of 100% coverage for reel-to-reel jobs, giving OEMs documentary proof that requested areas are coated as specified. Faster in-process feedback also shortens the time between detection and correction of any variance. For customers, the practical outcome is a single coatings partner that can support early feasibility, bridge to clinical builds, and sustain commercial volumes—without serial handoffs or repeated requalification.
Relaunching VitroStealth with manufacturing and QA readiness
Relaunching VitroStealth as an off-the-shelf coating reframed it from a technology in transition to a product with defined adoption paths. Formacoat paired the coating with validated application routes—dip, spray, spin, and roll—and fast UV processing to reduce time from evaluation to production trials. The performance profile is directly relevant to common device challenges. Non-biofouling surfaces help limit protein and cell adhesion; hydrophilicity improves wetting and capillary action; scratch resistance supports handling and assembly; and permeability supports sensor function where glucose or oxygen transport needs to be maintained.
The relaunch also focused on accessibility and support. Broader access across substrates and device designs allows teams to explore the coating on plastics, films, meshes, and other materials commonly used in minimally invasive and diagnostic devices. Improved documentation and service—important for both legacy DSM users and new adopters—lower the barrier to procurement and process qualification. Coupling product availability with scalable manufacturing capacity and documented quality controls created a coherent offering: a defined coating, proven application routes, and a path to volume with consistent QA. The product-and-services model encourages closer collaboration during evaluation and scale-up, aligning technical merit with the operational requirements of regulated device manufacturing.
Company Profile
Incorporated in 2002, Formacoat is a privately held medical device contract manufacturing company located in Chaska, Minnesota, a suburb of Minneapolis. Our roots come from the diverse community of Twin Cities companies that have made our area a world center for the medical device and life science industries.
As a uniquely positioned medical device coating services contract manufacturer, Formacoat is dedicated to providing value to its customers around the world by improving the design, functionality and performance of our clients’ medical devices.
We work expertly with our customers to improve medical device functionality and performance. Through aligned objectives and collaborative efforts, we make the tools of medicine run smoother.
We are specialists in providing coating-engineered application solutions utilized in sophisticated medical device design and development for scalable, dependable production.
Formacoat helps clients around the globe improve the performance of their medical devices through our coatings expertise. Formacoat’s collaboration includes access to a wide range of coating vendors and their technologies, to help us bring your coating challenges to life.
Coating for medical devices can have a myriad of functional capabilities: From hydrophilic to hydrophobic to anti-microbial to non-thrombogenic, Formacoat has the coating selection and know how to your device coated and into production.
Contact Details
2960 Chaska Blvd, Chaska,
Minnesota, 55318, United States
Links
Website: https://formacoat.com/
