Who We Are

Incorporated in 2002, Formacoat is a privately held medical device company specializing in biomedical coatings 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.

What We Do

As a leading medical device coating services contract manufacturer, Formacoat is unwavering in its commitment to augmenting the design, functionality, and performance of our OEM customers’ medical devices. We collaborate with our esteemed clientele to amplify biocompatible medical device capabilities and elevate overall efficacy.

We are specialists in providing coating-engineered application solutions tailored for intricate medical device designs, ensuring scalable, consistent production. With our global reach, Formacoat aids customers in enhancing their medical device performance through our hydrophilic and hydrophobic coating proficiencies.

Formacoat’s collaboration includes access to a wide range of coating vendors and their technologies, enabling us to tackle intricate coating challenges. From lubricious and abrasion-resistant to haemocompatible and non-thrombogenic, our biocompatible coatings add multifaceted value to a wide variety of peripheral-, neuro- and stent-related devices. Explore our extensive capabilities in hydrophilic and hydrophobic coatings for a variety of medical devices and understand how our partnerships with diverse coating vendors can benefit your specific project needs.

Our Customers

Medical Device manufacturers collaborating with Formacoat span a diverse spectrum of application types, designs, and corporate scales. This encompasses:

  • Vascular, cardiovascular, auditory, ophthalmic, and implant delivery sectors.
  • Devices like catheters, guidewires, tubing, and wire, as well as advanced film coating processes such as roll-to-roll applications, film, and screen.
  • Various medical businesses and specialized industrial applications.
  • Esteemed Fortune 500 medical device corporations, dynamic mid-sized entities, and innovative biomedical start-ups.
  • Both U.S. and internationally based medical device manufacturing firms

Our partners deeply value the collaborative insights and vast experience Formacoat brings to the table, especially when crafting a repeatable, scalable hydrophilic and hydrophobic coating medical device coating process. The rapport we establish and the strong personal relationships we nurture with our clientele are aspects they cherish immensely.

Furthermore, Formacoat, with its seasoned team, offers invaluable guidance on regulatory compliance, drawing from their deep-seated knowledge in medical device development and regulatory protocols. Recognizing that each partner’s requirements are distinct, our approach to addressing those biomedical coating needs is tailored and unique.

The ultimate satisfaction for Formacoat is witnessing our medical device company customers achieve enhanced performance with their medical devices, a direct outcome of our collaborative endeavors. As the demand for lubricious hydrophilic coated devices and specialized hydrophobic coatings escalates, so does our growth trajectory, echoing our ethos of fostering “Win-Win” client relationships.

Discover our expertise in applying hydrophilic and hydrophobic coatings to both inner and outer diameters or intricate part shapes and delve into our comprehensive medical device and substrate coating capabilities.

Our Affiliations

Formacoat is a long-standing member of the Medical Alley Association

See our listing on the Medical Device Directory

See our listing on the Medical Device Network

See our listing on Qmed

ISO certification

Formacoat ISO 13485:2016 Certification

Formacoat’s commitment to quality is highlighted by our ISO 13485:2016 certification. First issued on 22 July 2015, our certification was most recently renewed on 12 July 2021 by SGS United Kingdom Ltd, which shows that we have been assessed and certified as meeting ISO 13485:2016 requirements for: “Contract manufacturing of the application of medical-grade biomaterial coatings and contract manufacturing of the assembly of medical device components for non-active medical devices.”

Download a PDF version of our ISO 13485 certificate here.