About

Unrivaled expertise in coating solutions for medical devices

Who we are

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.

What we do

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. Each hydrophilic or hydrophobic coating for medical devices or other specialty products can provide different characteristics of lubricious, abrasion resistant, haemocompatible, non-thrombogenic and biocompatible value to your device. Click here to learn more about what our different coating vendor relationships and their products means to you and your project.

Our customers

Device manufacturers working with Formacoat cover a cross-section of application types, designs, company sizes and geographic locations including:

  • Vascular and cardiovascular, auditory, ophthalmic, implant delivery
  • Catheters, guidewires, tubing, wire, roll to roll applications, film, screen
  • Medical businesses, and unique industrial applications
  • Fortune 500 companies, mid-sized companies and small start-ups
  • U.S. and Internationally-based companies

Our customers value the collaborative input and experience of Formacoat staff and the way they relate to designing a repeatable, scalable coating process. Even better, they enjoy working with us and appreciate the personal relationships we foster!

In addition, Formacoat can provide guidance on regulatory compliance with its staff seasoned in medical device development and compliance expertise. Each partner’s needs are unique, and Formacoat’s response to those needs is unique as well.

Formacoat satisfaction comes when customers gain an edge over the past performance of their medical devices as a result of working together with us. As demand for lubricious hydrophilic coated devices and specialized hydrophobic coatings has grown, Formacoat has grown as well, with classic “Win-Win” client relationships.

Whether your requirements are to coat inner or outer diameters or complex part shapes, with hydrophilic or hydrophobic coatings, click here to learn more about our 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.”