COMPANY Categories: Coatings Solutions and Contract Medical Device
Medical Devices: Development Insight, Manufacturing Foresight
Incorporated in 2002, Formacoat is located in the southwest suburbs of Minneapolis, MN. 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. In the final stages of completing their new 38,000 square foot facility, with 3 – Level 7 clean rooms totaling 8,400 square feet of Cleanroom space, and with a catalogue of over 80 different types of coatings from 40 different vendors, Formacoat stands at the ready to take our customer’s concept to cash flow!
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. In our offerings from different coating vendors, we have a variety of different technologies to choose from which include Hydrophilic, Hydrophobic, Surface-blocking and Anti-fouling, Anti-Microbial, Heparin, Collagen and PSA/Adhesive. We have thermal cure, UV cure and grafting coating technologies as well. And with our vast array of equipment and technology, we are the experts in our field when it comes to coating Stents, Catheters, Guidewires, Mesh and Films. You name it, we coat it!
In the final months of moving into our new 40,000 square foot facility, with 3 – Level 7 clean rooms totaling 8,400 square feet of space, and with a catalogue of over 80 different types of coatings from 40 different vendors, Formacoat stands at the ready to take their customers concept to cash flow!
Why Formacoat?
The Formacoat Formula
What do you want and why? While this may seem like a basic concept, it is one that often times can be overly complicated and even missed altogether. We’re continually amazed at how important the answers are to those seemingly simple questions. Before we offer answers to your coating challenges, we want to know what you care about, even what the customer who use your device care about. By digging deeper and listening to our customer’s needs, we gain a better understanding of what you need that leads to improved results, sooner.
Another favorite formula: Medical device design insight yields manufacturing lubricious coatings foresight.
Our Hydrophilic and Hydrophobic Coatings Technologies and Vendors
We Collaborate with Different Coatings Vendors to Bring Your Custom Coating Solutions to Life
There is no one “best” medical device coating. Some are really 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 40 different coating formulators who offer over 80 different coating chemistries and technologies. We use 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.
In our offerings from different coating vendors, we have a variety of different technologies to choose from which include Hydrophilic, hydrophobic, Surface-blocking and Anti-fouling, Anti-Microbial, Heparin, Collagen and PSA/Adhesive coatings. We have thermal cure, UV cure and grafting technologies as well. By working with Formacoat, our knowledge of your device and needs gathers momentum if first options don’t work as well as expected, rather than you having to start all over with another vendor. When starting out with initial comparative studies, we can do comparison friction testing to augment your own functional testing.
Why Medical Device Manufacturers Partner with Us
Experience True Service with Our Value-Added Focus.
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’s 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/outer diameters or complex part shapes, click here to learn more about Formacoat’s medical device and substrate coating capabilities.
New Building
Formacoat has always aimed to be the primary port of call for medical OEMs in satisfying their commercial coating needs, whether it be for instruments used in cardiovascular or implant delivery, or guide wires and catheters. The increasing range of products coated and coatings means we are outgrowing our current facility and equipment. The new facility in Chaska, MN will allow expanding in our core catheter processes four fold, including a new coating system that work well for both small volume R&D runs at less cost, and for some products, “unlimited” lot sizes (larger than our batching production lines can do); film / mesh coating by two fold; six fold increase in ISO Class 7 cleanroom; and space for other work by increasing by three times the square feet of our current facility.
SERVICES
Advanced Biomedical Medical Device Coating Services
Formacoat® can coat your product with hydrophilic, hydrophobic or other custom coatings as a contract manufacturing service. We offer coatings from the full range of different brands, chemistries, and types of coatings. Formacoat draws from its extensive coating and device experience and this array of different technologies and coating vendors to help its customers find the best, most cost efficient and technologically appropriate coating for their application, all at single efficient source: Formacoat.
Making the Tools of Medicine Run Smoother
Advanced Biomedical. Medical Device Coating Services
Formacoat® is a creative biomedical company specializing in application of hydrophilic, hydrophobic and other custom coatings as a contract manufacturing service. We offer coatings from the full range of different brands, chemistries, and types of coatings. Formacoat draws from its extensive experience and this array of different technologies and coating vendors to help its customers find the best, most cost efficient and technologically appropriate coating for their application all at single efficient source, Formacoat.
We Make the Tools of Medicine Run Smoother
Medical Device Types
We won't presume to present an exhaustive list of potential part types or geometries within those types. That said, Formacoat's experience includes coating the inner and outer diameters, or the complex component shapes, of the following medical device types with anti-microbial properties, among others:
- Films up to 17" (41 cm) wide
- Micro-Catheters
- Drug Delivery Catheters
- Stent Delivery-System Catheters
- Embolic Capture Devices
- Medical Device Balloons
- Component Level Materials
- Hypo Tubes
- Micro-well plates
- IOL Insertion Cartridges and other ophthalmic devices
- And, in some situations, medical device Implants
Click here to learn how Formacoat's flexible approaches to your needs can help with most any substrate.
With an array of vendors and their diverse technologies to choose from for you, we are not limited to what any one coating vendor's abilities and limitations are. From this broad spectrum, we can pick from the best materials and technologies for your substrate and application. Materials range from PVC, Polyethylene, Polyurethane, PEBAX® to new materials like PebaSlix, to Aramids and Silicones to, well, you tell us! From polymers, metals and more...We'll Coat It Right!
Just as potentially hydrophilic "coatable" device types are numerous, medical device compatible substrates have a broad range as well. If your material isn't included in the following list, let's talk and explore the possibility of applying the right lubricious coatings for you in a scalable, repeatable fashion together.
- Silicone
- PEBAX
- PebeSix
- Nylon
- PEEK
- Polyurethane
- Polypropylene
- Polyethylene
- HYTREL
- Aramids
- Polymers With Radio Opaque Fillers
- Metals: SS/Nitinol
Touch and feel the difference; Order your free samples today.
Click here to learn more about Formacoat's increasingly diverse medical device coating capabilities.
Medical Device Coating Capabilities
Formacoat has been steadily increasing its capabilities with advanced processing technologies, tooling, techniques and an expanded equipment repertoire.
Capabilities:
- New! Roll-to-Roll Film Coating with medical device coatings:
- Up to 17" (43cm) wide
- Depending on the film thickness, hundreds of yards in length.
- This technology may also be extendable to mesh and screen materials.
- Plasma Surface Preparation:
- New! Multi-gas capable commercial plasma
- Chamber capacity up to 68" (172cm) long in a straight configuration.
- Atmospheric plasma options for select needs
- OD coated products (catheters and tubing, etc.)
- We have significantly increased our batch capacity for many products, allowing lower per unit pricing.
- For our most standard coatings process development and R&D trials can likely be minimized, reducing the overall cost and time to get to commercial production.
- ID coated products:
- Specialized processes and equipment for products needing hydrophilic hydrogel ID coating.
Click here to learn about the wide variety of coating types Formacoat works with.
Medical Device Coating Types
Because Formacoat is independent, we can work with a wide variety of coating types. These include :
- Traditional Hydrogels: The main class of hydrophilic coatings called "hydrogels." A hydrogel coating absorbs water and swells upon contact with water. These wetted polymers give these coatings their lubricious feel and excellent friction reducing properties.
- Niche Hydrophilic coatings:
- Micro-hydrophilic coatings: These are thinner coatings that do not swell appreciably on contact with water but that do present a robust hydrophilic surface that can be used in certain situations to good effect to reduce the contact angle on a substrate. They are not lubricity enhancing coatings.
- Nano-hydrophilic coatings: Do not swell on contact with water, so they are not lubricious but they can reduce the contact angle to good effect for certain specialized needs.
- Nano-hydrophilic Plasma deposited nano-thickness coatings work on metal alloys. They are extremely durable and can coat ID's to tremendous length to ID ratios.
- Nano-hydrophilic liquid applied coatings: These nano-thicknesses, non-ceramic inorganic coatings, may work better on more substrates but as niche coatings have more limited applications.
- Hydrophobic coatings:
- Several Low temperature annealing varieties suitable for some applications.
- These are not the classic, pigmented varieties that require high temperatures
to anneal such as found on metal guidewires.
Formacoat has been steadily increasing vendor relationships to include a wider range of chemistries and characteristic options.
Hydrogels (classic hydrophilic coatings for lubricity enhancement): multiple options for:
- Thermal Cure Hydrogel coatings
- UV Cure Hydrogel coatings
Micro-hydrophilic coatings and Nano-hydrophilic coatings to alter contact angles without swelling: multiple options including:
- Liquid applied organic and in-organic
- Plasma applied inorganic
Hydrophobic coatings:
- PTFE (liquid applied low temperature cure): several options
- Other more exotic materials for "super hydrophobic" characteristics.
- Plasma applied inorganic-ceramics
Click here to learn how Formacoat's flexible team-based approach can help smooth out the design and regulatory process for coated medical devices.
A Flexible Medical Device Coatings Resource
Perhaps the team you're working with has extensive mechanical design and regulatory affairs experience with deep history and expertise in a particular application area. Even when this is the case, Formacoat's lubricious, hydrophilic and hydrophobic coating 'know-how' is a welcome and valued complement to the project's success.
Perhaps you are "the team" and wish to capitalize on the medical device des
ign and regulatory expertise of the Formacoat staff.
- Large company partners gain value from Formacoat as a ready medical device coatings resource with flexibility to focus on your needs with an emphasis on responsive service
- Smaller company / start-up partners may find an unexpected complement to an internal team that will appreciate the regulatory perspective Formacoat provides when developing hydrophilic and hydrophobic coatings applications.
To learn more about our personalized approach to applying hydrophilic or hydrophobic coatings to your medical device contract manufacturing requirements click here.
Formacoat's Tradeshow Attandance for 2020
MD&M West 2020 | Medical Expo
February 11-13, 2020
Anaheim Convention Center
Anaheim, CABooth Number: 666
