Coating Services for Large and Small Medical Device Manufacturers
Choose Hydromer®, a coating services provider with 40+ years experience in hydrophilic coating technology. Utilize our extensive coating services, ranging from R&D and regulatory consulting to contract coating and technology transfer. We help simplify the coating formulation and application processes for medical device OEMs, startups, and CMOs.
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Why Choose HYDROMER?
Quality & Regulatory Compliance
ISO 9001:2015 certified with TUV Rheinland of North America. ISO 13485:2016 is certified with BSI
Hydrophilic Coatings Expertise
40+ years in custom hydrophilic coatings innovation, including R&D, formulation, testing, manufacturing & application.
Operational Excellence & Reliability
No project is too small, too big, or too complex. Our team will ensure the highest levels of quality & efficiency.
WHat we offer:
- Provide end-to-end coating support for your medical device or industrial product
- Help you focus on your core strengths and successfully launch medical devices faster
- Innovate customized formulations to meet your exact product requirements
- Offer custom thermal and UV-cure coatings, including our new HydrUV™ UV medical coatings.
- Utilitze a variety of application methods, such as dip, spin, flow, and our proprietary meniscus coating.
- Excel at coating a wide range substrates and devices with unique geometries
- Evaluate coating performance through rapid prototyping and feasibility testing.
- Produce our polymer products in-house at our Concord, NC, facility
- Have access to a reliable supply chain network to ensure short lead times
- Employ a validation protocol that follows cGMP guidelines
- Ensure all chemistries and processes follow strict environmental, material-handling, and employee-safety standards
- Support all your SOP and QA procedures and package and deliver devices based on your specifications
How It Works - Our Streamlined Coatings Process
Our experts work with you from the discovery stage all the way through development and commercialization. We work closely with you to understand your device, performance needs, appropriate materials, coating challenges, and regulatory requirements.
Below are the steps we follow to achieve the development and application of our coatings for your device:
- STEP #1: Technical Consultation
- STEP #2: Feasibility Analysis
- STEP #3: Sample Coating
- STEP #4: Coating Optimization
- STEP #5: Pilot-Scale Production
- STEP #6: Commercial Manufacturing and Packaging
- STEP #7: Documentation
- STEP #8: Regulatory Approval
Our COating Services
Contract R&D
We have provided research and development (R&D) services for companies large and small for over 40 years. From chemical analysis to formulation and process development and automation we can support your company.
CONTRACT Coating
Hydromer® offers contract coating services using our own proprietary hydrophilic coating formulas. Our facility is equipped to coat both prototypes and market ready devices at full-scale.
Specialized Analytical testing
Our in-house team includes highly qualified Ph.D. Analytical, Bio, and Polymer chemists who perform product analysis testing and development. Our capabilities span analytical, chemistry, microbiology, and process testing.
Coating Technology Transfer
Once developed, our procedures and technologies can be moved to a your facility through a methodical process known as “technology transfer”. This brings manufacturing and testing processes to your site.
Companies we serve:
Coating Services for OEMs
Hydromer®, Inc. functions as a comprehensive partner for medical device OEMs. Our services span R&D, product development, and regulatory compliance. We are committed to formulating custom, innovative medical coatings and services so that you can successfully launch your devices.
Click below to learn more about our coating services for OEMs.
Start-Up Companies
Hydromer®, Inc. has 40+ years of technical expertise, robust R&D capabilities, and a deep understanding of the regulatory landscape. Our coating experts will support your team in the development of your cutting-edge medical devices. We can create custom, innovative coatings that efficiently meet your startup’s product requirements.
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Coating Services for CMOs
Your CMO excels in large-scale manufacturing, but you may lack an in-house coating facility, or polymer chemistry and medical coating expertise. Partnering with Hydromer® can help your organization ensure streamlined coating formulation and application as well as regulatory compliance so you can focus on your core strengths.
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Customized Solutions For Your Specific Requirements
Our Coating Capabilities
Coating Technologies
- Hydrophilic medical coatings
- Antimicrobial coatings
- Thromboresistant coatings
- Drug-eluting coatings
- Cell growth enhacing coatings
- Anti-fog coatings
- Industrial coatings
- Custom formulated coatings
- UV-cure & thermal cure coatings
APPLICATION METHODS
- Dip
- Proprietary meniscus method
- Flow
- Spin
- Spray
- Micro-application for small and complex parts
- Internal lumen (ID) coating
- Custom coating application
EXAMPLE Substrates
- Acrylics
- Stainless steel
- Glass, mirror
- Metals
- Polycarbonate
- Polyethyleneimine (PEI)
- Polyurethane
- PVC
- And more
Need a
Hydrophilic Coating?
Frequently Asked Questions
Can Hydromer coating formulas be modified for specific needs?
Yes, all of our medical coatings can be custom-formulated as per your device or substrate requirements. We offer technical consultation and R&D services to ensure the best results.
Can you help us choose the right coating for our device?
Yes. Please contact us for a free technical consultation to discuss your unique challenges and product requirements. Our team has decades of experience formulating custom coatings tailored for our global clients.
What type of medical device coatings does Hydromer offer?
Hydromer®, Inc. has 40+ years of experience in manufacturing and supplying high-performance hydrophilic medical coatings. All our coatings can be customized as per your project requirements. Our coatings include lubricious coatings, antimicrobial coatings, thromboresistant coatings, drug-eluting coatings, and more.
How does Hydromer ensure coating adhesion and long-term durability?
We ensure proper surface preparation, evaluate different coating chemistries, and perform different analytical and quality tests. We have decades of experience and access to modern equipment; everything is set to minimize product failure post-production.
What kind of testing is done once sample coatings are complete?
Our team has an excellent knowledge of industry standards when it comes to testing medical coatings for reliability and safety. We perform various tests to ensure adhesion, proper thickness, lubricity, durability, shelf-life, biocompatibility, and more.
Can you train my team or install coating equipment at our facility?
Yes. We can help you with the development and application of the medical coatings in either your facility or ours. You can leverage our process optimization, custom machine building, and technology transfer services to set up your own facility.
What materials and device geometries can Hydromer coat?
Hydromer coats medical devices made of metals, glass, polymers, and ceramics. Our facility has the expertise and tools to coat both the inner diameter (ID) and the outer diameter (OD) of complex medical devices. We combine different coating application methods to achieve uniform coating across the entire surface even the most complex medical devices.
Do you offer UV-cure and thermal-cure coating options?
Yes. We have both options available. Our HydrUV™ and other UV-curable systems are proven to provide excellent hydrophilicity, crosslinking, and abrasion resistance. The best curing method is determined based on your unique requirements and coating challenges.
Can Hydromer incorporate my drug, API, or molecular entity into your coatings?
Yes, our Drug-Eluting coatings can encapsulate active pharmaceutical ingredients or therapeutic agents.
How are Hydromer’s coatings shipped?
The shipping method varies based on your location/country. We ship the products based on customer requirements.
What happens after we send Hydromer samples of our product?
We will first schedule your product for coating. We will notify you during each step of the coating process.
Do you help with regulatory documentation for FDA, EMA, or ISO submissions?
Hydromer®, Inc. has a dedicated team of regulatory experts. We offer end-to-end support for regulatory submissions. Our team will provide you with the technical data and supporting documentation needed for regulatory submissions.
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