Bringing a coated medical device to market requires more than selecting the right coating. It requires qualified equipment, cleanroom infrastructure, experienced operators, validated processes, and the quality systems necessary to support regulatory submissions and commercial production.
Building that capability internally can take years and require significant capital investment before a single coated device reaches a clinical study or customer.
For many manufacturers, outsourcing coating production provides a faster, more flexible path forward, allowing teams to focus on device innovation, clinical execution, and commercialization while leveraging an experienced coating partner to deliver production-ready coated devices.
Avoid the lengthy process of purchasing,
installing, qualifying, and validating coating equipment and manufacturing infrastructure.
Scale coating production without investing in facilities, equipment, staffing, and ongoing maintenance costs.
Leverage established coating processes, quality systems, and regulatory infrastructure built specifically for medical devices.
Surmodics has spent decades helping medical device manufacturers solve some of the industry's most challenging coating problems. The same scientific and engineering teams responsible for developing industry-leading hydrophilic, hemocompatible, antimicrobial, and drug-delivery coating technologies also support our contract coating operations.
That means customers gain more than manufacturing capacity. They gain direct access to the coating expertise, process knowledge, and technical resources behind thousands of successful device programs.
Whether you're preparing for a clinical study, launching a commercial product, or expanding manufacturing capacity, Surmodics provides the infrastructure and expertise needed to move forward with confidence.
Qualified coating equipment and test infrastructure already in place, eliminating the capital and qualification timeline required to build coating capability internally.
Experienced operators, quality inspectors, and coating engineers who have supported thousands of medical device coating development and production programs across multiple device categories.
Manufacturing-controlled environments engineered for medical-grade coating production, with the quality systems and process controls required for clinical and commercial supply.
Full engineering and technical support throughout the program, from initial setup and validation through ongoing production troubleshooting and process optimization.
Almost 50 years of coating innovation and expertise
Thousands of medical device programs supported
Clinical through commercial production capabilities
Direct-to-metal, inner-diameter, and silicone coating expertise
Integrated analytical testing and characterization services
Technology transfer and scale-up support
Medical device quality systems and regulatory infrastructure
Engineering support from development through
commercialization
Surmodics contract coating services are built around four integrated capability areas that support medical device coating production from preclinical builds through full commercial supply.
Seamless transition from contract coating to our customerʼs internal manufacturing.
Surmodics supports customers throughout the technology transfer process, including process characterization, equipment selection support, process documentation, OQ/PQ support, operator training, and scale-up activities. Whether customers remain in contract manufacturing or ultimately transition coating in-house, Surmodics provides a structured path forward with full visibility and know-how transfer.
Built for:
Coating processes at commercial scale.
Surmodics operates qualified coating production lines across hydrophilic, hemocompatible, drug-delivery, and antimicrobial coating systems. Production lines support UV-cured and thermal-cured coatings on a range of device geometries, from microcatheters and guidewires through large-lumen catheters and structural heart access devices. Coating processes are run by experienced operators with deep familiarity across the Surmodics coating portfolio. Production capabilities include guidewires, microcatheters, delivery catheters, introducer sheaths, balloon catheters, structural heart access devices, and ophthalmic delivery systems.
Built for:
Coating and testing equipment, ready to run.
Surmodics contract coating operations are supported by qualified coating equipment, simulated-use test systems, particulate testing infrastructure, surface characterization tools and the broader analytical capability set required to characterize coating performance in production. Equipment qualification and validation work is already complete, eliminating one of the longest timeline elements that comes with building internal coating capability.
Built for:
The engineering depth that built the Surmodics coatings portfolio, available to your program.
Surmodics contract coating programs include access to experienced operators, quality inspectors, and coating engineers who support coating production from initial setup through ongoing production. Engineering support spans process characterization, defect analysis, troubleshooting, performance testing, and ongoing process optimization. The depth of coating science expertise that informs the Surmodics coating portfolio is the same expertise applied to contract coating production. Technology transfer support is available for programs that ultimately bring coating in-house.
Built for:
Production under medical-grade quality systems, ready for submission.
Surmodics contract coating operations run under established medical device quality systems with the regulatory infrastructure required for global market access. Surmodics supports coating-related testing, characterization, validation activities, and documentation commonly required for regulatory submissions, including particulate testing, simulated-use testing, sterilization assessments, and accelerated aging studies.
Built for:
When coating production is supported by proven processes, experienced teams, and qualified infrastructure, manufacturers can focus resources where they create the most value bringing innovative devices to patients faster.
Move from development to
clinical and commercial production without waiting years to build internal coating capabilities.
Eliminate major capital expenditures associated with coating equipment, cleanroom facilities, validation activities, and specialized staffing.
Scale production capacity as demand changes without overbuilding infrastructure or carrying underutilized assets.
Leverage coating scientists, engineers, and production specialists with decades of experience solving complex coating challenges.
Manufacture within established quality systems designed to support regulatory requirements and commercial supply.
Most medical device companies don't struggle because they lack coating equipment. They struggle because timelines are compressed, resources are limited, and commercialization milestones continue moving closer.
Building coating operations internally may eventually make sense. But for many programs, the opportunity cost is significant delayed clinical studies, postponed launches, increased capital requirements, and resources diverted away from innovation.
Surmodics provides a different path. By combining advanced coating expertise, production-ready infrastructure, and integrated engineering support, we help manufacturers accelerate development, reduce operational complexity, and bring coated devices to market faster.
Surmodics contract coating operations are governed by customer confidentiality across thousands of program engagements. The depth of the capability portfolio shows up consistently across three dimensions.
Surmodics contract coating engagements are supported by an established technology transfer process. Equipment selection, factory acceptance testing assistance, technical transfer on-site or at Surmodics, extended on-site support, process characterization, Design of Experiments (DOE) and optimization work, and OQ/PQ build support are integrated into the engagement model. Mixing process validation, solution characterization, sterilization and accelerated aging studies, and ongoing technical tune-ups round out the transfer infrastructure. Support includes Design of Experiments (DOE), process optimization, process characterization, validation planning, operator training, and production scale-up.
Coating production engagements include ongoing trouble shooting support on-site or at Surmodics, equipment issue resolution, and defect analysis. The same engineering teams that informed the coating chemistry also support the production line, which means root-cause analysis happens in days, not months. Support may include coating defect investigations, adhesion challenges, lubricity performance issues, particulate generation analysis, and process variation reduction.
Coating and testing equipment, ready to run.
Contract coating engagements include regulatory testing support across simulated-use and particulate testing, lubricity and durability testing, surface characterization and finished documentation and reports to support the customers regulatory filing. The testing infrastructure that supports the Surmodics coating portfolio is available to coating production programs, ensuring that coating performance data and regulatory documentation requirements are met within the engagement, not outsourced to a separate testing partner.
Surmodics contract coating services are engineered for programs where
qualified coating capacity, experienced engineering support, and established
quality systems matter more than building everything in-house.
If you are a startup or growth-stage company that needs coated devices for preclinical or clinical builds without the capital to build internal capability.
If you are an established OEM that needs to scale coating capacity ahead of internal facility expansion or commercial demand.
If you have an internal coating operation that is at capacity and you need contract coating to support overflow production.
If you are launching a program where coating performance and regulatory readiness matter more than the strategic ownership of the coating process.
If you need specialized coating capabilities like direct-to-metal, inner-diameter, or silicone that would be difficult to build internally.
If you are transitioning between internal facilities and need bridge manufacturing capacity without operational disruption.
If your device requires specialized coating capabilities such as direct-to-metal coating, inner diameter coating, silicone coating, or other difficult-to-coat substrates.
Contract coating capacity is only part of the answer. The companies that bring better devices to market faster are the ones working with a partner that brings coating equipment, engineering expertise, quality infrastructure, and regulatory experience to the same operation.
Including UV-cured, thermal-cured, hydrophilic, hemocompatible, antimicrobial, and drug-delivery coating technologies.
Engagement from preclinical builds through full commercial production, with technology transfer infrastructure available when programs are ready to bring the coating in-house.
Contract coating, technology transfer, or hybrid engagement models calibrated to where the program is and where it needs to go.
Qualified equipment, manufacturing-controlled environments, and more than 35 years of coating science, engineering, and production experience behind every contract coating program.
Surmodics contract coating engagement models are calibrated to where the program is. From bridge production through long-term commercial supply, engagement is structured around the customer's operational needs.
Short-term or project-based contract coating engagements for preclinical builds, clinical trial supply, or bridge manufacturing. Engineered for programs that need qualified coating capacity without long-term commitment.
Multi-year contract coating engagements supporting commercial device supply. Production capacity, engineering support, and quality systems integrated into the customer's broader supply chain.
Quality and regulatory engagement layered into every contract coating program. Critical-to-Quality testing, particulate validation, simulated-use testing, and documentation infrastructure built into production.
Hybrid engagement models for customers transitioning between contract coating and internal capability, including technology transfer support, equipment selection guidance, and parallel-run production during transition periods.
Whether you need contract coating for early clinical builds, scaled production for commercial supply, or bridge capacity during an operational transition, Surmodics is built to engage at any stage of the program.
