Most contract manufacturers do one thing well. Extrusion. Balloon forming. Coating. Assembly. The result is a fragmented supply chain that forces device manufacturers to integrate the program themselves, manage technical transfers between vendors, and absorb the risk of every handoff in between. Each handoff is a place where design intent gets lost in translation, a regulatory requirement gets missed, or a timeline slips by another quarter. The companies that move the fastest are the ones that stop the handoffs from happening in the first place.
Multiple vendors managing extrusion, balloon forming, coating, and assembly create integration risk and stretched internal timelines. Each transfer adds weeks of qualification and documentation burden.
Moving a program from feasibility through clinical to commercial typically requires multiple tech transfers between providers, each with its own learning curve, validation requirements, and regulatory documentation.
Most catheter CDMOs treat coating as a downstream finishing step rather than a design decision. The result is performance compromises that surface late in validation, when the cost of changes is highest.
Surmodics is a fully integrated CDMO combining design, catheter manufacturing, coating expertise, and regulatory support under one roof. We deliver the entire catheter development journey in one place, from concept design and extrusions through to coating, assembly, packaging, and sterilization. Reduced handoffs. One accountable partner. Greater transparency. Faster execution.
End-to-end integration across design, catheter manufacturing, coating, assembly, packaging, and sterilization, with one accountable partner from prototype through commercial launch.
Few CDMOs combine deep catheter system knowledge with legacy Surmodics coating expertise. For programs that depend on torque, deliverability, and durability, the integration of formulation, application, and manufacturing is a structural advantage.
Cleanroom-certified manufacturing with available capacity, established quality systems, and a project management culture built for scale. Programs move from prototype to commercial production without switching providers.
Embedded partnership model. Flexible engagement, transparent communication, and a track record of collaborative problem-solving that fits both startup and large OEM operating models.
Surmodics delivers the full catheter program in-house. From precision extrusion and balloon forming through coating, assembly, packaging, and quality release, every step is integrated into one quality system, one engineering team, and one regulatory infrastructure.
From concept feasibility to design freeze, ready for clinical builds.
Surmodics catheter design capabilities include conceptual design and proof-of-concept evaluations, complex part design, complete catheter delivery system design, handle and mechanism design, and drawing package development. Design verification, assistance for validation, and preproduction support enable smooth transfer from R&D to commercial production.
Built for:
Capacity for nearly every type of medical balloon catheter design.
Multiple balloon forming processes including in-house custom balloon tubing extrusions, parison stretching and die necking, and specialty designs. Comprehensive balloon technologies span .014, .018, and .035 platforms, semi-compliant, non-compliant, and compliant constructions, up to 45 mm diameter and 300 mm length. Precision catheter extrusion and braiding technology engineered for radial-length catheters, ultra-low-profile DCBs, and high-pressure angioplasty shafts.
Built for:
Surmodics coating science applied in-line, not bolted on.
Hydrophilic, hemocompatible, and drug-delivery coatings applied within the manufacturing workflow. In-house hydrophilic and drug coating lines integrate with cleanroom assembly and quality control, eliminating the technical transfer and qualification burden that comes with using a separate coating provider. Additional applications like direct-to-metal, inner diameter, and difficult-to-coat substrate capabilities are integrated into the broader manufacturing program.
Built for:
Global compliance built into the system, not added at submission.
ISO 13485, EU MDR, and MDSAP certified. Surmodics provides quality and regulatory support helping OEMs prepare robust technical documentation and regulatory submission packages for EU MDR, US FDA, and global submission requirements, with 25 years of regulatory experience and over 25 successful 510(k) submissions across the organization. Design assurance and regulatory affairs teams engage and support at the earliest program stage, not at the submission deadline.
Built for:
Vertical integration is not just an operational choice. It is what makes faster development, cleaner regulatory pathways, and smoother commercial launches structurally possible.
One quality system, one engineering team, and one regulatory infrastructure eliminate the cycle-time loss that comes with multi-vendor coordination.
Programs do not change hands between feasibility, clinical, and commercial. Knowledge, documentation, and process control stay in one place.
Coating decisions are made in conversation with catheter design decisions. Performance attributes like trackability, durability, and crossability are engineered in, not optimized around.
EU MDR, MDSAP, ISO 13485, and Japan GMP infrastructure is in place. Documentation is built into the development process, not assembled at submission.
The conventional CDMO model assumes that specialization wins. Pick the best extruder, the best balloon shop, the best coater, the best assembler. Stitch them together. The assumption breaks down under the weight of the technical transfers, the documentation burden, and the time lost coordinating across vendors who do not share a quality system.
This is why Surmodics built vertical integration into the operating model. Catheter design talks to coating science. Coating science talks to manufacturing engineering. Manufacturing engineering talks to quality and regulatory. The conversation that takes six months across four vendors can happen in a single afternoon across one team. That is the structural difference, and it shows up in the timelines.
Surmodics catheter manufacturing capabilities have been refined across decades of structural heart, coronary, peripheral, and neurovascular programs. The depth shows up consistently across three dimensions that shape program outcomes.
Surmodics catheter design and manufacturing programs routinely involve multi-lumen extrusion with tight dimensional tolerances, large-bore delivery systems up to 45 mm balloon diameter, braided shaft constructions from 16 to 48 carrier configurations, integrated handle and mechanism designs, and high-pressure constructions engineered for structural heart procedures. Few CDMOs operate at this design ceiling.
Surmodics is the only major catheter CDMO that brings proprietary coating chemistry into the manufacturing workflow as a native capability. Hydrophilic, hemocompatible, drug-delivery, and antimicrobial coating systems are applied within the same quality system as the catheter build, with surface technology decisions engineered into the device from feasibility, not bolted on at finishing.
Over 25 successful 510(k) submissions supported by the Surmodics regulatory infrastructure. EU MDR, MDSAP, ISO 13485, and Japan GMP infrastructure enable global market access from a single manufacturing program. Surmodics is able to assist OEMs running parallel submissions across multiple regulatory bodies, the coverage compresses the timeline that would otherwise be lost coordinating across regional partners.
Surmodics CDMO services are engineered for catheter programs where the cost of fragmentation is highest.
If you are a growth-stage startup developing a transcatheter valve delivery system and need one partner from prototype through commercial scale.
If you are a mid-to-large OEM transferring an existing program out of an internal facility or away from a fragmented supplier network.
If you are scaling a structural heart program from clinical builds to commercial volumes and need cleanroom capacity already in place.
If you are entering EU, US, or Japan markets and need an EU MDR, MDSAP, and ISO 13485 infrastructure already certified.
If your program depends on coating performance attributes that demand the coating decision to live inside the device design conversation.
If you are running parallel design, coating, and manufacturing workstreams that are losing time to vendor coordination.
CDMO partnership is only part of the answer. The companies that bring better catheter-based devices to market faster are the ones working with a partner that brings design, coating science, manufacturing scale, and regulatory infrastructure to the same conversation.
End-to-end catheter design, balloon forming, braiding, coating, assembly, and packaging integrated under one quality system, with proven performance across structural heart, coronary, peripheral, and neurovascular categories.
Engagement from feasibility through post-launch support, with cleanroom manufacturing, established quality systems, and regulatory infrastructure already in place.
Engagement models calibrated for both growth-stage startups and large OEMs, from feasibility builds through technology transfer and full commercial production.
Certified cleanroom manufacturing with available capacity, ISO 13485, EU MDR and MDSAP infrastructure, 35 years of operational maturity, and the regulatory expertise to assist on over 25 successful 510(k) submissions.
Surmodics CDMO engagements are calibrated to where the program is and where it needs to go. The engagement model is built around four configurations that match how device companies typically operate.
Concept-stage engagement focused on design feasibility, coating evaluation, and prototype development. Engineered to support funding milestones, first-in-human readiness, and de-risked design decisions.
Full-program engagement spanning design, coating, prototyping, verification and validation, and pre-production. One team, one quality system, one accountable partner from concept through clinical builds.
Quality and regulatory engagement layered into every program. Documentation infrastructure for EU MDR, MDSAP, ISO 13485, and Japan GMP submissions, with regulatory affairs teams engaged from feasibility forward to assistance of submission.
Commercial manufacturing engagement with cleanroom capacity, scalable production systems, and tech transfer support for programs moving from clinical to commercial volumes.
Whether you are a growth-stage startup developing a first-in-class delivery system, an OEM transferring a program out of an internal facility, or a development team preparing for commercial scale-up, Surmodics is built to engage at any stage of the program.
