Life-saving medical devices made with purpose and precision.

Our cross-functional engineering teams support programs from ideation and early concept through commercialization. We combine human-factors insight, DFM/DFA (Design for Manufacturing/Design For Assembly) expertise, rapid prototyping, and robust risk management within a disciplined, stage-gated project-management framework. A key component of this early strategy is confirming our plan through the FDA Q-Sub (Quality Submission) process to confirm the regulatory pathway, align on testing expectations, and ensure the right design-control structure to formalize design and development activities. Further enabled by our integrated Quality Management System, this integrated approach accelerates development while improving product reliability, manufacturability, and regulatory preparedness, giving our customers a clear, validated path from concept to market.

We produce complex catheter and shaft systems for delivery systems, diagnostics, robotics, and electrophysiology procedures. Our capabilities also include sensor and electronics integration including ultrasmall disposable, camera-on-tip endoscopes and connected smart catheters. We keep with tight-tolerance control over lumens, reinforcement structures, variable durometers, bonding, and thermal processing, including multi-planar steerable catheters. Our integrated approach enables consistent performance in demanding cardiovascular and neurovascular applications, including torque response, pushability, kink resistance, high lubricity through our hydrophilic coating processes, and atraumatic navigation in complete compliance with ISO 10555 requirements.

From quick turn prototypes delivered in under 5 business days to production scale, we extrude high-performance thermoplastics and custom polymer blends into tight-tolerance tubing for minimally invasive and implantable applications. Capabilities include multi-lumen, braid- or coil-reinforced constructions, and rapid material qualification—all supported by continuous in-process monitoring to ensure consistency, biocompatibility, and mechanical reliability.

From complex geometries to multi-shot and over-molding, we manufacture critical components using engineered polymers and applying sophisticated tooling strategies. Precise process monitoring ensures repeatability, dimensional stability, and biocompatibility for components used in implantable devices, delivery catheters, and minimally invasive systems.

We convert high-performance films, foams, adhesives, and specialty composites into precision components and finished products using die-cutting, laminating, island placement, and laser processing. Tight process control ensures consistent performance for diagnostics, wound care, drug-delivery interfaces, and wearable technologies.

Our in-house automation and test-engineering teams develop custom equipment for assembly, inspection, and functional testing. These systems support tighter tolerances, reduced variability, and accelerated throughput, helping customers achieve consistent product quality and compliant, scalable manufacturing. We also have engineers specializing in test equipment designed for device-specific failure modes. For example, our team has designed and built custom fatigue-testing equipment for structural-heart implants—capable of reproducing mechanical loading conditions operating in real body temperature to evaluate long-term durability. Similar custom rigs have been developed for tensile, torque, leak, flow/pressure, and durability testing across a wide range of interventional products. All testing equipment built in-house are justified and validated for FDA testing.

All under one roof, we internally source multi-component assemblies—from catheter systems and implantable devices to IVDs—using controlled environments, validated bonding methods, automated processes, and in-line inspection. Our vertically integrated operations streamline transitions from prototype to full-scale production, including sterilization management, while maintaining traceability and process robustness.

We design and qualify packaging systems that protect device integrity, including oxygen and moisture barriers, through sterilization, transit, and extended shelf life. Our expertise spans across sterile-barrier materials, sealing, validation, and coordination with sterilization partners to ensure regulatory-aligned, ready-to-ship product releases.

We offer advanced CNC machining, Swiss-turning, and femtosecond laser processing for intricate metal and polymer components. Capabilities include laser cutting, welding, ablation, and micromachining—ideal for hypotubes, stents, nitinol assemblies, and other high-precision geometries requiring burr-free edges and consistent mechanical properties.

Our surface-engineering portfolio improves device performance, durability, and biocompatibility through controlled finishing, passivation, electropolishing, plasma treatment, and specialized coatings such as best-in-class hydrophilic coatings. These processes enhance lubricity, corrosion resistance, adhesion, and cleanliness while meeting stringent regulatory and ISO quality standards.

Our globally distributed operations provide on-shore and nearshore manufacturing options, integrated planning, and end-to-end logistics support. We manage materials, sourcing, compliance, and inventory to reduce lead times and strengthen continuity, delivering dependable supply for high-volume and high-complexity medical devices.

We engineer and process nonwovens, meshes, braids, and technical textiles for use in wound care, filtration, implants, and patient-interface products. Capabilities include electrospinning, dipping, forming, coating, laminating, and custom material integration to meet demanding mechanical, absorbency, and biocompatibility requirements.