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Our Company

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About DynaFlex​

DynaFlex is a full-service partner for medical device companies, specializing in catheter solutions, polymer innovations, and advanced manufacturing equipment. With decades of expertise, we support clients from early-stage prototyping to high-volume production, ensuring quality, efficiency, and scalability at every step.

Our Expertise

  • Catheter Solutions – End-to-End Design & Manufacturing

    • Comprehensive CDMO Services – From rapid prototyping to full-scale production, including assembly, testing, and certification.

    • Advanced Technologies – Expertise in multi-lumen tubing, braided/coiled shafts, steerable catheters, and high-performance coatings.

    • Scalable Manufacturing – Supporting clinical validation and commercialization at global facilities.

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  • Polymer Solutions – Medical-Grade Extrusion & Material Innovation

    • Precision Extrusion – Specializing in low-durometer materials (20D-60D) and multi-layer co-extrusion.

    • Next-Gen Materials – PFAS-Free EverGlide+, a PTFE alternative with superior lubricity and e-beam sterilization compatibility.

    • Custom Formulations – Tailored polymer solutions, including Pebax, TPU, TPE, and HDPE, supported by in-house polymer scientists.

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  • Equipment Solutions – Smart Manufacturing for Catheter Production​

    • Scalable for R&D & Mass Production – Supporting rapid prototyping and high-volume manufacturing.

    • Technology Integration – Powered by RTech for optimized process control and continuous quality improvement.

    • AI-Driven & Semi-Automated Equipment – Enhancing assembly, extrusion, and testing efficiency.

Global Manufacturing & Rapid Prototyping

DynaFlex provides flexible, end-to-end manufacturing solutions across strategically located facilities:

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  • Fremont, USA – Rapid prototyping lab, delivering mock-up prototypes within 5 days to accelerate early-stage development.

  • Irvine, USA – Headquarters specializing in design validation (DV), clinical builds, and regulatory support.Yorba Linda, USA – Dedicated polymer solutions hub, focused on high-precision extrusion tubing.

  • Taiwan Facility – High-volume commercial production, ensuring consistent quality, cost-efficiency, and scalable manufacturing.

 

​With a global footprint and localized expertise, we provide seamless support at every stage of the product lifecycle, from concept to commercialization.

A Trusted Partner in Medical Innovation

DynaFlex collaborates with some of the world’s leading medical device companies, specializing in:

Neurovascular Coil Delivery

Heart Valve Repair & Replacement Catheters

Steerable EP Catheters & Sheaths

Atherectomy, CTO, and Thrombectomy Catheters

Embolic Protection & Intravascular Imaging Devices

Balloon & Self-Expanding Stent Delivery Systems (PTCA/PTA)

Advanced Endoscopic Steering Devices

Welcome
to Our Site

From concept to commercialization, we ensure cutting-edge solutions that exceed expectations. Let DynaFlex be your trusted partner in innovation.

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