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Our Company

Dynaflex-Irvine

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.

Strategic Relationship with Pegatron

In late 2022, Pegatron Group-affiliated entities became long-term shareholders in DynaFlex, marking an important step in the company’s growth. The relationship brings together DynaFlex’s specialized expertise in catheter materials, engineering, and manufacturing with Pegatron’s experience in global manufacturing, automation, and supply-chain management.

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This strategic alignment supports DynaFlex’s continued development of an integrated platform serving customers from early-stage development through commercial manufacturing.

Read the Full Press Release →

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

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