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
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Catheter Solutions – End-to-End Design & Manufacturing
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Comprehensive CDMO Services – From rapid prototyping to full-scale production, including assembly, testing, and certification.
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Advanced Technologies – Expertise in multi-lumen tubing, braided/coiled shafts, steerable catheters, and high-performance coatings.
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Scalable Manufacturing – Supporting clinical validation and commercialization at global facilities.
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Polymer Solutions – Medical-Grade Extrusion & Material Innovation
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Precision Extrusion – Specializing in low-durometer materials (20D-60D) and multi-layer co-extrusion.
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Next-Gen Materials – PFAS-Free EverGlide+, a PTFE alternative with superior lubricity and e-beam sterilization compatibility.
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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
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AI-Driven & Semi-Automated Equipment – Enhancing assembly, extrusion, and testing efficiency.
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Scalable for R&D & Mass Production – Supporting rapid prototyping and high-volume manufacturing.
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Technology Integration – Powered by RTech for optimized process control and continuous quality improvement.
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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.
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Irvine, USA – Headquarters specializing in design validation (DV), clinical builds, and regulatory support.
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Yorba Linda, USA – Dedicated polymer solutions hub, focused on high-precision extrusion tubing.
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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.
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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
✔ Advanced Endoscopic Steering Devices
✔ Balloon & Self-Expanding Stent Delivery Systems (PTCA/PTA)
From concept to commercialization, we ensure cutting-edge solutions that exceed expectations. Let DynaFlex be your trusted partner in innovation.