Custom Catheter Fabrication
Hart designs and manufactures custom catheters engineered to integrate seamlessly with your medical device. We approach catheter fabrication as a system-level challenge—balancing material selection, dimensional accuracy, bonding methods, and clinical performance. Whether your application requires precision fit over a needle, compatibility with specialized hubs, or performance within complex assemblies, Hart delivers catheter solutions that are reliable, repeatable, and scalable.
Precision Catheter-to-Needle Fit for Reliable Performance
We engineer catheter dimensions and tolerances to ensure consistent, secure fit over needles and internal components. By tightly controlling wall thickness, inner diameter, and concentricity, our engineers help ensure reliable clinical performance across production runs.
Material Flexibility Aligned With Your Design Requirements
Hart works with a range of medical-grade materials selected to meet your device’s mechanical, chemical, and clinical demands. From flexibility and kink resistance to durability and sterilization compatibility, we help match material properties to real-world use while maintaining manufacturing consistency.
Fabrication for Both Off-the-Shelf and Custom Hub Solutions
Whether your catheter design requires standard hubs, custom-molded interfaces, or overmolded transitions, our team can fabricate catheter assemblies that integrate cleanly with downstream components.
Engineering Catheters With the Full Device Lifecycle in Mind
Catheter fabrication demands careful attention to how materials behave during assembly, sterilization, and clinical use. Hart engineers each catheter with these factors in mind—evaluating flexibility, bonding interfaces, dimensional stability, and compatibility with adjacent components. By addressing these considerations early, we help reduce development risk and ensure your catheter performs reliably from prototype through full-scale production.
100% Engineered and Manufactured in the US
Founder-owned and operated since 1976
FDA Registered & ISO 13485 Certified
Our Core Custom Capabilities
From simple catheter components to complex assemblies, Hart supports catheter fabrication through design collaboration, controlled manufacturing, and inspection-ready processes. Our vertically integrated approach helps ensure quality, repeatability, and regulatory alignment at every stage.
Tipping and Marking of Catheters
We apply tip forming, flaring, and precision markings to support clinical visibility, depth control, and procedural accuracy. Markings are designed to withstand handling and sterilization while maintaining clarity and durability.
Overmolding Fabrication
Hart provides overmolding solutions that integrate catheters with hubs, connectors, and transition components. Overmolding reduces assembly steps, improves structural integrity, and creates smooth transitions between materials for improved usability.
Catheter Assemblies Over a Needle
We engineer catheter-over-needle assemblies with tight dimensional control to ensure smooth advancement and predictable separation during use. Our processes support consistent performance while minimizing friction, misalignment, or premature detachment.
Case Studies
Explore how Hart’s engineering expertise has helped medical device manufacturers overcome unique design and manufacturing challenges. Each case study highlights our problem-solving approach and the measurable impact for our partners.
How One Medical Device Program Became a Long-Term Manufacturing Partnership
For complex medical devices, there are frequently multiple opportunities for improvement. Materials, assembly methods, packaging, and production flow all contribute to the ultimate success or failure of a complex device. When one thing goes wrong, it affects everything else down the line.
Optimization and Partnership for Reliable Endoscopic Needles
Hart partners with OEMs to design and build complete medical components and assemblies. Our integrated process combines engineering insight with full-scale production efficiency.
Scalable, Flexible Approaches to Custom Ophthalmic Surgical Devices
We design and manufacture precision needles for specialized medical applications. Hart engineers to meet exact performance needs through collaboration, quality, and decades of expertise.
Talk to Our Engineers
Our engineers are ready to collaborate with you on your next product. Whether you’re refining an existing design or developing a new device, Hart’s deep manufacturing experience ensures faster timelines, lower costs, and uncompromising quality.
(616) 887-0400
engineering@hartneedles.com
400 Apple Jack CT
Sparta, MI 49345
Monday – Friday
7:30AM – 4:00PM EST
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