Catheter Manufacturing and Development Services
Primo Medical Group operates a catheter development and manufacturing center focused on developing new catheter designs and the production of existing catheters and medical devices. With a range of capabilities, we can deliver precisely wound coils, including guidewire coil components, biopsy delivery coil components, and conduit spring pipe components. Our capabilities are supported with cleanroom operations and quality control measures to ensure the safety, efficacy, and performance of various catheter and endoscopic solutions.
Catheter Manufacturing Capabilities
Catheters are made, inspected, and tested according to your specifications. Our goal reaches beyond simple manufacturing; we aim to develop fully customized solutions that suit your specific project requirements, and assess the quality per your documented, pre-approved standards, while ensuring complete compliance with regulatory standards and protocols. With extensive catheter capabilities, we can produce medical coils, braided components, composite flexible shafts, and provide dynamic or static lamination, as well as tip forming services.
Medical Coiling
To support guidewires, we offer medical coiling to enhance the performance of medical devices. Medical coiling operations can produce components for guidewires and other medical devices with tight tolerances. With outer diameters ranging from 0.014 to 0.120, our capabilities include:
- Round wire from 0.003 to 0.020
- Flat wire from 0.003 to 0.012 thick to 0.0025 to 0.050 wide
Braided Medical Components
Made from wire or polymer materials, Primo Medical Group can manufacture pre-formed catheters in diameters up to 35 Fr in quantities from 10 to 10,000. Braided components are designed to enhance the flexibility and torque of the catheter while enabling reduced shaft thickness, with operations performed in cleanroom environments using reel-to-reel vertical and horizontal interlacing machines.
Composite Flexible Shafts
Composite flexible shafts deliver excellent kink resistance with optimized tracking and torque capabilities. Distal ends of the catheter can feature a coiled wire or a laser-cut hypotube for ultimate flexibility, and steerability can be added with laser-welded pull-ring/wire assemblies. These are available in single-pull, double-pull, or even quadruple-pull wire assemblies for unsurpassed steering performance.
Dynamic/Static Laminating
Dynamic and static laminating processes allow us to select the right solution for the product. Along with traditional equipment, vertical laminators offer uniform heat application via 360° thermal nozzles to maximize airflow and increase throughput.
Tip Forming
Using radiofrequency, reflow, and roll-cut processes, we provide tip forming to exact specifications.
Quality Assurance Practices and Cleanroom Operations for Catheter Manufacturing
Primo Medical Group is an ISO 13485:2016-certified manufacturer, maintaining continuous control over all aspects of our processes to ensure well-documented quality control and compliance with safety, performance, and caliber standards for our products. With extensive cleanroom operations, we utilize controlled environments across various processes for the efficacy of high-performance medical devices and critical assemblies. These operations are integral to our ability to produce components to precision tolerances, achieve repeatability, and meet quality expectations.
Frequently Asked Questions About Catheter Manufacturing and Development
To address common concerns about medical catheter manufacturing, we’ve answered some frequently asked questions about our manufacturing and development capabilities:
Why is quality control important in catheter manufacturing?
Because catheters are invasive medical devices, extensive oversight ensures patient safety by preventing defects such as tip breakage, surface roughness, or structural leaks. Quality control guarantees device reliability and regulatory compliance.
Does Primo Medical Group support cleanroom catheter manufacturing?
Yes, we operate over 47,000 sq. ft of ISO 7 cleanroom environments to support controlled assembly, cleaning, testing, and packaging processes for both disposable and reusable devices.
What materials are used in catheter manufacturing?
We work with gold-plated titanium, LVM, Nitinol, PTFE-coated, S/S 304V-316, S/S diamond-drawn, S/S rolled, tantalum, titanium, and tungsten materials in our medical catheter manufacturing operations.
Work with Primo Medical Group to Develop and Produce Custom Catheters
For over 70 years, Primo Medical Group has provided contract manufacturing services to support catheter development and production. Our capabilities include precision engineering, cleanroom production, materials expertise, and device support operations to ensure that finished components meet the highest standards for medical device performance and safety. As a full-service partner, we work with you from concept to fulfillment, providing prototype designs or large-scale production to meet your needs, backed by advanced equipment and decades of experience. Contact us to discuss your project today or request a quote to begin.