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Catheter Manufacturers

Last updated: January 2026

This directory lists 77 catheter manufacturers across the United States, from diagnostic catheter specialists to high-volume interventional device assemblers.

Buyers in this space are often solving critical problems related to device performance, such as achieving consistent lumen patency through complex geometries, ensuring precise tip forming for atraumatic insertion, or guaranteeing reliable coating adhesion under physiological conditions. The challenge lies in maintaining these critical parameters across millions of units while optimizing costs and lead times.

Supplier types in this category vary significantly. Some are vertically integrated OEMs offering full design and manufacturing services, while others specialize in specific processes like multi-lumen extrusion, laser welding, or balloon forming. There are also contract manufacturers focused on sub-assemblies, such as braided shafts or custom guidewires, allowing for modular sourcing strategies depending on a buyer's in-house capabilities and strategic objectives.

Successful engagement with catheter manufacturers requires thorough preparation. Buyers should arrive with comprehensive design packages, including CAD files, detailed material specifications (e.g., specific durometers for each segment), critical-to-quality features (CTQs), desired sterilization methods, and expected volumes. Suppliers, in turn, expect detailed technical specifications and a clear understanding of the device's intended use to provide accurate DFM feedback and quoting.

A significant trend in catheter manufacturing is the drive towards miniaturization and enhanced functionality, often involving integrated sensors or advanced drug delivery capabilities. This demands manufacturers with expertise in micro-extrusion, sophisticated bonding techniques, and the ability to work with an expanding range of biocompatible exotic polymers and advanced hydrophilic coatings to improve patient outcomes and enable less invasive procedures.

77 companies·53 emails·60 phones

Company Directory

77 companies nationwide

Houston, TX

Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer specializing in medical devices and components. They operate a state-of-the-art, vertically integrated facility, offering design and manufacturing services for quality, Made in USA products to customer partners.

Cleveland, OH

Based in Cleveland, OH, Applied Medical Technology, Inc. (AMT) specializes in the design, engineering, and manufacturing of medical devices. Their core business focuses on enteral device development, producing innovative enteral feeding catheters and accessories like G-tubes and G-JETs. All products are proudly American-made.

Athens, TX

Based in Athens, TX, Argon Medical Devices specializes in the manufacturing of a broad range of medical devices. The company produces various types of catheters, including drainage, biliary, urology, and peripherally inserted central catheters (PICC). They operate manufacturing facilities in Athens, TX, and Rochester, NY, serving the global medical community.

BD is a medical technology company that manufactures a broad selection of Foley catheters. These catheters are available in various materials, tip configurations, and balloon sizes to support urinary drainage for diverse patient needs. BD also provides connected care platforms and diagnostic solutions.

Salt Lake City, UT

Based in Salt Lake City, UT, Biomerics is a contract manufacturer specializing in the design, development, and production of complex, highly specialized catheters, steerable devices, and delivery systems. They provide end-to-end manufacturing, from materials to finished medical devices, with expertise in polymers and metals.

Houston, TX

Based in Houston, TX, Biotex Inc. is an ISO-certified, FDA-registered medical device CDMO. They offer over 25 years of experience in the design, development, and manufacturing of critical medical devices, partnering with clients from concept to commercialization.

Braun Interventional Systems designs and develops state-of-the-art medical devices for interventional procedures. They offer products like Accel® All Purpose and Biliary Drainage Catheter Sets, Occlutech® ASD Occluders, retrieval devices, and stent delivery systems, providing innovative solutions that enhance safety and efficiency.

Based in St. George, UT, CathTip specializes in advanced post-processing services for catheters and medical components. They offer precision tipping, bonding, flaring, and hole drilling, ensuring high quality and accuracy in the finishing of these critical medical devices for manufacturers.

Flower Mound, TX

Based in Flower Mound, TX, Ceutical Labs offers comprehensive medical device manufacturing services. They specialize in sourcing components, assembly, testing, packaging, sterilization, stocking, and shipping for various device types used across pharmaceutical, medical device, and personal care industries.

Jordan, UT

ClariVein manufactures the ClariVein IC device, a specialty infusion catheter. This catheter features a rotating wire tip for controlled 360-degree dispersion of physician-specified agents, primarily for use in the peripheral vasculature. It is designed to benefit both patients and physicians.

Bloomington, IN

Based in Bloomington, IN, Cook Medical invents and manufactures a unique portfolio of minimally invasive medical devices. Serving interventional cardiology, radiology, vascular surgery, endoscopy, and urology, the company provides essential tools like advanced PTA catheters for healthcare systems worldwide.

Miami Lakes, FL

Based in Miami Lakes, FL, Cordis is a global manufacturer specializing in innovative cardiovascular and endovascular medical devices. The company develops and delivers a range of advanced solutions for treating complex vascular conditions, including various types of catheters and related medical instruments.

Buffalo, NY

Based in Buffalo, NY, Nissha Medical Technologies specializes in the end-to-end design, development, and manufacturing of single-use medical technologies. The company partners with customers to create innovative healthcare solutions, including clinical wearables and surgical devices, ensuring high-quality results and efficient product advancement.

Footprint Medical Incorporated is a medical device company specializing in products for neonatal care. They provide complete kits for Peripherally Inserted Central Catheters (PICCs), including single lumen catheters and introducer sheaths. The company also offers training related to PICC insertion with stylets.

Garland, TX

Based in Garland, TX, Galt Medical Corp. manufactures a range of vascular and interventional medical devices. Their product portfolio includes drainage catheters, micro-introducers, and guidewires. The company provides private label solutions and OEM services for various medical specialties and clinicians.

San Clemente, CA

Based in San Clemente, CA, ICU Medical manufactures medical devices for healthcare providers. Specializing in infusion therapy, the company offers catheters, pumps, and related equipment. They also provide solutions for pharmacy preparation and airway management tools, designed to streamline workflows and enhance patient care.

Integer provides extensive expertise in catheter materials, design, and processes, partnering with clients to develop and manufacture custom coronary CTO microcatheters. They focus on delivering specialized manufacturing solutions for complex medical device needs.

Brentwood, NY

Based in Brentwood, NY, Stereotaxis develops advanced robotic systems for interventional procedures. The company also manufactures and secures FDA clearance for its own specialized interventional catheters, such as the MAGiC Sweep, designed to work with their robotic platforms.

Minneapolis, MN

Coloplast Interventional Urology, based in Minneapolis, MN, manufactures advanced urological catheters. They produce solutions like Folysil catheters, designed with larger drainage channels for higher flow rates. These innovative products feature an X-ray line, ensuring crucial visibility for healthcare professionals during medical examinations.

North Barrington, IL

Based in North Barrington, IL, Medical Murray specializes in the manufacturing of complex catheters. The company provides design, development, and production services for catheters used in vascular, gastrointestinal, urologic, and other interventional medical markets, serving medical device companies.

South Jordan, UT

Based in South Jordan, UT, Merit Medical Systems, Inc. manufactures proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures. The company specializes in catheters for cardiac catheterization and peritoneal dialysis, alongside other products for cardiology, radiology, oncology, critical care, and endoscopy, serving healthcare systems worldwide.

Anaheim, CA

Based in Anaheim, CA, Merit Medical OEM provides integrated manufacturing for medical devices. They specialize in producing Central Venous and PA Catheters, Transducer and Pressure Monitoring Kits. The company also offers superior molded parts, advanced coatings, and pressure sensor and MEMS wafer technology.

Cleveland, OH

Norman Noble, Inc., based in Cleveland, OH, is a medical device manufacturer specializing in implants. They offer advanced laser processing, 5-axis micro milling, and turning for challenging nitinol projects. Capabilities include vascular stents, heart valve and neurovascular device components, alongside orthopedic implants such as screws, bone plates, and spine cages.

Dayton, OH

Based in Dayton, OH, Norwood Medical specializes in precision medical device manufacturing and medtech innovations. They provide post-processing and assembly services for critical components. The company serves demanding markets such as cardiovascular, minimally invasive surgery, orthopedics, and robotic-assisted surgery.

Nventric, Inc. provides end-to-end medical device design, development, and contract manufacturing for OEMs. They specialize in producing neurovascular, coronary, and electrophysiology catheters, including various aspiration, balloon guiding, ablation, and diagnostic types, along with Peripherally Inserted Central Catheters (PICC).

Carlsbad, CA

Based in Carlsbad, CA, PFM Medical, Inc. is an independent medical technology company. They manufacture VETA Peritoneal Dialysis Catheters used in peritoneal dialysis procedures, providing products and systems for hospitals, laboratories, and nursing facilities. They operate as a US manufacturer and technology partner.

Poiesis Medical LLC is a manufacturer specializing in indwelling urinary catheters. The company created the Duette™ Bladder Care Catheter, an innovative dual balloon design intended to replace traditional Foley catheters. This advanced catheter aims to enhance patient care and reduce bladder-related harm events.

Minneapolis, MN

Based in Minneapolis, MN, Prevailing Medical is a contract medical device manufacturer specializing in complex catheter design and development. They provide precision extrusions and advanced catheter solutions, including steerable and sensor-integrated designs, within a certified cleanroom facility.

Santa Fe Springs, CA

Pro-Tech Design & Manufacturing offers comprehensive medical device contract packaging, assembly, and outsourcing services. With over 40 years of experience, they provide end-to-end solutions, including sewn medical products, design, and prototyping. The company is FDA and ISO 13485 registered, operating from US locations.

Dayville, CT

Based in Dayville, CT, Putnam Plastics specializes in custom medical catheter device assemblies. The company provides innovative, end-to-end medical technology solutions, including materials, extrusions, finishing technologies, and complete assemblies for life-saving devices. They have been operating since 1984.

Fremont, CA

Based in Fremont, CA, Q'Apel Medical manufactures cutting-edge neurological catheters. These products are designed for neurovascular access, helping navigate the brain's vasculature to empower therapeutic thrombectomy and cerebral aneurysm devices for stroke patients.

St. Paul, MN

Based in St Paul, MN, Quasar Medical specializes in custom catheter manufacturing and balloon design. The company offers a complete lifecycle approach for medical technologies, encompassing design, development, and production. They focus on delivering specialized catheter solutions for diverse medical applications.

Bland, MO

Based in Bland, MO, Roberson Machine Company provides precision CNC machining and manufacturing services from prototype to production. They specialize in medical parts and devices within a rigorously-controlled, sterile environment, offering CNC milling, turning, wire EDM, and additive plastics manufacturing capabilities.

Valley City, UT

Scientia Vascular develops advanced neurovascular treatment systems, specializing in catheters. The company manufactures Socrates® aspiration and Plato® microcatheters using a patented microfabrication process. These medical devices are engineered for predictable movement, sustained tube integrity, and precise therapy delivery in neurovascular applications.

Strongsville, OH

Spartronics provides FDA-registered contract manufacturing for medical devices and life sciences. They specialize in electronic contract manufacturing, offering services like printed circuit board assemblies, subsystem integration, and full-box builds. Serving highly-regulated markets, Spartronics delivers solutions from engineering to supply chain management and aftermarket support.

Strukmyer Labs is FDA Drug and Device registered, ISO 13485:2016 certified, and cGMP compliant. The company offers DEA and FDA registered drug compounding services under 503b guidelines, alongside its capabilities as a medical device establishment. They adhere to strict quality management systems for both pharmaceuticals and medical devices.

Grand Rapids, MI

Surge Cardiovascular offers a comprehensive portfolio of surgical products made in the USA. Since 1997, the company has provided innovative surgical solutions to customers. They focus on advancing science in the surgical suite with their range of products, likely including catheters for cardiovascular applications.

Eden Prairie, MN

Based in Eden Prairie, MN, Surmodics, Inc. specializes in precision manufacturing of complex catheter-based systems. They offer end-to-end development and scalable manufacturing, including extrusion, balloon forming, and advanced braiding. Surmodics also provides customized hydrophilic, hemocompatible, and drug-delivery coatings for intravascular medical devices.

Somerset, NJ

Based in Somerset, NJ, Terumo Medical Corporation designs and provides a range of interventional systems, including catheters, for accessing coronary, peripheral, and visceral vessels. The company is committed to advancing healthcare through its focus on solutions like carotid artery stenting.

New Orleans, LA

Terumo Neuro develops and provides a comprehensive range of access products, including catheters and guidewires, to assist physicians in gaining access to treatment areas. Specializing in therapeutic access solutions, the company supports medical professionals across various disease states.

Vesiflo, Inc. is an ISO 13485-certified medical device manufacturer based in Medfield, MA. They specialize in innovative bladder drainage solutions, including the inFlow device which uses advanced technology for emptying the bladder. Vesiflo also develops remote monitoring and clinical information systems for managing chronic urinary retention.

North Canton, OH

Based in North Canton, OH, Zcath Mfg. Inc. develops and manufactures patented intermittent urinary catheters. Their revolutionary ZCATH design features a molded open tip, no eyelets, a smooth surface, and lubricant grooves. Zcath focuses on reducing urine residuals, catheter-related trauma, and bacteria introduction for improved patient care.

Abbott is a medical device manufacturer specializing in cardiovascular solutions. The company designs and develops advanced catheters and other medical technologies, providing innovative products and therapies to healthcare professionals and patients worldwide for various cardiovascular conditions.

Solon, OH

Saint-Gobain Life Sciences designs, engineers, and manufactures high-performance components and integrated solutions for medical devices. Specializing in minimally invasive delivery systems and catheters, they provide capabilities from concept and prototyping through full-scale production, utilizing medical-grade materials and advanced processes.

Medtronic is a global medical technology company manufacturing a diverse range of medical devices, including advanced catheters. They produce specialized React™ catheters, featuring coil, braid, and nitinol construction, engineered for navigating vasculature during acute ischemic stroke procedures. The company develops innovative solutions for healthcare providers and patients.

MIS specializes in end-to-end design, development, and manufacturing of minimally invasive catheter delivery systems and components. They offer custom catheters, balloons, and extrusions, supporting innovators in the medical device industry from concept to full-scale production.

Tempe, AZ

Molded Devices Inc. provides comprehensive catheter assembly services for medical and healthcare clients. With over 50 years of experience, they offer cleanroom manufacturing, injection molding, dip molding, dip coating, tube extrusion, and advanced assembly techniques. The company supports product design and development from its US facilities.

Minneapolis, MN

Based in Minneapolis, MN, Mozarc Medical is a DaVita | Medtronic company specializing in kidney technology and medical devices. It manufactures dual lumen catheters, including the Mahurkar™ 10 Fr, specifically designed for optimal acute dialysis and internal jugular insertions to improve patient outcomes.

Irvine, CA

Based in Irvine, CA, PT&C designs and manufactures precision medical tubing and catheter tubing supplies. The company offers custom medical tubing services, including variable durometer tubes for various vascular delivery systems. They also provide PET heat shrink tubes for catheter stiffness modulation and component protection.

Radical Catheter Technologies manufactures advanced catheters leveraging a unique platform for superior performance. Their products deliver multiple mechanical properties, ensuring smooth navigation through tortuous anatomy, enhanced stability, and distal reach, praised by physicians for exceptional tracking.

Weston, FL

Stryker is a medical technology company based in Weston, FL, that manufactures a broad array of medical devices. The company develops and produces solutions that support healthcare professionals and impact millions of patients globally each year, including various types of catheters.

Knoxville, TN

Based in Knoxville, TN, Cordica Medical, formerly TEAM Technologies, specializes in manufacturing catheter-based medical devices and minimally invasive surgical products. The company offers comprehensive catheter manufacturing solutions, utilizing U.S.-based facilities and advanced technologies. They are ISO 13485 certified, FDA registered, and operate ISO 14644-1 Class 7 & Class 8 Cleanrooms for medical device production.

Richmond, TX

Velentium Medical is a professional engineering firm specializing in the design and manufacturing of Class II and Class III medical devices. The company transforms intellectual property into safe and secure products, offering comprehensive services including R&D, manufacturing, cybersecurity, and test systems for various medical applications.

Latham, NY

Based in Latham, NY, AngioDynamics designs, manufactures, and sells innovative, minimally invasive medical devices. They specialize in solutions for vascular access, peripheral arterial disease, oncology, and thrombus management. Their comprehensive product portfolio includes various types of catheters for medical applications.

B. Braun Medical is a healthcare company developing and manufacturing medical devices and pharmaceutical products. They provide advanced IV catheters, including the FDA-cleared Introcan Safety® 2 Deep Access IV Catheter. The company focuses on improving health and ensuring supply chain resiliency for critical medical devices.

Boston Scientific is a medical technology company specializing in innovative solutions for various health conditions. They develop and manufacture advanced medical devices, including catheter-based systems, to treat kidney stones, BPH, erectile dysfunction, male stress incontinence, and pelvic floor disorders, enhancing patient lives.

Fort Mill, SC

Based in Fort Mill, SC, Catheter Precision Inc. develops innovative catheter-based products for electrophysiology. The company focuses on improving patient care for individuals with cardiac arrhythmias, offering specialized devices like Vivo™ and LockeT.

Chattanooga, TN

Confluent Medical specializes in the design, development, and large-scale manufacturing of interventional catheter-based devices and implants. Leveraging advanced material science technologies, they produce complex and balloon catheters, extrusion components, and Nitinol components. The company provides high-performance manufacturing solutions for the medical device industry.

Newbury, OH

Based in Newbury, OH, DEM Manufacturing is an FDA-registered provider specializing in medical device engineering, prototyping, and production. They offer turnkey custom product development from concept to final build, handling low to high-volume manufacturing from their U.S.-based facilities.

Morgan Hill, CA

Based in Morgan Hill, CA, Duke Empirical offers turnkey design and manufacturing for medical devices, including VERGO® Steerable Access Sheaths. The company serves healthcare OEMs with precision medical device contract manufacturing expertise. Duke Empirical was acquired by TEAM Technologies, enhancing its comprehensive service offerings for clients.

Morgan Hill, CA

Duke Extrusion is a full-service contract manufacturer specializing in medical grade tubing and high-performance tubing applications for catheters. They produce medical extrusions, braided catheters, and complete catheter assemblies as finished goods for medical device manufacturers and OEMs. The company also offers medical tubing and material design services.

Lake City, UT

Based in Lake City, UT, Health Line Medical Products manufactures vascular access and infusion therapy devices. The company produces power-injectable, multi-lumen intravenous catheter kits, including PICC line, midline, central venous, and hemodialysis catheters. They offer configurations for adult, pediatric, and neonatal patients.

Murrieta, CA

Medical Extrusion Technologies Inc. provides custom catheter manufacturing and engineered thermoplastic extrusions for OEMs. They specialize in single and multi-lumen tubing, alongside FEP heat shrink for medical devices. Offering product development and contract manufacturing, they support projects from prototype to production.

Westlake, OH

Based in Westlake, OH, Nordson manufactures cardiopulmonary vascular cannulae and catheters. The company provides specialized medical devices, serving various healthcare applications with its advanced manufacturing capabilities.

Minneapolis, MN

NovelCath is a contract manufacturer of highly engineered catheter delivery systems. Specializing in design, development, and manufacturing, they produce minimally invasive interventional delivery systems for structural heart, electrophysiology, and neurovascular applications. The company operates facilities in Minneapolis, MN, and San Jose, CA.

Brea, CA

Based in Brea, CA, Paradyne Medical, Inc. offers turn-key engineering and manufacturing solutions for medical, biomedical, and life science industries. They specialize in designing and fabricating a wide range of catheters for applications like drug delivery, stent deployment, and steerable systems, serving OEMs and start-ups.

Fridley, MN

Resolution Medical, based in Fridley, MN, specializes in the development and manufacture of medical devices, including diagnostic mapping and energy delivery catheters. They offer comprehensive services for complex catheter delivery systems, supporting clients from concept and design through full commercial production.

Plymouth, MN

Based in Plymouth, MN, Teleflex Medical OEM custom-engineers and manufactures complex catheters to precise specifications. They serve as a trusted supplier, transforming client concepts into reality for the medical industry, leveraging their manufacturing capabilities.

Based in Lansdale, PA, Vygon USA manufactures a range of medical devices, specializing in vascular access products. They produce PICClines (Peripherally Inserted Central Catheters) and other central venous catheters, along with solutions for short, medium, and long-term access to peripheral and central vascular systems, catering to all age groups.

Maplewood, MN

Based in Maplewood, MN, VitalPath provides complex catheter solutions. The company specializes in custom catheter design, prototyping, and development, leveraging in-house capabilities and proprietary processes. They partner through the product development process for complex catheters and precision laser components, serving electrophysiology and structural heart markets.

Wellspect manufactures intermittent urinary catheters, offering solutions for individuals experiencing bladder and bowel-related issues. The company produces the well-known LoFric brand of catheters, designed to improve everyday life through advanced bladder and bowel care products that minimize the risk of UTIs.

Convention Center, NY

Freudenberg Medical is a vertically integrated CDMO partner specializing in medical device and pharmaceutical innovation. The company supports clients from ideation to full-scale series manufacturing, offering capabilities like precision molding, extrusion, and advanced material expertise. They provide minimally invasive catheter solutions, including handles, introducer sheaths, and hemostasis valves.

Nextern designs and manufactures medical devices, including catheters, steerable tools, guides, and delivery systems. The company vertically integrates device design and development with global manufacturing, utilizing four facilities and extensive clean room space. They specialize in single-use devices and implantable leads.

Jordan, UT

Route 92 Medical specializes in advancing neurovascular intervention through innovative medical devices. They manufacture products like the FreeClimb System and the HiPoint Reperfusion System, aiming to improve outcomes for neurovascular patients by refining access and transforming intervention procedures.

Somerset, NJ

Terumo Corporation is a leading medical technology company that designs and manufactures advanced catheter-based devices. They specialize in neuroendovascular and cardiovascular solutions, including minimally invasive interventional systems, guiding catheters, and microcatheters. Terumo develops innovative therapeutic technologies, serving healthcare professionals with high-quality, precision-engineered medical products from its US facilities.

Irvine, CA

Based in Irvine, CA, Toro Neurovascular designs and engineers advanced catheter technology specifically for stroke care. The company specializes in high-performance neurovascular devices, including thrombectomy solutions, aimed at improving patient outcomes for ischemic stroke. They empower physicians with cutting-edge tools globally.

San Antonio, TX

Viant Medical specializes in complex electromechanical assemblies, thermoforming, and finished device manufacturing for leading medical OEMs. The company offers interventional device solutions and comprehensive manufacturing capabilities to advance MedTech, serving various clinical markets.

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How to Choose a Company

  • For any Class II or Class III device, verify their ISO 13485 certification and a robust FDA 21 CFR Part 820 compliant quality system, especially regarding design controls and process validation for critical features like bond strength or lumen dimensions.
  • Assess their capability in core catheter processes like multi-lumen extrusion, reflow operations for shaft construction, braiding or coiling for torqueability, and precision tipping or balloon forming for your specific catheter type.
  • Confirm experience with the specific durometers and biocompatible polymers required for your device, including exotic materials like Pebax, Nylon, or specific polyurethanes, and their capacity for consistent hydrophilic coating application.
  • For startups, look for DFM (Design for Manufacturability) support and a clear path from low-volume prototype runs to high-volume production, including fixture design and automated assembly potential without compromising lumen patency or sheath integrity.
  • Evaluate the breadth of their in-house capabilities, such as laser welding, etching, printing, or a dedicated cleanroom for sterilization-ready packaging, as this can significantly reduce supply chain complexity and lead times.
  • Inquire about their in-line and end-of-line inspection methods for critical parameters, such as dimensional accuracy of lumens, coating uniformity, bond strength testing, and burst pressure testing for balloons, crucial for patient safety.
  • Be wary of manufacturers who provide significantly lower quotes without detailed questions about your design files, material specifications, or critical-to-quality features (CTQs) like tip geometry or catheter flexibility. This often indicates a lack of understanding of the true manufacturing complexity, leading to costly reworks and delays down the line.

Frequently Asked Questions

What specific quality system certifications should I look for in a catheter manufacturer?

You must prioritize manufacturers holding ISO 13485 (Medical Devices Quality Management System) certification, which demonstrates a commitment to quality and regulatory compliance. Additionally, for the US market, their processes must comply with FDA 21 CFR Part 820 (Quality System Regulation). If you plan to sell globally, inquire about MDSAP (Medical Device Single Audit Program) participation, which streamlines audits for multiple regulatory jurisdictions and ensures robust process control and device traceability.

How do I ensure a manufacturer can achieve the precise torque response and kink resistance required for my steerable catheter?

Achieving precise torque response and kink resistance relies on several factors: the right material selection (e.g., specific durometers of Pebax or Nylon), sophisticated shaft construction methods like braiding or coiling, and optimized reflow operations. Ask for process control data on their braiding tension and reflow parameters. Request samples from previous projects demonstrating similar performance profiles and discuss their in-house testing capabilities for torque transfer, pushability, and kink resistance to validate their expertise.

What is the importance of DFM (Design for Manufacturability) when sourcing catheter production?

DFM is paramount in catheter manufacturing. Engaging a manufacturer early in your design process with DFM expertise can prevent costly redesigns and delays. It ensures your catheter design is optimized for efficient mass production, reducing material waste, improving yield rates, and simplifying assembly. This proactive approach impacts everything from maintaining consistent lumen patency and precise tip formation to ensuring reliable coating application, all while driving down per-unit cost and accelerating time to market.

Should I provide my own mandrels or expect the manufacturer to source them for extrusion and forming processes?

It depends on the complexity and proprietary nature of your design. For standard lumen sizes, manufacturers typically have existing mandrel stock or can source common sizes. However, for high-precision, custom-tapered, or complex multi-lumen mandrels, it's often beneficial for the buyer to provide the exact specifications or even the mandrels themselves, especially for initial prototypes or critical features. Clarify this early in discussions; the manufacturer will still manage the wear, maintenance, and replacement of these tools during production.

What's the difference in expertise required for balloon forming vs. precision tipping on a catheter?

These are distinct, highly specialized processes. Balloon forming requires expertise in precise heat control, pressure regulation, and material stretching to create thin-walled, compliant balloons with exact burst pressures and compliance characteristics, typically involving dedicated balloon-forming machinery. Precision tipping, on the other hand, focuses on shaping the catheter's distal end, bonding various materials (often using radio frequency (RF) or thermal bonding), and achieving specific tip geometry and smoothness for atraumatic insertion. While both involve thermal processing, the equipment, process control, and measurement techniques are quite different.

How do manufacturers ensure consistent application of hydrophilic coatings for optimal lubricity?

Consistent hydrophilic coating application is a critical process, often executed in controlled cleanroom environments. It involves precise dipping or spraying techniques, meticulous control over solution viscosity and concentration, and accurate drying cycles. Manufacturers employ rigorous in-process visual inspections and specialized friction testing (e.g., using a tensiometer or custom jig) to ensure uniform coating thickness, excellent adhesion without flaking, and consistent lubricity performance across all units, which is crucial for device deliverability and reducing patient trauma.

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