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Medical Tubing Manufacturers

Last updated: January 2026

This directory lists 80 medical tubing manufacturers across the United States, from precision micro-extruders specializing in thin-wall PTFE liners to large-volume co-extruders producing multi-lumen catheter shafts.

Buyers in this category are typically solving critical design problems that hinge on the tubing's performance, such as achieving specific burst pressure ratings for high-pressure fluid delivery systems, ensuring optimal kink resistance in flexible endoscopic devices, or integrating radiopaque stripes for clear imaging under fluoroscopy. The exact durometer and material compatibility with the intended biological environment are often defining factors for success or failure.

Supplier types range significantly, from highly specialized micro-extrusion houses focused on extremely thin-wall, small-diameter tubing, to generalist extruders handling larger volume, simpler geometries. There are also integrated manufacturers offering a full suite of services including advanced co-extrusion, braiding, tipping, flaring, and sophisticated bonding techniques for complex catheter sub-assemblies, providing a more comprehensive solution than a pure tubing extruder.

80 companies·57 emails·59 phones

Company Directory

80 companies nationwide

Englewood, CO

Based in Englewood, CO, Accu-Tube manufactures precision stainless steel tubing. The company provides medical device and controlled industrial tubing to contract manufacturers and OEMs. With nearly 50 years of experience, Accu-Tube is ISO 13485:2016 and ISO 9001:2015 certified, meeting industry quality standards.

Hudson, MA

Based in Hudson, MA, Arterex Medical provides diversified manufacturing solutions for medical devices and life sciences. The company specializes in medical tubing, offering precise filaments, multi-lumen, taper, para, and tight tolerance single lumen tubing. Capabilities include cleanroom extrusion and secondary operations such as punching, skiving, grinding, and tipping.

Temecula, CA

Based in Temecula, CA, Axis Medical Extrusion specializes in precision tubing extrusion for medical applications. The company utilizes innovative technologies and process techniques to produce tight tolerance tubing. They are dedicated to delivering advanced extrusion solutions for the medical device industry.

Santa Barbara, CA

Bentec Medical, based in Santa Barbara, CA, provides custom medical-grade silicone fabrication services for medical device OEMs. They offer extensive material science engineering and fabrication capabilities, including design consultation, prototyping, regulatory support, assembly, sterilization, and packaging. Bentec also manufactures proprietary FDA/CE approved silicone medical devices.

Flower Mound, TX

Based in Flower Mound, TX, Ceutical Labs is a contract manufacturer of medical devices. They specialize in manufacturing simple tubing sets, ultra-precision devices, wound care, and ophthalmic products. Services include design, assembly, testing, packaging, and sterilization, serving diverse medical markets.

Chardon, OH

Based in Chardon, OH, Chardon Metal Products Co. offers ISO-certified custom metal fabrication. They specialize in manufacturing medical tube assemblies, including calf tube weldments, for rehabilitation equipment. Capabilities encompass tube fabrication, CNC machining, welding, and assembly services for diverse industrial clients.

Fairfield, OH

Based in Fairfield, OH, Clippard manufactures medical and laboratory grade silicone tubing. Their products are specifically designed for use in medical devices, offering various internal and external diameters. Tubing is available in convenient 5-foot and 50-foot rolls.

Menlo Park, CA

Based in Menlo Park, CA, Control Plastics provides custom plastic extrusion solutions. They manufacture profiles, tubing, and complex shapes using advanced technologies and diverse thermoplastics. Serving the medical, automotive, and construction industries, the company ensures precision and durability from concept to production.

Pomona, CA

Based in Pomona, CA, California Medical Innovations manufactures high-quality dip molding products for the medical industry. They specialize in medical-grade silicone tubing, catheter balloons, and other medical components, offering custom solutions. The company also provides prototyping, testing, and validation services to meet customer requirements.

Plain City, OH

Based in Plain City, OH, Elastostar Rubber Corporation custom manufactures electrically conductive silicone tubing. With over two decades of experience, they provide design and engineering for elastomer products. Their tubing offers consistent electrical conductivity and EMI/RFI shielding, serving demanding applications in electronics, aerospace, and essential medical equipment.

Portsmouth, NH

Based in Portsmouth, NH, Extrusion Alternatives, Inc. provides custom medical tubing and extruded components for the medical device industry. They specialize in DEHP-Free/Phthalate-Free PVC alternatives, polyurethanes, and various thermoplastics. Their ISO 9001-certified facility utilizes pyrogen-controlled processes and a HEPA-filtered clean environment for high-quality manufacturing.

Murrieta, CA

Based in Murrieta, CA, Medical Extrusion Technologies, Inc. specializes in medical-grade plastic extrusions. They manufacture custom-tailored tubing for catheters, multi-lumen tubing, and specialized profiles for drug delivery systems and surgical tools, meeting stringent healthcare industry requirements with precision.

Chattanooga, TN

Based in Chattanooga, TN, GenX Medical is a custom medical tubing manufacturer. They specialize in producing micro-bore tubing, bioresorbable extrusions, and multi-lumen tubing. The company offers diverse extrusion capabilities to meet specific requirements for various medical applications.

Strongsville, OH

Based in Strongsville, OH, GSH Industries manufactures custom plastic, aluminum, and rubber extruded profiles and tubing. They specialize in custom plastic extrusions, including PVC and polyethylene tubing, offering design, engineering, and tooling services for high-quality products to meet exact specifications.

GVC Direct, Inc. manufactures Silcon® Medical & Pump Grade Silicone Tubing, renowned for excellent product protection and flexibility. Serving Food, Dairy, Biotech, and Pharmaceutical industries, it's used in blood/fluid handling, dialysis, I.V. administration, and surgical drains. Custom lengths are available.

Allen County, OH

Based in Allen County, OH, Harrison Hose is a custom manufacturer of medical-grade tubing and hose. The company specializes in producing high-precision and hygienic tubing solutions designed for the healthcare industry, meeting the reliability expectations of medical professionals.

Oak Harbor, WA

IDEX Health & Science manufactures a wide selection of tubing specifically for medical devices and bio-related applications. They provide these fluidic components in various dimensions, materials, and colors, catering to diverse industry needs within healthcare and scientific instrumentation.

Irvine, CA

Based in Irvine, CA, Impact Catheters manufactures medical-grade tubing and components, specializing in braided shaft tubing and extrusion services. They utilize materials such as LDPE, Nylon, Pebax, and PET. With extensive experience, the company also designs and produces a range of medical devices including endoscopes and stent delivery systems.

Integer specializes in the design, development, and manufacturing of medical tubing and catheter shafts. The company provides these essential components for various medical device applications, serving the healthcare industry with custom solutions for critical medical devices.

K-Tube manufactures precision-engineered medical stainless steel tubing and industrial tubes, specializing in hypotubes and custom tubing. They provide components for medical devices like hypodermic needles, guidewires, and cannulas. As a US-based miniature steel tubing manufacturer, K-Tube serves critical medical, aerospace, and industrial applications with durable, versatile products.

Kent Elastomer Products manufactures a range of tubing solutions for medical and surgical applications. They produce natural rubber latex, thermoplastic elastomer (TPE), and polyvinyl chloride (PVC) tubing to specifications. The company is the sole US manufacturer of natural rubber latex tubing, with all products made in the U.S.A.

San Diego, CA

Based in San Diego, CA, Lighteum Medical manufactures precision metal components for cutting-edge medical devices, specializing in minimally-invasive surgery. They produce nitinol and platinum components, including wire, rod, sheet, and tubing. The company also offers advanced coatings and surface solutions, enhancing device efficiency for OEMs.

San Jose, CA

Based in San Jose, CA, Medeologix, Inc. is a manufacturer specializing in medical devices. They provide development and manufacturing services for essential products like catheters, medical balloons, and PET heat shrink tubing. The company focuses on bringing life-enhancing medical products to market efficiently.

Oldsmar, FL

MicroLumen, Inc. is an Oldsmar, FL-based manufacturer of high-performance medical and surgical tubing. They specialize in polyimide, PTFE, polyurethane, Pebax, and nylon tubing, offering custom-engineered and laser-machined products with tight tolerances for diverse medical applications.

Peterborough, NH

Based in Peterborough, NH, Microspec Corporation specializes in extruding advanced custom medical tubing. They are known for producing some of the smallest, most complex tubing with tight tolerances, supporting medical device manufacturers from concept to commercial production as a trusted extension of their team.

New Berlin, WI

Based in New Berlin, WI, Midland Plastics, Inc. manufactures flexible plastic tubing, including braided and reinforced versions. The company offers a full inventory of products utilizing various plastics like polyethylenes, polypropylene, and ABS. Midland Plastics has been manufacturing in the US since 1945 and holds ISO 9001:2015 certification.

Molded Products, Inc. manufactures medical-grade vinyl tubing, specializing in Class VI tubing designed for dialysis applications. Their products adhere to United States Pharmacopeia standards and are registered as FDA Class I and Class II medical devices, also offering related plastic connectors and clamps.

New England Tubing manufactures custom medical, specialty industrial, and commercial tubing solutions. The company provides engineering expertise to develop high-performance tubing for various applications. They specialize in producing custom specifications to meet client requirements across diverse industries.

Conroe, TX

Based in Conroe, TX, NovoSci manufactures and distributes single-use, disposable medical devices, including custom perfusion supply kits, tubing packs, and cannula tubing. They offer contract manufacturing and assembly solutions for cardiovascular and general surgical applications, operating from a state-of-the-art production facility.

Barrington, NH

PBS Plastics manufactures high-quality medical plastic products for the Medical Device and Biopharma industries. Specializing in advanced medical tubing, they produce essential components for fluid delivery systems, catheters, and surgical devices. With multi-line production in environmentally controlled white rooms, PBS Plastics delivers medical-grade tubing meeting precise standards and tight tolerances.

Precision Glassblowing manufactures and supplies various types of pump tubing, including silicone, Pharmaprene, PVC, Santoprene, Solva, and Viton options. Their silicone tubing is noted for medical-grade biocompatibility, making it suitable for life science research applications. The company also specializes in ICP accessories, spray chambers, nebulizers, and fittings for analytical instrumentation.

Dayville, CT

Based in Dayville, CT, Putnam Plastics provides innovative and dependable medical technology solutions. The company specializes in custom medical catheter device assemblies, offering end-to-end services from research to delivery. Capabilities include materials extrusions, finishing technologies, and complete assemblies for life-saving medical devices.

Mills River, NC

Based in Mills River, NC, RAUMEDIC Inc. specializes in silicone extrusion, manufacturing medical tubing in various hardnesses. They offer custom coloring, X-ray contrast stripes, and customized tolerances to match specific applications. Tubing is supplied in bundles or cut lengths.

Resonetics specializes in manufacturing high-quality stainless steel and nitinol tubing for the medical device industry. They produce a range of tubes, from tiny hypotubes to 12mm diameters, drawing them from in-house melted nitinol bars to ensure precise control throughout the process.

Los Angeles, CA

Based in Los Angeles, CA, Roberson Machine Company specializes in innovative medical device manufacturing. They provide precision CNC machining services, including milling and turning, for high-volume part production. The company works with various materials, ensuring quality components for medical professionals and the medical industry.

SAI Infusion Technologies manufactures medical-grade, platinum-cured silicone tubing, meeting USDA Class VI standards. This biocompatible and chemical-resistant tubing is sterilizable by Ethylene Oxide or autoclave, available in various sizes and bulk rolls. They also offer catheter design services for lab animal infusion applications.

Arlington, TX

Based in Arlington, Texas, Santopseal manufactures medical grade, food grade, and peristaltic pump tubing. The company produces rubber and plastic tubing from a wide variety of materials, tailored for specific needs like flexibility, UV, temperature, and chemical resistance. Santopseal offers free samples for compatibility testing.

Saginaw, MI

Speciality Manufacturing, Inc., based in Saginaw, MI, produces high-quality medical and research grade silicone tubing. They offer Class VI silicone, 50-durometer tubing in 50-foot coils across various inner and outer diameters. Products are available for purchase for both small and bulk quantity needs.

Laguna Hills, CA

Smooth-Bor Plastics, based in Laguna Hills, CA, manufactures medical tubing systems. The company specializes in producing heated tubes for continuous positive airway pressure (CPAP). Operating since 1971, this family-owned business recently joined the Plastiflex Group, expanding its product portfolio and global presence within the medical tubing industry.

Palm Beach, FL

Based in Palm Beach, FL, Syneo specializes in custom short and long-run catheter manufacturing and medical tubing assembly. They process diverse medical-grade materials, including single/multi-lumen and wire-reinforced tubing. Services include cut-to-length, hole-making, tube slitting, tip forming, printing, and laser-marking for medical device components.

Rosemont, IL

Tegra Medical manufactures custom and off-the-shelf medical tubing, providing materials for cardiovascular, neurovascular, and other prototyping projects. They offer secondary processes like grinding, cutting, coating, and end treatments, alongside custom mandrels. With manufacturing facilities in the United States, the company partners with medical device OEMs worldwide.

Manchester, NH

Based in Manchester, NH, Proterial Cable America, Inc. specializes in custom medical tubing extrusion. They provide medical device manufacturers with single-lumen, multi-lumen, and reinforced tubing solutions. Capabilities include rapid prototyping, high-performance materials, core mandrel options, and advanced processing, ensuring products meet leading industry standards.

Danbury, CT

Vanguard Products Corporation designs and manufactures high precision medical grade silicone tubing, custom gaskets, and seals. Products comply with FDA Regulation 21CFR177.2600 and USP Class VI, suitable for pharmaceutical, biotech, and medical applications. The company leverages over 50 years of experience, manufacturing all products in the USA.

Needham, MA

Based in Needham, MA, Vita Needle Company manufactures small diameter and custom medical-grade stainless steel tubing. They specialize in alloys like 304, 316, and 316 LVM, used in various medical device applications such as fluid transfer and implanted products. The company's primary focus is the medical market.

Rahway, NJ

Based in Rahway, NJ, Wytech provides advanced specialty wire and metal tubing solutions for complex medical devices. They offer stainless steel hypotubes, fine wire, and catheter mandrels, with services including precision grinding and laser processing. Wytech supports rapid prototyping and delivers critical ground wires for urgent development projects.

Irvine, CA

Based in Irvine, CA, AccuPath manufactures custom medical tubing, specializing in reinforced composite, multi-layer, and multi-lumen types. They produce components for minimally invasive surgery delivery systems, offering coil and braid reinforcement technologies. AccuPath also assists with catheter design and material selection.

Ametek EMC, specializing in medical instrument components, manufactures state-of-the-art medical device components and assemblies. Their capabilities include catheter assembly, silicone molding, laser processing, and the production of specialized items like Nitinol flexible shafts, titanium torque shafts, and laser-cut stainless tubes for various medical applications.

Glen Cove, NY

DirectMed specializes in manufacturing custom medical tubing ports and OEM components. The company provides custom tooling and contract manufacturing services, leveraging its manufacturing centers to deliver precise solutions. They offer products in materials like ABS and PVC DEHP Free, with Eto and Gamma sterilization capabilities.

Saint-Gobain manufactures medical tubing for a range of applications. The company offers a comprehensive line of standard formulations, including its well-known Tygon® and Bio-Sil® tubing. These products are developed to meet the specific needs of medical device applications, providing critical components for the healthcare industry.

Meditube specializes in medical manufacturing for the medical device industry, offering custom extrusion services. They produce catheter sub-assemblies, high-performance shafts, and balloon tubing. With over 30 years of experience, the company is committed to quality, holding an ISO 9001:2015 certificate.

Midwest Interventional Systems designs, develops, and manufactures minimally invasive catheter delivery systems and components. The company specializes in custom balloons and extrusions, offering end-to-end solutions for the medical device industry, from concept through full-scale production.

Tempe, AZ

Based in Tempe, AZ, Molded Devices provides custom plastic tube extrusion for medical devices, including single and multi-lumen tubing and catheters. They work with various thermoplastics like PVC, polyurethanes, and nylons, offering clean room assembly for complete product solutions.

Medical Extrusion Technologies specializes in producing single lumen and multi lumen tubing. The company utilizes a variety of thermoplastic materials and FEP heat shrink, offering quick-turn manufacturing services. They provide specialized extrusion solutions primarily for the medical device industry, catering to diverse application needs.

Southampton, PA

Based in Southampton, PA, NewAge Industries manufactures medical tubing, including their SILCON MEDICAL tubing. This product meets USP Class VI requirements and features low surface energy designed to resist adhesion and prevent bacteria growth, suitable for various medical applications.

Irvine, CA

Based in Irvine, CA, PT&C specializes in manufacturing custom medical tubing. They produce flexible, precise, low-hardness, thin-wall tubing for medical devices like stent and heart valve delivery systems, and neurovascular catheters. Services encompass variable durometer tubes, PET heat shrink tubes, and quick prototyping.

Knoxville, TN

Based in Knoxville, TN, TEAM Technologies specializes in designing and manufacturing catheter-based minimally invasive surgical and medical tubing products. Serving the healthcare and oral care industries, they operate ISO Class 7 & 8 Cleanrooms. The company is ISO 13485 certified, FDA registered, and MDSAP compliant, offering turnkey solutions.

Annville, PA

Based in Annville, PA, TekniPlex Healthcare manufactures medical-grade tubing and custom extrusions for the healthcare industry. Their capabilities include single lumen, multi-lumen, co-extruded, tapered, and braided tubing, available in a variety of configurations, polymers, grades, and durometers for diverse medical device applications.

Maple Grove, MN

Based in Maple Grove, MN, One Medical Extrusion specializes in custom medical extrusions and braiding for medical device OEMs. They provide single-lumen, multi-lumen, co-extruded, and striped tubing, utilizing materials like PEBA, PET, and polyurethane. The company ensures compliance with ISO 13485 and 90 quality manufacturing standards.

Torrance, CA

Based in Torrance, CA, Axiom Medical manufactures silicone extruded medical products, specializing in wound drains. Since 1976, this ISO 13485 certified and FDA registered company produces all products in the USA. They also offer non-medical silicone extrusions, applying medical quality standards to commercial applications.

Chattanooga, TN

Confluent Medical, based in Chattanooga, TN, specializes in the manufacturing of high-precision polymer tubing, including FILMCAST PTFE, for the medical device industry. They produce components for complex catheters, balloon catheters, and extrusion catheter components. Capabilities encompass precision tubing and rapid prototyping services.

Mesquite, TX

Dallas Plastics manufactures ultra narrow poly tubing using LDPE, LLDPE, and HDPE. Offering custom properties like heat resistance, their ISO 9001:2015 certified Texas facilities produce tubing for medical, automotive, and food packaging applications.

Morgan Hill, CA

Based in Morgan Hill, CA, Duke Empirical provides complete, turnkey design and manufacturing services for medical devices. They specialize in developing and producing advanced products such as VERGO® Steerable Access Sheaths, offering expertise for both new and existing product designs within the medical tubing and catheter industry.

Morgan Hill, CA

Based in Morgan Hill, CA, Duke Extrusion is a full-service contract manufacturer specializing in high-quality medical grade tubing and medical extrusions. They provide custom medical tubing and material design solutions, along with complete catheter assemblies for medical device manufacturers and OEMs.

Hagerstown, MD

Based in Hagerstown, MD, Fabricated Extrusion Company provides custom profile, sheet, and coextrusion services. They specialize in engineered resins and custom compounds, delivering precise tolerances for diverse manufacturing needs. The company also offers injection molding, finishing operations, and comprehensive design engineering support.

Mcminnville, OR

Freelin-Wade Co. manufactures high-quality medical tubing designed to be BPA-, latex-, and phthalate-free. Their γ-sterilizable, abrasion-resistant PVC tubing is ideal for various medical fluid and pneumatic systems. Based in McMinnville, OR, the company focuses on durable and safe solutions for healthcare applications.

Lewisville, TX

Based in Lewisville, TX, Medical Extrusion Technologies Inc. specializes in manufacturing custom medical tubing. The company utilizes in-house tooling capabilities to produce tubing designed to meet specific application requirements across various medical and healthcare industries, focusing on precision extrusion for critical components.

Farmingdale, NY

JBC & Company is a family-owned manufacturer based in Farmingdale, NY, specializing in medical-grade silicone tubing and custom silicone products. They provide high-precision solutions for medical and pharmaceutical applications, offering extrusion, molding, and secondary operations. The company is ISO 13485 certified, ensuring adherence to strict quality and safety standards.

Wallingford, CT

Pexco Inc. operates a facility that specializes in custom extrusions for a diverse range of applications. The company is a specialty medical tubing extruder, providing critical components for the healthcare industry. Additionally, Pexco manufactures products for fence, traffic safety, and various other custom extrusion needs.

Apex, NC

Based in Apex, NC, Polyzen, Inc. manufactures medical tubing through extrusion, specializing in thin-wall and lay-flat applications. They process various medical-grade polymers, including TPUs, TPEs, and nylons, within a class-10,000 clean room. Services encompass custom tube manufacturing and in-house compounding for medical devices.

Spectrum Plastics Group specializes in the extrusion of conventional and advanced medical tubing, offering both small-batch and high-volume production. They provide comprehensive solutions, including extruded tubing, catheter technologies, and medical balloons, supporting medical device development from ideas to final products with applications expertise.

Paso Robles, CA

Based in Paso Robles, CA, True Tube Inc. manufactures diverse tubing solutions. Their expertise includes medical, stainless steel, small diameter, precision, nickel, and ornamental tubing, serving various industrial applications with specialized fabrication.

Edison, NJ

Based in Edison, NJ, Accurate Rubber Corporation manufactures high-quality standard and custom silicone tubing and hoses. The company specializes in providing products for diverse industrial applications, including the medical, pharmaceutical, food & beverage, and automotive sectors, tailored to specific client requirements.

Cirtec Medical specializes in silicone extrusion, producing flexible, medical-grade tubing and profiles for Class II and III medical devices. They offer single-lumen, multi-lumen, and complex profiles for applications including implantables, fluid management, and delivery systems, emphasizing precision and material resistance.

DuPont manufactures high-purity, thermoweldable, single-use TPE tubing under its Liveo™ Pharma brand. This medical tubing is specifically designed for fluid transport and bioprocessing applications. It offers improved heat-welding, high tensile strength, and burst resistance before and after welding for critical medical uses.

Freudenberg Medical manufactures fluid transfer and silicone tubing for medical, biopharma, pharmaceutical, laboratory, and bioprocessing applications. They offer proprietary brands like HelixMark® and PharmaFocus®, manufactured in certified cleanrooms at their ISO 13485 certified US facilities. Products are available from stock for short lead times.

Northfield, IL

Based in Northfield, IL, Medline is a global manufacturer of medical and pharmaceutical-grade tubing. They produce platinum-cured silicone tubing engineered for superior flow properties. These solutions are ideal for critical transfer operations across the healthcare and pharmaceutical industries.

Nordson MEDICAL provides high-performance catheter components and plastic tubing solutions for minimally invasive procedures and fluid management. They offer medical balloons, heat shrink tubing, extrusions, and nitinol components, serving cardiovascular, neurovascular, and other interventional markets. Their fluid management offerings include luers, tube fittings, and quick connects.

Pierceton, IN

Based in Pierceton, IN, Paragon Medical specializes in custom stainless steel tubing and components for demanding medical applications. Their extensive capabilities include precision cutting, grinding, forming, coiling, bending, flaring, swaging, and laser marking. They also offer hypodermic tubing and high-precision needle manufacturing for various medical instruments and devices.

Professional Plastics specializes in manufacturing Silcon® Silicone Medical Tubing. Their products are made in the USA using advanced manufacturing techniques and high-quality materials, ensuring superior performance and reliability for diverse medical and healthcare industry applications. They focus on delivering precision-engineered tubing solutions.

Research Triangle Park, NC

Based in Research Triangle Park, NC, Teleflex Medical OEM specializes in custom-engineered and manufactured complex catheters and components. They provide medical tubing manufacturing services, including single-lumen, multi-lumen, and co-extrusion from thermoplastic and fluoropolymer materials. The company also offers balloon forming, diagnostic and interventional catheter assembly, and biomaterial solutions.

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How to Choose a Company

  • Verify the manufacturer's cleanroom classification (e.g., ISO Class 7 or 8) is appropriate for your device's sterile barrier requirements, and that they can provide full material traceability and USP Class VI certification for all virgin polymers and masterbatches, especially for implantable applications.
  • Assess their demonstrated capability to hold tight dimensional tolerances, particularly for features like wall thickness, concentricity, and lumen geometry in multi-lumen extrusions, crucial for consistent fluid dynamics or guidewire passage.
  • Don't just look for extrusion. If your design requires features like tipping, flaring, hole punching, custom printing, or thermal/UV bonding for sub-assemblies, ensure the extruder has these capabilities in-house or a validated supply chain partner, to avoid quality control issues and project delays.
  • Demand proof of current ISO 13485 certification and a clear understanding of FDA 21 CFR Part 820 Quality System Regulation compliance, backed by a robust validation protocol (IQ/OQ/PQ) for critical processes, especially for Class II or III devices.
  • A common pitfall is underestimating the impact of tooling design and lead time. Be wary of manufacturers who provide overly simplistic quotes without detailed discussion of die design complexity, especially for tapered or variable geometry tubing, as this often indicates a lack of experience with the intricate relationship between tooling and critical functional characteristics like torque response and kink resistance.

Frequently Asked Questions

How critical is cleanroom classification for my specific medical tubing application?

Cleanroom classification (e.g., ISO Class 7 or 8) is paramount for sterile devices or those interacting directly with the patient. For implantable or invasive tubing, it's non-negotiable to prevent particulate contamination. Less critical applications, like external device enclosures, might tolerate a lower class, but consistent particulate control is still vital. Always specify the required ISO class, as "medical grade" tubing doesn't automatically imply cleanroom manufacturing.

What material considerations are paramount when selecting tubing for implantable vs. external medical devices?

For implantable devices, biocompatibility is the absolute priority, requiring materials certified to USP Class VI standards and a full understanding of long-term in-vivo degradation and leachables. External devices still need medical-grade materials to prevent skin irritation and ensure chemical resistance to disinfectants, but the biocompatibility requirements are typically less stringent. Both require robust mechanical properties, but the long-term stability in a biological environment is unique to implantables.

How do I ensure a manufacturer can meet specific burst pressure or kink resistance requirements for my tubing?

Provide precise quantitative specifications for burst pressure (e.g., "must withstand 500 psi for 30 seconds") and kink resistance (e.g., "must pass a 0.5-inch bend radius test without kinking"). Ask for documented test methods, statistical process control (SPC) data, and examples of validation protocols (IQ/OQ/PQ) for these critical-to-quality characteristics. A capable manufacturer will have specialized testing equipment and a proven history of validating these performance metrics.

What are the implications of specifying a durometer range rather than a precise number for medical tubing?

Specifying a durometer range (e.g., 70A ± 5A) provides the manufacturer with some flexibility, which can be beneficial for process stability and cost, as it allows for minor material batch variations. However, for critical applications where flexibility or rigidity is paramount (e.g., guidewire tracking, precise catheter navigation), a tighter tolerance on durometer might be necessary. It's crucial to understand the functional impact of any durometer variation on your device's performance and communicate that clearly to the supplier.

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