In choosing an extrusion provider, the OEM should think beyond tubing and other products. Because the manufacturer often requires the services of an extruder early in the design process, the prospective supplier must be able to provide collaborative product development, as well as supportive and innovative design and engineering capabilities.
An essential component of product development is die building. Manufacturers benefit from working with extruders that have in-house die-building and prototyping capabilities, which is essential for creating consistent, high-quality products. In addition, in-house die building facilitates product modification and evolution. Hence, to accelerate die development, manufacturers should look for an extrusion partner that is also well grounded in CAD and CAM technology, 3-D prototyping, and EDM processes.
Medical device manufacturers should partner with an extruder that has a proven track record in providing not only simple, single-bore tubing extrusions but also complex multilumen, paratubing, and co- and triextrusion processes. The extruder should also demonstrate capabilities with a range of resins. For example, many medical device OEMs require medical-grade DEHP-free or phthalate-free plastics that can undergo all traditional sterilization methods.
In-line quality control monitoring and assessment are also important considerations. Thus, the OEM should choose a vendor that can demonstrate thorough and comprehensive quality control, regulatory, and document control capabilities. These capabilities may include in-line laser measuring to ensure strict compliance with outer-diameter specifications, ultrasonic monitoring of wall thicknesses to ensure tubing concentricity, and statistical quality and process control for providing real-time data and anticipating problems before they occur.
- Richard Brooks, vice president of sales/medical, Pexco Medical Products, Athol, MA.
Custom profile extrusions
An extruder offers custom profile extrusions made from PTFE and a variety of melt thermoplastic materials such as polyurethane, nylon, and polyethylene. Providing design, engineering, and manufacturing services, the company produces extrusions for a variety of medical applications, including catheters and replacement biopsy channels for the repair or manufacture of endoscopes. While its melt thermoplastic materials can be used to fabricate single- and multilumen tubing with a maximum outer diameter of 9 mm, its PTFE tubing features inner diameters ranging from 0.0366 in. with a 0.002-in. wall thickness to 0.068 in. with a 0.010-in. wall thickness. PTFE rod sizes range from 0.008 to 0.038 in. The vendor can also spool materials or cut extrusions to specific lengths.
International Polymer Engineering
Thermoplastic and composite extrusions
Using thermoplastic and composite materials, a supplier develops and produces extruded components, including handles, clamps, and hand grips for surgical equipment; parts for diagnostic and blood analysis equipment; and components for the orthopedic-trials market, trauma fixation, and surgical caddies. In addition, the company is developing and testing new materials that are designed for use in x-ray and MRI imaging applications. Based on premium-grade resins, the service provider’s products are manufactured in an ISO 9001:2008–compliant and FDA-registered facility. Because some applications require materials testing, the company’s in-house labs are equipped to analyze materials to ensure that they meet customer specifications.
Custom extruded thermoplastic tubing
Specializing in custom extruded products, an ISO 9001:2000–compliant contract manufacturer provides wire coating, balloon tubing, shrink tubing, and vacuum sizing. With capabilities ranging from development studies and engineering runs to prototyping and production-quantity runs, the company can fabricate final tube designs in single-lumen, multilumen, profile, bump, multilayer, and paratubing configurations. Extrusions are available in a range of thermoplastic materials, including PVC, LDPE, MDPE, HDPE, C-Flex, polypropylene, urethane, nylon, and Pebax.
Medical Extrusion Technologies Inc.
Flexible tubing and tubular shapes
Coupling extrusion capabilities with an inventory of existing tooling, a contract manufacturer offers custom flexible medical tubing and tubular shapes in a range of sizes and geometries. The company’s medical products are made from various materials, including PVC, TPE, polyurethane, and polyethylene compounds that meet medical certifications such as USP Class VI and EU regulations for phthalate and DEHP content. Extruded products include negative-pressure wound drains; insufflation systems; suction, extension, oxygen, and drain lines; catheters; IV systems; peristaltic pumps; cannulae; and protective coverings for surgical instruments. The company also offers radiopaque products and tubing that can be sterilized using EtO, gamma radiation, or autoclaving processes. As an ISO 9001:2008–registered company, the vendor maintains quality control standards, including tight dimensional tolerances that are controlled using laser micrometry.
Rigid and flexible tubing
Thermoplastic medical extrusions are produced in Class 100,000 cleanrooms at a contract manufacturer’s FDA-registered and ISO 9001:2008– and ISO 14001:2004–certified facilities. The supplier’s capabilities include single- and multilumen tubing, thermally bonded paratubing, coextrusions, triextrusions, custom profiles, SPC documentation, on-line measurement controls, and in-house wire EDM services. In addition, the company offers CAD/CAM, printing, bar coding, subassembly, and packaging operations. Specializing in medical-grade flexible or rigid tubing and custom profiles, the company fabricates extruded products made from USP Class VI materials such as PVC, polyethylene, polypropylene, polycarbonate, nylon, thermoplastic elastomers, radiopaque materials, and PVC alternatives.
Pexco Medical Products