The range of skills that the medical device OEM should expect of an extrusion outsourcing partner include design assist, project management, automated machining of extrusions, and more, according to Gordon Knott, medical market leader at Alexandria Industries (Alexandria, MN).
MPMN: Why should a medical device OEM consider collaborating with an extrusion supplier?
Knott: Medical device OEMs can gain design expertise and reduce product development time by forming early partnerships with extrusion suppliers. An expert extrusion partner will begin by understanding the end application and then proceed to recommend cost-effective design options, including options for structural components such as a C-arm used in MRI equipment. An extrusion supplier should also be able to help OEMs evaluate net-shape objectives, considering that the extrusion process produces a uniformly flat and smooth surface with less waste than machined bar or plate stock. And if suppliers have the dual capability of forming and machining extrusions, they can design a single, streamlined product to replace multiple components that may require several additional manufacturing processes.
MPMN: What competencies should the OEM demand of an extrusion outsourcing partner?
Knott: Medical device OEMs should partner with extrusion suppliers that can offer design assist and project management, automated machining of extrusions, stretch forming of extrusions, and other manufacturing processes. They should also look for partners that are technical experts in engineering design, aluminum extrusion, and stretch forming and bending, as well as materials science and regulatory compliance. Criteria that set some suppliers apart from others could include ISO certification, RoHS and REACH compliance, and machine and process validation. Because customers may assign stringent geometric tolerances to parts that don’t require them, it is also important that suppliers understand OEM tolerance levels. In addition, the OEM should partner with a supplier that can help improve product performance and safety while reducing ongoing costs by understanding product requirements and applications at the outset of the development phase.
MPMN: There been a trend recently of extrusion outsourcing firms offering more value-added services. What is the reason behind that?
Knott: As medical devices grow more sophisticated and precise, manufacturers need extrusion partners that can keep pace with increasing device complexity, while helping to streamline the production process. That’s why we’re seeing a trend toward more value-added operations on precision extrusions and added assembly processes. Such processes include precision machining, stretch forming, welding, finishing, and assembly capabilities.
Offering engineering services in the design and development of high-reliability drug-infusion systems manufactured from biocompatible medical-grade extrusion materials, Forefront Medical Technology is a fully integrated contract manufacturer. Its development expertise includes rapid prototyping by means of selective laser sintering, and the company additionally offers capabilities in in-house toolmaking, injection molding, extrusion, Class 10,000 cleanroom assembly, testing, packaging, sterilization, and global logistics. It has developed a pump tube assembly that forgoes conventional bond joints, instead attaching the extruded silicone pump tube to the mating hubs by means of a self-locking feature that eliminates leakage.
Forefront Medical Technology
Teleflex Medical OEM offers services involving the extrusion of PTFE, FEP, EFEP, and other high-performance thermoplastics in dimensions ranging from microminiature through 35F. Equipped to handle challenging applications, the company produces heat-shrink and spiral heat-shrink tubing, multilumen tubing, coextrusions, and profiles, among other extruded items. Its capabilities additionally comprise standard and embedded marker bands, radiopaque fillers, and braid and coil reinforcement, including variable-pitch, continuously coiled shafts. The integrated, full-service contract manufacturer serves as a single-source provider of diagnostic and interventional catheters and sheath-dilator sets and kits.
Teleflex Medical OEM
Extrusion of flexible medical tubing
Grayline Inc. employs standard and special extrusion equipment to manufacture custom flexible medical tubing in a range of sizes and geometries. The company’s extruded tubing is available in a variety of nontoxic materials, including PVC, thermoplastic elastomers, polyurethanes, and polyethylene compounds. It also offers custom tubular shapes and tubes with a connector or fitting inserted in each end. Tight dimensional tolerances are controlled by means of laser micrometry, which is also used to support the collection of full production-lot data.
Variable-flexibility extrusion technology
A provider of advanced extrusion services uses proprietary Taper-Tie continuous-extrusion technology to make variable-flexibility tubing for catheter shafts requiring high flexibility at one end for forward navigation and rigidity at the other to facilitate directional control by physicians. Specializing in the production of minimally invasive medical devices, Putnam Plastics Corp. designed the technology to replace traditional manual assembly of catheters with segmented shafts and eliminate associated labor costs. The continuous manufacturing method produces a catheter shaft that has variable properties along its length from the moment it is extruded. The process allows for quickly changing from rigid to soft grades of a designated polymer along the shaft while simultaneously reducing wall thickness during the extrusion.
Putnam Plastics Corp.
Alexandria Industries helps medical device OEMs build optimized products and improve manufacturing processes by providing engineering guidance and device components. The company manufactures precision aluminum extrusions in standard and custom versions and in sizes ranging from microscale to 12 in. in diameter for use in durable equipment and electromedical components. From product design to manufacturing and assembly, it can support customers’ supply chain, offering material expertise, certified aluminum grades, automated extrusion presses, and a Kevlar part-handling system.