Extrusion is a rapidly advancing field in medical device manufacturing. Extruders must keep pace with the increasing complexity of medical devices to provide enhanced, often-customized tubing features and material properties. Equipment manufacturers continue to make advanced machines that can manufacture smaller, more functional tubing with very tight tolerances--for example, interior diameter sizes in the 0.002-inch range, with high precision and multiple properties.
"In today's market, medical tubing is pushing the boundaries for smaller extrusions, tighter tolerances, and multilayers/multimaterials, along with new materials with a large range of physical strength, flexibility, and durability to accommodate the demands of new products," said Chad Freestone, director of engineering for Flexan, a Salt Lake City, Utah-based manufacturer of custom silicone and thermoplastic components and sub-assemblies for medical device companies.
COVID-19 is a new driving force behind the increased de mand for medical tubing. According to Markets and Markets, the medical tubing industry is expected to grow about 13 percent by 2021, for a total value of $2.9 billion--up from $2.6 billion in 2020.1 Much of this market growth will be related to the growing needs for medical tubes for drug delivery devices, catheters, nasogastric procedures, nebulizers, and bulk disposable tubing.
Some OEMs are producing their own tubing in-house to save money and time. This is an effective approach for basic tubing needs; however, OEMs tend to outsource more challenging projects to their extrusion partners, expecting them to have the knowledge and technical skills to turn these complex designs into reality, within very tight tolerances.
"Over the last five to eight years, many OEMs have acquired their own extrusion houses in the attempt to vertically integrate, and it has generally worked for that OEM, "said Tyler Ware, president of GenX Medical, a Chattanooga, Tenn.-based custom extrusion house specializing in tubing for medical devices. "The flip side is the other customers of the extrusion house now have slower service, longer lead times, higher prices, and a less desirable customer/supplier interaction. This has opened up opportunities for new extrusion houses to get their foot in the door, and typically they stay."
Even with such a high level of competition, the demand for medical tubing continues to lure new extrusion providers into the field, a number of which have no previous experience with medical tubing. "Some of the highly novel and niche processes are becoming more commonplace, with more companies offering these services,"added Charles Golub, market development manager for Saint-Gobain Medical Components, a Northborough, Mass.-based contract manufacturer focused on customized material solutions from silicone, thermoplastic elastomers [TPEs], and polyvinyl chloride. "Carving out a niche in today's market is tough, especially without a previously existing footprint."
Medical device manufacturers (MDMs) have increasingly complex extrusion needs that require very precise dimensional, material, and design specifications. They sometimes work closely with their extruding partners to develop innovative and/or custom extrusion solutions, such as transition tubes in which one mate rial transitions to another over the length of the tube, exhibiting different mechanical properties at specific points along the tube....