Medical device manufacturers (MDMs) continue to make smaller, increasingly complex devices with unique geometries that require high-precision components—including extruded parts. For example, since minimally invasive surgical applications are highly preferred in the operating room, MDMs are pushing for tight-tolerance micro extrusion tubing to meet the performance specifications for these highly engineered devices. Smaller tubing with added functionality is also in demand, such as thinner wall thicknesses with improved hoop/burst strength, smaller inner diameters that can handle more lumens, and tubes with higher flexibility and “softness,” but also greater torque resistance.

Although advances have been made for smaller footprints, measurement systems, cutters, screw design, materials, and material feed (all of which improve the extrusion process and expand the limits of what it can do), it doesn’t take long to fall behind the technology curve. Extruders must constantly strive to improve their processes and push their boundaries to satisfy the ever-challenging needs of their MDM clients. This also requires deeper customer intimacy and in-depth knowledge of their internal processes. And, with the U.S. Food and Drug Administration (FDA) pushing regulatory responsibilities further down the supply chain, extruders must also be experts on their quality systems and FDA requirements. 

It is no surprise, then, that MDMs are increasingly dependent on their extrusion providers to meet their needs for complexity, tolerance, quality, and compliance. In other words, they seek extruders who can provide complete (or nearly complete) device solutions, rather than just tubing. This reduces MDM risk, improves quality, and speeds up time to market.

“Customers are looking for strategic development partners, rather than just component suppliers,” said Ray Ledinsky, global market manager for Teleflex Medical OEM, a Gurnee, Ill.-based provider of custom-engineered extrusions for the medical device industry. “Finding strategic partners helps them shorten their supply chains, from compounding all the way through to the finished device.”

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