Medical Device Contract Manufacturing

A medical device contract manufacturer for custom tubing

Medical device companies choose a contract manufacturer for one reason: to get a part made right, on time, without building the capability themselves. As an ISO 13485 contract manufacturer focused on extrusion, MicroSpec handles medical contract manufacturing of custom tubing from first prototype to commercial run. Companies around the world depend on us to extrude custom bump tubing, co-extrusions, micro-extrusions, multi-lumen tubing, profile extrusions and coated wire. We specialize in medical tubing with outside diameters from about 0.004 inch to 0.625 inch (0.1 mm to 16 mm), using polyurethanes, nylons, engineering resins and other materials, including custom and proprietary formulations. We are a recognized industry leader in extruding vascular bump tubing.

Material, process and machine

Good extrusion comes from understanding how three things interact:

• Material properties, such as hardness, heat distortion, tensile strength, elongation and melt flow
• Process conditions, such as temperature, rate of cooling, flow rate and pressure
• Extruder capabilities and tooling, including our own proprietary crossheads, tips and dies

Our extrusion technicians are respected specialists in complex medical tubing, and they average more than a decade of experience. We draw on that experience to stay ahead of trends, reduce your risks and help bring your device to market.

Our production floor

Our production area holds 18 extrusion lines and 22 extruders, including co-extrusion and tri-extrusion lines, along with pellet dryers, precise cutting tools and testing equipment. A new materials drying room conditions resin before it reaches the line. Lines carry laser gauges that measure outside diameter as the tube is made, with process data on screen for the technician throughout the run.

Each new part gets a written plan before it runs. The technical notes from the quote become a checklist for tooling, materials and inspection, so the extrusion technician and quality inspectors know exactly what matters for your part.

We have run around the clock since 2012, with three shifts, and we welcome both prototype and high-volume commercial runs. Finished tubing is cut, bagged and labeled by lot, with flexible packaging options and Kanban programs for repeat orders.

Prototype to production

Our Prototype to Production Manufacturing Process program carries a part from first run through validation into commercial production on the same floor. Paired with our JumpStart Validation Program, it keeps your part with the people who first solved it.