A breakthrough medical procedure assisted by Spectrum Plastics Group
Deliver complex, specialty tubing for a medical device that would improve women’s health.
Engineer an intricate product that is consistent in appearance, quality and utility.
A thermoplastic PVC co-extrusion housing wires that maintains tight pull-pressure tolerances and dimensional integrity at each of 25 inspections during the assembly process.
A pioneering developer of medical diagnostics and surgical products was seeking a plastics manufacturer to develop a key component for a procedural device that would change the industry and provide women a new option to hormone treatments and surgery. It had been unable to find a company that could consistently meet a host of technical requirements: from three different pull-pressure specifications within two thermo-bonded tubes; to an internal wire configuration that delivers exact radio frequencies during the procedure; and finally, to the extrusion of a finished piece within a specific, precise horizontal plane.
In addition to finalizing the intricate design and the expensive embedded wire co-extrusion, the client needed a manufacturer that could deliver a product to doctors that would be consistent in appearance, quality and utility.
Enter Spectrum Plastics Group -- Athol, which had not previously worked with this medical industry leader, and so its Massachusetts-based medical sales and engineering team knew they had one chance to get it right. Instead of developing and delivering a prototype and leaving it to the customer to make it work, Spectrum took the lead. The engineering team leveraged its experience in the medical device industry delivering select materials in a co-extrusion with specific properties, such as anti-leaching characteristics, anti-kink or burst-strength, and dimensional requirements. The team also designed a specialty wire payoff system managed by a tension controller. The end result is a payout of wire that matches both the rate of tubing extruded and a consistent tension that avoids any stretching of wire, which would impact the electrical conductivity. Further, a self-contained housing was designed to prevent any contaminants from adhering to the wire.
The sales team served as a conduit and engaged with the engineering team and client to understand the critical requirements for thermoplastic bonding, the peel pressure differences, dimensions and tolerances. The team also took time to travel outside the U.S. to see first-hand how the complicated and delicate piece would be inspected and handled at 25 different points of the assembly process in order to deliver a product that could successfully and consistently yield an effective instrument for outpatient surgery.
After a year of working together, Spectrum delivered a prototype that was validated by the customer and approved by the Food and Drug Administration. During the first few years of the relationship, Spectrum continued to work with the medical customer to refine the product. The engineering team was able to scale back the amount of precious metal materials required without impacting the quality of the final piece and specify a new grade of tubing. Spectrum’s medical products and materials science expertise also meant it could work with the raw materials vendors to deliver tubing and wires in a way that would ensure a consistent tension throughout the extrusion process, which means the wires within would maintain their position, yield less scrap, deliver a clean product and most importantly, provide the required radio frequency during the procedure.
Since the beginning of the relationship, approximately 2,600 miles of product have been extruded in Spectrum’s Class 100,000 clean room in Massachusetts and delivered to the device assembly plant. In addition, millions of women worldwide have benefited from the outpatient procedure device utilizing Spectrum Plastics Group component tubing that has been called life changing by many independent reports.