These urethral sling introducers were designed by Diversified Plastics Inc. for regulatory approval. The tool’s plastic handle is a molded clamshell shape that combines a polycarbonate compound with an outer, softer thermoplastic elastomer overmolding.

A well-known medical-device manufacturer designed and developed a preproduction surgical tool that, unfortunately, did not meet specs and failed during testing. The tool, a urethral sling introducer, is used by surgeons to place a sling around a patient's bladder or urethra to treat stress incontinence. The tool must fit well in the surgeon's hand and provide the proper torque to easily glide the sling into place and secure it. Because the introducer failed due to problems with the injection molding of the handle, the manufacturer turned to injection molder Diversified Plastics Inc., Minneapolis, (divplast.com) to help modify the design.

“The manufacturer had hired a product-development company to make the prototype,” says Joni Davis, sales engineer with Diversified Plastics. “But the tool didn't effectively hold the needle in place or provide the necessary torque. Additionally, poor structural construction caused the handle to collapse.”

The injection molder then collaborated with the manufacturer to improve the design. The modifications led to the product's quick regulatory approval and successful introduction to the medical-device market. Diversified Plastics now manufactures several kinds of the urethral sling introducer for both female and male urinary incontinence. All versions are designed for one-time use.