A manufacturer of products used for foreign particle management in the esophagus found that the market for its product line was no longer growing. The Company decided that a redesign of the product line was the best way to increase market share.
They turned to Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, for a solution. Forefront’s team recommended converting the manufacturing process used for the tubing from a dipping process to the combined use of extrusion molding and injection molding. The team also recommended changes in the materials composition for other components used in the product. This paper discusses lessons learned in the redesign and qualification process, and the overall results.
Overview of the Design Approach
Forefront Medical’s team uses a standardized process in which customer requirements are assessed and a Design Development Plan (DDP) is created. A customer specification is then developed and market inputs are collected. Once the customer specification is approved, 3D CAD models are developed and analyzed. Design reviews which include functional analysis and risk evaluation are completed. After a customer’s team approves the design, prototyping and verification began.
The design team is located in Forefront Medical’s Singapore headquarters. The Company’s tooling fabrication facility and production facilities are located in China. Having a vertically integrated process, that includes design, design analysis, tooling and injection molding, enabled the team to consider a broader range of options, run design of experiences (DOEs) to test assumptions and develop a viable solution to all design challenges.