Product R&D

From Concept to Clearance: How Goddard & Aurie Created a Reusable Catheter System

Available from Goddard, Inc.

From Concept to Clearance: How Goddard & Aurie Created a Reusable Catheter System

Content Summary

Aurie approached Goddard with a proof-of-concept model for a reusable
catheter system that included a soft introducer tip, an insertion aid, and a
no-touch sheath. They tasked Goddard with redesigning the product for
manufacturability along with making improvements for use driven by user
feedback from previous formative studies. The client also wanted Goddard
to support the design control lifecycle from redesign through eventual
FDA submission.

Goddard assisted with material research, determining durometer and
material thickness, and provided continuous improvements through
prototyping and testing, supporting enhanced mold designs.
The successful collaboration between Goddard and Aurie on the reusable
catheter led Aurie to expand the scope of work to include the reprocessor,
bringing the electrical and firmware engineering teams onto the project.

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