Project Code: 17048
Project Title: Enteral Feeding Low Profile Gastrostomy Tube Medical Device
Project Type: Industry
Project Intellectual Property: Company Controlled
Project Citizenship Restriction: No
Sponsor Company: Xeridiem Medical Devices, a part of Spectrum Plastics Group
Description: Project goal: To modify an existing low-profile gastrostomy tube system to include a reflux valve. The primary function of a gastrostomy tube is to transfer liquid food and nutrients directly into the stomach through a stoma. A new injection mold plate, core pins and cap molds were designed in SolidWorks and fabricated using silicon injection molding. Durometer analysis determined the optimal hardness of silicon needed to maintain the correct flexibility, sturdiness and bio-compatibility that would ensure complete medical functionality. The team designed a hub to house the sponsor-provided cross-slit petal reset valve, a cap that securely closes access to the stoma, and a set of core pins used to fabricate gastrostomy tubes of varying internal diameters. Pressurized leak tests and tensile strength tests were performed in accordance with Federal Drug Administration and medical device regulatory compliance standards. The testing was designed to verify that the new device is substantially equivalent to the existing device for future FDA regulatory approval and commercial viability.