College - Author 1
College of Engineering
Department - Author 1
Industrial and Manufacturing Engineering Department
Department - Author 2
Industrial and Manufacturing Engineering Department
Advisor
Xuan Wang, College of Engineering, Industrial and Manufacturing Engineering Department
Funding Source
Paul & Sant Bonderson, Kim Vorrath, The Prague Foundation, and Cal Poly's College of Engineering Dean's Innovation Fund
Date
10-2025
Abstract/Summary
As 3D printing technology continues to transform the healthcare industry, the need for FDA-compliant additive manufacturing facilities in public universities has become increasingly important. While private companies and medical research institutions have successfully integrated 3D printing for medical device prototyping and surgical planning, public universities—including Cal Poly—lack the dedicated infrastructure needed to support FDA-regulated medical manufacturing and research. This project aims to bridge that gap by researching, designing, and implementing a dedicated FDA-compliant section within Cal Poly’s multi-purpose 3D Printing Facility. Over the course of eight weeks, student researchers will study FDA regulations, design an optimized facility layout, and implement a structured additive manufacturing workflow to ensure compliance with FDA, ISO 13485, and Good Manufacturing Practices (GMP) standards. The designated section will feature controlled workspaces for medical 3D printing, post-processing, quality control, and regulatory documentation, ensuring adherence to safety and validation requirements. Once operational, this facility will provide students, faculty, healthcare professionals, medical researchers, and industry partners with a regulatory-compliant workflow for designing and producing medical-grade 3D prototypes, while also serving as a foundation for future FDA-compliant proof-of-concept developments.
October 1, 2025.
Included in
URL: https://digitalcommons.calpoly.edu/ceng_surp/125