Rapid Medical Device Validation

case-studies Description

Rapid Medical Device Validation

The Challenge

During COVID-19 pandemic a fast response was needed to produce medical devices or modify existing medical devices ​. In this instance a sleep apnea machine was repurposed to serve as supplementary machines in hospitals. A T-splitter component that houses critical alarm sensors for ventilators in order to alert clinicians if airflow to the patient is interrupted at any point need to be built – fast prototype production was needed in order to get FDA approval.

The Solution

LOCTITE 3D IND147 HDT230 Tough Natural was perfectly matched to the design requirements. With the high temperature material, Fortify was able to produce a 3DP mold that was used to produce the T-splitter.


  • Reduced lead time from 6 to 1 week
  • Cost reduction from $4000 to $700 (compared to aluminum tooling)
  • 3D printed mold is offering 
    • Stiffness/robustness
    • Fast throughput and ability to test geometries with final material
    • Cost competitive ​options vs. traditional manufacturing

Developed together with