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

With the Henkel’s high temperature material, Fortify was able to produce a customized 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