Our minimum viable product (MVP) was easy to identify from the start: a single-piece cannula that would be easy to use and provide optimal comfort for premature babies. We were able to turn Dr. Mohamed’s initial sketches into a functional 3D model with CAD. Once the designs were modeled in CAD we could run Finite Element Analysis (FEA) and flow analysis testing. These test results were crucial to ensure our design was strong enough to support the weight of a baby’s head and provide enough airflow.

We used 3D printing to fabricate some initial test units for Dr. Mohamed to confirm fit and function. We then turned our attention to identifying a way to prototype and manufacture the device on a larger scale.

After exploring multiple fabrication methods, we found that dip molding was the best fit to scale up production. We designed mandrels in 7 different sizes and worked with a dip molding vendor to fabricate the devices. After progressing through a few design iterations to fine-tune the dimensions, several dozen devices were produced for clinical trials.

Meanwhile, Dr. Mohamed worked with a regulatory consultant to prepare the paperwork and testing needed to successfully gain FDA clearance. Root3 Labs assisted with some testing at this stage, as well. We were able to verify that the CPAP Cannula device would hold air pressure under the temperature and humidity conditions typically used in an infant incubator.