A battery-powered ventilator small enough to leave the hospital with the patient, and complete enough that nothing was traded away to get there.
Ventilators are usually a choice between capable and portable. The compact ones drop modes, alarms, or run time; the complete ones stay plugged into a wall in an ICU. This one had to work inside the hospital and outside it, on battery, without giving up the functionality clinicians expect. And every gram and millimetre had to come out of the mechanics and the board rather than out of the feature set.
Requirements and concept work first, so the size and weight targets were set against clinical function rather than discovered later.
Product, industrial, and mechanical design carried together, since on a device this small the enclosure and the pneumatics decide each other.
Custom PCB design and the embedded application on STM32F446 with a VAR-SOM-MX8 module, plus an Accel Edge TPU for on-device processing.
Production, preclinical trials, and quality control run as part of the same programme, not handed off at the end.
A portable ALV device that runs autonomously on battery and stays smaller and lighter than comparable devices on the market, with the functionality intact. We carried it from initial requirements through production, preclinical trials, and quality control.