Engineering the Electronic Platform for a Life-Supporting Critical-Care Ventilator – 7 Boards, Compliant by Design, in ~13 Months

A life-supporting device where an electronics failure could cost a life needed a partner to own the entire electronic platform

Our client is a US-based medical-device company building a next-generation critical-care ventilator – a life-supporting Class II device that continuously monitors and supports patient breathing. (Identity withheld at the client’s request.)

Ventilator electronics operate in a safety-critical environment where reliability, accurate sensing, and immediate alarm response directly affect patient safety. There is no margin for a silent failure. If a sensor misreads, if control logic stalls, if an alarm doesn’t sound – the consequences can be fatal.

The client had a target architecture, but needed a partner to own the electronic platform end-to-end: deterministic control, robust fault handling, and a certifiable, well-documented foundation. They would keep the clinical logic and certain hardware tasks in-house – industrial design, battery packs, and the ventilation algorithms themselves – but the electronic and embedded platform had to be someone else’s responsibility, delivered to medical-device standards.

This demanded a partner fluent in safety-critical embedded engineering and the full stack of medical device regulation – FDA 510(k), IEC 60601, IEC 62304 Class C, ISO 13485, and more. The client chose Yalantis.

Seven electronic boards integrated into a robust, compliant-by-design ventilation system

Yalantis designed, created, and tested seven boards that integrate smoothly into the ventilation system. The architecture is deliberately conservative: clinical content is strictly separated from the infrastructure that runs it, and the alarm path survives failure of the application processor. The key components:

A clear division of responsibility between Yalantis and the client

The engagement worked because responsibilities were cleanly split. Yalantis owned the electronic platform; the client kept the clinical core and validation.