One in 10 babies is born prematurely — a total of 15 million every year. Premature babies face the challenges of underdeveloped organs, particularly the brain, which has difficulty regulating its oxygen levels. Just 5 minutes of too much or too little oxygen can cause permanent, lifelong damage and put the patient at immediate risk of early death, making reliable monitoring essential in neonatal intensive care.

In this presentation, we will discuss the development of a reusable, non-invasive next-generation brain oxygen monitoring solution designed for high-risk neonatal patients, with a focus on the low-level embedded firmware of the oxygen sensor and its development in accordance with the IEC 62304 medical safety standard.

This work has several key technical elements:

* The firmware was completely implemented in the Rust programming language, providing static memory safety guarantees. 
* Traceability of safety requirements was built into the development process from the start. Requirements were linked to source code and test cases through our CI pipeline, enabling us to closely monitor project progress. 
* Hardware-in-the-loop testing on actual production devices was an integral part of the CI, minimizing the risk for surprises during integration testing despite a tight deadline.

Together, these elements enabled a development process spanning requirements traceability to automated HIL testing for a safety-critical medical device implemented in Rust. Attendees will learn the practical lessons, trade-offs, and challenges encountered while applying these techniques under regulatory constraints.