Linux can't [just] be cobbled together for medical systems

Using Linux in medical devices is becoming common-practice, but there are important factors which developers and manufacturers need to consider. writes Ken Herold, senior systems engineer at Wind River

Linux is the operating system (OS) of choice for a wide range of medical devices, from vital sign monitors to hospital bedside ‘infotainment’ systems to complex imaging equipment. Yet not all Linux implementations are alike. Because patients’ lives may be in the balance, software used in medical devices must meet stringent regulatory guidelines to ensure that it will perform as promised.

Trying to cobble together solutions from pure Linux without commercial support puts the burdens of testing, validation, documentation and compliance on the device manufacturers and software developers – an onerous, time consuming and complex process that can turn ‘free’ Linux into a very costly proposition.

There are, of course, commercial vendors of Linux who provide value-added stabilised versions of the open-source software, along with board support packages. Service, support and documentation levels, however, vary widely among them with some chip vendors providing software, but no real post-sales support...