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The software complexity of critical medical devices is growing rapidly. Pacemakers can be remotely programmed. Infusion pumps have been hacked. Digital radiography systems contain millions of lines of code. Some devices, such as electronic medical record (EMR) tablets, are effectively a generic personal computer, running massive operating systems. Medical device manufacturers face tremendous competition, promoting intense cost containment measures and time to market pressure. The result is that the current international regulatory environment for life-critical medical devices is hopelessly inadequate. Unlike the avionics industry, which has extremely rigorous requirements for flight-critical software and requires a comprehensive validation prior to flying, medical device regulators have historically focused instead on documentary guidance. While medical device software failures have caused patient fatalities and hundreds of recalls, there has never been a commercial airline passenger fatality directly attributed to software.
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