The Medical Software Pandemic: Challenges and Solutions


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.

There is a simple solution to this apparent untenable dilemma. Highly robust medical software can be developed at the speed and cost of high volume consumer electronics, such as smartphones and PCs. The methodology for achieving this combination of safety and efficiency is not widely understood. This seminar will describe the key principles and how they can be applied without sacrificing the latest and greatest multimedia, connectivity, and open source software features that improve usability. Furthermore, we discuss how regulators can dramatically improve medical software safety by reusing validated components and standards from other industries.

On-Demand Webcast
Webcast Duration: 60 minutes


David Kleidermacher

David Kleidermacher
Chief Technology Officer
Green Hills Software

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