The Center for Devices and Radiological Health (CDRH) recently upgraded its "software forensics lab", marking a substantial financial and time investment by the center to get at the root cause of the most troubling post-market device software failures. The CDRH reports that in 2006, 21% of all medical device recalls were for software defects - it is also estimated that one-in-three software-based products is recalled.
Medical device developers and company CEOs should be aware that this is an unacceptable situation and that it is going to rapidly change. Those that don't get it straight won't be around when the dust settles.
The purpose of this paper is to present the medical device developer guidelines for complying with the "suggestions" of the CDRH. Technology exists today that allows a company's current tools and processes to be retained, while presenting choices that developers can use to meet CDRH guidelines. EMF research has shown that these technologies are not only affordable, but that they can increase ROI and significantly reduce the chance of a product recall or a patient injury.
This paper is written to present alternative paths for developers to produce quality software for medical devices, minimize product recalls, and affordably provide comprehensive audit trails for CDRH inspectors.
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