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Critical Issues Confronting Medical Device Manufacturers, their CEOs, CFOs, Managers and Developers
Embedded Market Forecasters, Jan 2010, Pages: 14
The FDA's Center for Devices and Radiological Health (CDRH) reported 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. They haven't updated this data since, but one can assume that it might have gotten worse.
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.
Is there enough aspirin to relieve the headaches that our government is giving medical device manufacturers?
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. Keeping the company alive and your CEO out of jail are bonuses.
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