Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.

All too often, however, design controls and risk management are viewed as a pile of “stuff” that the U.S. Food and Drug Administration (FDA) and other regulatory bodies require during the design and development process.

The FDA design control regulations have now been in place for 20 years. They should be aids to guide medical technology professionals, but an overwhelming percentage of the medical device community approaches these activities as checkbox, low value-adding tasks.

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