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At The Intersection Of Quality And Metrics: What's Ahead In FDA’s Effort To More Objectively Measure Quality

 
• By Shawn M. Schmitt

Quality metrics are being developed by the US FDA to not only determine which medical device facilities to inspect next, but to also raise firms' overall approach to quality above baseline. In-process metrics work by the Medical Device Innovation Consortium will be used as the agency comes up with its own robust set of measurements. Meanwhile, FDA is gearing up for a new pilot program targeting 10-20 device manufacturers that will submit quality data to the agency; MDIC explains how to calculate its three quality metrics; and quality officials from Baxter, J&J and Stryker weigh in.

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US FDA is banking on developing quality metrics to not only aid in selecting which device facilities to inspect next, but to also raise firms' overall approach to quality above baseline. Metrics developed by the Medical Device Innovation Consortium (MDIC) is one piece of the puzzle – but the agency also wants its own set of metrics that it hopes will drill down even further to ensure best quality practices.

"When you look at quality metrics, the areas that we're focusing on are basically how firms structure quality metrics, the kind of metrics we should consider, and which metrics have the most utility for FDA, as well as for firms

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