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FDA Officials Concerned When Firms Don't Heed Good Consultant Advice

This article was originally published in The Silver Sheet

Executive Summary

CONSULTANTS CAN HELP DEVICE MANUFACTURERS resolve quality systems problems, but companies don't always follow their consultants' recommendations, FDA officials lament. “The real challenge in working with these consultants and contractors ... is making sure [the recommendations] are sustainable and business-friendly,” says Bill Duffell, senior VP for global quality and regulatory affairs for Gambro Renal Products. The company recently got out from under an import ban imposed by FDA with the help of numerous consultants. “We got to a certain point on some things where we needed horsepower in addition to our own horsepower,” Duffell says. Meanwhile, an industry survey finds that manufacturers tend to pay anywhere from $100 to $250 per hour for independent quality and regulatory advice.

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