Len Czuba started his presentation at Plastics in Medical Devices 2012 with a sharp tweet of a whistle he was dressed in his volleyball referee’s uniform to make a point. The president of Lombard, Ill.-based product development firm Czuba Enterprises Inc. spoke about the Food and Drug Administration’s role in the U.S. medical-device industry. Czuba said FDA is there to promote and protect public health, which is an extremely important role. "We can’t tolerate mistakes by the agency," he said at the Westlake conference, held June 12-13. Earlier in the conference program, some speakers were asked whether FDA is a friend or foe to the industry, and the response was somewhat negative. But Czuba spoke about his own positive experiences dealing with FDA officials. "If they’re not a friend to you, you’d better make them a friend," he said. "I’d seriously caution you and warn you about ever getting to be [in an] adversarial relationship with the FDA. I would strongly urge you to keep it a friendly relationship.
Plastics in Medical Devices 2012: Elliott Pritikin : Medical-device designers face regulatory pressures.December 12, 2012 6:00 am ET