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.
“And the way you do that is you seek advice on your project early in the game,” he said.
Czuba suggested medical-device manufacturers get to know the agency, understand what parts of FDA they deal with, know whether they're making a Class I, II or III device, and study the regulations and testing requirements.
The agency has many local offices, and Czuba urged attendees to make an appointment to talk with a local official about new products.
FDA officials won't tell you what you need to do to bring a product to market, but they will offer advice on your plans. And if you disagree, you can bring your experts into the conversation.
Czuba also offered details on some case studies where he was involved. In one, he worked with Baxter Healthcare Corp. to help commercialize Galaxy, a manufacturing process that fills a flexible, laminated bag with a heat-sensitive drug in an aseptic environment and finishes the product as a frozen IV solution.
The team met regularly with FDA, submitted preliminary information and worked out a plan for proving the product was safe. The result: The company received final clearance for the product two years before it was expected.
Not all the case studies Czuba covered were so successful, and he acknowledged that for startup companies, delays in bringing products to market “can be a show-stopper.”
But, unfortunately, some issues cannot be resolved quickly, which makes advance planning and understanding of the regulations critically important.