CLEVELAND—Do as you are told.
That's a key bit of advice for medical device manufacturers that want to get their products approved by regulators in emerging countries. It comes from Bob Hossack, an executive who has broad experience in the field with Baxter Healthcare, Boston Scientific and now Stryker Medical Corp.
If your technical people tell you an inquiry posed by a regulator "is a stupid question, you have to turn around and tell the regulator, "That's a brilliant question,' " said Hossack, Stryker's vice president for regulatory affairs, international. It's their country, and if a company wants to get into that market, it has to play ball, he said.
Hossack, who spoke on materials testing for medical devices outside the U.S. and European Union during the ACS Rubber Division's Advanced Materials in Healthcare conference recently in Cleveland, listed a number of hurdles medical device makers must jump over in order to obtain product certification in emerging markets.
The demands from the regulator, he said, might include: "My country wants the materials to be retested because the tests you did were greater than three years old; we need the exact specifications of the materials in order for me to test them; you need to buy the equipment for us in order that we can test them; show us how to do these tests."
It can be a tougher process than that, too, Hossack said. The government lab may retest all the materials and devices, then report the products failed. "You will have to explain that they really didn't fail," and then—carefully—show why.