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.
A device maker's people must gain the trust of the regulator in an emerging country, he said.
"The countries I'm talking about, it's all about relationships. In the U.S. it's 80 percent science, 20 percent relationships. In (the emerging markets) it's pretty well opposite of that."
Hossack said it's not that regulators don't know what they are doing.
In the developed world, there are giant regulatory agencies that review all products and mark them as safe for their citizens.
"But in a smaller country, they don't have that," he said. "They still have to figure out how to review those products and make them safe for their citizens. Do they trust the company, and do they trust the (firm's) regulatory person sitting across the table from them?"
Today about 80 nations don't regulate medical devices, and about 80 do. Hossack said historically all countries start as being unregulated, then go through a couple of phases.
The unregulated nations generally approve a product for their market if it is manufactured by a company residing in a country that is regulated, he said. Essentially, if it is good enough to pass muster in the U.S., it is good enough for them.
When a nation's regulatory enforcement begins to mature, that's when a company faces new challenges. This is the time when the emerging nation's regulators are in a learning curve, and where "the crazy questions come from," the executive said.
In the next stage of the maturation process of regulatory approval, the government agency wants full scientific review.
"If you look at countries like China, Brazil, India and South Korea, years ago when they had questions that weren't logical, you could sit down with them and say, "Hey, let me explain this to you, give you a pathway.' But they aren't listening anymore."
These nations all have their own regulatory foibles, and a company that wants to go to market in that region has to deal with the situation.
In China, for example, medical device approval is an 18- to 24-month process, Hossack said. All devices are tested in one of two labs in the country, and a company can't even submit its product to China's Food and Drug Administration until the tests are complete.
He recalls one situation where his company had a good relationship with the testing labs, and everything went through smoothly until virtually final approval—when a regulator ruled "that's not the right test." It caused a two-year delay in getting into the market.
In China, too, anytime a material—whether it's a blood-contact or non-blood-contact material—is changed, the device is considered a new product, and it has to enter that long approval process. Hossack said companies change non-blood-contact materials pretty regularly in a product's life cycle, and to comply with this rule is impossible.
"When you tell them it's impossible, they say they understand that," he said.
Hossack said it's not that he's a bad regulator. "He's stuck with a bad regulation—they have to work with what they have."
The result? Hossack guessed device manufacturers report about 10 percent of such material changes, because "you can't go to market otherwise."
China also varies from other nations in that a medical device can't be manufactured before the certification date, Hossack said. That means there's nothing in the pipeline when the device is approved, which can be a very costly delay in a highly competitive field.
India and Brazil have started down the path toward self-review of medical devices, and with that comes more challenges to overcome during this stage of their regulatory development. Eventually countries do become easier to work in, though. He said Japan is the model.
"Ten years ago, Japan was a black hole. Everyone was having problems getting their products approved," he said. Today, Japan's regulators are as logical as the U.S. FDA—if you carefully follow all the instructions.
"Approval time takes from eight to 24 months—eight if you do as you are told, 24 if you don't."
Why jump through all the hoops to get your medical device in an emerging market? Hossack said it's a simple dollars and cents equation.
The U.S. medical device market isn't growing more than 1- to 2-percent over inflation, and Europe is worse.
Hossack said that in the highly competitive, global market, U.S. medical device manufacturers have to get in on the 20 percent growth rate found in emerging markets.
"Some of our device life cycles are very short," he said. "You won't find many regulatory device people working on a product that will be ready five years from now. You'll find a lot of them are working on a product today that will be approved and sold this year."
It's a level of urgency that means appeasing regulators is critical, he said.