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The med-tech industry is watching closely as the Obama administration revamps the Food and Drug Administration (FDA), the federal agency that reviews medical devices for safety and effectiveness.

President Obama's choice to head the agency, Dr. Margaret Hamburg, a former New York City health commissioner, caused a stir when she said the agency's device unit is "clearly troubled." Of particular interest is the agency's 510k procedure -- a fast-track approval process for certain devices -- which is now under review by the prestigious Institute of Medicine -- a cause for some uneasiness in Minnesota, home to some 200 medical technology firms, including Medtronic Inc., the world's largest.

The Star Tribune asked Mark DuVal, a Minneapolis attorney and FDA expert, to discuss an agency in transition.

How does the 510k process work?

You have to establish substantial equivalence to a device that's already on the market. So FDA accepts that the safety and effectiveness for this type of technology has been proven. That doesn't mean you don't have to do testing. You still do, including animal tests and [laboratory] testing, sometimes human clinical trials. Increasingly, there's not much of a gap between 510k and pre-market approval [for more complicated devices]. It's starting to thwart innovation.

How so?

It's so expensive to develop a new device. I've heard some of the most experienced, successful medical device venture capitalists in the country say if the 510k program is [scrapped], medical device innovation will be destroyed because venture funds [to fund young companies developing new technology] will dry up.

What do people think about the appointment of Dr. Hamburg?

Everybody is kind of wondering why she was chosen. Nobody completely understood her qualifications for heading up FDA.

What will happen?

FDA is getting a lot more risk-averse. It's going to require a lot more clinical data [before devices are approved]. It's going to be a lot more expensive and take longer for products to come to the marketplace.

How much does it cost to commercialize a new product through the more stringent pre-market approval process?

Between $100 [million] to $300 million, but I've seen 510k products getting into the $100 million range. In this economic climate, where venture capital is not exactly free-flowing, it's totally disastrous for small companies. The device under review had better treat a big market, and be a blockbuster, to make it worthwhile.

Really, how many blockbuster products are left to be developed?

Not that many. It's a very mature industry. Product improvements are more incremental these days.

Shouldn't the FDA make extra sure that devices are safe before they're used on people?

Any product that comes to the market comes with risks. Nothing is totally safe. The benefits must outweigh the risks. The way FDA deals with risk is labeling [on the product], which provides some precautions on how to use it.

What about recent device recalls?

Most recalls that occur are almost always [pre-market approval products]. Even when a recall occurs, it's usually a minor thing that isn't jeopardizing human health in a major way.

Why do you think 510k is "under siege"?

It's been building in the last couple of years. Now they're trying to find a solution to something that's not a problem.

You think the 510k process works well?

It works very well. It's flexible enough for FDA to ask [companies] for more information if they have questions, and believe me, they do.

Is Minnesota's dominance in the medical device industry threatened?

If the 510k program is significantly altered, it will drive away venture capital and destroy the robust medical device industry in the United States. In Minnesota, we'd be hurt big time.

Janet Moore • 612-673-7752