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physicians put out a lot of information "for free."  In

fact, medical practice is steered by distribution of infor-

mation, whether word-of-mouth presentations at conferences

or technical journal articles, and it often results in "off-

label" uses of drugs and devices.  A free market for infor-

mation about devices will spur these activities.  Doctors

could build their careers independently from the device

manufacturers when they submit their clinical results to

peer-reviewed journals and professional meetings.  A physi-

cian's career, academic standing, and fortune can be built

on documenting a new use for a device or on replicating

successful trials or on debunking effectiveness claims.

Consumers may never read the New England Journal of Medi-

cine, but their physicians do.

No "Race to the Bottom"

Competition in the private market creates powerful

incentives to reduce costs.  One way to reduce costs is to

produce goods or services of a lower quality.  Called "race

to the bottom" in other situations, this is often cited as a

reason for public rather than private provision of goods and

services.  Would private competition in the market for

device certification produce a "race to the bottom"?

The executive officers of certification organizations

are keenly aware of the fact that competing to lower the

certification hurdles is destructive.  If the standards are

too lax, the third-party listing becomes meaningless to

consumers, and therefore meaningless to manufacturers, who

would have no incentive to buy the certifier's services.

There will be no change in the incentives that standards-

writing companies face if they are allowed to certify medi-

cal devices.

Just as the market produces low-quality goods, it also

produces high-quality goods, and consumers' desires dictate

which products remain on the market.  The market for stan-

dards and certification is no different.  The market will

generate a range of appropriate standards, each providing

the consumer a specific amount and type of information.

Consumers will demand at least some high-quality standards

and some labs to perform high-quality testing.  Furthermore,

the individual consumer need not know what the different

marks certify.  The consumer's doctor will know because he

has much more incentive to know.

The empirical experience of the last century has borne

out these observations.  As competing organizations have