Originally Published MX May/June 2002
EDITOR'S PAGE
Going with the Flow
This
issue of MX celebrates the 28 winning products in the 2002
Medical Design Excellence Awards (MDEA) competition. The technological achievements
represented by these products are impressive, no doubt about it, but just as
important are the business achievements of the company leaders who managed to
see their products through to commercialization.
There's nothing automatic about recognizing a good product concept, recruiting
staff to conduct R&D, funding a company whose revenues are likely years
away, understanding intellectual-property and regulatory issues, or developing
a successful launch strategy. Yet many of the company leaders who brought about
this year's MDEA-winning products have accomplished all of this—and a whole
lot more.
Medtech companies that have successfully mastered these challenges rarely stop
with just one product. So company leaders also have to plan for their next product—a
topic considered in this issue's roundtable discussion, "Filling
the Product Pipeline". Although the roundtable participants acknowledge
that a weak economy can make it tough for small companies, they also suggest
that the overall health of the device industry's product pipeline is good.
One independent measure of the fecundity of industry's product pipeline is the
number of devices that FDA has cleared to market. In 2001, for instance, FDA
cleared 3500 510(k) products, an average of 292 devices per month. The agency
also approved 56 original PMAs, an average of just less than five products per
month. So far, 2002 has produced similarly healthy numbers. In the first quarter
of this year, the agency approved 1181 510(k) products and 9 PMAs.
It's too soon to tell what effects the weak economy, or its gradual recovery,
might have on product submissions in the latter half of this year. But with
the continued ingenuity of medtech executives, we expect that the field of entries
for the 2003 MDEA program will be as strong as ever. For information about next
year's competition, visit the MDEA Web site at http://www.mdeawards.com.
Copyright ©2002 MX
