2006: Sign of Upheaval or Anomaly?
We would bet that most device companies
had a pretty good year in 2006. Financial markets were
strong and demand for medical technology was high. But
that might not be apparent from reading the mainstream
media, which had a field day with several stories that
cast the device industry in an unfavorable light.
In the February issue of MD&DI,
shed our own light on some of these stories
and discern whether they are anomalies or harbingers
of disturbing trends.
The industry's top-selling product, drug-eluting stents, saw sales fall. Some studies questioned whether they are too much of a risk for giving patients blood clots. A special meeting of FDA's Circulatory System Devices Panel on drug-eluting-stent safety garnered banner headlines. The agency determined that they are safe and effective if used as approved, but 60% of the time they are not used as approved. So while some of the alarm was not warranted, enough concerns were raised to make some doctors and patients leery of the products.
Another top-selling product, implantable
cardioverter-defibrillators, continued to attract media
attention over malfunctions. The devices prompted
intense debate over how FDA should handle recalls of implants.
FDA may change its definition of recall as a result.
These developments created headaches for Boston Scientific, a player in both technologies thanks to its acquisition of Guidant, and Johnson & Johnson, which decided to shell out for Conor Medsystems in hope of landing a superior next-generation stent technology.
Government fared no better in the
public eye. FDA Commissioner Lester Crawford resigned
under a cloud, undone by failing to sell off stock in
FDA-regulated companies. CMS Administrator Mark McClellan
took off in mid-reform effort, enticed by the private
sector. Critics of silicone breast implants howled over
FDA's decision to allow them back on the market. And
key members of Congress continued to berate FDA for
inadequate postmarket surveillance. The latter prompted
CDRH to come up with a plan to overhaul how it handles
postmarket information. Expect much more stringent reporting
requirements in the future.
Some of these developments will help fundamentally change the relationship between FDA and industry. Others are more significant as a way to sell papers. But none should be ignored.
Movers and Shakers of 2006
MD&DI examines the
events and people that influenced the state of the industry
in 2006 and provides perspective on the future of medical
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Laser-made identifiers on devices help to track products and protect them from counterfeiting.
Medical Device Design: Learning from the Consumer Industry
Device makers can use design ideas from the consumer industry and still meet regulatory standards.
Freedom of Information Act Requests: A Primer
Device makers should know how to get meaningful data from Freedom of Information Act requests.
FDA Rewards Many Figures in Utah Medical Case
Although the agency lost the case against Utah Medical, it has awarded bonuses to many employees who were involved. What message is FDA sending?
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