An interesting
Wall Street Journal blog post draws a connection to the
strenuous federal government's regulatory process and failure among
medical device companies. The article describes a report by the
Medical Device Venture Council. The 35 page document cites concrete
cases in which uncertainty in the government's system caused
medical device companies to collapse or endure needless holdups and
cost.
No company at NTEC, that I am aware of, recounts a
particularly unfair Food and Drug
Administration experience. However, the general sentiment of
uncertainty concerning the FDA among medical device entrepreneurs
is hard to ignore. The consensus seems to be the regulatory pathway
has become extremely cumbersome, especially when compared to the
European CE mark process. Several regulatory firms supporting the
CE mark process are recognizing this significant opportunity and
are prepared to leverage the inefficiencies in the U.S. to open the
European and other CE-mark regulated markets.
What this means for American entrepreneurialism in medical devices
is simple to deduce. The US market is no longer the obvious first
choice for startup medical device companies. Europe is emerging as
an affordable reasonable solution for medical device manufacturers
who balance risk and reward in an economy that has a grip on our
wallets.
The CE mark process is enticing because it is predictable - not
less stringent. No one at home or abroad wants to sell or promote
unsafe devices. What we strive for is a process that is
transparent, reasonable, affordable and safe for all. U.S.
entrepreneurs miss out on the largest single market in medical
devices when they take their innovations to other countries.
Additionally, Americans don't benefit from new innovations that
save lives and are cost efficient. The next threat is when
companies receive CE marks in Europe, the expectation is the
products will be manufactured there, too.
Let's remove the unreasonable regulatory risk. This does not mean
we should approve everything, but it does mean we have to
re-introduce a reasonable, predictable process. Ultimately, we have
to bear the costs for these uncertainties in the regulatory
pathway. Instilling confidence in entrepreneurs that they will be
treated fairly by the system will take concrete steps to ensure
credible change.
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