Med-tech now:
EVERY STEP OF the way the FDA
wanted more information, but would
never come to make a decision one
way or another. So the company tried
to comply, but it got to the point where
the FDA wouldn’t even let us get a
clinical study started after four years of
filing. It’s unbelievable, quite frankly.
–Dave Stassen, managing director of
venture capital firm Split Rock Partners (talking about a med-tech start-up
he had invested in)
I KNOW OF a company here in the
U.S. that has 8,000 patients in Europe
and can’t get FDA approval. It has
always been a question of risk balance.
The U.S. and Europe used to be fairly
aligned. And now they have become
quite divergent. –Mark McKoskey, life
sciences partner at professional search
firm VTL Search
WE HAVE DECIDED to follow
the FDA requirements because we’re
heading towards diagnostics with
our device, but we won’t need FDA
approval initially. We’re going through
the registration process but they’re not
sure how to categorize us at this stage.
Am I nervous about the changes at the
FDA? We should be, but we’re not. We
don’t fear a few hurdles. –Mat Johnson,
founder/CEO, of diagnostic translation
device company GeaCom, Inc
Med-tech in the future:
INVESTORS REACT NEGA-
TIVELY to uncertainty. With higher
levels of uncertainty come lower levels
of investment. If the climate gets too
uncertain in med-tech, the VCs and
the investment community will simply
move their money elsewhere.
–Dave Stassen
EVERY MED-TECH company
knows that their technology may not
pan out, but that’s not the case with
some local companies. They are in
peril right now even with proven
products and technology because they
can’t get FDA approval. It’s going to
cost companies, it’s going to cost jobs
and we’ll all be the worse for it.
–Mark McKoskey
I AM BULLISH on the fact that
everything we’re doing is game-chang-ing. It’s like what happened with the
Internet, or in other spaces. I believe
that the next five or 10 years can provide a huge gold mine for companies
that can come up with something that
is extremely contrary to the standard
med-tech model. –Ashish Gadnis,
founder and CEO of online medical
history tool Koozala
I DON’T THINK we could do what
we’re doing anywhere but the state of
Minnesota. I am just super-optimistic
about our business. We know there is a
need for our device, we are bullish on
the benefit of what we have, and that’s
what is propelling us forward.
–Mat Johnson
Investing in med-tech:
NOW THE FIRST thing I look at is
what the regulatory path on a product is because it’s a binary outcome.
Once you get approved, how are you
going to get an insurance company
or Medicare to pay for it? Then you
look at the clinical path and so forth
and how much you think it’s going
to cost. I look at those factors first
now because they have become the
biggest risk. –Dave Stassen
PEOPLE FORGET ABOUT all of
the infrastructure and related businesses that grew up around med-tech, and that make it possible for
so many device companies to thrive.
So it’s not just the device companies
themselves, but the thousands of jobs
that service the industry that are also
at stake. If we lose momentum, this
could have long-term consequences.
–Mark McKoskey
International Medica Foundation
January 2010 // Interviewed by Holly Dolezalek
Why Minnesota can be a med-tech giant: We’ve got great science, great companies, a skilled
workforce, and a huge number of lawyers and research houses and clinical study sites that have
sprung up around it. We also have strong funding mechanisms, such as venture capitalists, angel
funds, and people from the industry who are funding new companies. In the pharmaceutical and
biotech industries, we also have a strong workforce, but what’s lacking is enough private sector
companies and financing mechanisms. So the science being done here doesn’t get commercialized;
instead it leaves the state. –Dale Wahlstrom, CEO of BioBusiness Alliance of Minnesota
Martell Biosystems
September 2009 // Interviewed by Drew Wood
PHOTOS by MARSHALL FRAnkLIn LOng
ORASI MEDICAL
August 2009 // Interviewed by Drew Wood
Biotech in Rochester: Let me tell you why
Rochester. [They] agreed to participate in a
$100,000 no-interest loan, for five years. Then
there’s another fund there which is called a RAEDI
Fund (Rochester Area Economic Development
Inc.) and they have also committed to a sizeable
investment. So that’s attractive to us. The other
attraction is, quite honestly, that it’s right across
from Mayo. Once they start to see the success that
we have with this test, there’s no reason why they
wouldn’t go to us for those tests. –Phil Messina,
president and COO of Rochester-based early-stage
cancer diagnostics company Martell Biosystems, Inc.
Health care’s hidden cost: A lot of people see healthcare
costs going up and they see the costs of pharmaceuticals,
but what’s hidden in all that is that huge cost for creating
these drugs. It’s a lot of trial and error. The problem is the
tools—and we’ve heard this loud and clear—to be able to
track the disease and be able to measure the interaction
of the drug and the effect on the disease. And so we
believe this could have a huge impact on the cost of drug
development; more rapidly bringing drugs to market
and removing [unnecessary] ones.–Shawn Lyndon, co-founder and CEO of Edina-based neurological diagnostics
company Orasi Medical, INC.
