Board’s Back Page
Another MDT Editorial Advisory Board Member offers his insights on three
questions regarding the industry.
especially in areas of unmet need, because someday, a family member or even ourselves may be
in need of such devices.
Q: What significant factors are influencing
the development of medical devices?
Drues: Let me turn this question around by asking, ‘What factors are holding us back?’ Regrettably, there are many. Engineers think if they build
a better mousetrap, people will buy and use it.
But in medical technology, it is not nearly so
simple. While engineering and clinical challenges
are important, regulatory and reimbursement
can sometimes be even more significant.
When it comes to revolutionary development,
there are few incentives. In fact, we have created
disincentives for manufactures to take this
approach. Consider the regulatory path. Given
a choice, a company would prefer to develop a
510k device as opposed to a PMA. So in essence,
we have created incentives for companies to
bring to market products we already have, while
we have created disincentives for companies to
do anything really new, let alone revolutionary.
On the reimbursement side, we have similar
challenges (e.g., fitting a “new” device into an existing reimbursement category vs. creating a new one.
More and more, I am having to redesign my regulatory strategy to fit my reimbursement strategy.
Q: Where is the medical device industry
Drues: In a word – convergence! The idea of
having separate medical device, drug, and biotech companies is rapidly becoming an antiquated concept. In the future, we will simply have
what I call medical technology companies that
have elements of all three. And that “future” has
really already begun.
One of several companies I’ve helped start
was founded by three people: a mechanical
engineer, a pharmacologist, and a molecular biologist. So what kind of company is this: device,
drug, or biotech? All of the above? None of the
above? I have no idea. But that is the future!
Michelangelo said the greatest danger for
most of us is not that our aim is too high and we
miss it…rather that it is too low and we reach
it. Call me naive but I agree with Randy Pausch
who said, “Better to fail spectacularly than do
Founder & President,
MD&M East, Booth 1864
Q: In the medical device industry, where are
you seeing the most exciting innovations?
Drues: Most device development is evolutionary
(i.e., come out with one device, tweak it a bit to
make a new device, etc.) I understand the advan-
tages of evolutionary device development, but
here’s the problem – the light-bulb did not evolve
from the candle. This is what Harvard Business
School professor Clayton Christensen calls a
disruptive technology – a new technology that
“unexpectedly” displaces an established technology.
For example, coronary stents are useful devices,
but when we can grow a new artery in a patient
(called angiogenesis), how many stents will we
need? This may sound like “Star Trek,” but it’s not
nearly as far off as many think.
What excites me the most is helping to bring
devices to market that are truly new and novel,