Innovation's about thinking outside of the box.
It's about expanding on what we can do to help people.
Innovation is meeting unmet clinical needs.
It changes the status quo.
It can be a big change, a small change,
a complex change...
Innovation is hard.
It's not easy.
You innovate, you fail, you iterate, you fail again,
you iterate, you succeed....
Innovation, for us at FDA,
is this exciting opportunity to take a step forward and
look at what we've been doing and rethink and
re-imagine how we could do it better....
I think, if the Innovation Pathway is successful,
the ultimate winner is the American public.
The most exciting aspect of it is that potentially
patients will get their devices faster than they're
currently getting them.
The quicker we get them to market,
the quicker patients can have access to them and we
boost the industry, too.
For me, the really exciting thing is changing the way we
do business...
I'm most excited about the new interaction between the
innovator and the FDA...
The Innovative Pathway has gotten us together.
We understand one another better and we're starting to
talk the same language.
It also represents a real innovation in how FDA does
business, an employment of lean start-up style
approach...rapid prototyping,
continuous learning, engagement with stakeholders
early and often, all happening at light-speed,
that helps FDA deliver better on its mission for
the American people.
The Innovation Pathway represents a new way of
doing business within the Center's existing regulatory
framework-one where FDA staff and innovators engage
much earlier and in more collaborative and creative
ways.
If you have the FDA and the innovator on the same side
of the table, looking at all that unknown out there that
stands between you and the innovation becoming a
reality, having the guidance and support and the open
communication with the FDA would be fantastic.
The Innovation Pathway offers new tools and methods
that will deepen and broaden the pre-submission phase of
device review.
By doing so, we think we can ultimately reduce time and
cost in getting safe and effective new technologies
to the patients who need them.
The whole effort of the Innovation Pathway
essentially should be directed to the patient.
We are here to benefit the patient.
Providing new technology should be done in a safe and
efficacious way.
When we introduced the Innovation Pathway in 2011,
we had one applicant, which allowed us to focus on the
structure and foundation of this program.
That experience shaped the second version-Innovation
Pathway 2.0-which is now welcoming a small,
new set of applications for products that address
end-stage renal disease.
As is the nature of device development,
the lessons we learn from this experience will lead to
improvements in future versions of the pathway.
The Innovation Pathway is a CDRH experiment in thinking
differently-sort of a living laboratory or incubator.
We will test new approaches to premarket review,
using the latest technology for more real-time
collaboration.
We've started off the Innovation Pathway 2.0 by
looking at very early-stage and innovative device
technology-stuff that's really in its infancy,
which is a perfect testing ground for pre-submission
collaboration.
I say "2.0" because the very nature of the Innovation
Pathway is to empower CDRH staff and stakeholders to
find creative solutions to the challenges that they
face, which means the Innovation Pathway is about
and allows for continuous improvement through ongoing
experimentation.
It involves everyone on the team clearly understanding
not only the risks, but equally importantly,
the benefits of the device from multiple perspectives.
I'm encouraged by the openness to evaluate new
methods and tools to advance the field of regulatory
science, to ensure that we are getting the right
products, safe products, and effective products to the
marketplace.
When we find an approach that works,
we will roll it into our existing processes for
breakthrough technologies as well as other devices where
it adds value.
When one approach doesn't work,
we throw it out and move on.
What the Innovation Pathway is not,
is a lowering of our standards.
The U.S.
Standards of reasonable assurance of safety and
effectiveness and of relying on valid scientific evidence
have served patients and industry well.
We should not change them.
Our focus-as always-is patients,
while our target is broader than pre-market review.
So, the success of the Innovation Pathway will be
based on stronger collaboration with industry,
health care practitioners and patients,
a reduction of time and cost from product development to
market, and a smarter review process.
So, how do we define success?
That U.S.
patients have access to high quality,
safe and effective devices of public health importance
first in the world.
That's not a lofty vision but an achievable goal if we
embrace, as the Innovation Pathway does,
the entrepreneurial spirit that has fueled America's
success.
U.S.
innovation has inspired the world-and we have been the
global leader in medical device technology.
The Innovation Pathway is a creative,
experimental approach to the smart development,
assessment and review of medical devices that can
help maintain our leadership role, which, ultimately,
is in the best interests of the health of patients and
consumers.