The FDA Isn’t Blocking Medical Breakthroughs — Our Outdated Innovation Model Is – MedCity News

For
years,
I’ve
watched
promising
medical
technologies
languish
in
labs,
never
reaching
the
patients
who
desperately
need
them.
The
culprit?
Not
overzealous
regulators,
but
our
antiquated
approach
to
innovation.
It’s
time
we
stop
pointing
fingers
at
the
FDA
and
take
a
hard
look
in
the
mirror.

The
truth
is,
the
FDA
isn’t
the
enemy
of
medical
innovation
–
it’s
a
crucial
partner.
But
to
unlock
its
full
potential
as
an
ally,
we
need
to
radically
rethink
how
we
develop
medical
devices.
The
current
model
of
siloed,
proprietary
development
is
failing
us.
It’s
slow,
expensive,
and
often
results
in
technologies
that
never
see
the
light
of
day.

What
if,
instead,
we
embraced
an
open-source
approach
to
medical
device
innovation?

Instead
of
each
company
developing
devices
in
isolation,
what
if
we
create
open,
modular
platforms
that
thousands
can
build
upon?
Safety
data
could
be
shared
across
applications,
dramatically
reducing
the
time
and
cost
for
regulatory
approvals.
Manufacturing
could
leverage
existing
consumer
electronics
supply
chains,
slashing
production
costs.

This
isn’t
circumventing
FDA
requirements
–
it’s
giving
them
more
data
to
work
with.
By
enabling
thousands
of
parallel
innovations
and
trials,
we
could
generate
orders
of
magnitude
more
data
than
the
traditional
model.
This
wealth
of
information
would
allow
regulators
to
make
faster,
more
informed
decisions.

The
FDA
has
shown
openness
to
new
approaches,
from
breakthrough
device
designation
to
real-world
evidence
programs.
What’s
needed
now
is
for
us,
the
innovators,
to
step
up
with
new
models
that
work
within
the
regulatory
framework
to
accelerate
development.

An
open-source
approach
could
compress
device
development
timelines
from
13
years
to
3
and
costs
from
$650
million
to
$10
million.
More
importantly,
it
could
finally
bring
frontier
medical
technology
to
the
billions
who
currently
lack
access.

But
to
make
this
vision
a
reality,
we
need
to
overcome
our
resistance
to
change.
We
need
to
let
go
of
the
notion
that
keeping
our
innovations
under
lock
and
key
is
the
only
way
to
protect
their
value.
In
the
open-source
world,
value
isn’t
created
by
hoarding
information,
but
by
building
upon
shared
knowledge
to
create
something
truly
life-changing.

This
shift
won’t
be
easy.
It
requires
a
fundamental
change
in
how
we
think
about
intellectual
property,
competition,
and
collaboration.
But
the
potential
rewards
are
immense.
By
pooling
our
resources
and
expertise,
we
could
address
the
most
challenging
medical
problems
of
our
time
with
unprecedented
speed
and
efficiency.

The
challenges
in
our
healthcare
system
are
complex,
with
no
easy
solutions.
But
by
reimagining
how
we
develop
and
approve
medical
devices,
we
have
an
opportunity
to
dramatically
accelerate
innovation.
It’s
time
to
move
past
finger-pointing
and
embrace
a
collaborative
model
that
works
for
innovators,
regulators,
and
patients
alike.

The
technology
to
save
millions
of
lives
exists
today.
It’s
trapped
not
by
overzealous
regulators,
but
by
our
own
outdated
mindsets
and
business
models.
Let’s
break
down
these
self-imposed
barriers
and
usher
in
a
new
era
of
medical
innovation.

The
FDA
is
waiting
for
us
to
step
up.
I’m
ready
to
tear
down
the
walls
I’ve
built
around
my
work.
Are
you?

Photo:
Peshkova,
Getty
Images

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