US audience that everything
possible is being done to provide
access to the device in a reasonable
timeframe (and sometimes
maintaining momentum for a
past generation device in the US,
while US physicians enviously
watch their European counterparts
utilize the latest device or software
for their patients).
If you find yourself planning a
launch of a new medical product
in Europe while your US approval
is still years away, here are some
thoughts to consider:
Let’s start with stating the
obvious: in your global marketing
messages, no false claims, period.
They are illegal and unethical
everywhere. Always have the
data to support your marketing
messages, not matter where you
Start working with the FDA
early – way before you think you
• While this won’t be your
direct role, encourage your
counterparts in regulatory to
act quickly on the data coming
out of Europe, and begin
conversations with the FDA.
• Determine what part of which
action is happening in Europe
that can be used to support your
ongoing data needs in the US.
Work closely with your
regulatory team – probably more
closely than you think you need to
• The regulatory submission
process is extremely strategic and
thus strategic global marketing
needs to be involved from the
very beginning . What claims
do you need to make to sell the
product? What data do you need
to make these claims? How do
they differ between geographies?
How will naming regulations
change between geographies?
• Often, Regulatory is worried
that marketing is going to “go
rogue.” Working closely with
them will also establish mutual
trust and make the internal
process work faster.
Manage global messaging.
Mention regulatory approvals
and situations in all global
• It’s ok to do a world-wide press
release, if it clearly states the
product is not available for sale
in the US.
• It’s typically wise to have
separate websites for US
and OUS audiences, or (at a
minimum) to force a user to
acknowledge they are aware
that some products may not be
available in the US.
Use your clinical team to
communicate with the US
• It’s a gray area, but in general
you should not be talking to a
US physician about a product
not approved for use in the
US outside of certain specific
environments (specific requests
for product feedback, medical
advisory board situations, etc).
And your US sales team should
not be talking about it at all.
Example 1, 2, and 3 are three randomly selected
start-up company products that depict a
typical gap in approval based on geography