medical devices are slow to change
from what has worked in the past.
A great example of this change is
the ever-growing importance of
EHRs. In the past it was enough to
get you new product on formulary
and sell your physician. That is
no longer the case. You now have
to make sure it is in the EHR and
can be easily accessed by your
physicians in their normal work
flows. Understanding this channel—its update schedule, ensuring
your product is in their favorites,
providing the appropriate educational support—is now critical to a
SHALINI SHARAD: It’s an era
of consumerization and a “more
aware patient” who seeks second
opinion from Dr. Google. Some of
the challenges in launching a product arise when a traditional sales
and marketing model is followed.
This model would focus on heavy
promotions into the doctor’s office
in order to achieve the launch year
win. Traditional customers are
targeted through front line field
reps without focus on the pyramid
of other stakeholders who influence perceptions of the product.
This model lacks information on
disease management that a patient
is seeking today and hence is not
successful beyond the launch year.
How is launching a product for a
smaller indication different from
launching one for a larger indica-
HARRIS KAPLAN: Smaller indications require a greater degree of
focus and execution as there’s little
room for error. However, beyond
that, there’s often greater opportunities to innovate in smaller indications than larger ones because
What are the major hurdles in
launching a product in your sec-
DAVID BAKER: What has
changed over time is that managed
care has increasingly more influence on the success of new product
launches. Several novel products
have been approved and launched
in the past several years and seen
their uptake stunted by poor formulary access and reimbursement.
Payers seem increasingly willing
to just say no and not reimburse
new products for six months or
more unless they see clear clinical
advantages or receive substantial
discounts that put the net price of
these new products in line with
the current standard of care treatments.
We are seeing early signs of value-based contracting with payers for
specialty products where the payer
gets money back for patients who
don’t respond well to the medication. However, it is still early days
for such agreements and it will
take some time to see how those
arrangements work for both the
pharma companies and the payers.
I also believe that the highly publicized pricing levels and increases
of a few outlier products, and
frankly, “bad apples,” has further
tarnished the pharma industry’s
reputation and put everyone on
watch regarding their pricing approach with their new product.
HARRIS KAPLAN: I agree with
David’s point. As someone who
has worked with a number of
clients on launches, I think the
major challenge faced by most
companies is achieving a desired
level of managed markets access to
enable prescribing. That problem
is exacerbated by the fact that over
half of physicians are now employees, which means they will follow
or adhere to protocols established
by a hospital or plan vs. being able
to decide freely what drug to use
to treat a particular patient.
PAUL MURASKO: I believe the
major challenge is the ever-chang-ing healthcare landscape. We cannot launch products the same way
we launched a product five or even
two years ago. I am sure that is not
news to anyone, however change is
tough and sometimes pharma and
Doing the research. Finding the funding.
Recruiting patients for the trials. Conducting the trials. Filing the applications. The
negotiation. The strategies. The competition. The hopes and dreams.
There is no more stressful—and potentially fulfilling— activity in our industry than launching a product. Here we speak to a panel of people who
have been intrinsic to numerous launches, from many angles. If you’re
involved somewhere in the process right now, maybe this wisdom can
help you sort out your own challenges.