Paul Orlando, Vice President of External Operations at Olympus, discusses the need for improved collaboration between medical device design and manufacturing. He states that while companies establish procedures for early design for manufacturability, successful execution is critical. There must be both procedural and cultural changes to foster true collaboration between design and manufacturing from the beginning of the development process. Without this, designs may be frozen prematurely or unable to meet cost targets. It is absolutely important for the two functions to work together early and at the right stages of the process.

1. Interview with: Paul Orlando, Vice
President, External Operations,
Olympus
“Medical device manufacturers may
put in procedures to design for
manufacturability early in the develop-
ment process, but the execution of that
is critical. There must be a cultural
solution to go along with it,” says Paul
Orlando, Vice President, External
Operations, Olympus. “It is absolutely
critical for design and manufacturing to
collaborate early and at the right time,
both procedurally and intuitively,” he
advises.
Orlando is a panelist at the marcus
evans Medical Device Manufacturing
Summit Spring 2017 and the Medical
Device R&D Summit Spring 2017,
taking place in Pasadena, California,
June 19-20.
Is there a collaboration gap
between design and manufacturing?
How can it be closed?
There is a collaboration gap, but the
solution is not easy to achieve as it
requires a cultural and procedural
approach. Companies may put in a
requirement to perform or ensure
design for manufacturability during
phase I or even earlier, but the
execution is critical. There must be a
culture of really believing in upfront
early design for manufacturing and
understanding it needs to come from
company experts and suppliers. It is
absolutely critical for design and
manufacturing to collaborate early and
at the right time, both procedurally and
intuitively.
Without this collaboration, designs may
be frozen or they might not be able to
meet target pricing. It is difficult to
make improvements after a design has
been frozen or after the product has
been launched.
Who can best lead this mindset
shift?
In my experience, a robust program
management office, a strong program
and managers to drive adherence to
procedures and the culture lead to
success. It should be common practice
to ask questions and have indicators in
place during project approval and
reviews.
If you have that knowledge with the
people approving or running projects, it
automatically takes place. We imple-
ment what we call “Stage zero” in our
new product development process,
which forces cross-functional collabora-
tion earlier in the process.
What obstacles are common when
setting up such a culture?
Unless you have credible people to start
that culture shift, it is impossible to
drive any change. There must be an
understanding of that need at a high
level. Then you must start with some
pockets of experts who can demonstrate
the success of the proper level of
collaboration between manufacturing
and R&D.
What trends should manufacturers
prepare for?
In the past, it has been difficult for
suppliers to provide design for
manufacturing input because of
resource constraints. Some suppliers
actually charge a fee. Moving forward,
having the resources available to
provide that input without a guaranteed
return will probably become the norm.
What is absolutely key for success?
It is the combination of procedures that
formalize the requirement for collabora-
tion, a strong program management
office and process, a culture that
believes in the criticality of design for
manufacturing very early in the process,
and the right subject matter experts.
Not every project or product is the
same, so there must be some flexibility
in what resources should be deployed
and how, which would come from
having the right culture.
It is difficult
to make
improvements
after a design
has been
frozen or after
the product
has been
launched
The Culture Shift that Designing
for Manufacturability Requires

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