Medical Manufacturing & Outsourcing - Version A. April 2021 - 12

3D Printing

Titanium's material
characteristics make it ideal
for many high-performance
medical applications that require
biocompatibility. (Credit: EOS)

Implications for
Industry

AM isn't a new process.
Industrial-grade 3D printers have
existed for decades, but only in the
last few years has the technology
advanced to a place where it can rival
traditional manufacturing processes
in terms of production quality and
value. These advancements have also
opened new possibilities for the medical
design industry. It is now possible to
combine multiple components into
one 3D-printed part, create stronger
elements that are lighter weight, and
even bring new ideas to life that were
previously too complex to manufacture
because of traditional manufacturing
limitations. The medical industry
has only just begun to scratch the
surface of what is possible with AM.
That could change in the not-too--
distant future, however. We may look
back in hindsight one day at the corona-
virus pandemic as a tipping point for
adopting and utilizing AM. The pandemic
has already exposed weaknesses in
supply chains that AM can help remedy
through localized manufacturing.
The scenario described earlier with
the creation of digital warehouses
is already gaining momentum as
a way of producing lower-volume
components or products on demand.
Organizations with AM capabilities
were also able to offset shortages
in vital PPE for frontline workers.
Longer term, the pandemic's
economic impact may pave the way for
a period of innovation and advancement
12 APRIL 2021

in medical design. While it may
sound counterintui-tive, there has
been a lot of consolidation across
the industry recently, with larger
organizations acquiring smaller or
mid-sized ones. This is coupled with
temporary industry slowdowns as
fewer people elect to get procedures,
and R&D personnel have more time
to think about future use-cases for 3D
printing. These factors will even lead to
increased innovation from companies
identifying new and exciting ways
to leverage the technology. And the
organizations that don't already have
an AM mindset in their operations will
find themselves playing catch up.

Are You AM Ready?

Successfully implementing
and using AM requires more than
plugging in a machine, downloading
some software, and hitting print.
Additive manufacturing necessitates
medical design professionals to think
differently - to think additively.
Although AM is an agile and adaptive
technology, it's important to remember
it isn't intended to replace conventional
processes. Instead, it is another tool
in your manufacturing toolbox. For
instance, take the custom orthoses
and prostheses industry. They help
provide better mobility and improve
recipients' livelihood, but every patient
has different needs and anatomies.
With traditional manufacturing
methods, like casting and molding,
producing custom prostheses and
orthoses requires a high level of human

involvement and is costly and timeconsuming - not to mention that
patients in rural areas may have to travel
long distances on multiple occasions to
get properly fitted or for adjustments.
For these applications, 3D printing
offers virtually limitless design
possibilities and superior customization
with quicker turnarounds. The result
is a device perfectly adjusted to a
patient's specific needs. There is less
waste generated for the manufacturer,
and in some cases, the devices are
ready to be fitted in as few as 10 days.
Having an end-to-end manufacturing
process with the flexibility to produce
in whatever method makes the most
sense for each product is incredibly
beneficial and strengthens your entire
value chain. Getting to this point,
though, where additive technology
is fully integrated, is quite difficult.
The process is more complicated
than most people realize, and many
organizations fail to go beyond the
pilot stage. On top of it, the medical
device industry has significant oversight
to deal with, making it even more
challenging to reach its full potential.
Emergency use authorizations have
been pivotal during the pandemic,
but these are exceptions. Under
normal circumstances, manufacturing
and design processes are all well
documented and understood,
ensuring that the manufacturer
is making the same safe and
effective device every time.
As manufacturers start to think about
a future beyond the pandemic, creating
a low-risk AM pipeline becomes more
about shifting the way you think and
identifying gaps in your operations that
the technology can solve. Here's where
a knowledgeable AM partner can teach
you what you need to know so you
can apply it to the next product in your
pipeline. They'll help assess your AM
readiness, minimize risks in investments,
and optimize competitive advantages.

Steps for Implementing 3D
Printing

As noted, bringing on industrial
3D printing is more than investing

MEDICAL MANUFACTURING AND OUTSOURCING SPECIAL REPORT
Medical Manufacturing & Outsourcing - Version A. April 2021

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