(FDM), Laser Sintering (LS) and Direct
Metal Laser Sintering (DMLS). FDM
and LS use production-grade thermoplastics while DMLS offers a variety of
metal and alloy materials for complex
and durable parts. All three processes
have materials that are biocompatible
and can withstand repeated exposure
to high-heat sterilization methods like
Validate a design
Given the medical industry’s strict
safety standards, an important com-
ponent of the product development
process is testing prototypes to validate
designs. As medical professionals know,
before a product is approved for use,
it must undergo clinical trials that
can reveal whether design updates or
material changes are needed. While
these changes can lead to pricey tooling
modifications and production delays,
3D printing doesn’t require any tooling.
Altering a design is as simple as updating a 3D CAD file.
Building for function enables
Due to manufacturing constraints and
limitations, engineers must sometimes
compromise on design and functionality while building medical devices via
traditional manufacturing. For instance,
intricate features like holes and undercuts can be difficult, if not impossible
to include. These design restrictions
limit the parts’ ability to do the best at
performing their intended function.
But with 3D printing, design constraints are not an issue. They can help
lead to breakthroughs.
Exhibit A: DanaMed chose DMLS
to 3D print a surgical device to
transform ACL reconstruction. The
device, specifically shaped to match
the anatomy of a knee, enables sur-
geons to perform a surgical technique
that better reconstructs partially or
fully torn ACLs and reduces the risk
of re-tearing through improved graft
That’s just a taste of what 3D
printing can do. With the ability to
build complex parts layer-by-layer and
consolidate assemblies into one part,
medical manufacturing professionals
have nearly boundless opportunities to
create parts that are unique, specialized
and built for the task at hand.
Quantity: What’s your number?
3D printing has production flexibility
that other technologies do not. Particularly popular in medical technologies
are low volume runs for everything
from surgical tools to clinical trial
prototypes. Whereas it’s difficult to
amortize tooling’s costs for these
runs, companies like EMD Millipore
Corporation have realized 3D printing
can quickly and economically produce
parts on demand. The life science and
technology company developed the
Millipore Muse Cell Analyzer and built
prototypes using SL technology before
finishing, painting and assembling them
to mimic injection molded parts.
The ability to create customized
parts on a budget makes 3D printing valuable to the medical startups
that have a new device idea but lack
the finances necessary for full-scale
production via tooling. Users can use
3D printing to build functional parts
without accruing costs, then verify
final designs, raise capital and even sell
products before ramping up production.
3D printing presents many advantages to medical device manufacturers. However, it’s
important for them to understand the technology holistically before making leaps.
DanaMed’s Pathfinder improves ACL
reconstruction success rates.
The Millipore Muse Cell Analyzer is built
with SL technology and assesses cell
health parameters and immune status in a
matter of minutes.