Medical Manufacturing and Outsourcing Special Report - November 2021 - 10

rms Company has recently established a material
testing lab capable of conducting all the standard
tests necessary to certify their AM products.
The lab also conducts several specialized tests
as required by customer-specific specifications.
(Credit: Cretex Medical)
The Path to Standardization
for AM Medical Products
I
t has been nearly 20 years since
the first medical devices created
via additive manufacturing (AM)
have been implanted. In that time,
designing and creating prototypes for
novel AM medical devices and implants
has become rather straightforward.
The real challenge in medical additive
manufacturing remains the process
control and validation requirements
that must be met to gain the necessary
clearance from the U.S. Food and
Drug Administration (FDA). All
medical devices must have design
and process validations and a quality
control strategy. They also must be
produced in a facility with a quality
management system (QMS) that meets
the FDA's stringent requirements for
good manufacturing processes (ISO
13485). However, as there are still too
few industry-wide standards for AM
products, each product typically has a
unique set of specifications and process
validations. The real challenge in additive
manufacturing, then, is not designing
and creating prototypes, but designing
the process validations and test
methods necessary for each product.
10 NOVEMBER 2021
Before Additive Manufacturing
Before additive manufacturing
became a viable method for
manufacturing medical devices,
manufacturers utilized longestablished
specifications for
medical device materials and
associated test methods necessary
to control the production of medical
devices and surgical implants.
Most of these specifications were
created for devices manufactured
via traditional methods such as
machining. ASTM has a committee
(ASTM F4) dedicated to developing
and promoting these standards
for medical and surgical materials
and devices. Over the years, the
FDA has also established guidance
documents for process validations
and considerations for special
processes, an example being their
guidance on the testing needs for
titanium coatings on medical devices.
Unlike additive manufacturing,
conventional manufacturing has
well-established industry-wide
standardized processes that have
existed for decades in some cases.
Early Days of Additive
Manufacturing
In the early 2000s, when additive
manufacturing was in its phase of
early adoption, there were no standard
practices, test methods, validation
strategies, or even general guidance
for metal additive manufacturing for
medical devices and surgical implants.
When possible, AM engineers utilized
legacy standards and specifications
previously established for conventional
machining. However, as the
manufacturing methods and materials
for these processes are entirely different,
the specifications for traditional
manufacturing did not lend themselves
well to additive manufacturing. This
forced device manufacturers and
engineers to develop their own set of
product-specific specifications and
standards for AM parts to supplement
the legacy standards. Items included
in these product-specific specifications
included redefining the meaning of
a material lot, rewording necessary
microstructural requirements, and
specifying location and orientation of
quality control coupons for each project.
MEDICAL MANUFACTURING AND OUTSOURCING SPECIAL REPORT
Medical Manufacturing and Outsourcing Special Report - November 2021

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