emdt.co.uk
European Medical Device Technology Spring 2015 | 23
Process Control and Product
Release
Process validation is a tool used within
the medical device industry when it is
not easy to fully verify through inspec-
tion that product characteristics have
been achieved.
A medical device product specification
includes process limits and controls that,
when validated, mean that features such
as mechanical integrity, fatigue, chemical
degradation and sterility can be esti-
mated with a high level of confidence.
The single, custom-made nature of
AM products—including subsequent
cleaning, packaging and sterilisation
process parameters—are such that it may
be difficult to demonstrate that chang-
ing the size and shape of an implant,
for instance, will not drastically affect
the degradation of the implant through
fatigue or other means.
Establishing standard methods of
inspection and test systems, includ-
ing the development of nondestructive
technologies for AM products, should
be considered. These methods will need
to be internationally accepted within the
global medtech industry.
Summary
Additive manufacturing and 3-D print-
ing are generating a great deal of excite-
ment in the medtech community for their
potential to improve patient outcomes.
However, it is imperative that these inno-
vations are firmly supported by scientific
knowledge and safety considerations.
Consider the recommendations and
discussion points presented in this article
when commercialising your AM solution
to ensure that you have the necessary sci-
ence to corroborate your art.
James Pink is the medical devices, vice president at
NSF Health Sciences.
New applications for additive manufactuiring in
medical technology are developed at a breakneck
speed. The concern is, however, that as we expand
into the medical technology arena, we do so with
more "risky" applications at a pace at which the
science
may not corroborate the art.
