3 Common Misconceptions About
Medical Device Packaging
Here are three common misconceptions
about medical device packaging.
Misconception #1: Medical device packaging is
one-size-fits-all Every medical device is unique, both in terms of
design and indications for use. Manufacturers will need to
consider the design and functionality of the device. By
considering important device attributes like Sterilization
methods, intended use, end-users, transportation and storage
conditions, self life etc, manufacturers can avoid issues like
failed packaging tests, product launch delays, and regulatory
Misconception #2: Medical device packaging only needs to be
tested and validated once.
For new devices, there are three primary categories of package
validation testing: Integrity, or the characteristics preventing
the growth of microorganisms; Strength, or the strength/force
needed to open the packaging; and Microbial Barrier, or
confirmation that the chosen, porous materials provide an adequate
There are multiple tests used to evaluate a pass or fail for the
Itís important to note that any changes made to existing products
require revalidation and additional testing. These changes could
be major, such as the intended use or an all-new design; they
could also be internal directive shifts, like environmental
sustainability initiatives. In fact, even a slight change in raw
materials for previously-validated packaging materials could
result in further revalidation for years.
Misconception #3: Packaging can happen after design and
When design of packaging for medical devices is left to the final
hour, often to save time and money can increase the risk of
noncompliance. Instead, during
this process different sterile barrier systems can be evaluated
and manufacturing methods evaluated to best meet needs and
characteristics of a particular device.
For long-lasting success, manufacturers need to thoroughly define
the requirements of the unique deviceís packaging system much
earlier in the product development process. Prequalification will
only save money, time, and labor in a variety of ways.
Medical device packaging may be the last thing on an engineerís
mind, but thinking ahead and connecting the dots will only help in
a deviceís progress as it moves downstream.
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