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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 submission issues.

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 microbial barrier.

There are multiple tests used to evaluate a pass or fail for the packaging.

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 development

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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