THOUGHTS

Debunking Three Common Myths About Medical Device Packaging

Apr 17, 2019

The lifecycle of launching a new medical device into the market includes a significant number of milestones that can either facilitate or hinder the launch date of the product. One of these milestones that has a critical impact on the time-to-market strategy is medical device packaging. Although it may seem that medical packaging is the last thing on the mind of manufacturers, this is not the case. Packaging is a highly crucial element of the final output of medical devices. This is largely because the packaging not only ensures that the device is protected from any external damage, but it also plays a vital role in upholding the quality standard of the product till the time they are put to use.

In this article, we put some common misconceptions about medical device packaging to rest and also explain the key best practices involved.

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Medical device packaging only needs to be tested once

If a particular medical device’s packaging pouch or box is already in use, there are chances that you tend to ignore testing this packaging again. Although it might be possible to leverage the previous testing results partly, it is important to re-perform these tests. This is because there is more to testing the packaging than merely testing whether the pouch seals meet a minimum peel strength requirement.  It is also vital to test the chances of the device puncturing the pouch or whether the package can damage the medical device. In addition, while undertaking transit testing, if your device is sterile, it must be proved that the packaging will maintain sterility for the shelf-life of the device.

Medical device packaging is easy

It is a common misconception that packaging is easy and does not require a lot of thought. But the truth is, if medical device companies wait till the end to decide on their strategy, chances are that their time-to-market is going to be delayed. Medical equipment manufacturers must understand that it is critical to keep the device functional, and packaging plays the most important role here. The first design drafted for the medical device packaging might not pass testing or may be cost-prohibitive. It may require several complex iterations.

Medical device packaging decisions can wait until the end

It is a common misconception that since the packaging is one of the last stages before launching the product, the decisions relating to packaging can wait till the end. However, as mentioned earlier, packaging decisions might not be as easy as you expect it to be. Pushing these decisions to the last minute could delay the product launch. Furthermore, for the US as well as the European market it is imperative for medical device packaging to adhere to ISO 11607-1 and ISO 11607-2 standards.

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Medical device packaging best practices

medical device packaging

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