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If you asked people what comes to mind when you say designing a medical device, you’re likely going to have responses related to design controls or the device itself.  

What you’re not likely to hear is packaging or labeling (you can read our post on 3 common misconceptions about medical device labeling here).  

It seems that one of the last things on your mind when designing a medical device is how you’re going to package it.  

More often than not, it’s because people underestimate what it takes to design and test the packaging.  

Here are 3 common misconceptions about medical device packaging. 

1. Packaging Only Needs To Be Tested Once

If you’re using an existing pouch or box for your new medical device, you might think that you don’t have to test your packaging again.  

While you might be able to leverage some of the previous testing, you’re going to have to re-perform some of the tests.  

You might be thinking, “but the pouch or box didn’t change, why do I need to retest it?”

Testing medical device packaging is more than just testing that the pouch seals meet a minimum peel strength requirement.  

You also need to test that the device isn’t going to get damaged in the pouch and that the pouch isn’t going to get punctured by the device.  

While you will likely be able to reuse the burst, bubble, and peel testing, transit testing (more often than not) needs to be performed again with the new device.  

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In addition to going through transit testing, if your device is sterile, you need to prove that the device packaging will maintain sterility for the shelf-life of the device.

2. Packaging Is Easy

A lot of people think that medical device packaging is easy and not something that requires a lot of thought.  

The hard truth is that if you wait until the end to start thinking about packaging, your project is likely going to be delayed.  

It is critical for keeping your device sterile and functional. Packaging is more than just determining the dimensions of a cardboard box or pouch.  

That means your packaging might include a tray or a mounting card (die-cut insert card) to help keep your device secured in a safe position during transit.  

Designing that tray or card is much more complex than determining overall dimensions and may take several iterations. That’s why it’s important not to wait until the very end to begin thinking about packaging.  

Your first design might not pass testing or may be cost-prohibitive. As soon as the overall device shape and size is designed, you should begin working on packaging.

3. Packaging Can Be Figured Out At the End

It can be tempting to wait until the end to begin designing your packaging.  

Especially if you think it’s going to be easy.  

The problem is, you need to have your packaging on hand when you go to begin design verification and validation testing.

If you wait too long to design packaging, it might delay your product launch.  

Thought you just had to test your medical device and not the packaging? Think again.

Whether your device is being sold in the US or Europe, ISO 11607-1 and ISO 11607-2 are the go-to standard for packaging terminally sterilized medical devices.   

ISO 11607-1 (Requirements for materials, sterile barrier systems and packaging systems) focuses on 3 main areas of test:  

  • Packaging System Performance Testing

  • Stability Testing

  • Packing System Integrity Testing

While these can be done concurrently to save time, the stability testing (shelf life study) does take significant amount of time.

ISO 11607-2 (Validation requirements for forming, sealing and assembly processes) is quick to mention that the packaging processes need to be validated.  

Performing an IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) on the packaging processes is not quick.

Even if you can leverage existing testing for the IQ, you might not be able to for the OQ and PQ. Unfortunately, performing OQ and PQ testing is not quick.

The good news is that forewarned is forearmed.

Clearing Up the 3 Misconceptions

Now that we’ve cleared up three common misconceptions about medical device packaging: packaging only needs to be tested once, packaging is easy, and packaging can be figured out at the end, you’re one step closer to getting your medical device to market with fewer hassles and delays.  

Next time you start thinking about designing and developing a medical device, one of the first things that will come to mind is the packaging.


Medical Device Design Controls

Written by Jesseca Lyonsjesseca-lyons.png

Jesseca Lyons is a Customer Success Expert at greenlight.guru and a Mechanical Engineer by trade who loves working with cross functional teams, including both engineering and non-engineering disciplines. She’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. She believes the best part of being an engineer and working at greenlight.guru is that she can use her skills to help customers and make a positive impact in their livesClick here to get our actionable medical device content delivered right to your inbox 1x per week.


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