Successfully designing, implementing, and validating effective packaging that protects medical devices and maintains sterility when needed is a complex challenge. Many organizations don’t realize just how many considerations are involved and what it takes to develop the right package and prove it meets all requirements. Until an organization has gone through the process, it can be all too easy to overlook key best practices and follow the right timeline. These missteps can lead to cutting corners or costly delays, which almost always haunt manufacturers as they work through the testing and regulatory requirements to successfully bring a medical device to market.

After working with countless organizations from startups to OEMs to successfully navigate the medical package testing and validation process, Life Science Outsourcing’s team of experts recognize the medical device packaging issues that can delay and derail products on the path to market. Here’s a closer look at four pitfalls to avoid.

1. The packaging is too large

One of the most common packaging missteps is designing a package that is too large. Excessive space inside packaging gives products space to move around, which creates the potential for damage to the packaging and the sterile barrier. It also creates the risk of damage to the product itself. For medical device trays, one of the best ways to ensure the proper size and limit movement is to include elements such as ridges and holders that help keep device components in place. Often, this means designing a tray specifically for that device or similar devices.

2. The packaging creates potential compound folds

Too often, organizations fail to consider how individual products will be packaged together for shipment. Size is again a consideration. When a medical device pouch is too large and placed in a carton, the excess material can crinkle, fold, and become quite sharp – kind of like a paper airplane or a paper football. These sharp edges are known as compound folds and can easily puncture packaging in transit. These compound folds often cause products to fail bubble leak tests and other distribution simulation testing.

3. The packaging doesn’t undergo pre-qualification tests

A critical and easily avoidable pitfall is to start thinking about device packaging earlier in the product development process. Pre-qualification and pre-trial testing can help identify potential packaging snares early enough to avoid causing delays in the process. Better yet, when the product development and package design and validation experts can collaborate early in the process, it can head also create additional opportunities to streamline all aspects of the go-to-market process.

4. The packaging uses cheap materials

Too many manufacturers also stumble when attempting to reduce costs by using subpar materials. In addition to creating additional risks during transit and use, thin poly / Tyvek packaging threatens to derail package validation processes. What’s more, it can derail confidence at critical steps in the manufacturing process and with end-users.

Regulators and healthcare professionals alike who evaluate and use many similar medical devices may be less apt to trust devices with inferior packaging. It’s natural to wonder, if the organization cut corners on the packaging, were there other critical areas where they looked to reduce costs?

Utilize a proven medical device packaging partner

By finding the right packaging partner to help with key packaging decisions as well as testing and package validation, organizations can avoid some of these pitfalls. The team at Life Science Outsourcing has extensive experience helping organizations avoid these pitfalls and opt for proven approaches to effective medical package design, testing, and validation.

The keys to remember: Look for packaging solutions that utilize high-quality materials and limit the movement of components in transit. And finally, make sure you’re beginning the process of selecting and testing packaging options as early as possible.


To learn more about our Medical Package Testing services, be sure to visit our FAQ page or contact a member of our team today.