A medical device can be a sophisticated, sensitive piece of healthcare technology. As such, it must be protected, remain sterile, and benefit the patient who needs it. Packaging is a critical component that ensures all of this. This means medtech OEMs may need to consider the development and manufacture of the packaging almost as much as the device itself.

With this in mind, the packaging design and production must be handled with the utmost care and consideration for potential problems. This is where testing comes into play. Through a series of testing protocols, a partner can help ensure the package will fulfill its responsibilities as intended. This effort can confirm the right design was developed or, if performed earlier in the process, can help steer toward the best solution.

To gain insights on the numerous testing methods, validation strategies, and design input such partners can provide, Greg Schwinghammer, Principal Engineer at WESTPAK, participated in the following interview. In this Q&A, he speaks to ISO 11607, the impact of the home healthcare trend, packaging for combination products, and more.

Sean Fenske: Why do medical device packaging failures still occur, and what can be done to prevent them?

Greg Schwinghammer: Packaging failures often come down to something that was not fully challenged before final validation. We commonly see issues involving…