The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays?
In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practices.
Jeff has 25 years of experience in the medical device industry, specializes in getting new devices to market, and scaling your commercialization. He has extensive knowledge and understanding of ISO 11607-1 & -2, Packaging for Terminally Sterilized Medical Devices.
“The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There’s two parts to it, Part 1 and Part 2. Part 1 is all about designing the package and Part 2 is about validating the package.”
“Over a third of all package validations failed at the lab for transit. It’s staggering.”
“Less so do we see damage to the product itself. So, I’d say, 8 out of 10 times on these failures, it’s the product and the seal failing, not the product breaking.”
“One of the biggest problems we see is, (the FDA) they don’t do any validation. They say, ‘We’re going to do it later.’ That’s obviously a problem. You can’t market the product if the package hasn’t been validated. That’s why the FDA gives you a break on that.”
“The bottom line is you’re trying to maintain the product without getting damaged and without the sterile barriers getting damaged. That is the end goal.”