Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, "Medical Device Distribution Package Testing," during Medical Device & Manufacturing (MD&M) West.
The Food and Drug Administration (FDA) is questioning "the last-mile" distribution of pharmaceuticals; the trip leg before the packaged product is in the consumer's hands. It won't be long before they look into medical devices, probably starting with combination products.
If sales people distribute your product, they need to learn to use something besides the trunk of their car to store devices. Temperatures rise in cars left in the summer sun and plunge when left out in the winter in colder climates. Unless your products are tested to the car temperature extremes, do not use cars for storage.
Use a philosophy that when your company makes a product, it should be able to be pulled off a shelf, or anywhere in the world, and used safely by you or a loved one.
Go and visit a shipping organization such as the local Fed Ex and see what the load with your product looks like before it is shipped.
Get involved in standards organizations. This experience may help you, your company, and the entire industry; it may also help to educate and influence the FDA.
When it comes to industry standards, read literature, ask your carrier for recommendations, use available test standards, and ask others in the industry. ASTM D10 and ISTA are two main distribution testing standard sources.
Packaging is normally an afterthought and routinely underleveraged as an opportunity.
Package engineering is often confused with design or graphics.
Packaging and labeling are approximately 30% of the Quality System Regulations (QS Regulations) and mentioned in ISO standards for various medical device types.
The industry must consider packaging as part of the design process for a device as the FDA and ISO regulations say is necessary. [HCP]
By Jim Butschli, Editor
