January 4, 2018As we come out of the busiest season for every postal worker and mail man, we are reminded of how little thought often goes into the shipping and packaging of all the gifts and products being transported. It can be hard enough for the manufacturer to ship your online order to meet the gift’s deadline for arrival, so considering how the packaging affects the final result might be an unaffordable luxury. A set of fine china placed into a cardboard box with no bubble wrap might result in a pile of fine chips when thrown onto a delivery vehicle. Your family’s secret fruitcake recipe might arrive as a fruit-pancake after having your neighbor’s new weight set stacked on top of it at the warehouse while awaiting delivery. When we take the same look at the medical device field, many of the same concerns apply. Your newly developed medical device, sure to make a big market splash as the ideal blend of form and function, is only as good as the condition it arrives in to the end user. Additional design work is required to ensure that the form isn’t crushed and the function isn’t lost from poor transport conditions. Just like the piece of delicate china, care must be taken to ensure compressive forces, drops, constant vibrations, temperature fluctuations, and pressurized chambers don’t tamper with your perfect design in transit. When it comes to medical devices, several other considerations must take place. Most notably, shipping offers the ultimate test to the sterile barrier of your device. Even when the device itself is sturdy and resilient, a puncture to the packaging or a leak in a seal could render the device just as useless and more dangerous to the end user than a shattered component. Unlike opening a squished fruitcake, defects to sterile barriers might not be as obvious. At Poly-Med, our devices, components, and materials offer an additional packaging challenge. We produce a wide variety of biodegradable polymers which break down by bulk hydrolytic degradation. The very sensitivity to moisture that allows for novel applications such as timed pharmaceutical release, temporary structural strength, and reductions in device removal surgeries also requires that we consider packaging a main concern. When designing the packaging for our products, we must utilize materials which offer moisture, bioburden, and UV barriers in addition to the structural support required by other device types. Most often, this requires our packaging and materials to be thoroughly dried prior to shipment in order to extend the product shelf-life to its maximum potential. We also run extensive validation efforts on every aspect of the packaging design, where a small channel in the seal or puncture in a pouch is unacceptable. With the added design work and validation runs, we take the extra forethought and effort to ensure that products arrive just as they were designed, no matter how loaded the delivery truck is. If you are working on a medical device application and are interested in learning more about degradable polymers and how to successfully package them, Contact US to learn how we can advance your idea. Andrew Hargett, M.S.