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Combination product packaging concerns

Combining a medical device with a pharmaceutical to create a drug delivery device (like drug-eluting stents) is fraught with problems, yet it's a great opportunity for both the device company and the pharmaceutical firm. Devices often perform better, with increased patient compliance and improved medical outcomes. Pharmaceutical companies capitalize on the chance to take less profitable off-patent drugs and reintroduce them in a new way. Often the smaller medical device firm has to turn to its big pharma partners for help with funding, Food and Drug Administration (FDA) compliance, and so on. Not only is the road to launching a new product longer, tougher, and more expensive, the actual application of the drug onto the device remains a difficult proposition at full production speeds. Virtual design programs are helping medical device firms conceive new products much more efficiently. Doctors call for more devices to be MRI-compatible, often dictating a change in materials.

Packaging has to tackle the difficulties associated with delivering a sterile device that now includes a biologic. New materials with maximum barrier properties are often necessary. One wound dressing supplier went from dry to wet dressings. The biologic in the dressing deteriorated the adhesive on the dressing backing. When the backing adhesive was changed, the product had to switch from gamma to EtO sterilization, calling for a change in the packaging material.

This is not the formula for winning the race for "speed to market." The biggest challenge for packaging is moving up from the end of the process to the very beginning (clinical trials or earlier). As one supplier told me, "The FDA is going to approve the package that goes through trial. It's too late to change the package after that."

--By Jim Chrzan, Publisher
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