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