Design Inputs Require All Stakeholders
Too often, not all variables are identified when selecting materials and sterilization methods. As a result, the entire packaging project can be derailed, sometimes delaying new product launch for weeks or even months. Just as it is critical to define the device and package attributes and needs, it is equally important to identify all the relevant stages of the product life cycle in the development of the packaging system. For example, it could be that the device needs are all very well characterized and that the packaging system design protects that device well—until distribution testing creates holes in the sterile barrier system. The team is then left with trying to reengineer the packaging system without changing contact materials or the sterilization cycle.
In this case, it would have been useful to understand the distribution environment and the level at which the packaging system is to be transit-tested. It may also have helped to transit-test prototypes early in development or even consult with transit-test experts to detect a flaw in the protective packaging before a failure occurs this far down the development cycle.
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Your packaging supplier may be able to guide you. However, they are often consulted after a failure, not before. If you find yourself in this situation, you certainly are not alone. As Aristotle said around 350 BC, “It is possible to fail in many ways...while to succeed is possible only in one way.” Learn from the mistakes, and get more people involved the next time.