Mark Crawford, Contributing Writer06.06.17
Packaging and sterilizing medical devices today is not much different than it was 20 to 30 years ago. Most devices are still sterilized using ethylene oxide sterilization (EtO), steam, or gamma radiation, with standard Tyvek or foil pouch packaging.
However, these “legacy” sterilization methods are not as effective with newer, more complex products, especially those with advanced materials or biologics. Longer lead times for the packaging development requirements for these devices must also be considered; new packaging formats or materials typically require extensive validation testing, which must be factored into the launch timeline.
Many medical device manufacturers (MDMs) are reluctant to embrace new methods of sterilization and packaging unless a strong business case exists for working outside of tried-and-tested solutions. And, even though they know it is ultimately in their best interests to move forward with new technologies, some still try to make the old ones work—mostly to save money and hasten speed to market.
This approach, however, can easily backfire.
“Medical devi
However, these “legacy” sterilization methods are not as effective with newer, more complex products, especially those with advanced materials or biologics. Longer lead times for the packaging development requirements for these devices must also be considered; new packaging formats or materials typically require extensive validation testing, which must be factored into the launch timeline.
Many medical device manufacturers (MDMs) are reluctant to embrace new methods of sterilization and packaging unless a strong business case exists for working outside of tried-and-tested solutions. And, even though they know it is ultimately in their best interests to move forward with new technologies, some still try to make the old ones work—mostly to save money and hasten speed to market.
This approach, however, can easily backfire.
“Medical devi
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