The package design process for medical devices is complex and requires attention to multiple design, distribution and market factors. QTS has deep expertise to help you define your needs and assist you in developing a package that is effective and appropriate to the distribution and use environments of your device.
QTS can collaborate with you to develop a custom package if your device requires it. Custom packaging solutions can incorporate pouches, trays single or double barrier or a combination including foam, polyurethane or other protective packaging materials to provide the best packaging configuration for your device.
As an alternative to custom packaging configurations, QTS also offers QSEAL® Pre-Validated Medical Packaging.
Milestones for a typical medical device package configuration
- Analyze the device design for “package-ability.” QTS may offer suggestions of minor device design changes to enhance the performance of the package, especially through the distribution environment.
- Review the anticipated use environment. Consider presentation and ease of use in operating room with medical personnel. Determine barrier material selection and the number of barriers to employ (single or double barrier, flexible pouch vs. rigid tray, etc.).
- Design configurations for the secondary and tertiary box packaging.
- Design the sealing, distribution and aging protocols to support the quality plan.
- Assist with copy translation, instructions for use and label design.
- Conduct Risk Analysis and Failure Mode and Effects Analysis (FMEA) for the package design.