Medical Device Package Design Process

A robust package design process for a device will take into account several, often competing, design, distribution and market factors. QTS will help define the needs vs. wants and co-develop a package that will be effective and appropriate to the distribution and use environments of the medical supplies.

A typical medical device packaging engagement will address each of the following milestones: 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 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.

Read more about QTS packaging standards, or for more information regarding our medical package design process, please feel free to contact us.