Design transfer is the process in which the device design is translated into production, distribution, and installation specification.
Some of the common problem during Design transfer include
• Product developers do not have a finalized design.
• Manufacturing processes have not been validated, or documented.
• Safety issues
• Unresolved cost
• Delays occur even after all the documentation is approved, because manufacturing must receive, inspect, and finally release parts for production.
• Developers have not created a vendor supply chain based on an approved-vendor list.
• After making a few devices for verification testing, assume you will be ready to build full scale production volumes.