Design Transfer is the culmination of a design team’s efforts during which the product and process designs are transferred to production. This phase of design controls only receives a small mention in the FDA Quality System Regulation (21 CFR 820.30(h)) which states:
Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
Medical device manufacturers should not be misled to think that because the requirements for Design Transfer are succinct, so too should be the amount of effort and attention put in to carrying out this vital phase. Often, a medical device has been “flawlessly” designed, only to find out at the end of the product development process that it is not consistently manufacturable.
Below are three recommendations for conducting a successful Design Transfer:
- Involve Manufacturing From the Start – This could mean having a full-time manufacturing representative on the design team or periodically checking in with manufacturing engineering during the design process.
- Don’t Wait until the End to Begin – Design Transfer can and should happen in stages over the course of the device development. For example, product specifications must be transferred to manufacturing in order to build production units for verification and validation activities.
- Use a Design Transfer Checklist – Design Transfer requires the completion of the Device Master Record (DMR), which contains documents such as product drawings, process validations, manufacturing and inspection instructions, and training materials. Using a checklist can help ensure that nothing is overlooked. Hint: FDA looks for objective evidence such as this during inspections.
If you need assistance conducting or managing a Design Transfer, please call 512-328-9404 or contact us at email@example.com. You can also read previous Design Controls Series articles on avoiding common design controls mistakes and determining when to begin design controls.