Design Transfer

Design transfer is another critical phase of the design control of the medical device.  This is the phase of transferring the design into manufacturing or production. The key is to ensure the production specifications are being done right. This is to ensure that the manufactured devices can be repeatedly and reliably produced within product and process capabilities.

Therefore, to achieve that, it is critical to have frequent consultation and intensive interaction especially between design engineering and production engineering.

All must be involved with design review meetings and activities from the beginning to end. Intensive interaction is especially required when the device is new to the production team.

Some examples of production specification are as below:

                  

                  ·       Assembly Drawings

·       Component Procurement Specification

·       Computer-aided Manufacturing (CAM) Programming Files

·       Digital Data Files

·       Inspection and Test Specification

·       Manufacturing Instructions

·       Manufacturing Jigs and Aids

·       Master EPROM

·       Programmable Device Files

·       Prototypes

·       Training Materials

·       Workmanship Standards

Another key element is having a design and development procedure which include a qualification assessment for the completeness and adequacy of the production specifications.

Secondly, the procedures shall ensure all documents and articles regarding production specifications are reviewed and approved by respective team members.

Thirdly, procedures should also ensure that only approved specifications are used in the manufacturing of the medical devices.

I found that it is very useful to have all the documents about production specification into a formal ‘design transfer’ template. This template must contains all the final version of all documents of the design transfer.

 But, unfortunately, I had encountered many medical device manufacturers failed to have a seamless design transfer. For example, design engineering waited until the last minute to transfer to production and expect the medical devices to be produced perfectly. Therefore, it is critical that the manufacturing and production department not to get involved at the last minute.  You just cannot dump the whole design transfer documentation to the production team last minute.                                                                                                                                                                                                                                         

Reference	Criteria
21 CFR 820.30(h)	Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.