Clear all

Design Transfer

19 Posts
19 Users
0 Reactions
Posts: 78
Trusted Member

As a few of the posts above have stated, while the design team is working on the product development project, there should be a production team working in conjunction to ensure that production is ready to manufacture the product once it launches. Transferring a product design into production requires many considerations - does the company have the necessary manpower to work on the production line, or must new personnel be hired? And what are the training requirements for those personnel? Is there space available in the buildling for production, and does this space contain all the necessary equipment with proper process qualifications complete? With all that you need to think about during design transfer, it is important not only to involve the manufacturing team, but all other relevant departments in the company - for example, HR will be involved with hiring new staff, and Purchasing with procuring equipment and materials required for production.

Posted : 29/03/2020 9:40 pm
Posts: 82
Trusted Member

Product quality is among the most important things to monitor during this time period. During the development phase, when products are being designed, verified, and validated, the scale of parts being manufactured is very low, which makes it easy to control the quality of the product. However, once the scale gets ramped up to a production level, it's more difficult to control the quality of the product. Whereas one skilled operator may have manufactured all the parts that were used for testing throughout the development process, that most likely will not be the case once you get to the production level as multiple operators will probably be needed and they may not produce equivalent product. Additionally, you will need to monitor the performance of the product in the field to make sure there are no issues. If issues are reported, this will require changes, either to the product design, manufacturing process, risk documentation, etc. 

Posted : 08/04/2020 11:46 am
Posts: 42
Eminent Member

The process through which the design of medical equipment is transferred to production is the core definition of design transfer. This is only a superficially easy method to describe a much more intricate and continuing process. Design transfer is not a one-time affair; you are not handing the manufacturing team the reins and ordering them to take off. Design transfer happens across the entire design process when done properly. Nonetheless, in accordance with the FDA's statement on design transfer, your business must have policies in place to guarantee the transfer is carried out successfully. However, these procedures go beyond simply checking boxes. Before production can start, a number of steps in the design transfer process must be completed, such as proving successful design verification and validation and making sure your device master record (DMR) is complete and accurate. A design transfer checklist is frequently used by medical device businesses to confirm that all relevant tasks have been carried out and recorded. A thorough design transfer checklist also contains all the paperwork that must be given to the production team, such as the bill of materials, assembly drawings, and finished product requirements.

Posted : 06/04/2023 2:13 am
Posts: 78
Trusted Member

As others have mentioned before, I believe that having periodic meetings to validate the manufacturing team understands the requirements and process would be ideal. Due to the production process ramping up, many things can be overlooked such as the physical requirements of the product, like the dimension, color, or material. If meetings happened to ensure that everyone is on the same page then the company wouldn't lose out on money due to recalls. Organization of the files is also key as that could lead to confusion when coming up with the steps for production. Another way to make the transition smoother is to have someone from the design team overlook the process to ensure things proceed smoothly.

Posted : 02/05/2023 11:33 am
Page 2 / 2