Design Transfer may be one of the most important transitions in the design process, as it is the introduction of a design to production. Since this is such an integral process in the early part of product development, it must be well executed. The FDA requires the manufacturer to complete the following steps in order for the design transfer process to be considered satisfactory: establish and maintain procedures to effectively translate the design into production specifications, transfer the design into production methods and procedures, and create a production environment that will allow the product to comply with any regulatory or industry requirements.
The term “production specifications” is usually associated with written documents (drawings, purchase specifications, procedures, inspection specifications). While these written documents are typical in a medical device production, there are additional ways of conveying the design information. This can include training materials, digital data files, manufacturing jigs or molds, and samples.
In order for this transition to be effective, a thorough assessment of the product’s design documentation, selection of components and definition of production methods must be conducted. If a design transfer fails to be effective, it can lead to situations where workflow is interrupted, product quality suffers and/or components aren’t available as expected. On the flip side, in the case of an effective transfer, there can be lower production/material costs, a decrease in the expected time to market, or an increase of quality.
Some of the more common issues that arise during design transfer include:
- Product developers do not have a final design
- Business managers do not fully comprehend the scope of the transfer effort do not allocate the proper amount of time and resources
- Developers have not created an approved supply source for components
- The purchasing department does not have sufficient time to identify and approve vendors