The design transfer process aims to translate the design of a medical device into a production procedure in which the manufactured device can fully manifest its safety and efficacy in a way that complies with its essential requirements and standards. Essentially, design transfer begins with R&D extending out to a production department while taking the other entities into consideration (QA/QC, marketing, engineering, IT, etc). If there is a lack of communication however, then it is likely that the design will not efficiently be transferred to production in a timely manner or even worse, it might be compromised during the production process, resulting in a defective device that will get recalled.

An online article that covers the importance of the design transfer process states that delays commonly occur in this stage during the review and approval process regarding the documentation that is needed to initiate manufacturing (1). This is most likely because it is easier to authorize documents than it is to approve them, which can occur when one department is too cautious to the point that it burdens regulatory processes. Another technique for effective design transfer is to document every event that occurs during the design process. If a change in procedure has to be implemented, it must be documented, otherwise the mistake is bound to repeat itself. Finally, it is important to select a vendor that is compliant with the needs of the product being produced. This requires hiring a fast, flexible supplier that can account for last-minute changes while taking a risk-based approach (i.e. selecting a vendor that offers its components at a variety of tolerances).

Is there a way to apply verification or even validation steps during the design transfer phase? What other methods can be applied to a design transfer process to improve the transition? Is it necessary to update the design transfer protocol when producing devices from a clinical level to a commercial one? How might the design transfer stage differ between the design for a tongue depressor and a pacemaker in terms of the device’s ability to scale up and meet the expected demand?

Reference:
(1) Kirsh, Danielle. “Medical Device Design Transfer: 5 Things You Need to Know” (Nov. 2017) Medical Design & Outsourcing