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sns34 replied to the topic Design Transfer and Challenges in the forum Introduction to Design Controls 8 years, 4 months ago
Out of all of the stages that a company’s product goes through, design transfer is the most important. In this stage, the design of the product is introduced to production and requires a full evaluation of the product’s design documentation, methods to production, and components that are chosen. The process must be performed well and there must be verification in regards to the input requirements meeting the process output. When it is done correctly, medical device companies and manufactures can clearly understand and communicate the requirements and deliverables of the entire design transfer process. However, a misunderstanding of the requirements can cause failure in the process because it can lead to substantial rework and delays. The product developers need to be sure to have a finalized design and an understanding of the amount of time that it takes to complete the design transfer process. Effectiveness of the process will be reduced if there are safety issues that are brought up to the manufacturers, delays due to the wait time of the components and procedure being released, and also the delay of manufacturers receiving and inspecting the components for production before ultimately releasing them. In order to avoid failure in the process, the company should increase their budget in order to be able to produce more prototypes or redesigns of the product, and hire more employees and project managers to properly plan the process and manage workloads and necessary tasks.