Activity

  • Defining requirements of a medical product early in the process is very important to prevent some costly revisions later and any delayed time to market. Key to success of the medical device is to take into consideration the total product life cycle. The research and development team (R&D), the quality team, marketing team, regulatory, and industry standards should have a role as they give the inputs for the requirements of the project. The inputs for the DID should also come directly from the customer or the end user. The engineers should be able to take the customer needs and translate them into requirements or specifications for the project. This phase of the project is very important because the success of the project will be based on how the inputs or the customer needs are being translating. Surgeons are also important parts of this phase, as it is important to work directly with surgeons to get as much feedback as possible on designs and the specifications.