New companies are always entering the field of medical device development. These companies often have in-house engineers and designers, but they often lack the experience in working through the complexities of medical device design.
Working with a company specializing in the design of medical devices is a critical consideration. Even established companies that are in the medical device industry will turn to outside services to provide the expertise and experience that in-house teams may lack.
One important factor to consider in medical device design is that this is the first hurdle to get through for approval to proceed through to testing and trials of the device. The planning stage needs to be in depth and precise, addressing the identified needs of the patients while also implementing the right design control process to ensure a safe, dependable device that will meet regulatory requirements.
While medical device design may sound like one step, there are actually a number of steps that have to be completed in a specific order. This starts with first identifying the specific needs of the patient and the physician that the device will meet. This also includes reviewing current production and determining how the device will be different than what is already on the market.
Then, there will design input, which involves surveying or communicating with target groups to refine the product design. Then, once that is completed, it will be important to develop the schematics for the design, detail all specifications, make sure there is a risk analysis completed on the project as well as complete necessary studies, tests, and validation of the design.
All technical files and documentation will also need to be maintained during this phase, which will be submitted as part of the application. Additional data such as design history will also need to be submitted to show the methods used for the process and how they meet all required standards.
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