1. Identifying user needs - This may involve identifying problems with existing diagnostic tools, prosthetic or surgical devices, or recognizing a whole new unexplored market (novel device based solutions for diseases). The primary user of medical devices are physicians who either prescribe or incorporate these devices on/in patients.
2. Reviewing marketed solutions - The next step is to understand the technology and the shortcomings of existing solutions(if any) to the problem.
3. Developing possible solutions - This is the major brainstorming step where solutions are conceived for the problem based on the user needs. Many possible solutions can be obtained to solve the problem.
4. Identifying the best possible solution - In this stage, the results of the previous step are compared and the solution which best satisfies the user needs is selected.
5. Device Design Criteria - The solution selected is translated into design inputs for the design process.
6. Device Design Process - This is a comprehensive step where the design inputs are manipulated to develop a product design.
7. Developing a Prototype - The design is now engineered to produce a working model or prototype of the device.
8. Verification and Validation - This prototype is tested to check its compliance with the design needs and user needs. Based on the outcome of this step, the steps 6-8 might undergo several iterations.
9. Packaging and Marketing - Once the device is ready, it is sterilized and packed according to FDA standards and is ready for marketing.
The FDA regulatory process must also go hand in hand with the device design process. This would enable timely release of device into the market.
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