Design Input Requirements – 15 Questions to Answer

As discussed in the Foundation of Product Development series, establishing Design Input Requirements for a medical device is crucial. Here are 15 questions to help you down the path towards defining Design Inputs for a medical device:

1. What is the real need for the medical device?
2. What are the possible ways the device can be misused and/or used off label?
3. Where will the device be used?
4. Who will use the device?
5. How will the medical device be used?
6. What other devices / products will be used in conjuction with the device?
7. How will these devices interact?
8. How long will the device be used?
9. What are the operational limits of the medical device?
10. In what countries will the device be sold?
11. Where will the device be manufactured?
12. What are the regulatory and legal requirements?
13. How will the device be packaged?
14. What does the patent landscape look like?
15. What competitive devices exist?

Can you think of more questions?