Naturally, the goal in the design of new products is to solve a problem. That problem may be one that is affecting people’s lives in a very direct way. The best solution is one that has considered not only the risks the problem is creating for people but also what risks the solution has for the user, patient, family and people making the product.
We all love to jump in and start coming up with ideas to solve a problem even before we fully understand what all of the challenges are. There is nothing wrong with that as brainstorming approach. However, depending only on our first ideas always leaves the chance that some key issue was missed.
Fortunately, a defined approach on how to conduct product development has been created by key regulatory bodies (such as the US FDA and similar governmental groups around the world). That work is further reviewed and guided by international standards created by ISO.
This approach is known as Design Control. It does not tell you how to solve a problem. What it does is to give you the opportunity to make sure that you fully define the problem, set your goals, properly test, clearly show how the product is to be made, and make sure that risks get considered.
The result will then be that your new product can be reviewed, produced and improved without losing sight of the key aspects of the problem or how your solution works.
Most importantly, you will know that your product would pass the “Grandmother test” (Is this safe enough for my grandmother?)