The Food and Drug Administration regulates most products that are used in the medical market in the U.S. Other industries are subject to strict rules as well, but I’m not aware of any that require as much control over the design process itself, as does the FDA. Thankfully the government doesn’t tell us how to design. But it does insist that we formally document all the steps we took to reach the solution we now want to sell to the public.

The Design Control system that manufacturers (the regs consider medical device designers to be manufacturers) are required to have in place serves to document all design activities and to ensure that design features critical to the product spec have been reviewed and approved. It’s important to note that – because much of industrial design involves developing and evaluating numerous conceptual ideas – design controls aren’t required for feasibility studies. But once a concept becomes formalized in a Design Plan, medical device development must be documented in accordance with the FDA regs. If you become involved in medical device design beyond the concept phase, you’ll want to know what’s required. Here’s a great site where the FDA offers guidance on the Design Control regulations.