Formative Evaluation, Design and Reporting - Applied Human Factors In Medical Device Design Book Preview | PART 4

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Formative Evaluation, Design and Reporting - Applied Human Factors In Medical Device Design Book Preview | PART 4

Design is the best way to mitigate risks associated with use errors. This section, it's really about human factors in design. When we think about human factors, we always think about the testing. We don't necessarily think about design and how human factors fit into design. The fact of the matter is that if human factors aren't applied in design, then testing is really problematic.

If you look at that historical legacy of work, what is the root of all human factor? It actually goes back to 1997 in this publication that the FDA put out, it was titled Do It By Design. its ethos and its values still ring true and in fact, there's some really nice risk analysis to say, "Hey, you know what, design is the best way to mitigate your risk associated with use errors," said author Dr. Mary Beth Privitera.

This section, covers how human factors is applied in device design, in general, and then it gives a nice overview with specific considerations in designing combination products and then instructions for you. According to Mary Beth, "it is probably one of the most important chapters or sections within the entire book."