MD+DI's Brian Buntz spoke with product designer Mary Beth Privitera about clinical observation in medical device design and physician feedback during the process. In the first part of a two-part interview, Privitera discussed the "human element of innovation" and much more. Check it out at MD+DI online.

"The human element is the one common thread that is throughout the entire process and throughout the entire innovation cycle where you get the idea, the inspiration for the idea, and then there is a whole push from a regulatory perspective of making products that are more advanced with regard to ergonomics and human factors," says Privitera. "A new device might come out to market and it may be successful clinically but may be very difficult to use and therefore fail."

Privitera is a biomedical-engineering professor at the University of Cincinnati. She oversaw the Medical Design Excellence Awards judging process in 2011.

--Maria Fontanazza