Adiana, Inc., and the Development of a Female Sterilization Device

In December 1999, Paul Goeld, president medical device startup Adiana, Inc., faced several decisions about the company’s sole product: a new female sterilization catheter. The catheter had proved to be extremely successful in both animal and preliminary human clinical trials in Mexico. Adiana planned to request approval from the U.S. Food and Drug Administration (FDA) for an investigational device exemption (IDE) to begin full-scale human testing of the device. Before proceeding, however, Goeld had to make several decisions about how the company would treat the women who enrolled in the clinical trials. He needed to decide what would constitute adequate consent for the sterilization study and what responsibility the company would assume in cases where the device failed to prevent pregnancy.