Adiana Inc. and the Development of a Female Sterilization Device Harvard Case Solution & Analysis

In December 1999, Paul Goeld, president of the medical device startup Adiana, Inc, has encountered a number of decisions on a single product company: a new catheter female sterilization. The catheter has been extremely successful in both animals and preliminary human clinical trials in Mexico. Adiana planned to request permission from the Food and Drug Administration (FDA) for the test device exemption (IDE), to begin a full-scale human testing device. Before continuing, however, Goeld were some decisions about how the company will treat women who are enrolled in clinical trials. He had to decide what would constitute an adequate sterilization consent form and what responsibility the company will take over when the device is not able to prevent pregnancy. "Hide
by Margaret L. Eaton, Anjali Reddy, Aradhana Sarin Source: Stanford Graduate School of Business 19 pages. Publication Date: April 1, 2004. Prod. #: BME8-PDF-ENG

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