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Creating Trading Zones across Continents and Economies: The Female Health Company Mary Ann Leeper, Elizabeth Powell, and Patricia H. Werhane Chapter 12 in this volume, by Michael E. Gorman and Patricia H. Werhane, borrowing from Peter Galison (1997), defines a trading zone as a locus of communication, often involving the development of a jointly understood “pidgin” or “creole” between individuals or groups of individuals whose background or theoretical points of view were vastly different and sometimes incommensurable. In this chapter we shall see how trading zones are useful in commerce to produce some extraordinary results that would otherwise not be possible. The Female Health Company To understand the evolution of the Female Health Company’s work in developing trading zone strategies to enable the core operation of its business, we must first get a picture of the company’s struggle to play a role in the fight against HIV/AIDS. The story of the Female Health Company (FHC) starts in 1986, when three executives from a large pharmaceutical company decided to step out on their own to build a health care company. They set out to identify small health care companies that were struggling due to lack of resources and management talent but that had existing products, or products in development, with the potential to be the foundation for a strong future. To start, the three former G. D. Searle pharmaceutical executives, O. B. Parrish, William Gargiulo, and Mary Ann Leeper, bought management control of the Wisconsin Pharmacal company, located in Jackson, Wisconsin. They were intrigued with the base business and the prospect of licensing in the yet-to-be-developed “female condom” identified in Wisconsin Pharmacal’s product pipeline. At the time, AIDS was newly recognized as a deadly disease in the United States, particularly among men and women living in high-risk situations. And while male condoms had become a household product sold in almost every drugstore in America for prevention of 14 282 Mary Ann Leeper, Elizabeth Powell, and Patricia H. Werhane sexually transmitted diseases, nothing was available for women to use for this purpose. It seemed an obvious next step to introduce a female condom. Women needed a protection method that they could initiate, something that would be under their control. Parrish, Gargiulo, and Leeper assumed that, like the male condom, the female condom would soon be on the shelves of every store and widely purchased by sexually active women. The three senior executives now managing Wisconsin Pharmacal began to negotiate with the female condom’s inventor, Danish physician Lasse Hessel, and to seek the funding required to develop both the Wisconsin base business and what they hoped would be their “gold coin,” the female condom. While building a management board and taking the Wisconsin company public, Mary Ann Leeper, the COO of the company, undertook the long process of developing the female condom to meet the Food and Drug Administration (FDA) requirements and to gain final approval to launch the product in the United States. The Product and Its Launch The female condom is made of a sheer, nonlatex, polyurethane material and is shaped as a sheath with flexible rings on each end. Because the female condom transfers heat, the plastic used is strong and impermeable to temperature changes, humidity, and oil- or water-based lubricants. More importantly, the sheath cannot be penetrated by various viruses and bacteria that cause sexually transmitted diseases (STDs) like trichomoniasis , the herpes virus, the hepatitis B virus, and the lethal HIV. The condom’s uniqueness lies in the control it gives women to protect themselves against sexually transmitted infections as well as unintended pregnancies. The job for COO Leeper was not only the condom’s technical development but also the marketing strategy for its introduction. The product handed over from the inventor was basically a crude design. Leeper had to finish the product design, finalize the materials to be used, and ensure that the right preclinical, clinical, and safety studies were undertaken to a standard that would meet the U.S. FDA requirements. She and her team assumed that the marketing strategy should be similar to that of other consumer products that were sold in drugstores. However, the development of the female condom and ultimate approval by the FDA took over six years and at a cost that was magnitudes higher than originally anticipated. And development was only the beginning of the process; the product launch and marketing strategy were even higher hurdles to get past. Market research results...


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