July 1, 1997

4 Min Read

Medical Device & Diagnostic Industry Magazine
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An MD&DI July 1997 Column


Kathryn Tunstall confronts issues of women's infertility and contraception.

Success in business is often a result of being in the right place at the right time. That holds true for companies as well as individuals. Both Kathryn Tunstall, president, chief executive officer, and a director of Conceptus, Inc. (San Carlos, CA), and her company fit that profile.

Formed in 1992, Conceptus is involved in developing, manufacturing, and marketing innovative product systems that provide a nonsurgical access to the reproductive tract. The company is a pioneer in bringing technologies that have shown proven benefits in other areas of medicine (e.g., catheters) to the emerging subspecialty known as interventional gynecology. Products address improving both diagnosis and treatment of fallopian tube disorders, a primary cause of infertility, and surgical tubal ligation, the most commonly selected method of sterilization worldwide.

Women's health is, according to Tunstall, a field whose time has come. "We have seen a major harmonic convergence in women's health," she says. "First, women's clinical needs are changing, mainly because so many women are deferring childbirth in order to go to college or pursue a career. Large numbers of women face problems with infertility as they have their families later in life.

"Sociological factors are also at work. Women have more economic power, which has, in turn, created more political power. That power has helped influence such developments as the Women's Health Initiative at the National Institutes of Health.

"The third factor is the interest of the third-party payers," Tunstall concludes. "They demand that any new treatment options demonstrate cost-effectiveness."

The convergence of these three factors has resulted in making women's health a viable business opportunity today. There is a demand for minimally invasive, cost-effective products to address the clinical needs of women. Conceptus is positioned to supply those products, and Tunstall is positioned to lead the company's efforts.

Tunstall joined Conceptus in 1993, after 20 years of holding increasingly important management positions in manufacturing and marketing for several companies. Immediately prior to joining Conceptus, Tunstall served as president of the Edwards Less Invasive Surgery Division of Baxter International, a division focusing on the development, manufacturing, and marketing of cardiovascular catheters.

Conceptus's infertility products address a very large market. A major cause of infertility, fallopian tube disease and disorders are factors for more than 35% of the estimated 5 to 8 million U.S. couples who suffer from clinical infertility (defined as the inability to conceive after one year of unprotected intercourse).

The company's transcervical tubal access catheter (T-TAC) system gives physicians nonsurgical access and navigation of the fallopian tube, enabling a more direct and accurate diagnosis. The T-TAC system also serves as a tubal access "platform technology." When used in combination with other Conceptus devices under development, the technology may provide a less-invasive alternative for many tubal therapies. The T-TAC system has been marketed in 14 countries since 1995.

Initially, Conceptus was a private company. Unlike many other device start-ups, however, it had little trouble obtaining private financing. When the company went public in 1996, it raised twice the capital it had anticipated. Tunstall attributes a large part of that success to the fact that Conceptus was using technologies that had already been proven in other applications.

Tunstall's interest in infertility issues goes beyond the business world. She is on the national board of Resolve, an organization whose mission is to support and educate the infertile community and to advocate for better insurance benefits and more awareness of infertility.

"In most other countries," Tunstall says, "infertility is considered a legitimate medical condition. In the United States, we consider it a sociological condition, not a medical issue. I'd certainly like to see that changed. If we improve tubal access, we will see an increased demand for better, less costly, and more effective treatment of infertility."

As a woman at the helm of a medical device company, Tunstall is currently in a minority. That may be changing, however. "The good news is that there are a lot of women at the second level of management, serving as officers in significant device companies," Tunstall says. "It takes 20 years to develop a CEO, and it was about 20 years ago that women started moving into management roles in large numbers. I expect to see more women moving into the top jobs in the next five years."

Edward E. Waldron is a freelance contributor to MD&DI.

Copyright ©1997 Medical Device & Diagnostic Industry

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