Medtech Companies Focus on Women’s Health

In recent months, a handful of medical device companies have announced their intentions to place increased emphasis on women’s health issues. From sex-specific product launches to acquisitions designed to increase a company’s presence in the women’s health market, medtech firms are exploring multiple ways to grow their businesses by better serving the special medical needs of the female population.

Marts: Welcoming advances in women’s health.

“Women today have an array of medical options for female-specific conditions that they didn’t have 20 years ago,” says Sherry Marts, PhD, vice president of scientific affairs for the Society for Women’s Health Research. “It’s exciting that we are now starting to see gender-specific devices for conditions that are common in both men and women.”

New Knees

In May, Zimmer Holdings Inc. (Warsaw, IN) reported that it had received clearance from FDA to market its Gender Solutions high-flex knee, the first knee replacement designed specifically to fit a woman’s anatomy. According to the company, the knee replacement was designed based on three shape differences between men’s and women’s knees.

Booth: Best of both worlds.

“Knee implants have been functioning very well for men and women, but we want to meet women’s unique needs by making knee replacements that feel, fit, and function even better,” says Robert E. Booth, MD, chief of orthopedic surgery at Pennsylvania Hospital and one of the product’s surgeon developers. “The Gender Solutions knee is the best of both worlds. It’s based on the NexGen knee, a highly successful implant with great mechanics and 10 years of clinical success. Only the shape is different, to make it feel more natural.

“Mounting research indicates that a woman’s knee is not simply a smaller version of a man’s knee,” Booth adds. “The differences involve the bones, ligaments, and tendons in the joints.”

According to Zimmer, about two-thirds of the more than 400,000 annual knee replacement patients are women. In spite of the increased prevalence of knee pain and resulting disability among women, however, they are less likely than men to undergo the replacement procedure, the company notes. “Now that we have a knee shaped to fit a woman’s anatomy, we expect far more women will want to consider knee replacement,” Booth says.

“Zimmer’s situation is fairly unique,” says Marts. “As far as we know, this is the first company that has redesigned its product to fit women—and that is significant. Many devices are designed based on the male body, and orthopedics is where that is most obvious. With these devices, it’s not just about making them smaller.”

Whether a sex-specific device is necessary depends on the type of device, says Marts. In many cases, more research is needed into conditions in which women are affected disproportionately or differently, as is the case with certain autoimmune diseases, mental illnesses, and sports-related injuries, Marts says. “We know there are differences in how these conditions affect women,” she says. “The question is whether the treatment and prevention methods should be different for men and women.”

The Focus on Females

In addition to developing sex-specific products for conditions common in both men and women, some manufacturers are placing an increased emphasis on meeting women’s needs in relation to female-specific conditions. A couple days before Zimmer unveiled its Gender Solutions line, Cook Group Inc. (Bloomington, IN) announced the launch of its women’s health business unit. According to the company, the new division “will uniquely address some of the most prevalent issues in women’s health globally, including infertility, chronic pelvic pain, pelvic organ prolapse, and incontinence.

Cook’s Anné: A new focus.

“This new division is taking what Cook has done in the past in women’s health and expanding it into a much broader idea,” says Christina Anné, global leader for the women’s health business unit. Although the initial focus of the division’s products will be on urological and gynecological applications, Cook’s broad base of medical device experience provides an opportunity for the division to eventually expand into cardiology, endoscopy, and radiology applications for women’s health, she says.

Anné says the formation of the new division falls in line with the increased emphasis that health research organizations worldwide are placing on gender-based medicine. This includes continued calls for the appropriate inclusion of women in major medical research studies, one of the main premises on which the Society for Women’s Health Research was founded in 1990.

The new women’s health division, an offshoot of Cook’s urological division, plans to announce a variety of new product releases at the annual conference of the European Society of Human Reproduction and Embryology, which is being held in Prague this month.

“The advancements Cook delivers for assisted reproductive techniques enable physicians to address a much broader set of patients,” Anné says. “By improving catheter quality and guidance techniques, Cook’s devices are leading to more-accurate embryo placement than previously achievable.”

In addition to the new Cook unit, several medtech firms in recent months have pursued acquisitions that beef up their portfolios of women’s health solutions. In May, American Medical Systems (AMS; Minneapolis) acquired Solarant Medical Inc. (Livermore, CA), a privately funded company focused on the development of minimally invasive therapies for women who suffer from stress urinary incontinence.

AMS’s Emerson: Acquiring a foundation.

“Office-based incontinence therapy will be the means by which physicians will ultimately reach a significantly greater number of the 80 million women around the world suffering from stress incontinence,” said Martin J. Emerson, president and chief executive officer of American Medical Systems. “We at AMS are eager to actively advance the development activities to this end based upon the solid foundation of the Solarant intellectual property portfolio and product concepts.”

On the same day as the AMS announcement, Ethicon Inc. (Somerville, NJ), a Johnson & Johnson company, reported that it had acquired Vascular Control Systems Inc. ( San Juan Capistrano, CA), a privately held company that develops medical devices to treat fibroids and control bleeding in obstetric and gynecologic applications.

“This represents a strong, strategic fit with our gynecologic business,” said Sheri S. McCoy, company group chairman for Johnson & Johnson with responsibility for the Ethicon franchise. “The technology and knowledge we’ll gain will enable us to expand our ability to create new therapies for women.”

“Often what companies think of as women’s health are urogynecological applications,” Marts says. “Historically, many urogynecological conditions have been neglected. While many of them are not life-threatening, they do affect women’s quality of life. And they are now getting more attention.”

Realizing the Potential

These moves by medtech companies to expand their presence in and advance the field of women’s health represent only the tip of the iceberg. Not only does a market for gender-specific devices seem to be emerging, but research indicates that there is also an opportunity for certain manufacturers to increase the penetration of their existing products within the female patient population.

At the Heart Rhythm Society’s annual meeting last month, researchers from Mayo Clinic (Rochester, MN) reported the results of a study that found that, despite similar baseline characteristics, significantly fewer females compared to males are undergoing implantable cardioverter-defibrillator implantation. This difference is most apparent in the elderly.

“We do know that women reporting to physicians with heart disease are less likely to get referrals for advanced care,” Marts says. She says that research indicates that many physicians demonstrate an unconscious bias toward referring white males for advanced treatment above all other demographic groups—even when the same symptoms and health histories are present. However, Marts notes that many medical groups have recognized this bias and are incorporating education on this front into their curricula.

“It’s the cult of the typical 70-kilogram man,” Marts says. “That’s the example that was in all my textbooks, and to some extent we’re still suffering from that mindset today. However, we are starting to see a change.”

© 2006 Canon Communications LLC

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