Last month, the FDA’s Center for Devices and Radiological Health (CDRH) launched an ambitious and important initiative focused on improving women’s access to and outcomes from treatments using medical devices. This follows the publication of its 2011 draft guidance on the subject. The Health of Women Program commenced with an impressive two-day public workshop and included participants from all stakeholder groups.

To say the least, the discussion was eye opening and sobering. Let me share three specific points:

• Women are less frequently asked to participate in clinical trials than men. Furthermore, when asked, we opt out of participation in those same trials at higher rates than men. As such, trial results (among other things) may not accurately reflect treatment effects and/or safety issues in women. That’s left up to the real world to discover after the product is on the market.

• Although women undergo far more knee replacements than men, women who otherwise qualify for a knee replacement are not being offered that procedure at three times the rate of men who aren’t being offered the same surgery! In other words, for an equivalent disease burden, you and I are underserved relative to our male counterparts. To be clear, this pattern is not unique to the orthopedic industry.

• As if being underserved weren’t enough, a woman’s outcome after a knee replacement is not as good as a man’s. Don’t get me wrong — women get better from knee replacements. We definitely do. However, on average, we start with a worse preoperative level of function and never achieve the functional outcome men do.

So…in sum…we are understudied and underserved. And when we are finally studied and served, we underrespond.

See what I mean about the discussion being eye opening and sobering?

While absorbing this information, I couldn’t help but think of Joy Anderson’s incredibly mind-bending MedtechWOMEN Fireside Chat subject, “A Gender Lens in Investing,” and ponder the upcoming MedtechVISION 2013 topic, “Value in Healthcare.” Both relate directly to the FDA workshop. The differences and disparities mentioned above represent a multitude of unmet needs. (Hint: “unmet needs” is code for “opportunities.”) By using the optics of a gender lens, the medtech industry can focus on innovation that creates value in the healthcare system where it is currently not visible.

Unfortunately, in the present reform environment, our industry is allowing value to be defined for us. In my opinion, “value” in healthcare has become synonymous with “cost containment.” Sure, improving health is mentioned in passing, but the core of health (insurance) reform is about squeezing cost out of the system. To me, value is present only if an individual’s outcome is optimized and the collective health of a population improves as a result. (I’m a physician and that’s my bias. But I’m also influenced by Clay Christensen’s teachings on innovation and am concerned that efforts aimed solely at cost containment are simply “efficiency innovations” in disguise.)

Fortunately, opportunities exist to create this optimization-type of value in our industry by keenly and agnostically recognizing differences in the following:

• Sex-specific incidence and prevalence of disease

• Sex-specific expression of disease

• Sex-specific progression of disease

• Sex- and gender-specific experience of disease

• Sex- and gender-specific response to treatment

It’s when these sex- and gender-specific variations are identified, acknowledged, and understood that smart, patient-centric approaches (involving the use of algorithms, diagnostics, services, and therapeutics) can be developed and implemented to improve the health of people, not just of women.

Fundamentally, the FDA’s program is the foundation upon which personalized medicine will be built. We have leaps and bounds to go before we get there and it starts not with individual differences but with pattern recognition within and between groups. (As the saying goes, even though you’re one in a million, there are eight more of you in New York.) Every part of the healthcare ecosystem simply must participate in the process for personalized medicine to be realized in our time. As it relates to gender, stakeholders can employ a lot of complementary strategies. Specifically,

• For those studying the basic science of disease, it’s time to highlight the translational relevance of your findings on geno- and phenotypical sex differences.

• For those designing new products and services, it’s time to innovate taking into account the probability men and women will respond differently.

• For those running clinical trials, it’s time to focus on how to explore and report on sex and gender differences in what you are studying.

• For those regulating trials, it’s time to encourage gender stratification and/or subgroup analyses in a manner that catalyzes progress.

• For those teaching the next generation, it’s time to incorporate intentional and frequent didactic instruction on sex and gender differences throughout the care cycle.

• For those providing care, it’s time to observe the differences, communicate them to your patients, and incorporate them into your algorithms of care.

• For those receiving care (or advocating on behalf of someone receiving care), it’s time to start asking your physicians, “What differences do you see in how women respond to this treatment compared to men?”

The FDA is committed to an ongoing, interactive, multidisciplinary dialogue on this serious and complex topic. You can contribute by broadening your awareness of these issues (Gendered Innovations is an intriguing place to start), putting a gender lens in front of your gaze to see the opportunities, and then interjecting this subject as a recurring theme in your personal and professional conversations. Create a ripple effect by frequently engaging others. That’s the source of change. And who better to bring about that change than the 51%?

– Nancy M. Lynch, MD