https://mcdn.podbean.com/mf/web/rbq83n/Final_Bethany_-_6_28_22_944_AM9at9b.mp3
Episode Summary
As an expert Femtech lawyer, Bethany Corbin is using her knowledge and skill to help improve how women’s health is viewed and treated in the medical field. In today’s episode, we sat down with Bethany to discuss recent changes in femtech for midlife women, the vetting process for menopause and women’s health companies, the accuracy of an FDA approval, and the lack of women’s health products on the market.
First, we asked Bethany about the changes she’s noticed in conversations surrounding midlife women in femtech. She told us that in the last 6-12 months, there’s been a shift to an older demographic of consumers. Many products on the market today are targeted towards women who are in their more fertile years, but in online and startup companies, a noticeable shift has occurred. Midlife women’s healthcare has started becoming more prevalent in the femtech market. Bethany attributes this change to two main reasons: our aging population has made the midlife demographic larger and more marketable, and those with large platforms are starting to realize the large gap in women’s health care and are sharing their thoughts to their audiences, broadening the conversation to millions of people. For the products and companies that already cater towards midlife women, the ones we currently have are not always the best. Bethany explained how for applications such as period trackers, they have inaccuracies or have been proven to be using inaccurate technology to evaluate information. There is also an issue with app and product creation, for tech companies will often create their product without an obgyn or a women’s health expert there to consult and ensure that their data is accurate. HIPPA also does not apply to most femtech applications, so there can be gaps in accuracy. Because of this, Bethany recommends not buying a menopause or midlife product just because a celebrity endorsed it. Every person should instead look to the company of the product itself and view the testing and technological strategies that were used.
When asked about the privacy regulations of period trackers, Bethany said that with the overturning of Roe vs. Wade, conversations surrounding menstrual privacy have become more prevalent. With period trackers, a law enforcement officer could use several different strategies to obtain data from the app and persecute women who were pregnant and attempting to receive an abortion. When a person uses a femtech period app, many of those apps then take the data and allow for a downstream sale of it. This makes data available for anyone to not only buy but sell, putting a person’s personal information at risk. We also asked about the validity of an FDA approval for a midlife product. Bethany said that while every product and company is different, products that are FDA approved are more regulated than those that are not. For CBD, the FDA does have guidelines, and any company manufacturing or distributing CBD products has to go through proper testing and regulations. While FDA regulations on menopausal products can differ depending on the product itself, when it comes to health supplements, there are stricter guidelines that have to be followed. There are rules on what can or cannot be said on health supplement packaging, and the FTC regulates advertising to prevent deceptive language.
While products for men’s health have been around for years, women’s health has unfortunately been much slower to grow. For the reasoning behind the gap in healthcare, Bethany told us that women’s health hasn’t been prioritized for centuries. The term “femtech” wasn’t even coined until 2016, and it wasn’t until 1993 that women could participate in clinical trials. Up until 1993, only men’s data was available for healthcare, so women and men were treated the same, even if women required different care for different symptoms. Conversations surrounding women’s health were also far more private since there were so many stigmas surrounding the topic. Women were afraid to speak up to even their doctors and received lesser care as a result. And while women are more willing to talk about their issues now, society as a whole still needs to change. Funding is still an issue in women’s health, and often times, a femtech founder will try and seek investments for a product, only to be turned away by men who don’t want to discuss women’s healthcare. However, society is slowly changing, and conversations surrounding both midlife and menopause are becoming more prevalent in the media.
Women’s mental and physical health have become more popular trends in femtech, and Bethany stated that in the next few years, chronic disease management is going to cover about 30% of the overall market. Some companies are even working on advanced blood tests for ovarian cancer. For disease treatment, femtech is attempting to be more proactive on preventative measures, since emphasis is often placed on reactionary rather than preventative medicine. By creating products and technology that utilize prevention of disease, women will hopefully feel more confident advocating for themselves and trusting their doctors when sharing symptoms and concerns. Finally, we asked Bethany about the privacy and growth of telehealth services. She explained that before the pandemic, telehealth services were much less prevalent. However, over the past few years, the need and want for telehealth has skyrocketed, and many companies are using online care to reach patients. Most telehealth companies are HIPPA compliant and have proper security, so their safe to trust with data. Many telehealth companies can also now prescribe medication within state and federal regulations.
Bethany Corbin
Bethany began getting involved with femtech around 2018-2019 when she was teaching at Wake Forest University School of Law. She finished her healthcare LL.M. at Loyola University of Chicago and her thesis focused on liability for the internet of medical things (IoMT). When Bethany was at Wake Forest, she became interested in the intersection of connected health devices/IoMT and women’s health. As she researched this area, she realized there was a gap in the femtech discussion from the legal community. Bethany then began to build a scholarship portfolio around femtech during her time at Wake Forest and started speaking on this topic at conferences.
During Bethany’s research, she also realized that there were few attorneys who specialized in healthcare innovation and femtech. Rather than research and discuss these topics at a theoretical level, she wanted to help femtech companies navigate the challenging legal landscape in the U.S. For this reason, she transitioned out of academia and back into “big law” in Washington, D.C., where she pursued femtech as a side interest.
In January 2021, she was unexpectedly diagnosed with a pelvic mass at a routine annual physical exam. Bethany had no symptoms other than unexpected weight gain, so her primary care physician made an emergency referral to an OBGYN. Following ultrasound and MRI, the OBGYN explained that Bethany had a 15cm fibroid pressing against her organs and taking up the entire space in her abdomen. She was the equivalent of 5-6 months pregnant. The MRI also showed 6 additional large fibroids.
As Bethany navigated the care options for fibroids, she realized this is an extremely common diagnosis for women. Statistics estimate that up to 80% of women will develop uterine fibroids at some point during their lives. However, she had never heard of uterine fibroids before. As she researched treatment options, two things became clear: (1) there were no non-invasive treatment options – the main options were (i) wait and see (not an option in her case given the fibroid size), (ii) GnRH agonists (e.g., Lupron), which is a medication that can temporarily shrink fibroids but has negative side effects, (iii) uterine artery embolization (a medical procedure where particles are injected into the arteries supplying the uterus, cutting off blood flow to the fibroids, and causing them to shrink. Some have likened this to a heart attack for your uterus); (iv) surgical removal of the fibroids (myomectomy) (one of the top 10 most painful surgeries), or (v) hysterectomy. There had been little innovation and improvement in fibroid treatment options over the years, despite the prevalence of this condition in women.
Bethany also learned that fibroids are downplayed by society. When people learned she had fibroids, they often had a similar story to share – either about themselves or a family member with fibroids. It was such a common occurrence that she felt at times people forgot these were actual tumors in their bodies. In Bethany’s case, her tumor was so large that it was impinging on her bladder. If she told people she had a large benign tumor in her abdomen instead of a fibroid, they reacted differently. She was shocked by how conditions impacting women were negated as “normal.”
To avoid open abdominal surgery, Bethany had to go to Mayo Clinic. The skilled surgeons were able to do a laparoscopic myomectomy, where they dug into the layers of the uterus to scoop out the tumors, and then re-stitched the uterus. The procedure took seven hours, and the initial recovery was 6 weeks. The pain was horrendous. If Bethany gets pregnant in the future, she will either need a pre-planned c-section or will need to give birth at a major hospital due to the risk of uterine rupture from the surgery. Yet, most people continue to say, “it’s just fibroids.”
As a result of this experience, Bethany left her job in big law and joined Nixon Gwilt Law, the only law firm in the U.S. focused exclusively on healthcare innovation. Bethany’s practice focuses on helping femtech founders revolutionize women’s health so that they can make significant advances in care delivery for women.
In this episode, we discuss…
- [0:01] Bossa Bars
- [0:50] Guest Introduction
- [5:11] Start of Interview
- [5:52] Change in Midlife Femtech
- [9:22] The Vetting of Menopause and Women’s Health Companies
- [13:43] Privacy of Period Trackers
- [17:03] The Accuracy of FDA Approved
- [28:36] The Lack of Women’s Health Products and Femtech
- [38:06] Midlife Trends in Femtech
- [44:45] Privacy and Validity of Telehealth
- [49:13] Closing Thoughts
- [50:32] Outro
Useful Resources:
Bethany’s Website I [https://femtechlawyer.com/]
Bethany’s LinkedIn I [https://www.linkedin.com/in/bethanycorbin/]
Bethany’s Twitter I [https://twitter.com/bethanyacorbin]
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