Femtech Versus Medtech: Reality Check

Everyone thinks their baby is the cutest or the smartest; medical entrepreneurs are no different. Accomplishing medical innovation success is no easy task. Securing approval from regulatory agencies and funders is an incredibly frustrating and lengthy burden for innovators to navigate. Even if the vision is stellar, the barriers to move forward are incredibly challenging to overcome, inhibiting all but the bravest, most determined. While Femtech forums, incubators, and posturers wax on about Femtech efforts to snag millions to enable development of vision, I ponder whether the world at large is missing the big picture and most valuable focal point. Shouldn’t innovating and optimizing health and healthcare be at the forefront of the healthcare conversation regardless the gender innovating? And shouldn’t innovations to address needs in female health that have been long overlooked related to the stigma that still encases some aspects of women’s health be the pivot point?

I was advised a time or two about business in my late twenties by my great uncle Norm. He planted a seed the day he said to me “you come from a long line of strong women.” His comment didn’t strike me immediately, rather echoed in my head for decades and continues to do so to this day. Clearly I am all for equal female everything given my engagement and activities as both advocate and activist in pelvic organ prolapse and vaginal/intimate health energy, zones that remain highly stigmatized. I feel women have every right to chase everything/anything that they feel passionate about achieving. I’ve certainly had my fair share of doors slammed in my face over the years to recognize the ups and downs of innovation. That being said, I often feel that Femtech energy is missing the big picture when they repetitively spotlight funding, rather than focus on the health conditions and issues not being appropriately or sufficiently addressed in today’s continually expanding female healthcare realm.

I get it when it comes to the need for and value of an increase in females engaging in science, technology, engineering, and mathematics (STEM); women certainly have as much intelligence and capacity to innovate outside the box as men. And clearly female innovators understand women’s health issues on a more intimate level. Some amazing women with incredible tenacity have revolutionized foundations of health over the course of their lives. But let’s not forget the men who have provided ground-breaking change in women’s wellness, the pivot point being optimizing health, regardless which sex the visionary is. Let’s take a walk down memory lane, and then shift gears and brain-pick a modern-day female innovator, letting the lines of distinction between Femtech and Medtech blur a bit.

The Greek physician Metrodora refused to follow the traditional path of women in medicine between the third and fifth century in Florence, Italy, steering clear of midwifery. The book she wrote Diseases and Cures of Women, the first alphabetical medical encyclopedia, covers a wide variety of female medical topics. In the twelfth century Salerno, Italy was the nucleus of medicine in Europe, and was famous for having the first medical school with hospitals acquiring a world-wide reputation for excellence. Trotula was a physician and an instructor at the School of Salerno, and is considered the world's first gynecologist. Clearly both of these women were female health focused and certainly game-changers. However, we must acknowledge the value of women innovators in health for the benefit of both sexes, such as Letitia Geer for development of the modern medical syringe in 1899. Marie Curie, the first person and only woman to win the Nobel Prize twice, helping lay the foundation for the development of the x-ray and as well as cancer treatments in the early 1900’s. In 1986 Patricia Bath, both the first African American to finish a residency in ophthalmology in 1973 and the first African American female physician to win a medical patent in 1988, invented a laser-based system that made removal of cataracts more accurate and less painful. In 1991, Ann Tsukamoto developed a technique to isolate stem cells which led to advances in oncology. While not all of these advances are female specific, they all benefit women.

And let’s not overlook the innovations developed by men to advance women’s health. George Nicholas Papanicolaou was the pioneer designing the Papanicolaou test in the 1923 (commonly known as the Pap test), which transformed early detection of cervical cancer. Twenty years later in 1943, the Pap was finally acknowledged as a medical breakthrough. In the late 1950s, Robert Egan devised a method of screening mammography, publishing his results in 1959, and shared his insights in a 1964 book called Mammography. Nobel prize winner Robert Edwards MD developed human in vitro fertilization (IVF), and as a result the first “test-tube” baby was born in 1978 to much fanfare.

Clearly, both women and men have played a significant role in the evolution of health for women. And based on conversations I’ve had with the multitude of innovators I network with, both female and male, they all struggle for funding.

Now let’s take a walk with modern day Medtech visionary, Angela Spang, a medical device innovator, and the founder of June Medical. Spang’s mindset applies Nordic clean, minimalist design to surgical and medical device development. Listening to surgeons and watching their work for over 20 years, Spang uses her knowledge and experience from past corporate involvement at Johnson and Johnson, Endo/American Medical Systems, and AGN International to focus on smart but simple solutions that make surgery easier for surgeons and safer for patients. 

A surgical retractor is used to hold an incision or wound open while a surgeon works. Spang’s Galaxy II is a retractor system which contains disposable retractor rings, sterile elastic hook stays, and catheter drain/clip. The system provides the flexibility and adjustable features needed to have an optimal access to the surgical site. Improved access and vision reduce the risk for injuries and allows the surgeon to operate more efficiently. 

Self-retaining surgical retractors like Spang’s Galaxy II can be small, such as those for eye procedures, or large, such as table mounted retractor systems. The retractor can also be used to hold tissues or organs out of the way during a surgery. Benefits of surgical self-retaining retractors are:

~They free up hands of an assistant.

~They provide improved access to the surgical site.

~There are single handed adjustments in newer models.

~They reduce instrument clutter at the incision.

~The newer models are light-weight and easy to use.

~They reduce the number of staff needed in operating room.

~They provide great visual access for medical students.

The latest innovation Spang has birthed with the assistance of Vivo Surgical is the world's first self-retaining ring retractor with light attachment, Galaxy II? Lux. The LUX light attachment has four unique light strengths to easily adjust to the right intensity as well as angle. Bendable and flexible, LUX literally “shines a light” in surgical spaces and holds its shape throughout surgical procedures, enabling a clear visual of organs and tissues being repaired. Let’s dig a bit deeper into Spang’s history in Medtech.

What made you decide to become a medical device developer?

With 20 years’ experience in large corporations, my experiences with surgical innovation were nothing short of catastrophic. Every single idea we came across and brought into the process was taking forever to get discussed, and then discarded in favor of innovations with higher potential or more “wow” factor. The practical solutions I was interested in rarely made it through the front door. Leading women’s health divisions, it helped me understand the mechanisms behind which innovation gets funded and why. Very rarely women’s health solutions made it to the table, and almost never related to surgical innovation.  

What was your initial vision in developing your first company?

I grew up with parents who each ran their own respective companies, in an entrepreneurial home. I learned business with cookies and milk, and quickly realized that as a business owner, you are the most versatile and cheapest resource – and you’d better learn to work hard.  My vision for my company (related to the medical devices I wanted to make) was simply a solution to a problem. At the time I was running the women’s health division of American Medical Systems (AMS), a Medtech arm of ENDO Pharmaceuticals. The company had just decided to dissemble the UK direct organization and go to an independent distributor after having struggled to really break into the market for many years. I was acutely concerned for what this would mean for the women’s health division – we needed high technical knowledge and we were in a challenging space. At that time there wasn’t a women’s health specific device distributor, so I felt compelled to start one.

Can you share a condensed version of your business history, the first company you founded, and the evolution of your business vision?

When I first brought the idea to my then boss, he immediately dismissed the proposition, saying that would be a crazy move. At the time, I had followed him from a previous company, and having hired me twice, he clearly recognized my value. I continued to reboot the topic like a dog with a bone and finally, during an animated discussion in his office, he burst out laughing, sighed, and said he realized I wasn’t going to let this one go. He was right!  The company then took me through the toughest due diligence process ever, and on Oct 1, 2013 the June Medical UK team accepted the first orders for Monarc transobturator tape. I remember it so well; I even saved that first purchase order – it is framed on the wall in my office.

How many medical devices have you designed and where do your ideas come from? 

I have designed all the products in the Galaxy range, in total 14 different products, with 2 more launching this year. In the middle of the pandemic, I got a call advising me that due to Brexit and MDR rules, a manufacturer had stopped making a piece of tubing for smoke plume evacuation, so I designed one of those too. I ended up creating it slightly differently, taking out some unnecessary plastic weight and added a crush resistant feature, plus an adaptor to fit most machines. The eVeck kit is used for safe removal of smoke plume evacuation from speculums during colposcopy. The smoke can contain virus and cancer cells and can cause enormous damage to both staff and patients if not safely removed during the procedure. 

What roadblocks did you navigate in your first 2 years of developing your first company?

2013 was a challenge in many ways. I lived in Amsterdam with my then 6-year-old, and my husband had a full-time career as well. I had been given Asia, Europe, Middle East and Latin America women’s health, all regions outside the US. Then I simultaneously started June Medical, while I was finishing my 3-month notice period at AMS. At the same time, we were undergoing IVF for infertility – we had tried for another baby since our first was born, but due to a complex medical history, we knew spontaneous pregnancy probably wasn’t in the cards for us. IVF, as anyone who has been through it knows, can be very taxing both mentally and physically (especially for the woman) and we were over the moon when we fell pregnant. But the timing was the worst possible. I was pregnant with our 2nd child when we moved back to the UK 2 days before Christmas in 2014. I was well into pregnancy, managing a startup, handling the renovation of our house, juggling 2 house moves (one of them internationally). Baby number 2 was safely delivered in London in the summer, and as soon as possible, I carefully tucked her into the rocking chair next to my office chair as we set out to grow the business!  

What struggles did you experience as a woman in business? Was funding an issue in the early years?

In the early days in my career, I wasn’t very smooth, and I am sure I rubbed a lot of people the wrong way. I was always more focused on the delivery of the task than the political side of things, and I remember one of my first execs who when leaving that position said that he was really going to miss my capability of getting things done, despite the time he sometimes had to spend picking people up off the floor after I had tackled them on my way to complete the mission. I was both flattered and hurt. He continued to stand by me and helped shape my career (he doesn’t know this – I need to tell him some day). It wasn’t until a different boss complained of my doing the same thing and got me an executive coach (Margot Katz, amazing person, and author of “Tarzan and Jane: How to Thrive in the Corporate Jungle”), that I truly understood that I had strengths that others didn’t, and that I shouldn’t get upset with those around me who didn’t have the same capacity to see the strategic big picture as well as the process needed to complete the task at hand. Now I am continually focused on communicating the goal and the purpose, as well as my plans for how to get there. I will be forever grateful for those lessons; they changed my life in business dramatically.  

Funding has not been an issue for me, simply because I started with my savings, and wanted to grow organically. I haven’t taken on investors, because in my opinion if I wanted to answer to a board and lose the freedom to donate some company monies to charities, why start my own business? I could have stayed employed, which is far safer and easier and included flying business class, paid holidays, a guaranteed salary…all the things that startups don’t generally provide in the early years.

Do you feel held back in your business development because you are a woman?

Not anymore. There have been times when I have been told to wear no makeup, wear my hair tied back and dress in a suit instead of a dress, but now, I have a leadership team where women hold key positions, and I look back at my younger self and realize that the lessons I needed to learn were essential, and not just gender related.  That being said, I firmly believe that we need legislation to create gender-neutral boards and gender-neutral parental leave and will always welcome a debate on the topic with anyone who wants to discuss.  

How do you think we can encourage more women to engage in STEM and move into the Femtech and Medtech spaces?

This is an area where I constantly scratch my head. I have found that a lot more male innovators bring their ideas forward, and I can’t for the life of me figure out why. I KNOW that women are just as innovative, resourceful, and creative, and I see brilliant ideas from female surgeons….but they don’t tend to come forward as much. This is something I actively am trying to change, but I haven’t found the right mechanism yet. I will continue to speak up for STEM and female surgeons and business leaders, and I feel like I am not doing enough.  One of my real pet peeves is when June Medical receives emails from manufacturers or similar corporate entities asking us to buy their products or services, and the email communication is addressed to “Dear Sir(s)”. It may seem like a little thing, but it represents an old fashioned misogynism that makes me furious. We now have a standard copy/paste text for the team to reply to those emails, and it reads like this: 

“There are no Sirs here so I’m afraid you have the wrong email if you only want to address your communication to Men. We are a modern company that happens to have a female CEO, and we promote equality and fairness in race, religion, sexuality, and gender. We are not supporting or collaborating with companies that don’t share our values and follow the law.”

We will continue to fly the flag for female surgeons and business leaders until we have a truly gender-neutral balance. One of the benefits of running your own company is being able to take a stand in matters like these. That, together with our charitable efforts were two of the strongest drivers for me to start my own medical device company. Becoming a global player was not part of the vision, that part just sort of happened!  

Advances in women’s pelvic, vaginal, and intimate health are critical, as is their de-stigmatization. So the question I ponder is shouldn’t our focus be on driving innovation in women’s health in aspects of dire need or health issues shrouded in stigmatized silence, regardless the gender of the innovator or incubator sitting at the helm? Yes, we women deserve to engage in any field of expertise we so desire if our skill set enables us to get the job done effectively. Likewise, we women deserve to be equally paid, equally respected, and in the case of innovators/entrepreneurs, equally funded. At the end of the day, the focus should be on innovation in health, regardless the gender of the innovator, female or male. To dismiss the efforts of men pushing development forward in pandemic aspects of women’s health such as pelvic organ prolapse or stress urinary incontinence treatment is shooting efforts to advance women’s wellness in the foot.

Because the health market is currently ripe in women’s health development, it is also ripe for less than stellar treatments, devices, or procedures that may not optimize solutions. As is the case with any trend, this is a concern. While surgeons are savvy about how to discern the real deal from the snake oil, patients with less access to research, studies, and FDA documentation are not always as able to access accurate information. One of the perks of being a patient advocate and women’s health activist is the opportunity to test various innovations. The majority of the treatments I’ve tried haven’t impressed me much; I don’t have a placebo susceptible cell in my body. Those I test that pass the initial weeks of experimentation have my full attention, but I refrain from judgment until a test period is complete to assure I recognize issues as well as perks. I advise every device innovator who approaches me that I’m not easily amazed, nor do I sugar-coat evaluations. When I see a developer’s name lauded in media related to an innovation that failed to make it past my litmus test, I wince, because I know that while that device is unlikely to do harm, it is doubtful it will help much, wastes the purchaser’s money, and more significantly, depletes hope. The innovator gets a bit of light shined on them, and Femtech is lifted up, but at what cost to women’s health evolution?

As a pelvic organ prolapse patient advocate and a vaginal and intimate health women’s activist, my days (and truth be told, many nights) are filled with concerns about what we aren’t getting done, what we could do better, and what are we missing in the big picture. When 50% of the women of the world have unmet or insufficiently met needs, the status quo must be addressed in any way/shape/form possible. The reality is patients don’t care whether it’s a man or woman who invents the next ground-breaking, mind-blowing, stellar innovation to address unmet needs of any health condition.

The World Health Organization defines health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. At the end of the day, those suffering health concerns, whether they are physical or emotional or both (especially those suffering in silence), simply want to feel good again.

?#APOPS #womenshealthempowerent #EveryVoiceMatters

SHERRIE PALM BIO

Sherrie Palm is the Founder/CEO of Association for Pelvic Organ Prolapse Support (APOPS), a pelvic organ prolapse KOL, a global women's pelvic health advocate, a vaginal and intimate health activist, author of 3 editions of the award winning book Pelvic Organ Prolapse: The Silent Epidemic, and is a national and international speaker on multiple aspects of pelvic organ prolapse quality of life impact.

Sherrie’s points of focus are generating global POP awareness, developing guidance and support structures for women navigating POP, and bridge building within POP healthcare, research, academic, industry, and policy sectors toward the evolution of POP directives.

Additional information about APOPS, pelvic organ prolapse, or Ms. Palm’s book or speaking presentations is available on the APOPS website.

https://www.pelvicorganprolapsesupport.org/sherrie-palm/