A cervical cancer diagnosis in her late 20s came out of nowhere for entrepreneur Rachel Bartholomew. But while her body was in full rebellion, her brain was working overtime. During her recuperation from a full hysterectomy and lymph node removal, she’d connected with thousands of other women dealing with cancer through online support groups where they could share advice and frustrations with the healthcare system. “A lot of women shared really raw, honest feedback,” says Bartholomew.
Their experiences sparked an idea.
Bartholomew was struck by how many women complained about a pelvic floor rehabilitation device known as a vaginal dilator, a stick-like contraption that Bartholemew also found painful and cumbersome. “Everyone was just screaming at the top of their lungs about it,” she says. She did some research and learned that the current crop of dilators hadn’t been significantly updated since the device was put into use in 1938. They still looked like candlesticks and were rather primitive in how they dilated the vaginal tissue.
“I was like, ‘something needs to be done about this,’” says Bartholomew. “This is ridiculous, no wonder everyone hates this.”
Bartholomew started asking other women what they hated about the device and began to develop a prototype of a new type of dilator that would meet their needs. She founded Hyivy Health in 2020 with the aim of certifying her innovative update as a registered medical device. The Hyivy Floora is an ergonomic wand that uses a sensitive air inflation approach to stretch vaginal tissue as well as heat and cold therapy. Connected to an app, it provides real-time data to the individual and the clinician to help women deal with a range of pelvic health issues, such as endometriosis, prolapse, incontinence and radiation-induced vaginal stenosis. The potential market is vast — one in three women experience a pelvic health issue in their lifetime.
The device is poised to enter two clinical trials this spring — one at McMaster University with endometriosis patients and the other at Kitchener’s Grand River Cancer Centre. Bartholomew is working toward having Floora be approved as a medical device. She doesn’t want her device to be another untested wellness product, something that “Gwyneth Paltrow might tell us we’re supposed to do with our bodies,” she says. “I want it to be clinically validated, regulated, determined as safe and effective.” Should the trials and the certification go to plan, the device could be released as early as next year.
Here, Bartholomew talks about her innovation, the lack of funding for women’s health generally, and what changes need to happen to see investment in women’s healthcare progress.
You have many doctors on your team. How did you get them interested in your product?
When undergoing radiation treatment, you’re in the hospital every single day — it becomes your second home. I pitched the idea for Hyivy first to my radiologist. He shared my idea across the radiation pod and my oncologist invited me to chat with her about it. Once I got the clinical validation from the doctors’ side, I just kept asking them who else I should talk to. By the end of the research and development phase, I’d talked to sex therapists, pelvic floor physiotherapists, GPs, ER doctors, oncologists, ob-gyns, radiologists — everybody who could potentially touch this area of the body. I realized how far behind we are in women’s health research and even in understanding what patients go through.
How does your device improve upon the 1938 model that’s still in use?
Pelvic dilators are essentially plastic sticks on a handle. It’s like a Russian doll — they get bigger or smaller as you dilate them up or down. These devices stage up in half inches. So, think about that: you could be at one size, and it feels comfortable and then the next size up could create burning, sharp pain. They are cold, hard, mechanical and really painful. Our device’s dilation system uses air inflation. We can gradually dilate up even less than a millimetre. We paired the dilation system with a pressure sensor that essentially monitors how the patient is responding. We also added heating and cooling, which helps warm or cool the muscles as needed.
Why hasn’t the existing device been updated or adapted?
The understanding of women’s health is so archaic — women are still hearing ‘relax, what’s wrong with you?’ and ‘just drink a glass of wine you’ll be fine’ from healthcare professionals. We’re set up to fail women’s health from the very beginning — from how doctors are trained to how we conduct sex therapy and to how we teach sex education to students. Layer in stigma, and you’ve pretty much set up an entire environment to not treat women properly. Women weren’t even required to be involved in clinical trials until 1993 [in the U.S.; 1997 in Canada], so you have all this research and medication that has largely been tested only on men. It’s like, holy cow, how have we survived?
The investment and research gap in women’s healthcare have been cited among the reasons why women live in chronic ill health longer than men. What would it take to fix that?
I think the needle is starting to move in the doctor community. We still have a long way to go but there’s a lot of people who are fighting to get better research and data. The investment side is a whole other can of worms, unfortunately. This is something I battle with all the time. VCs and investors are largely male. Unless a female is at the table, the understanding of these things just isn’t there, which makes it tough. I’ve been told that a focus on women’s health is niche. But women represent 51 percent of the population, this isn’t a niche market.
I’ve been on calls with investors who bring their daughters or their wives into the conversation to validate what I’m working on. I love to talk about it, because we sit there and bitch about how bad it is, and then they come back and they say, ‘Oh you’ve got a home run here, this is so great’ and then it’s validated. So, thank you wives and daughters, but why do I need this second stage of validation with everything I do?
What would you like to see change to make it easier for you to convince people that investing in women’s health is worthwhile?
The opportunity is there and the numbers speak for themselves. It comes down to education.
Discover more about how innovators are closing the health and wellness gap for women at the MaRS Impact Health summit on May 3 and 4. Tickets are on sale now.
This interview has been edited for clarity.
Photo credit: Hyivy