Madorra A Non-Hormonal Solution for Vaginal Atrophy:
An Interview with Holly Rockweiler and Ryan Krone of Madorra
As Biodesign Innovation Fellows, what was the need you set out to address?
Holly: We wanted to find a way to treat vaginal atrophy without hormones in breast cancer survivors to improve female sexual function.
What key insight was most important to guiding the design of your solution?
Holly: Thinking about the need, when we told women we were working on vaginal atrophy many would say, ‘Oh my gosh, it’s such a huge problem for me.’ But when we spoke to gynecologists their response was, ‘That’s not really a big deal. Just give them hormones.’ So we uncovered a tension. And when we realized that there were populations who absolutely couldn't use hormones—for example, breast cancer survivors—we felt compelled to do something for these women.
“When we told women we were working on vaginal atrophy many would say, ‘Oh my gosh, it’s such a huge problem for me.’”
Ryan: We realized how significantly it affected their quality of life. And if we were to solve it, it would make a big difference to a lot of people.
Holly: From a solution perspective, we learned that available treatments had either focused on hormone replacement or downstream on lubrication. But no one seemed to be thinking about how to replicate what hormones do which, among other things, is to help maintain vaginal blood flow. We understood the importance of vaginal blood flow from the literature, and it really helped guide us when it was time to start thinking about how to address the need.
How does your solution work?
Holly: It works by reengaging the body's natural mechanism of lubricating the vaginal canal through vaginal blood flow.
Our device uses therapeutic ultrasound to generate a deep heat within the vaginal tissue that can conduct 5 to 8 centimeters deep without the device itself having to be inside. That increase in temperature creates more blood flow, which naturally brings about more lubrication.
Ryan: Through all of our research, we knew our solution would have to promote vaginal blood flow. And we heard from women that they didn’t want a solution that required insertion. And it couldn’t be a drug. So that really only gave us a few options. And luckily this one works.
At what stage of development is the solution?
Holly: We've done three clinical studies with earlier versions of the Madorra therapy. Now we're gearing up to do our pivotal study, which we will use to support our de novo clearance with the FDA.
Ryan: One thing that has been especially great is to see the patient response to our studies. As one of our clinical advisors, Dr. Shannon MacLaughlin, put it, ‘In clinical research it's rare that a study meets accrual easily, but we have seen phenomenal interest and enthusiasm from women to participate.’” And a nurse practitioner at the Stanford Cancer Center told us, ‘I didn’t realize how big of a problem this is. I’ve never seen a study flier with all of the pull tabs removed.’”
Reflecting on your experience, what advice do you have for other health technology innovators?
Holly: It can be very daunting to think about everything you have to do to develop a product and bring it into patient care. But as another fellowship alum likes to tell me, ‘How do you climb a mountain? One step at a time.’
“All the hard work is worth it when you see that you’re helping patients.”
Ryan: Don’t get dissuaded too early because your project is going to continue to morph. Some things will end up being harder than you expect, and others will end up being easier.
Holly: But at the end of the day, all the hard work is worth it when you have women from our studies saying things like, ‘Please change the world for women you guys. I cannot wait to have this product back in my life!’” [Quote provided to the Madorra team by a study participant.]
Holly Rockweiler and Ryan Krone founded Madorra out of the Biodesign Innovation Fellowship in 2014. To learn more, visit the Madorra website.
Disclaimer of Endorsement: All references to specific products, companies, or services, including links to external sites, are for educational purposes only and do not constitute or imply an endorsement by the Byers Center for Biodesign or Stanford University.