BOV 73 | Solution To Incontinence

 

Allison Watkins, Founder and CEO of Watkins-Conti Products, didn’t know that when she gave birth to, as she would say, “11 pounds of baby,” she would also give birth to a business. After experiencing incontinence and searching for solutions, Allison decided to create a better option. With her indomitable energy and focus, Allison raised money, completed clinical studies, and created Yonifit, a device that comes in 6 sizes for the potential management of SUI symptoms. Learn how Yonifit may solve your problem with SUI (pending FDA approval)! Listen and tune in now!

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Yonifit: The Solution To Incontinence With Allison Watkins

How Delivering An 11-Pound Baby Gave Birth To An Invention For Stress Urinary Incontinence

It’s so fascinating having these conversations every time I learn something that either I didn’t know about a product or an aspect of healthcare. In this episode, we’re speaking to Allison Conti, who is the Founder of Watkins-Conti Products, makers of Yōni.Fit, which is from foreign continents. I was amazed that Allison has done this and implemented clinical trials at Stanford and NYU, all while being a single mother in Oklahoma.

The reason I mentioned that is we know where these big entrepreneurial communities are heavily populated. Imagine that to get to any meeting, you have to leave Oklahoma and you’re a single mom. It’s complicated but she’s amazing. She’s like a juggler and an octopus. She must have eight arms doing all this stuff.

I remember you mentioning an article that was presented in one of the working mom magazines estimating that 1 in 3 women-owned businesses is owned by a mom. Talk about the concept of multitasking, bringing some very needed products to market, navigating the FDA, having a background in marketing and building an entire team and also, fundraising plus raising two kids is not a simple thing. Let’s talk to Allison.

 

BOV 73 | Solution To Incontinence

 

We are so excited to have our guest, Allison Conti. She is the Founder and CEO of Watkins-Conti Products, makers of Yōni.Fit. I’ve had the chance to work with and get to know Allison over the years that she’s been in this space. We are so delighted to have you on the show. Thanks for joining.

Thank you. I’m excited to be here.

You have an amazing story, and so many of the founders we speak to have a vision resulting from a personal experience, and you fall into that category. Why don’t you share with the readers what the impetus was for the creation of Yōni.Fit.

In 2014, I gave birth to a beautiful 11.004-pound baby. While I did not deliver her vaginally, carrying her in that last trimester, I started to experience stress incontinence, which is involuntary urine leakage. I did not know that was going to keep continuing and it wasn’t going to go away. After delivering her, it continuously got worse so I went to a pelvic rehabilitation. I tried some of the biofeedback devices. I was not successful in utilizing these products but they are successful for some women.

It did not work for me. I was in my early 30s and surgery wasn’t a good option for me. I wasn’t recommended that I have a pessary device or urethral sphincter injections weren’t a big thing back then. I was pouring over how to fix my problem and realized whenever I was doing kickboxing and on my period that whenever I wore a tampon, I would have less urine leakage. I started to study that and that’s how Yōni.Fit was born.

I wish you could have seen it for the people reading and I know you saw it, Allison. Alyssa has delivered countless babies and when you said 11 pounds her mouth dropped to the floor. Alyssa, how common is Allison’s experience of suffering stress incontinence during pregnancy and continued after?

I would venture to guess that stress incontinence is not uncommon but an 11-plus-pound baby is a milestone. I’m not sure whom to feel worse, you or your obstetrician but we’ll leave that for another conversation.

I felt justified in my complaints.

You have every right. That is a big baby and oftentimes we speak about the mode of delivery as the real root cause behind stress incontinence, which technically means involuntary leakage of urine with some extra pressure in the intra-abdominal cavity like coughing, sneezing or straining of some sort for those who may not be familiar with the term.

What happens is that if you deliver such a big baby vaginally, there may be some muscle stretching and tissue damage, even nerve damage that can alter the urinary flow. The thought always is, “Wouldn’t a C-section be protective against stress incontinence?” The answer you’ve proven is no, not necessarily. Carrying such a big pregnancy can put somebody at risk.

That’s exactly right. I was surprised that in my conversations with physicians, they didn’t realize that. It didn’t take a vaginal delivery to have this big of a problem. At first, I felt sorry for myself and worked through it, got a solution going and then I realized it’s 1 in 3 women. Some of the doctors say 50% of their patients experience this so I thought, “I have to help these women.”

We know that there are corrective measures that can be taken. It sounds like you ventured into many of them, including the Kegel exercises, more intensive pelvic for physical therapy to help strengthen those muscles and a pessary device. For those who’ve never heard of this, it’s like a little disk or cube that’s placed in the vagina to hold things up and create a little barrier against that intra-abdominal pressure with straining. It’s a surgery that comes with plenty of risks that could be involved and beneficial for some. Tell us about the Yōni device because I haven’t seen it. If you could describe it and its mechanism of action, that would be excellent.

It’s a very flexible and 100% medical-grade silicone. From the outside, it looks a lot like a menstrual cup. We have six different sizes. This is a smaller size. They get rather large but it’s engineered in the interior here to expand once inserted into the vagina and place the right amount of pressure right there at the urethral sphincter through the intravaginal canal. It’s holding everything in place and stops the involuntary flow. You do not have to remove it to urinate, which is nice. I get asked that question quite often. If it’s inserted properly, you shouldn’t be able to feel it at all. It’s extremely comfortable and easy to insert and remove. For me, it changed my life.

Yonifit is a very flexible and 100% medical-grade silicone. From the outside, it looks a lot like a menstrual cup. We have six different sizes. Click To Tweet

Does it work by creating pressure on the urethral sphincter? Does it change the angle of the urethral? Does it tuck up the bladder into the vagina a little bit more or is it simply preventing the pressure or exertion?

A lot of women experience prolapse but they don’t know it is like an early stage one so where we’re starting is intercepting between whenever women very first experience it and it’s gotten so bad then that they’re going to the doctor saying, “What in the world is going on with my body?”

To explain prolapse means that the organs are starting to relax and may descend in the vagina almost to the point where they’re coming outside. An early stage would be a minimal relaxation of those tissues.

For people who are learning this term or are interested in this area of the body or solutions, what are the impacts? What happens when you have either mild, moderate or severe prolapse?

Thankfully, it is not a deadly disease to have a prolapse but it can be physically very uncomfortable. Women find themselves very sensitive to even the slightest relaxation of tissues or organs from the vagina. It also can cause difficulties with regular day-to-day function, whether it’s with urination, leakage of urine or moving the bowels and with sexual activity in which there may be some mechanical issues that get in the way and make sexual activity difficult. This is a big quality of life issue and certainly can cause discomfort.

 

BOV 73 | Solution To Incontinence

 

We’ve talked about this all the time. One of the themes is when a woman is experiencing something, it’s not just one thing. I’ve shared this story before but there are so many things that incontinence could have an impact on. I was doing some research and I heard a woman say, “I am uncomfortable picking up my grandchild because I’m afraid of leakage.”

I thought that was such a fundamental instinct to pick up a child and cuddle with them. I want to go back to how you discovered this. Share a little bit more about your background. You were not an expert in female anatomy prior to doing this. What were you doing? What gave you the confidence to know that you could translate some of those skills into this venture?

I’m an entrepreneur. I started my career in radio in sales, in radio commercials and then I moved to work for a CBS affiliate and did TV commercials so I understood marketing and advertising a little bit. When I became a mom, I started an advertising agency because I was working many hours. Some of my clients came with me and I managed their advertising and marketing and then also started a business in the plumbing and construction trades. I was married at the time so I ran the backside of that business. Once all of this happened and I had my daughter, it was whenever I looked at the numbers and realized how many women had the problem that I thought, “This is a business opportunity.”

It’s funny that you were in plumbing. Did I hear that properly? You’ve gone from one type of plumbing to another, which I find ironic. How did you come up with the actual design? Did you have consultants in biomedical engineering or something along that line?

I was studying. I started with a tampon and it’s easy with a tampon and then I started to look at all the different options that are menstrual cups out there. I went to the Mayo Clinic website and learned about pessaries. I was trying to figure out a way to combine all three of them but the tampon with the cotton didn’t seem a good viable solution when women are on their period. It’s a combination of the pessary devices holding the organs in place with the menstrual cup.

The menstrual cup creates that seal on the cervix to prevent menstrual flow from leaking from the vagina. I knew that I had to figure out a way to not do that. If women were having a weakened pelvic floor, the removal of the device could injure them or create further issues with the organs descending through the vaginal canal. I had to think through that and also how to make it expand and stay in place in the vagina and hold everything in place. I read and it’s fun. All my friends would be like, “Come have a drink.” I’d be like, “No, I have to retain this information.” I drew a picture and hired a lady in Catoosa, Oklahoma to put it in CAD. I paid $600 for a prototype and used it in kickboxing. I learned that I had to make a few modifications and then continued that way.

Is this something that needs a prescription in the future? Is this something that a healthcare practitioner has to place or fit or is it a complete direct-to-consumer product?

First, we’re going prescription and we did conduct a clinical trial. We conducted clinical trials at Stanford, NYU and Thomas Jefferson University. The FDA asked us to manufacture a sham device, which is a device that is supposed to be engineered to be ineffective to prove that there is not a placebo effect. We did a small trial. It was 70 women but the efficacy, the quality-of-life stuff looks beautiful. I’m so excited.

Before we go direct-to-consumer, I want to hear more from the patient. I want to pay careful attention to a postmenopausal demographic. I want to think about comfort, continuously innovate and get it perfect. It’s going to be important to listen to the consumer for the first year maybe and do some more trials of long-term safety stuff and then hopefully, go direct-to-consumer with it.

Alyssa, one of the other themes that come up frequently is it’s wonderful when people can take a lot of healthcare decision-making into their hands. Often at the exclusion of the doctor that sometimes is not a great choice to go from all or nothing. There are lots of issues with delivering modern care that many entrepreneurs and companies are trying to fix. We shouldn’t throw out the baby with the bathwater.

The physician’s support and health and making sure that we’re creating something that’s not just a gimmick but a solution. We’re not all the same.

The physician's support and health are ensuring that we're creating something that's not just a gimmick but a solution. We're not all the same. Click To Tweet

It reminds me of a menstrual disc of diaphragms. These things sometimes do need to be fitted by somebody who can fit them for you rather than relying on a finger breadth. There’s something to measure for yourself what size you may be. As far as menstruation, you did not have to happen to mention that. Is this designed to also collect menstruation or in case, you have a little bit of blood, it will collect that?

It’s not creating that seal. If you are on the heavy days of your period, I wear mine but I have to wear a little panty liner the first couple of days. If you think about the difference between having nothing for your urine and your menstrual flow to having to wear a tiny panty liner, it’s pretty exciting stuff.

Here’s our Hot Flash, which is interesting. The average baby weighs about 7 pounds at birth. About 9% of all babies weigh more than 8 pounds and 13 ounces. Rarely, babies weigh more than 10 pounds.

I’m also super impressed with the caliber of your clinical partners who are studying this. How did you orchestrate that to get such big guns to research a product?

I’ve got the most incredible people making introductions for me. I’m fearless in my pursuit of asking people for help and it’s so amazing. There are many incredible women and supporters of women’s health out there that want to see change and want to help. It’s introductions from incredible people. I was going to say, Karen Drexler introduced me to the PI at Stanford, which was great and exciting for us and then Dr. Benjamin Brucker introduced us to Christina Escobar at NYU. Karolynn Echols through the Women’s Health Innovation Series.

You are in Oklahoma, which is not where people necessarily think is the heart of entrepreneurship. Talk a little bit about some of the sources of funding that you got. You’ve been creative and focused on getting funding. It would be helpful for people to know even when you’re not in New York or San Francisco and it’s hard in those places anyway. What have you done to make this path easier for yourself in terms of fundraising?

I bootstrapped like most entrepreneurs and put my whole life savings into it. My mom was my first investor. She experiences incontinence and it’s close to home for her. I don’t even know how many people I pitched to. I was ruthless with my pursuit and pitching to anybody that would possibly listen to me. Finally, a couple of guys that knew me and my family well, invested and then we were able to prove feasibility.

Once we conducted that feasibility study and proved that this wasn’t just an idea and that it was working for women, we started to get doctors on board as investors. Once we started to get doctors on board as investors, everybody else wanted to jump on board in terms of people that I had pitched previously. We’ve got some venture capital funding, which is exciting for us. That also helps catapult a company forward because its diligence processes are stringent. We uploaded over 1,100 documents on their diligence. That was a big win for us in terms of validating the company in the eyes of others.

Other than the clinical investigators at these amazing centers, do you have a medical advisory board? Do you work with urologists on this or are the studies sufficient?

I’ve got different physicians over the years that have advised me that I’ve gone to anybody that would listen to me. My background being in marketing and plumbing, heating and air companies, it was hard at first. I’m like a crazy person that would schedule appointments for myself as if I were a patient and then I would walk in with an NDA. In my purse, I would have my little Yōni.Fit that I would pull out. All the doctors signed it.

There was not one that said, “No sorry. I’m not signing your NDA.” I would listen. What I would hear over and over again is you’ve got to get through the FDA. This is going to be expensive and hard. I found a public conference at the FDA and flew there. My daughter sat on my lap and my mom came and babysat. I started shaking every hand in the room and still work with some of those people that I met there. It’s all been from the advice of other people.

I have a recollection that you got some money from some organizations in Oklahoma. Am I remembering correctly?

Cortado Ventures. Is that what you’re saying?

No. I thought there was some grant money that you might have gotten.

No, I still haven’t gotten any grant. I need a grant writer.

Here you are, coming from a very different area, pounding the pavement. It’s great for entrepreneurs and investors to hear how creative you could be. That is amazing. We have never heard that story that you go in as a patient so you know you’ll get on their schedule with an NDA and as my dad used to say, “You put yourself in the intersection and then you’ll get hit eventually.” You also did this as a single mom, which you’ve been pretty vocal about.

We talk about how demanding the life of an entrepreneur is. You’re in a space that’s challenging. You’re not in the hotbed geographically of entrepreneurship. You’re raising two children and building a company. How do you do it for people who say, “This is hard,” and then you add that whole other dimension?

Honestly, for me, COVID was such a blessing because it normalized my true life, which is there are always kids in the background. Before I would be like, “If you say a word while I’m on this call, you’re grounded.” They’ll pop in and out. Honestly, that was a huge blessing but I’ve got an incredible community too and friends that help and hang out with the kids while I’m working. It is a grind. It is not easy and at the same time, it’s strange. I feel so lucky that I get to do it. I’ve decided that it’s important that they understand because they see me working all the time. I’ve started bringing them to meetings with me. I bring my son often and sometimes my daughter comes and she thanks me for it.

 

BOV 73 | Solution To Incontinence

 

You’re probably raising some future entrepreneurs, for sure.

I hope they’re retaining something.

I noticed that you’re a member of Chief, as am I for a short two months. It’s super exciting and a great group that’s so inspirational. Did you turn to any networking through that group to facilitate your business?

Absolutely. One of our board members I met through Chief Jennie Martel, who is the Head of Global Brand Protection for Colgate-Palmolive. Her being on board with it, with her diligence in the intellectual property portfolio that she did and her advocacy for that helped us to catapult forward and raise more money once I brought her on. I love Chief.

From a practical standpoint, since this is mostly going to be a prescription product at first, where is your price point here? Do you expect to have insurance coverage? How are you going to navigate that?

I’m working on that. I’m learning. That’s what’s happened. We finished our clinical trials. I started getting the data trickling. I’m pivoting to think about commercialization. I met an incredible woman at JPMorgan who’s going to help with reimbursement, coding and everything. We’re working out all of the things with raw materials. We’ve got to think about not just having one supplier because this is such a huge. problem. I want to make sure that we can manufacture enough raw materials, as I’m sure you know is a challenge sometimes. I want this to be affordable. I can’t say for sure what the price point is yet but I’m going to do my very best to keep it under $100.

When you talk about the six sizes and there are many great stories about people going into pitch menstrual products, you say, “What are the different sizes?” They say, “People have different-sized vaginas as opposed to knowing that the larger sizes are for increased blood flow.” I don’t know if you saw this YouTube video that went viral asking a bunch of men if a woman could urinate while having a tampon in.

They were like, “No, I don’t think so. I’m pretty sure no.” This reflects a lack of knowledge on a lot of dimensions. How do people understand why six sizes? What dimensions are you looking at? How do you know? Is this only something your doctor can tell you in terms of the right size? There are a lot of questions in there.

The smallest size is 34 millimeters and then we’re going up to 50. The reason is we’re all shaped so differently and it’s not based on your address size or what size your Yōni.Fit is. It all depends on prolapse and laxity out of your vaginal canal. I created as much as I thought was needed based on other products in the market. I looked at and researched other things that were out there.

I’m going to give a little anatomy lesson here because I’m still very bothered by whether somebody could urinate with a tampon in. There are three openings. We have to keep that in mind. One of them houses a Yōni.Fit potentially is not where you urinate from. That should suffice. Number two, if you think about that, that’s a manageable size that you’ve mentioned, even the range of six sizes because your standard diaphragm is not that common or popular anymore. The most common size is 75 millimeters and they would go up to 90 and start down as low as 55. That was meant to be a little higher up in the vagina. This is pretty small and I would suggest manageable.

There are so many things when you’re dealing with the FDA. What is your dream target date of having this product on the market and commercially available?

July 23rd, 2023. They may come back and ask for more but we’ve been transparent with them. We’ve communicated a lot with the FDA, listened to them and tried to follow the rules and comply with everything that they’re asking for so fingers crossed.

Share your hashtag, which I happen to love, which you have on T-shirts. One of which I’m lucky enough to own on and on your booth when you’re at different meetings.

Public Cervix Announcement.

We named this Business of the V. We like clever things. In this space, a sense of humor goes a long way. Before we let you go, you’ve given a bunch of advice and I hope people reading are figuring out how to incorporate it into their entrepreneurial journeys. You’ve learned a lot. You’ve done this with two kids. Folks think about how long you’ve been doing this but one of your kids was a baby when you started and one was in elementary school.

If you could give one piece of advice when people hit roadblocks as we all do in any field that we’re in, whether it’s on the entrepreneurship side, the medical care side or investing. What has kept you? I’ve seen you over the years and you always have a smile on your face. For those people who haven’t met you, you’re very genuine. It’s not just a smile that’s painted on. I’m noticing, even in this conversation, that you have a calm. I don’t think I saw it early on and we don’t have to include that but I’m saying you seem so steady. I’m curious. What have you done to keep your emotions in check, not lose sight of the goal and when it’s hard, stay motivated and always have the courage to reach out and be willing to get doors slammed in your face?

Sometimes I feel like a crazy person. The calm is because I’ve seen the clinical trial data. I see the hard work paying off and I’ve heard the testimonials and stuff so it’s a matter of time. Intellectual properties come through but as far as keeping and going, for me, it was not my dream to be the urine leakage lady. I say that because it is so true. It’s this conviction thing where I feel like it’s something I meant to do. It is so personal.

It’s even more than just the leaking, a little bit of urine on your pants. That’s not what it was for me. It was more of the mental health side, stopping, having to worry about people. I was so worried about the odor. “Did anybody know? Could anybody tell what I was wearing?” There’s a calm there that comes with not having to worry about that anymore. Feeling confident that, at the end of the day, if I can help women in that same way, that’s the driver behind it.

There sure are plenty of women who are looking for help. What a great place to end this conversation. I’m looking forward to seeing this in the flesh. Best of luck and we’ll be holding our breath for July 2023.

Thank you so much. I love your show. Rachel, I love you. You’re so awesome and I’m honored that you invited me.

I am in love watching you on this journey and I smile listening to you and all these things that you’ve done. Your determination and passion give me chills. I also love hearing, because I’ve experienced this as well, how collaborative and helpful people in this space tend to be. What you’re doing is hard. It’s always great to have someone who’s helping you get to your goal.

Someday I hope to do the same thing for everyone.

I have no doubt you will.

Thank you, guys.

You’re welcome.

Good to see you.

Good to see you too.

 

Important Links

About Allison Conti

BOV 73 | Solution To IncontinenceAllison Conti, Founder and CEO, Watkins-Conti Products, Inc.

Allison Conti is an entrepreneur and inventor focused on solutions for women’s health and wellbeing at every stage of life. She founded Watkins-Conti Products, Inc., in 2015.

Allison experienced debilitating stress urinary incontinence following the birth of her second child. She quickly discovered that SUI affects one in three women worldwide and can lead to organ prolapse. After extensive research, she learned that the only solutions were surgeries, injections, pessary devices, or adult diapers. It was then that she first conceived of Yoni.Fit – a better solution to stop leaks and support women’s pelvic health.

Yoni.Fit is in the process of FDA clearance, following the successful completion of clinical trials at Stanford University School of Medicine, NYU Langone Medical Center, and Thomas Jefferson University Hospital.

A sought-after speaker, Allison challenges social taboos around stress urinary incontinence, women’s health, and mental wellbeing, and is passionate about elevating female entrepreneurship. She also provides mentorship to women inventors and business builders.

Watkins-Conti Products was named the “Most Promising New Venture” for 2021 by Oklahoma Venture Forum, and a Top Ten Nephrology and Urology Company by MedTech Outlook

 

About Watkins-Conti Products, Inc.

Watkins-Conti Products, Inc., (WCP) is a women’s healthcare company that develops solutions for women’s health and wellbeing at every stage of life. WCP’s flagship product, Yoni.Fit, is a patient-designed solution for stress urinary incontinence, affecting one in three women worldwide. Yoni.Fit is manufactured in the United States and encompasses five utility patents in the United States filed in 17 countries, two design patents, and three trademarks. WCP was named the “Most Promising New Venture” for 2021 by Oklahoma Venture Forum, and a “Top Ten Nephrology and Urology Products Company” by MedTech Outlook.

 

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