In short
Founder Feature with Margo Harrison (Wave By) on proactive menstrual health, cycle tracking/bodily autonomy, and Wave By’s OTC-to-FDA drug strategy. The episode also promotes “Opportunity Knocks,” a weekly Startup CPG campaign for startup CPG brands to submit to partners like Whole Foods Market UK.
Guest background
Margo Harrison is a board-certified OBGYN, former NIH-funded academic researcher focused on labor/delivery in low- and middle-income countries, and a Planned Parenthood provider. She has worked with 20+ venture-backed women’s health companies; she graduated residency in 2014 (Columbia/New York).
Key claims
Menstrual cycle understanding enables bodily autonomy and family planning. TikTok/social media are accelerating women’s health education and pushing OBGYNs to adapt. Wave By aims to treat period pain (and later bleeding) proactively premenstrually, unlike reactive symptom management. Inositol (myo- and d-chiro-) supports PCOS cycle regularity; adherence improves via blister-packaging (compared to Z-Pak).
Notable examples
Host’s PCOS cycle reportedly shortened from ~41–48 days to ~31 days after “Irregularity” (inositol) beta product; Wave By’s “start before period onset” approach; FDA meeting preparation described as strategic “game” planning.
Written by AI. May contain mistakes. Listen to the episode to check what was said.
Chapters
Tap a time to open that second in VOUnderstanding Menstrual Health
1:19 to 2:56
Discussion on the importance of understanding sexual and reproductive health for women.
“Because if you don't understand this whole thing that is happening with your body, and that gives you the opportunity to bring life into the world, you don't know how to be in control of it.”
WaveBye's Innovative Approach
3:01 to 3:55
Margo discusses WaveBye's proactive treatment for period pain and its significance.
“Welcome back to the Startup CPG podcast.”
Personal Experiences with Irregular Cycles
3:55 to 5:48
Host shares her personal experience with irregular periods and supplements.
“I tried your irregularity supplement and I only took five of them.”
The Science Behind Inositol
5:48 to 8:12
Margo explains the role of inositol in managing PCOS and menstrual health.
“and inositol is actually a supplement that is better at doing that.”
The Future of Women's Health Products
8:12 to 9:18
Discussion on the growing market for women's health products and their scientific backing.
“But what I think is relevant to what you brought up is we actually tested our products, even though it's going to be regulated and is going through FDA, we did bring beta tester products to market.”
Margo's Journey to WaveBye
9:18 to 11:18
Margo shares her formative experiences that led her to create WaveBye.
“If it's changing lives, you know, we'll have to consider getting it, remaking it or rebuying it again.”
Empowering Women Through Menstrual Knowledge
11:18 to 13:54
Discussion on how understanding menstrual cycles can lead to empowerment and autonomy.
“I became an NIH-funded academic researcher.”
Tracking the Cycle: An Empowering Journey
14:00 to 18:00
Learn about the importance and benefits of tracking menstrual cycles for personal health.
“And once they track a cycle, then they're off to the races.”
The Changing Landscape of Women's Health
18:00 to 24:40
Discover how social media and consumer voices are reshaping women's healthcare interactions.
“And now I experience bloating all the time.”
Navigating FDA Meetings: A Founder's Perspective
24:40 to 28:03
Gain insights on preparing for FDA meetings and the regulatory landscape for startups.
“I think I tried to like capture this on LinkedIn.”
Show all 17 chapters
Realistic Goals for FDA Approval
28:03 to 28:34
Learn about the realistic expectations and goals for FDA approval in drug development.
“Like, I really think it's going to go this way.”
Understanding FDA Approval vs. Supplements
28:34 to 29:38
Discover the differences between FDA approved drugs and traditional supplements.
“And can you tell us what the difference is between being an FDA approved drug versus a traditional supplement that's on the market?”
The Importance of Claims Protection
29:38 to 30:10
Explore the significance of claims protection when marketing drugs.
“But all the science that goes into that, too.”
Proactive vs. Reactive Health Management
30:10 to 31:45
Learn how the new product encourages proactive health management for women.
“Your product would not have that statement on it.”
A New Approach to Period Pain Management
31:45 to 33:16
Understand how the product shifts the paradigm of period pain treatment.
“And can you tell us what the difference your product would be?”
Timeline for Market Release
33:16 to 34:19
Get insights into the expected timeline for the product's market release.
“And so moving people in that mindset, I think, really differentiates us from a huge part of the market that already exists.”
Connecting with Wave Bye and Future Plans
34:19 to 36:28
Find out how to connect with Wave Bye and what they have planned next.
“But I think it's already a highly anticipated product.”
Transcript
Automatic transcript. May contain errors.0:02Did you hear that? That's opportunity knocking. We've been building something big. Introducing Opportunity Knocks, a new campaign giving startup CPG brands exclusive direct access to submit to leading retailers, distributors, investors, media, and more. Here's how it works. On Fridays, a new submission window opens exclusively for active Startup CPG email subscribers. Each campaign features a custom form tailored to that partner. Share your brand story, products, distribution, and traction. Startup CPG delivers your applications directly to the partner's team. Some campaigns include a live fireside chat so you can meet the partner and ask questions directly.
0:44To get every drop, subscribe at startupcpg.com slash OK. That's just the letters O and K. Today's drop is live and it's with Whole Foods Market UK. Ready? Go. Go subscribe. Go submit. Good luck.
1:18We have to have a deep understanding of our sexual and reproductive health. Because if you don't understand this whole thing that is happening with your body, and that gives you the opportunity to bring life into the world, you don't know how to be in control of it. You don't know how to plan a family. You don't know how to avoid pregnancy. You don't know how to get pregnant if you want to get pregnant. And so for me, being an OBGYN is really important to then helping women. They're deeply connected to their menstrual cycle. because to me that ladders up to bodily autonomy and bodily autonomy is required for someone to fulfill their potential.
1:55Hey everybody, this is Caitlin Bricker, Managing Editor at Startup CPG. We are back with another founder feature and today we are getting personal and it's in the best way possible. I'm sitting down with Margo Harrison, founder and CEO of WaveBind, a pharmaceutical company developing a proactive treatment for period pain and bleeding. Margo is a board-certified OBGYN, former NIH-funded academic researcher, and Planned Parenthood provider who's worked with over 20 venture-backed women's health companies. We're diving into why Tracking Your Menstrual Cycle is about bodily autonomy and human potential, how TikTok is pushing women's health forward faster than medical school curriculums, what it's really like preparing for an FDA meeting, and the difference between reactive symptom management and proactive menstrual health.
2:45Plus, we're going to hear a little bit about our own personal experiences with our periods and tracking our cycles, and we hope that it empowers you to do the same. As always, enjoy.
3:00Hey, everybody. Welcome back to the Startup CPG podcast. This is Caitlin, and today I'm here with Margo Harrison, founder of WaveFi. Margo, welcome to the show. Thank you so much. So excited to be here. Thank you for the opportunity. Oh, of course. I have been really, really waiting to have you on the podcast, and I know we've had some missed connections and rescheduling, but such is life. I'm glad we're here and we're doing it now. So before we jump into all things WaveBuy and Margo Harrison, can you tell us just very briefly what WaveBuy is? Way-Fi is a pharmaceutical company. We are bringing to market a novel direct over-the-counter pharmaceutical to treat period pain, and eventually we'll get an approval for bleeding as well.
3:46So we're developing a novel product to be first in market to be proactive and preventative for period pain and bleeding. I am very intrigued. I tried your irregularity supplement and I only took five of them. I'll be completely honest with you. I lost track because I was traveling. My periods went from, I believe it was 41 days, 42 days, 48 day cycles. After five days of taking the irregularity supplement, it went down to 31 days, I believe it was. I had not seen a spike like that ever in my cycles. Now, if I actually stuck to the protocol. I'm like, how is now? What happened after? Did it day?
4:29I'm sort of curious. 31 days, 30 few days. Okay. So it's sort of like. It was like a reset button. That is exactly how I would describe it. I have PCOS, polycystic ovarian syndrome for anybody who's listening. I got a cute little mustache and beard and it's hard to lose weight and like maintain a healthy weight and all those fun things. I am just used to having an irregular period and it's unpredictable. And now I really feel like, OK, I have a handle on this. There's just like just a few day window where I'm like, OK, I could get it this day. I could get it that day. That has not happened to me.
5:02And I don't even know how long. It's amazing. Congratulations on having a more regular cycle. It is a big deal. Thank you. As people listening now and people with PCOS. So that product for people with PCOS who are listening or for others that are curious, the sort of active ingredient in that product that really makes a difference is the inositol. So it's sort of a combination of d-chiroinositol and myo-inositol. And inositol is actually, I don't think it's made it into the American College of OBGYN guidelines yet, but in the Canadian guidelines, they've already made the leap to say that inositol is better for people with PCOS metformin.
5:39So a lot of people are on a prescription drug called metformin. It helps regulate your insulin. It's sort of, PCOS is essentially a metabolic disorder, and it sort of helps with metabolic alignment and insulin resistance. and inositol is actually a supplement that is better at doing that. So our product, that one product that is on the website if people are interested, I call it sort of the miracle ingredient of bioregularity is the inositol because it essentially helps the eggs in the ovaries to function to the best of their ability. And what happens with PCOS and what happens with adolescents and perimenopause is that the body just sort of loses the ability to communicate really effectively between the organs that matter for the menstrual cycle, so the brain and opiaries.
6:24And so it's sort of helping that communication go better by helping the eggs speak louder and more efficiently. And so, yeah, it's a great product. It's evidence-based. The reason that when you take WaveBi products, they work for people and change people's lives in this way is because they were deliberately developed by an OBGYN, which I am, based on evidence to improve people's lives. my life was improved. I mean, I am not exaggerating when I tell you after one dose, which was only two pills. It's not like I was like drinking a huge bottle of something or having to like eat horse pills to make this happen.
6:59I felt activity going on in my stomach, in my uterus, my ovaries. I'm not sure where it was coming from, but something was happening and I was feeling it within a few hours. And I was convinced at that point that, okay, this is working. I just needed to see when my period came. And then, you know, I texted you and I was like, you're not going to believe this, but you're going to believe this because you did create the product. This was the goal. But I was shocked. I was shocked. I had faith that it was going to happen, but I just, it really, it did feel miraculous when that happened for me. That's amazing.
7:36So thank you. Biggest endorsement. Five stars. Fire Regularity. Check it out. 10 out of 10. No, no. I should actually go write you a review. I have a whole list of brands that I need to write reviews for. So thank you for sharing your experience. It's interesting. Like as I started the call, I said we're a pharmaceutical company. We're developing this drug directly over the counter. But sort of an interesting combination between a biotech company and a direct consumer go to market strategy. So a biotech company is creating novel therapeutics, new drugs. And so we are creating a new drug, but it's sort of a direct consumer pathway.
8:10And that sort of gets into investing and feces and why it's hard to fundraise in this space. But what I think is relevant to what you brought up is we actually tested our products, even though it's going to be regulated and is going through FDA, we did bring beta tester products to market. So bioregularity is one of our tester products. And the concept behind it was that it would help women's periods be more regular so that they could time appropriately taking the other medications, which are more. So I said we're first to market and proactive and preventative period pain and bleeding treatment.
8:39So what differentiates our product is a couple of things, the timing, the formulation and the packaging. But the timing is really you start before period onset. And so then a lot of questions come from consumers and investors. How do I know when my period is coming? And I'd love to say a lot of people have irregular periods. And so bioregularity was really developed in order to support a more regular menstrual cycle in order that people could be prepared and take control of the menstrual experience and really have a better one. So our product reduces period pain and also reduces period bleeding based on the research.
9:14So that's where the bioregularity came from. It was a beta testing product. If it's changing lives, you know, we'll have to consider getting it, remaking it or rebuying it again. But I appreciate the support and feedback. And it's always great to see people feeling better. That's the whole goal. I do feel like right now we are seeing a boom with women's health products that are focusing on hormonal health, that are focusing on periods. I have never witnessed something like this previously in a retail setting. now I'm seeing bars, I'm seeing drinks, I'm seeing supplements come up that are not just bullshit, that are actually backed by science and are formulated by a doctor.
9:54So can you tell us more about your background and how you got into creating WaveBi and what inspired this? Yeah, so I guess it's just a question of like how far back we want to go. I mean, I think people probably had their formative experiences. I had a formative experience as a teenager. You know, I traveled abroad and lived with a family in a low-income country and spent some time with a woman that I was living with. And somewhere during this day, she looked at me and she said, we're getting water five times a day. I was college educated. I can speak English. You're like a 15-year-old. You came across the world because you're having teenage angst.
10:32And you're going to go back to this amazing life. And I'm going to be here getting water as a college-educated person. And that was like sort of the formative experience of my life was seeing a woman with a huge amount of potential. And obviously, you know, both highly educated and highly intelligent. She had like forgotten her English. And by the fifth day of me being there, she was fluent again. So clearly somebody with a lot of opportunity contribute and her potential was being wasted. And so that kind of, you know, you don't know this when you're a 15-year-old, but when you're a 30-year-old and you look back at your path and your trajectory and what you've done, you can sort of connect the dots and why you did something.
11:09And so this person, this experience, this witnessing this loss of human potential directed basically the rest of my life. I became an OBGYN. I became an NIH-funded academic researcher. My research was focused on labor and delivery in low - and middle-income countries. I wanted to help women space their pregnancies, survive childbirth, because I think that's the most fundamental piece of being able to then live your life and make decisions on top of that in that setting. So what I believe is that humans have value. Then I believe that women have value. I think a lot of people don't think women have value.
11:46And I believe that humans have potential, but women have potential. And for me, I went into OBGYN because I believe that in order for women to fulfill our potential, we have to have a deep understanding of our sexual and reproductive health. Because if you don't understand this whole thing that is happening with your body and that gives you the opportunity to bring life into the world, you don't know how to be in control of it. You don't know how to plan a family. You don't know how to avoid pregnancy. You don't know how to get pregnant if you want to get pregnant. And so for me, being an OBGYN is really important to then helping women.
12:23They're deeply connected to their menstrual cycle because to me, that ladders up to bodily autonomy and bodily autonomy is required for someone to fulfill their potential. And so that's sort of the through line of what I believe, why I do what I do, why I've created WAVE. So again, WAVE-BY is a product that will start premenstrually. It's the right ingredients, the right drug at the right time to reduce period pain and bleeding, but it's also packaged in a way to support adherence. So it's sort of like a Z-Pak. The Z-Pak is just an antibiotic. It's like whatever. But you put in a Z-Pak and everyone's like, oh, I need a Z-Pak.
12:59Like I have a cold and, you know, it's like a thing. So, you know, WaveBuy is packaging in the blister pack to support adherence. When you package something to help the patient or help the consumer, it increases adherence 40%. So we're creating the right product at the right time for women to embolden them around their menstrual period, but really to embolden them around their cycle. Definitely people are leaning in on cycle tracking, which it sounds like you are too. And if they aren't, I want to help get them there. And so that's really the vision of the company is a world full of women who've achieved bodily autonomy through a deep understanding of the menstrual cycle.
13:33And maybe our product was sort of the gateway or the entryway into understanding that menstrual cycle in order to give them that control. But, you know, the mission is like just make the period better. You menstruate 450 times in your life. It's seven years of your life. That is a huge amount of time to advance your potential or to be blocked in your potential. And so let's give women their time back. But let's also give them a tool that makes them feel so much better that they lean in on really tracking the cycle. And once they track a cycle, then they're off to the races. I could not agree more with you.
14:06And to answer your question, yes, or to confirm what you were saying, yes, I am tracking my cycle now. I'm 36. I didn't start tracking my cycle until I was 30. I started tracking it during the pandemic in 2020. I was never taught how to track a cycle before. I'm not sure my mom was ever taught how to track her cycle. It was never something that was taught in my health class or sex ed classes. and I had this realization as I was tracking my cycles when I was pregnant, found out I was having a daughter, I would go in for my appointments and the doctors would say to me, when was the date of your last period?
14:41And typically I would say to them, I'm not sure. And nobody would ever say back to me, well, you should probably start tracking that. It was just not a big deal. So I never had that encouragement or incentive to track it because if it wasn't a big deal to my doctors why should it be a big deal to me now I'm learning it actually dictates my entire life like I think it should be illegal for anybody to talk to me when I'm in my luteal phase for example just saying I saw a sweatshirt that was in like collegiate letters that just said luteal across it as it would typically say like a university name and I was like okay genius but I have learned so much tracking my cycle.
15:22I'm able to learn when I'm ovulating when before I used to just think, okay, like this discharge must just be like a random thing that happens every now and then. No, it's related to my cycle. I didn't know any of this. And I feel, I feel like I was robbed of an experience being able to track my cycle growing up. I lost out on so many years. I think I got my first period when I was 14, maybe like seventh or eighth grade. I think it was seventh grade. It's maybe like 13, 14. And I didn't start tracking it until I was 30 years old. Now I'm like excited. I don't want to push my daughter growing up by any sense of the word or by any means.
16:03But now I'm excited that when she grows up and she gets her period, she is going to have a lifetime of information to refer back to. And it is just, we are living in such an insane time right now that all of that data that woman can start collecting is so empowering. And I agree with everything you were saying. Yeah. I mean, I have a friend and she started using one of these trackers and she was like, I now feel so much joy when I see my period come because it came when I was expecting it and it makes me feel so connected with my body and who I am. I was expecting it overnight. It came overnight and then she felt like joy.
16:43So it turns your period from something that has been framed traditionally as something that is negative or bad and turns it into like, let me actually understand what's going on and give myself some grace and also like decide if I want to intervene and how I want to intervene and give me that power to do that. So I do think like people are like, my period used to be whatever. And then I had kids and then it was like this and now I'm perimenopausal. It's like these kids, like our daughters are going to know themselves to the point that when something changes, they'll know how it changed, be able to communicate with their physicians so much better than we have been able to do that.
17:21You know, it's such a fraught relationship women with their OBG lens right now, because the education that we had as OBG lens, which just so completely traditional and and really lacked all of this information that women really want now, which is nice because it's pushing the field forward. But I do think that it will allow our daughters to go in and say, like, for 10 years, this was my experience. And now I'm having a different experience in this specific way. And it narrows down symptoms in a way that can raise a flag for a physician. So instead of ovarian cancer being ignored for three years, to be able to say, I'm never bloated, except during my gluteal phase.
18:00And now I experience bloating all the time. Or I was only ever constipated, you know, when I was on my period. And now I'm constipated all the time. I can't poop. And like for that to somehow start to percolate up and to quantify things and give more data is going to allow for a more fruitful relationship because people respect their OBGYNs and want them to help. It's just they have felt hurt by them in the past. And I think it's because they don't have the tools to help the OBGYN better. And the OBGYN certainly doesn't have the training or the data, say like, this is what the research says. So I think it's all headed in the right direction, but it'll be nice for our children to, you know, be able to leverage that data, like you said.
18:42Absolutely. And how long have you been an OBGYN for? I graduated from residency in New York at Columbia in 2014, and now we're in 2026. So. And how do you feel the landscape has changed from your perspective, whether it be working with patients or seeing other pharmaceuticals that are coming out on the market or haven't come out on the market and research? How do you feel it's changed from your perspective? Well, I think the nicest thing was like sort of getting involved in innovation. And I didn't really get involved in innovation until I would say 2022. But since then, I've been privy to sort of the startup world and all of the companies.
19:21I actually started a consulting firm working with venture-backed women's health companies. So I was working with women's health companies as a clinical and a research guide. And so you start to be like part of the social media. You start to see what's out there, following the trends, following the conversations, listening to the CEOs, listening to the non-medical side of things. And it was really nice to have the perspective to be able to take the looking glass and look back at the OBGYN profession and be able to see it from the other side, to see it from the consumer's eyes. And so how I think it's changed is, I mean, probably I believe that the answer is really like social media and people just being willing to share and share their experiences and stories happening and things going viral and probably TikTok changed women's health more than like anyone wants to admit.
20:09But like if somebody can't find their information, that's where they're going. And then they're going to pick the voice that they listen to. So it may be the acupuncturist that gets their ear and it really speaks to them the way that they get it. It may be startup CPG talking about supplements and really that catches the ear and that speaks to them and it has trust in some way that the OBGYN has lost trust because it hasn't been a safe space traditionally for people to really share what's going on with them. And I think that it hasn't been a safe space because the OBGYNs haven't had the proper training.
20:39And nobody wants their doctor to say, I don't know. And that's really what the doctors need to be saying is like, I hear you. I hear what you're going through. I don't have a solution. Let's try to figure it out together. And I don't think doctors are willing to say that. Maybe they are now, but they didn't have the menopause training, the perimenopause training. I mean, now it's all the rage. But like, I think it's really the consumers who are purchasing, are buying, are demanding, are learning, are speaking, are engaging. And that's really pushing the OBGYNs, I think, to stay relevant. And they also are like not bad people.
21:11Like, obviously, they want to help their patients and they're realizing where their gaps are. So I think that the consumer, the woman has moved the field forward in a way that no one else could, giving her a voice and giving her a way to share her experience where other people listen and have a platform is really what has pushed the rest of the world forward. And so I guess what I think has changed is, you know, willingness to talk about things that people weren't willing to talk about for. I don't know that face to face people are 100 percent willing to talk about them, but they're certainly willing to talk about it like on social media where they like don't know who's going to pick it up or whatever.
21:44Which is very interesting, isn't it? It is interesting. And by the way, you are on my FYP on TikTok pretty much every single day. Maybe it's not you, but it's somebody from your team. So nice job. Amazing. Well, thank you for following us and supporting us. Of course. Yeah, I think that's what it is. I think it's really TikTok is the answer, probably. Thank you, TikTok. You know, I think it's one of these topics that has been surrounded by such a taboo for so long. Like periods should be hidden. They're gross. They're this, they're that. It is not the case whatsoever. Like, I do think that the bandaid has been ripped off.
22:23That women feel like they can talk about this in a public space among men, not just among women, and not be shamed for it, which is unbelievable. I see founders who have their sons on Instagram talking about how they understand their mom's cycle now. I'm talking about you, Anastasia, if you're listening. And it's cool, you know, it is great to be able to have that understanding. I've seen videos of their, of fathers with their sons and the sons are saying like, yeah, a girl got her period in school today. So I gave her my sweatshirt to tie around her waist. And I'm like, what? I probably would have just gotten made fun of back in what year was it?
23:02Like, I don't even know. I'm not even going to try to say, but you know what I mean? It's just so different now. Yeah, it's amazing. Well, let's see. I think I started the company, like really started doing stuff for Waves in 2023. I'm trying to remember if it was 23 or 24. Doesn't matter. There's a big Greek Orthodox church across the street from our house and they have like a big Greek festival in June every year. So my kids put out a lemonade stand and they make like 200 bucks because like everyone's just walking right by our house. It's amazing. So I took just an Amazon box and like cut off the thing.
23:36It was literally just a piece of cardboard and rode like way by, like way by to curate pain or something like that. Stop curate pain before it starts and put it on the table. And the people who engaged on it were men. My dad, you know, the girl's mortified and she's standing back. But the dad was like, what is this? My daughter really suffers. And a boyfriend, the girl was also like, why are you asking about my, it was a boyfriend. They care. They live with you. They don't want to talk to you during your luteal phase. You make it miserable for them too. So they want something better for women as well.
24:05I think I totally agree with you. It's really nice to see people stepping up and being willing to talk about it in public. But that was very public space and, you know, pretty religious community and people were definitely engaging. It's music to my ears. It really is just a sign of the times. And you did mention very briefly earlier about the FDA. And I do understand that you have a meeting with the FDA coming up. Can you tell us how you're feeling about that? And how do you prepare for meeting with the FDA? What does that look like? So I am really, really excited. I think I tried to like capture this on LinkedIn.
Read the full transcript
24:44I didn't want to sound like a douchebag when I said it. But like, I think there's a lot of fear around FCA. And especially as a biotech, like what they say, what they want you to do, it really can change the course of the company and how many studies you have to do, how much money you have to spend. And so I think it is very justifiably, very scary thing. You know, I think this is just my own personal thing. The harder something is, the more interesting it is to me. Like part of the reason I'm starting a company is because everything else wasn't interesting enough. This is interesting because it's hard and like something's always happening.
25:16And so it keeps you very interested. And so in a weird way, I'm really interested in the FDA meeting because either it goes really well and that's great for my company or somehow they change the rules of the game. I just, I think of everything as a game. It's all a game. It's probably not the right way to think of it, but it's like, am I winning by like getting an investor? Did I win part of the game? Like when I go to FDA, how's the game going to go? What's the move that they're going to make. And that's just genuinely how it goes inside my head. And because of that, it doesn't feel scary. It just feels like what hard thing is going to come my way and how am I going to solve it?
25:51How am I going to continue to move this incredibly important thing forward, regardless of what happens? So the way that we prepare, it's really interesting. I've been involved with some other companies. I said I was a consultant before and I went to some FDA meetings with other companies. And we did so much preparation, hours and hours of calls, really interesting conversations, really thought provoking conversations, extreme strategy. If they say this, like, here are the five things we could think about. What do we think is the best one? So my current regulatory person is just kind of like, she doesn't do any of that at all.
26:25And I'm like, are we supposed to be like doing this? Like, what are we doing? Like, are we preparing? Like, what are we in the war room? Like, are we strategizing? Like, what's happening? And in a way, I'm like very grateful for it because I think at the end of the day, they're just going to say what they're going to say. And so you deal with it like when you hear what the actual, you know, responses as opposed to driving yourself crazy. And so me and Claude went pretty deep on like how it was to go badly and how we would strategize about what might happen. And so I've done some strategy work, but I'm sort of, I think, really respecting that she's not allowing me to be the impulsive, crazy person I am and start to try to move all the pieces before the pieces have actually been set.
27:06So I think we put our best foot forward. You know, we put an argument forward that we think is respectful of the consumer, is respectful of the over-the-counter status, is respectful that, like, we need to prove the things that we think we should be allowed to say. So I think it respects the game field, the playing field, and it respects sort of the rules of the playing field. And I think is a nice sort of middle road. And so we've put that argument forward. And then next week we get to hear what they think basically of our argument. And so I'm just so excited because I just want someone to put that, you know, we put our stake in the sand.
27:41We just need to know where they are. Are they even on the same playing field as us? Are they on a different playing field? like just hearing from them and how they want to change the game then allows me to work within those new parameters and I think one thing you do with investors is you really you have to be as honest as you can but you put forward like really this is what we asked for and you know I put it at this percentage that they agree with me and you want it to be this you want me to say this other thing and I think that other thing is possible but it's only like three percent possible so like Let's just be realistic.
28:13Like, I really think it's going to go this way. And so I think, you know, having been met with them, I can say they did say this. They did agree with this. They did not agree with this. And so it just helps move us forward in our path because our goal is to get approval, to get this drug on the market and to make 4 billion people's lives better and 8 billion people's lives better vicariously. And can you tell us what the difference is between being an FDA approved drug versus a traditional supplement that's on the market? Yeah, I'm not a regulatory person. So probably somebody else in startup can answer this and they're going to like listen to the podcast and be like, she is wrong.
28:50So, you know, if something goes through FDA approval, I would say the active ingredient in it, you're trying to make a claim about the ingredient. And if you're trying to make a claim about something and say that it actually treats a sickness or an illness or an issue, then it needs FDA approval, which is why like with supplements on syrup CGG, everybody's, you can't claim it works for like a disease or anything like that. You know, you took something like inositol, you could probably make it into an FDA approved drug. You could probably formulate it in some way and put it through an FDA approval process so that you can say it makes periods more regular.
29:26But, you know, if you put inositol on as a supplement, you would have to say something like it's a hormonal support. It provides hormonal support or something like that. Just be really careful about what you say. So, you know, going through FDA approval, at least for something that you're putting inside your body as a therapeutic, is really about, like, was what you're putting in the body safe and effective for what you're saying it is and sort of getting that claims protection from them? But all the science that goes into that, too. Like, if you're putting it in your body and you're saying, like, this dose is affected, are you doing the science and drawing blood on people and actually showing that that dose response does happen?
29:57So I think it's kind of like doing the science to prove the claims versus, you know, but I think somebody else in regulatory can answer that better than me. I think you did a pretty good job. To me, what pops into my mind is when I see a supplement and there's a little asterisk that says this statement has not been like regulated by the FDA or blah, blah, blah. Your product would not have that statement on it. And you'd be able to say this does this. Correct. Our future product. We have one FDA approved drug that we've been selling as a beta product. That's really like a white label product. And then we have supplements.
30:33We do have the hedge of the appropriate FDA not approve this on our supplement products. But yes, we will be going through an approval process. Our product is not supplement. It is a drug. It is a pharmaceutical ingredient. And so we will be showing them that we think it is safe and effective for women to be taken premenstrually. and will have a very specific claim around that, that we can market. It sounds like it is the ultimate seal of approval, aside from getting your consumers to say, this worked for me, if the FDA is saying, okay, all systems go. And then your consumers can say, okay. I think it is a major differentiation point.
31:12And it gives us legitimacy, obviously, with physicians and pharmacies as well. So we care about the ultimate end consumer more than anything else in her life and her cycle and her ability to fulfill her potential. But being able to tell that story to her could go through a number of different channels. And I don't, some companies have very successfully brought supplements into OBQI and offices and created huge exits. But, you know, we do want to be a trusted product by all stakeholders in the women's health system or field or whatever. And yes, mothers are not going to give their daughters a product unless they feel like it's safe and effective for those bodies.
31:48Right. And can you tell us what the difference your product would be? If you were going to compare us to everything else on the market, let's say, everything else on the market, I would argue, is reactive to women's symptoms. So women are waiting. They're like, oh, I don't feel that bad. Like, I'm getting my period today. I got it. I'm on day two. You know, usually day one is the worst. I'm on day two. So I'm just going to go to work. I'm going to be fine. And then she gets to work. And she's like, OK, actually, I feel terrible. She's waiting for that moment when she feels terrible and then she goes fishing around in her purse and finds the little baggie of whatever she brought with her.
32:24And then she takes it and then she feels a little bit better and then hopefully she can get through her big meeting at lunch. Our product is like completely changing that paradigm. We are empowering women to be proactive with their period pain and bleeding management. So that means treating the period before it even starts. So certainly some people get pain and everyone gets PMS. Some people will actually have cramps before the onset of bleeding, but a lot of people might feel okay. And what we're asking FDA for is approval that we can say to that woman who might feel okay, go ahead and take these medicines because when the bleeding comes in a couple of days, your life is going to continue.
33:02And you are not going to get behind and you're not going to be chasing pain. So, you know, I would say the biggest shift here is that we are asking women to take a proactive approach to their health instead of a reactive approach to their health. And so moving people in that mindset, I think, really differentiates us from a huge part of the market that already exists. So we are a medicine. We are similar to some products on the market and different to other ones, but we're a long-acting medication that starts premenstrually. And again, it's sort of differentiated by the system, in the system being the timing, the ingredients, and the packaging.
33:41That sort of makes it female forward or uterus forward for the whole community. And do you have a timeline on if you get your approval, when you could actually go to market with this and when it would be available to the public? Yes. So I think a safe, honest answer to that question is probably late 28, early 29. I think that we're working on a couple of different moves that could maybe make us get to market an earlier 28, early 27. If the meeting doesn't go well next week and we're asked to do a number of other different studies, that could certainly push our timeline out. But I think it's already a highly anticipated product.
34:22People are really excited about it. For those people who've tried our beta products, it's really been life-changing. So we're trying to move as fast as we can to meet demand. All right. So I'm having so much fun learning about you and your journey as a founder. I'm sure other people are going to want to follow along. And I am going to be on the edge of my seat learning what happens with your FDA meeting. I'm hoping you come out with a win and you can say you won and move on to your next win because I've been seeing that you've been having a lot of wins on LinkedIn. So for anybody else who wants to follow along, where can they find you on Instagram, your website and your LinkedIn if you want to share that too?
35:01Yeah. So the company is called Wave By. It's meant to represent Wave By to period pain. So Wave and then B-Y-E. Our socials are at Wave By Inc. I have like an Instagram, I guess, and a TikTok. I haven't been posting that much. It's called at founding underscore Wave By. On LinkedIn, we are Wave By. The Wave and By have a space on LinkedIn. It's two words. So we can search for us on LinkedIn or you can look up me personally, Margo Harrison. Our website is www.wadeby.co. And the website, it should allow you to purchase some beta tester products if you're interested in that. We just sort of updated it with the future product.
35:47People were getting profoundly confused by going to our website. Investors were like, I don't understand what you're building. So we're trying to streamline the stories helling a little bit. So we're working on a rebrand right now. So hopefully we'll have a beautiful website up later this year that really walks people through the timeline. And what we're trying to do introduces the team. And I'd love to give insight into like the manufacturing and some videos of like where we are in that process and how the science is going, like off the lab table and, you know, how the clinical trials are going and stuff like that.
36:16So we'll try to bring people along for the ride. And then, again, we have some tester products that people are interested in trying it out. So you can find us there. please do go and try them out. If you're suffering from anything that I described or that's being described on the website, just give it a try. I can almost guarantee you that you would not regret it and that you will be just as amazed as I was. Thank you, Caitlin. Thank you, Margo. This has been such a fun chat and I'm glad that there are safe spaces and safe people like you to be able to have these discussions. I loved my OB when I was pregnant, but if I could choose to have you as a gynecologist now, I would choose you every single time.
36:57See me at Planned Parenthood in Denver. I still see patients, so happy to see you there. That is good to know. Denver, you heard it here first. Margo, thank you. I'm excited to keep following your journey and good luck. Thank you, Caitlin. Talk to you soon. Bye. CPG BFFs, we've now arrived together at the end of another episode of the Startup CPG podcast. As you may know, we're not just the top globally ranked CPG podcast. We're a community of tens of thousands of CPG founders and experts, and you should join us if you haven't already. Head to startupcpg.com to sign up. You'll get an invite to our Slack community, hear about events near you, and get access to opportunities that connect you with buyers, investors, and other brands.
37:44It's free. So what are you waiting for? I'll see you in Slack and in real life. Thanks for listening.
From the publisher
In this episode of the Startup CPG Podcast, host Caitlin Bricker sits down with Margo Harrison, founder and CEO of Wave Bye — a menstrual health company developing a proactive, OB/GYN-formulated treatment for period pain and bleeding. Margo is a board-certified OB/GYN, former NIH-funded academic researcher at the University of Colorado, Planned Parenthood provider, and founder of a femtech consulting firm that served over twenty venture-backed women's health companies. She brings a rare combination of clinical expertise, research credentials, and startup experience to one of the most underserved categories in consumer health.
Wave Bye is not a supplement and it is not a conventional OTC pain reliever. It is a pharmaceutical-grade product designed to be taken premenstrually — before the pain and bleeding start — shifting women from a reactive approach to their period to a proactive one. With an FDA meeting on the horizon and a pipeline that could reach market as early as 2027, Margo is building something that has never existed before in the over-the-counter space.
Caitlin and Margo get deeply personal in this one — from Caitlin's own experience with PCOS and the impact of Wave Bye's Bioregularity supplement on her cycle, to what it means to grow up never having been taught to track your period, to why TikTok has done more for women's health than medical school curriculums ever did. Margo also walks through the science behind her formulation, what it actually means to seek FDA approval for a drug versus selling a supplement, and why she views the FDA meeting not as something to fear but as the next move in the game.
Listen in as they cover:
- Why bodily autonomy begins with understanding your menstrual cycle — and why that matters for human potential
- How Inositol works for PCOS and why it outperforms Metformin in Canadian clinical guidelines
- What makes Wave Bye different from everything else on the market: timing, formulation, and packaging
- The difference between a reactive approach to period pain and a proactive one — and why it changes everything
- What FDA approval actually means for a consumer health product and why it matters for trust
- How to prepare for an FDA meeting — and why Margo's approach is less war room, more game theory
- Why TikTok is pushing women's health forward faster than the medical establishment
- The moment Margo put a cardboard sign on a lemonade stand table at a Greek festival and the dads were the ones who stopped
- Why tracking your cycle is one of the most empowering things a woman can do — and how our daughters will have it better than we did
- Wave Bye's timeline to market: late 2027 to early 2029 depending on the FDA outcome
Whether you're a founder building in femtech, a consumer navigating your own menstrual health, or someone who has simply never been taught to track their cycle, this episode will leave you informed, empowered, and ready to wave bye to period pain.
Episode Links:
Wave Bye Website: https://www.waveby.co
Instagram: https://www.instagram.com/wavebyeinc/
Margo Harrison on LinkedIn: https://www.linkedin.com/in/margoharrisonmd/
Listen on Spotify: https://open.spotify.com/episode/3lEvr8doFjx89HW382Hy55
Don't forget to leave a five-star review on Apple Podcasts or Spotify if you enjoyed this episode. For potential sponsorship opportunities or to join the Startup CPG community, visit http://www.startupcpg.com.
Show Links:
- Transcripts of each episode are available on the Transistor platform that hosts our podcast here (click on the episode and toggle to “Transcript” at the top)
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- Questions or comments about the episode? Email Daniel at podcast@startupcpg.com
- Episode music by Super Fantastics
