Ever wondered what it’s like to pitch a product that women put in their vaginas to male investors? Find out in this episode of Pitch Please! In this episode we dive into the world of Hyivy, a groundbreaking medical device company that is revolutionizing women’s healthcare. Our guest, Rachel Bartholomew, the CEO and founder of Hyivy, shares her inspiring journey from cancer survivor to entrepreneur, and how her personal experience led her to create a solution that addresses the challenges faced by women with pelvic-based cancers and diseases.
In this episode, Rachel discusses the challenges and rewards of medical device innovation, highlighting the complexities of developing and bringing a medical device to market. She also shares her vision of empowering doctors and patients alike, and the importance of clinical research in the journey towards launching Hyivy.
We explore the unique features of Hyivy’s intelligent pelvic rehab device and its potential to transform the lives of women. Rachel takes us through the exciting moments of uncovering groundbreaking data and the endless memorable moments of pitching a product that challenges societal norms.
Don’t miss out on this captivating episode as we delve into the compelling moments that prompted Rachel to start Hyivy and her unwavering passion to revolutionize women’s health. Tune in to discover how Hyivy is reshaping the landscape of medical device innovation and paving the way for a brighter future in women’s healthcare.
Mike Flywheel: What’s up everybody. It’s Mike we’re back here on the pitch please podcast today. We’ve got Rachel from Hyivy; they’re an intelligent pelvic rehab device for women with pelvic based cancers and diseases. Um, that’s my high level summary of it. She’s going to give you way more detail and a way better pitch than me. Let’s welcome to the show Rachel Rachel if you want to kick us off with a quick background of your role at Hyivy and maybe a little bit about yourself.
Rachel Bartholomew: Hi Mike thanks for having me and thanks to the audience for taking a listen. My name is Rachel Bartholomew I am the CEO and the founder of Hyivy Health. Essentially, Hyivy was birthed out of a pretty unfortunate situation. When I was 28 years old, I was diagnosed with cervical cancer. And I was handed an 84 year old technology post-cancer to help with you know all of my symptoms that I was going to deal with after the fact. And you know, digging into women’s health, I realized that was like you know it’s not just this. It’s everything in women’s health. Um, and I…you know wanted to innovate and change that narrative, so I created a medical device that conducts a number of different therapies but also monitors a number of gynecological conditions and yeah, the rest is…the rest is history.
Mike Flywheel: Obviously a very pivotal moment that inspired this so I’ll want to talk about that as well. But maybe let’s talk about your time before your you know, big role as founder and CEO of Hyivy. What were sort of the things that you were doing and skills you were building over your time and career journey, and life experiences that maybe have readied you or maybe haven’t fully readied you even for some of the things you’re tackling today.
Rachel Bartholomew: Hundred percent so I come from a family of entrepreneurs. So I think that really was always there. I’ve always been a risk taker; I actually raced motocross. When I was a a small child up until 18 when my mom said you’re not allowed to be on a bike anymore when I got really hurt so you know I’ve always been a risk taker and I’ve been around you know family and people who are risk takers. So I’m used to that environment. And as I started to get into to school I actually had a small slight career as a musician making music and learned how to promote myself from my dorm room, um, ended up becoming a top charting musician one hit wonder. Um, did a bunch of radio shows around the world at like 18-19 years old which is crazy but really learn like that entrepreneurial marketing like get out there put yourself out there be creative, um, kind of you know, ah, personality I guess you could say that. Inspires entrepreneurs and then I was doing my undergrad in business and finished that up and kind of wanted to know what was next didn’t really want to do an MBA. Um, so I actually did masters of business entrepreneurship and technology at Waterloo.
Rachel Bartholomew: Ah, very different essentially in the first week you’re told to come up with a pitch idea in the first week for 5 minutes. Um I took what I knew and at the time was ah, not racing motorcycles but now racing cars. So I actually got into the car world and just pitched an idea of essentially a need for speed but with your own car to be able to modify it virtually using VR and AR um. And that kind of kicked off a journey of a company called the maud market that I started for 5 years. Um, that was kind of my first venture alone into the world of of startup land. I did end up exiting that company and it was a whirlwind of a journey I always joke that. I messed up so many times that it’s like a standup comedian um level amount of of mess ups. Um, but really learned you know what I should and shouldn’t be doing when I do this again, but you know I didn’t I really want to do this again and it kind of fell into my lap and as an innovator I kind of got forced against my will to go down and just have to try to fix a problem. In the intermediary between all of that, I taught entrepreneurship to quantum computing students postdocs which was very interesting for 6 years. I was an entrepreneurial advisor at the university of Waterloo for a couple years. Ah I was an innovation manager at a financial institution. So I got to play in the innovation lab space and then I ran Wilford Laurier’s startup incubator for a bit so I’ve gotten all of the innovation entrepreneurship ego system landscape stuff. Um, and yeah, just ended up being crazy and starting another company. Yeah.
Mike Flywheel: Wow Um I’m like trying to it’s fine. We’re good I’m trying to chunk out all the different parts in my mind because I was like I don’t want to interrupt but I’ve got a ton of questions.
Rachel Bartholomew: Um, sorry um. Ah, yes, go for it? Yeah yeah, okay yeah.
Mike Flywheel: Rich experience in entrepreneurship and we will talk about that and I’m sure you’ve got lots of advice but like let’s go way back. So like motocross and you did this for like ah until you were 18 and like we’re talking like motorcycles going off dirt jumps or like motorcycles on tracks like.
Rachel Bartholomew: Yeah, yes, yes, yes.
Mike Flywheel: What got you into that? You just naturally wanted to start that or you just my bike’s not fast enough like ah how did that start? yeah.
Rachel Bartholomew: Yeah, so I mean as a kid I rode horses and then I guess horses weren’t tasked enough I don’t know are not you know, gnarly enough I guess um, no my my father was a he erased moocross back in the day back in the the 60-70s and so. Um, naturally got a star bikes. We lived out on a farm and we had the space to do it. We loved it and we’re like hey we can start racing and so I was like 8 or 9 my brother was even younger and we just fell in love with it and it became. Every single day like I was training with professionals. Um I was going across Canada in the Us racing. Um, so yeah I mean it became part of my everyday lifestyle and it kept me from partying as a high school student. So I guess that’s a good thing.
Mike Flywheel: Well, it sounds like a lot of fun I Know how excited I get just getting like a little bit of air on a normal bicycle. So I imagine just amplify that and it’s insane. So somehow you went from that to also becoming.
Rachel Bartholomew: Ah, yeah, yeah.
Mike Flywheel: Ah, you called yourself a one hit wonder. Maybe you’ve got other hits too? But ah, an artist out of your dorm room. What was like was your artist name too? Like did you have an artist name? What was the song, what type of music was this? What kind of instruments did you play? So many questions!
Rachel Bartholomew:
Yeah, yeah. Ah, you you’re calling me out right now Mike and this is information I tried to keep on the down low. I guess it shouldn’t have shared it. Um, okay so I was an electronic music deejay back when like EDM was just becoming a thing.
Mike Flywheel: So you were the real deadmau5, hey.
Rachel Bartholomew: I did more. It when deadmau5 was going out so I actually stood hang out in kind of the DJ roof with him as well. But um, yeah, so I was in the Toronto scene, I deejayed it on Queen Street specifically, but I also produced and then I stopped. Doing more DJing and more producing. Um, and so I had a ah one hit wonder called Roll Roads. It’s on Spotify. Oh no, oh no on my my name is kill pixie. Um.
Mike Flywheel: Hold on. Don’t don’t don’t go too fast because I’m literally adding this to my playlist.
Mike Flywheel: Okay, Rachel I need to know what was the name of your your artist name or dj name. What was the name of this song that made you famous I’m sure yes, are curious. They probably have Spotify open right now or Youtube or let us know we’re going to find it by the way. But tell tell us a little bit about it. Ah Rachel you.
Rachel Bartholomew: You’re calling me out right now. Um I try to not talk about these things. It’s fine. Um, so my my deejay name was kill pixie on k I l l p I x x I e on Spotify, Apple music I guess all the things. Um, essentially I came up with the name from an Australian graffiti artist who had a character called killpixy and yeah, so I was creating electronic music. Ah, back in the day back in the you know early deadmau5 days. Um got to party with him a bit too which is kind of cool, but I was I was nineteen so I couldn’t even enter the clubs in the US. But um, yeah I started deejaying I got to do a bunch of um,
radio shows in Europe. And I was on a label called Liquid Music in Miami and I had a one hit wonder I guess you could call it. We got to the top of the charts. Um called Rural Roads. And yeah, it was a lot of fun I really got to learn. You know how to market myself and how to put myself out there and um, yeah, and and really be creative and keep that kind of momentum flowing and ultimately you know did this out of my dorm room. Um in between lectures. So.
Mike Flywheel: So impressive, Um, combining those experiences with like what is probably most than most more than most people have in their life. But then you also had this like massive spectrum of entrepreneurship learnings and involvement.
Rachel Bartholomew: Thank you. No.
Mike Flywheel: Um, is there like something along that journey that really stands out to you as guidance for others that maybe haven’t had all those experiences or maybe the guidance is go be a dja then an entrepreneur I’m not sure but like you know is there something that you you know, really stood out for you.
Rachel Bartholomew: Oh goodness where do I start? Um I think you know entrepreneurship is really about finding something. You’re truly passionate about solving right? and it’s not so much about. The actual solution and you know what you’re what you’re Creating. It’s about like falling in love with a problem and everything is rooted in problems. Um, and sometimes those problems you know aren’t significant. Sometimes those problems are you know. A smaller piece of a larger puzzle. Um, sometimes those problems and are not yours right? So um, you know when working in an innovation lab I’m solving problems for the bank I’m working for um, you know you’re you’re digging into stuff that you just never have experienced before versus. You know, starting a company from something that you’re super passionate about um and then sometimes you fall out of love with those problems. Um, and that kind of happened with my first company is I kind of knew that I was the anchor to the company and I needed to hand it over for it to kind of live in its next form and Stage. So. I Think that’s kind of the biggest piece I think the other piece is um I always say taking a risk is not jumping off a cliff without a parachute like you can do these things without feeling like you’re going in completely Blind. Um.
Rachel Bartholomew: And the last thing that I’ve always you know, played to I guess you could say was you don’t have to be an expert in things to do it. You know there’s that kind of like I Forget what they call it.. There’s a certain. Thing where it’s like you go into something and you’re not the expert in it and you feel like you’re almost faking it. But in reality yeah imposter Exactly that’s what I was thinking of imposter syndrome. You know I don’t think that that’s a thing and entrepreneurship because in reality um some of the best.
Mike Flywheel: Like Imposter syndrome a little bit.
Rachel Bartholomew: Best ways to get to know something is to not have those walls and those barriers around certain industries and and that experience right? So you know going into a financial institution. Never like never knew anything about that right teaching Quantum computing you know students um about entrepreneurship. Know nothing about Quantum computing Still don’t really know anything about Quantum computing right? Um, and then you know, starting a health care company as a patient that’s never touched the health care industry at all. Um. You know you’re you’re learning as you’re going and I think it’s all about the attitude and how you are as a person to be able to say Okay I’ve learned that what else don’t I know and how do I solve that right? yeah.
Mike Flywheel: Um, I think that’s great advice because um, there’s a few things 1 you’ve you’ve had an amazing set of experiences that have helped you build up some of this confidence around entrepreneurship. But there’s so many people that I’ve talked to that are like especially in the first couple years of most companies.
Rachel Bartholomew: Yeah, yeah.
Mike Flywheel: You’re going to be a generalist and you aren’t going to know everything about everything but actually the most important thing is that you’re the type of person that says I’m going to figure it out and I’m willing to learn and try because specialists you don’t have the luxury of hiring specialists at everything. Um, when resources are constrained so you need actually really um, strong generalists with a willingness to learn and try new things and so I think that’s good guidance which is maybe don’t um, trip yourself up too early in the process. Don’t worry about what you don’t know or that you aren’t the right person.
Rachel Bartholomew: So again.
Mike Flywheel: If you’ve got the passion and conviction take that step and um it pairs with something else I’ve heard often which is just start by putting one foot in front of the other don’t don’t get overwhelmed by it. So it’s really really great advice now you sort of have always been on this destined path to be an entrepreneur.
Rachel Bartholomew: Nope.
Mike Flywheel: Ah, so you’ve been in this space. You’ve had, you know, people around you that have really influenced your desire to become an entrepreneur. I want to talk about Hyivy a little bit so maybe let’s start with a pitch. Of what Hyivy is, and then I really want to understand the background and the compelling moments that prompted you to start this business I know you talked a little bit about your your fight with cancer back when you were 28 and that was one element of it. But you know you’ve talked about the element of “Am I the one to solve this?” And so I really want to talk about that piece as well and even learn about Hyivy, but let’s start with the pitch. We’re on a show called Pitch Please, so Rachel your best pitch please.
Rachel Bartholomew: Um, oh boy. Okay, so 1 in 3 women will deal with some sort of pelvic health condition in her lifetime. So when you think of your mother, your sister, your grandmother, your wife… at least 1 of them is dealing with some sort of pelvic health condition, yet a lot of this goes unanswered and is not talked about right? And so when you dig into this further, you realize that women don’t have very many options. The device that I was given through my cancer journey you know was an 84 year old device that hasn’t been innovated on. And you pair that with OBGYNs and you know other healthcare practitioners seeing a 35% increase in demand for pelvic health treatments and using finger measurements to essentially get data. We’re living in the stone age for women and so what we wanted to do was create something that not only provided a more comfortable therapy that brings this therapy into the twenty first century but also pairs that with a number of data points we can collect. And so we have a device, I’ve got one here, essentially conducts a number of different therapeutics similar to what you do other places in the body hot and cold packs on your shoulders same concept here.
Rachel Bartholomew: Massage, stretching with dilation, and drug delivery and lubrication that’s paired with simple sensors, temperature pressure moisture that essentially looks at a number of different indicators to say how is this body doing, how is this body recovering. And where can we go and how can we predict potentially things that could happen. And we pair that with a mobile app where we collect self-reported data and then we send that all of that data in a package to a software that the clinician uses to essentially remote therapeutic monitor the patients. So I like to say, think of it as a CPAP machine for women in their pelvic floor and…
Mike Flywheel: Wow, It’s super complex. Lots of different pieces. Software, hardware, innovation, data healthcare. Um, maybe let’s start on the simplest of these, which is like how did you arrive at the name Hyivy? And then we’ll talk a little bit about that that journey and even kind of getting this started.
Rachel Bartholomew: Yeah, yeah, sounds good. So I came up with a company when I had just finished my first set of treatment which was a hysterectomy which is essentially the removal of your your female organs. Um, this was to kind of cut the cancer out of my body. Um, and it was a very invasive experience and in Canada we only do open up Dominol. So. It’s actually hip to hip cut cut open um lots of scar tissue. Lots of issues. Lots of sensitivity and and these types of problems and so um. When I was on my bed rest waiting to kind of recover I started connecting with these Facebook groups of women. Um and really saw that it was a number of different women that were dealing with these problems and I thought initially was hysterectomies only um. And so hence the H-Y in Hyivy um, based in hysterectomy and then when I was playing on words I came up with ivy because when you actually look at the ivy leaf which I have one in the back here on. It’s actually in the shape of a uterus and the fallopian tubes as the um, kind of ivy ah vines I guess you could say and it just clicked and it was kind of like “Hi pelvic health” “Hi gynecology” “Hi women’s health”.
Rachel Bartholomew: You know those were the kind of play on words I was playing with it and then you know I realized very quickly. It was way beyond just hysterectomies. But um, that kind of paired into digging into the cancer side digging into it’s also menopause. It’s also post-partum. It’s all of these different things. Um, so it’s based in hysterectomies but it it doesn’t stop there.
Mike Flywheel: I think what’s cool about that is even in just the sharing of your naming. You just talked about um your learning that you just talked about a few seconds or minutes earlier which is like sometimes you know you think you know some things and you don’t know it all. But you’re willing to evolve and change and I think you. Did that as part of the name. Um, which is which is super cool now you made that sound like this is just like 1 sit down where you just like oh look inspired by some ivy oh I have h I from hysterectomy I’ll just joining them together like.
Rachel Bartholomew: Um, yeah.
Mike Flywheel: I laugh about it but I always want to know like how long it took businesses to come up with their name, because some people like yeah, were just like you. We just knew, we’ve always known or some people are like we spend months on this or we’ve paid thousands of dollars for this. Was this, like, simple for you or or did it kind of come naturally as you were kind of getting things started?
Rachel Bartholomew: Um, I will say I’m sure the drugs helped as a part of the recovery process. You know I’m kidding I’m kidding. No I mean you know having a point in time where. My body was shut off my my brain had to be active right? and I I was going through something so traumatic that I almost latched on to solving a problem and um, doing all the things that you have to do at the start of a startup like. Primary secondary research as a way to distract myself about what I was going through right? So you know the creativity side is is a fun side and it gets your brain. You know I guess the right side of your brain going? Um, but you know the idea really came out of um. Connecting with these women on Facebook talking to them. You know on an ongoing basis seeing the problems that they were going through that weren’t just my problems. Um I had actually dealt with some of these issues prior not cancer but different kind of area and was given this device 11 years prior and what I found out that I would have to literally like brush the dust off of it to bring it back out again. I was like okay, it’s been eleven years like have we done anything about this and as I started to research I realized like all of these patients were dealing with it.
Rachel Bartholomew: Nothing else has changed then I found out that it hasn’t changed for 84 years and I’m like are you kidding me and at that point in time when I had done that kind of secondary research and some of that primary with the patients I had started my radiation treatments and so i. In radiation, you’re in the hospital every day to get treatment and I looked at it as the perfect opportunity to talk to doctors because you’re not going to be around that many doctors that often in your life unless you work in healthcare and I don’t so. I use that opportunity to actually pitch to a lot of the doctors. Um I always make a joke that like I was laying on the radiation table and Bruce who is my radiologist was like aligning me up under the machine and could leave my side so I’m like perfect he has to listen to me here’s my pitch and um. Had a really crappy powerpoint and a really crappy mockup of like clip art of a product and I just kind of pitched the idea and he shared it across the radiation pods. It got back to my oncologist who called me in I thought I was like dying or something but in reality it was that. Um, she wanted to chat about what I was I was thinking and working on and what I always made sure to do because they don’t come from this world was who else should I talk to and that allowed me to not just work in the cancer space and talk to all of the doctors in the cancer space. But
Rachel Bartholomew: Get in front of like gerontologists ob bgyns yeah er doctors sex therapists physiotherapists like everybody who works in this space and touches this this patient group and I just kept asking who else should I talk to and. That was the 1 thing that I felt I failed at at my first company that you know they always say what is it Steve Blank tells you to get out of the get out of the room get out of the office and go out and talk to people right? That’s like his Rahrah rah thing. And I was always like all this is business school stuff like who cares? Um, and I I truly like in my first company failed at that and I said I am not going to invest $1 in this company unless I’ve talked to like x number of people about this and surprisingly like. People love to talk so you ask them questions. Youll let them go. They’re going to divulge way too much stuff. Um, and stuff that’s going to be truly helpful for you right? So I think that was where I knew I had a clinician and a patient problem to solve.
Mike Flywheel: That’s super cool. Ah to your point you know people talk we now know about kill pixie. But um I think I think there is a really good learning there which um, you know back to that entrepreneurial advice which is. Before you focus on trying to build something or even if you are building something trying to build it to perfection get input and feedback along the way that’s the concept of you know you’re talking pre-mvp almost Mark your research but from from actual people not just binging and googling. Um, but then when you start to have a product getting lots of people to weigh in and give their thoughts and give their advice which will help make it real and then when you have an Mvp people paying for something when it’s not perfect actually gives you market validation that is like this is a real problem because if people only pay when it’s perfect. It’s not a big enough problem. Usually. Um, so I think that’s really like great advice ah to to share now the the product itself where are you at actually before before we go there. You talked about like the thinking about this problem. Doesn’t mean that you make the leap to make a business out of this was there a moment where all of the thinking and discussion.
Mike Flywheel: Turned into you Rachel are going to embark on a journey to make this your next startup and a business problem. You need to go solve.
Rachel Bartholomew: Yeah, so this gets into a big conversation around women’s health and it’s not just my area. It’s many areas. There’s a lot of white spaces and a lot of problems to solve. Um. You know I think fundamentally at the core I want to solve this problem for myself selfishly right? Um, and then you know you hope you help a couple million women in the process. But I think as I started to talk to doctors and I realized like the amount of doctors that told me. I give a bunch of drugs across my desk to research I never get devices and I even had some doctors tell me that before the current innovation which is literally plastic stick on a handle eighty four years old existed. You see as glass test tubes and still use glass test tubes and inside the body to do this therapy. Yeah and pair that with what the women were saying and some of that fundamental research digging. Realizing that a like we don’t even understand the anatomy in women’s health right? You look you just Google you know women’s reproductive organs and you’re going to see every shape and size under the sun like nobody’s got this right? pair that with research that’s just.
Rachel Bartholomew: Fundamentally, not there women. We’re not supposed to be a part of or were not required to be a part of clinical trials until 9094 so we just passed thirty years right pair this with just grin and bear it women like you know you’re in pain drink a glass of wine. Relax a little and women just screaming saying this is this is not natural. There’s nothing about this and I’m divorcing my husband’s I’m thinking about suicide I’m thinking about all of these things and it’s. You fundamentally go like somebody’s got to do something about this right? and you dig in more and more and you realize like we don’t understand the anatomy. We don’t understand the fundamentals here like somebody’s got to do it right? and like okay. If I’m going to do this might as well make a business out of it in the process. Um, so part of that process was gathering information about how the the logistics of the business and selling devices and you know direct consumer versus medical device works and um, you know started to get out. Into pitch competitions and starting to pitch this a little bit more out there and winning competitions and realizing okay people also kind of think I have a business here too. Um, so I think it naturally morphed that way and that was kind of the first six months of the company. Um, it was crazy because i.
Rachel Bartholomew: Won a bunch of pitch competitions one was in New York I packed a box to move to New York right when covid hit New York and I was 3 3 people on a plane. Um I had gotten a new apartment The whole place was a ghost town and everything shut down like the whole incubator everything and I had to pack my box up and jump the border back again because I get stuck there. Um and covid hit and everything shut down and I like to say that. As much as it was so difficult to create a product when you need to be physically in-person holding things interacting with things. It was also a great time for us to understand what do we know? What do we not know what do we not know that we not know kind of thing and. How can we fundamentally start to answer these questions. Well we all sit in a room bored to tears. So it was a perfect time for us in that first year of covid and that first year of business um to understand what do we want in a product and we went out and. It’s so funny. We went to sex toy stores and bought a bunch of stuff and hacked them apart and built stuff and then I essentially I called them like our little. We look like drug dealers like we’d be in a parking lot with our masks on and like our hoods up and like covered and we’d hand a bag over to like my electronics.
Rachel Bartholomew: Person or like my one of the other girls on my team who would test these products and you know do an exchange and then leave Um, but that’s how we got it done and that’s how we like did fundamental product research and um. Kind of that initial anatomy and and body research that we needed while being in complete lockdown. Yeah.
Mike Flywheel: That’s a crazy story. Um, how, so what stage are you at so like this sounds like COVID. It’s obviously a few years behind us from that Moment. You boarded the plane and then boarded the plane back with your your box. Um. How long has Hyivy, have you been around? What sort of stage are you at because it sounds like then you were still tearing apart sex toys and and doing a lot of research and understanding and figuring out. It’s obviously been some time and you showed, you know, a product. Where are you at in this journey right now?
Rachel Bartholomew: Yeah. So we started in 2021 that was kind of when we are. Sorry, 2020 it was, sorry. I’m like already behind um so it was 2020 that things hit. We incorporated in February, which is literally when COVID hit. That first year was all about product research medical research and and gathering that information to make decisions 2021 was all about what kind of company. Do we want to become I made a decision that I wanted to be a medical device and I wanted to do fundamental research. I raised our pre-seed round in that process, at the height of what we call now like “Venture Capital Lalaland”. Um, so I think it was it was perfect timing for us because you know we had some things figured out but still not a lot figured out and we raised money. Um, which was amazing and got us to ah 2022 which was all about finessing and figuring out. How do you make this thing a reality. How do you go from prototype stage to fully blown product. Um, and so 2022 was all about manufacturing. So we actually manufactured in Canada went through you know design for manufacturing and all of those pieces because taking something and from prototype to something that’s actually functionable is is a really really tough thing. Um and you know 2023 now has all been about how do you finesse that.
Rachel Bartholomew: How you perfect that in order to get into clinical trials which is now kind of the stage we’re at so we’re doing clinical trials with McMaster University and endometriosis and um grand river cancer center my own cancer center. Um, in pelvic-based cancers and having users actually using this in a clinical monitoring setting and just closed our seed round um, raised some more money expanding in the Uk and the us and really kind of growing the.
Mike Flywheel: Wow! Congrats! Those are like some amazing milestones and the grit to power through those timelines too, right? I think there’s a lot of obstacles to get thrown in your way that some people would would sort of throw in the towel or be discouraged. What would you say sort of been your learning on that journey? Of 1 of the hardest things or most challenging things and and you know maybe how you dealt with it.
Rachel Bartholomew: The next level now. Thank you. Yeah I mean it’s fear of the unknown, I think is a big piece of it. Um, you know we’re learning all of this and making that decision to be a medical device first and foremost has been the biggest hurdle for us because when you make that decision. You’re making a decision to be under heavy regulatory scrutiny and we have never played in this space before so we’re learning Iso thirteen forty five we’re learning FDA, we’re learning Health Canada, we’re learning what clinical trials mean and how to create a product that, you know, stands up to those requirements and those standards. It’s a learning curve for sure and I think that’s been a big challenge for us. And I think you know growth has been a huge thing for us. We know we’re onto something amazing. We get a lot of attention for it and how do you maintain all the things that are coming your way. And then of course, this isn’t just specific to me. This is specific to everybody. It’s people management, right? How do you manage people? How do you manage in a growing company? What people um, need want their desires are how do you handle that manage that and you know I still don’t have the answers to that right? I still fail on that quite often and um, you know, just trying to figure out that.
Rachel Bartholomew: Um, not only for my team not only for the people that we interact with but also me as a leader like who am I as a leader. How do I want to show up and as challenges come my way that I’ve never experienced before how do I work through them. Um I Think that’s what you know. Some of the toughest challenges you can go through.
Mike Flywheel: Yeah, it’s great advice now you talked about your decision. You know you you have heart you have ah a hardware I guess innovation software innovation. Um, and you said that you you had a decision to make. Of whether you wanted this to be branded as a medical device. What’s the opposite to that decision and what are the repercussions or like what what influenced you to go down this path and what’s the alternative because I imagine there’s people in Health And Health Tech building software considering hardware. Do you make a medical device or not. What are some of the like pros cons or what kind of helped you weigh what decision to go down here. Yeah.
Rachel Bartholomew: Yeah, great question. So it wasn’t so much the software and the hardware piece because I think the software came naturally out of the hardware and the data components right? and that’s kind of an add on to everything. Um, what the big decision was was a directing. Consumer product versus a medical device and we’re in this weird world of quality of life. Is it a you know is it helping with sexual health does it become a sex toy. Can you kind of. Gray this area which a lot of places can kind of gray around wellness wellness is some of the you know I get more and more skeptical as I you know I’m in this industry of vitamins and all these things like do they truly work. And because the Fda in Health Canada doesn’t have any oversight over sexual health and sexual wellness and um the impact of that specifically in sex toys um, a lot of people can release product that doesn’t require. You know those claims which means that you know you can go to market as a wellness device. You don’t have to make any medical claims but still could kind of bridge this gray area and your perfect example of this is our lovely Gwyneth Paltrow and goop um who you know.
Rachel Bartholomew: Tells women to stick a jade egg up their whoahs and it is going to give them magical powers I don’t know and they’re like $1500 right? Um, and you know some people believe it godspeed like good for you. Great um, and. But when I look at my experience like what if paltrow is not going to help me in my cancer journey like I’m sorry like maybe spiritually but not from a body standpoint. Um, and I didn’t want to be that I wanted to fundamentally understand.
Rachel Bartholomew: How do we improve something at a level. Um that is effective and efficient and really makes an impact in how do we have doctors at the realm of this and how do we get doctors to step step up and that’s not by going direct to Consumer. And I think the biggest thing that I ran into in making that decision was medical Device hardware is hard medical devices is harder right? Um, you have so many you’re you’re so far away from revenue you’re trying to figure out kind of your next steps and how to get there. Um. And you scare the crap out of investors because they’re like you’re so far away from revenue I’ll never see my ah roi and I’ve had investors literally say why are you not going direct to consumer make me my money back and when I have an investor say that I’m like we’re not Aligned. We. We’re not on the same alignment in Vision. I Don’t want to be something that is thrown into a drawer and forgotten about I want something that fundamentally shows women that it can help them and I think the biggest thing is like if we fail in our research of trying to understand that. I Think that tells us just as much as passing and getting through clinical research and having great results because we don’t know like nobody knows because nobody’s done it and so we’re playing in this crazy world of like.
Rachel Bartholomew: Yeah, we don’t know what we don’t know so let’s just go out and try to figure it out.
Mike Flywheel: I Love it. It’s a very good like summary of the the credibility you want and the utilization and the implementation of where your innovation fits and into helping people. Um along this journey. There’s got to be um.
Rachel Bartholomew:
Oh.
Mike Flywheel: A bunch of stories that sort of bring a smile to your face or an inspiration. What’s sort of like the most memorable or exciting story in this this journey for you that you know could inspire some others.
Rachel Bartholomew:
Oh goodness. Um I mean I think my biggest motivation are the patients that we interact with right? Um, every once in a while I get a phone call and a voicemail left and I had a voicemail from a man in Midwest. US um, older gentleman who was was sharing that his wife is bedridden and they’re looking for solutions and he’s just trying to help his wife and as we started talking. He said you know I will I will cross the border I will do whatever I can and. Those are the motivators for me right? I have a list of patients who call me and just chat patient to patient and I think that’s my the 1 thing that like gets me out of bed in the morning is that you know it’s not just me. It’s a whole bunch of people that are dealing with this. You know I think the other things are you know more product related like we’ve stuck sensors on this thing and stuck it where the sun don’t shine and found like insane data that we don’t know what it means and we’re trying to unlock this key. And it’s so exciting because it’s like this new frontier of learning something about our bodies that we just don’t know yet. Um, so I get really really excited about that and and kind of talking to that and then you know.
Rachel Bartholomew: Endless Memorable moments of pitching you know something that women put in their vaginas ah to male investors will never never get old or you know taking this thing that looks like some space gun Slash. You know sex toy through airport security that will never get old. Um, yeah.
Mike Flywheel: Yeah I can imagine the airport security one is a hilarious moment when that comes out of your bag. Um, so if people want to help find out more. You know you talked about a big piece of this being the people that you’re helping.
Rachel Bartholomew: Um, yeah.
Mike Flywheel: Where should they go or what you know what helped does Hyivy need at this current stage or maybe even for the next 6 to twelve months ahead?
Rachel Bartholomew: Yeah I mean there’s endless amounts of ways that anyone can get involved I mean from a business standpoint. We’re looking for partners in manufacturing in reimbursement in. Um. You know clinicians who want to test and and work with us and so we have a way to connect on our website for that purpose. Um, we’re also always looking for patients to talk to. We pay you to talk to us and share your journey. And there’s a way to sign up on our website. Um on our focus groups as well. Um, and then yeah I think just you know, keeping track of where we’re doing our clinical research if you’re involved in ah one of those clinics that we’re doing research with. Um, which are all kind of up on the website feel free to reach out and get involved in the clinical research and as we get closer to to launching our hopes is that we can start to convert. Um, those focus groups and those people who’ve interacted with us to actual customers who have something in their hands and get to. Get to you know be the first people to test it. So yeah I guess it all comes back to sign up on the website. So.
Mike Flywheel: That’s awesome, and the website for anyone. Well we’ll put in the show notes as well. But for anyone listening and writing it down right now or listening in the car. What what’s sort of the the place where you can go find out more?
Rachel Bartholomew:
Yep. www.hyivy.com
Mike Flywheel: Amazing! Well Um, if you’re ever hiring by paying for flights for people to fly around to different countries and put that in their bag just to see what happens sign me up happy to fly around wherever you need me to and just give you all the funny stories might be great like marketing like.
Rachel Bartholomew: Um, it’s great. Yeah.
Mike Flywheel: Ah, Thousand and one airport moments but you know just just planting ideas in case, that’s ever a role I’m first in line please um that all I’m sure it will be even easier for someone like me to explain why that’s in my bag. Um, well.
Rachel Bartholomew: Um, TSA will love you like they love me.
Mike Flywheel: Rachel thank you so much for joining us on the show today I learned a ton. Um I’m going to be interested to follow your journey and you know learn a lot more about what you’re talking around new innovation and data and things around women’s health that people just aren’t talking about. Um your story is super inspiring I love. You know I’m going to also listen to um your your music later I’ve kind of written it down here for anyone that didn’t catch it at the beginning. It’s pi pixie ah, you know, ah ranks in the in the likes of deadmau5.
Rachel Bartholomew:
Um, oh no great.
Mike Flywheel: Um, but Rachel thank you for joining today any closing words on your side.
Rachel Bartholomew: No, thank you Mike, and thanks for having me. And yeah I’m looking forward to connecting more with your audience.
Mike Flywheel: Amazing! Thanks again for anyone that tuned in and make sure to catch us on the next episode of pitch. Please Thanks again.
About Rachel Bartholomew | (40) Rachel Bartholomew | LinkedIn
Rachel Bartholomew is a 2 time entrepreneur who is now working on her second company, Hyivy Health, created after her recent fight with cervical cancer. Hyivy Health is creating a pelvic rehabilitation device for the 1 in 3 women worldwide who will experience a pelvic health complication in their lifetime. Rachel is a graduate of the University of Waterloo and has been working in various roles in the entrepreneurship ecosystem for over 15 years.
About Hyivy | Pelvic Health Rehabilitation | Floora™ – Clinician Software (hyivy.com)
Hyivy Health is currently developing a single platform for clinicians including pelvic health physiotherapists and gynecological health providers including remote patient monitoring combined with the first ever smart and multi-therapeutic vaginal dilator.
If you or someone you know is currently struggling with pelvic health challenges, Hyivy Health is currently searching for folks to participate in our focus groups. Learn more and sign up at hyivy.com
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