Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility

 

 

Robert Fenton: 0:21

Dr. Amy Beckley has a PhD in pharmacology and her personal battle with infertility and recurrent miscarriage led her to develop a new kind of fertility test in 2016, prove is now the only FDA cleared test to confirm oblation quality at home MFB fertility, Inc. Is it based medical company created to empower women to know more about their reproductive health? MFB fertility researchers develops and sells in-home tests for fertility tracking purposes. The first product developed is called a proof test, which measures the presence of progesterone metabolites in urine and these tests have allowed couples to better monitor their fertility at home. thank you joining. You've pretty awesome story. And I'm excited to learn a bit more and share with everybody. The work that you're doing. Amy, can you maybe tell us a bit about your background? How did you get to doing what you're doing today?

Amy Beckley: 1:16

well, you know, I thought I wanted to be a doctor medical doctor, and I was in college and volunteered in the ER and it was horrible. I just, it wasn't for me. I almost passed out when the doctor was like, here, hold this guy's hand while I give him stitches. So like maybe this career choice should be a little bit different. and I started working in a biotech company and really got interested in creating products that would help people. And so I went off and got my PhD in pharmacology. I did hormone signaling. I, you know, what makes the breast cancer metastasize, we didn't stress signaling what causes glucocorticoid or cortisol signaling to go crazy. And you get all these different conditions. so it was really interested in how the systems talk to each other and how hormones are regulated, what happens when they don't function. Normally. What causes disease on the body. and I always knew that I wanted to help people with products, right? So those are the two kind of background pieces I had. I got my PhD moved to North Carolina and did a post-doc and I, you got married. We bought the house. the good neighborhood with the new school and, and everything was like set up, you know, sort of career. It was like, all right, cool. Next comes kids right. You know, i'm an educated woman did all the right things in the right time. And, we tried and we were unsuccessful, I knew something was wrong, but all the testing that the doctors did was a hundred percent normal. And I was diagnosed with. Unexplained infertility, which is like a slap in the face to a scientist to tell you, we don't know what's wrong with you. And then to say, we don't know what's wrong with you. And the only way you're going to have kids is to spend $30,000 on these really invasive, really stressful procedures. So it was, you know, that's really the was my options. I said, all right, we'll do it. and so we did it and we went through two rounds and I did have a son, via IVF or in vitro fertilization. He is now 10. But always in the back of my mind was like, there's a reason I'm in fertile. There's a reason I just don't know what it is.. When my son was about two I went back to the doctor's office and I was like, you know what? You know, I'm not able to conceive. And when I do it always ends in loss. and I really think it's a hormone imbalance. I think that there's just something going on with the hormones that we're missing on a blood draw, and I want to get pregnant, but I do not want to do the invasive procedures. can I be my own Guinea pig? And I can, I just, do the hormone, hormone replacement type of things, medications. As opposed to these invasive procedures where they take out and fertilize them and put them back in. He's like, yeah, sure whatever you know is not as successful, but you know, I'm not going to force you to do IVF. Because he knew I was a scientist, so he knew it wasn't a change of mind. so we did that and I was put on very simple medications. I, thought I had low progesterone. So, so progesterone is the hormone that prepares the body for conception. If you don't have enough of this hormone, you cannot implant. And therefore it's either very difficult to get pregnant or impossible. and so my theory was I wasn't producing enough of this. So my blood tests was great, showed the nice high level, but then it was dropping too soon. And so, you know, when you ovulate your egg is released from the ovary, it's got to traveled down the fallopian tube to get fertilized, go implant into the uterus which takes about seven to 10 days. And so you could do a blood test on day seven and then your progesterone drops by the time it gets there, it's not a good environment. And so that one theory was I had what's called a luteal phase defect or problem with ovulation that was causing me not to conceive. and so the therapy, the treatment was give my body more progesterone because it wasn't making enough. And so it would prepare the uterus and it would keep it a nice environment. And I, I did that and I conceived and she's a healthy seven year old. And that was where the idea of proov came in, where it was like, if I could make a diagnostic test that could tell people what's going on with their cycle. And if they're having a healthy ovulation and there's this implantation window, you know, where the embryo can implant, you have healthy levels of this hormone. It'd be incredible because you could just provide all this information, take that information to their doctors, and hopefully not have to do IVF or, you know, take other roads, you know, explain the unexplained, so to speak

Robert Fenton: 5:44

That that's really huge. how did you, I mean, that you're FDA cleared now, which is really awesome. I'd love to talk about that journey, but I think it's very easy to gloss over what you did. I mean, it sounds like. It was a whole lot of money and time spent and spent on fertility right now. I'm not sure what the amount of capital of asset and R and D is every year, but you were able to on your own figure something out that people hadn't yet, and, you know, get maybe a sample size of one, but still you were able to demonstrate a proof of concept. you had a pharmacology background, but how did you, I'm just trying to picture, how did you go about that? Because we hear all the time. People often experience problems, particularly in bio. It often comes from deeply personal experience because wading into the unknown of the human body is quite daunting. And typically I think you need the motivation of some personal thing to make you want to really do that. How did you start the process?

Amy Beckley: 6:35

So I'm going to go back toto what you said there's a whole bunch of funding and this, and there is, but it's to make IVF better it's to create better embryos is to be create better banking systems, um, you know, egg freezing media. That's where all the money goes because that's, you know, IVF is $20- $30,000. And so if you can improve success rates, even just a little bit, you're going to get more business through your clinic. And so there's tons of money in that field. preventing IVF, there's like zero money for it. Nobody that like, who's going to fund that the IVF clinics, you know, the, the investors aren't going to fund that because why would they take business away from IVF? If, you know, if you can solve an issue for a hundred dollars supplement, that actually goes to the pharmaceutical company, you just cost that clinic 10, $20,000. Right? So there's that. So that leads into how is actually going to take this idea and make a product, you know, cause investors weren't going to invest in it. They didn't feel like it was a big enough market, a big enough thing. It wasn't IVF was pulling business away from IVF centers. we didn't have money. I mean, we'd spend it all fertility treatments. And so we actually did a crowdfunding campaign. I developed a prototype. you know, I bought the materials and did the prototypes in my basement. Um, I, you know, bought all the regions and I was like, yep, this works. And then we did a crowdfunding campaign. Oh no. Then we went on the FDA website and was like, okay, if I'm going to have this kind of device, what do I have to do? And we read the regulation, we pieced together a quality manual.

Robert Fenton: 8:13

You actually read all the regulations that, that singles you out as uniquely determined person already Amy.

Amy Beckley: 8:19

Oh yeah. Oh yeah. And it gets better because we'll get, we'll get to further part of the story, but basically. I was like, I'm going to make this device. It measures a hormone called Pregnanediol Glucuronide pDG for short. And I like when the FDA database Pregnanediol Glucuronide and it's like, Hey, there was somebdy in 1989 that had a PDG device. And so, you know what, there was a product code and regulation and it was a class, one exempt. I'm like praise the Lord. We have a pathway. And so, you know, we, we registered with the FDA. and we've got a contract manufacturer that was FDA registered, ISO certified, all that fun stuff, and got a quote from him on how it was, you know, to build the design history file and all that stuff. And it had crowd funding and said, Hey, it's going to cost us this many dollars, you know, in, in return, you'll get the first batch of these tests. Um, and we were funded in 48 hours.

Robert Fenton: 9:09

Oh, wow.

Amy Beckley: 9:10

So, I mean, that's how it started.

Robert Fenton: 9:11

What were some unexpected roadblocks? Cause you haven't been in business before. You haven't really done anything like this before. And healthcare particular tend to be good scientists and they don't have to experience the big commercial part of the world.

Amy Beckley: 9:29

Yeah. The challenges were, I mean, I was a scientist. I did, get an MBA one class at a time with the whole idea of starting this business. So I had enough business knowledge to be dangerous, I guess. and when we launched, we, the only thing we were following were FDA guidelines. So they couldn't like pull us off the market. We, you know, bought a $50 logo off of, you know, Upwork. We had very generic packaging where it literally just had the product name, the expiration and the lot number and we packaged them in plastic bags and sold them on Amazon. Cause I couldn't carry my own inventory. and that's, that's how we did it. And I took on a co-founder in early 2018, who was the marketing side who gave it, the ProoV name, gave it, the branding came, it gave it a box. and, and so. You know, challenging, challenging was when the FDA called us and told us that it's not an exempt device. And then we had to get a clearance. That was very challenging.

Robert Fenton: 10:30

Yeah. Let's maybe spend some time there because if the cleared now, so tell us how you, how you did that. And first of all, I'm curious how come it wasn't exempt because you'd read that it was.

Amy Beckley: 10:46

So it is exempt. So that product code is exempted as a low-risk device. What they said that we tripped the limitations on was the fact that we were the first OTC device. So our business model is, you know, we want to give the woman the power of the information and they want, they need a test at home and they need to buy it off Amazon Target you know, anywhere. And have that information before they go in and talk to their doctor. I mean, ideally we don't want to have them wait to be like 12 months or have three losses for them to have the opportunity to go to the doctor and then the doctor to say, okay, you need this and this. We wanted them to have that information from as early as possible. Um, and so we went to direct to consumer route, OTC and They decided that nobody had ever had one of these in the market before that was OTC. And that we had to do a 510 (k) to clear it for at home use.

Robert Fenton: 11:40

So just the normal510 (k) process. How long did that take you?

Amy Beckley: 11:43

About a year. Little over, yeah. About a year.

Robert Fenton: 11:46

Did that create any commercial bottlenecks or were you able to, just because you had the crowdfunding, how many people were waiting on the tests?

Amy Beckley: 11:55

So we were actually in market when the FDA told us that. Yeah. what I like to say is FDA can change their mind at any time. So just because you were okay yesterday doesn't mean you're going to be okay today. So, I mean, they called us and they're like, Yeah, you can't be marketing this. You haven't done a 510(k) and I'm like what are you talking about we, we called you guys and we, we asked you, and this is the regulation. Like I don't see any issues with this. you know, but because we had had that interaction with the FDA and we were trying to be compliant and we were, you know, working with them, they let us continue to market the device. As long as we worked with them during the whole 510(k)process. So that was very, very, very lucky for us that they let us do that.

Robert Fenton: 12:41

Yeah. It's I think it goes to another point that people often have told me, which is the goal of regulators is not to consult with you to tell you that everything is okay. Often times our job is to tell you that things aren't okay. And then you've got to fix them. And there's this, there's like, there's a small line there. I think you said they can change their mind.

Amy Beckley: 13:01

Yeah.

Robert Fenton: 13:02

Yeah. You gotta be really careful of that But it sounds like you've gone from strength to strength. I was looking at the news about you folks recently before this, before our call today and air force had just invested in you folks. Maybe tell us about that. It's fascinating from what I've read.

Amy Beckley: 13:16

Yeah, absolutely. We were at a conference and, um, a woman from the air force came up to us and she's like, I love what you guys are doing. The air force needs this technology. I said, really. She was like, yeah. Do you know the infertility rates are three times higher in the military than in civilians. It's like really? She's like, yeah. Yeah. So, I mean, I looked it up and it's anything from physical separation ,deployments, you know, not being able to go to a clinic and get the help you need because you're working. exposure to, to chemicals, you know, strenuous work, poor water quality when they're deployed, like all these factors together increase infertility rates. And so we proposed a remote monitoring system that can help, you know, track a woman's hormones, um, because the majority of the infertility cases are due to problems with the ovary and not being able to, ovulate very well. And so, so we, we just designed the product. It measures all the hormones across the cycle and can really help woman understand if she's ovulating properly. And then she shares that information with her doctor and her doctor can, you know, remotely treat her if it's a hormone imbalance, similar to kind of what treatments I had. Or take the next steps, but it's saves them trips to the clinic. Waiting times they can do it from across the world, um, all kinds of things. So, so that's an exciting project that I'm happy that we get to work with them and provide that resource for them.

Robert Fenton: 14:50

Yeah, that's pretty awesome. Um, are you able to track the impact of that or is that part of your work? I'm curious.

Amy Beckley: 14:57

Yes we are. We're tracking that. Yeah. So we're still developing that product right now. So we don't have any of those metrics, but yes, we'll be able to track the metrics. Absolutely.

Robert Fenton: 15:07

I'm excited to keep following your story and see how that goes. I also read that Colorado has this awesome thing called a Titan 100 it's it's uh, it's a great name. You recently made the list. So congrats on that. What's the startup environment like in Colorado now? What's it like building a company there?

Amy Beckley: 15:24

It's good. I love Colorado. They've been i mean the first money into the company besides our crowdfunding campaign was the state of Colorado. They really want to support businesses. They want to bring jobs. We did an intern program through them who brought us a fabulous employee that we're hiring full time. We're in the final stages of a CE Mark and ISO 1345 certification. And so, the export office is helping us with, you know, financing that certification and, helping our website with the different languages and you know, those kinds of things. So, it's a state has been very, very supportive of us as a business.

Robert Fenton: 16:05

I just realized we're nearly at the end of time here, I wish I had a lot longer to ask about that. Uh, I've seen a lot of people moving to Colorado recently, and I know that they've been doing, a lot of work on, on the business side, but taking it step back, Amy, looking at what you've learned over the years, working on this, any, any lessons I learned to share to other people here, anything you can share to smooth the path for the next person you in healthcare sees a problem firsthand and believes they can solve it.

Amy Beckley: 16:30

You know, I guess if it's, if it's a passionate enough thing for you, you find a path. you know, the thing that was our saving grace and with the FDA was that they knew we were doing good. They knew, we cared about what we were doing and we wanted to work with them. We did not want to pause harm. and, and that went a long ways. Um, so always, always collaborate with the FDA. They're not, they're not the enemy. They're just trying to keep people safe.

Robert Fenton: 16:59

that message gets lost sometimes. But yeah. Thank you for reiterating that. So, Amy, thank you very much for joining today. I really enjoyed the chat and, uh, looking forward to keeping in touch.

Amy Beckley: 17:09

Yeah, likewise. Thanks for having me.