WOMEN'S HEALTH DAY featuring MARGOT BORGEL

Hi! I can't hear you.

How about now?

Yeah. All good.

Awesome.

Stephen's here.

Lovely.

The panelists. Bruce never wants to be promoted. Oh, I'm gonna go get my vest because I'm freezing. That'd be very.

Hi, Marco! Can you hear me?

Okay. Yep.

Hi, Jay said. He's probably going to come.

Okay. Good.

To me. He'll be here.

I gave you several slides at the beginning. You probably don't want all of them. It's up to you, though. left them in. I'm probably gonna just kind of flick through them pretty quick.

Okay.

But yeah, I just left him there.

Cool Hi! Sean!

Hey? Good morning! How's it going.

Good morning. Great, thank you.

I can't remember where you're based.

Me!

Yeah. Margo or me.

Either of you.

I'm in Charleston, South Carolina.

Oh, that's right.

I'm in Pittsburgh, Pennsylvania.

That's right. I knew both of those things. I just forgot.

Did I freeze, or did somebody else freeze? Did Shawn freeze.

Looks like Sean froze. You're fine. I don't know if I want to show myself or not.

You're muted.

Hello! Marco!

Hello! How are you?

Fine. Thank you.

Just got kicked out of my own meeting. I think it was an Internet connectivity issue. I'm trying to promote Joe.

Thank you.

I'm looking for the dots.

Yeah.

Make host, make co-host, make co-host.

There we go. We can. I can. You can focus. And I can invite some of our friends to come on the camera and meet our special guest.

Okay, great. So let's let's Margo start with some really easy questions while we're getting warmed up and people are still joining. Tell us where you're calling in from.

Sure. So I'm based in Charleston, South Carolina.

And are you from there.

I'm not from here, so I'm originally from New Jersey. Spent about 10 years in Atlanta, and now I'm here.

We're in New Jersey.

Middletown, Monmouth County.

How far is that from you, Andre?

About an hour.

They even. That's too far for Andre to travel. I invite him to this conference every year, and he's always too busy.

I'm glad I give you something to talk about every week, Joe.

Every week. I'm just. It's a little peer pressure. We want you to come, Andrea.

I feel one that.

Have you talked to Mrs. Domino about this.

Not yet.

Can you put her on.

No, unfortunately she's not here.

Okay. Well, oh, wow! Not only is Maren back. We haven't seen her in a month of Sundays. but her cohort, Marvin Barron, is back. I haven't seen him in even longer. Margo. You have Paul. I'd like to ask When was When was the 1st women's health? Day? Slash month period? When did it start? How did it start? Do you know.

I don't know the answer to that. No, I have a whole slide on the progression of women's health initiatives through like regulations, but not I wasn't prepared for that question.

Well, I think I think tomorrow is International Women's Day generally. So it's just the day of the woman.

True.

And so we're we're to celebrate womanhood generally. And and we're here today to talk about as it relates to Med Tech, as it relates to women's health, as it relates to issues which are near and dear to us. So with that in mind, I wanted to learn a little bit more about Margo's background. And what? How long she's been with Rqm. Plus what she studied in college, and you know and I don't know all those all those fun things like, you know, what makes her qualified to talk to us about the subject, and.

Sure. Well, 1st off I am a woman, so I think that makes me qualified to talk about women's health. No, but I. So I've been at Rqm plus about 2 years. I'm the director for global regulatory affairs. I specialize in Ibds. But Rqm plus as a whole focuses on Med tech but I've so I've been here 2 years prior to that. I worked at the BSI notified body for about 4 years, so was in a European regulatory space for a long time. And prior to that I have about 8 years of industry experience in medical devices and Ibds.

You would be assigned.

What years was I there? 2019 to 2023.

I'm interested in. Why you left that. Because, boy, do we need notified bodies. Maybe. God.

No, I loved that job. I really did. I left because I had a good opportunity at Rqm. Plus it just kinda came up and you know, being I wanted to continue to progress my career, and you know the notified body has very limited opportunities for people in the us to get into higher leadership positions because you have to work on a European time zone.

No.

And so that was part of it. And just, you know, overall, I wanted to do more with the Us. Market more with FDA. Kind of expand my regulatory reach beyond Europe.

There we go. Please continue.

Yeah, what was the what was the other part of the question? Schooling? I have a bachelor's and a Phd. In chemistry. My Phd. Was in more of like a biochemistry enzymology focus. So that's kind of when I started to get into this space. did an assay development project as part of that Phd. And that led me into the diagnostic space. When I left grad school.

Do you work with our friend Allison Komiyama.

I do. Yes, very, very closely. Yep.

Have come to our conference a few times.

Yeah, she's a great speaker. She's.

I have forever been grateful to her because I think it was maybe my 3rd conference. It was my 1st time in San Diego, and she had just given birth 2 days earlier, but she had promised to be in a workshop panel, so she was there, and I was like.

Wow!

You have my respect forever.

Yeah, she's great great person, great colleague.

Yeah. She's delayed.

Super knowledgeable.

Do you often get to work on a project with her, or are are your ex? Do your expertise overlap? So you get this assignment. She gets that one.

Yeah, I she sometimes supports my projects just because of her vast FDA knowledge. Right? So if there's a unique situation on the FDA side. She definitely comes in to support. You know, my focus is mostly with Ivds. So she focuses more on typical medical devices. So there's a little bit of a difference there, but definitely work together on some projects. Yeah.

I'll be intrigued, and I'm sure you'll touch upon in today's conversation. How you feel. This political climate will affect women's health.

I'm not going to get into too much detail.

No, you don't do politics. I get in trouble. Open my mouth. But but surely there's there's some impact I'm I'm anticipating at a minimum, a defunding of planned parenthood. Though. Maybe you have a comment every day that won't attend.

Yeah, I mean, I think there's a lot of What ifs we could put out there? Right? But yeah, we'll get there. I have. I have some things to say, but not gonna get too political. Anya.

Okay. Well, let's see what you got, young lady.

I'm going to share some slides. If I could figure out how here we go. Can everybody see.

That he can.

Okay, so I'm gonna talk a little bit about tackling bias and women's health device development and some general things about women's health in med tech for this talk today. Maybe if my slides will move, there we go. So I work for our Qm. Plus we talked a little bit about this, but we just launched a new brand campaign. We don't make med tech. We make med tech happen so just a little bit about our Qm. Plus if you're not familiar. We have a full suite of Med tech services for the whole product lifecycle that includes consulting services for regulatory and quality consulting clinical trials. We have a full service Cro lab services through our Jordi labs as well as reimbursement services.

If you're not following us on Linkedin, please do. So we put out a lot of great content. This month. We're focusing on women's health. So lots of great initiatives happening there. We have another live show happening later this month. Let's talk about women's health. Let's talk about Women's Health Campaign, a blog series coming out so lots of great things happening. We're always doing new stuff. Hey? And then just a little bit about our expertise, and then I'll stop the the salesy stuff and get into the content. Okay, so women's health and Med tech, I think it's important to frame the discussion to talk about money, because that's what makes the world go round so

investments in women's health have really skyrocketed. Recently. We've seen about a 20 year high in 2024 in investment in women's health. And the market is currently valued at 52 billion dollars in 2023, projected to double by 2029. So.

This is my 1st time, seeing that expression femtech.

Is, that.

Unfamiliar to anyone. Raise your hand. If you've seen or used that expression. you can do it virtually if you want to click on the button. Okay, thanks.

So yeah, so you can see down here. the breakdown by therapeutic area 2023 in gray, 2024 in yellow and women's health between 2023 and 2024 really has jumped up in terms of research investment dollars being put into the industry. I think it's also important to note that women influence 80% of healthcare decisions. So even though women make up only about 50% of the population, they're making most of the healthcare decisions for their families and for themselves. And so I think that's also frames this in a way that you know we should care what women think, what women are using, what women do

to just take a little bit of a look back at where we started, where we came from in the Us. We didn't see any specific inclusion of women in research until 1986, when the Nih established a policy encouraging inclusion of women in clinical research. 1990, there was an office of research on Women's Health established and then, in 1993, we saw the 1st requirement of inclusion of women and minorities in nih sponsored clinical trials. So this is, you know, 22 years ago was the 1st time women were required to be included in a clinical trial. 1994, we saw the office of Women's Health established

1998. The FDA issued demographic rule which basically meant they had to capture demographic data as part of clinical trials. In 2,000 the Nih launched the Women's Health Initiative And then, more recently, in the last 10 to 11 years. FDA has started to put out some specific guidance on this. So 2014, there was guidance on evaluation of sex sex specific data in medical device, clinical studies 2018, on inclusion of pregnant women in Studies 2020 on enhancing diversity for clinical trials, and then in 2022, the 1st draft guidance for the Diversity Action plans were published. So you can really see that this is new, a newer

effort, you know, the last 20 years has really been it for women, being included in research for medical devices and for clinical trials in general. And really only very recently, have there been any specific guidance on how to do that analysis, how to include pregnant women who have typically been excluded. We could see a very similar timeline for Europe. So 1997, Ema started encouraging inclusion of women in clinical trials and analysis of data by sex. So the Us. I think it was 1986 was the 1st encouragement in Europe. It's even later. But at least they're also analyzing the data by sex. At that point.

2,001 Clinical Trials Directive was adopted which had some specific considerations around demographics, populations included in studies 2,005. Ema released guidance on the investigation of medicinal products in women. 2,005 was the 1st guidance for medicinal products in women.

Good.

20 years, 2,010. There was a an initiative to kind of improve the use of women and gender specific considerations in clinical trials. 2014. We saw clinical trial regulation come into play which strengthens requirements for inclusions of women and underrepresented groups. 2017. We have Ivdr. And Mdr. Established. So those also require, you know, more specific requirements around populations of intended use to be. you know, researched and evidence provided prior to placing devices on the market.

2018, we saw guidance on the inclusion of sex and gender in analysis. and then 2020 Europe Ema provided guidance on including pregnant and breastfeeding women. So this is very new. I think it's it was shocking to me when I pulled up these numbers. How recent some of these things happened. but just putting it in perspective. When we look at today, some trends and innovations happening in the industry for medical devices, we see surgical solutions for endometriosis being big in the field, wearables and biofeedback devices for injury, prevention and family planning. transcutaneous electrical nerve stimulation for menstrual pain and a lot of AI driven health monitoring for breast cancer and other diseases on the Ivd side.

There's a lot happening as well. We're seeing a lot of point of care. A move towards point of care for Hpv. And Sti screening breast cancer diagnosis and monitoring remains really high in the diagnostic space pregnancy and ovulation kits. We're seeing some technological advances with AI, so where you can take a picture of your ovulation strip, and the AI will determine. You know, a concentration based on the the line. How dark the line is! So that's pretty cool. And then yep, someone have something to say.

Just very cool.

Yeah, really cool and also non-invasive prenatal testing. So we could do genetic testing now, based on blood samples taken from the mother. And they're actually able to separate out fetal DNA from the mother's DNA. So also really really cool advancements there. Some things that have been in the news recently that also relate to women's health. So some more biofeedback, so preventing acl injury with 3D. Motion analysis. Some some plant extracts and early leads against breast cancer. new procedures, laparoscopic procedures for fibroid

ablation and alleviating pain. So this would normally be a surgical invasive surgical procedure with a hysterectomy. Involved they're looking at ways to reduce that hysterectomy rate and treat the fibroids in other ways. And then digital health tools for cardiac risk determinations. So lots happening in the space. That being said, there's still a lot of challenges that are that are here that we're facing. You know, those timelines. I showed you late adoption of considerations for women's health within the medical device design. So only very recently, where companies required to even think about women when they were making devices, and a lot of things, you know, were not designed to be used by women, and

they just are being used by women. So a good example here is face masks. So face masks. All the standards for face masks were based on a man's face. and during Covid it was actually found that the N. 95 s. Did not fit women's faces properly, and so women were having to over tighten their masks, you know, which is uncomfortable, and it's all because the standards to create the masks were based on some man in Scotland. Like some guy's face was like the mold they used to create. All the masks. You know. And that's definitely because of late adoption, right? Nobody told them they had to use women, and so they never did.

and that that's still continuing today. Also, AI design and training, there can be huge bias introduced. If you don't design your AI correctly, don't have all the correct inputs. And if you don't train it with a diverse data set you can really end up with in a place where you're misdiagnosing or your AI is is not proper for women or for certain groups. and then design and verification, design, verification and validation do not always include representative groups for testing. So if your device is like a gender sex neutral. You still have to make sure you're using representative groups. Otherwise there may be bias introduced that you don't know about.

We'll get into that more. Excuse me. So there are challenges. But there's a lot of opportunities. You know, because women were left to the wayside for so long. There's a lot of opportunities for new treatment options specifically designed for women. There's a lot of places this space could go. And there is that significant investment that we talked about earlier. So let's talk a little bit about bias within the design development lifecycle. I think it's important to note. You know, we talk a lot about sex differences in clinical trials and making sure you have representative groups in clinical trials. But really this bias can be introduced anywhere within the product lifecycle. So concept, the device is developed with a male dominated idea, even if even if the person designing it doesn't realize that. So.

Tell me about that. What does that mean? Exactly.

Yeah. So you know, a man comes up with an idea for something, and.

Why is that yours? Why are you starting there? Why doesn't woman come up with an idea for something.

Yeah, a woman could come up for an idea, and then it could be biased towards met the other way. Right? It goes both ways for sure. So I think this is all about You know, we all have our own bias as people right. And you're gonna think about yourself and the world around you when you're performing tasks.

Are you saying that medical devices is a male dominated field, and therefore more ideas come from men.

That's true, I think. Yes.

Is that your point?

Yeah, yeah, I I mean, I think that's my point. I think not that it always comes with a male dominated idea, but that it can right. I think my point is that this can happen as early as design, right as early as thinking about like, how something fits into somebody's hand right. If you don't think about like a woman surgeon using a tool. then you may run into an issue later. Right? If you're just thinking about dexterity. Like all of these different considerations.

I mean I even it's not my field, of course, but I'm imagining. How would I change a tool for a woman's hand versus a man's.

The grip. Size the how far apart the like. If you have to grab something right? So your hand is gonna be bigger than a woman's.

Do you think it could? Do you think most? I don't know. Typical tools that you'd find in an or, for example, can support a market of the man size and the woman size.

What do you want to talk about victory?

I don't. I am not sure I know the answer to that, but happy to hear if anybody else has any inputs, any thoughts.

I suspect this is not why you have your hand raised, Andre, but you have something to contribute.

Yeah, no, it's not about that. Just Margo. We have an interesting case where we were developing a therapeutic device for one of our customers, and they went to a cro for for the to create the study. And one of their entry criteria was that they wanted both men and women in equal amounts to be tested, and the Cro said that they could not do that, that it would be impossible to run the study if they had to include equal amounts of men and women, so I don't know if that was a bias against women, or just something that was not practical for them.

That's interesting. I mean, I think it would depend. Ha! On what the device was. And you know there's a lot of considerations there, right. But I'm kind of surprised at that. Sierra's reaction.

Yeah, it was actually electrical stimulation device for biofeedback. And it would. I mean, we weren't directly involved. We were developing the device for them, but I know that they they were concerned that they said, Well, you know, they can't actually include they can't actually allow for the 50 50 split on men and women.

Hmm! That's interesting.

Yeah.

I might look at some other Cros.

Right.

Okay, so design. you know, I think this is really, if if a device is considered sex neutral, different use cases and residual risks are often considered sex neutral, and then you never get into that deep dive of. Is there a difference? Right? So if you don't look at the data. You don't know if it exists. So, starting from a place of assumption that your device is sex neutral can lead to to some bias validation. So this is where we traditionally think about bias in terms of sex differences. Your validation doesn't include sufficient differentiation. Your usability studies are not done on representative populations, and your clinical trial did not have a representative group.

And then post market surveillance again, if you're not looking for the difference, you're not stratifying your data that way. and you would not show specific issues even if they were there. For female populations.

So I heard an interesting case recently, and It was a notified body who shall remain nameless, and they the the medical device was a hospital bed, and they came back and they said, Has this hospital bed been tested for pregnant women? And The company said, we don't know, and they said, Well, guess what you have to take that off your population, you know intended population intended use list because you don't have any evidence that this hospital bed is suitable for pregnant women.

comments, thoughts.

Yeah, I mean, I think that shows that the industry and the Regulators are moving to a place where they want to see specific data. I think I'm not an expert in hospital beds. So I'm not gonna get into. Whether I think that was an appropriate question or not. I think that is definitely shows that Ivdr and Mdr both, you know, are going to require population specific data for any claims that are being made for the device.

Straight by your example in red.

Yeah. So risk management. So this is a real life example of an Rqm plus consultant who was supporting a risk management a risk assessment for a client, and they were doing the risk assessment for a breast pump. and they ranked severity of harm for leakage of pumped milk as very low. The engineers on the project didn't see an issue with this, but if they had talked to any single human being who had ever pumped milk with a breast pump. This would not be a low severity issue. This is a major issue for somebody who is using a breast pump.

Now, is it? Is it a major issue? Because it's like that's a pain in the ass. But is that really a safety issue.

Right? That was my question.

It it? That doesn't mean that severity of harm should. But you. But it's a user preference, but that doesn't make it a risk, a high risk.

Sure. So it doesn't make it a higher risk from a safety perspective. But it's still something you need to consider in your risk. success. And in your design, right? If you're designing a breast pump I can't like. No woman is going to buy a breast pump that's constantly leaking. They're going to get rid of it and get something else right. They're going to complain. There's going to be.

100%.

So.

I just don't see how you could break the severity of harm from that as high.

Okay.

And the efficacy.

Breast pump for 5 years, guys. And this was our number one complaint from a risk perspective, there is 0 harm. So it's not a high risk from a harm perspective. It is a high trend for complaints and customer feedback. And so yes, that is a consideration. But I I did this for 5 years, so we did not report leaks, but they were our number one complaint for breast pumps.

But it's a technical complaint, right? So you will submit it as a device.

Usernames.

No, you did we? We actually decided that it was not reportable. It's so. It was a malfunction in that. But the problem was, it's not just the malfunction of leaking of the device, it is. Ha! The fit on the women's breast. It's a ton of factors in it. So we, as a company decided that leaks were not reportable. The FDA supported it. They never, they never questioned our decision on that. and we kept doing design changes. It was our number one issue. We were always looking at it, so it wasn't being ignored as a company, but the approach was accepted. I mean, I went through 3 FDA audits, and they didn't challenge the non reportability of this

of that.

Yeah.

I think the I think the key thing there is that you're you. You worked on the design right? Basically.

I have also worked for Medella. In Greece we have sold breast pumps, and I remember that we have create one very good training for the ladies. because we have 2 scenarios, the scenarios where the breast pump comes home, or they in the 1st fast they use it really with one support. So it is. Really, you can eliminate a lot of risks by the correct use. If you receive this training, let's say before you start to use it. That is what I want to add here.

Sure. No, I mean.

Cautious that we like make statements that can be cascaded throughout the organization. And I think it's really based on the product. But your intent is, I think, the example is that we didn't test it with women doing clinical trials which we, this company did. We tried it with various age groups, various breast size. Very. You know all kinds of different factors on it, because, believe it or not, all the men's husband wives were pregnant and had different kids. So it just kind of.

Yeah, I think.

Free trials and stuff like that. So.

Yeah, I think.

I just wanna be careful that you make that kind of a blanket statement.

Sure I understand that I think the point here is just to you know it sounds like your company. Did everything right here? Right? So you you tested it on women. Obviously, because that's who's using the device. You know, you've received complaints. You're con consistently working on the design to fix it. You're working on training right? These are all the things you should be doing. What you don't want to happen is for them to say, Okay, this isn't an issue. We're not going to do anything to minimize this risk. Yeah, we're gonna do very little to minimize this risk. Because, after all, it's just a little bit of spilled.

Can you? Can you repeat, can you repeat, please, how exactly was the leg as to understand it a little better during the let's say, the application of the of the connection, part for the bracing. for the pumping process. There it was, the records, or in in one other component of the device.

Yeah, I you know, I don't have the specifics here because it wasn't.

Because it's important. Yeah, I, the way how you apply that on the breast. Yeah, sure, it plays. You have to create one vacuum practically. Yeah. And it is important that you follow the steps. 1st of all, you have to apply, as far as I remember, one cell. and of course you have to clean. Yeah, but it it is one process. I must look back. And maybe in the next session I can bring it this brochure. Yeah.

Yeah, I think you know the. And I didn't mean for us to get kind of you know, I understand there's a lot happening here. The the point here is that just because it's not, it doesn't seem like a big deal doesn't mean it's not to the user, and that you should consider that in your risk management and in your design, right? So you should be putting controls in place for things like this, even if it's not a major safety issue, because it is still a major issue to the user. That's, I think, the point I'm trying to make here. Right? So you know you have to think about risk and how it relates to the different populations for your device. And make sure that you're designing in a way that benefits

the different populations as robustly as possible.

And what classification is the breast pump? And like they.

Talk to you. Okay, talk to you.

Yes.

Okay? Good. Discussion.

Well, class 2 in the Us. I think there's other countries where it's not even considered a medical device.

Yeah, understood?

Okay, post market surveillance. So if you assume everything is the same, you will not be looking for any differences. So I think complaint. Handling processes need to be need to allow for the disaggregation of data to help identify differences in populations. So between male users and female users. If this is not possible, you're not going to be able to detect trends between your different user populations. and again, this can kind of feed out of the risk assessment. If you've done your risk assessment in a way that accounts for the different populations using your device so that your device is intended for then that will tell you if you need to be disaggregating your data in the Pms stage. But if you treat your device as sex neutral the entire way through the process. Then you're not going to be able to see

specific trends based on user. and here's just some examples of where we see kind of a a gap in data for women's health and Med tech. So hypertensive disorders in pregnancy are linked to a 40% higher risk of atrial fibrillation and more aggressive coronary artery disease. But there is no postpartum care that determines or considers long term effects of Hdp. So women who have hypertensive disorders, while they're pregnant, get discharged, go through their postpartum visits as if nothing is different and they're never followed up on from a cardiac perspective.

Second example, is, algorithms for cardiovascular disease were specifically designed with men in mind. So even when they went back and added female indicators, like menopause, pregnancy, history, etc. They don't perform as as good on women as they do on men, and this can be really be extrapolated to any condition where AI is front and center. So if you're not, if you're trying to add in things at the end of your AI, and it wasn't designed that way from the beginning, you can see some issues with bias introduced all right, regulatory landscape. So you know, I think a lot of the topics. That are kind of hot right now, for women's health really end up at the complex

and higher risk areas of our regulatory landscape. So cancer, detection and monitoring, you know, we're seeing a lot with breast cancer and Hpv non-invasive prenatal testing over the counter technologies. We're seeing a lot with implantables for hormone regulation and birth control artificial intelligence and cardiovascular disease. So all of these things end up higher risk, you know, both with Mdr. And in the Us. FDA, so you know, there is a little bit of a higher regulatory burden for those higher risk devices. And then we kind of touched on this in the beginning. But it's really unknown how recent political decisions are going to impact women's health initiatives. You know, I think there's been a lot in the last 10 years in terms of gender and diversity initiatives

that are kind of up in the air right now. and I think we can expect to see a decrease in government spending on research for women's health just based on the events of of recent. And this is pretty Us. Centric. You know. I don't think the same is true for Europe, but in the Us. I think we will kind of see some of these things roll back. and I don't know if anybody else has seen this. But this is the disclaimer that has been added to certain FDA guidance documents that mention gender. And so this kind of gives a look into how the current administration feels about

this path forward. So this is on the currently on the website for the guidance on AI bias in medical devices and the diversity, action, plan, guidance. It may be on others that I'm not aware of.

What! What practical implications will this have.

Yeah, so it's hard to say. You know, I think what we're what we're telling clients right now is keep doing what you're doing, you know. Do the right thing for your patients and for your populations. You know, before the Diversity action plans were a thing, and before you know, some of this guidance got put into paper. FDA was still concerned about this right. They were still raising concerns in submissions when there was populations that were missing, or when the data wasn't disaggregated appropriately. So I think. you know. focus on what's best for your patients and their populations, and less on what the Administration thinks, and I think we'll all end up on the right side of this.

Michelle.

I've got.

Had a wild story that happened to me last month. I was working with a company that made that makes pelvic wands, you know, both just plain ones and not, and vibrating ones, and hot and cold, and you know, like all the features across their product line. they got a untitled letter. they got an untitled letter from the FDA. That says that they need to see their 5, 10 ks. Because pelvic wands for vaginal use exceed the exemptions in the regulation for the the device, and I'm like.

Feedback.

It just says genitals in the regulation, and there are 4, 5, 10 ks. All from before the nineties or before, and all of them were for penile penile dysfunction like erection, dysfunction. And so the FDA was pursuing this company because pelvic wands are for men. That's what.

That's that's crazy.

It was. It was obscene, like what they what they were saying, and I went back all the way in the Federal Register all the way to the 1st proclamation of that regulation in 1979 and 1979 specifically calls out, not only vaginas, women's pelvic floor vagina. This female, like it, was at least in 3 or 4 different places in the proposed rule. Then in the final rule, like a year or 2 later. Well, because I found that in Federal register, too. 2 people had commented to the proposed rule, saying that they really don't want they use vibrators for pains in their legs and calves, and they they don't. They think it would make that use too too difficult to underneath that regulation. And the regulation specifically said Vaginas.

So the FDA to address those 2 comments said, Okay, we're going to make this this like more. We're going to change the wording here to be clear that this is not supposed to be used like on your leg. and the way they changed it was, instead of saying, a vagina female, whatever. They just turned it into, for use in genitals only.

When was this?

1980. So fast forward somewhere along the way between between 1980 and the I can't remember the year the 1st penis erection thing had a 510 k. It it the it gets down classified to not needing a 510 k. For you know, unless you exceed exemption. So my argument is, those 4 for penises exceeded the exemption because they were penises. and it was for vaginas. And that is a different intended use. And FDA said, but the precedent is that the penises have 5, 10 ks, so once the exemption is in place, everybody need the only people who can use the exemption? Are the people that have the same intended uses who is in the 510 Ks.

The regulation was never for penises. It is in an obstetrics and gynecological product code. I am still. I'm in in that meeting. I was trying to like, not talk because I was in it. I was supposed to be the quality man. I was supposed to be the quality person, and.

How well did you.

No! Well.

In in hiding your meta messages.

Yeah, no. I had to also turn my camera off because of the faces that was making. It was just.

Something to consider.

I just could not not say anything, and I just said because the FDA threw out. you know well, cause, the client was saying, well, you know the why don't you have like, you just need to do a mass. And it's gonna be easy to identify a mass industry, notification. Because you're creating like this this business thing like where you're coming after me here to shut my business down. But this is like every single company, except for the 4 that have penises should not be, are all illegally marketed. And they're they're like, well, our resources, this. And we have limited resources. We can only deal with what people report to us. Blah blah! And it was all bullshit, too. And I turned my camera on. I said, you guys have used limited resources of the FDA about 6 times now. But for the limited resources you have, this is really the highest risk

risk to women's health that you guys have got the capacity to pursue right now. I said. I'm not even speaking as a regulatory expert. Right now. I'm speaking as a woman that I find that offensive. and then I didn't say anything so. But I I've just been so close I I still may call and ask him if I can do this, but I want to write up a case, study and and send it in like, okay, if if you here's 1 of the 10 you need to repeal right right now, like. you know, if you got to pull 10 out, start here because this this is some nonsense, and I also find it offensive. How much resources are being dedicated to this, because it was also clear that FDA was going after other companies, but they couldn't talk about it.

That was unhappy. But thank you for sharing.

Sorry I digress, but I think I think it's my point is to this slide. I think it's fascinating that they're gonna put that up, and then do do this at the same time.

All right. Go ahead and unmute yourself. You had some background noise. I know you have something to contribute. You know how I wouldn't push the asset. There we go!

I'm at Starbucks. It's really loud. Sorry. I was just gonna have a happy story that the Nih just actually granted one of my female health their grant, because it's for female health, that's all. Happy story. I know they were like. Put it on hold, and then they just granted them their Nih grant for Sbi. So that's all.

When was that?

Back on there. Huh!

Was that.

Yesterday.

Congratulations.

Story, but it's for a female sexual dysfunction device for Pk.

Like this.

Go back on mute because it's loud.

Okay, what I'm not following is like Carrie's example, where there's something for female sexual dysfunction. And are you saying that the interpretation by the FDA was. This is somehow in violation of.

Nih, not FDA. The obgy branch right now is being freaking ridiculous. I agree with Michelle on that, because I've had another one where they? It was for a male clip, and it said male penis for female incontinent device, and because the regulation States male, penis incontinent clip, however, every single freaking obgyn for female incontinence device has been using this product code. However, the regulation which everybody knows intended use is how you go down the list. However, it says, penile incontinence clip, because it refers to a penis the current obgyn

people we have in place right now said. Well, it says Penis, in the regulatory group. and I got into it. And I'm like it's in the regulation, and we all know it takes an act of God to change the regulations and look at all the intended uses right now. So we went head to head. I went with the current green group. That's in place right now. The Nih or not the Nih, but the FDA Obgyn group. So, Michelle, I'm with you on right now with the current.

Yeah, and so.

Going back on mute.

Part that is shocking about that is, they they flat out, told him that. Yeah, you know, you have to get a 15 K. But once you get a 15 K. None of your competitors have to have a 5, 10 k.

They were.

Yeah, because.

Read.

For the precedent.

They were all down classified per the Cures Act. All of those devices were down classified, and for the Cures Act they're all 510 K. Exams. They're all anyway. Sorry.

No no great great great discussion.

Thank you.

For that, Carrie, because that was the last place where I was like trying to scavenge the Federal Register, and I couldn't find where it down was down, classified specifically by.

They were all on the cure, Zack. They were all.

Oh, that's.

Classified in there, and I have all of them, if you need them. I have the whole.

I would appreciate it because.

Yeah, I have everything.

I'm on a soapbox now.

Yeah, I'll give you my soapbox, too, on that one, because I have them all. Okay.

Let me let me share what's going through my filtered brain. Some weeks back. So I made a a comment that one of our family members found biased and offensive. And so I'm trying really hard not to let my liberal sideshow. However, the reason I nurtured this group was so that we can lift up industry and we can do something positive. Long time. Friends might remember I created a website called No. 2.3 back in 2012,

and it was because of the medical device tax, and we garnered 11,000 signatures. And to this day John Eckberg insists that that's the reason that that got turned away. It's hard for me to believe, but he said that there was this huge map with, you know. spots of where people in the country had signed this thing from, and it was such a visual that our legislators were like, well, shit, this isn't just a Minneapolis thing, and they began to talk about. I again. I find it hard to believe that that had that kind of impact, but he insists that it does. I'm wondering in this environment if there's any kind of reasonable expectation that a concerted campaign

to fight for women's health initiatives on this Women's Health Month and others, could be expected to have a positive outcome or an influence. What is the group think about putting in the effort? Versus? Yeah, I know it's you know you stand, and I just I'll put myself on mute now because and want to keep friends. Anyone dare to comment.

I would think, Joe, if we went back to her previous slide about what's trending in women's health, the kinds of devices, and we were to look. Yeah, right there, cancer detection, non-invasive prenatal testing. I think you'd almost need to be addressed at the therapeutic category level. I think that really, it's like, what are you trying to do? What are you trying to achieve? And that. you know getting the manufacturers aligned about what their priorities are around their specific therapeutic category to me. That would probably

be the most effective approach rather than sort of blanket making it. You know, women versus men kind of thing, but really like in this particular field, we need to protect women. We need to make sure that there's representation that there's a lack of bias. That sort of thing. That's my opinion.

Anyone else.

I agree with Shawn. But I think if we start with one item. maybe we can make a difference, because there's too many things. So which one will be most important.

And do you have an opinion, or.

So my opinion it's I guess none of these. It's mental health just after the pandemic. Everybody's alone. So if we start.

Sorry after the pandemic. Everyone.

Everyone is alone. So we are all segregated to our computer screens, or you know, we are inside our homes or people have returned to normal life. But a lot of people have not. So if we start with one topic, and you know, we can decide what it is. then we can combine to focus their attention on 1 1 thing. because there's too many things that are related to mental health. Everything starts with how you eat, how you feel. In my opinion, I know there's.

Before I before I let you go. Just let me understand. Is that a gender specific issue? I understand that's an issue. But since we're talking about women's health.

It is.

You just said, related specifically to a gender.

Yes.

I think that women and men respond differently to that kind of trauma. So yeah.

Maybe we need to follow up offline because I'm I'm intrigued.

I wanna make sure that our guest gets to be get through her presentation.

Oh, I'm done! This is that was the last slide.

Oh, okay, I I.

Ending it with a bang with the.

There is still a hand up, so do you.

You, can you? Steven? I know you're on the ready. If you have a link to.

Yeah, 1st of all.

Your site, or something.

Agree with you. Currently, I'm working on an excess finger cuff. We use finger cuffs for blood pressure measurement, and the original sizes were designed around the people who worked there at the time so predominantly male, and we have an L. Size M. Size and S. Size cuff, but the S. Size. Cuff don't will not fit on a large group of women. So that's exactly how it worked from from from from years ago. But I wanted to say that even if you have all men's clubs, you can still make Let me see, Joe said. I could share my screen. Where is it?

Yeah, I believe I believe it's as simple as you hitting the share button on the bottom.

Fibromyalgia.

Here. Okay. And this one.

Can you see it?

Let's see if I need to do something to.

No, this is this.

Here we go, yeah.

Here we go. Oh, we made devices to measure Emg, and there was a professor in Houston, Professor Zhang. He used our grids to wrap it around the pole and put it into a vagina to measure pelvic muscles, because a lot of women have pain when they contract those muscles when it's like, How do you call it? Well, it contracts too much, and especially when having sex, it's it's it's painful. So a lot of people won't have sex. So what then? The original procedure is, then, that they use Botox to tone down a few of those pelvic muscles.

and there's a side effect to it that a lot of those women get incontinent. So what Professor Sung found out is that if you measure your pelvic muscles and you find out where the nerve endings are where the motor end plates are. You can use much less Botox. and you get the same effect that it relaxes the muscle which you don't get incontinence. So we were all enthusiastic, and then they said, Well, for $400 or $250 per probe. I cannot sell this. Can you design it for for less? And together with the director of Post Rama, I designed this one, which is it's not really the design goal was $10, and I think we're now at 12. So

it's not too far off. But it's not really also not really disposable. It's more like a single person use, so you can use it. Once lay it aside, and then, when there's a follow up procedure, you can use the same device if you like. So and this one is is oh, I think it it in the design as a design. It's a great success, because we used in mold labeling. That's the same thing you do with like margarine cups or ice cream cups where you have the printing on the outside. But what you do is you put your printing inside an injection molding machine

the the plastic from the inside. So and this way, because the the the electrodes were a little bit resist. You can put some electro gel in it, and also, if you put some more gel, and it's like a lubricant which makes it easier. So out of a design perspective. I think it's 1 of the great successes ever. But then the the company who ordered these. they had no idea how to put something to market. so I guess they got a grant from I don't know where, and as I see, they still have a website about us. Hill met. and but, as you see, at the development milestones they they end in.

I guess they made it before quarter 1, 2023. So I guess it just went up in smoke. And it's it's it's I think it's an example of you. Do something with the best intentions, with the best engineering ever. But there are so many other factors that that can prevent it from being making it a success. It's it's sometimes a shame. I guess, if those guys were were a member of this group, and they would have learned a lot from other people. Then this could maybe could be a success. And I don't think there it's. It's on the website from posterama. So there was. we thought about having a patent on it, because it's really a very elegant way of making a lot of electrodes from the outside of a surface.

But that is on on display right now means that there's probably not a patent on it. So everyone who sees it now can can run away with it. So that's what I wanted to share.

Well run away with it. How far? Because.

Hmm.

You say, run away with it. But if initiatives like these are going to find a lot of resistance, and they'll run away with the same frustration that these folks have.

You know, I looked at their business plan, and and they say how they want to fund it is like getting money from the Botox factories, manufacturers. But then, if you use less, Botox, how do you want to make money from Botox manufactories? It doesn't work that way. So they had a totally awkward business plan.

You can stop me sharing because I think I can do that, or you can probably undo that. Say.

But it's also to say that I think a lot of men are working on on women's health medical devices. and of course you try to attract as many women to your development as possible. But it's still a matter of fact that in engineering there are not a lot of women working.

Yeah. And I think half the battle is just recognizing the that the considerations right? And I think a lot of men are doing the right thing and are doing what needs to be done. Just keep going mute.

And you just shared a link in the comments.

Yeah. So this was to Luke's comment. They didn't really know how to bring their product to market. We're starting a new two-part Webinar series with 2 speakers. One is about nailing your value proposition to attract investors, and the next and and and to define your audience, and then the next part around. It is really the secret sauce around. you know, finding your right product code and getting your device paid for. And so I think that this is a really interesting 2 part series, and they're going deep into some stuff that doesn't get talked about a lot. But I think this is exactly the kind of thing, Luke, that would have helped your your clients understand the value of what they have and how to.

3 years too late!

Yeah, daily and a dollar short. But you know, there are other companies that are in the same position. And if you have clients that are struggling with these topics. Then, you know, I would encourage you to to join. Anyway, that's my plug for the next webinar.

Keep it on.

I've gotta run. But I really appreciate you indulging me, Margo. Yeah, thanks for joining. Thanks for a great discussion.

Yeah. Okay, bye.

Yeah, I'd like to thank everyone for, especially our speaker. and our Qm. Plus for introducing me, Steven. Thank you. And you know, I think this is different than one of our usual topics. But an important topic. I learned a lot today that I didn't know. I've never heard the word penis and vagina used so many times on a call ever. And but you know, when when you're speaking about gender. I don't see that there's any way around that. So thank you. Everyone and.

Before we hang up, Marco. How many folks are in California? I know Allison is. But is there a hub there, or is everyone working virtually.

Everyone in our Qm. Pretty much works remotely. We have several consultants who live in California, Allison being the main FDA resource out there, but there are a few others. Lots of people on the East coast, lots of people in Minneapolis area kind of all over the country. We have some in Europe as well.

I'll send her a note. But you have a call with Allison reminder that we're gonna be meeting actually, 2 months from today may 7, th right near her home in Newport Beach, and she's a friend of the family. I just enjoy having her there, whether she hooks up with Shawn, and gets on the actual agenda, or just graces us with her knowledge in the audience.

Sure I'll let her know.

Would be great next week. we have Dr. Arlen Myers. He's a well known figure in Med Tech, and he's going to be talking with us about the confluence of Med Tech and AI.

So that would be an interesting conversation. Sorry to jump in with a last minute question. I'm sorry I'm transporting these kittens that are getting on.

Sure, Patricia, what have you.

Bye. This might have been discussed. Thanks, thanks a lot for this presentation. but I had a question that it might have been hit upon. But what about those that had gender reassignment surgeries? And how does that play in when they're building these medical devices? It depends on what the medical device is right, but.

Yeah.

In in terms of monitoring like blood pressure and those types of things. And you know, integrating that into the bias in AI.

Yeah, I mean, I'm i i can't say that I'm an expert in that but I think you have to consider the factors right? So if your device is. if there's potentially differences for those people who have had those procedures, then you should potentially disaggregate them from your data set. Make sure you have a representative number of people. You know, in your clinical trial, or or usability study, or or depending on what the device is, you know, appropriate for the device. I think how you then present that data to the agency may change over the coming weeks, months, years, and I can't really speak to that without waiting to see what happens. But you know, doing the right thing for your patients and making sure that you're accounting for variables like that is always going to be important. So if there's health considerations that are different for those people compared to others definitely, you want to consider them.

Emma, you just shared a link with. What's this about.

Who.

Yeah.

I'm sharing the link to a company that's based here in Montreal. They're called Eli Health. I just find what they do. Very, very interesting, haven't worked with them, but they're very strongly innovative in the field of femtech. So they're developing this technology that can detect hormones and saliva, and really putting patient monitoring at the hands of females, you know, tracking all kinds of insights. And I just think it's interesting a lot of the information.

They join wait lists, so they're not in market yet. Do you happen to know where they are in there regulatory.

I think they were pursuing well, I'm not. I'm not sure I haven't kept up with their regulatory.

Your your company's not working with them.

No, no, no, but I just find what they do. Very interesting. The founder, I think, and her husband were facing some infertility issues. And so they're both engineers. And one of them was working on the hardware portion of this and the other was working on the software portion of this. I think it's just very interesting, because they're putting a lot of the information that's unknown in the field of infertility. There's something called unexplained infertility, and a lot of times. It can be just helpful to gain insights into how hormones play a part in infertility and the treatment of of these kinds of issues. So just kind of new developments in the field. I think it's important to keep track of. I like to see companies.

Well, you're a very welcome addition to our family. I'm glad you started to join us.

Yeah, it's my pleasure.

Just a a reminder. And it's been a while since I've done this. But everyone who's on this call has an expertise that can teach us something. So if you have a topic that you'd like to be our featured speaker. if me or Shawn the Buzz. we're booked through this month. But more weeks, of course, to follow, and we have, I think, just 8 sessions before 10 x. So if there are any in particular, that would be an appropriate lead in to the topics that we'll be covering there. They will be especially welcome. So on behalf of our Qm. Sean and myself. Thanks for joining us today. Make it a great week.

Thank you.

You all thank you again.