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Measuring the Pulse of Women's Health Tech: Where ...
Measuring The Pulse of Women’s Health Tech
Measuring The Pulse of Women’s Health Tech
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Well, good afternoon, everyone, and thank you for being here. I'd like to welcome you to this session, Measuring the Pulse of Women's Health Tech. Where are the cardiovascular solutions is what we're going to be tackling today. I am Sana Al-Khatib. I'm a cardiac electrophysiologist at Duke University Medical Center. And I am super excited to be here. I hope you guys have had as great of a day as I have. And I am really thrilled to have these experts with us today to share some insights with us about this important topic. And what I'd like to do is to start by asking each of you to take a couple of minutes, introduce yourself to the audience, and tell us about things that you have done or are doing on women's health tech. So we'll start with you. Welcome. My name is Jen Minan. I am a director of R&D in Abbott's vascular business. Also a key contributor in our diversity and research office. So we're focused on creating more inclusive clinical trial ecosystems, focused on investing in solutions for underserved communities, including females. Wonderful. Go ahead, please. Hi. I'm Shavini Fernando. First of all, I'm a patient with Eisenmenger syndrome, which made me develop OxyWear, which is a wearable pulse oximeter, which was first approved as a wearable for continuous oxygen measurements during motion. And because most of the time people think you need to measure oxygen only while you're seated and still. But as a patient, I know how my oxygen drops when I'm climbing stairs and hills. I tried to explain it to so many people, but no one wanted to do it. So I was like, might as well just do it on my own. So we just got clearance, and we have a majority of patients, because if you know in the pulmonary hypertension and all the cardiovascular, it's majority women. And most of them that get diagnosed only during pregnancy. But it's hard to explain this to people. So I thought, might as well do it on my own. Good for you. I love it. Next, please. Hi, everyone. I am Nino Isakadze. I am a cardiac electrophysiologist at Johns Hopkins. My research focuses on digital health technology and atrial fibrillation management. And we have a multi-component intervention that leverages smartphone app, smart watches, as well as weekly check-in calls by nurses to modify risk factors in this population. And we spend a lot of time with human-centered design and specifically understanding the specific barriers for men, women, and individuals from different racial and ethnic backgrounds. So that we identified unique challenges in each of these populations, and it really helped us design an intervention that was suited for diverse patients. Wonderful. Thank you. Go ahead, please. Yes. Hi, everyone. I'm Alicia. I'm the founder and CEO at BlumerTech. So my background is in electrical engineering and computer science. I was part of MIT's computational cardiovascular research group, where when having access to huge amounts of data from large clinical studies and everyone building AI models, we realized early on that most of this data was overly represented by males and very poor data from females. And we wanted to see how algorithms would perform with women cohorts, right? We realized early on of the underperformance. We also think that there's a lot of things that if we don't build AI properly, it could perpetuate existing problems in the system, because women are already having worse outcomes today with existing technologies. So that's why we created BlumerTech. We have a wearable garment, which we call the BlumerTag, tech augmented garment for tag. It's in the form factor of a bra. So it continuously and remotely acquires physiological data from women. Wow. That's very interesting. Well, thank you very much and welcome. What I'd like to do is certainly encourage anyone in the audience to please ask questions. I'm hoping this can be interactive. And as we talked about, we want to talk about solutions. But before we come to talking about that, can we talk a little bit about what you think are the major challenges that we're facing in this field? What are the main barriers? Why have we not made as much progress in this area as we've seen in other areas? So maybe we'll start with you and go down and next time I'll start with her. I promise. Absolutely. I think one of the major barriers to creating solutions is that there's a lack of data historically and even currently there's underrepresentation of females in clinical trials. So even just starting from the basics of we don't know where to begin because we don't have the data to do so. Good point. Please. Yeah, it's absolutely true. And then I think most and I'm sorry for all the men out here, but most of the stuff is actually developed by men. So because of that, most of the time they don't understand exactly what's going on with women and what exactly women needs and women's problems are. So I always say it's very important to have a person from a customer involved in your whole design process so you know you are developing and designing something that the person will actually use. Because no point of developing something that's in your head that you think might help the people if no one's going to use it. So that's the biggest problem. There's so many things, but none of us are able to use it because it actually doesn't work on us because it was not tested or made with us. So we heard lack of data. We heard lack of representation of input from people who are going to be using the product. So that's an excellent point. Yes, please. Yeah, I just want to echo what has been said by previous panelists that, you know, there is a paper that actually was published in 2022. I was a co-author where we found that for specifically atrial fibrillation trials out of 136 trials, only 35 had women as co-authors on the papers. And, you know, 14%, you know, was where, you know, the women were in charge, like the first author or the senior author of the paper. And we definitely know that in atrial fibrillation studies women are underrepresented. So again, like echoing this point of how we can diversify the patient populations that we're studying is very important. And the second is women have, like, specific challenges. As you mentioned, you know, patients in the human centered design session shared that they have, like, they're more likely to be caregivers. They have, you know, work and have to balance the family and, you know, some are, like, you know, experiencing childbearing and so forth. So all of these need to be taken into account as we are designing, so involving them in the intervention development and enrolling more women. That's a very important point that you bring up, because you're exactly right. Like, if you have women involved as co-investigators, as co-trialists, they are more likely to think of those issues and perhaps contribute in ways that can help us recruit more women into trials, which is something that we want to try to do and keep women involved and engaged. And also really encouraging more junior researchers and clinicians to participate in the design and conduct of research. So thank you for bringing that up. Yes, please. Yes. So to build on top of everything that has been said, right, like, one of the things is that even though, yeah, we talk about the lack of data, we talk about the lack of female representation and things like that, there is evidence, we have over 30 years of evidence that shows sex differences, especially in cardiovascular system, right? And for me, until very recently, we started to see papers finally publishing sex disaggregated data. But we need to keep seeing that sensitivity and specificity in AI algorithms. We need to see it sex disaggregated. I want to understand the performance of all of this work that people have been doing, but they don't come necessarily like that. And that's a huge problem when we look at the future of AI. That's an excellent point. And to follow up to that, you know, I think one major thing we have to do is raising awareness. How do you raise awareness among researchers, among consumers, the public? So have you had any experiences where you've needed to do that? Can you share any insights about how best to do that? Well, I do have to say that over the last few years, fortunately, there has been a shift, right? We've seen big movements. The American Heart Association and Women Heart do a good job raising awareness about heart disease in women with Go Red for Women campaign and their champions movement. I do think there's more to do in the product side and the technology side. I think what Shabini pointed out is a very strong point because here there's people that are building and using products, and we have evidence, right? So we need to start tapping into how is this performing for my patient? Was my patient studied when they gave the results? Because otherwise, are you doing what's best for your patient? We need to start questioning more. Other thing I want to bring up is like when you build these EI models, when you create those models, obviously if you don't have accurate data on women and make sure that the data actually can represent different phenotypes, you may end up with wrong answers in terms of things that the algorithm. This is bias that you will be introducing, and I think it's really important for people to be cognizant of that and be proactive to prevent that from happening. What are your thoughts? Well, you just mentioned it's garbage in, garbage out, you know? Yeah, exactly. Thank you. Please. And in terms of like raising awareness, you know, society. as they're doing an excellent job, and I think it falls on us as well as investigators and company founders and so forth, that to involve the patient advocacy groups to whoever we are designing the interventions for. For example, we focus on atrial fibrillation. We have partnered with the patient advocates. You know, there is, you know, each disease specific patient groups on social media and so forth that has like 30,000 and more patients. So just spreading the awareness and having patient advocacy groups and patient advisory boards on your studies, women, that's very important to help support, you know, help them support that initiative of raising awareness. Yeah, I can echo on that because I'm a patient, so when we were testing our design, like starting from the mobile app design phase to beta testing, what I, I'm a part of all the patient support groups, so how I did that was I got my policy as a designer, because by background you may not know I'm a video game developer, although I designed a medical device. So something in theory, what I always have followed is when you're testing something, you should test it with eight-year-olds and then 65 plus year olds. If both of those generations can use it, anyone in the middle can use it. Because the people who can't handle tech and who needs it as literally really handheld guidance is those two populations. So if they are able to figure it out, everyone in between can figure it out. So because of that, when we design the whole app, we designed it with all the patients in the pulmonary hypertension, like all the support groups who are like 65 plus. And we got them feedback, we get them to test the whole thing. And even when we were beta testing, we tested with all those patients and then we tested with patients who have Raynaud's, caloderma, all the issues with reading numbers. So likewise, when you test with people like that, who you think has issues with getting devices used and who will have reading issues, you will be able to solve a lot of things and, like, literally you can prove, you know, you can eliminate all the errors and have all it, like, properly proved and get it all tested. So when you if you do it from the beginning itself, the chances of you having to go back and redo stuff is less. So that's something I think everyone needs to keep in mind because users should start from the beginning, not at the end of the whole thing. Go ahead, about awareness, please. Well, I was just going to kind of piggyback on on your usability comment around, you know, the user from an age perspective, but also, you know, from for myself as a female, a mother of three, full time job that I travel, it's it's so important for the usability to fit into my life. It can't be clunky. It can't take a long time. It can't be, you know, another application, another something to wear. So just kind of awareness around the whole patient or the whole person for what they're going through, not just how does how does your app influence, but how does it fit? Yeah, absolutely. So so as we talked about and what I heard from you is that raising awareness is actually at different levels, right? Like we've heard about raising awareness of cardiovascular disease and certain things that are specific to women and how you need to be thinking of how women might be different from men. That actually applies to also other underrepresented minorities. So we have to keep that in mind. We also heard about raising awareness regarding the importance of women participating in research. How do you make sure that you raise awareness among women that we need to participate, we need to engage, and then raising awareness among people who are developing products that you really need engagement from women and you need their input every step of the way as as you very nicely articulated. And in my view, like there's so much that you can do, including with digital health, to actually accomplish all of that in terms of of the raising awareness piece. So so that's really good. I'd like to pivot now and talk a bit about what are the solutions? Now, obviously, how you presented the problems, I think many of us are thinking of several solutions in our heads right now. But if I may actually ask you to kind of talk some about solutions that would address some of these issues that we raised in terms of lack of awareness, lack of data, lack of input from people who we need input from or leadership in research. What are your thoughts? Where do where do we start? So I don't think that there is one solution. I think that there are many solutions. At Abbott, we are focused on starting from the beginning. So partnering with women as one to give and promote opportunities for learning around clinical trial, support clinical trial management to female cardiologists. I think raising awareness by creating a template for a diversity action plan. So in 2025, the FDA will require sponsors to submit a diversity action plan for any clinical trial. And so it's it's holding the sponsor accountable to ensuring that there's female representation in the clinical trials. And I think all of us should should hold people accountable to to that commitment throughout the process. Absolutely. Very well said. And as you know, the FDA is pushing for that NIH is pulling for that. So the more we can get, you know, these regulatory agencies, these funding agencies to enforce those points, I think the better off we will be. So thank you. Go ahead, please. Yeah. And then also another thing is you need to, like, encourage more women in STEM to step into the development, because always if you check a STEM class, it's very less women. And if you check an engineering class, it's very less engineers who's female. And then when a female founder goes into developing something, then everyone judges. They think you're not capable of doing it. Right? Investors judge you. Everyone judges you. They think it's not going to be right. It's not going to work. Only men are capable of engineering. Men are capable of developing. So we need to cut that whole, you know, the unconscious bias out first. Because that unconscious bias is still there, even though there are so many good women who's doing engineering and who's developing products and stuff. So and that literally discourages all the women. Like, you know, everyone's not crazy like us to just go like a bull and fighting everyone. So that discourages most of the other women who's in the STEM to take a risk and go ahead and do stuff that they believe in. So we need to fix that whole mindset issue so that we can encourage more women to go and participate and help other women and develop the stuff. And before we speak with men, it has to start from women itself, I believe. So not to put you on the spot, because this is an excellent point. Can you maybe share with us some of your experiences in terms of how you were able to overcome some of those hurdles in your career? Yeah, for sure. Because, like, when I started, for example, I know FDA is there, but even FDA didn't believe me that continuous oxygen during monitoring motion is important. Because when I went for the pre-submission meeting, they asked me, who needs this? So I wore my oxygen cannula on, and I told them I need it. And then to give an alert, they said, no, you can't have an alert. And why do you need an alert for blood oxygen? And I was like, has any of you choked? If you have not choked, you won't understand this. The day you choke for the first time, you will understand why you need to know it first. And then when I had to go raising funds, investors were like, we can fund you, but we need to put a male co-founder with you. And I was like, everything is already founded. What is he going to come and find? There's nothing for him to come and find. So why should I give him half of the company and just put a namesake founder name on him? And, like, then they wanted to buy out the company. And the reason behind that was because I'm a woman, I'm brown, and I'm disabled. So people would not fund my company. And they wanted to change the whole business model to sell the company as an efficacy device to pharma and scrap the entire patient market out. And I was like, patients are dying, not pharma. So why would I go to the patient, scrap the patient out when I can already do both? And it went into a really heated argument, and they said, like, they literally told me you can save the world after you become a billionaire. And I said I'll save the world and then become a billionaire if I can. So it's, like, if men has one hurdle, women has, like, a thousand hurdles to jump. That unconscious bias is always there. And when it came to raising funds, I couldn't raise money. They were saying the value is too high, I'm not capable of doing it. So I had to raise money at a really low valuation to get through FDA. And even FDA is not easy. So you need a lot of money. By the time a woman found a get through FDA, you have already lost almost all your company. So it's really hard. It doesn't make things easy for women to go at it. But you should just sorry for my language, but you need to suck it up and just go and tell them I'll prove it how it's done. Otherwise no one believes you until it's done. It's perseverance, actually. And as was stated before, when people see people like you in these roles and being successful, I think that encourages other women to venture into these initiatives. So thank you so much for sharing your experience. No problem. Go ahead, please. It's hard to follow your story. But, you know, we definitely mentioned the regulatory importance that, you know, the regulatory agencies have requirements for the inclusion of women. And also funding agencies and, you know, authorships on the teams. When we're designing research teams, make sure that we have representation in our research teams and have patients involved in our as investigators as well. But what we did was, you know, with the development of the intervention, you know, similar to what you mentioned, we involved women and also men from the first step of the intervention development. Even, like, what was the components of the intervention would be were informed by this, you know, patients who were, you know, we called it human centered design, but you can call it focus groups and so forth. And understand, like, unique challenges to each of the populations for whom you are designing the intervention. That way, when you are at the, like, you are ready to test it in a clinical study, you have product that is usable by women, men, and also people from different ethnic and racial backgrounds. Thank you. Go ahead. Yes. For me, it's mind blowing that we're in the 21st century and that we still talk about half of the population of being an underserved market in the cardiovascular industry. You know? It's such a big industry. It's the biggest getting funded in reality. But we're not where are the solutions, right? And I think something that you mentioned, right, like, when we started thinking about our solution, we thought let's make it as easy as wearing a bra because she's not leaving her house until she wears her bra. You know? Like, she's not getting out of the house without her bra. Things have changed post pandemic, but that's when we started, right? And for us, this was thinking about our user, how can we acquire physiological data continuously in a way that it's going to be useful for the physicians so that they can improve their communication between their patient, improve the quality of the data that they get from this patient because unfortunately because most of the designs that exist have been done on a flat chest. They don't really think about sex differences or the noise that different body types and sizes can cause, right? In addition to that, when we thought about the solution that we were bringing and how we would differentiate ourselves, right, we really wanted to look at, like, there's different life stages that women have that all of this evidence is pointing to, right? Premenopause, during pregnancy, postmenopause, very different life stages, and we're using the data and building tools as if it was the same, and we know that things change. So why aren't we using that as part of our toolbox? I think you bring up an excellent point. We actually even feel that in clinical medicine also. Where a woman presents with some kind of symptoms and they may get dismissed by male colleagues. Our male colleagues are excellent. They're very capable, but I think because we go through those experiences ourselves, we get pregnant, we deliver, and have some of those symptoms, I think we are more likely to think about these possible reasons for some symptoms or some clinical pictures that people present with. And so I think it is on us also as clinicians, you know, of all sexes, of all, to really learn all these things about women. And so there's that analogy also between what you're describing and clinical medicine. So let me here, I don't have any questions from the audience yet, but if you have any questions, please feel free. Again, I want to make sure that everybody's questions get answered. So we talked about, you know, women specifically. I want to go a bit deeply into this and talk about women who are from underrepresented minority groups, because there you even have more challenges in terms of raising awareness, in terms of, you know, getting their involvement in research and hearing their voice and their input. Do you have any thoughts about certain approaches that we can adopt as a community to make sure that those women specifically also get heard, get engaged, get involved? Thoughts? We'll start with you. Yeah, I think trust is a huge factor in these underserved populations. And I think once we flip into more data-driven approaches, and if we empower her, and I think in all of these areas, right, like when I was hearing Shavini's stories, I was thinking about like, wow, she's very empowered. And when you can empower other people around you as well to advocate for their health, because to your point, we hear all the time, it's all in your head, right, like all of these comments of symptoms that she's feeling and getting dismissed, and they see it more often, right? Like these are populations that acknowledge that they see it, but also they have more distrust in the system. So you want to give them the tools so that they can advocate and have data-driven care rather than like subjective care. We don't want that subjective when you dismiss someone just from seeing them without doing a test. Go ahead, please. Yeah, I will give an example. So we recently completed a pilot study where we were testing digital health technology enabled risk factor modification program for AFib patients. And we're in Baltimore, we're primarily serving patients from diverse backgrounds, but we found that in our study, despite that, like 90% were white, right? So we spent a lot of time afterwards while we were planning the larger trial, and we came up with a solution where we conducted a community advisory board where we engaged patients who are leaders in their community, churches, you know, local communities who are like influential in their local communities and asked them, like, you know, this is what we're trying to accomplish with our study. How can we reach populations at the community level? And you know, just things that we'd never thought about were brought up, like, you know, we have a fear on this date. Bring your information, and we're going to, like, send patients to your clinic. Then, you know, we're screening patients in the markets, we're screening patients in the senior homes, and, you know, give us information, we're going to send patients to you. And we also, like, reached out to local community health centers as well. So that was, like, a very eye opening experience that you have to actively work on getting to community and engage them as you are designing the study, how to recruit and retain the diverse populations in the study. Thank you so much for bringing that up. That's a wonderful point that you're making in terms of community engagement, and it takes effort, it takes time, it takes gaining trust of leaders in that community, you know, going to churches, going to barbershops, whatever that might be. But I honestly feel it's so important for us to do it, and we just have to think of, you know, efficient and effective ways to do that, and, you know, I really want to kind of see how far we get, because, like, some people now are skeptical about, like, how successful we can be, but I don't think we should give up. I really think we should do everything we can to reach those communities and pull in those women who are incredibly important, and other, not just women. Like, all these people in these underrepresented minority groups are so key to get to engage. Go ahead, please. Yeah, so something we do is, like, we work with all the disease foundations, because they know exactly the people who we can work with, who's underrepresented, like, who can't afford stuff. So what we do is we partner with, like, we work with COPD Foundation, American Heart Association, Pulmonary Hypertension Association, like, Scleroderma, like, all the foundations which has issues with patients on getting pulse oxy readings, but those are the people who actually reads them, needs a reading as well. And then with them, what we do is we reach out to the support group leaders, because the support group leader knows their patients the best, like, who can afford, who can't afford, and we literally created a program where we get people to donate devices, and so that we go into those support groups, and we get them to send us patients who can't afford so that they can get a device. And in return, all they have to do is give us honest feedback on how they would love the device to improve, what more they want to see in this device, and at the same time to volunteer to give us that data so that we can use that data to improve the device and to understand what's going on and to use it for clinical trials and all. Because with that, you can get more people involved in the study, and you can at the same time you're helping someone else who can't afford to get that device or the help they need. So it's pretty much we're helping the community as well as getting the community to get involved in your work as well. Well, exactly. It's a bidirectional relationship, right? Like, they get involved, they provide feedback, you give back by, you know, taking their input, but also ultimately developing products that are going to work best for them. Exactly. Very good point. Go ahead, please. And I think to build on that with patient advocacy groups or groups where that patient population may sit are great places to understand the intersectionality, not just gender, race, ethnicity, other social determinants of health that are important to consider, especially trying to reduce barriers to clinical trial participation. So travel stipends, stipends to cover child care, adult care, stipends for the institution to offer extended hours, weekend appointments, early morning, late at night, so that we can reduce barriers for all patients across many different social determinants of health to expand our enrollment to the patient populations that will benefit from the device or the therapy. Yeah, without a doubt. And in fact, in some of the trials, they've implemented some of that, and it actually certainly augmented enrollment of women in the trials. We have a question from the audience. Go ahead, please. Thanks, Alicia, and to all of you for everything you guys do. I wanted to stick on this point that several of you have raised, and I brought this up in a couple other sessions. When we think about diversification of data sources for our underserved and for a broader generalized population representing the US Census as opposed to what we have today, some of this is also going to come down to our opinion and our evolution of policy on data. We are the only industry that is still very archaic with regards to data sharing, privacy. If you look at every other industry, whether that's financial technology, consumer tech, social media, for sure, we're just giving away our data for free. And that's irrespective of whether you're affluent or on the lower socioeconomic standpoint. And guess what? They are able to get such individualized targeting and signatures that we just can't do. Because I don't think this is an FDA thing. I do think that this is almost a congressional update to what we really think of HIPAA as, because for whatever reason in our industry, we are so afraid of data sharing, but we do it in every other industry, which I would argue some of it is more sensitive information than our EKGs or our blood pressure, right? I'm posting pictures of my kids in my house everywhere. I would say that's a bigger threat to me personally than sharing some of that data. So I'm curious on you guys' thoughts in that regard from a policy standpoint. That's an excellent point. Who would like to start? I can add to that. Because as a developer based on HIPAA, what I understand is what they don't want is your personal information and tied to that health information. But I don't need anyone's name, age, all that. What we need is the sex, the demography data, and the health data to understand exactly for that particular demography what's happening. So something that we are doing with our app is we literally get them to give permission to give just that health data and the demography data without their personal data. So we can use it for clinical trials and for people who want to do all these AI things and all. And I think we can do that. Because the HIPAA is on the personal information, right? So that's how we have developed the whole security system as well. So the health data is separated from the personal data. And it's connected through encrypted like a connection key. So when you delete the records, everything related to the person, the personal information, it's deleted. But that health data, someone can pull that data to use it for the health data analytics. Because that is what you need to understand what's happening in a demography. So if everyone in the device industry can do something similar, I think we can build a huge database. Like, for example, I went to an ALS conference, and that's what they're doing for ALS. They're pulling all the data from all the ALS patients to understand the science. Other points of view. I know you want to add something. But let me just get them to can I get them to weigh in or do you have a burning point? I just wanted to say advocacy on what you just said. If we can all take a unified approach on opt in, like we do with every other industry. Exactly. I love your point that you made. But also I actually like the idea of saying, well, we're not going to like really collect specific identifiers about you. So to the extent that we can really minimize those identifiers, instead of like getting someone's date of birth, we don't need that. We don't need that. You can get like age range. You can do so many things and be creative. Other thoughts about the data sharing point? Yeah, and exactly. We have like data silos, right? In our study, we have patients opt in to give us our data. And they are data for our study, but we are not able to like cannot extend that to other studies. But there can be language in those kind of agreements that you agree also that data goes into like larger database. And we just did a survey on like just a simple like Facebook page for patients with atrial fibrillation. And my mentee is going to be presenting that at the abstract session. Patients didn't really consider privacy as a big issue, which was very interesting. So obviously there are going to be like it's not one size fits all that everybody not everybody is going to give like swipe yes to sharing that data. But, you know, 80 plus percent of the patients on that social media owned technology for their AFib management. And their concern was not privacy. So as long as we're transparent and like, you know, that they are able to read the data agreement, I think that's something that will hugely benefit us as we're developing like, you know, AI models and so forth. Go ahead. And maybe just to add a point, you know, I think that there are there are data sets that are poolable, you know, with within Abbott, we are trying to be consistent about the data that we collect even in clinical trials. But I think it's the way that you collect the data. It's the definition of the data. So, you know, even looking at continuous glucose monitoring, if you pool all of the sensor data across all different companies or vendors or sponsors, the way that we collect the data is different. And so pooling that together may not make sense. So I think that that is also something to consider why we're not making things a little bit easier and a little bit larger from a data volume perspective. Go ahead. Yeah, I will say that coming from this could be a very long topic. So to make it a little more succinct, right, just because one industry is doing it doesn't mean that it's the right thing to do. Right, Like in the airlines we see all the time that people have to opt out and they in theory tell you you can opt out from the face imaging, but everyone's doing it because they think they have to. So everyone's giving out their face when you're entering a flight. It says very little there. You can opt out. But people don't do it. Right? To your point. It's maybe not that they don't care about their privacy. It's largely because they don't they're not aware. Right? They haven't been raised awareness about. And now with all of these things politically, post Roe versus Wade, we have to be really careful about the data we're giving about women's bodies. So we really need to be careful how we ensure who owns the data, how are we using it, how are we protecting patients as well. So this could turn into a large topic because I think there's a lot of things that no industry is doing correctly. And we need to dedicate the real time to think how we're going to solve it. So we can scale the models. Sorry. Because we want we really want to personalize it. Yeah. I agree with that. Indeed. I mean, one thing I think that will go a long way is if we are very transparent with the patients in terms of how their data are going to be used. Because part of the issue is people want to know how their data are going to be used. Like if you tell me that you have these great things that you're going to do that are going to lead to discoveries that are going to lead to, you know, progress in the field, I think many people would say yes. They're giving you genetic data, you know. That are going to benefit my kids and my family for hundreds of years. Indeed. We need regulation first. You know, we need to make sure that there is regulation on those databases and so forth so that it's not available for people who could use that in a, you know. Yeah. I think FDA just put cyber security. We had to upgrade to SOC 2. So it's very secure now for devices. Other thing I want to add to answer your question is with regard to funding agencies, like especially like the NIH, they're becoming they're focusing so much on data sharing. And they're really pushing investigators to, like, highlight how they're going to do it. Like holding people's feet to the fire to share as much as you can and to really provide a strong rationale as to why you cannot share data or, you know, most of the data. And you have to present a compelling argument as to why you can't do it. Now, one point I do want to go back to, you mentioned when we were talking about the problems, you mentioned lack of data. Okay. And I completely agree with you there. We didn't really hit it hard in terms of how do we solve that issue? So we talked about it some in terms of data sharing, what have you. What are your thoughts about how do we get there in terms of building those databases, that data sets that are going to really help us, you know, make progress in this field? I think some of that we've touched on a little bit. Having female study leadership in a clinical trial so that we're looking at equitable recruitment strategies. We are intentionally designing a clinical trial and even before then the product with the female in mind. And with certainly underrepresented communities elsewhere. But I think starting from the very beginning, we can start to build all of the solutions that we need to get the data at the end. Absolutely. And ensuring that it's quality data and that you, you know, protect the data. And we talked about the security as well. So I do want to get to a very important topic. But just to kind of summarize for people, what we heard so far is that the main issues that we have here, the main barriers are the lack of data on women because of lack of representation of women in registries, in studies, in clinical trials. We heard about the fact that many times products get developed without input from women. And you really need that. It's so important to keep that in mind to make sure that the, you know, consumer, women, can actually use the products that you develop. So that's really key. Talked about how you build the data, how do you make sure that you have good quality data, secure it. But really great representation from women, including women coming from underrepresented minorities. We also talked about the lack of leadership in research of women. So we really need to be mindful of that. I think, honestly, funding agencies can play a role there in terms of when these applications come to them. I think they can play a role in terms of, like, you know, where is the diversity in this in the research leadership team? So and so one thing I do want to talk about is we have several people in the audience who are still junior people. They're trying to decide what they want to do. And honestly, if you ask me, I wear so many hats in my career. One of my favorite hats is when I, you know, communicate and work and mentor either junior faculty or trainees, fellows, residents. We all were there at some point, right? And so a question from the audience that really resonated with me, I do want to thank the person who submitted this question. If you can go back in time and you want to give yourself an advice, you know, for about something that you know better about now, what would you what would you give your older self or your younger self? What kind of advice would you give yourself? So I'll give you actually just a few seconds to to think about this. Any other questions from the audience? Okay, none so far. Would you like to start? What advice would you give your younger self? Well, I can start because yesterday I went back through memory lane in a conversation. And to be honest, one of the things when I started early in this journey of entrepreneurship, right, a lot of people recommended that I apply for an NIH grant. But I was not feeling ready for that. Like, not yet. We need to do more. We need to do more. Right? And when we finally years later decided to apply for that, because we thought the application was very a high bar. We wanted to do a very good application. They came back to us and they said, but this is not phase one. You should apply to phase two. And what? You know? And phase two application is much intense. Right? And so I learned how to do an NIH award application until very farther in advance of our product. It was harder, I think. And we could have done a phase one earlier if I wasn't scared of putting myself out there and trying it. We were fortunate to get our phase two direct to phase two award and privileged because I think it has been an amazing opportunity to work with the NIH. I would have done it earlier. So in your mind, would you have, like, needed to get more advice perhaps? Connect with NIH? You know, project officer? Trying to understand the process better for people who are seeking funding? I think it's more of, like, I should have trusted myself more. I think it's more, right? That's why her experience was so, like, wow. I think I overthought. We did a lot of things and we always thought we're not ready, we're not ready, we're not ready. And we were. You know? Absolutely. So I think there really trust yourself. Especially if your mentors and the team that you work with are giving you that reassurance that you're ready, then proceed. Don't doubt yourself. Don't doubt yourself is the point. Go ahead, please. So for me, I think, you know, now that I have more experience, I realize that this is a very bumpy road. And there are rejections and probably more rejections than successes. And in the past, I used to, like, really preserve it on, like, the rejections and, you know, spend a lot of time. And then I realized that, you know, you just learn something and move on. And then, you know, it's not always that it's going to be, like, a straight path forward. So I think with time, I definitely learned to, you know, not focus on rejections, but then, you know, move forward and try something different. Different approach. Absolutely. Especially in academia, you get far more rejections than acceptances. That's actually the truth. Not to discourage anybody, but especially if you are a researcher and you're applying for funding, but certainly stick with it if you're passionate about it and you have the right teams, you have the right ideas, you connect with people, you get as much information as you can get, you'll be successful. And you have to celebrate your successes. I think many people, you know, keep focusing on, like, I want to do more, do more. Take the time to celebrate your successes as well. But I agree. Don't get discouraged if you get rejections. Because that's part of it. That's part of the process. And outside of academia, too. I mean, I'm in an academic place. This has been my universe. But that's true of any setting, really. Go ahead, please. And then when you start doing something absolutely out of the box that no one has done, a lot of people will say you are crazy, it's not going to work. And it's going to be 90% no's, and you will have just 10% yes. And not even 10, like, 5%. The balance 5% maybe. So and you will hear a lot of, like, there are days that I pitched at the beginning when I started, I was like, am I doing the right thing? Because I pitched to eight investors and all eight said no on the same day. And I feel like hitting my head on a wall. Because it's not just you. You're responsible for your whole team as well. And once you start it, after you take funds, there's no turning back. Once you take investments, you're stuck there. So a lot of it's just like she said, it's an absolute roller coaster ride. And it's more downs than ups. And there are days that you will have, like, zero bank balance, but you still need to just pull the whole boat and cross the river. So don't get disheartened. Go watch a comic and just bounce back and come back and do the whole thing. Don't give up. The whole reason why the medical industry, the device industry doesn't have innovation coming out is because if you're doing hardware, no one invests. And if that hardware needs regulatory, then it's no, no. No one wants to put money. Anything regulated, no one wants to take a risk. So most of the people, they give up either because they can't take that pressure anymore or because they can't be responsible for the team and they don't get funding and then that's the whole that innovation dies halfway. So just go through it. Get through that thing no matter what happens. Just go break all the barriers and cross the wall and you will see how many people come running behind you after you have the clearance. I am just having that moment. And it feels so good to say, no, I don't need your money anymore. So it's such a great feeling. Just go to that level and you will know how that feels like to say no to all those people. Yeah, well, that's an excellent comment, honestly. To kind of do something that you're passionate about, stick with it, don't give up. But also the one thing I would point out, several cases in my career, there were instances where I felt like I can't just keep going. And then like the next day, something great happened. So like that win, that success that you're looking for can be around the corner. And I always feel like I'm so glad I didn't give up yesterday because it happened the next day. So certainly keep the faith. Thank you. Yes, go ahead. Maybe a little different take, but probably something that all of us can relate to is, you know, I've been in a male-dominated field and industry most of my career. And I think if I could go back and tell myself to trust my own voice, there was a lot of times when I second-guessed bringing something up, you know, speaking just because I didn't trust my own voice. And I think the learning from that is to now advocate for females in industry, females in STEM, to make sure that when they hear their voice, that they trust it and they speak up. Very good advice. Well, we only have about five minutes left. And what I'd like to ask each of you to do as we try to close here is if you think five years from now, okay, what do you think is going to happen in this field? You know, women's health tech, what will be the major advances that you see in the next five years? And it's okay to dream. It's fine. So we'll start with you. In the next five years, I think women will be in a leadership position as far as digital health solutions. We already know that women use digital health solutions 75% of the time. It's more than men. And I think we're going to end up dominating that field. And I also think we'll have a better understanding of the female patient from a cardiovascular disease perspective. Wow. That would be lovely. And I would think is more funding will come into women's cardiovascular device companies. Because if you check, only 3% funding goes into femtech. And from that, also 10% only goes into cardiovascular. So I wish and want to see that this whole narration changes and people would fund more female-founded companies and more women's cardiovascular companies. And this whole the narration around funding companies and trusting women-founded companies will change in the next five years. Let me ask you a quick question about that. Because that's an excellent point that you bring up. Is this because of the biases? What accounts for that really terrifying statistic? It's just most of the like, for example, like, if I take my cap table, I have gone even it has to start from women itself. I have gone to women VCs thinking that they will help me. But all the funding that they put goes into, like, women's, like, you know, reproductive and all the other stuff. But nothing comes into cardiovascular. They don't think that they need to fund this. And then my cap table is 10 women and the rest are all men. It was easier to convince men because they have their mother or their wife or their kid who's having an issue. So they see the whole thing and they want to fund this so that their family, that person can have a solution. And before we ask men to change, I think women needs to change. Right? Without you changing and you supporting the other woman, it's hard to ask men to support women. So I think it has to start from there. And if women itself undermine the women's capabilities that they can do this, that this is not because investors check in quick return. They put cash where they think quick money is going to come. And because devices and regulatory takes time, they don't want to put money there. They want to put in software platforms and everything that will give them a quick return. So that whole narration and everything needs to change and women need to first trust women on what they're doing and they can do it better before you ask men to change. They say we fund women and we have a VC fund that funds women, but they actually don't fund women. So a really small amount of funding comes into devices that's into cardiovascular women health. So that's why most of the companies die because they don't have money. And that's where actually also raising awareness is so key. Exactly. Because those companies need more money than developing a software. Good points. What about you? What is your prediction for the next five years? So, I mean, you said dream. So, you know, I'm an electrophysiologist. So we're only like 10% of the whole electrophysiology. So I really think that our next five years, we're going to have more women, which would mean like more women who are doing clinical trials and are working on having more representation in clinical trials. And I really do think that with digital health, we can increase access to care, like to women who are at home caring or, you know, in the childbearing stage, the digital health will give them healthcare at home. So they can increase access to care this way. Well said. Alicia, you have the last word here. Yeah. So when you talk about the future, I always like to think about the past. And just five years ago, we weren't talking about women's health in an event like this. So the fact that we are puts us front and center in this main stage. It's very exciting what we can think about the future. Right? Because I do believe that there's a lot of companies already that exist today that will turn the page and we will improve outcomes. Right now it's seven times harder to diagnose women of cardiovascular disease than men of the same age. I think that's going to change. We're finally going to catch it early and not when it's too severe because she's having very strong symptoms. So I think we're going to be able to give better healthcare and we're going to be able to build solutions that are actually tailored for her and with her in mind. That's very, very well said. What a nice way to end this session. I do want to thank each and every one of you for being here, for sharing your experiences and your insights. I personally feel inspired. So thank you very much. I also want to thank you all for your attendance and your interest and have a good evening. Thank you.
Video Summary
The panel, titled "Measuring the Pulse of Women's Health Tech: Where Are the Cardiovascular Solutions?" featured experts discussing the current state and future potential in women's health technology, focusing particularly on cardiovascular solutions. Dr. Sana Al-Khatib, a cardiac electrophysiologist, introduced the session and attendees, emphasizing the day's theme.<br /><br />Panelists included Jen Minan from Abbott's vascular business, Shavini Fernando, founder of OxyWear, Nino Isakadze of Johns Hopkins, and Alicia Chong of BlumerTech. They highlighted challenges such as the lack of data on women due to underrepresentation in clinical trials, insufficient female leadership in research, and products developed without input from women.<br /><br />Solutions recommended included promoting women in STEM, ensuring more female leadership in clinical trials, engaging patient advocacy groups, integrating human-centered design, and leveraging digital health technology. They also emphasized the need for diversified data sources and overcoming biases in funding.<br /><br />When reflecting on their career experiences, panelists advised trusting one's voice, persevering through rejections, and advocating for women in leadership roles. Looking ahead, they envisioned a future with better healthcare solutions tailored for women, improved diagnostic accuracy, and increased female representation in research and clinical trials. The session concluded with a call for more awareness, equitable funding, and patient-centered design to drive innovation in women’s cardiovascular health.
Keywords
Women's Health Tech
Cardiovascular Solutions
Clinical Trials
Female Leadership
Human-Centered Design
Digital Health Technology
Diversified Data Sources
Patient Advocacy
STEM Promotion
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