Speaker 1 (00:04):
Hello, and welcome to Healthcare 2040, a series that matter produces together with Baxter. I am Jeana Konstantakopoulos, Senior Director of Partnership Engagement, at MATTER, a healthcare technology incubator and innovation hub with a mission to accelerate the pace of change of healthcare. And we do three things in service of this mission. First, we incubate startups. Since we launched seven years ago in 2015, we've worked with more than 700 companies that range from very early to growth stage startups, and we have a suite of services to help at every stage of development. Second, we work with larger organizations such as health systems, life science companies and payers and companies like Baxter to strengthen their innovation capacity. We help them find value in emerging technology solutions to unlock the full potential of their internal innovators and create more human-centered healthcare experience through system level collaboration. And third, we're nexus for people who are passionate about healthcare innovation. 

Speaker 1 (01:05):
We bring people together to be inspired to learn and to connect with each other. We produce a lot of programs, including large scale events for the broader community and small forums exclusively for our members. Today's program is part of our healthcare 2040 series, where we look at what healthcare might look like in 20 years and how we're gonna get there. We've had a great collaboration with Baxter to produce this series, Baxter's based here in Chicago, and has evolved significantly over the last seven years with a focus on connected care, earlier diagnosis, workflow management, and other tech enabled healthcare innovation. So for today's topic of conversation is the future of chronic pulmonary care. We're fortunate to be joined by Dr. Ruth Tal-Singer, Tom Westfall, and Dr. Eric Seifer. Dr. Ruth Tal-Singer is the president and CEO of the COPD Foundation, and is internationally recognized as a patient focused innovator health care leader and clinical scientists with extensive research and development experience leading to the delivery of approved medicines for patients. In her role at the foundation, DRT sign advocates for transformative approaches to disease prevention, diagnosis and treatment for COPD, bronchitis and nont tubulars microbacterial lung disease. Uh, we're happy to have Ruth start our program. So Ruth, I'm gonna ask you to come on and share a little bit with us. 

Speaker 2 (02:35):
Sure. Hello everyone. Let me share my screen. And while I do that, I will thank the organizers for inviting me to speak about chronic lung disease in the future. And because next month is COPD awareness month, I will talk about COPD or chronic obstructive pulmonary disease. One thing that we've been aware of, um, during the Covid Pandemic is starting to think more and more about the lungs and breathing. So hopefully today's discussion, we'll talk about how we get to the horizon that eradicates diseases like COPD. So, COPD is a global health crisis, and recently, actually in September, was described as a pandemic because a pandemic, um, impacts people in different continents and impacts a very large part of the population. So if we look at numbers on the slide, starting from the left 2017, the global estimates of chronic lung disease, not just COPD 545 million people around the world diagnosed in 2021. 

Speaker 2 (03:48):
We're seeing 384 million individuals around the world that are diagnosed with COPD. There are no numbers on undiagnosed, but basically the estimate is one in 10 people over the age of 40 diagnosed with COPD in terms of mortality. COPD is a killer, and 3.3 million deaths were attributed to COPD in 2019. And that's probably an underestimate because when people have COPD, the cause of death many times is either cardiovascular or infection. Moving to the bottom left, let's talk about horizon. That's what we're talking about today. If we don't do something, the estimates that COPD is on the rise, and in the UK study that I'm showing here, and estimated increase of 39%, and this was relative to 2011, but more recent literature suggests that COPD leads to global costs of, uh, rising to 4.8 trillion in 2030. 

Speaker 2 (04:57):
If we look at United States examples based on hard numbers, we're talking about 49 billion in 2020. So this is a major health crisis. As I mentioned before, COPD is a killer, and COPD survival is comparable to a lot of cancers. We look at a graph in the left here. We've done pretty well at reducing heart mortality associated with heart disease in the United States, stroke, and even accidents with improved safety measures. But you're seeing this graph here, it's women in the United States, COPD or chronic obstructive pulmonary disease is on the rise. And if we look at 2021, African American women were shown in this, in this publication that looked at race and gender. It's the only social demographic group to have had an increase in COPD mortality. So this year, Dr. Manino and I published a paper or, or in the tutorial saying that we need better understanding of factors that are responsible for increasing mortality among younger women in many countries, because a lot of it could be attributed to healthcare disparities or health disparities. 

Speaker 2 (06:21):
In September 22, the Lancet Commission on COPD proposed that we classify COPD to different types. Although we've known for a very, very long time that there are many risk factors associated for COPD. When you talk to somebody, even pulmonologists about COPD, they see the old smoker because that's when the disease is diagnosed. That smoking definitely contribute, uh, contributes to a lot of COPD cases. But you could see on the screen here that there are many types of COPD, many risk factors in never smokers as well. So I'll give only very, very few examples. So, genetic, COPD has always been associated with alpha one antitrypsin deficiency, and those individuals have emphysema, early onset of lung disease. But we've shown that there are many genetic factors, other genes that are associated with the risk of developing COPD. 

Speaker 2 (07:24):
So that is this type one that's been defined. Another component that I wanted to highlight is that early life, even in utero to midlife events, impact the risk for COPD. So you see the picture of the child, but a child of a woman who smokes is at risk of developing COPD or early life infection is associated with risk. Even if a person doesn't smoke, they could still get COPD, occupational COPD in firefighters, in first responders, in military, um, people or people who work in dusty and polluted environment. That is a risk factor for COPD. So I'm not gonna go through the whole list here, but what I want you to walk away with is that anyone can get COPD. Yes, of course, smoking vaping, that is a major risk for this pandemic. But when you think about other risk factors, don't rule out the fact that somebody can get COPD without ever smoking. And obviously, multiple exposures contribute to another type of COPD. 

Speaker 2 (08:35):
On this slide, I wanna show that COPD'S diagnosed and treated later in the course of disease. And that is important if we are to eliminate the disease. So as I mentioned before, when we think of COPD, we think about some old person who smoked today's definition, and today's diagnosis is when someone's lung function is not normal based on spirometry. That is the graph on the top here from the Lancet Commission. And the bottom graph, What they're proposing, which I definitely believe is critical if we are to intercept with the disease pathway, is to diagnose COPD In a broader definition, the considers other factors like lung imaging, like symptoms, and in the definition of COPD, because this is akin to treating blood hypertension, for example, or high blood pressure when somebody has a stroke. 

Speaker 2 (09:33):
We want to prevent this from ever getting to not having a lung or not having lung function. So on the left text is a concept that I'm highlighting here is when you think of young people especially, and you want to intervene early, there are pathophysiological mechanisms that we call endotypes that could translate to very, very different diagnostic prognostic and therapeutic approaches. And that is when we talk about the horizon in 2040, think about the opportunities that are here to intervene early, intervene in young people, COPDs, under prioritize over the years, maybe because of the stigma of smoking. If you look at this graph from the United States, uh, NIH funding the blue bars are US death in 2020, and the yellow is the funding for research for that disease. And what I'm highlighting in the red square is proportionality of deaths over 2020 relative to the funding in 2020 is quite quite compelling. 

Speaker 2 (10:43):
So this is an under prioritized disease. Why, I don't know, possibly related to blame and shame and lifestyle, um, of smoking that is associated with COPD. So it's not all doom and gloom, and I don't want to to leave you, uh, the panel, uh, with, with, with a concept that this is all bad. There are opportunities here, and especially opportunities for innovation if we are going to eradicate or eliminate COPD. The first one is mitigation of the risk factors that I listed before around exposure, but think about exposure, not smoking later in life. Think about what can happen even in utero for babies or children that are exposed to pollution and to smoking. Anyone can get COPD. That is a theme that we're bringing our lace up for Lungs campaign at the COPD Foundation, identifying early COPD. 

Speaker 2 (11:40):
This is an opportunity for innovation as we think about the horizon, because we need new diagnostic tools, even some of those that are available to really improve them, make them affordable, make them easy to use relative to spirometry that is currently used and intervene. Early this year, we launch, uh, a concept called pivot, a project called Pivot Patients inspired validation of outcome tools because regulators, clinician payers don't really look at those other endpoints. They look at spirometry, they look at death. We need to keep that in mind with new targets, targeting mechanisms, we can potentially accelerate the development of treatments. And I know matter, uh, it's quite, uh, focused on trying to improve and accelerate treatments for patients. So patients in the center and not alone on the right figure. There is that. The whole idea is we can all work together to try to accelerate and improve therapeutic approaches and design clinical trials with ai, with artificial intelligence, we can have synthetic cohorts, we can have platform clinical trials. 

Speaker 2 (12:53):
And with the technology of remote monitoring, we can also improve trial diversity and inclusion. As I said, it's the minorities and, uh, people in rural, um, areas in the world that are undertreated and underdiagnosed. So technology can really help. And this is my last slide, and I hope that people will join us and our partners in a campaign called Speak Up for COPD, because we can no longer afford to overlook lung disease and overlook COPD. So hopefully with a picture of Alina here who's a spoke one of a spokespeople, this is not about an old smoker. Anyone can get COPD and I hope that you join us. Thank you. 

Speaker 1 (13:38):
Thank you, Ruth, for that overview, both of, uh, where we're at today, where we're headed, and really where we have op opportunities to innovate, uh, and bring us forward. So I think a great foundation for the conversation that we'll have today. Um, with that, I'd like to introduce the rest of our panel. Uh, Tom Westfall is the chief scientist of the respiratory health division at Baxter, and has been designing ventilators for over 30 years. He was the vice president of r and d for Care Fusions respiratory Division, and developed several generations of critical care and home care ventilators and has worked on invasive, non-invasive and high frequency ventilators throughout his career. Recently, Mr. Westfall was the Vice president of r and d for Breathe Technologies, a startup company that created one, uh, pound ventilator for COPD patients. And the system. The Life 2000 has provided thousands of COPD patients with mobile noninvasive ventilation, allowing patients with stage four COPD in improved quality of life. 

Speaker 1 (14:43):
Welcome Tom and Dr. Eric Seifer is a pulmonologist and medical director of population health at St. Lawrence, and a senior physician executive consultant for innovation at Hillrom. Eric is recognized as a thought leader in pulmonary healthcare, and his research interests and experience include smoking cessation, pulmonary rehabilitation, idiopathic pulmonary fibrosis, COPD and more. Our moderator today is Dr. Carlos uia, Vice President of Medical Affairs at Baxter. Carlos provides medical oversight for evidence generation and dissemination activities, and offers guidance in product development pipeline and digital health strategy. As the conversation ensues, please feel free to submit questions using the q and a function at the bottom of your screen. Carlos will weer them into the conversation as appropriate. And with that, let's get started. 

Speaker 3 (15:45):
Thank you. Good morning, Gina. Uh, good morning everybody. Our, our hosts, our panelists, our panelists, and our our guests, uh, here today. Ruth, first of all, thank you very much for that presentation. Uh, that was a really, really great overview and a and a very good, um, opener for our conversation. Just wanna tell, you know that we got our first question and somebody wants to learn more about the COPD 360 net. So, you know, keep, guys, what we'll do is we'll be able to give you some information through the chat function and the q and a. So, so we keep those things going. Um, Ruth, before we turn over to the rest of the panelists, maybe I'm gonna follow up with, with a question, um, you know, from one of our, our, our, our guest, um, talking about NIH founding and, and what could we do about, you know, linking or improving the funding for the research around COPD, or, or what activities are, is the COPD foundation doing to increase the funding for, uh, this, um, research? 

Speaker 2 (16:45):
Thank you. It's a great question. So the first thing that we're doing is advocacy. And I think when we talk about speaking up, uh, we are trying to work, So NIH has provided funding for research, but you could see that it's proportionally low. So advocacy, but also submitting grants and submitting grants to, to not giving up, uh, to try to get more funding for research. But certainly that's a big area that we're trying to advocate for because you could see how low it is relative to other diseases. 

Speaker 3 (17:16):
Great, thank you. Well, I'm gonna turn it out to Dr. Siper. Dr. Siper, thank you very much. Maybe looking for your opinion as a pan, as a, I'm sorry, as a practice in pulmonologist. Uh, obviously when we talk about respiratory disease and we talk about the covid pandemic, you know, impossible not to connect the two of them. So what is the impact that you have seen in your practice, uh, that Covid has brought, brought to COPDpatients, and how is that impacting your practice today? 

Speaker 4 (17:45):
Well, uh, if you wanna focus specifically on covid and its impact on my practice as a pulmonologist, first and foremost, pre pandemic. Uh, every patient that I interacted with, it was a old school patient comes in, gets seen in the office, and, uh, when covid hit, obviously everything shut down. And what Covid did, I mean, telemedicine was already happening, but it was moving in a snails pace and what it did, and it, it, it, it, it, um, escalated the acceptance and the scalability of the scaling of telemedicine. So pretty much overnight, my practice went a 100%, um, telemedicine Now as restrictions have been, um, on covid restrictions have, uh, backed off. Uh, now I'm, I have a mixture of patients where I see them in the office, and I do, I see them, uh, uh, with telemedicine phone calls. And the question that I get asked frequently is, Are we gonna return to the way things were? 

Speaker 4 (18:52):
And the answer is no. Uh, unequivocally no. It's, uh, what's, what, what CO's been a scourge unequivocally, but there are upsides to this experience. And, um, I always look to turn s and the lemonade. And the lemonade here is that providers and patients realize through the covid experience that a lot of what we do as pulmonologists, um, can be done remotely through telemedicine. So, um, I do believe that when the smoke clears, no pun intended, that, um, probably in my practice and what's happening right now, and my practice is settling in about 50 50, that half the patients, I, I still, still half my day, uh, that I see patients, the days I see patients, I see them in person, and then half, half the patient load is virtual. Um, and that's working very well. I know there are other providers that, uh, it's, it's, it's even more virtual and less in, in, in person. 

Speaker 4 (19:56):
But, uh, just recently, this just came out, uh, this was in the New England Journal Catalyst and, um, it talks about this specific issue busting three myths about the impact of telemedicine and parody. And the idea, the concern was that with the advent of telemedicine, that this would reduce access to vulnerable populations, which it did not. In fact, the opposite, uh, vulnerable populations tend to be early adopters of this. Number two, that, um, when, uh, cms, uh, that there was parody in terms of telemedicine versus in office, that that would encourage the abuse of telemedicine visits and encourage the, uh, increased spending of ordering tests, labs, and x-rays. The opposite has happened. This is all through the University of Rochester experience. So this is, that's what this is about. But in fact, um, there's less labs ordered and less studies ordered. And the third, and probably the most important is did it, does telemedicine compromise quality? 

Speaker 4 (21:05):
And, and they were looking at ed visits, hospitalizations, patient satisfaction. In this particular report, it just came out October, this month mm-hmm. <affirmative>, and the answer is no. So that, um, telemedicine is unequivocally here to stay. And, uh, there's a, there's a certain, there's certainly an upside to reaching out to populations. I live in a very rural and resource, uh, limited community and up, up, up upstate New York and telemedicine has actually been a boon to me being able to reach out to my patients. Combining that with remote patient monitoring, um, Covid has really, um, helped us move in that direction. Mm-hmm. 

Speaker 3 (21:47):
<affirmative>. Perfect. Thank you, Dr. And you know, you touch on telemedicine and I already see some questions coming up and people want to talk about remote patient monitoring. We're gonna come back to that. I'm just gonna maybe turn it over to Tom right now. Tom, as a technologist, you know, I think that's probably the right word to describe you, you've been involved in a lot of product development, um, specifically ventilators as we have heard. Tell us about, you know, what sort of got you into the respiratory care space, why respiratory health is an important space to do innovation and, and what are some of the sort of recommendations and, uh, and maybe some tips for our audience that is com for a, a significant number of, of the startups and innovators? 

Speaker 5 (22:34):
Oh, well, I guess I kind of fell into respiratory. You know, I, I came outta school and, uh, worked in aerospace and, um, did that for a few years. And then, uh, uh, instead of building bombs, I ended up going to a company that, that was, uh, helping people's lives. And I was just a lot more, you know, from my perspective, um, uh, a lot more meaningful for your life, right? If you're doing something, you're creating something that's actually helping people, um, in, in their, in their own lives. Um, so, you know, I mean, obviously getting a good education in your field, and you've gotta love engineering if you're gonna be, be good at it. Um, so that's obviously something you want to do to, to try to get into it. But I think the most important part, and what helped me a lot was, uh, early in my career, I spent a lot of time talking with pulmonologists and getting to know them and trying to actually understand the problem. 

Speaker 5 (23:21):
So I'm a real big believer in kind of, uh, you know, when I talk about innovators is there's a lot of times it's technology in search of a problem as opposed to, you really need to understand the problem. Uh, and that kind of would be my recommendation as I see a lot of the technology today. There's lots of things we can monitor, um, and we'll talk maybe a little bit about that later on, but are we monitoring the right things? And so it, you really need to start by what is the problem you're trying to solve. And, and, and to do that, you have to really understand the physiology, like I said, going back and talking to the pulmonologist, and, you know, the human body is, is physics. It's, it's all constructed that way, but you have to understand the disease state, What are you trying to measure? Uh, and then in what environment are you trying to measure it? And start to try to answer those societal problems. Uh, and then you look at the technology and say, What a technology can I apply to try and help solve those problems? And, um, so I, I think that's, that would be kind of my recommendation for the, the technologies coming forward. 

Speaker 3 (24:23):
Thank you, Tom. Uh, Ruth, coming back to you, Um, you give us a very good perspective of where we are today. Um, let's go to 2040 where we are, you know, sort of like the topic of the discussion. Where do you wanna see, sort of like the COPD space around? Is it help with diagnostic tools? Is it treatment tools? Is it novel technologies, long replacement, you know, the sky is the limit. Is it a little bit of everything? What will be your, your, your thinking, Ruth, as to where should, uh, or what should 2040, uh, should look like in this space? 

Speaker 2 (25:00):
Thank you. I think it's really, I would love to see better techno, better application of technology at improving health literacy of the population and understanding the risk factors and how to mitigate them. Certainly, I would love to see new treatments that prevent disease and cure it early, Uh, in the stage of the disease, I'd like to see better technologies for oxygen delivery in covid 19. We've seen the crisis of oxygen, but we're still, we're putting people in space. But when it comes to oxygen, we're working with technologies in the 1960s. So I'd like to see innovation that is available today, applied in the prevention and treatment of patients. 

Speaker 3 (25:46):
Thank you, Ruth. Um, Dr. Seifer, same question for you. What, what would you like that 2040 look like for those patients? 

Speaker 4 (25:55):
You know, I, I knew this was coming and I, I was up last night thinking about this, and I thought, Do I want to keep this nice and simple, or I wanna be, because I wanna stir the plot and I'm gonna do both. Uh, you know me, Carlos, I'm gonna do both. Um, I, I see, um, huge opportunities for, I mean, the rocket science of medicine is there. And, um, the future, you know, what, what, what does 2040 look like? Uh, passive home monitoring for patients, uh, being able to determine what's going on with their oxygen, what's going on with the various widgets in the home, whether it's c a, oxygen, noninvasive ventilation. I mean, the future, I have chronic lung disease, I'm at home, and this is constantly monitoring me in a passive way. And with machine learning and AI could actually make ongoing real time out, uh, decisions and adjust my auction, adjust my cpap, adjust my settings. 

Speaker 4 (26:54):
I mean, that, that is, we are capable of that now. And I see that coming and, um, that's all very exciting. But this is where the controversy is. Um, I was invited to go to Washington in 2003, this is 20 ish years ago, and speak at something called Managing Chronic Illness and Public Programs, Chronic Illness. And they had someone, they had the, uh, national director from Robert Wood Johnson Foundation there. They had SEAT Central Budgeting Office, They had the Agency for Healthcare Research and Quality. They had cms. And the first person to talk, uh, was the guy from the Robert Wood Johnson Foundation. And his, his whole thing was common problems, shared solutions. He was talking about chronic illness, chronic disease, common problems, shared solution. He said it over and over again. I kept seeing wax on, wax off. And he kept doing this. And I'm listening to him and I'm thinking, as a pulmonologist, that doesn't work for c o p. 

Speaker 4 (27:52):
It does not work for chronic disease. So he finishes, he leaves the red seat parts, and I follow him, and I get up in front of everyone and I go, That was great. But common problems, shared solutions does not work when it comes to COPD. COPD is a unique problem that has, requires unique skill sets and unique solutions. And then to prove my point, I asked the audience, I said, How do you diagnose high blood pressure? What is high blood pressure? What is hypertension? It's high blood pressure. How do you diagnose that thing on your arm? Okay, diabetes, what is it, high blood sugar, You check the blood sugar. What is COPD? Does anybody wanna tell me what a COPD? And then how do you diagnose it? Not one person took a stab at it. 

Speaker 4 (28:32):
So here we are 20 years later mm-hmm. <affirmative>. And if I got that same group of people in the room and asked and put, presented them with the same question, it would be the same answer. And even today, 40 plus percent of PCP still think they can diagnose COPD by putting their hands out and going Mm. You know, doing a history, doing a physical look at a chest x-ray. And, and we know right now that there are millions of people out there being treated for disease COPD, they don't have, they have something else. They're not gonna get any better cuz who missed the disease. The flip side is there are millions of people out there that have COPD we've yet to identify. So to answer your question, Carlos, we we can, we can move forward all this technology, but I think at the same time, what we should be doing as a healthcare, that what we should be doing is going back and cleaning up our house and coming up with a, a foundation, a, um, paradigm for this disease that works. Our current foundation, our current paradigm does not work. And, and, um, that's very controversial to say, but their idea, I just, I just chucked the grenade into the room and I, I would love Ruth and Tom to jump in on this, but I really think that the rocket science part is the sexy part. And that's actually, as far as I'm concerned, that's the easy part. The harder part is doing the, what I just discussed, 

Speaker 2 (30:03):
But I I think this is a great point that you raise and in many ways we're victims of our success because the first treatments, first COPD were bronchodilators really treating lung function. And we ended up with a definition that requires spirometry, that requires post bronchodilators spirometry, which in primary care is really difficult to apply. And as you said, the disease of specialists, and I agree with you that we need to change the paradigm. Yes, we were successful developing bro bronchodilators for breathlessness, but we ended up with a definition of a disease that is treatment for something that's very, very late stage in the disease process. And I agree with you, we need to go back as, as a field, and that's what the line sub commission was saying and redefine what is COPD because the majority of people don't really understand it, especially in primary care. It's very confusing. 300 pages of gold, what, what primary care clinicians gonna read it. So I think the proposals we need to get together and say, yes, we were successful with bronchodilators and, and with steroids, but this is late. Let's think about somebody has chronic bronchitis. They're told you just have chronic bronchitis. No, it's not normal to have conference sputum. And maybe if we change the definition, we'll be more successful. 

Speaker 3 (31:27):
Yeah, absolutely. Ruth and, and Dr. Shipper, I mean, this is great and, and you're getting the chat going as well. You know, I think one of the things that I wanted to, so maybe add some context. So somebody also added, you know, the role of the rep of the respiratory therapist as well in the disease. So he is, he's not only the, you know, changing the paradigm, the diagnosis paradigm, the treatment paradigm, and also the, you know, the management paradigm where you're involving, you know, a broader, uh, group of clinicians and you're thinking about your respiratory therapies as well and the role that they should play. I just wanted to make that comment. Yeah, 

Speaker 4 (32:00):
I said, go ahead. 

Speaker 5 (32:03):
I think this is a great discussion and um, it kinda goes back to what I was saying when we start, which is, is, you know, what is the problem we're trying to solve, right? And I mean, it's interesting for me because there's all kinds of technology out there. You can get a smart watch, right? That can do your, your blood saturation, your heart rate, your all kinds of parameters. But are we measuring what's important? Um, so we got lots of data, but no information, right? We don't actually know what it is we're trying to measure. And we've talked about this for a long time in our business, which is we really not sure what we wanna measure in terms of chronic patients. You know, I mean, other than maybe elevated respiratory rate, when you're in a, you know, a passive state, right? You're starting to put your, you're going into distress at that point. It's too late. Um, so I I really, your, your comment, Dr. Seifer is uh, right on, I think in terms of trying to understand what is it that we truly need to measure. Um, there's lots of technologies out there, but I don't think we know what the, what it is. 

Speaker 4 (32:58):
There's two things I wanna respond to what you just said, <laugh> and what Carlos said about the rts. Um, I'll respond first to you, Tom. Um, just cuz you can measure something doesn't mean you should measure it. Yes. Also, um, the problem is if when I was actually, when I was in Tennessee and I was the co-chair of the respiratory steering committee for 10 care, which was ages ago, I made this, my hypothesis was that if you look at PCPs, their universal week suit is pulmonary. And we did an assessment statewide and proved the point that the knowledge for COPD was there was a gap between all the other diseases and COPD. Then when you looked at the actual, what the providers did with that knowledge, the gap even got wider in terms of the practice of that knowledge. 

Speaker 4 (33:45):
PCPs, right now, what they want, they don't want to be buried with data because they don't know what to do with that data. Right? What they need is for that data to be collected to go into some black box where the brain trust exists, and then outcomes, an action plan that then could be given to the PCP and say, This is what you need to do with this patient. This is what this patient's missing. They're missing maybe their lama they're missing the, the, they've answered certain questions that, that highly suggest. They have the bronchiectasis phenotype, they need airway clearance. Um, so they just need concrete messages that could, they can act on and actually do something actionable that improves patient outcomes. Yes. And, and, and right now, everybody with all their widgets, they're trying to generate all this data, but they don't know what to do with that data. 

Speaker 4 (34:39):
They don't know how to get that data to the PCPs, the PCP can connect the dots for the patient. And that's the segue into the next thing. Carlos brought up the rt. I do believe that the big frontier right now in this space is the post-acute care space. Yeah. You know, we got the acute care pretty squared away. I mean, there's obviously room for improvement. I'm, I can see Ruth nodding her head, but the postacute care space is where we're gonna win the war with this disease. And I firmly believe that the, the per the people that we really need are respiratory therapists who are, have training in how to deal with chronic disease, chronic lung disease in the post cure, post-acute cure space. Well, the problem is they only have so much time where they're being trained and they have to learn all the rocket science so they could pass their registry exam. 

Speaker 4 (35:36):
And a few, like a month ago, less than a month ago, I was sitting with the people who were in charge of deciding what those questions look like. And it was unequivocal that the majority of those questions are testing competency for the acute care space. So if you really want to move things forward, we only have to get together in a room and agree what our end goal is, Tom, and then how do we get there? So we have to change the education for the rts. We have to change it so that we train them for posting two care. We have to, we're not gonna, and these programs are not gonna do that until we change the questions on the exam because they want their people, they're graduating to pass. So it's, there's a lot of connectivity here. That's 

Speaker 2 (36:18):
Interesting. Yeah. Yeah. And maybe I could comment on that because the whole concept of patient at the center, but not alone, it's Allied health, it's respiratory therapists, it's nurses who sees a doctor. I mean, most people in primary care see a nurse practitioner. And it's really the education on lifestyle changes on prevention before somebody gets COPD. So it's not just the post-acute care, it's the awareness. You walked into a PCP office that says, How old is your heart? Well, what about your lungs? Nobody asks you, do you get breathless when you walk or do you have any symptoms? And symptoms matter to patient. Nobody says my f p one is abnormal. So I agree with the comment on respiratory therapists and the foundation. We have educators, we're nurses and respiratory therapists because we really need to educate primary care, those in rural areas, those that are not in the big specialist centers to understand prevention, exercise, lifestyle limiting exposure in addition to behaviors like smoking cessation, that, that are really important, uh, in, in preventing disease and acute events like exacerbations that we're all very focused on. But that is too late. We need to start early. 

Speaker 3 (37:34):
Perfect. So yeah, great conversation. And I'm telling you that Chad is like super lively and everything. So hey, I'm cognizant that I have an audience that is very, very keen on technology. So, so why don't we use all of this and then start shifting the conversation towards the technology aspect of it, because this is really important. So Dr. Seifer, you talk about telemedicine, you know, big, big bucket. Um, you know, there is then more specifically remote patient monitoring. So, you know, people are asking about the technologies that you can use, uh, that are digital stethoscope, somebody, you know, like brought it up and all sorts of, you know, there is ultrasound technology, rf i d anyway, like, you know, sky's the limit sort of thing. So maybe before we ease our way into specifics of the technology, Tom, your experience with a sort of regulatory environment and the ability for these technologies to go to market, somebody brought it up, you know, what is that regulatory framework that is gonna support these technologies? And then Ruth, I'm gonna just throw this there. So after Tom responds also from the foundation perspective, what is the reimbursement environment, you know, for these technologies as, as people are, are thinking about innovation? So Tom, I'm gonna start with you and sort of like this regulatory framework and ability to innovate. 

Speaker 5 (38:47):
Uh, well, we hit a nerve there. I would say <laugh> on the regulatory environment. Uh, I have found the regulatory, the, you know, the FDA in general is always 10 years behind what's going on in terms of innovation. And, uh, when you're really trying to innovate and go out and do something new and different, um, we had a a, a case in my old company where we did close loop FIO two for neonate. Okay. They, they, um, uh, very little, you know, babies, they desaturate multiple times an hour, right? It's, it's, you literally have a nurse turning up the oxygen, turning it down, turning it up, turning it down. We spent years trying to get it through the fda. We got it into Europe, and it became standard of care over there. And there were several places and we still couldn't get it through the fda. 

Speaker 5 (39:29):
So the regulatory hurdles are huge. Um, they're, they're very difficult. They're, uh, you know, the whole, the whole aspect of the FDA is the five 10 K, which says it's a preexisting device. You just wanna show equivalency to what existed in the market. And that's how you get your product approved in the marketplace. Well, when you're trying to innovate, you're not doing what, you've done something before. You're trying to do something new. Uh, and anytime you're doing feedback off a, off a biological signal, um, that immediately pumps it up to a Class three device, which means you're doing multiple clinical trials. And so the expense and barrier becomes extremely high. Um, so I, I would say that the regulatory environment needs to mature. There needs to be some way for people to innovate, uh, and be able to take it, you know, with a board of physicians or something. 

Speaker 5 (40:16):
I clearly, we wanna keep the technology safe and that's what the FDA's overall concern is. But as an engineer, I find it very anti-innovation, if I could say that. <laugh>, um, and I know you did, you were gonna ask Ruth the question on reimbursement, but I do have a little bit of experience with that, with Medicare. Um, cuz we, like, we have this home care ventilator today, you know, that, that does home care ventilation. And I, and I see kind of this same thing. Medicare's whole focus is keep the cost down. Um, and so and so again, they don't, they don't wanna give you a new, um, a new code for being able to get reimbursed for your product. Uh, so, so it's very, very difficult again, to innovate because there's, there's these fixed financial, um, uh, definitions and they're based on what was not what's going to be. Um, and so I think, I think the whole regulatory government, um, I don't know how you solve it, but it definitely is a huge, uh, barrier to innovation. 

Speaker 3 (41:14):
Ruth, what are your thoughts, your experience from the foundation? 

Speaker 2 (41:17):
Yeah, so two comments. I wanted to, to comment around regulatory approach because it does tie to payer perspectives. And, and truly for the last 12 years, we tried to qualify because patient focused drug development has been an area the FDA declared years and years ago. And we tried to qualify new outcome measures, but we decided with Pivot that 12 years is too long to get something like CN George respiratory questionnaire with 42,000 patients, uh, evidence. Uh, it's too slow. So we decided to go with Pivot, which is getting the scientific community and, and, um, manufacturers and, and payers together saying, this is a validated outcome. So if a technology is there, let's validate it, not wait for the FDA to qualify it around payers. We've had some success in some ways, uh, because of covid with virtual pulmonary rehabilitation. So we know that pulmonary rehabilitation is the best preventers of hospitalization in people with COPD and people with chronic lung disease. 

Speaker 2 (42:25):
So it's a huge burden on society, but there was always resistance to approve pulmonary rehabilitation. One positive element of covid is that there was a realization that yes, this is good, but, but also to start getting reimbursement, reimbursement of portable oxygen concentrators, re reimbursement on liquid oxygen. Again, I said technology could go better, but even if it's available, patients get stuck with treatment that may not be appropriate for them. And somebody in rural America who needs pulmonary rehabilitation, there's nothing around them. So virtual is an opportunity for, for shared decision making and impact, but reimbursement is very, very slow, uh, as is regulatory environment because of the priority, I believe, and also not the recognition, the impact and the cost of diseases, the disease progresses. 

Speaker 3 (43:22):
Perfect, Thank you. Uh, Dr. Zeer, um, maybe another domain of, of, when we think about technology and innovation, um, earlier you talk about equity, right? And then there is a component of technology equity, right? Where there might be a digital device between, you know, access to internet, quality of service, you know, do you have it on a phone, you know, on a computer, and so on and so forth. Your practice being in a rural area. What do you think about the digital capacity, sort of speak of the ecosystem to take on technology and, and what are your thoughts on that space? Sure. 

Speaker 4 (43:58):
Um, you know, I, I choose deliver, I do, uh, I, because it is rural and because it is very resource challenge, because if you can make something work here, then you have something that's truly portable. And, um, you know, I, it doesn't get more research resource challenge in where I live. Um, the I, and to answer your question, there's a, there's a, I'm not promoting this particular device, but there's a company called Spire. They have a RPM device. Um, I have over at this point, 50 patients that I use Spire technology. So, um, even in a community, I mean, 100% of my telemedicine virtual visits, 100 of my virtual visits are phone calls, no video feed. Uh, because of the issues with the internet and my age, population, education, et cetera, et cetera, my patients can handle the phone just fine. You bring in a video feed, it's a train neck. 

Speaker 4 (44:58):
So we do the telephone and the, and, and even in a very challenged location, um, the Spire technology works and there's this, I want to just take a moment. There's this bias, I call it royalism, that if you, that patients live in rural, in rural communities, they're not motivated to take care of themselves. Um, they're not motivated to get in any clinical research projects. They're not motivated to, to do anything productive. And it's the opposite. If, if you look at, um, spires onboarding success and the retention rate with, in my practice, I have the best onboarding and the best retention rate of any other place, and I'm in where I live. So depending on how you define what is rural, half of the people that live in the United States live in a rural, live in a rural setting. They don't live in Chicago, New York, Atlanta. And, um, so to answer your question, Carlos, I do believe standard of care, what will be standard of care in 24, I'm making a prediction. I got my little crystal ball standard of care will be some form of tele telemedicine and remote patient monitoring. I believe that that is what is going to close the ga the care gap, especially in rural communities. 

Speaker 3 (46:24):
So let's let, let's go deeper into that. Cause I know, again, like I said, we have a very technology focused audience. Um, maybe Ruth, uh, when you think about that sort of remote patient monitoring slash telemedicine, you know, let's say, you know, virtual interaction with the patient, whatever that means. So we don't get into, you know, kinda like the definition of each one of those. Um, where, where do you see that interaction? Where do you see the, the strengths or the need? What is sort of the highest technology need that you see today to make that, uh, interaction successful? 

Speaker 2 (46:57):
Good phone and good wifi access. We do know that, uh, even in the United States. And then when you start thinking globally, because I'm a globalist, uh, that that is a key definition. We saw that with Covid, people did better or people had access and, and I agree it could be a telephone or a smartphone, but, but, uh, access to, to internet, also health literacy. All of us learn differently. So we need to make sure that some people prefer in infographics. Other prefer, um, just, just hearing a lecture, hearing videos. Technology needs to make sure that people learn different, There are different cultural barriers. Language in the United States, people speak different languages, read different languages. So I would like to see things that are available, uh, for people regardless of where they are. And one thing that the foundation that we try to implement is not just focus on internet and technology. Having that phone, having peer coaches or patients and caregivers who could talk to patients and really help navigate them through their journey, um, with, with, uh, self management. And I agree with your point around rural people. We have the circles project that is in a rural area. Patients are extremely motivated. We just have to give them the tools and the information and not assume a bias that they're not motivated to be in, in clinical trials or, or manage their help. 

Speaker 4 (48:29):
I, I tell you, when I approach my patients about clinical research or whatever it is, they say, Thank you, Dr. Seifer, for thinking about me. I mean, <laugh>, I mean, thank you for thinking about me. Of course I would, would love to participate. Um, and, um, so, uh, that's a, a real bias. I'm not sure where it started, but it, it's, it's not true. It's not true at all. 

Speaker 2 (48:56):
What's the business, right? It's, it's transporting somebody to a big center, and that's in COPD 360 net. The whole idea of working with primary care networks is that we need to be where the patients are. You can't transport somebody 50 or 60 miles to measure their blood pressure, essentially. Uh, and, and we need to change the way that we do clinical trials. 

Speaker 3 (49:19):
Yeah. Um, we're talking about the, um, you know, the, the need for sort of communication or like at a basic level phone is sufficient. Um, how, uh, important or, or relevant will be to have additional technology that will help you do, you know, clinical assessment, you know, such as, you know, we, we heard somebody was mentioned at a stethoscopes, spirometry I saw on the chat. I get, what, what, uh, how important do you think it is to, to evolve that sort of technology to be able to do that remote assessment? And I think you mentioned earlier, you mentioned passive patient monitoring and so on so forth. 

Speaker 4 (49:54):
Yeah. Um, well, this gets back to something that I was talking, well, I was addressing Tom's, uh, comment. Um, the art physical exam is dying <laugh>. And, um, I see providers walk in rooms all the time without the stethoscope. And we're talking, not just PCPs, we're talking subspecialists, cardiologists and pulmonologists. What are they doing in there? I'm not sure. The point I'm making here is, again, if you had remote, uh, some remote away to do oscultation to listen to someone's lungs and you gave that raw data to the pcp, would they know what to do with it? So, and the answer I would say is no. So, um, I think that if there is going to be that kind of technology that could do oscultation, it has to go into the black box where the brain trust is, where then something actual comes out of it to give to either the patient or to the provider. 

Speaker 4 (51:02):
And eventually, this could be a closed loop where your AI and machine learning could be actually doing the oscultation, doing that assessment and then adjusting that person's environment to accommodate what is going on with the patient. I mean, it sounds a little creepy. I'm not sure I want to be alive <laugh> in that world. Um, but it, it, it could work if it was done correctly. And of course, one last thing, that loop needs to bring the patient back in as a partner. So the patient, part of the secret sauce here is that you're never gonna make everything right with technology. You can't forget the patient is really the mastering commander of their ship. So whatever is going on with that ai, machine learning has to get the patient engaged and say, This is what's happening. We're making this adjustment, adjustments in your machines, your widgets, and you need to now start doing the things that you were taught to do in terms of self-management. 

Speaker 5 (52:06):
I, I wanted to add kind of two things there. One was, you know, you talk about doing the diagnostics in the home, and, and I think you're right, and, but it, it's interesting where the technology is gone. And in some of the other fields, uh, we have a product in our, in at Baxter with our retinopathy where you can actually, um, they, you know, you look into this little, um, device, it, it takes a measurement of the eye, right? And then it over reads it and it sends it to the ophthalmologist to do the interpretation, you know, or to a center of ophthalmologists to do the interpretation. So I think the same thing, we don't do that with lungs, but the same kind of thing could happen, right? Where you could sit, take a test, send that data, you know, all that, you know, like you said, an F O T or something like that. 

Speaker 5 (52:47):
Now it's gotta be, it's gotta be, I'll call it idiot proof, right? Because the user, some of those are very technique dependent. And so that's, that's probably part of the challenge. But the getting the data to, to, you know, maybe it goes to an ai, but I still think the pulmonologist is gonna be definitely in the loop and there's gonna be, you know, those experts. The, the second part for me though is, you know, once you do a diagnostic, that's one thing, but the other part is, um, it's not always a matter they absolute, but are you getting better or are you getting worse? It's, it's really the trend, right? Where are you going? And so I think that continuous monitoring, you know, you see that, like you were saying before diabetes, right? You used to prick your finger, okay, now you have a continuous glucose monitor. We should be able to do the same thing in the respiratory, you know, whether it's a watch or a necklace you wear that's a stethoscope, whatever, you know, and provide that real time trending of the data so that you can see what's happening to the patient over time. Cuz the disease isn't, it doesn't happen in a moment of time, right? It's a continuous, it's a continuous process. 

Speaker 2 (53:46):
I like the concept that you raise around shared, It's really a partnership between the clinician and the patient. Absolutely. And then the technologies is a tool, but we don't wanna rule out the role of the clinician. And even in 2040, the whole idea is that there is a human element here of the clinician partnering with the patient and what's important to that individual and, and also, um, using the technology appropriately. 

Speaker 3 (54:11):
Yeah. Yeah. And I think somebody actually also brought it up on the chatter talking about the need for empathy and then the role that empathy play or should play in AI that is missing. And, and I remember in, in previous, um, some of these sessions that we had in the past, you know, people had talk about high technology, but with high touch, right? High technology doesn't mean low touch, high technology doesn't mean, you know, don't involve with the patients. So I think that's a good clarification. Um, also, uh, there's somebody else, John, talking about things that can be done remotely already. That, that's correct. I mean, we acknowledge that are a lot of technologies that are in existence today that can be managed remotely, uh, blood pressure, spirometry, EKGs, and, and there are multiple things that can be done. And, but the question is, you know, how much more of those technologies we need. 

Speaker 3 (54:55):
And, and, you know, is it just like you said, maybe Tom was saying, is it just the technology or is it the OR, or Dr. Sefer, is it the technology or the technology with the information, with the trending, with the context and, you know, to be able to sort of provide a better, you know, a comprehensive view. All right. I'm gonna, we have only, uh, three minutes left, so I'm just gonna go like a, a quick run of questions and this is your moment to give, um, some advice, recommendations, thoughts to the audience, right? So as you think about people who are innovating early innovation in this space or wanting to innovate in this space, specifically in respiratory health, what will be your recommendation for those individuals who, who, who have a passion for respiratory care, have a connection or respiratory health and want to innovate on that space? Maybe I'll go ladies first. I go not let Ruth go first. 

Speaker 2 (55:48):
Thank you. So I think we, we mentioned it before, think about what problem you're trying to fix and focus on that and zero in on that, if it is around oxygen, if it is around providing those AI tools or providing better clinical trials. But what are we trying to fix? I, I think to me that is the key, and don't just use technology for technology's sake, is how can we really transform and disrupt healthcare? 

Speaker 3 (56:18):
Perfect. Ruth, Tom, 

Speaker 5 (56:20):
I completely agree with Ruth. I, I mean, I think the very first thing you need to do is understand the problem you're trying to solve. Look at the patient holistically. Think about what is the disease state? Is, is it, you know, is it, is it, it's not just oxygen, right? What is the whole disease state? How are you trying to manage that disease state? And then go back to first principles. Look at the technology that you can apply to solve that problem. 

Speaker 3 (56:42):
Thank you, Dr. Sefer. 

Speaker 4 (56:46):
Um, I think that pharma, uh, healthcare device companies have a, uh, common blind spot, which is to, um, bring in their koa ls, their key opinion leaders, uh, their thought leaders, canvas them for their information and say, Thank you, goodbye. Then they go in a room where the cake is being made and then they make the decisions, but those clinical people are not in the room. So all this pressure is on there. And yes, there are other elements to making these decisions about immediate and long term strategic planning. What happens is that clinical voice is not there to advocate and what is and what comes out of that room. That cake does not, it's not the ideal cake. <laugh>, Pharma does it, industry does it. And I think moving forward, if we were gonna change a paradigm, you need to have your clinical people in the room where the cake is being made. And I think the outcomes would be much better. 

Speaker 3 (57:53):
Yeah. Thank you. Topher point, uh, very well taken. So thank you very much. All right. I see, uh, Gina, we have Gina coming back. I, I wanna thank you. Um, it was a great, great conversation, uh, very dynamic. A few, you know, bombs thrown out there, which actually were very good and a lot of engagement from our audience as well. So I wanna thank everybody who had the opportunity to ask a questions. My apologies, I couldn't get to all of them, but I think I was able to weave in as much as I could. Uh, thank you again and I'm gonna turn it over for, uh, Gina to Gina to close us up. 

Speaker 1 (58:29):
Thank you Carlos. And thank you also Ruths, uh, Tom and Dr. Seifer. Uh, what a, a great discussion today. And, um, I hope that as we look towards 2040, forgive the joke, we can have our cake in edit it. Two. Um, with that, it is, uh, COPD Awareness month in November. I, uh, we dropped the COPD Foundation's website, um, into the chat a little bit earlier. Please, uh, if you are interested, go and find out more, whether you're an innovator, a clinician, an academic, or just a general, uh, lung enthusiast. Please, uh, see how you can participate. You can also visit us@matter.health Forge slash events for other upcoming events here, uh, at matter. And, uh, we'll see you soon. So thanks everyone.