Career Pivot - From Clinical Cardiology to CMO of a Startup Focused on Hypertension
Dr. Jay Shah is Chief Medical Officer at Aktii, where they are developing technology focused on identifying and monitoring hypertension. Dr. Shah is a practicing Cardiologist who pivoted his career from strictly patent care, to becoming the CMO of a start-up. In this episode he shares his thoughts on career pivots, how he researched options that were the right fit for him, what it is like to be a CMO in a start-up, what hypertension is and the difficulty of diagnosis, and how wearables can change the way hypertension is managed.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! Very few of us make a career decision when we're in our early 20s. And get it completely right. There's so many things that we don't know about what a job is going to be like, or don't understand about what the real world is like, we have changes in our interests over time, we have changes to our family situation. And we also have financial changes that may lead us in all kinds of different directions. Dr. Jay Shah is our guest today. And he has an interesting story to tell about his career, and what pivots he's made. I'm really excited to bring you this conversation. It's really covers two parts. The first part covers his career, and how he approached changing expectations and different pivots that he's made. I really think it's important for all of us to listen in on this part of the conversation, and how he approached all of these changing expectations and pivots. And it also gives us some insight into issues our customers may be dealing with, but also serves as a reminder that each of us is on our own journey. And we all have the ability to pivot if it makes sense. And if we have the courage to do so. The second half of the conversation deals with the issue of hypertension. And Dr. Shah is the Chief Medical Officer of Aktiia, a company that's dealing with, with the hypertension issue by bringing a new product and a new perspective to an old technology, the blood pressure test. Here's our conversation. So Jay, you've recently gone through a career transition, and moving from clinical medicine, and still doing some political medicine, but but also doing some things within industry within within companies. So let's kind of start off with the first phase of your career, and then we'll get into the second phase. So what drew you to medicine? And it was was it something that you've always wanted to do or tell me a little bit about your journey in medicine,
Jay Shah, MD 03:09
the journey started pretty early as I think it does for a lot of people who go into medicine, just because the pathway and training is sort of fairly long. So yes, I had sort of was drawn to it. Liking the sciences and biology, I had one physician in the family sort of kind of influenced me as well, I thought it would give me a good balance between sort of science and interacting with people and on in a long term way. And I thought that would be interesting and enjoyable as a primary component of any career. And but I will have to say that most of us make these decisions when you go into medicine well before you know exactly what that actually means. But that's why I went you know, started the process and you know, went to medical school at the University of Missouri in Kansas City, which was a great place to be a medical student, you know, a safety net hospital in a city general kind of place where you've given a lot of responsibilities and learned a lot, very quickly. And then I happened to do my residency at Massachusetts General Hospital, which was a totally sort of one eight ish type of place. Yes, it was also a sort of general hospital. But you know, the colleagues in the peer set that I was now among, were really, truly inspiring people, you know, doing amazing things and really opened my eyes and broaden my lens of what's possible in medicine. You know, I'd have colleagues who were who had come from running NGOs in Africa to others who had started their own biotechs to to others who had come from the White House, doing a fellowship, so all these different things, which was a phenomenal sort of eye opening experience. And then I did my cardiology training at Washington University in St. Louis, which was a great place for clinical training, just solid, high level, top notch clinical institution, an academic institution in the country. And so I just did, you know, got a really deep training in cardiology there. And I really enjoyed that.
Patrick Kothe 05:05
Let's let's go back to the residency for a second. So you're in, you're in Missouri and and you're applying to different places. What was it about? Boston? What was it about Mass General that was so intriguing to you?
Jay Shah, MD 05:21
Well, I mean, everybody in medicine, people know, the name of Massachusetts General Hospital and Brigham and Women's Hospital, these sort of Boston programs that are premier academic centers, part of Harvard Medical School. I never really imagined that, that that's where my path would go. from Kansas City to Masters general, but by luck, or chance and hard work, or a combination of all, all three, that's where I ended up so you earned
Patrick Kothe 05:51
it. Don't be humble, you learned don't give those tickets out for free?
Jay Shah, MD 05:57
Yeah, well, it was it was a it was life changing. And one of those things that, you know, one of those career steps that most people have at some point, and along the way that just drastically changes the trajectory of of a career and life really.
Patrick Kothe 06:13
So you do your fellowship in back at Wash U. And then you begin clinical medicine. First of all, what type of cardiology? Do you practice?
Jay Shah, MD 06:26
So I trained as an invasive cardiologist. And what happened after I did my fellowship, I did something probably a bit different. For sure, as I went out and started my own practice from scratch, in Portland, Oregon. And it was just got some weird looks from my mentors at Wash U and other people said, What are you doing? That's not a common thing to do these days in Cardiology is to sort of go out and hang your own shingle and start your own practice. So
Patrick Kothe 06:55
did you have any, any ties to Portland? Or why Portland?
Jay Shah, MD 06:59
No, in Portland was because we we were looking to maybe experienced the West Coast. And it was a difficult, really difficult time to find a job in medicine. This was just this was 2012 11 and 12. So just after the sort of great recession, we were kind of just coming out of that the Affordable Care Act had not gone into effect yet. So many physicians were waiting to retire didn't most hospitals weren't hiring physicians or hospital systems, because they weren't sure how the Affordable Care Act would actually affect them. And so it was actually a very difficult, very challenging time in medicine to find a good situation within a larger metropolitan city. There's always jobs. I mean, certainly if you go into rural places, or you know, underfunded areas, that there's always jobs. That not to say that there's it's impossible, but to find it, you know, a position. And it was for me and my my spouse, at the same time in the same city that had a reasonable metropolitan area around it. It was really difficult.
Patrick Kothe 08:09
She is she a physician as well, she is yeah, what is her specialty?
Jay Shah, MD 08:13
She had, she's also happens to be a cardiologist. So it made it quite challenging in that regard. At that time, so one of the opportunities that we got was in Portland and we thought, Well, why not? You know, try it out. We've never been to the West Coast. And and so that's, that's how we ended up there.
Patrick Kothe 08:32
And you said invasive, so cath lab type things. Interventional cardiology,
Jay Shah, MD 08:40
well as I trained to do, you know, in the current work in the cath lab doing Cath, but the The truth is that when I went out and started my own practice, I quickly found that I was the office practice was so busy and got so there was so much work there to do in the office that I ended up pretty quickly giving up and not doing any real invasive procedures very quickly. And what I did is just found a very good working relationship with a great group of interventional cardiologist and electrophysiologist. Who, who would help me with my patients when if they needed a procedure. And that's how that's generally how modern cardiology practices work that people have these niche specialties and certain people do procedures largely and see very few patients and others see a lot of patients and not don't do as many procedures and as setting up an office practice in multiple locations as it grew. And as the success of the practice became apparent. It just became sort of overwhelming. And so I just spent all my time largely in the just growing office practice.
Patrick Kothe 09:49
So sometimes we we have an expectation and that expectation is changed as you said it gets it gets modified. You are trained to do that. do procedures. And I think procedures are fun. I mean, you're doing something, you're solving an immediate problem, you see immediate results, you're using your hands, it's different than an office based practice. And it's not to say one is better than the other. But were your expectations changed, did that that was that hard to move from, I'm doing the procedures to now I'm talking to patients all day long, it's medication, it's referrals.
Jay Shah, MD 10:30
Expectations, when you're when I was in training to expect to reality of what practice was, you know, really like, huge, huge difference there isn't it is, I think the first three years in practice are actually the most important in a physician's career, they are actually where you really learn how to practice, what is your practice, like, you're going to have to modify your expectations, take your training, but apply it to the situation, the practice the setting the location that you're in, and really optimize it for that setting. And they're never going to be perfect, or almost never, they're not going to be a perfect match. And so yeah, I mean, there were many things that I was trained for, that I was not and didn't end up doing. And conversely, there were many, many more things that I was doing, that I was not trained for in fellowship. And in fact, that was the bigger change in expectation. So in starting your own practice, essentially, you're starting your own business. So learning how to do you know, cost analysis, and real estate deals and buyer and purchase, you know, purchasing your own equipment, hiring staff, managing the staff, budgeting, you know, planning in multi year phases, how to build a practice, how to build a, you know, community network, these are things that are just not taught, these are not taught in medicine, in training, all of those things is so critical to running your own practice, and business, that I was really picking up a lot of skills while I gave up or didn't do some of the things I was trained for. And I realized that but at the same time, I was learning all these new things. So I think that to me, was the that was more than a fair trade off.
Patrick Kothe 12:16
So so you're up in Portland, you've got a successful practice going on there. What happened next?
Jay Shah, MD 12:23
So yeah, it was built the practice guide, it was basically, you know, very successful practice. By seven years, I, you know, I really, everything was set up and running very smoothly, it just sort of showed up and did all the clinical work. And then was going just fine. And I really enjoyed the patients, I really enjoyed the people, I work with my team. But we haven't we, my wife and I, as I mentioned, she's a physician, we had an opportunity to go to the Mayo Clinic, and to start a different kind of, sort of practice within the Mayo Clinic and to sort of build a program that for me was for complex aortic diseases. And so that's, that's what we did. And so we ended up in there, Arizona site and campus and I built the practice around complex aortic diseases, so much more specialized in what I had been doing for the last seven years. And she built a practice around cardio oncology.
Patrick Kothe 13:17
So complex aortic diseases. Tell me a little bit more about that.
Jay Shah, MD 13:21
Yeah, that's, that's sort of people who have, who are at risk for or who might have aortic aneurysms in the chest or abdomen. So the aorta is the largest artery in our body. And sometimes for for many reasons, people develop aneurysms or enlargement in different locations. And that can be life threatening if they tear or rupture that can lead to death very quickly. And so it's a management of, of people, either who are at risk for that, or who actually have an aneurysm. And sort of following them long term deciding when they need surgery, working with the surgeons, getting them through surgery, then fallen, you know, and then after care after that. So it's kind of very, very much a narrow sort of niche focus, but it's a very important one.
Patrick Kothe 14:09
So you've now you're you've built another successful practice at Gmail. But medicine has been changing over this period of time, as you mentioned, you know, you're trained one thing you learned something else a good trade off there. Now, you've got some other things, but a lot has changed in medicine. What was that like for you tell me about your what was going on in your head as a physician and you're seeing all these changes around around you? And kind of putting yourself in the future and saying, is this what I want to do in the future?
Jay Shah, MD 14:42
I don't think there's any right answer here, I think. But I think for me, at least there it had become sort of I think I had peaked in terms of growth of knowledge and personal growth. Sort of, you know, you get part of being an expert is knowing More and more about less than less. And, and, you know, especially in medicine, it's being really good at certain subsets of either patient care procedures or whatever, being really, really good at that. And then just doing it again and again and again and again and again. And to me, that felt somewhat limiting in terms of personal growth, that over I had practiced by this point over 10 years. And, you know, I could, I was very good at the clinical practice. But I wasn't necessarily learning in a significant way I've learned new medicines would come out new procedures would happen. And yeah, you've just sort of add on to your knowledge base. But beyond that, I wasn't necessarily growing in some way. And, and so that's what got me thinking about, Okay, well, you know, is this really what, where I want my career to be for the next 20 years, 30 years? Or should I do I need to really take a risk, take a right turn, go somewhere different, try something different, and, and maybe challenge myself again, which I hadn't necessarily felt since I started that practice in Portland,
Patrick Kothe 16:15
so many clinicians that I speak with have been frustrated and looking for things outside of clinical practice, due to just a whole host of different things, especially coming through a pandemic. And you know, that, that added stress, there's, there's been so much burnout talked about, there's been so many people that have been upset with medical records and corporate medicine. All of these things are issues that are out there today. Were those issues on your mind, as you were looking at this as well.
Jay Shah, MD 16:52
I mean, I think that just sort of yes, all those things are the background of medical practice. In fact, majority of what, what sort of my day was filled with actually was probably minority patient care, direct patient interactions, the majority was task based work on a computer, responding to messages, you know, going through an inbox, responding to emails, doing that kind of stuff. So yeah, I think that, you know, we know that people have a better higher satisfaction when they're, you know, really thinking that they're practicing at their highest level, are in any role or any field. And I think in, in medicine, and a lot of in a lot of fields, that's not necessarily the case that we have these skills, but we're actually utilizing them for oftentimes, sort of more task based work, driven by computers, electronic medical records, etc, all the things you mentioned, that are needed. I mean, they're really critical to modern day medical practice. It doesn't work if you don't do those things. And to really, comprehensively take care of, you know, do a great job for patients, you have to do those menial tasks. And for whatever reason, there's lots of them probably, you know, a lot of those sort of menial tasks have fallen to physician. So it's just added to this sort of task based mentality. And I think that contributes a lot to burnout and, and people blame the EMR, okay, the electronic medical record, that's just sort of a symptom or an example of this part of the job. But that is part of the job, and you can't unfortunately separate them. Some people try to hire people to take care of all of that, and maybe in the future, AI will take care of a lot of that, because it is eminently possible that that or that a bot could handle a lot of these things. But currently in for the reasonably foreseeable future, this is certainly a primary point of dissatisfaction.
Patrick Kothe 18:51
Well, it's really interesting when you started talking about making the decision to get into medicine, and you make that decision. And you've got a view of what medicine is, is like when you're when you're 1820 years old. And you've got it you said you had a physician in the family. So you had some view of what it was like, but you don't know until you get into it. And your experience is going to be different than somebody else's experience. So we you spent all of this time training and educating yourself and going through residency fellowship, you get out there and it's a it's a different animal than then what you thought it was. And then as you said, you keep digging down and focusing and focusing and focusing and now it's repeat tasks. So what you thought when you're 18 and 20 years old, is completely different than what you actually experienced. Is there some way to bring some of that learning closer to people who are at that decision point? Do I get into medicine or Not?
Jay Shah, MD 20:00
Yeah, I think that's a that's a bad as a primary challenge for medical schools. And even before that, you know, I guess undergraduate schools where people are kind of considering a career in medicine or going to medical school, these are real sort of existential challenges to those sort of educational programs is how do you really give a student an accurate understanding of, of what they're what they're think they might be signing up for? And, and how also, how is the education representative of real practice? I think there's, there's some major gaps there. And so I think the educational system, they're struggling with it, they're trying, I think, personally, I'm trying I what I do is I volunteered to mentor medical students in there first, second, third, fourth, you know, the first few years of their training, as an advisor as a mentor, certainly, because I've had this somewhat unique career path where I've not stayed in one place, one type of medicine and gone academic and private practice Mayo Clinic. Now start up. So there's all these different things. So I feel like I have a very good perspective about the breadth of what you can do in medicine. So I try to impart that at least, what I can do myself, but I think that that is a significant challenge for training programs, because at the end, many, many students come out large amounts of debt, the only clear way to pay that debt back is to work as a physician, and many of them, you know, experienced burnout fairly quickly these days, or at least, like, like you said, sort of, there's a major gap between expectation and reality. And so I think that hopefully, we can get to close that gap somewhat.
Patrick Kothe 21:53
I've never found a perfect job, I've never found a perfect career, there's always good things and bad things about whatever we do. And I've been a medical device for for all of my career. And there were periods of time, I had great job satisfaction, but there were, there were challenges there too. I mean, I was, I was a sales manager, I was, you know, on a plane for five days a week, you know, coming home, my wife had responsibility for for the kids for that period of time. That wasn't, that wasn't fun. From the family standpoint. It was fun, you know, fun job, fun career, it helped me build a career. But those are the types of challenges that we have and things that we have to manage. Same thing in medicine. I'm sure that there's a work life balance, and there's a family balance that, you know, experience there, too.
Jay Shah, MD 22:44
Yeah, I think so. I mean, I think realistically, a good thing about good part about medicine is that achieving that balance for vast majority of physicians is very possible, it's a choice. But making that choice can be difficult, but it is a choice. So the idea that of dead a physician has to practice 7080 hours a week, or some crazy set of hours where they're not home, or they're not able to be home. Again, for the vast majority of specialties. I don't necessarily think that's, that's always accurate. I think it's, it's sort of ingrained in the culture in some of these fields. But it's not necessarily the case. And I mean, a good example would be from, in cardiology, with, you know, my practice. When I started, before we had kids, you know, I was, I would leave early in the morning, like 530 in the morning, I would get home six in the evening. But then as we as we grew our family, I sort of had to make a conscious choice to balance income and time away from home with being home. And so then I started taking time off, I started taking afternoons started taking every Fridays, and had to try to find that balance. And I think I found it and but it's a work in progress, always. But I think it's possible. And I think that's one thing that is really great about medicine is that you can dial up and dial down again, for most specialties, I think pretty well.
Patrick Kothe 24:10
I think you know, what you're describing is that there are areas that you can move to you, you expend a tremendous amount of time and learn to give value back to the community with clinical medicine on one side, then you moved in and pivoted a little bit. And you took over a new challenge and then you pivoted again and now you've pivoted another time, you're still utilizing the training that you have, but it's doing it doing it different. So I think you know, as you as you said, it's understanding who you are, what you want out of it and actively managing your career to get what you need at that time because you know, beginning of your career, you don't have kids you know, you can go full bore into having family challenges and yeah, you want you want to move in little bit different. So tell me about the next phase of your career and tell me about moving into the startup world.
Jay Shah, MD 25:09
Yeah. So, you know, I was there at Mayo, and, you know, I was thinking about, okay, how can I how can I sort of regain some of that challenge that excitement and, and, and sort of learning. And I did sort of a pretty lengthy exploration of careers outside of clinical medicine, sort of informational interviewing with that went on for like nine months. And really, it was very helpful to kind of cross things off to to understand what's possible, but then also eliminate what really didn't sound like would be a good fit for me. And so then I arrived at a fairly smaller set of, of opportunities of companies and of types of jobs that I was looking at. And so that's how I ended up finding this position as Chief Medical Officer for a startup called Actaea. I've been there almost two years now. And so I started first of all part time, so I sort of, you know, try before I buy kind of mentalities like I started 50% time, cut back clinical 50%. Try that for about six to nine months. And then, you know, they asked me to go full time, and then I was comfortable enough by then with the people the mission, the sort of organization as a whole. And I said, Okay, let me I think this is reasonable enough to take this risk. And I'll go full time, or, you know, vast majority of my time, I still practice a little bit. And so that's how I made that decision. And I've loved it. I mean, there's so many, again, that that learning curve, from sort of Assam taught, asymptote has now you know, gone back to this sort of really, exponential curve. And I've really enjoyed pretty much everything I've been doing within the company. So that's how that process went. For me, it did took a long time. I mean, it was not like, I just put my resume out there and got a phone call, probably a good 18 months before, from start to finish, before I actually took a took a role.
Patrick Kothe 27:03
You've been embedded in medicine for a long period of time startups are different medical devices is different. What was the big differences that, that you saw in moving from medicine career into a business career?
Jay Shah, MD 27:19
Well, first of all, I didn't know very much came from came from a, you know, type of job where, you know, clearly, people come to me because I was the expert, or I am the you know, I'm the one who has the at least knows how to get figured out the problems. But in this, in this role in the startup role, or any business role, really, my expertise still exists, clinical expertise still isn't, that's why they want a physician in the team and on the company. But the knowledge of how to apply that expertise to business development, commercialization, product development, regulatory, and r&d, which is all of kind of what I do. No idea, I had no idea, you know, so all of those things were, I had to learn. And I had to learn fast, which is, you know, part of the benefit of being in a startup that that, you know, you have to learn fast, and it's dynamic, and, you know, everybody's sort of doing multiple things at the same time. And there's an expectation that no one's going to know everything. So that that that was helpful, is also exciting, and, and a little bit, obviously, a little bit risky. So those are the things that I've really had to learn. And I'm still learning, they don't finish, they're not complete, but, but I'm still learning that sort of application of my clinical expertise into each of these business functions.
Patrick Kothe 28:44
Just like in medicine, you had an expectation, you're walking in the door into medicine. Now, you had expectations, even though you did 18 months worth of research onto it, you had expectations, and, and then reality hits you, what were some of the things from a reality standpoint, when you moved into into this role?
Jay Shah, MD 29:03
Well, one of the good things was I didn't really come with a significant amount of expectations, because I didn't really know what the whole job was going to look like. And they were upfront with me about that tooth, this is a startup series, a small company like we're going to, there's going to be a lot of things you're going to do. And what I found is that it kind of goes in phases that for certain three or six month phase, my focus is, is on one specific area, or a couple specific areas, but then three or six months later, that shifts to a different area of the business that needs a little bit more of my attention and focus. And then that shifts again, and you know, so it's constantly shifting and changing, which is the exciting part. You know, it's not always the same thing. Each day is different. Each priority is different. And the way you look at it is slightly different. I think that's really an exciting part and really helps me continue to learn. And so I think that that's how I have approached it this time, or at least with this pivot And I've done things from very basic level things that probably most chief medical officers wouldn't necessarily think about doing, to talking to the founders and CEO about the vision of the company and how we take it forward. And, you know, to investors, and fundraising, all these sort of large strategic sort of initiatives as well. So that that breadth of, of initiatives is also really interesting and and has been a great learning experience.
Patrick Kothe 30:29
So when you were doing your informational interviews, I imagine you spoke with several chief medical officers. What did they tell you? And what type of chief medical officers did you talk to? Did you talk to ones at large companies at startups, tell me about kind of that informational interviewing portion?
Jay Shah, MD 30:49
I talked to all, I from you know, the Chief Medical Officer of like JPMorgan, to the chief medical officer of a small biotech, each sector is bit different. I mean, that was pretty clear. That was one of the things that it was helpful to find, because the Chief Medical Officer JP Morgan, is occupational medicine. And it's talking about like, work safety and, you know, health plans, and how do we assess that, and what's our what's JP Morgan's COVID response for all that simply, so this sort of very global but more occupational focus, but a chief medical officer for biotech is thinking about clinical trials and data and how to get that molecule developed and going and phase 1234. So it's a drastically different, you know, sort of work, and, and thought processes, but, but some aspects were common among, among all of them. And again, it was really about bringing that bringing your clinical expertise as a physician, into whatever field that that company was in, and applying it appropriately to the initiatives of the company. And that's really was the sort of key takeaway. And that's also something that I've told other physicians that that have asked me at least is, we have a tendency, or at least some physicians do have a tendency to devalue their clinical experience in the context of business of any business and say, Well, I don't I don't have business experience. That's not why that I don't think that's why businesses hire doctors, they don't they have business people to do that. They they're not asking me to run the financing of the company, they have a chief CFO to do that. They're asking me, What is my clinical perspective in every situation? Or how why does this make sense, in every situation in every sort of function, and I think that's really important to remember, is, that's really the value that we bring to medical focus company. One of the
Patrick Kothe 32:47
other challenges with a chief medical officer is you've got your perspective on how medicine should should happen, what clinically is going on. But we also know that every physician has got their own opinion and physician is medicine is practiced by individuals and their own strategies. But when you come in a company, you're one opinion. And there are many others out there. So if somebody hires a chief medical officer, and they become the arbiter of truth, there's some issue there, because it's their truth, it may not be the truth for the marketplace. So tell me a little bit about how you handle that. And knowing that there are other opinions on medicine out there that may differ from yours,
Jay Shah, MD 33:43
I would say the first thing is that while the chief medical officer, or at least in my position, I give guidance, give ideas, give direction, and have an underlying probably, you know, we all have our own bias and the way we look at the world. So we have that, of course, we bring that to our physician, in our opinion, but at the same time, you need to always talk to the customer, whether the customer is a physician, or the patient or health system, or a payer, or a pharmaceutical company, you have to talk to them, because you have to get confirmation or lack of confirmation, that that your idea makes sense, you have to sort of confirm that the market or the customer actually wants it that way, or wants a product that way or you know, wants delivery that way or whatever it is that your that you're thinking about. But there has to be a confirmation and so you have to listen to the customer always. And most of the time what happens, at least in my experience is that we might have an initial idea and the overall direction of that idea is right is good. But then the implement implementation might be different. It needs to be tweaked. The delivery needs to be tweaked the enterprise the contracts need to be different our approach to marketing language, all these things so we have to kind of continuously you know, have Our ear to the ground in each one of our customer segments, and reframe, revise and refocus, you know, in the end, the customer is the primary user and has to have the best experience possible. Otherwise, obviously, the product or the device or whatever it is that you're trying to take the market, there's not going to be as successful.
Patrick Kothe 35:21
So Actaea is got quite a an aggressive mission. When you're a physician, you've you're managing an individual, you're one patient at a time, when you're in a company, you have the opportunity to affect a broader number of patients. Tell me about Actaea what you guys are doing and the problem that you're trying to solve.
Jay Shah, MD 35:46
So Actaea, the problem, our mission is to help you know 100 million or more people with high blood pressure, hypertension, improve or optimize their health. And at its core, it's based on around a core technology innovation, and we can go into detail about, but really, the purpose of it is to put blood pressure and hypertension, tracking optimization in the, in the hands of people, patients, and make it much easier for healthcare systems to manage many more patients who have hypertension, much easier, faster and better. That's really the idea around Actaea. The way we do that there is a core technology innovation, which has to do with a right now a our own device, which is an optical sensor and LED light based device that delivers validated and accurate blood pressure readings, both to the user as well as to the physician or healthcare provider at the same time, and does it passively automatically. And without any sort of user intervention.
Patrick Kothe 36:54
And that device is a wrist worn device.
Jay Shah, MD 36:57
Yes, currently, it's a wrist worn device.
Patrick Kothe 37:00
So let's talk about hypertension. For a second, you said that, you know, the the numbers are staggering the number of people with hypertension, high blood pressure, what happens if if somebody is not managing their hypertension? Well,
Jay Shah, MD 37:14
so as you said, the numbers are truly huge, like 1.4 billion people in the world 100 and 30 million Americans, you know, one in two adults from at age 65. And what happens as high blood pressure takes its toll and does its damage over long periods of time. And this is the key is that time is the primary element in how hypertension causes its death and disease. Usually, high blood pressure starts in 20s 30s and 40s of life where people are not paying attention, usually to their health, they feel like they're healthy, high blood pressure causes no symptoms. And so unless somebody is really, you know, very aggressive about looking at their blood pressure on a routine basis, they oftentimes will not know they actually have hypertension. And so generally goes for years, if not decades without a diagnosis. And so over time, what that does is that to each individual underlying Oregon, brain, eyes, heart, kidney, aorta, reproductive system, pancreas, every organ is exposed to this higher blood pressure. And over time, it does damages the small vessels and each one of those organs and cells and and those organs start to die. And so in the end, what does that actually look like? It looks like a heart attack, a stroke, kidney failure, vision loss. And, and on and on. There's all kinds of other high blood pressure related diseases. But the underlying problem that caused those disease may have started 20 or 30 years ago.
Patrick Kothe 38:46
And how is hypertension managed right now,
Jay Shah, MD 38:49
right now it's managed, you know, in a fairly reactive way. So someone has to know they have high blood pressure and only way you know, you have high blood pressure. So if you check it, and most people, everyone knows that a cough is the typical way traditional way we check for blood pressure. But those are episodic, one time readings, only giving you that one measurement at one moment at one time in the day. So to really understand your levels of blood pressure over time, and blood pressure fluctuates continuously. So to really understand what is your overall sort of trend and level of blood pressure over months and years, using a cough, you'd have to take it multiple times a day, every single day, for months to years on end. And we know that that's just people just don't do that. It's just not built for that. And even though cuffs had been around for many decades, even people with high blood pressure, only 24% of them will actually use a cuff even once a week. So the vast majority of people are just not measuring and monitoring their blood pressure. So partly the automated nature of our device where someone just has to put it on and then can forget about it and we get 20 to 3020 added 30 readings a day will build you that trend over a long period of time with a very easy to wear, you know, easy form, nice form factor sort of device. And so we can really look at that trend of blood pressure over long periods of time.
Patrick Kothe 40:16
So let's talk about the trend for a second, how much does it fluctuate daily?
Jay Shah, MD 40:22
Well, it kind of depends on what timescale you're looking at, like, if you measure it, at resting blood pressure at one, you know, in the morning, over a couple of days, that probably will be somewhat similar. And that the guidelines recommend you check if someone's going to screen for high blood pressure, they check it at home twice in the morning, twice in the evening, for at least a week to really understand sort of that transit averages. But the blood pressure can fluctuate 15 to 20 millimeters of mercury within one day. But one day, one hour or even one week, is not really that important to understand your overall, you know, decade's worth of blood pressure, what you really want to understand is, is your blood pressure in the first two or three months of the year, the same as the last two or three months of the year. And the only way you understand so that's sort of the timescale that is reasonable to think about with blood pressure on at least a month or two or three. And to really understand that that trend, that's how we're talking about it. And that's what we are constantly thinking about at akti, as our perspective is, because high blood pressure does its damage over long periods of time. The most important thing to look at in our opinion, is how consistent is your blood pressure over a long period of time, and then optimizing that consistency is the key to lowering the risk for future blood pressure driven events.
Patrick Kothe 41:52
This may be a difficult question, but I'll ask it anyways, is hypertension something that comes builds over time? Or is it more of an acute event where it spikes,
Jay Shah, MD 42:04
it can be both. So there's not like a perfect answer there. But for the most the majority of people with sort of the usual scenario of hypertension, it is generally something that starts sort of slowly and builds over time. And, and there's a lot of research around that and generally starts as I said, 20s 30s and 40s of life. And generally people start fairly mild levels of hypertension. But then over the years, at some point it become may go higher and higher, or may just stay in this sort of mild level for a long period of time. Both are possible. So there's not like a necessarily a usual case. But that's oftentimes how it happens.
Patrick Kothe 42:46
What is the treatment for hypertension.
Jay Shah, MD 42:48
So the treatment, you know, at first when someone first of all is to diagnose it, that that in and of itself can be difficult and often takes years to someone gets the actual diagnosis. But once it's diagnosed, then usually depending on the level of how high is the blood pressure, the default will be lifestyle modifications, which we would all can probably rattle off a topic off top your head, diet, exercise, salt reduction, alcohol reduction, stop smoking, lose weight, these kinds of things. And, and if it's hot, if it's what's called stage two or stage three or higher, then immediately adding medications would be part of the treatment, if it's elevated, or stage one, then you might give a three to six month trial of just lifestyle only to see if someone can actually modify their blood pressure, just using lifestyle interventions before thinking about medications, so it's a combination of lifestyle. And medications, generally,
Patrick Kothe 43:49
we've got a lot of wearables that have come out recently. And the good thing about a wearable is you don't you don't have to put a blood pressure cuff on you. You don't have to put a something and actively go do it. It's something that you you wear all the time, and it's a passive data gathering. So that's an essence what you guys have is a wearable that's passive that measures the blood pressure over long periods of time, which is great that you're able to do that. But there's also an accuracy accuracy component to that too. Is it? Is it accurate enough to do that. So let's talk a little bit about the trade off because you know that you may have a perfect test. But if it's so difficult to manage, nobody uses it. That's not useful. But you have to pass a bar. You say this is Chris is good enough demand. So let's let's talk a little bit about efficacy.
Jay Shah, MD 44:54
Yeah, so blood pressure validation is very protocol driven. So all blood pressure cuffs first So all blood pressure devices are regulated medical devices. So we want to probably draw a very clear distinction between commercially available wearables, and a medical device and medical product. Ours is a medical product class to a medical product, and is regulated is approved. And we have extensive validation data from it, it looks like a just a simple wearable, it looks like something you can buy on Amazon. But the science behind it, and the validation data is all there. So let's talk about how validation works for blood pressure. blood pressure cuffs are the standard of how we measure blood pressures. And they all have significant ranges of error. And there's an accepted range of error. They are all validated, all of them are validated in one particular position and environment. And that is a seated and relaxed position. And what does that mean? It means that your feet have to be flat on the floor, your back has to be flat against a chair, your arm has to be at heart level, you should not have eaten or drank anything for 30 minutes, no alcohol for 30 minutes, no exercise for 30 minutes, no talking for five minutes, you should not be talked to for five minutes, you have no clothing on your arm, you have nothing in your bowel or bladder. And then you can take a blood pressure and that is the environment and position that all blood pressure cuffs are validated in no other position. None, not when you're standing, not when you're lying, not when at any other position. So does that actually make sense for when your blood pressure is is, you know is that the best time to measure blood pressure. And I would say no your blood pressure fluctuates, you're in an office, you're in a meeting, you're at home, your kids are yelling at you, you're one to 17 other things happening in life throughout the day, and your blood pressures reacting to those things. So the reason that validation exists is just that's just traditional, that's historical of how cuffs you know need to be validated. That's why the body position is such that's, that's what's recommended of how to take a blood pressure measurement with all cuffs. So that's how validation exists. So in that body position and environment, we have shown that our device is as accurate as a cuff. But the catch is, is that we take measurements in other body positions, we take a measurement when you're standing, when you're lying down when you're asleep, when your arms over your head. And when your arms down by your side, when you're in a meeting we'll take measurements at at other appropriate times. And the thing is, is that there's no current validation standard for any of those other positions. But we have the data, we have our own validation data, and we publish it for all those body positions. And so like you said very, very correctly, is that in medicine, we have to balance maybe the most accurate or the sort of quote unquote, best or historical test and it standards with is it practically going to do something in the real world of healthcare, when you're actually talking to people in their real life, at home, outside the clinical trial outside of validation setting? Is it actually going to be beneficial. And I think you can make a pretty good argument that cuffs are good, they're accurate, they're fairly good in that in that standard position, but people don't use them. So how good are they really, when you deploy them in a real world setting. And you can argue, oh, people should use use them. And they should just just get better at using them? Well, that's fine, they've had 50 years to do that. They don't do it. So time to move on, you know, they're like, come up with a different idea. So you know, that's, that's, that's really where we're going with this. And that's our perspective. And we do want to be regulated, we do want to set our own bar very high. We are our founders are part of the international standards committee, we publish all our data, all our validation data, it's very important to us to gain that trust. Because we know and recognize that we are novel technology. This is, you know, and novel in the sense that these other technologies have been around for 50 to 100 years. So it is a big change. You know, all physicians in the world, all providers in the world have always been trained on that same way to take blood pressure. So it is a big thing to ask to change that mentality. So we need the data to support it.
Patrick Kothe 49:15
So business model, I'm assuming you've got a hardware component, you got a software component, the hardware component, as we've said, is a wrist worn device, your technology is not necessarily the wrist worn device. It's a technology that can be embedded within a wrist worn device. So I imagine that you're in conversations with other companies that have wrist worn device to embed your technology and into them. Is that correct?
Jay Shah, MD 49:42
Yeah, that's correct. And so you know, we purposefully our founders very intelligently, purposely built this device out of off the shelf equipment, nothing proprietary in here. High quality but standard optical chipset LED lights and sensors and a accelerometer, you can find these sensors in all high quality, wrist worn devices. And they did that very purposefully. Because all AIP, as you said, is an algorithm that takes the raw signal data and processes it and gives you the blood pressure and heart rate readings. And so yes, while I can't mention any one company by name, because we're under NDA with all of them, is that the the overall goal in the future is to embed the software writing on top of any third party hardware device of significant enough quality to get us those raw optical signals. And so the software will be the regulated part of it, and it can convert any third party device into now a validated class to a blood pressure device.
Patrick Kothe 50:49
Jay, let's talk about the data real quick, is the data that's coming back off of these devices, do you have access to that, because that could be extremely rich, in terms of what you can do with it.
Jay Shah, MD 51:01
You're talking about third party devices, no,
Patrick Kothe 51:03
any device or third party device or your devices data ever come back to you that you can see and take all of this data is coming back from all of these patients in mind that for information? Yes,
Jay Shah, MD 51:16
answers, yes. And we have a consent part of the app, that patient, you know, people will have to consent for us to look at that data. All we don't sell it ever, or we don't identify, but we use it for research purposes. But yeah, the answer is yes. And we have compiled a data set that is now approaching 100 million data points. For blood pressure, this is just based on. We have 45,000 now active users, and so and growing at several 1000 and more now per month, so that datasets is sort of exponentially growing. And I think that's a very astute point is that what we can now look at are these huge volumes of data and start to understand for the first time start to understand what do these complex blood pressure datasets contain? What insights might they contain beyond just blood pressure level beyond just average? You know, numbers this or average numbers that what other insights do they contain? Can we start to be predictive? But who's going to respond to what medication? Who's salt sensitive and who isn't? Who is at higher risk? Even though two people might have a same blood pressure of 130? Over 81 of them has a stroke at age 65? Why does that person have a stroke and the other person doesn't have a stroke, maybe there's something within this dataset, that that will give a signal that this person is at higher risk. So there's all kinds this data, it's incredibly rich. And we're just right now just scratching the surface with a lot of other research partners, to start looking at that data, and combining it with imaging data, biomarker data, genomic data, and health, health record data to really understand what they mean. And I think this is that that is the real transfer. From a medical standpoint, that is the real transformational component of that data set.
Patrick Kothe 53:12
And I think having that as an independent data source is great. But if you've got a wearable that may have ECG on it may have heart rate variability on it heart rate, you hook into a scale. So now you've got all of these other things that are coming in the richness of that data can really bring some nice insights and it to Well, this has really been a interesting, fascinating conversation. Jay, I really appreciate it. One final question. As we said, a lot of us are dealing with decision issue, either ourselves or family members. So in general, when we're talking about hypertension, what type of advice would you give to people in terms of managing or identifying hypertension?
Jay Shah, MD 54:02
So I would say, my opinion is certainly as a physician and and also as the chief medical officer, and then just just general, sort of common sense, I guess, is that just to be proactive, chronic diseases of all types, whether it's hypertension, or obesity, or our diabetes, or whatever they are 99% of the Year and time is spent outside the healthcare system outside the physician's office. So the primary sort of, I would say burden but also opportunity falls on us as individual patients as people to really take charge and now now there is so much ability with technology and tools to really understand your own data and really be a proactive and empowered consumer of that data and participant in your own healthcare. And I know that from on the physician side when I have patients who are empowered and who are proactive. It is so much easier. And I would say our outcomes statistically are better. But it is so much easier for that person to really get a satisfactory result. It's never perfect not going to be, you can't prevent everything but to get a satisfactory result with their own health care. And, and what's most important is to feel and know that they are doing everything that they can do to optimize their health for the future. And that's all you can ask for. I mean, right now, in this world, like, that's the main goal is to really do the best you can to optimize your health. And I think that now falls in always has. But now I think clearly, patients can really take control and be empowered.
Patrick Kothe 55:43
We are all on our own individual journey, some of us are going to stick pretty close to a well worn path, while others are going to create more interesting ones, ones that may hold great, but different experiences, and some that we just don't know how it's going to turn out a few of my takeaways, you may have expectations until reality hits you. And this really deals with flexibility. What Jay described his first opportunity after his training was completed. And he expected to go out and practice invasive cardiology, but found out that his patients needed something else and the practice needed something else. So he recognized it. And that was this perfect first pivot to serve a need that that existed within within the practice. So instead of complaining about it, he dug into it and really learned a bunch of new things, and enjoyed that journey. The second takeaway is, when he did pivot, he planned and researched what that pivot was going to be all about. So prior to becoming a chief medical officer, he talked to others in the field, all kinds of different people. And what he said is, it's as important to rule things out as it is to rule things in so really, to be diligent in your diligence, to understand exactly what you're going to be be into. And then he also said Be patient, it took him 18 months to find, find the right opportunity for him, but it is the right opportunity for him at this point. The final thing and it had to do with the technology that they're dealing with, the trend is your friend, we think about blood pressure, and all of our experience with blood pressure is different. And what they're doing there is something that's that's different and looking at the trend instead of an individual tested at a point in time. So taking that blood pressure once a year at your physical may not ever turn up a diagnosis, but the issue that you're gonna be dealing with with your health could be impacted and could be something that you'd be living with for forever. This technology that is that they're utilizing. It's simple, but it's in the background. And even though it may be different or less than the gold standard, it's going to provide the feedback that's needed. So even a concept as old as blood pressure can be reimagined and applied in different ways to provide new insight. So is there something that you're working on or that that is in your field of influence, that you can reimagine as well? Thank you for listening. Make sure you get episodes downloaded your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast as interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
