July 26, 2023

AB: Ansley Bowen | AJ: Dr. Alie Jahangir,

AB: On today’s agenda, we’re talking about health equity from a medical device lens. We are going to bring on Dr. Alie Jahangir. He is the Director of Medical Devices at Global Technology and Engineering at Pfizer. So without further ado, I’ll bring on Dr. Alie to introduce himself and present as well.

AJ: Absolutely. Thank you, Ainsley. I really appreciate it. And thank you, everybody, for this opportunity to allow me to be in this forum and present on some of the works that we’re working on to impact the health equity through our digital transformation. Can you guys see my screen or you can’t yet? I don’t think you can.

AB: Not yet. There we go.

AJ: What about now? Can you see it now?

AB: Yes.

AJ: All right. Fantastic. Great. Great. Let me just get my screen here in order and we can – we’re ready to go. All right. And Ainsley, how much time do I have? Sorry.

AB: Yes, you are good to go until 1.45.

AJ: Fantastic. Great. All right. Well, as I said, it’s a pleasure to be here in this Digital Health Symposium, and I’d like to obviously extend my appreciation to the organizer of this forum for bringing people from a very diverse group of people, I guess, from industry and academia to discuss the impact of digital transformation on health equity, which is an incredibly and critical social issue of our time. So without any further ado, let me start my presentation and obviously I’m going to start with my first disclaimer that the content, views and information and opinions expressed in this presentation are solely mine and do not necessarily represent my employer’s view in any shape or form. So given the diversity of this audience, I want to take you through a journey. A journey where actually you will appreciate everything that I’m going to talk about in my presentation. And that journey essentially starts with a historical lesson, I guess, that human societies have gone through at least four different industrial revolutions, starting with an industry 1.0 around 1784, which essentially led to the introduction of steam and water power. And 90 years later, and to just warn you, everything, all of this actually happens every 90 years. I1870, we’ve had the Industrial Revolution 2.0 started resulting in mass production, assembly and electricity. And again, another 90 years later, in 1960s, we faced the Industrial Revolution 3.0, which heralded the electronics, IT system, automation, and to some extent, robotics, as you can see on my graph. And we are where we are today, which actually we’re talking about Industry 4.0 and even 5.0, where we’re dealing with cyber physical system, industrial internet of things, and et cetera, which result in autonomous decision-making and cyber physical system using machine learning and big data analysis. Now, by extension, each of these different platforms have essentially translated into a specific framework or roadmap. So in the pharma, we’re actually talking about Pharma 4.0, which as I said, it’s a framework and not a detailed roadmap for digital transformation and implementing the elements of Industry 4.0 or 5.0 in life sciences. And the reason why I say it’s a framework and not a roadmap is because every organization will have to craft its own unique journey into this roadmap and basically go from there. And part of this framework obviously is health equity. So without any further ado, let me provide you with a little bit of an explanation of what do I mean by digital transformation. And it’s essentially the process of developing organizational and technologically-based capabilities that allow a company to continuously improve its customer experience and lower its unit costs and over time, sustain a competitive advantage. Now, as part of that, what I wanted to show you is some of the examples of tools that we currently have at our disposal to implement this digital transformation technology and revolution. And you can see like in this outer circle, you can see artificial intelligence, modeling, big data analytics, and we go into wearables, which I’m going to elaborate a lot more on, predictive modeling, AR, VR, blockchain, et cetera, et cetera, that works both at the level of software and hardware. And it essentially is revolutionizing and changing the business as we see today. In other words, it’s actually impacting things like in development, in manufacturing, in marketing and commercialisation, in quality, and in fact, to improve the processes that we’re working on right now. And a result of that is quite clear. And again, these are not coming from my work. These are coming from big consulting companies that have done research across industry. And they’ve demonstrated that the benefits to help your organization by properly and strategically incorporating digital transformation would result in lower costs, lower inefficiencies, better decision-making process, improved interaction with patients. There lies the question of health equity and basically a medical record data base with secured access that we can rely upon. Now, this all sounds good from a theoretical perspective. So let me actually give you a little bit of a clear example of how the medical apps and softwares and everything that I’ve just described helps in clinical decision- making of doctors on their day-to-day – on a day-to-day basis. And as I said, these digital tools have a vast potential to improve our ability to accurately diagnose and treat diseases and to enhance the delivery of health care to individuals. So now, to actually illustrate this, what I put here is a digital patient’s health care journey that starts with utilization of some of these tools. That includes wearables, non-wearables, smart devices. And as you can see, it pretty much impacts end-to-end. Anywhere from preventive care and wellness, which enables patients to prevent the onset of diseases through clinically proven devices that measures different metrics in their body. When it comes to diagnosis and treatment decision, it provides diagnostic information to inform patients and health care professional to make decision on treatment regimens to improve clinical outcomes. Obviously, when it comes to treatment, it acts as a standalone treatment with proven clinical efficacy or complement existing treatments by enhancing clinical outcomes. And of course, managing high-risk care management, which means it allows patients and ACP to monitor and track symptoms to continue to refine and optimize treatment regimens. And everything that I say here, it might, as I said, sound good, but there are actually companies out there that actually focus on specific therapeutic areas by developing digital therapeutics to impact clinical outcomes. And here are some of the examples of that. So when it comes to the area of preventive care and wellness, we can actually talk about the heart disease, that they drive behavioral change through weight, food, and activity tracking, followed by interactive coaching and personal challenges. When it comes to diagnosis and treatment decision, breast cancer, there’s a company out there that monitors the breast metabolic change for accelerated cellular activity, common in tumor, leading to a very early detection of the breast cancer. Same thing with the diabetes, that they actually use the gamification in application to encourage better glucose tracking and the treatment. And of course, something, and when it comes to high-risk care management to asthma, that help people to understand the current asthma condition through a set of tools to adjust dosing accordingly. And the benefits of that, again, it’s quite clear. And what I mean by that is that it obviously reduces the cognitive burden on our physicians and improve access to our patients. It lowers the healthcare costs, improves the quality of care, and improves the personalized care and services, which is actually the very essence of digital technology, that we can actually develop treatments that are aimed at the specific patient population. Now, with that in mind, I just wanted to actually make a foray into a little bit of an FDA role in facilitating the use of these technologies. And in fact, as usual, I think government’s running behind the technology, and I think FDA is playing a catch- up game here to actually – to facilitate the use and implementation of this digital technology. So, let me actually focus on three different levels. So, organizationally, I think FDA continues to evolve to keep pace with trends in digital transformation of data analytics. In fact, in September of 2021, they announced the new Office of Digital Transformation, which is tasked with advancing FDA’s overreaching – overarching technology and data modernization effort. And ODT sits in FDA Office of Commissioner that encompasses agencies, information, technology, data management, cybersecurity. At center level, FDA’s Center for Device and Radiological Health, CDRH, launched a Digital Health Center of Excellence to help to coordinate digital health projects at CDRH and enhance the coordination of other agency centers. So – and they kept on releasing a whole bunch of guidance documents on real work, evidence program, digital technology in remote data acquisition. And so, they’re actually doing a lot of work in this. And I think what’s important is that this is just a selected list of the FDA guidance and documents that have been essentially coming out to help the industry of releasing these technologies. Now, of course, what we have to focus on is some of these digital tools and wearable devices is indeed one of them. So, let me provide you with some growth figures here. So, if you look at this in 2022, the wearable medical devices market was estimated at around $22.4 billion and is expected to reach at $60.4 billion by 2027. That represents a CAGR of 21%. So, the core market drivers are the rise of lifestyle associated chronic diseases, growing geriatric population, and increasing popularity of home health care and remote monitoring and the focus on personalized care. So, some of the examples of these are, as you can see, they’re all here. I mean, you can see spirometers, you can see glucose monitors, you can use your watch to monitor blood pressure, oxygen saturations, et cetera, et cetera. And in fact, a lot of these wearable devices are in fact used to monitor, screen, detect, and predict. And there lies where technology can help in health and health equity. And the reason for that is as follows, that obviously, the randomized clinical trials are considered the gold standards for providing evidence and effectiveness of clinical interventions for prevention and treatment of human conditions and disease where there’s a need for pharmacologic behavioral accommodation approaches. However, using this sort of traditional in-person approaches are often highly complex, expensive, time-consuming and burdensome for both staff and participants. And with the explosion of the digital technology and steady rise of internet and mobile technology, digital technology integration into RCT operation can lead to a reduction in cost and minimize complexity to reduce burden. And here are some of the areas where we can actually insert the digital technology. That could become very effective in recruitment and retention. It can work in digital health data and collection and data analytics. And the reason why I actually talk about digital clinical trials is because of a lot of the challenges that we have. And I think we’re running a little bit out of time, so I’m going to accelerate through these slides here. I think despite the unprecedented potential of digital technology to improve equal access to affordable and competent healthcare, there’s a risk that this rapidly advancing technology may exasperate exclusion, introduce unexpected biases, and in fact, widen the digital divide and continue to leave some population behind. And these, I’m just basically wanted to define what the health equity essentially means, which is the fair and just opportunity for every individual to achieve their full potential in all aspects of health and wellbeing, regardless of their race, ethnicity, gender, sexual orientation, disability status, location, or age. But these fairs and just opportunities rely on understanding of systemic biases and developing and allocating resources to accommodate differences in social, economic, and environmental experiences. I’m going to show you some mind boggling numbers here. That’s 15 to 24% of Americans lack any sort of broadband connection to internet with which to use mobile health technology. So, and this is coming from Brookings Institute. So, no matter how advanced these technologies get, if there’s 30% of the population cannot take advantage of it, it actually renders this technology kind of useless. 38% of household earning less than $20,000 a year lack broadband subscription within rural or urban centers. The average majority white communities have average broadband adoption rate of 83.7, while the average majority black communities have a broadband adoption rate of about 67%. Now, what’s really also important, I alluded to the clinical trials, is that the clinical participant pools often don’t even reflect the racial and ethnic diversity of the US population. What I mean by that is that while racially and ethnically diverse consumers make up nearly 40% of the population, about 80% of our clinical trial participants are indeed white. Now, this is a study that was conducted by Deloitte, and it actually shows when they ask consumers have they ever heard of clinical trials, 14% of non-Hispanic white says yes. I’m going to go to non-Hispanic black, 23% haven’t even heard of this. So the question really then is that, that poor patient engagement with technology, lack of access, low digital health literacy have been shown to contribute to poor health outcomes. And technology leader are in an ideal position at this juncture of our history to tackle the digital divide and achieve a more equitable digitally enabled personalized care model. Now, of course, we need to consider the distrust of medical community – toward medical community, limited access to trial sites and lack of general lack of awareness where clinical trials are among the barriers that keep many people participating and improving access to clinical trial diversity can indeed improve the health equity as well as scientific rigor of some of this work that we’re trying to do. So what can we do? Well, from industry and technology leaders, I think we should look at some of these four pillars of how we can improve this. So one is to look at the provider side and look at the consumer side. So from a provider side, we can actually focus on digital solution, which means healthcare services aligned with delivery via digital tools and platforms that intuitively designed and well integrated and offered in collaboration with payers and offer partners. If you look at the workforce competency, that means that provider teams trained in delivery of digital health solution in a redesigned care model that has been optimized for a new workflow. And if you look at the consumer side, it actually means to facilitate digital access infrastructure, availability of technologies and tools required to participate in digital health landscape, including broadband networks and adequate devices. And of course, focusing on digital health literacy, which is education in the positive outcomes and benefits available by digital services and skills needed to effectively access them. And with that, I’m just going to summarize the saying that healthcare industry essentially must begin by considering how inequities in access limit the number of reachable patients by determining which dimension of health inequities their solution could address. And most importantly, equity must be embedded into all aspects of digital health solution from design, development and deployment, especially within organizations, high priority and strategic initiatives with the objective to improve lives of our patients, increase the efficacy of healthcare system and obviously as a positive impact on the greater economy. So I’m sorry if I went a little bit above my time, but I think that’s all I have and I’ll be happy to address any questions that you might have.

AB: Thank you so much. I really appreciate for such a thorough presentation that you presented for us today. It was fantastic. Thank you so much for being a part. If anyone has any questions, can definitely follow up in the chat if that’s okay.

AJ: Absolutely.

AB: Thank you so so much.

AJ: All right, take care.