"Healthcare has been interesting because it's the last industry to really embrace technology. There is a lot of technology in care, in treatment. You know, we're all familiar with medical record systems now, EMRs, patient portals, your MRI, your X-ray systems. But it's really the use of data that, you know, healthcare is now only truly embracing."

Intro:
Welcome to the Agile Digital Transformation Podcast, where we explore different aspects of digital transformation and digital experience with your host, Tim Butara, content and community manager at Agiledrop.

Tim Butara: Hello everyone, thank you for tuning in. I'm joined today by Richard "RJ" Kedziora, co-founder of Estenda Solutions. They're a leading company specializing in custom software and data analysis for healthcare and medical companies. And our topic for this episode is digital health. We'll start by defining this specific term, digital health, before diving deeper into topics such as regulated software development for healthcare, the current and the future impact of AI in this field, as well as some examples of Estenda's work with clients.

So, RJ, hello, welcome to the podcast. It's a pleasure to have you with us today. Do you want to add anything here or should we just go ahead and explain to our listeners what's really meant by digital health? 

Richard "RJ" Kedziora: Yeah, thanks, Tim. Thanks for having me here. I'm really looking forward to this conversation about digital health. Just a few quick words. I came up through the software development programming ranks, and then got into general project management, program management and started my own company with a good friend, Estenda. And we just hit our 20th anniversary. 

So it's been quite a journey over the years. We've always focused on the idea of digital health before it was even called digital health. And as I've been reflecting these, you know, last few weeks over those 20 years, it's been an interesting journey because we went from a world where it was very little data to where now there's just so much data. What do you do with it? So it's been an interesting two decade long journey.

But, you know, you asked the question, what is digital health? And it is an interesting question because it's a very broad category. Generally, I think of digital health as the use of technology, computers, algorithms to improve patient care, streamline processes and improve overall management of people with various diseases.

And it even gets into EMRs. And billing. But you can also look at it as, you know, X-rays, MRIs and those types of things. Healthcare has been interesting because it's the last industry to really embrace technology. There is a lot of technology in care, in treatment, you know, we're all familiar with medical record systems now, EMRs, patient portals, your MRI, your X-ray systems. But it's really the use of data that, you know, healthcare is now only truly embracing in this world. So how do we make use of data in this digital world to improve that patient care and streamline processes?

Tim Butara: So data is definitely, that's like the first note that I made for myself. The data and innovation in data and how it's handled has been crucial for the concept of digital health to even properly evolve.

And also, as you mentioned, it's not the case that health care hasn't been using technology. It just that because, I don't know, I've heard from several people also on our podcast here as well, we talked about it, I think at least at least once or at least a few times that health care tends to use a lot of outdated legacy tech that's super hard to replace.

And then how do you then reconcile this with new tech that's data driven while still having to kind of keep the system functioning in place because the patients still need that access to that healthcare, right? So it's not, it's not just something like that, okay, we can take down the site for like, as long as the rebuild or redesign or rebrand is going to take, because then, you know, what's going to happen to healthcare and the patients that need access to that site?

Richard "RJ" Kedziora: Yeah, absolutely. And it's interesting in healthcare. I've developed accounting systems and inventory management systems over the years, even railroad car scheduling system. You know, you got to make sure the right railroad car gets to the right place to pick up materials and do shipping. And it's all very important.

But in healthcare, you're dealing with the health and wellness of of people, you know, it makes a difference. And for that reason, you know, even, as we're talking about what is digital health, there are various levels in different ways of categorizing, you know, we have your EMRs, which captures electronic medical records, which captures the information around patients, but they were really designed around billing and they're not well liked by the healthcare professionals out there.

I think that's something that we'll see over, you know, the next decade kind of thing of how they evolve to improve use by the healthcare professionals. But then you get into medical devices. And you have the idea of software on a medical device. So, you know, think of your blood glucose meter or blood pressure cuff that's, you know, taking a reading from an individual and has an algorithm to manipulate that data.

But as technology has improved even today, you now have software as a medical device. So it's, there's no physical hardware involved, but you're actually providing, you know, algorithms. So think of like insulin recommendation algorithms, and then, you know, there's probably if you go look in one of, you know, the Apple store, Google store kind of thing, you know, I've seen numbers 300, 400 000 digital health applications that are out there.

But, you know, do they work? You know, some do, some don't. But what's evolved in even like the last five years is this new idea of what are called digital therapeutics. And it's, digital therapeutics are digital health apps, but are evidence based. They're clinically evaluated and actually reviewed and approved by the FDA here in the U. S. or by European regulatory bodies to make sure that they actually do what they say they do. So the bar for use of these systems as digital therapeutics has has been elevated. 

And I think of the difference between drugs versus supplements. So supplements. There's lots of them out there. They may work. There's not a lot of evidence around them. And that's what your general health apps are. But then you have medications that have gone through a rigorous testing clinical trials review by regulatory bodies. And that's the idea of a digital therapeutic is that it has an elevated capability there.

Tim Butara: So digital therapeutics are key to successful digital health. 

Richard "RJ" Kedziora: Yes, absolutely. And one of the challenges in the world of healthcare is the ability to provide care to all of the people that need it. It was at a conference just last week and they were talking about mental health and there's, you know, we need more mental health professionals. It's a growing problem here in the U. S. and globally. It's difficult to train all those people and have them accessible. My wife happens to be in pediatrics. And, you know, the idea of a pediatric psychologist to help, you know, children with ideas of mental health. There's not a lot. And I live in the Philadelphia area, there's going to be some here in the Philadelphia, but if you move into the rural areas of Pennsylvania, it's going to be a lot harder to find those individuals that are properly trained.

So, if we can take the technology, the digital health apps, the digital therapeutics, which have been proven to make an impact in the lives of these people, that's how we're going to scale healthcare. 

Tim Butara: And what does the phrase or the term regulated software development means in the context of what we're discussing today?

Richard "RJ" Kedziora: I think about just regulated in software as a medical device, that digital therapeutic. These systems have the capability of impacting your life. Hopefully for the good, you know, we want to make sure that they're not going to do any harm, you know, doctors take a note, you know, do no harm. 

It's the same thing when we're talking about digital health applications. You know, we want to make sure that we think it's going to do X that it actually does and doesn't have any detrimental effects. And that even there's no, you know, biases in these, that it works for the audience that, that we're targeting and it works a lot with larger companies in the R&D groups, smaller startup companies, organizations, helping them develop innovative solutions.

So as we come up with these ideas with our customers, you have to, you know, it's one thing for me to say it works or the customer, like, oh, we have this really great idea. Let's try this. You know, there is clinical evidence, there's research around this, you know, particular approach we're going to take, but you need to take it to clinical trial.

And that's where that regulation comes in. Estenda happens to be what's called ISO 13485 certified. And really, it's around having good software development processes. Everything is well structured, processes and procedures, very template driven, to make sure that you consider all the different things that you need to.

Tim Butara: Just before I ask you to tell me more about Estenda's work, I just want to take a quick detour because what you said about these systems having a direct impact on people's lives and this being the reason why it's so important to get things right here. This reminded me of the concept of business critical code, right?

You know, it's one thing if, you know, an engineer, or whoever is working on a digital product, screws something up while working on a, I don't know, messenger app. And it's something completely different if a similar bug happens like, you know, on a plane landing system or, or on a cancer detection system or on a blood pressure measuring system. So really good points here about the importance of regulated software development here. 

Richard "RJ" Kedziora: Yes, absolutely. And they were good examples. If you're a patient with diabetes, one of the treatments is taking insulin to help control and lower your blood glucose levels. If you take too much, you know, you can potentially die. So you have to be really careful when you're developing, you know, insulin dosing algorithms, making recommendations. 

And in some cases there's, there are companies that are developing closed loop systems, which basically means the computer, the technology involved is making those decisions about how much insulin to, you know, inject into the person. And these have proven to work very well, but it's taken, you know, quite a while to get there to that level of technology. 

Tim Butara: Well, okay, now I think you should tell me a little bit more about some of, maybe some of the most unique, most successful, most complex projects that you've done with Estenda. 

Richard "RJ" Kedziora: We've been in business for 20 years now, so it's been an interesting journey. There are a lot of things I'd love to talk about, but because we do work on the innovative side of things, signing NDAs is a very frequent thing that we do. But there are things I can talk about. One of our major projects we've been working on for, we've been involved for 20 years now, is with the Joslin Diabetes Center and the Indian Health Services, which here in the United States is responsible for the Native American population.

And if you are a person with diabetes, it can affect the microvascular, small blood vessels within your body, in particular our eyes. And there's a condition called diabetic retinopathy. It's the leading cause of preventable blindness. So if we can find it... It is very treatable. 

So the project is called the Joslin Vision Network, JVN for short, but it's a system of cameras, in this case digital cameras, that take a photo of the retina of your eye, the back of your eye and then those images are provided to trained professionals to assess for retinopathy.

And if it's found, then we can treat it kind of thing. That technology has been around for a while and probably the last 10 years or so, various vendors, including ourselves, are developing AI systems to read and evaluate those images. And one of the challenges in AI is is bias, you know, so you have to make sure that for your population, these technologies works.

And one of the interesting things within the JVN project, with these images of eyes that we're working on, you have to... different cameras take different types of images of the retina. So some of those systems that are available on the market look at a very narrow field, a small percentage of your eye.

Our system is using, you know, ultra wide images. So you're seeing more of the back of your eye. So what can we learn about the patient's conditions and retinopathy from being able to see a wider percentage of the back of the eye? That's one example. We help, you know, other people, companies develop weight loss solutions for, you know, targeting primary care.

So how can we help impact and change patient behavior? So, you know, developing those solutions. So mobile phone is really the predominant interaction for the user, for the patient. Whether the clinician has, you know, web based application that's integrated in their EMR to bring that data together. 

A lot of what we've done over those years, I mentioned, you know, early on this idea that 20 years ago data was pretty sparse, particularly, you know, when you looked at diabetes and you were doing finger sticks, you know, people did not like. You know, still, people use finger sticks and it's, you know, not a fun experience, but now there are also continuous, you know, glucose meters, which, you know, are generating data every minute in some cases.

So you've gone from this world of sparse limited data to now just so much data you don't know what to do. And think of, of a doctor, particularly here in the U. S. where you might have 7, 10 minutes with a patient and, you know, different patients come in with a different app, with a different device. It's like, what are you supposed to do as a physician? As, you know, a nurse in that practice, a healthcare professional, you're just being overwhelmed with it. 

So it's the world of healthcare and what we work on these days, you know, where it used to be, how do we deal with limited data? It's now how do we deal with, you know, just vast amounts of data and extracting the meaningful information from that data and surfacing it to those health care professionals so that they can have a meaningful impact in that patient's life. What do they really need to be aware of? 

Tim Butara: Well, both of these examples actually lead perfectly into the final question that I have for you today, RJ, which is related to one of the hottest topics in tech today for the entire year, and maybe not just in tech, which is AI, obviously, and I'm guessing that as you mentioned with the example of the blindness prevention technology, which uses AI, and we also know that AI is much, much more capable of handling large amounts of data in the right, in the more efficient way than humans are. So I'm guessing that AI is and will continue to have a huge impact in the field of digital health. Do you agree? 

Richard "RJ" Kedziora: Oh, absolutely. 100%. It's interesting. In my personal history, when I was in college, I really thought I was going to go on and get a PhD in artificial intelligence and then I got my first job offer and went into the world of business and came back around, you know, years later now, still, you know, heavily involved in AI, and it's changed and morphed, you know, over the years, different ways of looking at it and generative AI, you know, is the big thing that everybody's talking about, sort of an inflection point in terms of technology and capabilities.

It does have its challenges. But, you know, using it today, many healthcare practitioners are starting to use it. And I think today it's around reducing the burden. You know, how do I make practicing medicine better? You know, you can use AI to summarize a medical record. As, you know, EMRs are now everywhere. You think of that patient encounter. You know, the doctor, instead of talking to the patient, is looking at the computer and trying to type in all the notes kind of thing. So are they paying as much attention to the patient as they could be? You know, maybe. But with the power of AI, now that AI can listen to the conversation and record those notes.

So now that provider, the healthcare professionals, can turn their attention more to those patients. So, yeah, there's, there's a lot of capabilities that are coming. You do have to be, you know, aware of biases in the generative AI solutions these days. The generative AI solutions, you know, exhibit what they're calling hallucinations making up data.

So you do have to be careful and aware of that, but the whole idea of AI, and you alluded to it, is based on data. It's what data are you using to train these systems? How do you make them better and improve them? And yes, generative AI has some problems and challenges, but it's really new. 

You know, you think of where, you know, the first iPhone was in the early 2000s to what we have today. That's a very short span of time. So think of what generative AI and these other systems are capable of today, but think about what they're going to be capable of 10 years from now. 

Tim Butara: Man, I can't even imagine, like I can't even imagine what they'll be capable of next year.

Richard "RJ" Kedziora: Very true. So I read a lot of science fiction, and it's one of those things that we tend to think the advancement of technology is going to be more than it really is in two years, but we tend to underestimate it where it's going to be in 10 years. So it'll definitely be interesting. 

Tim Butara: That was a very, very good point. And actually a perfect note to finish the episode on, RJ. Just before we jump up the call, if our listeners wanted to learn more about you or learn more about Estenda, where can they do that? 

Richard "RJ" Kedziora: Yeah. Our website is estenda.com, is good. And personally to connect with me, LinkedIn is always good, Richard Kedziora is always probably the best place to reach out to me.

Tim Butara: Awesome. Well, RJ, thanks again for a great conversation and have a great day. 

Richard "RJ Kedziora: You too. Thank you. Bye. 

Tim Butara: And well to our listeners, that's all for this episode. Have a great day everyone and stay safe. 

Outro:
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