Medsider: Learn from Medtech and Healthtech Founders and CEOs - How Remote Testing Can Change the Game for Patients and Clinicians: Interview with Katherine Ward of Healthy.io

Episode Date: July 9, 2020

I recently sat down with Katherine Ward, Chief Commercial Officer and managing director for Healthy.io. She has worked in healthcare for 28 years — including 15 years with the UK National Health Service and 11 years with United Health Group where she was the Chief Executive with United Health UK and Chief Growth Officer with Optimum International. In this conversation, we cover what Healthy.io does for the broader healthcare community, lessons from the COVID-19 crisis, clinical-grade population health technology, decentralized remote diagnostic screening, and how their technology works with existing health systems. Interview Highlights with Katherine WardWho is Katherine and what is her background?What is Healthy.io and what challenges or problems do they solve for patients and clinicians?Why the time finally come for decentralized remote diagnostic screening, using urine testing as an example.Lessons on the importance of virtual testing from the COVID-19 crisis.How Healthy.io has approached the regulatory and reimbursement landscapes, including their clinical trial strategy.How their population health technology works together (with and within) existing healthcare systems.Katherine’s favorite genre of books, the leader she most admires, and the advice she’d give to her younger self.See more...

The third variant of the kit measures albumin chretamine and what's called the album into creatin ratio. And this is really important test that everybody with hypertension and everybody with diabetes should be doing every year. It's an indication if you have an abnormal result that your kidney is beginning to degrade. So it's one of the first markers for understanding and identifying chronic kidney disease. So it's nationally, internationally best practice that everyone should have the test done once a year, but certainly globally, actually, you find a lot of people with diabetes and hypertension

who haven't done their test again, because it's that same aggravation of having to get a pot and go to the lab and take time out and get the test taken. And actually, again, we're enabling people to do that at home. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. On today's program, we've got Catherine Ward, chief commercial officer and managing director for Healthy.io. She's worked in healthcare for 26 years, 15 in the UK National Health Service and 11 years with United Health Group, where she was the chief executive of United Health UK and chief

growth officer for Optum International. In this interview with Catherine, here are a few of the things we discuss, why the time has finally come for decentralized remote diagnostic screening, lessons about remote care from the COVID-19 pandemic, Healthy.io's focus on clinical grade population health technology, including regulatory considerations, the reimbursement landscape, and their approach to clinical trials, how technology can work together with and within existing health systems, Catherine's favorite business book, the business leader she most admires, and the advice she'd give to herself five to ten years ago. There's a lot more we cover in this wide-ranging discussion, but I wanted to call out a few things before we get started.

First, if you're new to these Medsider interviews and want to be updated when the next one goes live, head on over to Medsider.com and enter your email address. Rest to You won't be spammed. In fact, the only time you'll hear from us is when a new conversation goes live. Again, it's super simple. Just visit medsider.com. And right there on the homepage, you'll see the opportunity to enter your email address. Second, if you continue to enjoy these interviews, please give us a rating.

In your podcast app, just open the reviews tab and click on the old five stars. Thanks again, it really helps us out. All righty, without further ado, let's get to the interview. Hey, everyone. Welcome to another episode of Medsider Radio. And on today's program, we have Catherine Ward. Catherine, welcome to the program. Appreciate you coming on.

Thank you for having me. I'm going to provide a little bit of a bio on yourself, and you can certainly fill in the gaps if I don't get everything correctly. And then we'll talk a little bit about maybe some of the points we want to touch on as part of this discussion, which I think will be very interesting because we're recording this here in the tail end of March 2020 in the kind of the, you know, sort of the apex or like at least close to it with the coronavirus or the COVID-19 challenges that most of us, you know, I imagine that are listening to this. conversation are experiencing. And what you're what you're doing with Healthy IO, I think is very,

very timely. I think it should be a fun discussion. But by way of background, Catherine, you're the chief commercial officer and managing director of the UK and Europe for Healthy I.O. And we'll certainly get into what healthy I.O. is and the problems you're solving for. But you've got a very, I mean, what appears to be a very impressive background, you know, 26 plus years of healthcare experience, 15 years in the UK National Health Service and both provider and payer roles. In 11 years with United Health Group, where you were the chief executive of United Health UK and then the chief growth officer for Optum International. So that's at least a high level overview.

But anything else you think would be valuable in terms of your background or your bio-catherine before we get started? No, it's actually now 28 years in healthcare. So it feels like a very long time and really three legs of the stool as you've just described public sector in the UK NHS and then large global multinational healthcare company in UHG and then now my move into startup. So I literally went from being employee number 456,006 at Optum to being number 23 of Healthy I.O. That's great. Such a different, a different paradigm for sure. But your experience kind of in that, in that world, I think is probably

paramount for what you're doing at Healthy I.O. So on that note, let's talk a little bit, I want to set the stage for people who are listening because we're going to get into, you know, most of this conversation is going to revolve around, you know, some of the challenges that you're solving for with Healthy I.O. But if you can help me understand maybe in a few minutes or less, what sort of the elevator pitch for Healthy IO? And, and Catherine, before you answer that, maybe it, I'm not sure if it makes sense to approach this in two different ways.

One, if I'm a patient and maybe one if I'm a healthcare provider, because you're really, you're solving challenges for both kind of segments, if you will, of the healthcare ecosystem. So can you help us get a better understanding of Healthy I.O. And the challenges and problems you're trying to solve? Sure. So Healthy IO is the first company in the world to get a CE accreditation, which is the UK equivalent of an FDA approval,

and now FDA approval for using the smartphone camera as a chemical grade diagnostic device. We're founded at five to six years ago now by Yonatana Diri, who was the chief technology officer for Jimon Perez when he was president of Israel. So Yonatan was traveling the world with the presidential delegation trying to position Israel at the forefront of genomics, of densov research, of all the big ticket items that one day are going to transform healthcare, when he realized that the biggest investment in tech is actually going into the smartphone camera. And that's because of the 8 billion selfies that are uploaded to the cloud every day, mostly my children. And that if you could take that investment into healthcare, you could get the transformation that we're all so eager to see,

happen actually happen more quickly. And you'd also get it to happen at low cost to those healthcare systems because the hardware and software is being invested in the by the tech companies and the consumers buying the device. So ultimately it ought to be good value proposition for particularly government-sponsored healthcare systems like the NHS and the UK. So with that in mind, created a first product, which was digital urine testing. That was on the basis that it's the second most common diagnostic test done on the planet. There's 200 million done in American outpatient departments across the country every year. There's 42 million done in the UK National Health Service every year. And it's also colour-based interaction. So you can actually

use the smartphone camera as your device to enable an accurate urine test to be done. So essentially it's a combination of a kit, which is a pot, a dipstick, the same dipstick that's used currently. We haven't tried to reinvent this. We're not trying to persuade clinicians to do something different at a colour board and enabled that's enabled through an app which is a chatbot on the patient's phone where essentially a chat bot talks them through the process of filling the pot, dipping the dipstick, placing on the colour board and scanning with their phone. And that then translates the combination of that colour board and dipstick into a clinical grade result, substantially equivalent to the point of care analyses in the hospital.

And that result comes in real time onto the patient's phone but also into the electronic medicine. record so the clinician can see it in real time. So that's the kind of first product family. Second product family is then take that ability to identify change in color in arbitrary light conditions with arbitrary phones into wound care. And we've created two calibrating band-aids or plasters sit either side of a leg ulcer or pressure saw and enable an accurate perimeter measurement of the wound, enable a 3D reconstruction of that wound and for tissue type to be identified through colour and a standardised image then to go into the clinical record. where often clinicians are using paper tape measures and tracing paper as their major tools in

this field at the moment. So if I take your question from a patient perspective, this enables you to bring your care close to home, particularly the urine testing can be done in the comfort of your own home. You don't have to take a sample to the lab in your handbag. You don't have to use the facilities of the restrooms in the hospital or the clinic, which are not always the nicest, certainly in the UK. And you can understand. that testing in the privacy of your own home, knowing that it's accurate and that your condition can interpret it remotely. And if you are a healthcare provider, that will enable you potentially to avoid unnecessary outpatient footfall. It will enable you to undertake remote

monitoring for rural populations. It will enable you to actually reduce the cost of delivering that healthcare in time and potentially also pick up people who's not perhaps done routine screening that involves urine testing so that you can better manage population health. So really are kind of advantages from both the patient and the provider perspective. That's super helpful background. So just at a high level, if I'm going to summarize this correctly, because I think most people are going to understand the implications for the health care system. But if I'm a patient, let's start with just the urinary testing. Instead of having to go to schedule an appointment with a practitioner or to schedule an appointment

at a diagnostic provider, you know, here in the U.S., you know, the most common are places like Quest, Diagnostics and Lab Corp, and those types of companies. Instead of having to go in person, I can do a healthy I.O. test at home through kind of a similar type of process, except I'm using my own smartphone and basically do all of this virtually in home instead of having, you know, experiencing sort of the inefficiencies of the former scenario of what I described in setting a, you know, having to set up an appointment, go to a physical location, wait on the results, etc. Does that kind of make sense? Yeah. My understanding. Yeah, and if you take it from example of, for example, a pregnant woman who,

pregnant women out there will know, you have to do a lot of urine testing during a regular pregnancy. If you have a high-risk pregnancy, so if you have hypertension or gestational diabetes, you can end up having to take a test into the lab three times a week. And that will involve doing a first-of-day sample, putting the pot in your handbag, carrying it with you into work, then you're having to take time off work or having someone else look after your kids, taking a bus. You know, there's a whole set of inconvenience related to this, as well as then having to use the facilities potentially in some of these clinics, and all of that goes away because you can basically take the test in the comfort of your own home

first in the morning, and that result will just be sitting with your clinician when you go to see them later in the day, or they can just call you up to say that everything's fine, or there's something that they want you to follow up on. It reminds me of kind of almost this move, and we're going to kind of get into this topic in more detail, but it's almost like the equivalent of talking to someone, you know, 30, 40 years ago that was, that still uses a fax machine or snail mail to communicate. And it's like there's, there's all of this technology that is being either discovered or enabled that allows for so much more efficiency across the board, regardless of the vertical. You know, and obviously we're

talking about health care, but it's amazing at how slow our systems are at adopting this type of technology, considering that kind of the major need. So before we go, much into that topic. And I know we're going to, you know, later on in the conversation, I hope to cover a little bit more about how this idea came to life and sort of the regulatory pathways that you followed there at Healthy IO and trying to navigate some of those complexities. But before we get too far into that conversation, in terms of the urine testing, and I know you talked a little bit about the wound healing technology that you guys are working on or have available, but specific to the urinary test, what sort of diagnostics does that entail? Is it for specific,

Are you looking at urinary testing for a specific condition or is there more that you can theoretically test? Like as an example, if I wanted to use Healthy IO for just general wellness as an example, you provide those sort of diagnostics or is it specific to certain conditions? So we have three versions of the urine test and each of them has a different dipstick. So this is how it's predicated. One of them has 10 parameters dipstick, which is basically multi-stick, which clinicians will be very familiar with, but essentially that measures leukocytes, nitrite, blood, protein, glucose, ketones, bilirubin, urivolenogen, specific gravity and pH. Our main use case that we're engaged in with

that kit is in maternity, which I was just describing earlier, but we also have use cases in renal and in our primary care relating to that dipstick. We have a second version that is measuring three parameters, leukocyte, nitrite and blood, which is a subset of. of the 10. And those are that kit specifically around urinary tract infection and we're very focused on uncomplicated UTI in 16 to 64 year old women where we're very engaged in retail pharmacy and engaging pharmacists and the pharmacy teams in enabling women to have rapid access to treatment and really helping them to steer away from needing to see the primary care physician and going through the whole process which certainly in the UK can be quite cumbersome

to kind of get their treatment very rapidly. The third variant of the kit measures albumin chereatinin and what's called the album into creatin ratio. And this is a really important test that everybody with hypertension and everybody with diabetes should be doing every year. It's an indication if you have an abnormal result that your kidney is beginning to degrade.

So it's one of the first markers for understanding and identifying chronic kidney disease. So it's nationally, internationally, best practice that everyone should have the test done once a year, but certainly globally, actually, you find a lot of people with diabetes and hypertension who haven't done their test again, because it's that same aggravation of having to get a pot

and go to the lab and take time out and get the test taken, and actually, again, we're enabling people to do that at home. So those are the three kind of clinical use kits. Now, in theory, the temperameter dipstick does give you a set of indications that you could look at from a wellness perspective and, you know, there's people who do ketone diets, there's people who would be looking more generally to see if there anything going amiss here

that I should be keeping an eye on. We have deliberately really steered away from that market. So when we were first set up, when the company was first set up, when we first sort of established the mission for how we want to operate, we have the option of the less regulated, direct consumer wearable fitness world,

which would have been a lot easier in terms of the regulatory pathway. But our mission was really to be embedded into the mainstream health system and actually be part of the clinical outcome that we need to get to from a, you know, as a society that we really want to kind of drive and improve health outcomes. And actually, we were a better place to do that embedded into the mainstream of healthcare than we were on the fringes of that wearable world. Now, that wellness and direct-to-consumer world is really important. And there's a lot of companies and a lot of products that are really developing in that space. And I think we'll see

over time a change in the paradigm where that becomes much more of driving force. But there's also huge and important kind of volume of activity that needs to be clinically and medically sound in order to drive the right outcomes. And we've really set our stand out to be part of that mainstream healthcare environment. So we haven't actually focused on that wellness space at the moment. That's super helpful. And thanks for kind of touching on that. I think it helps step the stage for kind of the next sort of stage of this or the next kind of part of this conversation, if you will, which is really around the broader need for kind of this concept of remote screening. And I think it's obviously very pertinent kind of in light of the current,

you know, COVID-19, you know, pandemic and challenges that we're all facing. So I'd like maybe to touch on that and get your thoughts on that, especially considering your experience and kind of the population health and coverage and reimbursement. And then we'll maybe, you know, segue into kind of the early strategies that you followed there at Healthy I.O. to navigate some of the complexities. But let's start with kind of that broader needs. So can you maybe touch on that in light of the current, you know, coronavirus-related hurdles that we're all experiencing? Yeah, sure. So as you alluded earlier, we're in an interesting position as a company that's been trying in the market for the last three years to be change managing and transforming

healthcare systems across the planet in trying to adopt technology and to try and move towards remote monitoring and diagnostics and trying to really encourage clinicians to enable this to happen. And I think anyone who's been on the journey of startup in healthcare and trying to kind of embed technology will bear the scars of how difficult that change management can be and how many stakeholders there are that you have to enable and get on board and how you have a very high bar in healthcare in terms of the research that you have to and the evidence that you have to kind of lay out and then the evidence you have to lay out for a specific pathway in a specific geography with a specific provider before people would trust that you can do things and I think one of the things

that we've seen with the advent of coronavirus and the radical transformation that's had to be kind of undertaken and I speak with more authority on the UK situation because that's where I embedded in terms of where I'm living and a lot of where my work is focused. And we've seen a radical transformation into almost every outpatient episode now taking place virtually. So suddenly where previously there was a question mark about can you safely do this whole outpatient from a remote setting, particularly where we're dealing with renal patients, for example, and there have been concerns,

could you, you know, would it be reasonable to do a urine test when that patient clearly will lead a blood test too? And suddenly the whole quality, anxiety and risk aversion

that we've seen just had to dissipate because it's more risky to bring a patient in for a blood test than it is to undertake a consultation without a blood test. But actually, if you can have a urine test, at least you've got some parameters and some markers to enable you to understand

better how that patient is doing. So although remote blood testing is not yet fully available, for example, for renal patients needing blood creatinin and potassium as a marker that might have been a barrier in the past for not doing home urine because we don't have home blood. In fact, now they'll say, actually, I'd rather have the urine test result and the patient's safe in their own home and a telephonic consultation than I would bring them in. So we're actually now seeing a lot of the barriers that we previously had coming down for people to actually say, let's just get on with this. And I do hope, let's

see that that will be a lid that's harder to put back on once patients realize that actually there are kind of safe ways to manage their care remotely that they don't have to make that journey into the hospital with their sample every time that actually there is some convenience to them as well as benefits in the short term with the safety aspects. So we've been very focused on our offer in the world of maternity, particularly in helping pregnant women to stay away from clinic. We're focused on that UTI pathway I described, urinary tract infection pathway and enabling women to be remotely testing and receiving antibiotics as appropriate, and also the support that we can give for

remote outpatient and to enable digital primary care and telemedicine to function more effectively because they are not just having the video or the telephone consult, but they've also got a diagnostic to underpin and back them up. And from what I understand about how the US is evolving too, a lot of the previous challenges around licensing on the state basis for telemedicine and some of those barriers that for a long time have been difficult to navigate for some of the kind of more startup enterprises are starting also to dissipate. So it's a very interesting time. Yeah, I mean, I completely echo your thoughts on this. And I'm sure there'll be other silver

linings, right, that come out of the, you know, some of these COVID-19 related challenges. But that's certainly one of them is that these, what I would consider, and I'm not sure if you you want to go there yet, but what I consider, like, unnecessary roadblocks to adopting some of these, whether it's technology or just adopting different processes, some of them are just entirely unnecessary, the roadblocks I'm referring to. And these current challenges have really, in kind of one swoop, have a lot, a lot of those roadblocks to kind of diminish. And we experience, you know, just anecdotally, like at Juve, we're seeing the same things. I mean, our devices are design for home use, and we are allocating more and more resources towards clinical trials.

And most of those clinical trials that we're sponsoring are virtual in nature. And we use a company, I'm going to give them a shout out, proof pilot, and really cool, a platform, technology platform that allows us to do these clinical trials virtually. And, you know, I was just having a conversation yesterday with a group around trial design for a potential study that we're going to sponsor. And it involves probably involves a little bit more of a hybrid approach. And we're kind of walking through those. And normally, I think, without these coronavirus challenges, the normal, like, predisposition to these virtual trials is kind of like, I don't know, seems kind of risky, not the norm, kind of atypical. I'm not sure exactly how we can do this. But now with the coronavirus,

it's like, you know, people are completely open to listening and doing things in a little bit a different way, a way than, in my opinion, makes more sense and it's much more efficient. But, yeah, to echo your point, I mean, we're seeing, you know, in real life, some of those larger hurdles and barriers kind of being broken down across the board, whether it's in your case, you know, enabling diagnostics virtually or in our case, you know, trying to conduct clinical trials virtually. It's kind of a similar vein, if you will. Absolutely. We had a classic example a couple of weeks ago where we've been launching a project for maternity in the UK hospital. Although we are CE accredited and our device is, you know,

good to go, we've got all the approvals we need. We've got our data protection and all of our equivalent to HIPAA, thought, everything kind of ready to go to be fully commercial, the hospital still insisted on taking a kind of IRB approach and wanting to do an evaluation before they rolled it out more comprehensively. And then they needed us to go to ethics approval for the IRB equivalent. And we've been in this process for almost nine months. I mean, literally as long as it takes to grow a baby. And they, the maternity team eventually came back two weeks ago to say all research in this, you know, across the whole of the UK NHS has been put on hold because all of the research clinicians are now being placed back on the front line

to get on with, you know, the important work of caring for people during this crisis. So they were going to have to stop the proposal. But then they said, but can we use the kits next week? Because actually we've realised we really need them in this environment. We were obviously delighted that the proposal is now moving forward and we're, we've gone life today actually, but on the other hand, slightly frustrated that for nine months we've been jumping these barriers of all the kind of the theory and the licensing and the process of an IRB equivalent to a trial when really none of that was required and it took this crisis to

unleash them to actually get into action rapidly. And we'll still, of course, evaluate how it goes and we'll be able to pull together some great evidence from the back of the project that really was a very nice lesson in how sometimes the crisis should not be wasted. No doubt, no doubt. On that note, before we kind of get into sort of maybe some of the origins of healthy I.O. and some of the challenges that you've been able to kind of navigate through, you know, in the kind of the complex healthcare ecosystem, is there anything else that you can speak to, you know, based on your pretty extensive experience with kind of the world of healthcare economics and population health, why we need to be doing more of this virtually, you know, whether it's

diagnostics, whether it's clinical trials or certain clinical trials and all can be done virtually, of course. But anything else that you think is worth touching on for those listening that may be still kind of skeptical of some of these newer approaches? Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadiaire, CEO of CVRX, and so many others.

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