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.

Scott Nelson: Hey everyone welcome to another episode of Medsider Radio and on today's program, we have Katherine Ward. Katherine, welcome to the program. Appreciate you coming on.

Katherine Ward: Thank you for having me.

Scott Nelson:  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 sort of the apex or at least close to it with the Coronaviruses, the COVID-19 challenges that were that most of us, I imagine, that are listening to this conversation are experiencing. 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, Katherine, you're the Chief Commercial Officer and Managing Director of the UK Europe for Healthy.io. We'll certainly get into what Healthy.io is and the problems you're solving for. But you've got what appears to be a very impressive background of 26 six-plus years of health care experience, 15 years in the UK National Health Service in both provider and payer roles and 11 years with United Health Group, where you were the Chief Executive of United Health UK and then the Chief Growth Officer for Optimum International. So, that's at least a high-level overview. But anything else that you think would be valuable in terms of your background or your bio, Katherine, before we get started?

Katherine Ward: No, it's now 28years in health care, so I feel like a very long time and three legs of the stool, as you've just described, the public sector in the UK and then large global multi-national health care company in UHC and then now my move into startups. So, I went from being employee number 456,006 at Optimum to being number 23 at Healthy.io.

Scott Nelson: That's great. That's a different paradigm for sure. But your experience kind of in that world, I think is probably paramount for what you're doing at healthy.io. 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. Most of this conversation is going to revolve around some of the challenges that you're solving for with Healthy.io but if you can help me understand maybe in a few minutes or less, what's sort of the elevator pitch for healthy.io? Katherine, before you answer that, maybe 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 health care provider because you're solving challenges for both kinds of segments if you will of the health care ecosystem. So, can you help us get a better understanding of Healthy.io and the challenges and problems you're trying to solve?

Katherine Ward: 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 clinical great diagnostic device. We're founded five/six years ago now by Yonatan Adiri who was the Chief Technology Officer for Shimon Peres when he was President of Israel. Yonatan was traveling the world with the presidential delegation, trying to position Israel at the forefront of genomics, of stem cell research, of all the big-ticket items that one day they're going to transform health care when he realized that the biggest investment in tech is going into the smartphone camera. That's because of the eight billion selfies that are uploaded to the cloud every day, mostly by children.

If you could take that investment into health care, you could get the transformation that we're all so eager to see happen more quickly, and you'd also get it to happen at low cost to those health care systems because the hardware and software are being invested in by the tech companies and the consumers buying the device. So, ultimately it ought to be a good value proposition for, particularly government-sponsored health care systems like the NHS in the UK. So, with that in mind, he 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 are 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 color based interaction. So, you can 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 and a color board that's enabled through an app which is a chatbot on the patient's phone, where essentially a chatbot talks and through the process of filling the pot, dipping the dipstick, placing on the color board, and scanning with their phone. That then translates the combination of that color board or a dipstick into a clinical great result, substantially equivalent to the point of care analysis and the hospital and that result comes in real-time onto the patient's phone but also into the electronic medical records so the clinician can see it in real-time. 

So, that's the kind of first product family. The second product family is then taking that ability to identify a change in color, in arbitrary light conditions with arbitrary phones into wound care. We've created two calibrating Band-Aid bill plasters to sit on either side of the leg or pressure sore and enable and accurate perimeter measurement of the wound and do a 3D reconstruction of that wound and the tissue type to be identified through color and the standardized image then to go into the clinical record, where often clinicians are using paper tape measures and tracing paper as their major tools in the 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 undertake that testing in the privacy of your own home, knowing that it's accurate and that your clinician can interpret it remotely. 

If you are a health care provider that will enable you potentially to avoid unnecessary outpatient footfall. It will enable you to undertake remote monitoring for rural populations to enable you to reduce the cost of delivering that health care in time and potentially also pick up people who are not perhaps doing routine screening that involves urine testing so that you can better manage population health. So, kind of advantages from both the patient and the provider perspective.

Scott Nelson: 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 discuss an appointment at a diagnostic provider here in the US. The most common are places like Quest Diagnostics and LabCorp and those types of companies. Instead of having to go in person, I can do a Healthy.io test at home through kind of a similar type of process except I'm using my smartphone and do all of this virtually in the home instead of experiencing sort of the inefficiencies of the former scenario of what I described and having to set up an appointment, go to a physical location, wait on the results, etc. Does that kind of make sense? My understanding of that.

Katherine Ward: Yeah. And if you take it from the 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 test that they sample putting the pot in your handbag, carrying it with you into work. That you're having to take time off work or having someone else look after your kids, taking a bath. 

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. All of that goes away because you can take the test in the comfort of your own home first thing in the morning. 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 that there's something that they want to follow up on.

Scott Nelson:  It reminds me of kind of almost this movie and we're going to kind of get into this in this topic in more detail, but it's almost like the equivalent of talking to someone 30, 40 years ago that still uses a fax machine or snail mail to communicate. It's like 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. We're talking about health care, but it's amazing at how slow our systems are at adopting this type of technology, considering the major needs.

So, before we go too much into that topic and I know we're going to 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 follow 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? Are you looking at urinary testing for a specific condition or is there more that you can theoretically test? As an example, if I wanted to use Healthy.io for just general wellness as an example. Do you provide those sorts of diagnostics or is it specific to certain conditions? 

Katherine Ward: 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, basically a multi-stack which clinicians will be very familiar with, but essentially that measures leukocytes, nitrites, blood protein, glucose ketones, bilirubin, urobilinogen, 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 cases in renal and in primary care relating to that dipstick. 

We have a second version that is measuring three parameters, leukocytes, nitrites, and blood, which is the subset of the 10, and that stick is specifically around urinary tract infection. 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, the pharmacy teams, and enabling women to have rapid access to treatment and helping them to steer away from needing to see the primary care physician going through the whole process which certainly in the UK can be quite cumbersome to kind of get the treatment very rapidly.

The third variant of the kit measures albumin creatinine and what's called the albumin creatinine ratio. This is an important test for 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, a best practice that everyone should have to test done once a year. But certainly, globally 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. Again, we're enabling people to do that at home. 

So, those are the three kinds of clinical use kits. Now, in theory, the 10 parameter dipstick does give you a set of indications that you could look at from a wellness perspective and, you know, just people who do Ketone diet, people who would be looking more generally to see is there anything going on this here that I should be keeping an eye on. We have deliberately steered away from that market. So, when the company was set up, when we first sought to establish 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. 

Our mission was to be embedded into the mainstream health system and be part of the clinical outcome that we need to get to from, you know, as a society, that we want to kind of drive and improve health outcomes. We're in a better place to do that embedded into the mainstream of health care than we were on the fringes of that wearable world. Now that wellness and direct consumer world are important and there's a lot of companies and a lot of products that are developing in that space. I think we'll see over time a change in the paradigm where that becomes much more of a driving force. But there's also huge and important kind of volume of activity that needs to be clinically and medically sound to drive the right outcomes and we've set our standard to be part of that mainstream healthcare environment. So, we haven't focused on that wellness space at the moment. 

Scott Nelson: That's super helpful and thanks for kind of touching on that. I think it helps set the stage for kind of the next stage of this or the next kind of part of this conversation if you will, which is around the broader need for kind of this concept of remote screening and I think it's very pertinent kind of in light of the current COVID-19 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 in kind of the population health coverage and reimbursement and then we'll maybe, you know, segue into the early strategies that you followed at Healthy.io to navigate some of the complexities. Let's start with kind of a broader need. So, can you maybe touch on that in light of the current Coronavirus related hurdles that we're all experiencing? 

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

I think one of the things that we've seen with the advent of coronavirus and the radical transformation that has had to be kind of undertaken and I speak with more authority on the UK situation because that's where I am in bed with in terms of where I'm living and a lot of where my work is focused. We've seen a radical transformation into almost every outpatient episode now taking place virtually to suddenly where previously there was a question mark about how can you safely do this whole outpatient from a remote setting, particularly where we're dealing with renal patients, for example. There've been concerns would it be reasonable to do a urine test when that patient clearly will need a blood test, too? 

Suddenly the whole quality, anxiety, and risk aversion that we've seen just had to dissipate because it's riskier to bring a patient in for a blood test than it is to undertake a consultation without a blood test. 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, though remote blood testing is not yet fully available, for example, for renal patients needing blood, creatinine, and potassium as a marker that might have been a barrier in the past and not doing home urine because we don't have home blood. Now they'll say, I'd rather have the urine test result and the patient safe in their own home and a telephonic consultation than I would bring them in. 

So, we're now seeing a lot of the barriers that we previously had coming down for people to say, let's just get on with this. I do hope let's see that will be a lid that's harder to put back on once patients realize that there is 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 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 that offer in the world of maternity, particularly in helping pregnant women to stay away from the clinic.

We're focused on that UTI pathway. I described the urinary tract infection pathway and enabling women to be remotely testing and receiving antibiotics as appropriate. Also, the support that we can give for outpatients 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. 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 start-up enterprises are starting also to dissipate. So, it's a very interesting time. 

Scott Nelson: Yeah, I mean, I completely echo your thoughts on this and I'm sure there'll be other silver linings that come out of 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 want to go there yet, but I would consider 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 in one swoop have a lot of those roadblocks to kind of diminish. We experience just anecdotally like at Joovv; we're seeing the same things. I mean, our devices are designed 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 and we use a company. 

I'm going to give them a shout out, ProofPilot, and a cool technology platform that allows us to do this in these clinical trials virtually. I was just having a conversation yesterday with a group around trial design for a potential study that we're going to sponsor. It probably involves a little bit more of a hybrid approach. We're kind of walking through those and normally, I think without these Coronavirus challenges, the normal, like a predisposition to these personal 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 people are completely open to listening and doing things and a little bit of a different way, a way that in my opinion makes more sense and it's much more efficient. But yeah, to echo your point, I mean, we're seeing in real life some of those larger hurdles and barriers 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. 

Katherine Ward: Absolutely. We had the classic example a couple of weeks ago where we've been launching a project for mortality in the UK hospital. Although we are accredited, and our device is good to go. We've got all the approvals we need. We've got our data protection and all of our equivalent HIPAA sorted everything kind of ready to go to be fully commercial. The hospital still insisted on taking an ILB approach and wanting to do an evaluation before they rolled it out more comprehensively than they needed us to go to ethics approval for the ILB equivalent.

We've been in this process for almost nine months. I mean, literally, as long as it takes to grow a baby and the maternity teams came back two weeks ago to say all research in this 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 the important work of caring for people during this crisis. So, they were going to have to stop the proposal. But then they said, can we use the kits next week? Because we've realized we need in this environment. We were delighted that the proposal is now moving forward. 

We're gone live today, but on the other hand, slightly frustrated that for nine months we've been jumping these barriers of all the theory and the licensing and the process of an ILB equivalent to a trial when none of that was required. It took this crisis to unleash them, to get into action rapidly. 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. But it was a very nice lesson on how sometimes the crisis should not be wasted. 

Scott Nelson: No doubt. No doubt. On that note, before we kind of get into maybe some of the origins of Healthy.io and some of the challenges that you've been able to kind of navigate through in the complex health care ecosystem. Is there anything else that you can speak to, based on your pretty extensive experience with kind of the world of health care economics and population health? Why do we need to be doing more of this virtually whether it's diagnostics, whether it's clinical trials? There are certain clinical trials now that can be done virtually, of course. But anything else that you think is worth touching on for those listening to that maybe still kind of skeptical of some of these newer approaches?

Katherine Ward: Yeah, I think I've got a great example here which I briefly just spoke earlier about that I think has got good with US and UK points to this one where I mentioned earlier that everybody with diabetes and hypertension ought to have a urine test once a year to test for their protein in the urine and give an indication of their kidney function. We know that in the UK, between 50 and 60% of people with diabetes do the test. Only about 30% of people with hypertension. In the US, the figures are considerably lower. 

So, we took a group of patients who had not done the tests for 12 months. So, they were by definition, in-adherent to the current testing processes. We did this in Yorkshire in England, and we did this with Geisinger in the US, and in the UK we took people with diabetes who hadn't done the tests. In the US we took people with hypertension who hadn't done that test. We essentially reached out to those people telephonically. We asked them to consent to the project. We engaged them with the fact that they haven't done their kidney test, but that the test would be coming to them. We sent them an SMS message while they were on the phone that allowed them to download the app onto their phone and ensure that we knew that they got a phone, that they understood that it was a kidney test and that they were signed up.

We sent them a kit through the post, so they got it the next morning. They did the test and the results went in real-time into their physicians' electronic medical records. In the UK we went from zero adherence on the population to 72% of the consenting population did their test and in the US it was 71%. So, very similar results in two very different healthcare systems. But essentially in both cohorts in the UK we found 11% of that population who have proteinuria meaning they have the first sign of kidney degradation. In the US, it was 10% and those patients are people who would otherwise have gone then to three or four years potentially and not been picked up as having that early-stage kidney problem until they became symptomatic, at which point they stage four or five for kidney disease, meaning they were well on the road towards dialysis end-stage renal disease. 

So, if you think about that from a patient perspective of unknowingly having chronic kidney disease and we know there's a missing million in the US who have chronic kidney disease and don't know. The missing million in the UK, sorry. There are 37 million people in the US who have chronic kidney disease and don't know. If you think about it from a physician's perspective where you're dealing with somebody who otherwise might not have been engaging with you until you had to then deal with them as a very complex patient. But if you're thinking about it from a payer or population health perspective there are huge costs to that end-stage renal disease trajectory.

Just on the health economic evaluation, we did in the UK population, they extrapolated if we were to repeat the uptake that we'd had in that population up in Yorkshire and translated that into 1.4 million people in the UK who have diabetes and haven't done the test, we could save 209 million pounds for the NHS just in five years for the diabetic population alone. If we added the population with hypertension it would be 660 million pounds of savings. So, you've got a huge kind of case study here of a test that is relatively easy to do but, patients don't like doing it. 

They don't get engaged in doing it, but if you can then translate that into a digital approach where they don't have to leave the house it's very simple, very intuitive. It doesn't interrupt. The clinicians see the result of the workflow so it's not putting more work burden on the physicians. You've just speeded up the access to health care, but most importantly, improved both morbidity and mortality and essentially health care costs. So, I think that's a    great example of why digital is important. 

Scott Nelson: That's such a great overview. So, thanks for touching on that because I think to your point, this is all about especially for some of these chronic conditions, it's all about prevention. If we can help prevent some of these chronic conditions even at various stages, there's such a massive cost saving to the broader system. So, that's very helpful. So, on that note, I'd like to spend a little bit more time with what we have left covering some of the hurdles at healthy.io that you've been able to navigate through with Healthy.io. 

I think you the fact that you touched on this earlier Katherine and the fact that you have pursued it's been the vision to sort of embed Healthy.io in the mainstream health care ecosystem versus kind of taking a more general wellness approach. Let's talk a little bit about you’re the regulatory pathway because the pitch, you're trying to get practitioners health care systems involved and getting system-wide in buy-in that this is a feasible approach. So, let's talk a little bit about the regulatory constraints and what you've been through to date. So, can you speak to some of the bigger or larger, I should say, regulatory hurdles that you've been able to cross in kind of the early years of Healthy.io and maybe even what you're experiencing today?

Katherine Ward: So, we have a CE approval which is the UK and European equivalent to FDA approval for all of our urine tests and wound care products. We have two, 510 K's in the US. We have plus 2 FDA clearance as a medical device and we have another hurdle in the US that we're still engaged on crossing, which I'll talk about in a second, and then we're partway through the approvals process in Japan at the moment. So, we've got an experience of regulatory hurdles across the globe. I'd say there have been some interesting parts of that journey. So, one has been usability, which has been very interesting. 

In the early days of the company the approach to how do we ensure that a user appropriately uses the test and gets the results that they need to get. So, we've got kind of two major areas where we have proof points for regulatory assurance. One is, you know, does the kit work and does the result that's clinically driven by the combination of the kit and the app match the point of care automated analyzer. Is it an accurate and clinically appropriate kind of result. But also, can a consumer in their home use the kit appropriately to engender that result? So, how easy is it to use as well as is accurate? 

So, the first clinical trial that the team undertook was a failure. This was because my jokes about this not being one myself, but because they are a bunch of Millennials, they created a YouTube video that you could watch and then do which was the mindset and mantra of that generation as to how you learn and on board with something new but immediately lost everybody over 65, failed the first clinical trial and then had to go back to redesign the app to become very intuitive. So, it is a chatbot as I mentioned earlier. She talks you through undertaking the test but it's a combination of spoken word, text message, and video so, every step that you take through the process. She asks you, for example, to unbox the kit and check that all the parts are there and then you press the button to say that you've understood that. 

Then you move onto you take out the dipstick and you unwrap it, but you don’t dip it yet and then you press the button to say that you've done this. She then will ask you to fill the pot and then to dip and then she times you to make sure that you don't take a reading that's too early and get a false negative or reading that's too late and get a false positive. She then shows you very carefully how to place the dipstick on the color board and how to take the scan with your phone.

So, we now have a 99.5% usability rating across 18 to eight-year-olds because of how intrusive it is. But it was that first approach to the regulator that revealed how we had to do things differently and enabled us to get through that hurdle. The other thing to say with the FDA is that we've not been able to go all in one go to say, here's the phone that becomes a class two medical device for interpreting urine dipsticks and it can be used by the consumer and you can use it on every phone. So, all of those different elements had to be broken down into a step by step approach with the FDA that enabled us to set a predicate and then to move on. 

So, we anticipate that we'll have clearance for all phones. We've got clearance for one type of phone at the moment by the end of the year but it's been a process of taking it to step by step with the FDA and engaging and communicating and building our credibility with them on the way because we came right on the tail of the whole [32:52 inaudible] scandal in the US and had to, I think, probably work twice as hard to ensure that we were not deemed to be in the same sort of world that they operated in and that everything we set out was clinically provable and appropriate.

I feel like the quality assurance team is quite a team of them now, right at the forefront of understanding how you navigate and ensure quality and quality assurance and they're honestly amazing. We had our auditor in a couple of weeks go for the annual audit for our CE accreditation and were deemed to have no nonconformity, zero nonconformity, not even any minor ones, which I've never in all my years come across that level of quality and kind of commitment to that quality process. So, that's been an interesting journey on our way. 

Scott Nelson: That's super helpful and I think that there's a couple of things that stand out to me in listening to kind of you explain some of those regulatory hurdles that you've been able to cross is one on the usability front. I mean, I can completely understand sort of the rationale, especially if there's a younger team that's working on that. That would kind of presume yes, this is straightforward. Everyone understands this. But I think hearing you explain that it just makes me realize all the more that it pays off to empathize with the end-user across a wide variety of demographics, to empathize as much as possible. 

It just reminds me of a conversation that I had recently in a similar sort of similar vein when we were talking about inclusion, exclusion criteria for a clinical trial. It was within the context of trying to do these virtual clinical trials. The guy that was helping us begin to put more thought to this was like she mentioned, you know, what if someone doesn't have a mobile phone. I just thought, well, that's a    good point. There's still probably a segment of people, especially the older demographic, 70 years plus-ish, something like that, very well may not have access to a mobile phone. So, in that scenario, what do they want to do? How do they enroll in the trial? It was just a    good point and I just thought of that as you were kind of explaining the usability challenges that you had to solve for early on. Then your comment with respect to communicating with FDA and I know you're based in the UK and FDA is very obviously US-specific, but this idea of like communicating early and often know. I've heard so many other people and I know I don't want to go too far into the weeds to make this a regulatory conversation, but I presume the other regulatory experts comment on that very same thing.

I recently listened to an interview with, and her name is escaping me, the founder of 23andMe and she mentioned that that was kind of the inflection point that they experienced in terms of trying to make some progress on the regulatory front with their genetic testing was making a concerted effort to proactively communicate with the FDA and treat them almost like a very key stakeholder or customer that they need to serve and be aligned with. Your comments seem like they bring those previous experiences or conversations to light for sure. 

On that note, I know we're getting a little bit of short on time here, Katherine and I want to be I want to ask you some more fun, entertaining questions here to conclude the interview, but Healthy.io, you've been able to sponsor clinical trials. So, can you speak to the approach to this? Most of us listening to this conversation understand that typically clinical trials can be very expensive, are needed for sure, especially if you've got a technology that, to your point, is sort of you're embedding yourself in the more mainstream traditional health care ecosystem. But clinical trials can be tough. They can be resource constraining, expensive, etc.. So, can you maybe speak a little bit to how you, and I know you're not the default, you're not leading all clinical trial strategy there at Healthy.io but maybe can you speak to the general approach there?

Katherine Ward: Sure. So, I think we've touched on already the sort of critical trials that we've been through for the FDA approval process. But I think what's been just as important for us in establishing credibility within the healthcare environment has been the health economics study that we did in the U.K. with York Health Economics Consortium. The usability study we did with pregnant women with Johns Hopkins in Baltimore. The randomized controlled trial we've done with Geisinger on the hypertension model for people with chronic kidney disease that I described, those have been on the back of clinical relationships that we built with champions who've wanted to use the product but also to use it to further their area of interest or study.

So, we've been fortunate in meeting some very eminent and interesting clinicians on our journey. Professor Joe Coresh, for example, who's the Professor of Epidemiology at Johns Hopkins at the Bloomberg School of Epidemiology and Public Health. He's been key in supporting what we're discussing for example and engaging in that study process. So, rather than kind of funding large scale clinical trials, we've tended to back in through our relationships with clinicians and health systems into work that they wanted to do. We've had the joint bid for the funding.

We've been a party that supported a funding bid that somebody else has made. For example, were involved at the moment in a large population health study in the Netherlands with Professor Ganzevoort at the University of Groningen. He ran the clinical trial back in 2006 where they were engaging the general population in screening for kidney disease. At that point, they were mailing a dipstick in an envelope out to the population to see whether they could get a good uptake in population screening that way. They ended up with a large number of false positives because it's quite hard for people to do urine dipstick on their own without full instruction and all of the ways that help you to kind of stay on the appropriate route to doing that. 

So, we ended up when Professor Ganzevoort saw the kit and saw that he could potentially replicate the study from 2006, but this time using a and accredited device that would enable accurate results to be coming in from the population, he jumped at the chance. He has now bid for the funding. The funding is coming from the Dutch government and the National Kidney Foundation in the Netherlands and we're part of that trial but it's not us leading it. It’s not us funding it. The kits are funded as part of the trial and that's been our approach to ensuring that we are everyday building that evidence base and that credibility in that research, kind of real-world studies and health economic studies about how we're operating, but not being the lead investigator ourselves and not, therefore, having to kind of make those huge investments in the clinical trial space that I know a lot of other devices and diagnostics companies had to do. 

Scott Nelson: Yeah, that's super interesting and maybe for those listening that have a deep background in clinical trial strategy, it's kind of obvious. But I love the approach of leveraging a lot of maybe the inbound interest for lack of a better description and your physicians as researcher champions and letting them lead the way. It's my understanding of how you describe that which certainly seems like you'd be able to free up a lot of resources especially if grants are being awarded that can help cover some of those costs. So, that's an interesting approach.

Katherine Ward: Yes, but when it comes to risk, of course, because you're not in control if the findings are not in your favor, I think we're confident enough about our usability and our accuracy and the way that the product works to be quite comfortable with our approach.

Scott Nelson: This has been a super fascinating conversation. I mean, maybe I'm a little bit biased because I love companies like healthy.io that are blazing some trails when it comes to trying to do things not only more efficiently but working within the virtual context. So, super interesting conversation and Katherine we'll maybe finish off the discussion here with a few I like to call it rapid-fire questions, not necessarily rapid.

Your answers don't necessarily have to be rapid-fire, but they're a little bit more fun and entertaining questions. So, on that note, is there, we'll conclude the chat here with these last three questions. But the first one is, is there a business book that stands out that you value or that's been super helpful in your professional career?

Katherine Ward: Do you know, I    don't read business books. I'm a big reader. So, when I go on holiday, I will take 40 novels and literally read one a day. I know that you in the US don't have holidays quite in the same way that we do in the UK. In the UK we take two weeks and we cut off completely and we try and power up our brains with different things. I will read quite happily 14 novels in a two-week space, but not so much the business books.

Scott Nelson: I love that answer. So, on that note is that you typically read, I mean, novels. Is it fiction, non-fiction, maybe a little bit of both?

Katherine Ward: A bit of both. Yep.

Scott Nelson: Okay, great. I love the idea of kind of resetting, repowering. To your point, it seems like it's a little bit harder to do that here in the US. We're not used to kind of taking those longer breaks but probably should be more proactive about doing that for sure.

Katherine Ward: I spent a lot of time in my United Health Group days trying to persuade American executives of the value of vacation, but I'm not sure

Scott Nelson: You're maybe up against the wall when it comes to that for sure. But the next question I've got for you. Is there a leader, a mentor that's been very impactful across your career in various organizations? 

Katherine Ward: Yes, always lots. So, I had a tremendous experience at United Health Group. It was a sort of advantage and a disadvantage at the time that I had a lot of different bosses in the course of my 11-year career. Sometimes people who joined the company through acquisition, sometimes people who were caretaking the international business. It was always a kind of potential, I guess, that the company was trying to evaluate its very large and extensive portfolio inside the U.S. versus what opportunities were global. But I had tremendous opportunities to engage with very senior executives throughout that time. Quite often we were able to punch above our weight in terms of the scale of our international business with the kind of executives that we were engaged with within UHG. So, I won't call out any particular by name. Several of them will know who they are but there's a lot of amazing people that I engaged with while I was there. 

Scott Nelson: The last question I have for you. Is there a piece or maybe there are multiple pieces of advice that you give to your 25 or your 30-year-old self?

Katherine Ward: Not to close any doors. So, I think I've been relatively unusual in having a 15-year career inside the public sector. Most government employees certainly in the UK environment would stick within a government space, usually for their whole career. I felt very smug when I transitioned out that I was able to manage the transition into a large for-profit American corporate, which is probably about as different an environment as I could have found myself in. But I did find myself 11 years later that I'd possibly become institutionalized in the second large institution of my career.

So, you kind of expect me institutionalized in a large government corporation but when you then move into a large private sector world I wasn't probably alive to the risk as I should have been and now I've moved a third time into a startup environment which is very different. Again, I think I would counsel my 25-year-old self not to become institutionalized and to always have your mind open to the next opportunity. So, I'm glad I've made this transition now into this new startup world.

But I think for a lot of people, there's a risk that you become, you know, successful and comfortable in the area that you're working and perhaps close down some of those opportunities that might be there. So, I'm pleased that I've made that transition over time.  I would look back and make myself aware, probably more aware of than I had been at the time. 

Scott Nelson: That's great stuff. It reminds me of some of the advice that Erica Rogers who is the CEO of Silk Road Medical, which is fast growing. They recently IPO'd, a successful medtech company here and here in the US. But she mentioned this concept of like, you know, kind of have a graceful exit keeping those doors open in the process. So, I think that certainly is some great advice. So, on that note, can't thank you enough, Katherine, for coming on the program.