Episode 1: Transforming Diabetes Care through Personalization and Innovation with Lisa Huse

“Even if a technology solves a significant problem, it won't succeed unless there's a clear economic pathway and someone willing to pay for it.” - Lisa Huse

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Episode Spotlight: Innovative Diagnostics and Economic Challenges

BRADLEY: Welcome to Boombostic Health, where we challenge the business of healthcare and explore bold ideas that drive meaningful change. Each week we bring you candid conversations with top experts, innovators and leaders exploring the latest trends and technologies shaping the future of healthcare. Join us and be part of the conversation in transforming healthcare.

Unveiling the Economics of Innovation

BRADLEY: Hey folks, welcome to Boombostic Health. I'm Bradley Bostic with my guest here, Lisa Huse. In Boombostic Health, we'll cover innovations and bold moves that are being made by bold healthcare leaders in the healthcare industry.?

And today our topic is about innovative diagnostics and how we can make it so the economics are there to support these innovative approaches because without it, they'll go out of business. So Lisa, welcome to the show.

LISA: Thanks for having me.

BRADLEY: Absolutely. Lisa's background, she's had a great career in healthcare and she's really just getting started launching new innovative companies. She was with Roche, I think all over the world and has been in the business of aligning the economics of the healthcare system with different diagnostics. And it's not an easy job to do, but it's one that I think you have great passion for. And Lisa is now in the venture studio world where she's launching new companies with the Boomerang Ventures Group out of Indianapolis.

As we get into the topic here, Lisa would love to hear just a little bit more about, you know, for our audience, the things that you've done in your career so far before we dive into what you're doing right now and how that relates to this whole paradox of you've got amazing innovation that's out there, but not necessarily any way to support it financially. Introduce yourself and talk a little bit more about your background.

The Art of Behavioral Change in Diabetes

LISA: Yeah, you bet. I've spent over 25 years in healthcare, always on the commercial side trying to extract value from different innovations. Started with Roche working in diabetes care. So the metabolic world across blood glucose monitoring, insulin pump therapy, continuous glucose monitoring, both in the US and Europe.

After working on different innovative models, even trying to launch them within a big multinational company, after leaving that organization, I went on to work for a precision medicine software startup. As you mentioned, I recently transitioned into working on other ways to prop up new innovations coming out of universities, founders, or other entities who have found a problem in healthcare.?

Now they're trying to figure out if that problem in healthcare has a license to hunt. We go through a very rigorous process going through everything from regulatory to reimbursement, to commercial model, trying to find ways for startup technology to flourish in the existing healthcare environment. I am very passionate about helping new technology find its way and spending a lot of time in artificial intelligence as well.

BRADLEY: That's awesome. When you were at Roche and you were in the diabetes world, that would have been during the period where it went from a pretty onerous approach to having to keep track of how you were doing with your blood glucose levels to more like remote monitoring, that sort of thing.

LISA: You had disparate pieces and parts where you might have one diagnostic product that didn't talk to the therapeutic product, or you had an app that was trying to be an intermediary between. A lot of those worlds were coming together. Different companies finding new and novel care pathways. A lot of services were emerging as well because we all know diabetes in many situations is a behavioral disease.?

You have to change everything from your exercise to what you eat to how you operate your life. I was working on some novel business models within our own organization to find new service models to help people adapt their behaviors. There were a lot of converging topics that were hardware-based, software-based, and service-based across all three of those.

The Power of Personalization

BRADLEY: Did you find a recipe that successfully got people to change their behavior? Because isn't it like medication is the answer?

LISA: No, not in diabetes. Definitely not in diabetes.

BRADLEY: I was being facetious. But I mean, it is hard, you have to work out and do different things. In the diabetes world, what were the constellation of things that you did to make it so people actually changed their behavior?

LISA: Yes, there was no one answer. It was about personalization and helping people find their own version of what good looked like, enabling both the healthcare professional side and people at home. I think that's another trend that as we're living in 2024 and beyond, personalization and care at home and evolving your own way of caring for yourself and engaging the healthcare community that surrounds you, that's really becoming more and more important.

Back then, we were trying to experiment. We were doing a lot of experimentation with motivational interviewing, helping people uncover even within themselves what was important to them.

The Intersection of Passion and Economics

BRADLEY: Almost like psychology, like they were trying to get into what their psychology was.

LISA: Yes. Trying to get into kind of inner motivations and helping people find their own behavioral nuances that they felt were realistic and something they could accomplish. Because when you oftentimes engage in the world of diabetes, you feel like you have to reinvent everything you do. Okay. I can't eat anything I want to eat. I can't operate the way that I want to. I have no flexibility. But in reality, if you try to change anyone's behavior that much, they will never do it. None of us would ever do that.

BRADLEY: It becomes...incentive drives behavior. What's the incentive? We talk a lot about economics here where if there's no margin, there's no mission. Was there an economic incentive for the individual patient that was diabetic somehow? If you make these changes, then your health care premium will cost less or...

LISA: No. At that point in time, when I was working on some of these models, it was all about what was important to them personally. It was not about the economics, it was about walking your daughter down the aisle. It was about seeing something happen in your future that was important to you.

Navigating the Chasm of Innovation

BRADLEY: What's your motivation, in terms of your lifestyle, your goals? Interesting. Well, ultimately the diabetes space obviously is understood by the healthcare establishment and it gets paid for, right? And so when you were with Roche, you were dealing with the diagnostic and all this monitoring that was in this known world of, we've got to manage this and monitor it, otherwise people have very expensive, problematic outcomes.

LISA: Often those pieces were reimbursed, insulin pump therapy, not for everyone, but you know.

BRADLEY: So insurance is paying for that somehow. You fast forward into this next stop along your journey after you departed Roche after a really successful career there to get into the software side of healthcare and hey, you've got the cloud, you've got AI, you've got all these brilliant people that can transform the way healthcare gets delivered. I think you learned through that journey that there is sort of a gap, you know, a chasm really between what could be possible and how that can be paid for. Can you talk a little bit about that?

LISA: Yes. Working within startups and also working for founders who are trying to find their way with the economics of healthcare, I think oftentimes you get very enamored and passionate about your technology. You found a problem, you get passionate about your technology and you find-

BRADLEY: You fall in love with your idea.

LISA: That's it. You fall in love with your idea and you believe that your love of the idea.

BRADLEY: I've never done that before.

LISA: I can't imagine you have.

BRADLEY: Okay, sorry. You think your love of the idea though, that it makes sense to you, so it's going to make sense to everybody else.

LISA: And you'll be able to convey that love and that love and the solving of the problem in and of itself will command a fee. What the realities of healthcare say is it's a series of trade-offs. It's a zero-sum game.?

Within healthcare, you have to find the economic pathway that will unlock the potential of that product because you may wish that you've solved a problem or that you've keyed in on something that clinicians really want. If there is not someone who is willing to or motivated to pay for it, it won't be successful.

I've seen this in multiple examples over the past few years as I've been working with startups and working with new technologies and working especially in the AI space, which is a whole new world where people look at it and see the promise and want to do something with it, but they find themselves looking at that saying, well, where do I find the money to pay for this? If I can't make money from it, then perhaps it's not, it doesn't have a future.

I talked to one healthcare system working on a technology I'm working on. He said, you know, the clinicians would love this. It would solve a real problem for us. If I can't make money from it, it has no place in my healthcare system.

The Complex Web of Economic Buyers

BRADLEY: Right. Yeah. You have this combination of if there's no improvement to the bottom line, then it won't get adopted. But then it's also the change management part about getting clinicians to actually adopt whatever this new thing is.?

What is the recipe that you've seen? Also, I think before you get to that, what are the ways that these different either diagnostics or therapeutics can be paid for? Because like we talked about earlier, it's not just insurance companies.?

There are other models outside of that. Maybe just give a little bit of a lay of the land there, because I think that'll help set the foundation for talking about some of the companies that you're actually working on now.

LISA: When we're talking about economic buyers, there are so many potential economic buyers. You have, of course, insurance, and that's where people go initially. There are employers. Employers have motivation for their employee base.?

You have the healthcare systems themselves, big entities or small. You have clinicians who, as business owners, could be motivated. And of course, we as consumers, as patients, or as caregivers, have a set of motivations.

Each and every one of those can have a different set of motivations, and oftentimes, they're in complete conflict with one another, whereas a clinician might want to have access to a certain kind of technology. If the health system they work for doesn't see the ROI, they don't want to pay for it or a patient wants something desperately to make their life easier. If that's seen as a convenience by the insurance company, they don't want to pay for it. So there's a lot of conflict.

The Battle for Reimbursement

BRADLEY: Let me try to provide an example of that, the last thing you said. In my career of 20 plus years, it's been more than that. Once you get to 20 years, you just stick at 20 plus. I was involved with a company in the genomics space that was going after this problem of switching errors in biopsies.

It's pretty startling when you find that some solid single digit percentage of all biopsies that are performed that are going to render some kind of a really impactful diagnosis are either the specimen is contaminated, or it's switched at the lab. So you're getting a diagnosis that says, for example, you have prostate cancer, but actually the tissue that that test was done on isn't even your tissue.

At the DNA level, you can determine that you definitely have the right tissue that's getting a biopsy. This particular company, which was called KNOW Error, was providing this diagnostic where they would take a specimen from the patient and run the DNA analysis on that. There was DNA analysis done on the actual biopsy, and then they would match so that it would say, this is absolutely your tissue because at the DNA level, it matches.

It was getting paid for by insurance as a diagnostic that enabled an accurate diagnosis. Ultimately, one of the Medicare regional contractors decided, we just think that's quality assurance. We don't think that's necessary and sort of completely disregarded the $30 million settlement for the person who had a radical mastectomy because of the switch.

Anyway, that's just an example of where you've got something that's getting paid for by insurance, but it's deemed to be not clinical or something. With the stroke of the pen, all of a sudden that innovation can't be paid for. In any event, I know you have some other really cool examples of that, and you're an expert in this space. Also, I think for clarity, you're working on really the messaging and positioning that can ultimately get whatever the economic buyer is to be compelled to buy whatever this is, right?

The Future of Diagnostics

BRADLEY: So, move forward to, unless you want to talk any more about the precision medicine AI stuff you guys were doing and some of the trials and tribulations that you had there with aligning the economics with the promise in healthcare. Is there anything you want to share there before we move into the new companies that you're now working with?

LISA: No, let's go into the new ones.

BRADLEY: Okay, cool. I always like talking about new stuff. I was so intrigued to hear that. As we all know, healthcare is vast. It's trillions of dollars in spend so a little problem in healthcare is a massive economic problem.

There's this thing that anybody who's a parent knows called an ear infection. An ear infection always shows up at 7 p.m. on a Saturday night and all the doctors are at home doing whatever they're doing. You're going to the urgent care and getting exposed to other germs and it takes a long time and it costs a lot of money. How could we make that a much better approach and come to find that this little tiny part of the overall healthcare world is about $4 billion, you said?

LISA: Yes, $4 billion in direct. If you start to put the indirect costs of missed time at work, additional babysitting, transportation, it goes well above $5 billion annually invested in the U.S. in the common ear infection, the pediatric ear infection.?

It's the number one reason that pediatric office visits happen. It's the number one reason that children go on antibiotics. It's one of the top reasons that non-urgent cases go to the emergency rooms. There's really a lot of burden to this disease that we've always been managing the same way, which is you go to one of three places: your pediatrician's office, your urgent care center, or an ER.

It is not easy to diagnose an ear infection. In fact, when you look at the experience level of clinicians, it can gauge from 50% accuracy to 75% accuracy, but doesn't really get above that. So it begs the question, is there, number one, a better mode of accuracy? And number two, is there a better way to diagnose ear infections to minimize the disease burden?

There's technology that's coming out of a really prominent university and clinician group that could transform how we manage ear infections. I've been working on this for some months and exploring what the economic pathway looks like. Like I mentioned, you talk to one healthcare system who said, if I can't make money off of this, then I can't see a pathway for it.

Going back to one of your original questions, so what do you do with this? What type of pathway could it find? There you start with a problem that we could solve, which is the accuracy of the ear infection, and you evolve it to. Well, what if we were to transform the mode, time, and place that ear infections are even addressed? Because some other stats around it are 86,000 physicians, that will be the shortage of physicians that we have in the U.S. by 2036.

BRADLEY: Is that all MDs?

LISA: All MDs. That's all MDs.?

BRADLEY: 86,000 would be the shortage based on the amount of demand from patient care episodes.

LISA: Yes and the number of people who are going into the medical profession. That's just the physician, that doesn't count nurses, nurse practitioners.

In April of this year, or when the matching happened with clinicians, 30% of pediatric residencies went vacant, so 30%. Year over year, we have more and more of a gap that's being created where, you know, you're going to have to wait longer and longer.?

I've experienced this personally with, you know, getting into my pediatrician office. Previously you called, you got right in within hours. Now they do a full assessment and they triage you. How serious is it really?

I've learned to play a game. I've started to figure out what are the words that I can say to get that appointment so that I skip the line in front of other people, but that's not how it should work. We have to come up with different ways. And I think-

BRADLEY: Can you reveal that secret? What are the words that you say? Skip the line?

LISA: Green snot. Okay. Anything green, green phlegm, coughing up green phlegm, they'll see you for that. That is the magic elixir to get into your pediatrician office.

What this has now transformed into, the problem that we're seeking to solve, is not just the accuracy of the ear infection to help the clinician and to help the overall diagnosis of the ear infection, but to give it different opportunities for time and place.

We're looking at what could telehealth look like? What could care at home look like? How do you keep that person who is seven o'clock on a Saturday, and instead of them going to an urgent care that could cost them or the healthcare system somewhere between $200 and $500, how do you keep them out of the urgent care center? Or worse, they go to an ER, that's $1,500 to $2,000. How do you keep them from going to an ER? Give them other options. So how do you democratize? That's what we're looking at.

Revolutionizing Ear Infection Diagnosis

BRADLEY: Can I ask a really just fundamental question? So we're talking about diagnosing an ear infection with something like a smartphone that we're using to do this? Or is there some hardware? How does this thing work?

LISA: In order to get an image of an ear infection, you have to have an otoscope. So there would be the integration of some kind of otoscope to you and capture a digital image of-

BRADLEY: Okay. You'd have, just like you have a thermometer to take somebody's temperature, you'd have this apparatus that plugs into the port on your phone and can be placed in the ear and then run the analysis, reading that image - and then everybody always says AI, right?

LISA: Right.

BRADLEY: Could you explain how AI actually is used in this example?

LISA: In this example, it is reading the factors that contribute to an ear infection. It's analyzing the image and bouncing that up against a bank of thousands of images of ear infections.

BRADLEY: Okay. There's some type of a visual signature that says it's red, it's inflamed.

LISA: It has all the features.

LISA: Yes.

BRADLEY: And is there some kind of connection to the temperature as well that the patient has or no?

LISA: Not necessarily. It's image based, but, you know, we're looking at how do we wrap in other contributors too.

BRADLEY: Right. If you're a clinician. Because theoretically this could be the tip of the spear and all kinds of ways to do diagnostic data capture. That's really what you're talking about is how do you make it so the data capture can happen in an effective, accurate way remotely for somebody and then get transmitted. Because you're not eliminating the doctor.

LISA: Absolutely not. Clinician in the loop. So human in the loop, you know, diagnosing any condition, you need to have that clinician. In the world of telehealth, that clinician would have visibility to the image and the image analysis, what the result is.

BRADLEY: Interesting.

LISA: And they would ultimately make the decision and guide that patient on what do they do. Right. Do they get a prescription? Do they need to go in and have an in-person visit with a clinician? So that clinician would definitely be involved. It's not replacing them, but rather giving them better tools to do it virtually.

BRADLEY: Right. In the ultimate example of this, would it be paid for by the consumer? Or, because that's what this whole topic is.

LISA: Right.

BRADLEY: This is really cool. Why wouldn't you want to be able to just use this diagnostic with your phone, have it connect to your doctor, have them say, yep, it's another ear infection. And then you move on with your life and they get the prescription and whatever. But who pays for that?

LISA: Yeah. So I think this is a question, and you look at short-term versus long-term. I see a lot of technology that's evolving right now where it's starting out as consumer pay. Might this product launch as a consumer pay at first potentially? Ideally, it would move and have reimbursement behind it, have the support of your employer covering telehealth and telehealth providers.

BRADLEY: Because then you don't miss work because you had to go drive home and take your child to the doctor or leave home your home office or that kind of thing. Right?

LISA: Right. And I think we have to look at, you know, how do we pave our way to get to those levels of reimbursement and support by employers? One of the dynamics we're experiencing, I think, a lot as a health care system is a lot of those innovations, they start with consumer pay. I'm not suggesting that that's the right way and the ideal pathway, but we're seeing it even in women's health.?

There are recently huge amounts of money that were put into women's health. Most of the innovation that came out of these grants started with self-pay, consumer pay, at-home care. The goal is that they will evolve over time and see more and more reimbursement.

BRADLEY: This seems like an interesting one because parents are keenly interested in doing anything that it takes to make sure that their kids are comfortable and happy. It seems like there would be a consumer angle that could make sense with this kind of product.

LISA: I believe there is. I think there are a lot of, you know, any parent who's had a screaming baby, toddler, non-communicative child who is really in need of some kind of support, you will do anything and everything and all the way to taking them to the emergency room. At what could be potentially really high cost for you personally, and certainly high cost for the healthcare system. I think having other options and giving people choices is really where the healthcare system will go. But it's not set up for encouraging reimbursement behind it.

I was driving up here and saw multiple billboards, there was one with a shiny-faced baby who looked miserable. It was a billboard, it said, urgent care, why wait? So we live in a fee-for-service environment. Those urgent care centers want you to come in the door, the ERs, anywhere you want.

BRADLEY: Yeah, urgent care centers are not excited about a way that you could completely bypass having to go to the urgent care center.

LISA: No, not necessarily.

BRADLEY: Not economically. Even if they feel like it could be good, they also have to keep the lights on.

LISA: Right.

BRADLEY: This conversation and the direct-to-consumer pathway reminds me of Cologuard. I've had a chance to speak to the CEO there, and he was explaining that for years, they were struggling to try to get traction with this Cologuard product. For people who don't know, it's a way for you to do a collection yourself and then send in a kit to the lab, and then you ultimately get some indicators on whether or not you should be screened in a more invasive way for colon cancer. It's not 100%, but it's directionally very helpful.?

Ultimately, they just said, you know, increasingly people are aware that they should have this kind of thing done, the screening done, insurance isn't paying for it. Let's go ahead and start doing more conventional direct-to-consumer marketing. They loaded up with lots of capital and just took the plunge and they invested huge. It was everywhere on TV.

I think we remember it like the little ad with the little box that was walking around. You know, hey, get Cologuard. I don't know where that stands from a reimbursement perspective today. I know that's been a fantastically successful story in how direct-to-consumer can work. It seems like that's probably a lot harder sell than the kind of thing you're talking about.

LISA: I think there are other examples. Another one is dense breast tissue. With many women, they have dense breast tissue. Beyond a standard mammogram, they should have additional testing. It costs $300 out of pocket. It's encouraged for you to do it but for a long time, it wasn't covered by insurance.?

There are now more and more insurance companies that are paying for it. It started with self-pay and started with, you know, a group of people who are concerned enough that they're willing to outlay their own cash and take their healthcare into their own hands. But that's been the starting ground. I think whether it's Cologuard or dense breast tissue diagnostics or other like this diagnostic for ear infection, we're going to see, I think, a lot of these technologies that come out and emerge directly to consumers.

BRADLEY: Yeah.

LISA: And then find their way to reimbursement.

Navigating Regulatory Waters

BRADLEY: So there's another layer in this, which is regulatory.

LISA: Yes.

BRADLEY: In the U.S., we have the FDA. In Europe, they have the EU MDR. There's all this formative exploration happening with this combination of data and AI and hardware. Historically, it's just been you have some device, you do a study, it gets approved. It takes forever. It costs a ton.?

Once it's approved, it's in the market but that device stays relatively static. How do you see that regulatory layer in these innovative diagnostics? Is the FDA saying, we have to approve all this stuff before you can go diagnose people or collect the information? Can you talk about that a little bit?

LISA: I was actually listening to something earlier today that was talking about more especially care at home and how the regulatory bodies are looking more at remote patient monitoring. They're dialed into a lot of the connected care ecosystems that are emerging more so than they have in the past, especially since the pandemic. This is an area where I will say it still is unknown to me exactly how you approach it. Conflicting approaches.

BRADLEY: Right. It's still getting figured out.

LISA: That’s it.

BRADLEY: I do think there is a level locking in these models and knowing it’s this version and there has to be some kind of release control. But it's probably a solvable problem.

LISA: I think it is solvable. I do think that there will probably be trial and error, some that try novel approaches and find that the FDA decides to become aware and engaged and involved more than we expected. There'll be other areas where we experiment and can move on. I think we're gonna see a lot of great things, but that's one where I'll say that I'm still learning myself and hope to continue to learn.

BRADLEY: Yeah, awesome. Well, thank you so much for being on the Boombostic Health podcast. It's awesome to have you here. You're a wealth of knowledge and thanks for the amazing work that you're doing to advance healthcare for patients. I think that what you're working on, I think it's gonna make a huge impact. Like I said, I think you're just getting started.?

LISA: I hope so. Thank you for having me.

The Verdict: Legal and Regulatory Insights

BRADLEY: Welcome to The Verdict with Emily where we explore the regulatory and legal aspects of these innovative, bold ideas that are being presented on Boombostic Health.

We just had Lisa Huse here with us who is an expert on aligning economics with diagnostics to try to make it so that we can bring more innovation to the market. Emily, thanks for being here.

EMILY: Thank you for having me. Appreciate it. Absolutely. So Lisa, let's get started. Appreciate it. Thanks for having me. Absolutely. So, you know, you were able to listen to what Lisa was talking about with this new diagnostic that they're working to commercialize in ear infections and massive $4 billion problem. And there's a way to diagnose this issue remotely but the path to get that commercialized isn't just introducing it to patients who would be willing to pay for it or their parents.?

BRADLEY: There's a lot more to it. So maybe talk a little bit about what are the regulatory considerations or what is that path that goes from here's something that can work to it's actually going to get paid for and it passes muster.

EMILY: Sure. Before any device will actually get reimbursement from a payer perspective, whether that's a commercial payer or Medicaid, it has to go through the FDA approval process. So presuming we've gotten to market and we've done all of that. What's interesting about what Lisa was describing, and I think she kind of hit the nail on the head when she was talking about medicine still being fee for service, is there is a trend or a tendency amongst payers to only reimburse for things that are reactive, right? There's no interest in doing anything that's proactive.?

While her product is amazing, and I think it has a lot of clinical utility from a payer's perspective, putting my payer hat on, there's already a way to diagnose this. They're not jumping for reimbursement. When that's the case, when you have this sort of struggle to get the coverage, then the way to do it is to go to market to the consumers, which becomes this direct marketing or direct to consumer marketing pathway that allows you to establish data, prove clinical utility and why this is of value to payers and why they should cover it for reimbursement.

There are considerations that when you're doing direct to consumer marketing. And so anytime you're making any type of representation directly to a patient, you have to meet certain marketing requirements. You have to be transparent about what you're trying to disclose, what the device is, what its intended purpose is and what you can actually use it for. You cannot do any type of off-label or non-intended use.

BRADLEY: Meaning, if this was designed to diagnose an ear infection, you shouldn't use it to diagnose a sinus infection.

EMILY: Correct, exactly. And the disclosures that you give to the patients have to be in just plain language, right? No large medical words, nothing like that that's going to confuse them. Any type of representation must be-

BRADLEY: I can say like three out of four dentists recommend it.

EMILY: Exactly.

BRADLEY: But like what kind of claim can you make before you step into dangerous territory?

EMILY: Great question. We get this from a lot of clients when we review their marketing materials. It has to be something that's supported by scientific evidence. You can make a statement saying, in 86% of cases that were tested, this yielded a positive diagnosis for an ear infection. What you can't say is like, this is the world's best device and it's going to diagnose anything better than any other device or physician in the world, right? Because those are pretty profound statements that aren't backed necessarily by scientific-

BRADLEY: Well, and it can't replace a physician.

EMILY: That's the other thing when you're doing direct-to-consumer marketing, being careful about allegedly equipping a patient with a quote-unquote diagnosis, right? Because the patient is then armed with maybe more information than they're prepared to use. And then they think they're in this position of being able to treat it because they've received this diagnosis. You still have to have that intervening physician oversight.

BRADLEY: Then there's the layer in between the introduction of a promising new diagnostic and commercialization that involves whatever type of approval, the FDA or UMDR, whoever the regulatory body is. Could you just touch on that part of this journey a little bit? And just in terms of I'm an innovator, an entrepreneur, considering doing something like this, is that a quick process? Do I fill out a form? You know, what does that look like?

EMILY: It's not a quick process at all. It takes years of research and development to get something like that approved through the FDA. And you're not allowed to go to market at all until you have that type of FDA approval. So that would be your first step. Before you even consider doing a direct-to-consumer marketing strategy, you have to get your FDA approvals, which involves a clinical trial or some other trial of establishing the utility of the device before it's approved to go to market in that sense.

BRADLEY: Makes sense. Well, I think one of the powerful aspects of business today is that you do have social media and other ways to get to consumers in a hyper-targeted manner. So hopefully that opens more pathways to have the economics that you need to prove the utility. Because it's the chicken or the egg.?

You have the device, it's so promising, but you haven't been able to use it on a lot of patients because nobody's adopting it yet. But then you have to somehow prove that it works on the patient. Some pathway to have trials. At the end of the day, you need some kind of counsel probably to navigate that. It sounds like there is a path. It's just a matter of being ready to have the persistence to get to the end game. It's probably not gonna happen fast.

EMILY: Exactly. You have to be prepared for that.

BRADLEY: Yeah, cool. Well, thanks so much for bringing your legal and regulatory expertise to the Boombostic Health podcast.

EMILY: Absolutely, thank you for having me. Thank you.

Looking Ahead: Bold Moves in Healthcare

BRADLEY: Well, thanks so much for being here for Boombostic Health. It was an awesome conversation with Lisa Huse about the future of diagnostics and how you can align economics to ensure that you realize this promising new future. Also to Emily for coming in with the verdict to talk about the legal and regulatory considerations as you navigate these kinds of diagnostic innovations and bring them to market.

Look forward to seeing you at the next episode where we'll have another fantastic guest who's making bold moves in healthcare to improve patient care and also improve the bottom line and make the business of healthcare work. Have a great day!

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