CONFLUENCE OF MEDTECH AND AI featuring DR. ARLEN MEYERS

Morning.

Morning. How you doing.

I'm well. How are you?

Good.

I'm in Baltimore. Where are you?

Denver.

Denver as the weather.

It's a little rainy, but it should warm up actually, that some years. March is the snowiest month of the year.

This is true.

Climate change. Who the hell knows? I mean, just never know. We we've had. We've had snow in June. We've had snow in September. You just never know when it's gonna snow, but the rest of the time it's actually pretty. It's it snows, and then it melts off. It's not like the east, where it sticks around forever. So do you live in Baltimore.

No, I'm here. I'm at the Wraps Conference, the conferences this week that I'm attending. And yeah, that's I live in Philadelphia area.

Yeah, that's what you told me. So I would imagine the regulatory affairs. Professionals are all wrapped up in part of the pond. Artificial intelligence that software as a medical device and all that stuff.

Some of them are, and some of them are, amazingly detached from that topic.

Well, that's a good thing to talk about today.

It's it's it's, you know, the traditional, implantable device. Companies, you know, are not particularly interested, you know.

They suffer what I call from cranio rectal inversion, syndrome.

I know what that is. Yes, yes, that's that's it's quite a medical.

Okay.

Putting in yeah, they they do. you know, and then, like a daylight and a dollar short, they'll be like, why didn't anybody tell us. you know that this was that this was coming? Where is Joe?

How many folks do you usually get to sign on to these.

Somewhere between 20 and 40, you know, it's like it's, you know, not a huge group. But they roll in in the 1st few minutes. So that's why we're gonna start with

And then you down, you upload it to a Youtube something, or they can, or a podcast host where they can unload it.

Exactly.

In video and in audio.

Video.

Definitely. Yes, they see this.

Yes.

Yeah, yeah, there was an actually article today about has podcasting out podcasted itself. And the basic headline was that audio only podcasting has seen its day.

Hmm! Do you believe that.

Yes, I think it's it's the next iteration of death. By Powerpoint. I mean, if you just listen to 2 people talking 1st of all, you don't get to hear anything ex for the 1st 20 min, because it's all advertising. and they're back and forth and bantering around and all that they really don't get to the meat of the subject. And then you're sitting there listening to usually 2 people and their idea of interaction and engagement is, I'm gonna ask you a question, and then you respond. But the whole point of this is is audience engagement. Which is this process of allowing people to ask questions during the session.

Hmm.

It is much edit. Do not tell them what we think. They want to hear.

Well, after a week of listening to presentations from the stage. I've had just about as many as I can take

Right. It's the same thing at in conferences. Panels are ridiculous. They they're just boring and and nobody wants to listen to, you know. Stuff. They want to get their questions answered.

The most exciting moments have been where they really engage with the audience.

And that's what I try to do pretty much. I mean, I won't do that. You know. I'm I'm trying to engage, because fundamentally.

People.

Yeah.

Joe, are you promoting people.

I am, and I'm very engaged.

It's good to see you again. It's been a while.

We've not spoken in more than a decade, I think.

Yeah, how you doing.

And admiring from afar.

Oh, good!

So you've both been well for the last decade.

Fortunately.

Hi! Ireland!

Hello! How are you?

Good! How are you?

Good. Where are you coming to us from, Carrie.

Golden. I just saw you. Oh, that's right. You just did. I did.

Yeah.

Hello, world, traveler, sean.

Baltimore, reporting from Baltimore.

Oh, I thought you were overseas.

That's next month.

So.

And getting stuck in Ireland was last week.

I guess this poor thing.

Debuff.

Yeah.

Well, I know that typically we we spend a good deal of time just convincing and saying good morning to folks, but I've not spoken with Arlen in a good long time, and I know that he's a font of knowledge to share. And I agree with you, Arlen. I hate panels. I've run 14 conferences, and I've I stopped panels after like the second one. There's just too much dead time, and Heaven help you if you're one of the 4 people not speaking right now. You're just sitting up there for your turn in 10 min, and I just I've never enjoyed that dynamic. I'd much rather do what we're doing here.

Yeah, sure.

I would like to introduce you to Mohammed, though, means pistachio in Arabic, and he comes from a deep pistachio family background, and as a fellow Arab. I enjoy pistachios, and when he's not eating nuts he is nuts, and he he is an expert in cyber security, and he works with a bold type.

Yeah.

And they are the people I send folks to when they need any kind of mobile connectivity solution for medical devices. I think that's very relevant with the types of products that your audience is finding.

Alright!

Worth discussing.

Hi, mom.

Hi! Nice to meet you, and thanks for the wonderful Intro, Joe.

Yeah, where are you? Mohammed?

I am in. I am west of Orlando, Florida.

Good. Yeah. Actually, you know the guy who is on a shark tank. Steve, whatever his name is. No, Robert, Robert.

No, they they yeah, I can visualize what you're talking about.

So, Robert. I was just at hims and long story short. That there's a whole other story. But he was a keynote, or he's telling a story about the history of Shark Tank. All that. Well, it turns out that I'd say about half of his presentation was an infomercial for his company and his company is a cyber security company. and he actually made his 1st millions in total in cyber security. But his basic solution is what he refers to as lake houses. So the basic idea is that the problem is uploading all this AI and stuff in the cloud. and that presents 2 basic problems, one cyber security to cost.

because the more data you use, the more expensive it becomes to shuttle it up into the cloud. So people are using data lakes and data whatevers. So his cute little side thing is that we're gonna bring the cyber security to you rather than you having to bring the cyber security to the cloud. Arlen. I'm sorry I have to interrupt. Jose has a cute little side thing to show us. Okay.

Today, some women's thing.

This is international Middle Month.

Calendar. You're a week late, Jose. Dang it was that last week I thought it was 2 weeks in a row.

It's a month long thing you you spoke over his his applause line as you introduced your daughter.

Oh, man! Alright.

What is her name?

Oh, this is Calla Calla Magdalene. She's 2 months old today.

You've got so much hair already. I'm jealous.

Yeah.

You have plenty of hair, Michelle, what are you talking about?

Do you know how much money I've invested in vitamins and scalp treatments, and like all the things for like 3 years? That's why I have hair. Even Paul could have hair if.

Don't know. Dr. Myers, do you know of any solution that would give Paul d'souza hair right now? Are you aware of anything on the market I'm gonna take. Let's.

Let's let's take a moment to introduce our speaker. So Dr. Arlen Myers is a physician, entrepreneur, and founder of the Society of physician entrepreneurs has a very storied career and has I met him recently, and he is going to talk about the convergence of AI and Med Tech, and what it's going to do to our little industry. And we had a fascinating talk a couple of weeks ago, and I thought that he would make a fantastic guest, and that a lot of you are gonna have things to add to the conversation. And I think this is gonna be one of our better talks.

that's all I'm going to say. And why don't you tell us a little bit about how you got to where you are? Starting with. I was a child. I was born a poor child.

In a room. Well, thanks for the kind introduction and welcome to the group along. So here's the short version grew up in Philly. Parents of Eastern Europe, Eastern European immigrant kind of thing. So it was like the immigrant story. I eventually I went to Med school and college back East, and then I'm an ent facial plastic surgeon. By training I wound up finishing my training. I got recruited to Colorado, the University of Colorado, where I spent the next roughly 40 years, being an academic surgeon during that time. And so I'm just. I was a typical academic search. Publisher, parish, and all the stuff that I could academics do. So I, during that tenure

myself. Again, short story and several other people invented a gadget that optically detects cancer in the mouth. It's like a Geiger counter for cancer. And that experience kind of led me to where I am now. and I can go into all the details. But where I am now is that I I don't see patients anymore. I stopped seeing patients in 2,015, and I'll tell you why. But I wound up doing what I'm doing after multiple career pivots. I teach healthcare innovation and entrepreneurship. I consult and advise to multiple companies. and I co-founded and run the society of Physician entrepreneurs the Society of Physician entrepreneurs is a international open. Anybody can join including anybody in this audience.

It's an open ecosystem. So it's an international open nonprofit. 5, 0, 1 c. 6, c. 3. Biomedical and clinical innovation ecosystem and the problem we're trying. And the mission is to help our members 80 bucks a year cheap. Help our members help other members get their ideas to patients. The problem we're trying to solve is that most white coats. data scientists, engineers, graduate students, doctors, anybody, health, professional. Every single one of them thinks they have a good idea. Most of them don't. It's just an idea. It has little or no potential commercial value, and even if it did, they wouldn't know what to do with it.

including me, so that I I you know there's nothing worse than a reform center. I was clueless because I thought it was a good idea. And and you know, that's what I did in the trenches. And I want a gadget that can detect oral cancer. And I don't want to have to go through some big rigmarole to do it. So we created this gadget. but we never got it over the goal line. and that frustration of getting it over. The goal line led me to what I just described.

I wanna thank Paul. While you were speaking he shared 2 links for our friends to learn more about you, including a link to your paper. So thank you for that.

Thanks.

It's good to see you again.

Hi! How are you?

Good, good! I I was involved. We were chatting with 4 or 5 months ago, with my involvement with the interesting company called Protectsa Health.

Right? Has a robot medical device.

For.

And I'm an advisor just in disclosure. I'm an advisor to protect some and a number of other companies. It's kind of what I mentioned. It's kind of what I do which is a whole, another subject of non clinical careers. How do you get doctors? The whole rigmarole? We can have that conversation. If you want.

Marlin, if you don't mind me saying I haven't seen Lee Stein on one of these calls in maybe a year and a half. So, Lee, I'm gonna ask you again to join the panel, because I know you have something to contribute to this conversation. So, Sean, you were saying that you and Arlen met. What conference was it? At? What? Which conference did you recently? See Arlen in person?

No, I didn't see him in person. I was. I can't. I can't remember exactly how we got into that.

I think it was a Linkedin thing, or I wrote something, and you responded, or I responded to something you wrote. Something led to another. It's kind of how we got together.

Like most of my connections we met through Linkedin, I'm gonna put up some links to a webinar that we're doing 2 part webinar that we're doing next week. Starting with nailing your value proposition, this ties into directly what he just discussed, which is med tech entrepreneurs, not understanding what their value proposition in and part 2 is getting paid for your medical device. And so it's market access. But it's specifically related to understanding. If you have a viable product, and if it's anybody's ever going to buy it. you know. Because you can have the greatest idea in the world. Michelle and Rene have talked about this but if nobody's ever gonna adopt the technology for a variety of reasons, and you're never gonna get paid for it. Then you're gonna spend a lot of years and a lot of money breaking your own heart.

I think it was maybe 8 or 9 years ago I was moderating a panel. It wasn't my event. and I posed a question to some Vcs. I said, you know I have this big group, and people think that I know everybody, and I can get them in touch. And I can you know all these things? And sometimes I'll have an entrepreneur physician. Say. I've invented this thing. I use it in my practice. It's helped so many people. I'm looking to commercialize it. And I said. You know, but I see that they have no management structure. They have, you know, no IP protection. They have no prototypes haven't started right, you know they don't have money to. And I said, I I don't know what to say to them, because I don't want to crush their spirit.

What do you recommend? And to a person they all said, crush their spirit. You're doing them a favor. Tell them the truth about what you see. Given your background and your knowledge so that they don't squander their youth, vitality, and resources on an idea that will never go anywhere. Arlen, would you agree.

Yeah, I would. And it's you know, it's radical can or whatever. If you're an advisor, that's what you get paid to do. And if you don't, you're not doing your job. So it's yeah, hopefully. they get it. A lot of people don't get it. And that that leads to the question is, why don't people learn from their experience? Why don't people listen? And there's we could have? I mean, that's a whole long conversation, but that's the truth.

I'm afraid I know more than one mercenary who would string the person along with subconsulting fees about something.

A lot of it has to do with the dunning Krueger effect. You know you don't know what you don't know, but you're not willing to admit it, and doctors are notorious for that. I mean, we, you know, we've been told we're the smartest people in the room since we're 8th grade. Well, guess what in this era there is no smartest person in the room, particularly because we have artificial intelligence.

Yeah.

Which brings us to our topic today. So let's use that as a launching pad. Please. Start that conversation first, st Allen, where would you.

Yeah. So the there is. Well, where I think we should start is just some general overview. Of how do you? How do you incorporate artificial intelligence into whatever it is you're doing, and what are the intended and unintended consequences? The latest example I've seen? You know I. I have this thing where secure. and I describe what we have is as a sick, siloed, sick care system of systems. It's not a in the industry knows it's a sick care system. We're out. We're now at 5.6 trillion, probably going to be 6 next year 94, 95% of his spent taking care of sick people, not prevention, not chronic disease management, not all the other stuff.

So it's a sick care system, with all the bells and whistles and works that goes with it now. So I say that sick care, like any industry, cannot be fixed from inside. It has to be fixed inside out, outside in innovation. But the counter to that is. there's a lot of what I call non sick care entrepreneurs, that is, people who are not healthcare professionals. and we're seeing a lot of those folks getting into the game to try to best case do their best to fix a very broken system. So it's techies. It's entrepreneurs. It's investors. It's people that you know, make gazillions of dollars like the guy on shark tank

who made a lot of money doing cyber security and now wants to do it in secure the problem with that is that it? There's a lot of positive things that come from outside in GPS telemedicine. You name it. I mean, most of the significant improvements in sick care have not come from really smart doctors. It's come from people that have done other things in the Department of Defense, in NASA, in tech, in cyber, in all artificial intelligence is the latest example. So the good news is. There's a lot of good stuff that comes from outside in the bad news is there's a lot of bad stuff that comes from outside in.

and the latest example, and I just wrote a thing about this is there was an article about cars. automobiles, and all of us who own cars. Now understand that if you buy a new car tomorrow. it's no longer an automobile. It's what's being referred to as a mobile transportation device. Now, that doesn't quite have the same ring, as you know, the the Bmw. The ultimate driving machine. But that's what it is. It's a computer on wheels. And all of the complications that go with that, I think, are burning out car owners just like digital health and artificial intelligence is burning out doctors. And incidentally, it's burning out patients.

The latest example is, for example, if you have diabetes and you're using a transcutaneous, glucose monitor. if you think about the burden. and that's what it's referred to in the literature. It's a patient burden. I call it Burnout. I have a friend who has diabetes. He uses a transcutaneous glucose device that's hooked up to an iphone that tells the user what your glucose is any point in time. Well, guess what? He doesn't comply with his diet. He doesn't comply with insulin dosage. So guess who assumes the responsibility of monitoring his glucose, his wife. or it could be a person 1,600 miles away.

So I think we need to rethink what I call with this AI med tech. And I call this biopharma tech med, not med tech. Sick care has become a data industry that happens to take care of patients. So it's no longer putting metal in a hip. It's a different deal. and you sort of have to understand not the least of which is the what I call the burnout impact factor of your device or idea, or drug or digital health solution.

I think you're making an important point, and I want to make sure I track with you. You're talking about burnout with the device. And the colleague that you refer to has an automated system monitoring his glucose. Doesn't it have an alarm or something that says when something is precariously low. Why are we relying on his wife? I I didn't track that.

It has an alarm, and his wife suffers from alarm, fatigue. What I'm saying is that the the use of it when I don't? It's the same thing in medicine. I mean, you keep getting alarm fatigue from signals that really you shouldn't get. They're not properly filtered. so it's the same. But she has to deal with it. But he is. And that's just I mean, that's a compliance issue. That's an adherence and compliance issue. And you probably know that 50% of patients don't take the medicine they're prescribed. In fact, they throw it away. So who knows how many people actually use the device that they're supposed to use. If it involves these various AI or digital health applications.

If I could jump in just because I have the device. I use it in the the diabetes device. and it has made a life changing. I'm trying to get your point I'm with. I'm with Joe on this trying to get your point. So on one hand, you said, the data is good because the data has changed my life right? And you're right. The monitor goes off. I mean, good Lord, I mean, you know we have now switched. I have to put it on today because I don't turn it on. I don't put it implanted. At night there's a learning curve, and I can't sleep. The alarms go off at all the time and stuff like that. But my numbers have changed right? So there's the benefit of that right right.

My machine.

So what I'm saying.

It's this, it's this, like I got to insert mine on. I got the dexcom.

Yeah, it's like a dex.

Right.

Right life changing. I get your point, but the numbers have shifted, the numbers have shifted right correct.

Correct.

And.

You're.

Element of. There's this element of I don't know co-management, you know, or being able to start interacting with the data. It's a new. It's a new skill we have to develop. It's a whole new relationship with our own health, augmented with data.

You know, it's interesting.

Is indicating.

Love to hear Arlen's reply. Nelly, if you don't.

Thank you. Sorry.

The literature indicates that there's a compliance burden. That's what it's called. You're a smart guy. You have the wherewithal you have the money. You have the knowledge. You can speak English, you have access to the Internet, etc, etc, etc. But if you take someone who does not have those things.

Yeah.

You're screwed.

It's definitely not something for everybody.

Well it should be.

Agreed.

Right. I mean the last I heard. Doctors are supposed to distribute care equitably.

There's a huge learning curve in in learning how to manage the data. I'm totally with you on that.

Right. That's my point. And worst case it leads to patient burnout. They get frustrated and they don't. It's it's another obstacle to compliance.

Yep.

I'd like to ask Jose, who specializes in making devices of this kind. I'm surprised to hear. You know. I I think of Dexcom as one of the names that crack the code and really made a difference in in patient health. Why do you think that alarms are going off all over the place. I'm not a user. But why do you think it's so sensitive in the bad way.

I mean, I think, yeah. Usability is kind of the key here, and understanding all of the various types of users, because, you know as Arlen just mentioned. You know, if you got a user like Paul, who's tech savvy? And he's, you know, he likes data and that kind of stuff. Then it's a great instrument. But if you take somebody who's my dad and he's 82 years old and he barely knows how to handle his phone, then it's a different one. And so it's a challenge on manufacturers to really be able to develop devices that satisfy both ends of that spectrum. And you know. And and also you run into a challenge sometimes when when too many engineers are the ones trying to do some of the usability, because they're like, oh, it's simple. You just change the setting right? I mean, you know. And I think there's a lot of us were maybe more tech. Savvy you think like, Hey, you should be able to change the alarm systems, and you know, and the phone, or whatever. But if you're kind of a person who's not very tech. Savvy? You might not even know how to arrive at that. So it's a challenge that every tech company faces. Yeah.

I have to call on Sue because she's an entrepreneur, and she just created a device. She just took herself off camera. Maybe she'll come right back, and the the Usability testing wasn't among fellow engineers. It was among the people who would be using her product. So.

Yeah, I don't mean the usability testing. I mean the design right cause. And at all.

You know, usability testing is just sort of like, okay, are people able to use it? And and by the way, the criteria usually for usability testing is if they screw this up, is somebody going to get hurt, you know. And so some of the stuff around fatigue, for example, that Arlen's talking about. You might not see that in a single visit Usability test like if somebody usability testing, because that might not be a thing that happens until 3 months after you've.

That's interesting. Yeah, that's a good point, Nelly. You've been patient.

So I literally was just talking to my naturopath. I've been on a journey for 2 years of like, you know, getting healthy weight loss, and.

And you look fantastic.

Thank you, but I threw a tantrum, and what it means is as a human nature. We have so many elements in our lives that are controlling us, our computers, our cell phones, our refrigerators, our device, our medical devices that you get to a point where it's like you're so burnt out. You just shut down and stop like I literally a whole month. I didn't take my vitamins. I didn't do anything, and then, like I've gained 16 pounds. And so it's just like, wait a minute. Ellie, what's going wrong. I don't, I got tired of doing the right thing, I got burnt out. so I mean, it's a kind of a natural thing in human nature, and I saw it with my senior because I was a caregiver for 2 seniors, and it's the same thing. They'll go. They'll be really good for 3 to 4 weeks, and then they get burnt out, and they don't want to do it anymore, or they feel controlled or manipulated. It's it's a psychic that you have to deal with. And so I call it rebellion. They want to rebel. I think Arlen's calling it burnout. I think it could actually be both.

Techno fatigue. Here in the comments. Do you have a an idea, arlen a solution to this? Do you think AI can play a positive role in reversing techno fatigue.

Yeah, I have a lot of ideas, I mean, but I want Carrie to cause. I don't want to tie this up too much, Carrie, what is your thought?

I'll tell you, from the regulatory reason why we have all these alarms and crap, I'll call it I helped get cleared. The was eos eos health with with Livongo, which was the Teladoc that sold for 18.1 B. As well as the dexcom. 4 device. It's the regulatory burden is why we have all of these alarms and stuff which goes back to the Iso for the for the glucose monitors, and we have to have all the alarms.

That's true.

In the performance and the regulatory burden, and when we were trying to put all the alarms when we were going into these for the when we were having them all to go over the counter so we could have them. So you have them on your phone and they can go over the counter. That's what the FDA. We went back and forth, probably 5 rounds with the Eos Livongo device, so that it would be. We had the providers so that they could it could be at the household. Let's say so. You at Paul could do it at home. and you could push it to whoever you want to, so your wife could now be your care

person to do it, if that makes sense. And so the I mean.

Affairs, you know, to your to her point the answer to your question, Joe. One is, I mean, there's a lot of ways to deal with this, but one is rethink reg affairs, particularly as it applies to software as a medical device. There was a long article that was re- recently written that appeared, I think, in Jama by the former Commissioner of the FDA, made the point that Oh, but are we over categorizing AI solutions as software as a medical device, and, secondly. since there are so many direct to consumer devices, it should we separate the regulatory burden between direct to consumer devices.

All the stuff you see at the consumer. Electronics show versus medical grade consume devices. Now, I don't know the answer to that question. But that's a potential solution. But 2 I think that the the safe and effective burden at best is is kind of minimal. I would like to see safe and effective and cost effective. because I think there's way too many shiny new objects. and there's no Moore's law in sick care. In other words, we just keep piling more stuff on and spending more money. So I think, like other countries do, we should have some sort of cost, effective analysis that would further inform what?

Rather than just as a whole long list. But I'll give you a 3rd one, and that is, there are significant gaps between scientists, engineers, and healthcare professionals in mindset. and there simply is not enough collaboration. Techies are from Venus. Doctors are from Mars. It's like being married for 30 years. and if you don't talk to each other, and if you don't inform each other in terms of subject matter, expertise in terms of the ecosystem in terms of workflow. Then that's a problem.

I really have to thank Shawn. I've known you for more than a decade, and it took him to get you to join our program. You just raised so many points that we could go off into different directions. But let me hold my tongue and ask Dr. Carr what she has her hand raised for.

Well, you asked me to talk about the human factor study. So we went to FDA and they requested that we conduct 15 more human factor studies which we're going to kick off and finish next week. So I'll know next week if we're pretty much if we're going to be approved or not. If we have 100% success, I think it looks good. Our 1st test we completed. I've known Arlen. I've known you for a few years I joined Soap in Washington, DC. Area with Jeffrey Housefield in 2,018, and.

Good for you. We're good friends.

Yeah.

So let me just make a point.

What you do.

Oh, sure. So let me let me just make a point about this human factors testing so coincidentally. 2 weeks ago I was invited by a friend of mine who does mid tech commercialization to be a person. a a person that was gonna be one of the people to do the human factors thing. And you show up at a hotel room in Denver. And this device is a is a electrical, a smoke evacuated device for a electrocautery scalpel. It's like a Bovie. but it's there's a smoke evacuator that goes with it. And the basic problem they were trying to solve was that when you cut skin or you cut an organ. Now

let me refresh your memory. I'm a surgeon, so I'm kind of familiar with what this looks like in the operating room. and the idea was, we want to get rid of the smoke when you make an incision. That was the basic idea. And I gotta tell you that all the time and effort that went into that device. 1st of all, there was an incredible amount of disposables which brings up the whole net. 0 medicine conversation. Secondly, what I was asked to do was Arlen. We want you to sit down. Use this device. I saw a 6 min video on how to use it. First, st you're a it was not a human kidney. It was some kind of meat or different textures. You make a couple of incisions, and then you grade it.

Well, I gotta tell you that. I think that's a pretty minimal bar. and I and I filled out the form, and I said, as far as I'm concerned, it gets to Joe's question of what were you thinking? I mean? This thing is ridiculous. I can't believe that they spent all this time and effort and money.

Now you're thinking now you're talking like my New York head.

It's like ridiculous. Yeah. Well, I came from Philly. So we're kind of used to the same thing. both assholes. Sorry exactly. Just tell it like it is. You don't like it. So, you know, buy a pretzel. But the point is, it. I just thought it was so ridiculous. So I. But that just adds cost. It adds regulatory burden. It adds inconvenience. It it really doesn't help. So I don't. I just question that whole thing, and and I guess that rule was recently changed or they had to upgrade it. And and it didn't really provide them with the input I think they would, but I'm sure they did. I mean, these people aren't stupid.

See how these things work. They see how jobs get done. They see the workflow. They see the potential issues. And then to come up with something like that, I I just think, is criminal. It's a shame. It's just an incredible waste. And we have to pay for it.

Victoria. If you take yourself off mute, I don't know if your camera is working.

Oh!

Think this is the 1st time you'll be contributing to our call. Introduce yourself to the group, and then, share your thought.

Okay. So my name is Victoria Ziendi. I'm from the Detroit Metro area, and my company, Alberta Rose Incorporated, which is myself. was named after my grandmothers, and I specialize in writing, structuring, and editing for reference presentation and documentation with the primary focus in biomedical biotechnology and life science. I was a caregiver to my grandparents, as well as my mother, who passed away about a year and a half ago of Copd. So my company comes from a lot of different areas, my experience, my education. I'm an engineering physics major with a biomedical engineering intent. But I'm writer first, st

and really what I wanted to address with Dr. Myers was when you were talking about AI and the fatigue of AI within patients, and just for my opinion on it to contribute. You know, people with conditions such as my father was a heart patient, and they're dealing with the condition as it is, which is a challenge. And then to have some type of artificial intelligence within them and to deal with that. So I agree with him there in that AI will never really replace a human because humans have created AI. So I think we'll always be one or 2 steps ahead of that. And to use it within the context that it was created.

Let me just let me just comment a little bit on this AI collision with Med tech and biopharma. There's a couple of just again, a couple of issues. One is, what are the success factors so far because we're in their infancy with this. But so far, what are some success factors that are associated with successful deployments of an AI solution in a healthcare environment. Mckinsey is all over this. Most of the Pwc people, I mean they just every single day they write more stuff. And they actually came up with 10 best practices. But I will tell you that 2 or 3 of them that I think are pretty important are one

governance. In other words, who is running the show when it comes to AI. Is it a CEO. Is it a chief AI Operations officer these days? Now there's an International association of AI certificated officers. Oh, is this everybody's business who should so governance is a really important part. and particularly with the CEO buying into the deal. Now let me remind you that the 2 biggest issues and and I'm talking to these people. In fact, next week I was asked to be on a panel to talk about. What do members of boards of directors of healthcare organizations need to know about artificial intelligence.

and that's a whole nother conversation. But the point is this is about risk management and the risks involved with art. The deployment of artificial intelligence to sick care are substantial. I don't need to tell you that. but the board of directors, a in many hospitals do not know anything about healthcare, let alone artificial intelligence. particularly in rural areas, small community hospitals. They're paragons of the community. They're appointed to the Board. God bless them. The hospital is a pillar of the community, but they really don't understand what's going on. So there has to be education at the Board level in terms of analysis and risk mitigation

for AI at the board level, let alone everybody else in the food chain. The second thing is, you have to rethink workflow and process mapping. because it's just garbage in garbage out. If all you're doing is automating stupid, wasteful process potentially harmful processes, you just make in a more. And and actually, when you look at the analysis of successful deployment, those 2 things stand out. There's a whole bunch of other stuff. And and, for example, there are AI councils. Now. what do you do about the ethics of AI and AI risk management to patients?

Do you need a separate artificial intelligence, Irb. when it comes to approving Irb things and risk to patients. Do you need a separate Ethics Committee that understands the AI ethics part? Not just should we pull the plug on grandma in the Icu. So there's various big picture topics that people are trying to get their arms around. And finally, this whole issue of return on investment when it comes to AI in Med tech and biopharma, or in care delivery. My take home at this stage in time is at this stage of the game. In some respects it's a fool's errand trying to define Roi, particularly the money part.

So in couple of months I'm gonna be speaking to manual care function. financial Management Association, which is, gonna have their annual meeting in Denver. a bunch of Cfos of all the hospitals around the country. And they want to know. I have 2 problems. How will AI solve this problem? One. We're running on fumes and razor, thin margins that is decreasing reimbursements and revenues and increasing costs and labor costs. And 2, we can't find people to work here and stay here. So how does artificial intelligence help me solve those 2 problems. So I really think we need to get real with this.

Hospitals are going under. People are quitting the profession. Patients are suffering. The sick care system is getting sicker. And we're applying this artificial intelligence. In my opinion, snake oil sometimes to solve problems that really are pretty far down the list. so I'll just get some response from that.

There's something that you said earlier that I'm I'm very. It's been sticking with me, and maybe this is the point where I can bring it up. You talked about what you think is Hi Carrie's dog.

About? How.

Perhaps we're doing a disservice by treating a all AI as software as a medical device. How do you make? How would? What is a practical way for us to approach it. so that it is properly regulated, but not overly burdensome. Do you have a thought on that.

Well, 1st of all, most of the artificial intelligence in healthcare is not being used to take care of patients. so that most of the artificial intelligence. Deployments are being used for operations and finance. Rep cycle management. How to operate, how to improve the efficiency and efficacy of workflow in a central supply area, robotics in certain areas, nursing floor process, mapping information, all that other stuff. the actual use of it in medicine in terms of of taking care of patients of all. So let's just be clear that there are over a thousand. Now.

FDA cleared software as a medical device devices 70 to 75% of those are in radiology. the vast and then the remaining tail are typically in computer vision dermatology. You scanning to determine melanoma versus non melanoma, ophthalmology. retinal scanning to detect early diabetic retinopathy. Pathology, auto diagnosis of pathologic specimens or frozen sections in the operating room so these are these are pattern recognition applications.

They're used mostly for diagnosis when we get into clinical decision support. In other words, the difference between generative AI and predictive AI. Very few doctors trusted. And actually there are very few that are actually deploying it at scale for clinical decision support. Because at the very beginning there was this big thing about epic rolling out a sepsis predictor model that was wrong. And people got sick and died. So, P, we're so we're so risk averse that I think we kind of need to separate the wheat from the chaff and use it where it's applicable, and rethink how we're going to use it. Actually, in clinical practice.

Are you going to? Or speaking at Daniel Crafts next next?

Unfortunately not. He was nice enough to invite me. But no, I'm not. It's health tech in San Diego at the Hotel Colorado. But yeah, he has a good meeting. We we were there. We were there at him. But no, I'm not gonna be there.

And that's going to be a rich topic there. What about the notion that you brought up about potentially regulating consumer facing devices versus medical grade devices differently.

Right? So I have a home blood pressure cuff fortunately, my blood pressure, I think, matches better. But I gotta tell you that. first.st I I'm not sure whether it even works. and, as I understand it, the regulatory approval of a home blood pressure cuff allows the manufacturer 20% leeway off the ground truth. So when I go, if I go another story to an actual doctor or a facility to have my blood pressure measured through a standard sphygmomanometer. You know the auto one that you see that the May does when you go into the office.

I don't know which one to trust. I don't know whether I should trust the one in the office, or should I trust the one at home and the the American Heart Association and the American College of Cardiology. A lot of folks have looked fairly specific. Are they measure of people's blood pressure, and in many, many instances there are ones that just didn't make the grade. They didn't get the good housekeeping seal. They are not in consumer reports, and so the Aha and the Acc. They recommend certain products. But I can tell you, and I do this on a fairly regular basis, whether it's standing, or sitting, or lying down, or what time of the day, or which arm is it? And it's the cuff on right, and all that other stuff.

So to answer your question, a. I think we need to do a better job of validating and verifying the specs to these things. And 2, we're not talking about, you know, a washer or a dryer. We're talking about something that people are using to live longer. and I don't. I don't see why we have a separation between consumer devices. I'm not sure what that means versus a medical grade device. What difference does it make who uses it? Whether it's a nurse, a doctor, a patient. I think it should all have the same standard of validity.

But you're advocating for them, being.

Yes, I'm advocating for the industry, and if they don't do it, the FDA is going to do it to make sure that patients are using things particularly as care is migrating away from the hospital.

That makes sense.

That they're their nurses now. They're their own doctors. People are doing more Diy medicine with this standard of what you're using to take care of yourself be any different than if a doctor did it, or a PA, for that matter, the doctor isn't going to do it. and in reality the PA does it.

I have to say.

Even get to see a doctor.

To those of you who are watching this recording. This is a great example of why it's good to show up. Live because we've been having a rich discussion in the chat that's too much to share here. So join us. Live next time, if you can sue you wrote the white coat syndrome. I'm not familiar.

I think Arlen probably knows when you go into the doctor's office. You're rushing in. You're late for your doctor. You sit down, you wait a few minutes, and then the doctor says, Quick, go here, and then you walk down 3 or 4 hallways. Finally you get there. You sit down, and as soon as you sit down the nurse takes your blood pressure, and it's high. When you just took it an hour ago. and it was at home, and it was low. So so a lot of people get nervous about their blood pressure. When they're in the hospital they see a white coat and their blood pressure skyrockets. And but it's just temporary. So I think if if there's needs to be training done with the nurses to say, Hey, don't take your blood pressure right away. Sit down, relax, then take the blood pressure.

Right phenomenon. And and actually, as I said, there are a lot of other factors that.

There's so many variables.

What's gonna happen to your what it's did you have coffee? Are you lying down? Are you standing up, or you? It's just a lot of variables.

I think I think another thing that's that's interesting about your discussion is the the shift of the burden, the administrative burden onto the patient. So, for example, fill out all these forms online before you get here, confirm that you're going to be here. Do all this administrative work for us. And then you get there and they ask you the same questions over and over again. And you know, it's like, I filled out all those forms online. Now you're wasting my time asking me the same questions all over again. And you know, 1st I go to the the the person who's, you know, checking my vitals. They ask me the questions. Then I go to the PA. Then I finally see the doctor, and and

by the time I'm done I've answered the same question 3 times, plus I filled it out online. If they had just read the form about what medications I'm on. I put all that information in the online form. But it's the same with the airlines. It's the same with every industry where the burden is shifting to the consumer. So this is my point as chronic care, management, and remote, patient monitoring become more and more prevalent in the United States, and the burden shifts to the patient. I think there has to be some level of competency among the medical consumers to take take responsibility for their own care.

Yeah. So I just read an article called How to Screw Up the Patient Operating Manual. So the analogy again is, you know, when your car. The USB. Port in my car broke. It doesn't work so I can't. It's all another sort of stupid story. But the point is, when you go to the operating manual of my car to try to figure out how to fix this yourself. Good luck! It's the same thing with the patient. They simply the instructions that we give them after the clinic visit are undecipherable. They're too long. They don't have pictures. They're written actually, at a at a too high a grade level to to understand. And incidentally.

when the patient uses Chat Gpt. That output is at a 12th grade reading level.

Unless they know to say.

Most of the time it needs to be at a 5. That's what the Wall Street Journal is. So it it. The whole thing is just wrong. It's just not working. So I call this the patient Operating operating Manual. And we need to do a much better job.

Jose. You've been patient.

Oh, yeah, I don't know if this is too off topic, Arlen, but I'd be curious to get your thoughts. I mean, I you know, kind of home monitoring and taking medicine to the home has sort of been a goal, for I don't know at least 30 years, maybe longer, and it seemed, during the pandemic like we might make significant strides in that direction, and then it kind of seemed to drop off afterward. It really hasn't captured as much adoption. I think one of the big barriers has always been around reimbursement. I'm just curious if you what impact are you seeing with AI on both the the just, the larger adoption of

treatments and diagnostics going to the home. And then also, if you're seeing on the reimbursement side some movement that makes it so that you can start to see the light at the end of the tunnel, of that becoming a reality.

Well, couple of points one again. There is no Moore's law in sick care. In other words, we just keep piling more stuff on used to be. You had a problem with your hand. You got an X-ray. Now you get an X-ray, a Ct scan an Mr. Scan, a pet, Mr. Scan, and a God knows what else, and it's an enormous amount of money, and it really doesn't give you, except in certain circumstances, that much more information. So I so I believe AI is certainly adding cost. And it's trashing the planet. And I'm not sure it's really solving a whole lot of problems, with certain exceptions. So that's the. So I think it's gonna drive it is driving up costs. Now in terms of reimbursement.

Yeah. And now, who knows what's gonna happen with this administration, but in terms of of reimbursement for using artificial intelligence. Technology. And the example that I'll give you is, if you've had a screening colonoscopy recently. You'll probably know after the doctor, or whomever does, the procedure comes out and talks to you, they give you a picture of the inside of your colon. And so it's a video picture of all that. and artificial intelligence is being used in many instances to screen for dangerous problems that might otherwise have been overlooked by the endoscopist. So that brings up a lot of questions. Number one, did you give the doctor approval? To do that? To use artificial? Did you give it

understood, informed consent? Informed consent is not understood. Consent, whole nother topic. But did you give consent for the doctor to use artificial intelligence to do this? Second? Who pays for it? I mean, do you? Is is that included in the colonoscopy? Or is it going to be a separate bill? Is there gonna be a separate facility fee for it where you're gonna be stuck out of pocket. Who's paying for this stuff? 3, rd should it be reimbursed by a Medicare system that's gonna bankrupt the country in 5 years. So it- it the nothing is free. So that's why I'm saying.

Is that there should be cost reductions, right? That if you're, you know, if you've got a machine that's making the job of the physician more efficient, or that's cause, you know, like we all have stories about stuff right? Like my dad's diabetic. He's in a wheelchair. He had surgery a couple years ago, and I remember taking him to the doctor to see a neurologist because he was having a problem with one of his legs, and it literally took us like 6 h, all in, you know, between me driving up, getting him in the car, taking him over there, unloading him, waiting for the doctor for a 5 min conversation that could have been done from home, or probably could have been done by AI.

And so, you know, from the patient side you get this frustration of like, hey? Some of the costs and inefficiencies aren't just in the medical system. They're in the patient and the caregiver system. And you kind of have the hope that a lot of what doctors do is algorithms that AI over time can take some of that load off. And it could result in cost.

But you're talking about 2 different things. You're talking about patient experience. You're talking about physician experience or caregiver experience. And you're talking about cost. One is not related to the other. And when was the last time you saw your health insurance premium go down. despite all of the technology that is employed. It doesn't. It doesn't get translated, and that has to do with the system that has to do with how things are paid for. You understand that.

We have

Because we're in the age that everyone has an expectation of. Why can't you deliver care like Amazon delivers packages? So we have a much higher bar to cross. and because of what I call the cranial rectal inversion, syndrome. sick care is incredibly change resistant.

Yeah. Administratively. We're almost at the top of the hour. We have 2 hands up. Let's see if we can. Victoria. If you could be concise.

Sure I'm just gonna say it. Briefly, I just agreed with what everybody said when they kept talking about, just from my experience and taking care of my mom like they like, Sue was saying, you fill out the form online. And my mom would sit with me, you know. And she, she was basically at the end of right before she passed from Copd about a year or so, and then you go in the doctor's office, and they want her to do it again. So just that repetitiveness. So, yeah.

All.

And but and let me just let me just point out that the last time I got on a chat, or the last time I got on a phone call trying to get tech support or anything in industry. It's the same deal. They don't get it right, either. You know. They ask you for in order to give you better information, give us your social security, number, your credit card number, whatever. Guess what the 1st question they ask you is.

Know it's Max.

What's your social security? It's a bad thing, right? It's just.

Paul, you wrote a a comment. You want to share that with the group.

Well, yes, you know we have all this tech coming in right? I mean devices, forms this, that AI, a question to you, Dr. Arlen. Do you see this? This tide fading back in where we get a maturity model and the tech starts to fade away, and we can become more human in our medical practice, and the experience like this white coat thing. And right, I mean, do you see care becoming care.

Okay? So do I see this happening in the future where we won't even be having this conversation. because the technology, when we get it right will be so embedded in the care process. You won't even notice it. All you want to do is drive your car to get from A to B. You don't care how it works. You don't care how all this stuff happens. You just want to get from A to B, so it's going to be in the background. As it is in many instances. Now. Secondly, I think that in terms of cost and in terms of the sustainability of the system and actually getting back to caring rather than just health care that I see a positive flow from younger generations. I deal with a lot of medical students, residents, people with pre-med engineers, that kind of stuff.

They're pretty juiced about wanting to change the system. You remember how we were when we wanted to change the system when we were 20 something years old. So they're pretty good at wanting to do this. And they're very tech savvy? And they're already using large language models, much like the early days of the Ehr, when people were bringing their own laptops. Because then you had your own being right, bring your own computer cyber security issues, same thing. So we've seen this movie before. I think we're gonna have to be patient with letting people like me and older, you know, laggards die so that the young generations can actually fix this thing. Now.

the final point I'm gonna make is that private practice is on fumes. So if I I was in private practice for a number of years. and I believe that the corporatization of medicine, the consolidation of medicine. the private equity, influence of consolidation, and how the business model works statistically and in the literature hasn't done us any good. It's raised prices. It's restricted competition. And it's compromised care. So how do we fix that? I think we're at the point where maybe 2025% of the private practice floor has been reached. I still are fed up with court working for the man.

I think that they're suffering moral injury. and I think that they're gonna go back to private practice. Now. So to get to the point, I think that will be the richest in the niches. There still will be standard corporatization and rates of physician employment. but I think the new frontier will be a reinvigoration of what I call private practice. Entrepreneurship, not private practice management. That's an operations function.

Would that be closer to consumer medicine and stuff like that?

Well, that's a different business model. And to that point I do not believe concierge medicine is scalable. It's too expensive. It's about 6% of primary care. People simply can't afford it. It's it's it's 1% medicine. It's it's for people who can afford it to do it. It's not something that's gonna solve medicare.

Passes, yeah. Yeah.

It's just not gonna work. It's it's a niche play. It's not gonna solve the big picture and be scalable.

I have to ask. I know we're out of time. But you went and said something provocative again. This notion of the pendulum shifting back potentially towards private practice and the way to stand out. Perhaps in this new economy? Are you in your role as advisor and and lead for soap. Are you guiding your audience that way? Are you encouraging physicians to consider that as a.

Yes.

Forward!

Yes, and the point that I make is physician. Entrepreneurship is much more than just creating a company. The deployment of innovation using a viable business model. and you can do that as an entrepreneur. You can do it as a sick tech or a tech entrepreneur. You can do it as a social or a public health entrepreneur. You can do it as an entrepreneur, and you can do it as a private medical practice entrepreneur. You can't do it the old way. You just simply cannot do it the old way the rules have changed. So the mindset is the beginning. The medical clinical mindset is different than the entrepreneurial mindset. And what I'm talking about is a correlation of 2, and if you don't embrace that mindset and supplement the clinical mindset with the entrepreneurial mindset. Do yourself a favor, and don't go into private practice.

Arlen. Thank you. You came here with a goal to have a conversation that engaged us. Well done, sir.

Thank you.

Thank you.

Very much arlen.

Next week we are going to continue our conversation with Michelle and Rene for Part 2 of commercialization pitfalls. We will see you at the same bad time next week. Arlen. Profound thanks. Have a good week. Everyone.

Thanks for having it.

Charlotte.

Bye.