Telesurgery, Telemonitoring, & Immersive Reality — Mark Carol MD, SonaCare Medical

Is remote surgery a growing trend? Are robot-assisted surgeries becoming the norm? Whatever happened to Google Glass? Is da Vinci’s market domination ending this year? Join our next live webinar with Mark Carol, MD, neurosurgeon of 30 years and CEO of SonaCare Medical. Discuss what is holding back surgeons from embracing telesurgery, telemonitoring and what’s happening in the surgical technology industry that’s getting us smaller, better, interconnected, self-learning devices.

2018 trends in telesurgery and augmented reality:

  • common blockers to telesurgery adoption
  • examples of remote surgery applications
  • new players to watch in the medical device industry

See Mark Carol’s Telesurgery, Telemonitoring & IR summary post here.

Transcript (click to expand)

00:05 Q: Thank you to everyone for tuning in this week for our telehealth secret to success with Craig. I’m actually pretty excited because I’ve known him for quite some time now. We’ve chatted quit about healthcare. Before we start, can you just share a little bit about your background? How did you get interested in broadband or in telehealth?

00:30 A: Okay, so, my background is 30 years of helping cities, actually helping people in general, understand technology and how to make the business case of using this technology in their school or business or whatever. So, you’re actually trying to use this technology to save money, make money, or run your organization more effecitvely, right? So, that’s what I do for a living. It’s just I’ve gone from helping people undertstand a specific technology or product to now I talk about this thing called community broadband, where it’s a city being, building a network, to improve various aspects of the city and of the people that live and work there. So, with grounding I call 20 years of being, working with tech companies, I basically feel that the marketting of those services or products, or now, we’re talking about, you know, categories of products, whether we’re talking programs, or we’re talking about telehealth. So, this whole thing of marketting, we’re always talking about markom, public relations, and so fort, but you’re basically trying to either take advantage of opportunities, or you’re trying to get rid of obstacles in your way of having a successful product right. So, now, we talk about broadband as a category and, so, policy is either an obstacle or an opportunity. As I was going around and talking about broadband in general, I had a stroke two years ago, and I call this stroke of insight, is that I’m in the hospital dealing with all theses issues and the treatment and the rehab, there are various things that were made easier because of high speed internet. My doctor, when I went to the ER, he was actually 45 minutes away, on a computer, watching my process and figuring out if I needed to have certain type of medication and so fort. That was all done through broadband, right. And so, the insight was so many people in rural areas and in urban areas, they don’t have good broadband to enable them to have better healthcare. And as I went forward, from the stroke, I started understanding more and more about various technologies that run over broadband. What I realized is that telehealth has a great opportunity to change how people are dealing not just with, you know, healthcare in the hospital, but like at the rehab, the mental health aspect of it, the living healthy aspect of your life after you have a serious situation like a stroke. And so, that’s how I started to really move forward because I’ve become to understand the correlation between telehealth and broadband. You know, looking at it, if you don’t have big broadband, you don’t good telehealth. If you don’t have good telehealth, you will shortchange people until they get this, making best use of technology.

05:39 Q: Maybe you can share some insights on your presentation? Then, after that, we’re going to open to the audience some questions.

05:49 A: No problem. So, I look at policy and broadband. Okay, because if you have good broadband policy, you will have a platform for getting your telehealth applications and services to the people who need it the most. If you have really bad policy, this becomes a problem, getting telehealth out there becomes a problem, a thing. You know, the telehealth world has done, in my mind, a pretty goof job of rallying support within congress and the white house for telemedicine. I think that’s a very good thing. You know, I think that there needs to be an equal effort to address broadband. Coming back to the whole thing, if I have good broadband, I’ll have good telehealth and vice versa. But, you have to understand the particulars of broadband policies and so fort. And so why don’t they just go through some of the issues of federal state and local policies and how they play with what you wanna do in telehealth. What I would ideally like to see here is that the people who are building these community networks would meet up with the telemedicine folks, the associations and so fort, and we come together because that becomes a counter to the incumbents who are trying to get policies that do not benefit either broadband or telehealth. So, if I look at the federal level, right, so, you know I think a lot of us have familiarized with the net we travel with and so the net, the basis of net you travel with is that we have wonderful folks who want to make sure that we have good access for everybody, small town, big town, whatever. And, why this is important is that you don’t wanna have your telehealth applications get hung up because of the relationship with that one ISP, one internet service provider, has with another. They’re trying to get a better advantage, right, and so you don’t wanna have telehealth become hostage out the marketting whim of various incumbents, large telephone and cable companies. Another aspect of federal policy, it deals with the speed issue. Right, we have what’s called 30, 25, mega speed download and 3 mega bits, right. What this means at a practical level for the telemedicine folk is that you need to have adequate speed in order to get your products and services, make that available to your customers, or the hospitals, or clinics, or whoever is part of this telemedicine process, right? So, the speed is a big deal while, you know, there are folks within, you know folks within congress and within White House and so fort, that are trying to lower the speed rather than raise it and this has an effect on how do you get money that goes out to build the broadband networks, and again the operation `of those networks after they’ve been built. So, you gotta pay attention to that issue and, in a little, I’m gonna talk about which part of the telemedicine world can deal with, you know, federal policy in theory, but basically, you’ve got that mentality, you’ve got speed, you’ve got broadband from it, because who gets money determines how well broadband gets advanced in rural areas and low-income urban areas. And so, like, for example, news comes out that the FCC is going to make 500 million dollars for broadband fillouts. That sounds great, but you have to look at the rules of determining who gets that money. Will it be the people who are actually building that birds that are super fast, or we’re gonna get money going to people who basically give us very inadequate broadband. And then, this broadband is an area that could become more of a federal policy discussion that like sate policy discussion, but understand if the federal branch decides that they wanna make it illegal for cities to build broadband, there are a lot rural areas that would not have broadband without having their cities, their counties, being able to do that. At the state level, we’re starting to see states, like Hawai, Montana, New York, New Jersey, where they are passing rules to reinstate net neutrality. So, in other words, the ability to have, you know, equal access to broadband is being, that now has been taken away at the federal level, now the states are saying, “we’re going to ensure that there is net neutrality”. States are worried to have some of the bigger issues of speed. For example, in California, and Tennessee, both of these states set the qualification for what makes broadband, what broadband it. They have lowered the bar and that’s a discussion that should’ve been attacked at the beginning of the last legislative session, right, because what that means here in California or in Tennessee is that, you’re probably gonna have problems getting broadband, especially telehealth to those rural folks in those affected states. There’s another state issue which is this phone call carrier of last resort, everyone who takes money from the feds or from the states, have requirements to provide some sort of broadband service or telecom service to rural areas. If you remove those, you’ll have a situation like the one we have in Texas where a hurricane comes in and devastates the infrastructure and the telephone companies have no responsibility to replace that. So, you know, just think about that for a second, so again, if you’re trying to get telemedicine out to rural areas of texas and they get no ability to replace the infrastructure that was there, what are you gonna, who you’re gonna sell your telemedicine applications to, you hear a lot today about small cells, which is usually talked about in the realm of 5 g, you need to have what are basically, these actually big transmitters that enable you to have 5 g right. Well, if you don’t have the good policy that addresses that, those small cells, you will in effect, negatively those people that typically don’t get good broadband to begin with. So, you have to pay attention to that and lobby and do whatever you have to do in order to keep that avenue open.

15:57 In the last area, municipal broadband. If you go to my website, which is CJSpeaks, I have a report that lists of the states where they have prohibited community-owned networks. Okay. This is important again, if you go, if you try to get your telemedicine, telehealth products out to the rural areas of North Carolina, South Carolina, Luisiana, there are 20 states that have various levels of restrictions on municipal broadband. If you wanna, ensure that cities and communities are able to build the infrastructure to have better broadband, then these restrictions have to be addressed and usually, what we’ve seen in the past is that every year there are one or two states that try to make their restrictions worse and we have one of two states where the incumbents pick telephones companies try to get laws passed that restrict community broadband. In those, specially in those fights, that’s where we need to have a presence of folks in the telemedicine industry. Right, because people will stand up and listen if you say that one of the reasons we need to have broadband and municipal broadband as an option is that it will effect how well we can get telehealth out there in those underserved areas. But, that part in connection with the other organizations and cities and so fort that fight at the state level, this needs to be a fight that is also joined by people in the telehealth area. This so you have here, this is a look of which states have a carrier less resort requirements and I would pretty much guarantee you that in many of those states, those blue states and the ones that have implicit requirements, there are efforts being made to undo those requirements and the thing, why they get away with those things is people aren’t paying attention. A lot of people don’t know that this is even being discussed, so, the same there’s a map that show where we have good telehealth policy, you need to look at the states that have good broadband policy, in my humble opinion.

19:24 And then there are the municipality policies where ultimately, we talked about, do they have policies that make it easier for companies, small or large, to be able to bring broadband into that city or county. Often, there will be some sort of policy that tries to ensure that there is competition. Because, if there is competition in the broadband spaces, if it’s not just comcast or just 18 t providing services, right, you will get a better deal, you will get a better policy, you’ll get better likelihood that you won’t have to worry about get whether my telemedicine app will be slowed down by the big companies. Okay, so what is the city doing to affect that. And then, there’s, how does the facility, the community facilitates community owned broadband. There was an article yesteserday that said that a city in Colorado, there’s a restriction in Colorado that says that you have to have a vote in order to, a referendum, in order to get broadband. Right, a city in Colorado said, you know what, these are turning into a fart where the incumbents spend lots and lots of money to try to affect the outcome of the votes. Right, so this groups of states/cities just said, “you know what, we are going to not do that process, we’re not gonna have, we will get our feet back and we’ll get validation and everything from the city, from the residents, and so fort, but we’re not gonna go through a formal voting process.” I have mixed feelings about this, but this is an example of a city policy that is affecting community-owned broadband.

21:49 I would say that that different of the telemedicine world, so you have the association and those are the bodies that will fight for good broadband policy or partner with other organizations that will try and get good broadband at the federal level, I think that they’re the best equipped to get in to that DC process. There are the telehealth resource centers which there are two national groups and 12 regional groups and one of their purposes in being is to affect policy at the state and the federal level. If you do not know, you know, or what is the TRC in your area, you might wanna take some time to get to know them because there are there to make your life better, whether you’re talking about the hospitals or the healthcare providers, or you’re talking about those who are selling services, okay, but those folks are an ally and I’ve had a conversation with the national organization and they’re very much aware of the correlation between broadband and telehealth and so, they are very much aware and following policy decisions that will effect broadband. So, get to them. Then you have the service then then there’s the product then there’s the so fort. When we are dealing with some of the state battles to keep good laws on the books regarding this whole broadband. It is often very benificial to have some of the bigger names in an industry be part of that fight, that, it’s not always a fight, but there are times like Georgia for example. Georgia went out of its way to assess the needs of broadband through the state and this is an example where the benders can have an impact on the broadband policy that can affect them. So, it’s in your best interest to be quick to follow this. And then, the healthcare facilities, the healthcare professionals and so fort, I would say that their hoskiel, where you can have the biggest impact is at the states and the city level because that’s where I think your willing to talk about telemedicine, telehealth healthcare in general and can be brought to bare and you can actually see your results for your effects. And then the close, some of the folks that you might want to partner with, you know, you go to the telehealth world, the same as there are state and national legislators who are friends of telehealth, there are friends of broadband. Sometimes they may be the same people but you need to find out who influences broadband decisions at the state level and the national level so that you can affect what they’re doing and making sure that broadband policy helps telehealth. Right, you have the various policy and activist organizations so similar to the TRCs, there are different organizations in broadband or in the broadband world that fight these battles, that speak out on behalf of the consumers, the businesses and so fort. You have vendors and ISP, wireless ISPs, all of that private sectors folks that are building broadband that are more in touch with the community level. You wanna work with them in helping to get better policy and, then ultimately you think that, the holidays and the co-ops that building these networks, and by the way, there are 750 either city governments, country governments, or co-ops that are building these networks and all of them are going to affect how adequate is the broadband in those areas that a lot of the telemedicine vendors are trying to reach. So, that’s the, I think the lane there, I’l turn it over to Milton now and we can have some question from the audience.

Additional Q&A with Dr. Carol

Q: Thank you for your vision and innovation that helps many of us consider potential new uses for VSee and optimization of tele-medical applications. As many of my colleagues are pre-occupied with medico-legal concerns – liability, malpractice, privacy, etc. — how is that addressed in this model?
– Bradley Dreifuss, MD FACEP (Emergency Medicine and global healthcare capacity development)

At this time, most of our users are concerned only about HIPPA compliance when using SonaLink (our VSee-based “product” for remote interaction). This is addressed by turning on the screen share after the startup screen on our treatment software – from that point onward there is no patient identifying information that is shared. Hospitals, and especially academic centers, are more worried about firewall issues. This we have had to handle on a case-by-case basis, and in some cases have had to disable SonaLink because we could not satisfy the facility’s IT department. We have a cybersecurity initiative underway currently to develop a global solution that will satisfy all users.

So effectively, the way to think about what’s happening with our technology is imagine that a surgeon is doing an appendectomy, and they see something that they haven’t seen before, and they’re not sure exactly how to deal with it. So they get the nurse. He dials up the professor at the local university, and the professor gets on the phone, and the surgeon describes what he’s seeing; what he’s doing. And the professor says, “Oh, I’ve seen that before. This is how you should deal with it.” And then the surgeon goes back in post. That’s essentially what we’re doing. We have somebody remotely doing that by using VSee. We’re able to share with the remote doctor, everything that the local doctor is saying, but there are medical legal issues associated with the information. For instance, that patient’s treatment plan is traveling over the web to a remote position, remote user. And so there are HIPAA issues associated with that. The data from that treatment is being stored on the local computer. There are HIPAA issues associated with that. So we have to implement certain firewalls. We have to implement tartest1n, we have to implement certain ways that the data is managed and treated in order to protect the patients, privacy, medical, Legally, we haven’t anticipated for seeing any issues above and beyond that, which one would normally run into if a third party was advising the local doctor.

Q: Will Tele-supervision/ telementoring become a standard of care? Liability issues for failure to receive expert input if adverse outcome?[Dale Alverson, MD, UNM Health Sciences Center for Telehealth and Cybermedicine Research.]

Our hope as a Company is that this becomes a de facto standard and therefore competitors that do not offer something similar will be at a disadvantage. That said, the FDA did not identify it as a mission critical component of our product offering. In addition, many physicians are reluctant to use it (it is optional activated by request of treating physician) because, as is the case with most of us, they do not want someone looking over their shoulder all the time. We work hard at getting our users comfortable with the idea that we will not share, either internally or externally, information about their cases or their abilities, but not all of our users buy into that.

Q: Can SonaCare technology be used for treatment outside of prostate cancer?

By the end of this year, we will be applying in early clinical investigations the technology that we have – both the Sonablate, which is a non-invasive or minimally-invasive device and something called Sonatherm, which is a smaller version of that probe, which is an invasive device. We will be running early clinical trials in rectal cancer, cervical cancer, breast cancer, thyroid cancer, kidney cancer….And interestingly enough, we’ve only talked about using focused ultrasound in this conversation to destroy tissues, but if you dial the energy down and you change the pulse sequences, it doesn’t destroy, but it alters the local cellular environment – reversably. So we are involved in some early trials, looking at using low energy focused ultrasound in the treatment of peripheral arterial disease, using it to alter the blood brain barrier, etc. If you look up on the web, “the focused ultrasound foundation” it has a page on their website which lists all of the various applications that focused ultrasound is being looked at for clinical benefit. The ones that I described are specifically the ones that we’re looking at.

Q: Any future plans for utilizing technology to repair bone fractures and such (besides treating cancer, tissue abblation and such)…using Ultrasound?[Sarder Sohel Ahmed]

Bone interacts differently to ultrasound technology than does soft tissue. Our device currently is not configured correctly to impact bone repair/healing etc. However, we have been investigating using our technology to impact soft tissue function surrounding bone, for instance in conjunction with stem cells in the treatment of cartilage and ligament damage. We have had early success with this application and are planning on exploring in greater detail.

Q: SonaCare has some sort of Referral Assist function. Do they treat patients from other states & from abroad and what referral case management system do they use in those cases?[Vlad Kuznetsov]

Although we once were in the business of treating patients directly at off- shore locations, we no longer do so. We field inquiries through our website and other points of contact that we then refer to the users of our technology closest to the inquirer’s location of residence. We provide a map on our website with the locations of all users so the prospective patient can reach out to whomever he wishes.

Q: During the procedures, do you tend to see any issues around lighting or sound that are going on with the amount of other equipment in the OR? [John Kornak, Ellumen]

We have had no interaction issues to date. This makes sense since there is little else going on in the room other than the use of anesthesia equipment (no electrical surgery equipment being used). We did have one instance, during a combined robotic/HIFU procedure, where the electro cautery system used for the surgery caused interference with the ultrasound images while the electro cautery was being used.

Q: What are the primary ways in which surgeons are using telemedicine? What are the biggest blockers to using telemedicine in surgical post-op follow-ups?[Alex Zhao, RosettaMD]

Unfortunately I am not well versed in telemedicine in general. We look at our use of the technology as more tele-assist or tele-observation then delivering telemedicine. Based on my limited understanding, most telemedicine is used as a means of remote patient interaction – diagnosis, consultation, checkup, etc, rather than actually delivering a medical intervention.

Q: Are there age limitations to have this type of procedure?[Vicki Hitchcock]

No, albeit prostate disease is usually one of older men (age 55 and above). That said, there is no clinical determinate for age limitation on the use of focused ultrasound for the treatment of disease.

Q: What is the progress so far with resolving the issues with the low bandwidth for overseas market?[Sarder Sohel Ahmed]

Not sure I understand the basis for the question as most of the overseas market in which we operate have a greater bandwidth than we do. We use SonaLink to connect doctors in Europe with our users in the U.S. since Europe has more experience with our technology than do doctors in the U.S. We also have provided remote support through SonaLink for treatments in Turkey, Israel, Mexico, and South America.

Get more expertise on telehealth regulations, physician adoption, and more from our telehealth video podcasts or see talks from Univ. of Calif. Health, DaVita, Microsoft, Dell from our 2017 Telehealth Failures & Success Conference.

About the Speaker:

Mark Carol SonaCare CEO

Mark Carol, M.D.  is the Chief Executive Officer & President of SonaCare Medical. Dr. Mark Carol is a neurosurgeon with over 30 years’ experience in the medical device and health care services arenas in publicly traded and privately held companies. Widely viewed as the “father of IMRT” and a household name in Radiation Oncology, he has a proven track record of taking nascent disruptive technology, in multiple disparate fields, from conceptualization through commercialization.

He was the founder and CEO of NOMOS Corporation, the “first mover” in the development of 3 paradigm shifting technologies in radiation oncology, intensity modulated radiation therapy, inverse treatment planning and image-guided therapy. He was also the CMO of Xoft, Inc., and Alliance Oncology, where he developed clinical program strategies for miniature x-ray sources used to deliver therapeutic ionizing radiation (Xoft), and developed novel oncology treatments sites through JV or direct ownership (Alliance). Dr. Carol held development & consulting Medical Director positions with large NYSE and NASDAQ companies, such as Varian Medical Systems, Accuray Incorporated and Siemens Oncology.



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