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Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

February 16, 2022

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense, particularly when tracking abnormal eye movement? 

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Scott Anderson, Chief Clinical Officer (CCO) at SyncThink about the groundbreaking work the company is doing in advancing neurological assessments by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.

You’ll hear how Scott went from his position as Head of Sports Medicine program at Stanford University, where he was part of a multidisciplinary research collaborative studying the natural history of head injuries. Though the technology was initially developed to aid in concussion protocol and the clinical care of athletes with head injuries, the potential of EYE-SYNC technology is now used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.

 

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Some highlights of this episode include:

  • SyncThink specializes in neurological assessment by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.

  • Besides concussions, EYE-SYNC technology is used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.

  • Verbal or motor actions are the result of real-time brain function using the eyes to orient yourself to what’s happening and respond in real-time. Neurological deficits in performance occur across one’s lifespan due to disease or impairment.

  • SyncThink’s EYE-SYNC technology has the potential to proactively prevent health problems in the future. It could facilitate the migration of hospital-based care to consumer-based driven care to preserve brain health. 

  • If used as a surveillance or monitoring tool, EYE-SYNC can identify improvement in brain function based on medication deployment. It helps clinicians learn to better titrate medication to specific individuals, such as children with ADHD.

  • Scott admits that he faced logistical challenges and obstacles when doing clinical trials to get the first FDA clearance for following concussion patients.

 

Links:

Scott Anderson on LinkedIn

SyncThink

FDA - Medical Device Overview

FDA - 510(k) Clearances

Q-Collar

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes from SCOTT ANDERSON:

“There’s a whole host of neurological disorders that have a high prevalence of abnormal eye movements associated with it.” 

“Your eyes actually serve as the window to the brain. It allows you to orient yourself to the things that are happening around you.” 

“Your brain uses your eyes to select content it wants to interact with.” 

“Our bread and butter is the software and analytics and the eye tracking measurement, and there’s a whole host of these cases for this.” 

“As technology evolves, too, as well, there will be, I think, several opportunities in order to accelerate the clinical utility of something like eye tracking for a whole host of neurological conditions.”

 

Transcription

Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts in companies.

Etienne Nichols: Hello. Welcome to the Global Medical Device podcast. Today, we are talking to Scott Anderson from SyncThink. Scott has a really diverse background. He was a distinguished leader of the Sports Medicine program at Stanford University. It was there he met subsequently worked alongside Dr. Ghajar as part of a multidisciplinary research collaborative studying the natural history of head injuries. So over a three- year period, Scott worked closely with Dr. Ghajar to roll out investigational studies into the eye- technology. His technology looks at eye tracking, and that is the device that we'll be talking about today. So in addition to his deep product knowledge, Scott also brings market expertise in domestic international sports organizations. He's actually a spotter and a consultant for the NFL. And prior to joining the team at SyncThink, he served as the chair of the Pac- 12 sports medicine committee. So it's interesting conversation we have today with Scott talking about their product, how they brought it to market and the different barriers that they overcame. I hope you enjoy today's episode of the Global Medical Device podcast. Let's get started. Hey, everyone. Welcome back to the Global Medical Device podcast. This is Etienne Nichols. Joining me also today is Scott Anderson, and of course your host Jon Speer, founder of Greenlight Guru. Excited to be back with you guys today, so we're excited about this episode. Like I mentioned, we have Scott Anderson. He has 10 years of experience with the Sports Medicine Program at Stanford University. He's also a consultant on the National Football League. Prior joining the company that where he is now, he served as the chair of Pac- 12 sports medicine committee. We'll talk more about his different background and things that he's involved in, but I'm excited to be with you all today. Scott, you want to add anything to that? I'm sure you can add a lot, I'm sure?

Scott Anderson: Well, thanks that Etienne and Jon for having me, I really appreciate it. It's great to be with you guys. I think it's a really exciting time for how healthcare and healthcare technology, and I'm excited today to talk a little bit about some of the stuff we've been working on at SyncThink and how I think my unique background plays a part in the work that we do. So I'm glad to be with you guys and excited to talk more about what we're up to.

Jon Speer: Just to remind folks your current role, you're the I think the chief clinical officer at SyncThink, right?

Scott Anderson: Correct.

Jon Speer: And we're at talk all about that. And, and folks, if be curious in the meantime, or while you're listening, you can check out sync thing, just go to their website. And we'll talk a lot more about them here in a little bit, but it's very easy, it's sync. com, S- Y- N- C- T- H- I- N- k. com. And it's really cool technology and I'm excited to learn more about it today. Yeah.

Etienne Nichols: Speaking of the technology, so why do don't you tell us a little bit about it? I'm very curious about your background and how you applied it to this product, but maybe we can set the stage by talking about the product just for a moment.

Scott Anderson: Sure. So SyncThink is a neurotechnology startup based in Silicon Valley. And we really have specialized in neurological assessment, and really how we do that is we've built a digital health proprietary, digital health platform that's based on eye tracking and capturing and recording and objectively measuring eye movements. And what people often don't really realize is that there's a whole host of neurological disorders that have a high prevalence of abnormal eye movements associated with it. And so we built this platform that leverages a virtual and/ or augmented reality headset that the patient wears to capture and record and analyze the patient's eye movements in a series of very brief assessments. And so we do different types of assessments to essentially measure real- time brain function. And real- time brain function can be captured accurately using virtual and augmented reality head mounted displays that are embedded with sensors and infrared LEDs that can illuminate the eye position inside these headsets, and so this allows cameras to record what their eyes are doing. And a lot of our kind of proprietary secret sauce is built on the measurement, the algorithms, the quantification of what the eyes you're actually doing relative to whatever content we provide inside the headset.

Jon Speer: You mentioned there are lots of neuro I guess, issues that your technology can help with or help diagnose or determine. I mean, obviously the big one that most listeners are probably familiar with, especially those sports fans out there is concussions, that's obviously been a hot topic for the next few years. What are some of the other neurological conditions that you see where your technology can be applicable?

Scott Anderson: I like to look at this in three categories, you have neurodevelopment, you have neurological function or neurological performance and you have neurodegeneration. And what people don't actually realize, I'm going to kind of give you a little bit of background on the science behind this real quick, which is that your eyes actually serve as the window to the brain and allows you to orient yourself to the things that are happening around you. And so your brain actually utilizes your eyes to become oriented to what's happening around you. And so you can interact with people and you can respond to things that are occurring in your environment. I like to say that your brain uses your eyes to select content it wants to interact with, whether that be on your phone or if something's out in my environment. I'm at a baseball game and a ball's flying at my forehead, I better do something. Right. And so I have to move my eyes to select that ball, understand where it's coming from and how fast it's coming towards me. And then I have to have a sensory motor response, whether that be, I yell, oh, my God or I move my head out of the way, right? So either verbal or motor actions are the result of real- time brain function using the eyes to orient as to what's happening and then to be able to respond to it in real time is essentially how your brain is operating throughout the day. And this can we see deficits in how this performance occurs across the lifespan. And so certain conditions that occur in children such as autism and ADHD in adulthood or early adulthood, we see this highly prevalent in acute injuries like concussion or vestibular disorders where people have acute attacks of dizziness and in neurodegenerative diseases like Parkinson's, Alzheimer, dementia, schizophrenia, even. All of these share one thing in common or two things in common, I would say is that traditionally they have always been diagnosed subjectively and the clinician is used to asking the patient about their symptoms or what's happening to them in order to make a diagnosis by exclusion. And secondly, they all have a really demonstrated prevalence that's been published. Some of these conditions way back into the'60s of having abnormal eye movements associated with them. And so what we've spent the last 15 years doing from an R& D standpoint is categorizing these abnormal eye movements and separating them out from each other to be able to show that these eye movements signatures, or what we refer to as biomarkers of disease or impairment are unique and distinct from each other.

Jon Speer: All right. So this might be an oversimplification, or I could be totally way off base, but you're developing technology that's leveraging neuroscience to help with diagnosis of certain neurological conditions whereas the previous gold standard in many cases was clinician assessing symptoms. It's not that they didn't have science, but they weren't using the neuroscience to support their decisions in some cases.

Scott Anderson: Correct. And I would take it a step further and say in many situations, these neuro specialists were doing things like MRIs or CT scans to look at the brain, but really that gives you information about the anatomical structure of brain, not about the neurological function, the functional capabilities of the brain, how the neural networks connect to different aspects of the brain and how they deliver messaging to allow execution of visual processing of information. And so we've never really had this type of technology before and I'm really bullish on this idea that this can also be something for consumers. You want to know how your brain performances today, and if it's optimized for what you're going to do for your job, or if your brain is actually functioning the way that it should be, or if you have something that's affected. If you have drug or alcohol abuse, if you're abusing drugs and alcohol, I should say, I mean, it's going to affect your brain's realtime function. If you're sleep- deprived, it's going to affect your realtime function. If you're highly caffeinated, it's going to help you optimize your function. And all of these measurements can be taken instantaneously from moment to moment and when these behavioral modifications occur it changes. And so we can see in real time how it changes, whether it's getting better and going up, whether it's getting worse and going down. And oftentimes, this follows our lifespan and it gets better as we grow and we develop it's optimized while we're young and middle aged adults and then it gets worse as we get older. And so able to know that and to equip people with objective information, to show them, this is really critical information for clinicians, one, to make better clinical decisions, and two, to identify the appropriate therapeutic interventions that these people need in order to overcome these conditions, or to at least manage them.

Jon Speer: As I hear you talk, I'm optimistic because I think so much about the healthcare system, especially in the United States is reactionary. It's dealing with something that's already happened and it's like slapping a bandaid on it a lot of times or throwing a pharmaceutical or what have you. But what I like about or what I hope is the potential about what I'm hearing you describe is the ability for us as humans to be more proactive about our own healthcare. We go to the doctor to get physicals or maybe you get a baseline EKG or whatever the case may be. Well, why shouldn't this be part of that regimen so that I as a human can know where I'm at and get that early warning sign so that I can take a proactive measures before it becomes a big deal.

Scott Anderson: That's spot on, you're exactly right. And that's what we're really keenly interested is creating more accessible access to this technology, not only within the healthcare system. But as technology evolves, we really see that there's an opportunity where potentially this could be something that is enabled on consumer devices, your phone, your Apple watch. Potentially in the future. You're hearing a lot of talk about AR glasses that you just wear and you know, it's going to replace the cell phone and we think hat's something that's highly probable in this decade that's likely to occur to allow us to I think facilitate the migration of hospital- based care to consumer- based driven care where you and I are dictating what type of help we need from the healthcare system by monitoring our own brain health and making decisions to preserve it.

Jon Speer: Very cool.

Etienne Nichols: So I'm curious so when you went through the validation, you mentioned like 10 or 15 years R& D search or research. So as you went through, I'm sure you interact with a lot of different patients, did you start to almost diagnose them in your mind before you even got to the product or?

Scott Anderson: Yeah, it's a great question. I think we were really after is, and I'll go back ways early 2000s, this started our founder, Dr. Jam Ghajar is a neurosurgeon and really got his start looking at this type of measurement tool or measurement capability with the department of events. We had a lot of people who were having brain injuries from the Afghan wars and from and associated sequel coming back from wars, having undiagnosed head injuries, having PTSD, having reliance on drug and alcohol problems to cope overmedicating with prescriptions, those types of things. And really he received an initial grant to look at trying to develop a measurement system for something that could be simple and easily deployable to be used in the field battle to justify whether or not someone should be removed from duty. Because they wanted to all these people were coming back from the wars with all kinds of problems, burdening you the U. S- based healthcare system for veterans.

Jon Speer: And to mention their quality of life is terrible. And nothing was being done at the point of where the injury is occurring, right? It was nobody was saying anything and so a year would go by and they would come home and they have all these deficits. And so really that's where this idea came from was we need something that's mobile, that's very simple to use that any army medic or any soldier can use in a forward- field deployed capacity and get a quick measurement on somebody and determine whether or not they need to get out of there. And that was the kind of whole basis for that and we had a series of grant and funding that came from the Department of Defense over a 10- year period that allowed us to not only develop the technology to meet their specifications and regularization requirements, but also to do the studies, to look for the specific unique identifiers of abnormal eye movements that occurred with traumatic brain injury. And we were able to identify this and the military was like, okay, well, how do we know that's related to traumatic brain injury? We have a high prevalence of ADHD in our military population, we have a high prevalence of sleep deprivation in our population can we study those populations as well? And so we began to study look for signatures for ADHD and sleep deprivation and found that those were all different and unique to each other. And so then we started saying, huh, this is really interesting, let's start looking at other conditions outside the military population and it just kind of grew from there. And in 2017, after 10 years of studying this and working with the military received our first FDA approval through a pivotal clinical trial that we did with military soldiers, athletes, and civilians and that allowed to commercialize the technology beyond just a military version. And so we've really only been in the market for a little over three years in the healthcare market, but it's early days still for us and technology is still evolving, but that's essentially where it started.

Etienne Nichols: But right now, what are the indications for use right now since it's a broad spectrum? Is it just brain trauma or how do you define that?

Scott Anderson: So we have a very broad and a very narrow clearance. Our initial clearance was for viewing, recording and analyzing eye movements in human subjects in support of visual impairment identification. And so this allows us to essentially provide this technology in support of any condition where there are abnormal eye movements. So all the conditions I previously mentioned, this can be used by a clinician in order to do that. Recently, a few months ago, we received to our first kind of clear indication for as an aid to concussion device or technology probably three or four months ago after another kind of deeper clinical study that allowed us to get a more specific clearance for that. We have additional clearances that we're targeting and going after currently to expand those even further. And I would also say too that we're in the middle of a national study for ADHD and so that's kicked off in 2021 and we're in the middle of that right now. It's an exciting time for us to expand those indications even further.

Etienne Nichols: Very cool. So the ADHD, are you targeting youth population as well or is it just the adult population?

Scott Anderson: Yeah, both adult and children in adolescents.

Etienne Nichols: That's exciting.

Scott Anderson: And what we're really doing is a lot of our initial studies that showed the presence of this biomarker and ADHD was in the military population so it was heavily based on adults. And so what we're doing with the national study now is working with clinicians all over the U. S. to capture more data specifically, I would say with an emphasis on adolescents and children to verify the presence of the biomarker in that population as well and also to validate the changes that occur in real time brain function during titration. Because many of these patients are placed on a dosing regimen to control their ADHD, right? They're medicated. And one thing that's really interesting about our technology is that if utilized as a surveillance tool or for serial and monitoring, we can see the improvement in the brain function based on medication deployment. And so it helps the clinician learn to better titrate the medication to the individual.

Jon Speer: I mean, I think that's huge, I don't know if big pharma will be fans of that necessarily. I think that's always as a parent my kids are older now, but as they're growing up, I mean, it's crazy. And at the end, sadly, I hope not. But here in a few years you might have to deal with this too, but how many kids are diagnosed with ADHD or whatever the case may be and prescribed medication? There's litany medications, but I always wondered how does one know that that's effective? And usually it's that back to that symptoms, right? You are like, oh, well, they had these symptoms before and now those symptoms have less and so therefore it must be effective, it didn't seem like there was a lot of science behind it

Scott Anderson: That's right. And I think it's our understanding of this population is still in its infancy, it seems to be highly more prevalent here in the U. S than in other countries. And I think in talking to these professionals all over the U. S. over the past 18 months or so, it's clear that there's an urgent need for objective information and helping them manage these patients. Because I don't think anybody feels right about putting a seven year old on medicine, on pills. And so I think there's something there that we're keen to evaluate further and to explore through this trial. And to your point about the pharmaceutical companies, this is another side of our business that we do work with pharmaceutical companies. And part of when we first were commercialized, we did work with a company called Shire who was a heavy producer of ADHD medication, they've now been purchased by Takeda. But we had some initial work with them on this front that gave us kind of a head start and understanding what the market opportunity was looking like.

Jon Speer: I can imagine as a physician, I would want to prescribe therapies or whatever the case may be that I wanted some certainty to know that this was going to be effective with my patient. So I can see that being an awesome tool and a resource. And the other thing I think is interesting as we're talking, I can almost envision that the SyncThink platform could be a vehicle or a mechanism for other device developers, right? There's been so much area or focused on areas and Parkinson's, and even Alzheimer's dementia that it seems like, wow, I, maybe I should engage SyncThink and collaborate with us in some way, shape or form to do a study that can help us design products and technologies that could be more effective.

Scott Anderson: Absolutely. And I think that's kind of our bread and butter is this the software and analytics and the eye tracking measurement and there's a whole host of use cases for this. And we're early stage startup and I don't know that we're going to get to all of them, right? So we're certainly keen to work with other organizations who have potential interest in pursuing those other markets. And I think we've been approached by those folks in the past and haven't really been from a company standpoint in a place to be able to entertain that because we wanted to keep our focus on what we're doing. But I think there's a place for that in the future. And I think as technology of bulbs too, as well, there will be I think several opportunities in order to accelerate the clinical utility of something like eye tracking for a whole host of neurological conditions.

Etienne Nichols: When you went through, I'm curious if we go back in time just a little bit, were there any obstacles you really faced? One of the things that made me think of this was, it sounds like you had almost the perfect setup with the military, the different populations with these different very obvious diagnosis, obvious might not be the right word, but what were some obstacles you faced though?

Scott Anderson: Well, I think it's when we were doing our clinical trials to get our first FDA clearance, it was quite a challenging endeavor, I would say in the sense that when you're trying to essentially follow for a year concussion patients in different locations that are military, civilian and athletes becomes a logistical challenge. And so what ended up happening was this is a really interesting story actually, is that we had two research groups, one in New York, Boston area, and one in Northern California. And we built and fashioned and retrofitted Winnebago basically and built a whole inside of testing booths. And whenever we register somebody, we had different time points in which we had to reassess them and so we take the Winnebago to their location and do the follow up testing. And so we were basically mobile on wheels going through New York and Massachusetts all over those states and also Northern California to be able to track these people down and capture them in their locations, whether they're at home or at their sporting venue or the army base or wherever they were. And so I think it took a small army of people on our side to be able to pull this off. We had a significant research organization working on this to make sure that we were doing it correctly and following all the protocols. So it was an extensive effort to get 10,000 people.

Jon Speer: Etienne, I have a slight variant of your question. I mean, so Scott, when you talked about the initial focus was for military applications and then as the team got into that, they realized, oh, there's a potential application over here and one over here and one over here. That seems like a good, bad problem to have good in that, there's lots of potential use cases, but maybe and it distracts your focus, right? So can you speak to sort of the pros and cons of that?

Scott Anderson: Yeah. I think people always talk, especially here in Silicon Valley about not boiling the ocean as an early stage startup, right? And that's something, I think that we were very hyper aware of like knowing our limitations and knowing that there's tremendous market potential for this. And there's potential a lot of opportunities for us to, I think, grow and scale our technology into different use cases. But I think we really had the mentality that we really needed to drill down our focus into areas that we knew that we were good at. Our founder is a clinical specialist and concussion, I am as well. And it was kind of the first step for us was to focus on that because we knew the market, we knew how to pull off the studies, where we had treated people with those conditions for a number of years and for decades even and we had done prior studies in those with the military. And so I think it was once we sat down and decided what are we doing, we could go for 5 or 10 of these things. No, it was either raise$ 250 million in a seed round or be logical and focus on what we knew best and it grow from there.

Etienne Nichols: That's awesome. So you said 10, 000, so my head's trying to get wrapped around that number for a validation, is that how many people you were following?

Scott Anderson: Yeah. We had 10, 000 subjects ages 7 to 70 and took, I would say two years to identify these individuals and track them longitudinally and test them at different time points, so it was quite the effort.

Etienne Nichols: That makes me feel pretty good about the technology, that's a good number.

Scott Anderson: Yes. We do pride ourselves in having the largest kind of normative eye tracking database in the world and the large part of that is because of the clinical studies that we had done previously prior to commercialization.

Etienne Nichols: Well, I'm excited about the big data behind it. Did you have to sync up with other, I don't know, databases of information, for example, when you talk about sleep deprivation, it seems like a moving target based on the person you're talking to. I'm just curious how you define some of those things?

Scott Anderson: I think in many situations our preliminary studies looking at sleep deprivation was done with military soldiers because. I don't know people know this, but there are certain conditions under which the military purposely sleep- deprived soldiers. And so we were very lucky to be part of some to have access to those populations while they were going through that process. And we actually coordinated army bases known for doing a lot of unique things with technology and also doing some really interesting things to soldiers to see how they respond. And so we worked very closely with the folks at Fort over a period of years to do different sleep deprivation studies and that's where we got our original kind of signature pickup from those studies. And then from there, as we did additional trials we had to be very careful about the conditions in which these people were sleep deprived right? We couldn't just take our word for it, we had to really have a very, I think, specific protocol that they had to follow. And you have people that drop out of studies like that because it is a moving target, right? So you do the best you can and you look for the consistency in the participation and you try to do the best you can.

Etienne Nichols: That's cool. Any other stories about as you were going from different places, different places, looking at the concussions, obviously you're served as a consultant on the National Football League, any thoughts on that or how that went?

Scott Anderson: So what I do for the NFL is different than my day job with SyncThink. I'm part of the concussion protocol for the NFL and I've been active for, I think this is I just finished my 10th or 11th season, something like that. And so I've been doing it for a long time and really my job is to serve as a injury observer on game days. And so basically I'm the guy that sits up in the booth and pulls people off the field and communicates to the sidelines to have those players evaluated. It initially started as something that is specific to concussion and you look for certain criteria that makes you suspicious in order for that to justify them to get evaluated, but it's grown to musculoskeletal injuries and other things as well. And so it's a very unique program, I actually enjoy it and I think it's definitely made the game safer, having eyes in the sky to communicate with folks. We provide a whole host of video feeds from different camera angles and we pipe them down to the sidelines so that the medical staff for each team can view the injury from the angle, which it's best to be, be viewed at. And so gives them some insight into the mechanism of injury and the severity of injury as well.

Jon Speer: I just can imagine your set up on game day, you have like a whole wall of screens of things that are happening?

Scott Anderson: I have a couple of technicians that work with me in the booth and then there's one on each sideline. And the technicians that are with me in the booth have a joystick controller and this allows them to select a different and to rotate the play and to slow it down, speed it up and we have a whole tagging system that goes into a database. And it's really interesting, I think when I explain to this people, they think it's fun, but it's also can be very nerve- wracking because you have to make decisions that are going to affect outcomes of games potentially by taking people.

Jon Speer: I mean, you're trying to do what's right for those athletes, I can imagine it makes it difficult to be a fan at the same time?

Scott Anderson: It is, I cannot watch a game now, college or professional without looking at it through that lens because I'm just constantly pointing out, oh, that person just injured this or this person just, so it's less enjoyable, I'd say.

Jon Speer: Well, and obviously concussion awareness is one of the higher profile potential applications of SyncThink. And as you were talking about that, I was reminded, Greenlight worked with the company a few years ago, they had developed this thing, I think they call it the Q- Collar, have you heard of this thing?

Scott Anderson: Yep.

Jon Speer: And it's basically like a thing you wear around your neck and just a hearing about the development that. Because up until that point and probably even yet still a lot of helmet manufacturers were trying to modify the designs of their helmets to prevent that. But it's like, ah, that seems the wrong approach, but that Q- Collar is really interesting and I'll often look it up to see where they are, but they had some pretty promising results I know in their early studies.

Scott Anderson: Yeah, they did.

Jon Speer: Ken, have you heard of that? The Q- Collar?

Etienne Nichols: Yeah, priority to designs. Sorry. I thought you were talking to Scott, my bad.

Jon Speer: It's kind of cool, it's simple how it works.

Etienne Nichols: I love how they, I mean, sometimes the simplest designs are the best. They just looked at that woodpecker, it's like, why doesn't a woodpecker get a concussion? It's just that around the neck, that's very cool. I know they're cleared in the United States now, so it's pretty exciting to see that. One of the interesting things about them and I'll let you talk to just a second, sorry. They went as I believe just a device that could be sold and then they became a medical device, I know yours is a diagnostic for a medical device. Now FDA cleared any thoughts on those different pathways maybe not them specifically, but just curious if you toyed with those ideas.

Scott Anderson: Like I said, there's something that I think you walk the line between protective equipment, so to speak or a medical device that can prevent situation from happening or enable the evaluation of an event from happening or from event that has happened. So I think part of this, in my opinion is there's this convergence happening between technology and enterprise/ healthcare use cases where everybody, I think particularly with XR technology AR and VR is rushing towards healthcare, right? There are so many applications where VR and AR and I would say biometric devices can be used for healthcare purposes, everyone is rushing towards that. But what's also happening simultaneous to that in the swim lane next to it is that consumers are taking more and more ownership over their healthcare, over of their health data and managing it themselves, right? They're with wearables and fleet trackers and activity monitors. So I think there's a natural convergence happening and where these are going to collide and we're going to be leveraging these consumer devices for healthcare purposes. I mean, look at the Apple watch, the Apple watch has an FDA clearance, it's a consumer device. And I think we're going to see a lot more of that in the future. I think, like I mentioned before as we get to consumer glasses, these things are going to be able to detect all kinds of different problems. Your phone is going to be able to tell you whether or not you have certain potential neurologic or musculoskeletal disorders just based on the jitter in your hands or how often your hands are how tightly the hand is gripping the device. And then when we get to, I'm really excited about the potential of contact lenses, smart contact lenses, to be able to basically operate as augmented reality fields to help filter information and can be voice directed or eye directed towards a whole host of conditions. So I think these are going to be naturally, I think the future is where we're going to see a lot of this happen, where we're going to be able to use medical data or patient data that's derived from the consumer for healthcare use case. And the medical devices of today are also going to become consumer devices and vice versa, so it's really interesting.

Jon Speer: Well, and not just the medical devices are going to become consumer device, but the tech that we all have, the consumer devices are going to have medical- device applications within them.

Scott Anderson: That's right.

Jon Speer: I'm with you, I'm excited about that. I mean, I've talked with guests in the past, like a lot of we'll just say fitness trackers of things that people are wearing on their wrists or what have you. Those are not really regulated by and large by FDA right now, they're determined to be a general wellness device. So I think from a regulatory point of view, I think those companies to make that leap from being a consumer device to a medical device, there's a leap. And by the same token, I hope FDA and other regulatory bodies are, I know what I'm about to say is maybe in the category of an oxymoron, but I hope they're quick and adaptable enough to be able to accommodate that as well. And I know there's lots of programs underway at FDA to try to accommodate, but these things are moving way, way more quickly than the regulations can keep up with.

Scott Anderson: Well said. I think when it came out, initially softwares in a medical device that was the first kind of formalized effort. And I think you see a lot of people running at that, right? Is can we leverage software that can exist on a consumer device or on a proprietary medical device to be used for healthcare purpose? I think that's the first step, I think we're going to see others as well. But I agree, I think there's a long way to go before they match the speed of innovation with technology, so it's challenging.

Etienne Nichols: Well, it's exciting. I'm excited to see the future for SyncThink and it's exciting to hear what you've accomplished so far.

Scott Anderson: I appreciate it. I think we move at the pace of technology and I think the next five years are going to be really fast in terms of how technology evolves. And I think we're going to see a lot of evolution in terms of how our products and services reach the market and for the different use cases that we talked about.

Jon Speer: Absolutely. I appreciate you sharing so much today. Thank you.

Scott Anderson: Yeah, no problem. It's great to be with you guys.

Etienne Nichols: All right. We'll let you get back to it. As to our listeners, thank you for listening this to the global medical device podcast. If you want to know more, go over to the www.greenlight.guru website and we can direct you to more information on SyncThink as well as Greenlight Guru's global medical device platform.


 

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...