2021 EnMed Student Innovation Symposium Part 1

good afternoon my name is erica green and i'm one of the course directors for one of the inmed pre-clerkship curriculums named practice of medicine and it is my pleasure to welcome our students awardees faculty leaders and our community to our first in med symposium innovation symposium we're so excited about this opportunity this was the plan last year but due to covid we could not highlight our students and their progress but we're hopeful that this will be an annual event which will build in terms of [Music] bringing attention to this unique program not only within our institution but the medical center with expectations that will gather attention both nationally and globally so we hope that you enjoy this afternoon program and it is my pleasure to introduce our executive dean of the inmed campus and chief executive officer dr rodrick pedigree dr pettigrew uh thank you erica and good afternoon in med class of 2024 and those of you who have joined us from the class of 2023 uh as well i want to add my welcome but also add my thanks to dr greene and also dr sears who conceived of this symposium as a follow-on and a concrete step in helping us to achieve our goal of training you to be innovators it is based on the practice of medicine course which erica and dr uh uh bhagavir lead and uh and instruct you in but also doc dr sears and in fact uh i have to credit dr sears with the unique name that we all have embraced for the awards that will be given today in the first part of this program the innovas following from we all family with the emmys and the grammys and the espys and the tonys now inmed introduces to the world the anovis but i would like to actually start or i've already started maybe i'll say continue by reviewing our mission and i think that's a great place to continue with at this beginning of the program and our mission is to develop a new healthcare professional who is trained to be an exceptional physician and also equipped to invent practical solutions to healthcare problems we do this through the convergence of engineering and medicine and we call such innovators physicianeers we bring to the world this new type of health care profession in this physician here this particular effort that we are recognizing today as described by dr green is indeed an early course-based step in the process of our developing physician years where medicine and engineering and innovation principles are blended i have a definition a practical definition that i use for innovation it's invention put to use so the overarching goal of this particular symposium is to take this initial critical step in developing such innovators those who develop inventions that are put to use and the overarching motive is quite straightforward so if you think of where we are in the practice of medicine today and where we would like to be with the prevention of disease where possible and when disease does occur we'd like to be able to detect it early on and after making that detection with precision early on for that for the therapies to be delivered also precisely uh many of these preventive measures will occur in the home detections early on would occur in the home and when there are therapies and interventions that are delivered those ideally would be invasive to minimally invasive so all of that requires technological innovation so we could not possibly get to where we would like to be in the delivery of healthcare without the kind of innovation that we're training you as healthcare innovators to deliver so this symposium and the innova awards represents the first step in that process for inman this particular process really focuses more on the ideation and uh an understanding of what it would take to deliver a product into the practical space where people could use it but that is uh just the additional the initial step there are of course additional steps and one of them is to actually invent a solution to a healthcare problem with the goal of bringing this to the marketplace where appropriate while all inventions will not be commercialized in some will to help realize this process we've also instituted a separate program that will be introduced at the end of the novi awards and the goal with this particular goal and this is called the capstone program this is open to all med students who will partner with established investigators at methodist to tackle known problems in need of solutions the first round of applicants to this particular rnd program which provides funding to execute the projects have been made and the decisions for those applicants will be announced after the anovi awards the funds to support these projects are courtesy of four generous donors those donors are well known to us sue smith and craig brown and gene and frank raymond we are indeed delighted that they are able to join us and we will hear from them briefly towards the end of the program so now it is my pleasure to turn the virtual microphone over to dr moreno who will introduce our keynote speaker dr moreno thank you dr pettigrew i really appreciate that i appreciate the opportunity to to introduce our distinguished keynote speaker today you know one of the key attributes of this program is that it incorporates a unique master of engineering degree curriculum that's focused on the design and implementation of medical technologies so the first stage of the design process of course is identifying and precisely defining the problem or opportunity for innovation that exists and to do that obviously you've got to engage stakeholders and talk about the people that have frontline experience with those opportunities and challenges um and then you know once you've kind of got that information together you can start to you know the ideation problem in earnest and today you know we're going to be recognizing students that in this first year in the program that have just been introduced to some of these ideas you know have done an outstanding job in this part of the design process but you know the point i want to make really as i as i start to prepare this introduction is that the other primary mission of inmed is the implementation so we don't want to just design a solution we actually want to see the solutions that in-med students come up with to these challenging real world problems actually find their way into clinical practice now i'm honored to introduce our keynote speaker today dr ben herzog he's a medical device engineer and entrepreneur he received his phd from brown university where you have participated in their artificial organs biomaterials and cellular technologies program he's got extensive experience with venture capital private equity management consulting and working with medical technology startups i think he really likes actually doing that working with companies that are are in that early stage in those growth phases of the process and he's had a lot of success in this area he's actually the founder of proserian it's a company that's produced aortics which is a percutaneous mechanical circulatory assist device and and i'm proud to say that uh some of my former graduate students actually work with proserian he's an entrepreneur in residence for the johnson and johnson center for device innovation in the tmc and currently he's the director and executive chairman for a company called intelligent implants now i can just keep going on and talking about that but i think uh you know hopefully you're as excited as i am to hear from ben himself so with that being said uh dr herzog i'm gonna pass it to you and thank you for uh agreeing to come talk to the students and the rest of the people here that are participating in this inaugural symposium ben all right thank you michael i'm afraid you might have oversold me a little bit so now i'm nervous let's let's see i can share my slides here and while you're queuing that up i'll just let the students know that we are going to have some time for a q a so as he's presenting if you want to put questions in the chat i'll be monitoring the the chat and we'll help moderate the q a at the end of this talk yeah please i'd love this to be interactive um it's kind of i'm looking forward to next year when we can get back to doing this all in person and get back to the normal wins so i'd love this to be interactive so thank you i'm thrilled to be here um honored to be here and i thought i'd just you know my the title of my talks from napkin to bedside and it's really just a perspective from a houston-based medical device engineer entrepreneur and i just wanted to share some thoughts um about that process i'm really excited about nmed i'll talk a little bit about that how i think that addresses one of the um you know key talent gaps that we deal with in in this field and especially here in houston i did have some alternate titles as i was kind of working on this talk and thinking about all the different things i could talk about i kind of found myself wandering around so one of my alternate titles was random musings of a medtech innovator inspirational is probably a bit presumptuous but then you know as i thought about the process and how long it takes how hard this is my other working title was this is hard damn hard be ready to roll up your sleeves and i think that's one of my key themes here today is this is a hands-on feel this is a get in get dirty do it make innovate um and i think you'll see that common thread through my talk today so what i'm going to cover some cool stuff i used to work on some cool stuff i'm working on now a little bit of perspective of the houston med tech scene which i'm really excited about it's better than it's ever been we'll talk about napkin to bedside and with this process of getting an idea and innovation all the way to the point where you can help patients some thoughts on how inman fits into that and then just some partying thoughts wisdom if you will so i like to deliver the punchline up front just so you can be thinking about this and chewing on it while i'm talking and come up with some good questions but you know no surprise i found that success is driven by talented people and that's a big one and that's one we have to be aware of and and more importantly this field is very interdisciplinary you know there's a technical part of it there's a medical part of it there's a business part of it there's a regulatory and quality systems and it i've worked in other fields um as a consultant and more than any of the others this is a very interdisciplinary field and it takes a lot of different skill sets to get to the finish line so i encourage you to continue to broaden your knowledge base you're coming from a very strong position which is the the engineering and medicine piece of it and i think that's a great core but but as you'll see there there are there are a lot of different uh dimensions to this so i encourage you to continue to broaden your knowledge base and surround yourself with smart and experienced people um as a startup ceo that's really my number one job is to bring those people together create a team that can help navigate all this at the end of the day you know our main job as physicians as as our main job especially as a startup ceo is to mitigate risk so i'm always focused on what are the risks ahead how do i get to where i want to take this what are the risks in the way how do we have backup plans and again there are many risk factors and challenges in this field well beyond the the medicine and the technology so these are kind of my key takeaways i want everybody to kind of think about this as we as i wander through all this material so for the last decade i've been working on interventional cardiology device i helped co-found a company called presirian and we're developing a catheter deployed heart pump tiny little heart pump 18 french that's deployed in a quick cath lab procedure and sits in the descending thoracic aorta downstream of the heart upstream in the kidneys and let's see lost my slide advance there we go um so as i reflect back on that uh you know it's a long path it takes a long time there are a lot of challenges to address i first saw this back in let's say 2009 2010 met dr reynolds delgado who's a heart failure cardiologist texas heart institute and ron's had this idea on a napkin if you will he is a cardiologist that specializes in late stage heart failure he was the cardiologist piece of the bud frazier billy cohn uh you know group that you know they've done more lvads and heart pumps than anywhere in the world but reynolds was coming to this equation as the cardiologist he's the one that manages the patients and decides who needs a pump when and then gets the patients back after these invasive surgeries and reynolds said boy we just we've got to get to these patients before they're so late stage that they need this big evasive lvad and if we're going to do it it needs to be an interventional tool we need to be able to take people with a cath lab and avoid surgery and we need to intervene in this progressive disease much earlier and if we can do that hopefully we can change the trajectory of these patients and so frankly i saw this i was fascinated but it was like reynolds i mean i don't know if that'll work putting a little tiny pump it doesn't have any valves just in the middle of the aorta i'm not sure that'll work but you know what i know how to figure out if it does work and if it does work this could be huge so i early on went to my garage and started hacking together some prototypes and we did bench top testing and we did animal testing and we did dozens and dozens and dozens of animals to try to prove that not only does it work but be able to explain exactly how it works and then systematically go through the risks that we could see ahead of us and just make sure we could address those risks so many many animal studies many many prototypes different iterations um we attracted a strategic investor it's it's no everybody seemed to know now that boston scientific came in and led our be round back in 2015. we've now raised over 60 million dollars we are in the clinic we did first in human in south america we're now doing humans in australia and the us um and things are going great but we made a lot of mistakes along the way in retrospect i can look back and think there were probably ways to do it faster and and better but it's going great um and this idea of putting this little device downstream of the heart turns out it works really really well and and it's exciting because we can now in this 10 minute procedure um offload the heart reduce the workload of the heart but just as importantly for these patients get the kidneys working and get the volume off and so we talk a lot about chronic heart failure but the the nature of heart failure is very episodic and so we realized even though we have this vision of this chronic device people can go home with and walk around um one of the big unmet needs is acutely decompensated heart failure and specifically those patients who are diuretic resistant where they show up at the hospital their hypovolemic that's exacerbating the heart failure making it even harder for the heart to pump once the drugs stopped working the diuretics stopped working we have very few tools for these patients we now have a tool we can put in in 10 minutes in the cath lab we can get the kidneys working and get the volume off and we can get these patients stable and healthy and pull them back from the proverbial cliff and then discharge them after one day five days seven days and get keep readmission rates really low so this is exciting um there are lots of ups and downs though i wanted to share some of the ups and the exciting kind of inflection points for us this is a video i don't know if this will come through it's not that important but video of a sheep we named charlie and this was probably circa 2014 this was our first fully ambulatory percutaneous cath lab procedure so for the first time a circulatory assist device you put in the cath lab and a couple hours later after the animal recovered it's a fully ambulatory walking around so this really you know got everybody excited this is the future and um there are a lot of different places in heart failure we can address but ultimately we want to get to a point where we could put this tool in a patient send them home and offload the heart for six months nine months a year um i talk about how it being a heart it's a hard road but it's also totally worth it um one of the most things i'm most proud of was doing first in human studies we went down to south america this was back in 2016 and to see a device that i took from a napkin to prototypes in my garage and then all of a sudden we're implanting it in humans for the first time is really really exciting somewhat terrifying as well but really exciting and it kind of felt like it made it all worthwhile we did six patients down in paraguay and these were patients these were high-risk pci patients patients who had diminished heart function they were heart failure patients but they also had a blockage in a coronary artery and they wanted to put a stent in but if you've got a patient with a weak heart it's pretty dangerous to go into the coronary artery and block it with a catheter while you're blowing up a balloon and trying to place a stem so we used our device as a safety net while we did this and i can say with great certainty that um for at least one of those patients they would not have survived without our pump they had complications during the stent placement they ended up spending like an hour in the coronary artery trying to retrieve a stent that had slipped off and the whole time their hemodynamics stayed nice and level and that patient they retrieved that stent they put a new stent in patient was fine that's really exciting and that you know that um hopefully that's an inspirational part that all this hard work that we do and this path that we have to navigate you get to moments like that you say boy i feel like i'm doing something really important um and i feel like we can you know save a lot of lives with this device so how do you get there you know how did i get there as a medical device ceo um i wanted to share this there's no one-size-fits-all there are a lot of different paths but maybe this will give you a little perspective of my background and maybe the reason i look at problems the way i do so i started engineering degree mechanical concentration got involved in biomedical stuff my senior year for senior thesis project ended up going doing my phd in medicine a lot of experimental surgery a lot of biomaterials a lot of applications oriented research and then i was a technical consultant in the boston area for med tech startups so deep technical skills lots of technical skills medicine engineering science all that and one of the things i saw was that there were these great technologies you know groundbreaking technologies that weren't going anywhere and then i would see what i considered pretty mediocre technologies that looked to be very successful raised a lot of money had teams startup companies and the only thing i could figure was they just one of them had better management than the other so i realized well i really need some business skills i need to add that to my toolbox so i did the management consulting route i was a consultant with mckinsey and company which is a global strategic consulting firm i did work for big medtech and big pharma all kinds of stuff but i really learned to talk to the board room and think about strategy and think about the business side of things and talk the talk and walk the walk on the business side it was a great learning experience and it really added to my skill set and my what i call my toolbox after that i went to baylor college of medicine and helped manage baylor's venture activity then went to alpha dev which is the precursor to fan and innovation studio and here it was learning deal skills you know how do you build a com put together a company how do you create a cap table what are terms you know reasonable terms commercial terms to get things done how do you raise money um and after doing this a while i just felt like i really had the entrepreneurial bug and so i actually found pursuing in the alpha dev portfolio again it was just this idea um and i said you know what i want to go do that i want to go run with it and then when i handed over the range to pursuing in 2019 i ended up at johnson johnson center for device innovation which i'll talk about a little more so a breadth of skills and i just think that's what it takes here you either need to build those skills yourself or you have to surround yourself with people that have those skills or both so one of the common themes here though was tinkering and so this is me circa 1986 maybe 1987 state of texas science fair i was a real geek and i loved it i loved to make stuff in the garage i loved to tinker at the time i was really into competitive bicycling and remote control cars and race cars and i got interested in aerodynamics and i ended up building a 15 foot wind tunnel in my parents garage with a bunch of reclaimed attic fans and i hooked my computer up to it and i started doing measurements on aerodynamics and uh aerodynamic efficiency and stability um and that's that's just what i did i tinkered i made stuff i always went to the garage and tried to build stuff and i think that's that's important that and so i i want to you know hit home with this message to be curious and tinker and spend a lot of time in your garage and that could be literally your garage or figuratively but get in there and roll up your sleeves and do stuff and answer questions because you'll always learn something if you try to do it and sometimes we talk about doing the last experiment first in this when we think of this great idea try to push it as far as you can with basic prototypes because you won't get it right the first time but you're always going to learn something and you're usually going to learn something that you didn't anticipate and that's powerful too so spend a lot of time in your garage so this is my new garage johnson johnson center for device innovation this is if you haven't been over there go visit um look me up i'll take you on a tour this was a kind of skunk works my word not johnson johnson's but for early stage development of medical devices and there's no there's not another one like it in the whole world and it's this amazing place where you have machine shop and all of the tools and the people and the skills to take things from an idea all the way to down the path of commercial and what's happened in big medtech is something that happened in big pharma a while ago which is the yield of internal r d is pretty low at this point and there are a lot of explanations for that but the reality is r d within big medtech is very focused on incremental improvements to core technologies um a lot of time is spent trying to get the last 50 cents of cogs out of a device figuring out how you build a device in 50 000 units you know improve the commercial viability but it's not focused on innovation it's not focused on new markets typically it's not focused on high technical risk and so that's the realm of the innovator and that's a different type of engineer that's a different mindset and so j and i guess a nod to that said hey we want a place where we can have this skunk works again my determine up there is where these crazy ideas can go and live and a place where you put all the pieces together you know make your space the have all the supplies handy have a mix of engineers and business and commercial folks and do things quickly and try to reduce that cycle time of innovation idea to working prototypes to animal studies you know simultaneously answering questions about commercial viability and regulatory path and clinical path and so this is where i've been hanging out and it's an amazing place it's an amazing resource it's here in houston in the texas medical center and i'm and i'm excited it's here so i joined cdi's and entrepreneur residents with this idea that i helped move some of these technologies farther along the commercial path and so i wanted to just share with you a couple things i'm working on right now that i'm really excited about uh first we're calling nucor medical it's a technology it's gonna be the first technology that we're spinning out of cvi um this is a minimally invasive lung nodulectomy tool so it is a tool that allows you in a minimally invasive procedure go in and pluck suspicious lung nodules out and you can do it sealing the tissue as you go so you come out you get the whole lung nodule and you can do it quickly and low risk and a little bit of background lung cancer is the big one in cancer lung cancer is the number one cancer killer more people die of lung cancer than the next three cancers combined and one of the problems is we just don't find it early enough so currently if you're diagnosed with lung cancer less than 19 of 100 people will survive in five years which is kind of a shocking statistic and the reason is we're not finding it early enough if you look at lung cancer that's diagnosed at stage one eighty percent of those people are still alive at five years now that's still a bit shocking to me that only 80 are alive but in this cancer you've got to get it early and that's where we really struggle to get lung cancer early cancer the lung cancer first appears as radio opaque nodules that are visible on a chest x-ray or ct and there are a lot of different reasons you might get a lung nodule it's not always cancer in fact statistically it's usually not cancer but cancer always appears as this nodule and figuring out which ones are cancer and which aren't has proven to be very very difficult and one of the ways we think about it is the size of the nodule as nodules get bigger the chance their cancer goes up but it also the chance that their later stage goes up and so we're trying to get earlier and earlier and earlier and one figure out what these nodules are are they cancer or not and if they are cancer treat them and treat them early so right now the tools that we have at our disposal are one needle biopsy and two surgery in needle biopsy we take a hollow needle and we poke the nodule and we get some cells and we give that to pathology and we try to figure out what that nodule is and surgery obviously you're going in and you're cutting out a lung or a lobe or a segment of a lung with needle biopsy our challenge is it's a big mass it's over 30 millimeters usually those are all cancer they're solid tumors they're easy to poke with a needle and whatever you get is going to be cancer they're easy to diagnose but as we go smaller and smaller and earlier and earlier it gets hard just to target nodules um you know eight millimeters is kind of a cut off but once you get down to five millimeters four millimeters it is really difficult even to hit that nodule and on top of that early nodules are much more heterogeneous so a large mass you know 90 percent of the volume 95 of the volume um is cancer but in these early nodules it can be a tiny fraction so a five six millimeter nodule um you know maybe less than ten percent volume wise is actually cancer and then you've got inflammation and all this other stuff so even if you can hit that nodule you can poke it multiple times and still miss the cancer that's there so this shows up in the data so this is some data on kind of the patient journey from identification of a suspicious nodule all the way to confirm cancer and what you'll see is all of these things show up here of of the four million suspicious nodules we see we're only biopsying 10 of those nodules and of those 10 25 of those end up being non-diagnostic meaning we went in we did this needle biopsy and we don't know what we've got it's it doesn't confirm anything if you go look at the ones that we say are benign we have a you know five to fifteen percent false negative rate so this is one where we poked it we thought we got good samples we said it's not cancer but hey surprise it actually was cancer and it progresses and so we're just we're missing our opportunity to intervene early in lung cancer and this is the big problem that we set out to solve because not only are there a lot of nodules right now but the number of nodules is going to continue to increase right now about 4 million knobs suspicious nodules show up a lot of them coming from symptomatic patients a big chunk of them coming from incidentals meaning a patient who had a chest x-ray or a ct for something else and all of a sudden you see a little something funny on on the scan and then we get a couple of nodules from actual screening but what's going to change here is that over the last decade we've learned that actively screening high-risk patients um can can actually move the needle and lung cancer so there were some guidelines put out in 2014 and just recently updated this year that dramatically expanded the number of patients that are going to be eligible for screening so now there's about 14 and a half million patients in the us that will be eligible if we look at things like colonoscopy and mammography we can say look probably at steady state 60 70 percent of those eligible patients will end up getting screened we know what the incidence of nodules is it's at least one out of four of those patients is gonna have something um and so we're gonna see a big bump in the number of nodules and we're going to need to know how to deal with these so we came up with what we call miter core and this is a tool a technique to go in when you have an early nodule that you can go in target it we have what we call an anchor needle which in a lot of respects is like a biopsy needle but instead of taking a tissue sample we uh expand these nightmare anchors and capture the nodule and so now we have held the nodule and we can use this tool to core down in a minimally invasive procedure to get that whole nodule and and excise that nodule so first step under ct guidance or other radiographic guidance get our anchor uh wire in there and capture the nodule once we have that we can advance miter core to the surface of the lung and it's kind of like a torque screw we can rotate it take a bite of lung tissue and then we use rf energy we compress that tissue and use radiofrequency energy to seal that tissue before we cut it and we just keep advancing the tool until we've captured the whole nodule and then we have a similar use of rf energy to excise we cut the base seal and cut the base of this column of tissue that we've just created and we can get that whole nodule out now hand it to pathology get a definitive diagnosis in some cases since we've gotten the whole nodule this will be curative but we also own that track to where the nodule was so we can imagine you know local delivery of chemotherapeutic agents or rf ablation of margin a lot of things we can do now that we've gotten the nodule out and we own that space so this is really a game changer in lung cancer there's no tool like this right now so excited to be bringing this out and and one of the things i want to highlight is um being at cdi our ability to take this idea and take it and run it quickly through id on a napkin all the way to the point where we have a large animal chronic large animal data here's a a picture of a well-heeled nigellectomy site this is seven days post-op no air leak you know this was a quick five-minute procedure to get this nodule out and at cdi over 18 months we tested 15 different you know fundamental different techniques and technologies to do this and i'll be honest with you the first five didn't work in fact there were some spectacular failures but we could see like hey boy if we fix that maybe this would work and we just iterate quickly and having 3d printing and having a machine shop and having all of this allowed this to compress that innovation cycle and move fast and get to something that works and not only does it work but it's very repeatable it's a quick procedure so now mitre core is at the point where this is ready to advance to first in human there's a lot of work to do a lot of challenges but we have pretty clear visibility now to getting this to first in human and demonstrating that it works on a patient that's one model of cdi um that is an internal project somebody at j said hey wouldn't it be cool if we had a widget that did x y and z you made the widget the other model for cdi is called a resident company and resident company is a a innovative company a startup company that's out there that that has some strategic alignment with j and we can bring them into cdi give them access to all these resources and help accelerate their development so the next company i'm working on right now is called intelligent implants and this is a wireless remote technology for the acceleration of bone healing and this is a company that was founded in sweden we found it we brought it in now there's part of the team is here in houston and we're helping develop this technology so one thing we've known for a very long time is bone has this piezoelectric property that when you compress it you get a voltage and somebody many decades ago figured out that if you apply a voltage you can accelerate the healing this is one of the physiologic signals that the body uses to say hey we need more bone and you create more bone and then the strain goes down and the voltage goes down and so it's somewhat self-regulating so for many decades there have been these products on the market called electrical stimulators and everything on the market are these external electrical stimulators after you have spinal fusion or some other orthopedic procedure where you want to accelerate bone healing you put these things on externally and you get this big diffuse electrical field and you can accelerate that bone growth but what we've done in intelligent implants has said hey if we apply microelectronics principles maybe we can put that signal that electrical field right at the point where you need bone healing so it's kind of a local drug delivery version of electrical stimulation and we've developed this we call it a platform because i think you could apply it anywhere you need to accelerate uh bone healing and we're going after spinal fusion first this is one of the big unmet needs in orthopedics very expensive invasive surgery to fuse vertebrae 25 of these don't fuse and so we're going to apply this first to spinal fusion our system's got three components um the first is the implant itself with the electronics embedded in it and in the spinal fusion case it's called an inner vertebral spacer we have a second external component of the system we call the ecap external communication power module and the ecap's worn by the patient when they're getting their therapy and it transmits power to the device and sends instructions to the device for therapy and communicates with the device and then can really relay that information to what we call the smart fuse cloud which is a cloud-based app that the physician and the patient can both access so now we have this therapeutic device that is talking to the cloud and relaying information in real time to the clinician and there's no system like this out there in orthopedics so the device itself you know vertebral spacer we've kind of copied the form of there like 500 different intervertebral spacers on the market but we've embedded the electronics in there and we've embedded antennas to receive the power and aid in communication and then this little implant has eight electrodes on it and so what those electrodes allow us to do is create that electrical field right at the point where you need the stimulation so you can get a higher local dose you don't have any systemic effects it's very controlled and because we have eight electrodes we can control the shape of that field so not only can we lay down bone but we can actually steer where that bone is going we can actually reverse polarity um and get rid of bone so we have a lot of control over where that new bone gets laid down and then what we did that was equally as clever said hey i wonder if we could take measurements from those electrodes and learn anything about that surgical site or what's happening and sure enough by taking impedance measurements those electrodes we could actually see the new bone getting laid down because bone is an insulator and as the new bone gets laid down we can see this signal so now we have not only the therapeutic piece but all this remote monitoring piece that we can feed the clinician real-time remote information we've done a couple dozen large animals now um we put two implants in the same animal at different levels and we'll stimulate one of them and what we've been able to show is the stimulated level we'll see a 3x increase in bone growth at very early time so an acceleration of healing and acceleration bone growth and not only is there more bone but the maturity of the bone is better as measured by trabecular thickness so more bone earlier and higher quality bone so we're very confident this will lead to better outcomes and spinal fusion get people back on their feet quicker fuse some spines that wouldn't have fused otherwise in high risk patients so it's exciting um i think that the the device like this has to stand on the therapeutic aspect of it that's what's going to get its use early on but this idea of remote monitoring and being able to transmit information to the physician in real time and aid in clinical decision making throughout the duration of the therapy this is really exciting and i think a lot of the value created here uh ends up being derived from this piece of the puzzle so we'll be able to show a clinician uh some standard deviations and help them understand is there a piece patient healing kind of ahead of the curve behind the curve ultimately the physician will be able to make tweaks to the therapy steer the um the therapy increase the dose reduce the dose all those things and they can do this from their office without having to bring the patient in for diagnostic imaging so i kind of think this is the future of medical devices that we've been talking about for a long time whereas previously it was just kind of a dumb implant the surgeon the rep a well-defined business model today we're seeing a lot more technology come into this and we're seeing things like robotics and enabling technology and and the surgeon and now it's more than just a surgeon there's a care team and the rep is is more of a technician and but we're still relying on the old business models but the future that i see and this is where intelligent implants is i think we're already there is we have smart implants that can feed us information not only provide therapeutic benefit but allow us to further enhance outcomes that's exciting to me and i think there's an opportunity then to rethink business models in this field there's going to be a lot of value derived from this data not just the real time decision making but then looking back at the data and being able to tease out better ways to do this and i think they're going to be different ways that we are able to monetize that value so the theme in my you know uh uh path has been transformative innovation i really like big complicated transformative technologies that have an opportunity to really change the way we deliver medicine to really impact a lot of patients but transformative technologies also mean high complexity so technically they're complex you look at the things i've described here there's there's mechanical parts to it electrical software all different parts of engineering and science they also have complicated regulatory paths you know simple technologies that are iterations and things we already have end up usually as five 10ks but but these transformative technologies are often pmas and more complicated longer regulatory paths with clinical trials and big expensive clinical trials the reimbursement and health economics of these things tend to be more complicated the business models and the opportunity to rethink business models is more complicated and then the market development when you've got something brand new um it's not always a slam dunk to get it on the market just because it works there's a lot of market development issues and challenges that we fix but i like this i think transformative technologies are exciting and what's interesting is if you look at the data this is kind of the investor perspective silicon valley bank does a lot of data analysis on our field um transformative technologies actually do better in the end they get to they get acquired early because they're new they're new revenue opportunities they're helping a lot of patients so there are a lot of entrepreneurs and investors that gravitate towards 510ks because it's easy to say oh this is simple we have a clear path to market we can get on get to market faster that's all true but if you're building the new version of a mouse trap and there are a lot of mouse traps out there you've got to prove that you get revenue and get market uptake to prove that your mouse traps better than all the other mouse traps whereas pmas and these high complexity deals end up getting picked up early and get a lot of resources behind it so surprise transforming technology seemed to do better in the end so let's talk a little bit about texas medical center um you know we're sitting here in the largest medical center in the world and by most measures um you know we we have all these patient encounters all these surgeries it's it's the biggest medical center um and we've always been long on innovation um you know part of this comes from the kind of forefathers of the medical center the the michael debakeys and the dent and coolies um this uh this willingness to try almost anything and push the boundaries of medicine so i think the cultures evolved around that and these amazing you know world-class institutions we have and then on top of that in houston a city that that really is known for entrepreneurism a lot of it comes from the wild catty mentality the acceptance of risk the acceptance of entrepreneurial risk so we are long on innovation there's no question there for a long time i've said this is the happy hunting grounds if you're a medical device entrepreneur but it's frustrating because if you look at the big med tech centers across the country we're not in the conversation yet and and as somebody who grew up here and work here this is really frustrating to me and the most frustrating part is austin has started to show up in the conversation and if you look at the numbers by all metrics we've got lots more going on than austin does in this our med center the number of companies the number of physicians institutions all of it but we're not in that conversation just yet so it's it's made me think a lot about why is that and and try to dig into it and try to figure out you know what do we do about that so spent some time with some of my cdi colleagues thinking about well what are the attributes of a successful innovation hub and there are a lot of different ways you can slice and dice this but we kind of came up with this framework which is infrastructure which is incubators accelerate everything that supports the entrepreneurial community there's the innovation piece the ideation the clinical research intellectual property all that there's talent and and you know here it means experienced entrepreneurs subject matter experts in this broad range of skills that we need to navigate this and then there's capital you know investors active investors who are focused in this area now if we look at houston we have clear strengths and innovation we are long on innovation there's no question there we're also we also have a great strength in infrastructure and this part's newer you know in the last five to ten years all of the great work that texas medical center innovation is doing what you're doing with nmed johnson and johnson coming in with jlabs we have a very active entrepreneurial community here with a lot of support that's great where we still have gaps i feel is talent um and capital and there's been a lot of discussion a chicken in the egg discussion about which do you need first which is more important i'll tell you i think talent's more important and if you have the other three things you can bring along the money but we have lots of engineers here but they're not usually engineers focused on med tech you know we don't have a lot of regulatory consults we don't have a lot of these subject matter experts so that's something i think we need to focus on and if you think of this path from ideation innovation all the way through commercialization and product launch i like to break it up into three big chunks there's research there's early stage development and then there's kind of commercialization and product launch and if we plot what i call the yield curve of a mature ecosystem from research all the way through to product launch you have a natural attrition not everything makes it through each of those transitions there what happens is if you have a talent gap and to a lesser extent an investor gap you get a lot of fall off in that transition from research to early stage development and a lot of things just don't make it they can't make it past that and so i think the talent gap is is a is a big problem that we need to continue to address again i'll say houston huge strengths and innovation huge strengths even in infrastructure and things like that but if you look at the number of companies and the number of technologies which arguably there's more than there's ever been i've been playing in this space for almost 20 years now here in houston and there are more deals and they're coming from not only local but they're coming from the outside that's all very exciting but but i see a pattern of first-time entrepreneurs deals that struggle to raise money beyond just seed round inexperience with talking to strategics and stuff and everybody every successful entrepreneur was a first-time entrepreneur but i do think we need to focus on this and put the other pieces around those deals because i see just a huge opportunity in closing this gap and if you believe that we are long on innovation and we've got so much innovation by addressing this gap we are going to dramatically increase our commercialization yield and we're going to put houston on the map and i think that's important so one of the things um that i've gotten excited about are what are models that help that help do this and more things we can be thinking about and there's lots of data that supports this idea that outcomes of successful outcomes or startups are highly correlated with the experience of the team and you can slice and dice a lot of different ways this is data looking more from the investor standpoint but how much time do you spend on diligence how much industry and experience does the team have how active do you manage these things this is all about if you're more hands-on then outcomes are going to be better for these startups and so one of the things that i'm excited about is what's called a venture studio or a startup studio and this is a new model that's been used a lot in the tech industry but really hasn't been applied to medical devices and if you kind of create a two by two matrix here to help compartmentalize different models for supporting innovation you know put capital you know investment on the y-axis and then support hands-on approach on the x-axis we can start plotting so in the lower left quadrant low capital low support i have i think that's where the incubator model stance you know an incubator somewhere that's the bricks and mortar piece it's a place where you can go rent space and have a place for your young company to live it's an important has a very important role to play if you have lots of capital and you're lower on the support side this is where venture funds live and my venture buddies will argue all day long that they're they're high support but as the funds get bigger and bigger and they have to put more and more money to work it's different model than it was in the early days of venture where the venture guys were all successful operators and rolled up their sleeves if you have lots of support but little capital um this is what i call the accelerator you know this may have an incubator component to it but there's curriculum there's lots of things to support young entrepreneurs entrepreneurs and help make the deals move faster and then up in the upper right quadrant is where a venture startup studio would go lots of support lots of hands-on focus on company building but capital and resources to invest in making those successful and so if we look around houston we can kind of uh populate these quadrants with some of the local players the venture fund tmc venture fund and austin you know sante and s3 just pure venture funds in the incubator bucket jj's j labs is a great example of an incubator corporate you know incubator but you can pay to go get a bench there have some office space use lab space not have to build your own lab very important role accelerator good example is tmcx curriculum for young entrepreneurs help connect them with players in the medical center help accelerate the development of that and the only thing we really have that approaches venture studio is cdi now this is a corporate venture studio this is all done for the benefit of j but i think this model really touches on addressing some of these important needs and and i think it's the right model for here in houston so anyway just some usings on what's happening here and the data now because we've watched what's happened in the tech community we have a lot of data on how successful these venture startup studios could be so it's pretty clear that startups that originate in a studio and start their move faster and generate stronger returns than ones that don't so let's revisit the key takeaways for a second success is driven by talented people our field's very interdisciplinary it's not just the technology and medicine um i encourage you to continue to broaden your knowledge base surround yourself with smart and experienced people that's one of the most important things you can do and again our job is to mitigate risks and that risk comes in lots of different flavors so get good at identifying the risk you don't have to be an expert i don't feel like i'm an expert in anything but have developed this broad perspective it allows me to kind of anticipate risks and then figure out ways to address them before they become problems so why am i so excited about nmed and what y'all are doing well i think this fits directly into what i've been talking about this idea of a physician here i think it's brilliant and it's starting to address head on this interdisciplinary nature of what we do and tackling the two kind of big issues of the clinical unmet need and kind of in the trenches seeing these needs and really understanding these needs and combining that with the engineering skills to be able to solve those problems and you know training kind of creating a new generation of innovators that have this built in you know as part of the fabric of their being i think this really addresses uh one of the big problems that we're dealing with as an industry but but also here in houston so i would argue that nmed addresses part of the innovation piece you know needs finding and being able to solve those problems and come up with solutions it certainly addresses that some of the talent um gaps that we have and then from an infrastructure standpoint again this is all the kind of framework and foundation that supports the and grows the entrepreneurial ecosystem uh here in houston and around the world so you know cheers to enmed and a m and methodists and everybody involved i'm really excited about what y'all doing and i'm hoping we find some more ways to interact between nmed and cdi and j j and all the other activities around town because i think there's a lot to be done here so couple quick parting thoughts don't be scared to work on transformative technologies i mean all of these things need solutions but don't be scared by the high complexity of things that are really going to change the game and medicine and address big unmet clinical needs get get comfortable and start to get motivated by people saying that'll never work i can't tell you how many heart failure cardiologists have told me oh that little pump will never do anything oh my patients never die of heart failure you know and and you know if you if you just heard that and really dwelled on it early on you'd never do what we do so that is motivating to me i love to say it all right we'll see about that you know and in the end i'm hoping i'm right and then finally there's this concept japanese concept ikigai uh which i love which is kind of roughly translated reason for being and you guys might have seen this before but it's this intersection of you know addressing big needs with things you like to do and things you're good at and things you can get paid for at least most of the time and i feel very blessed to have found mine in med tech innovation and i encourage you to find yours figure out where all that intersects because what we do is hard and there are lots of challenges but it's worth it at the end of the day and it's a lot easier to go to work every day if you're passionate about it and feel like you're doing some good you're going to help a lot of patients that's it all right great thank you thank you ben that was a great talk i do have some questions for you uh so the first question um refers to the environment that you have and the people that are there uh you know at j and the cdi and so you know you talked about teams and how you guys are coming to decisions that you're making when you're doing these innovations so the question is what type of people compose the innovation team at johnson johnson are they different types of engineers or are there people representing the business regulatory and clinical science and medical innovation what's the dynamic of the team during the concept generation design development portions great question and kind of core to my presentation here so i can't speak for mothership grande but cdi it's its own unique beast so it's a it's a mix there's a big engineering team but there are also folks like myself that are entrepreneurs there are folks we have um people who are signed from j that know the marketing side of it reimbursement economics and so we can draw on all that experience and and i think that that's kind of the power of it so whether you have your own cdi or you're building your own company you've got to make sure you can you can address all of those challenges and risks by bringing the team together so we we just we have a process where um you know we review a lot of ideas crazy ideas some of it's the cdi team some of it's jay somebody at j saying hey wouldn't it be cool if we had a widget that did this or that some of it's looking at external companies like intelligent implants and figuring out how we work with them um but we're systematically addressing all of these risks and challenges and some of its technical build prototypes show that it works figure out how to make it work better and some of it's geez how do you even get that to market you know who's going to pay for that what's the regulatory path look like and does that impact because all of the answers to all those questions often impact your design and what you go after so very interdisciplinary team very engineering heavy you know at the end of the day we do a lot of tempering and i like people that can go to the machine shop and make stuff one of my favorite uh interview questions when i'm hiring you what's the craziest thing you've ever built in your garage and i found a high correlation the interesting answer for that question the success especially on the technical side okay i've got a so another question for you is that and this one i think is aimed more at you personally so uh you know what is your acceptance criteria for beginning a project and how do you balance having you know a diverse portfolio of projects or even opportunities uh with spreading yourself too thin yeah another good question um i don't know if i've got a concrete answer for that i'll tell you it does take time though i'm all i'm incubating stuff and there are very few things that i look at and say oh yeah i went in on that because it's such a multi-dimensional problem for all these reasons we've talked about today it may be the most amazing technology in the world but there are a lot of other things that i got to figure out so i do lots of my own diligence i just dig in um you know perserian we tinkered with for two and a half years before we raised any outside money you know just answering big questions and we'd show it to people and they'd say oh it'll never work because of this this this and this and we're like oh we weren't even thinking of that let's go figure out if that's true you know and and you start to build this body of evidence so you need that body of evidence to convince investors but i needed to convince myself is this something that i want to take to investors you know is this worth doing and it's not just the technology that actually kind of feeds into one of the other questions which was you know when you're doing all these different iterations you know at what point do you say okay this this is the one we're going to take to the investors or we're done now how do you make that decision that's a great question and there's a couple there's something called the 80 20 rule that you've probably heard of that i like that you're going to get 80 of your answer for 20 of the effort and when there's another saying i like you know don't let perfection get in the way good enough and knowing good enough is hard and but but you got to be disciplined about it so i'm i'm total ocd i'm a perfectionist you know i hear stories about steve jobs wanting to review like a thousand different shades of beige for the first macintosh sometimes i feel like i get stuck in those cycles but being really disciplined and hey this is good enough to go to the next step and it all ties to value creation so i'm always looking for where's the value creating milestone it's answering a technical question sometimes it's often it's proving large animal proof of concept you know first in human is is a big inflection point but first and human is very different than commercial so you have to learn what's good enough to go do first and human get that done create that value inflection point and then you have the resources to make it perfect and go commercial and all that so that's a great question yeah so another question actually this one's related to some of the things that you talked about today the smart spacer and the nodule biopsy uh in particular uh the question is you know what do you see as the biggest kind of future uh challenges in developing these and you know what have been the biggest challenges so far um so specifically on these projects in the long nigelectomy tool uh carving into the lung is complicated it's all airways and blood vessels and that's why this hasn't been done before so figuring out and fruiting that you can cut and pour and seal at the same time allows you to get this nonzero out so the big challenge now is of these four or six million nodules that are out there we're still going to have to risk stratifying we're going to decide which ones do you look at and say it's got to come out and there are a lot of those right now where we already say that we just don't have a tool we're like boy we really want to know what that is but i can't take this patient to surgery to figure that out um so that's the big challenge is still is how do you risk and this is part of the market development for a tool like that how do you frame the tool with the wrist stratification so you have a high hit rate of going in there grabbing something oh yeah that was cancer i'm glad we got that so there's a big challenge there and then on the um intelligent implants spinal fusions are complicated and there are a lot of risks there are a lot of reasons why those patients don't fuse so the big challenge there is getting into humans and showing that we can accelerate healing the animal models that are used in spine are healthy sheep you know young healthy sheep and they grow bone really well it's still the best model that's out there but we often run into these situations where the animal model is only so good and making that translation from animal model to human and showing it works in humans that have a disease state that's a big jump and so now we're really focused on making that plan and getting the device ready for that we just were awarded breakthrough technology designation from the fda for that device so that's going to help navigate that path and get us into humans quickly very good so um another question now this one you know is about the students again in terms of you know they've got this background in engineering and they're in medical school and they're trying to innovate

2021-07-08 22:38

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