Health Innovators
Health Innovators

Episode · 1 year ago

Creating a reimbursement path w/ 3X entrepreneur Larry Jasinski

ABOUT THIS EPISODE

Creating a whole new market and getting CMS, Medicare, and Medicaid to issue reimbursement codes isn’t easy. In fact, you’d have to be a little crazy to try. Crazy or brilliant.

3X entrepreneur Larry Jasinski definitely isn’t crazy. He knew his company ReWalk was on to something big - and had the data to prove it.

From humble beginnings at Boston Scientific to international entrepreneur, Larry knows his stuff - and is opening up to our listeners and viewers on this week’s episode!

If you’re struggling to break into the market or commercialize your product, you really need to listen to what Larry has to say.

In this episode, he shares the story on how he commercialized his product overseas, brought it to the US, and then compiled the data to support the issuance of a reimbursement code.

Amazed? We were too! So get ready for some insights and tips that just might help you weather the commercialization process along the way! 

Here are the show highlights:

  • What it’s like to create a whole new market (1:11)
  • The biggest limiter to bringing disruptive or incremental innovation to market (3:56)
  • From idea to commercially viable - which path do you take? (5:31)
  • The current perspective on the investment community (8:03)
  • What innovators should do when pitching investors (10:09)
  • How to approach commercializing a product internationally (15:06)
  • Why having cross-discipline exposure can be key to success (22:27)

Guest Bio

Larry Jasinski is CEO of ReWalk Robotics, a company that produces structural exoskeletons that give paralyzed people the ability to walk again.

From his beginnings at Boston Scientific, Larry attributes cross-disciplinary experience to his successful ventures across the globe - from Germany to Israel to the United States.

Larry earned his BS and MBA from Providence College, University of Bridgeport.

If you’d like to reach out to Larry, you can follow him on LinkedIn at Larry Jasinsky or on his website at www.rewalk.com.

Welcome to Coiq, where you learn howhealth innovators maximize their success. I'm your host, Dr Roxy,founder of legacy, DNA and International Beth selling author ofhow health innovators maximize market success through handed conversationswith health innovators earlier doctors and influencers you'll learn how tobring your innovation from idea to start up to market domination, and now,let's jump into the latest episode of Coiq. Welcome back to the show coiqlisteners on today's episode. I have Larry Cizinski with me, who is the CEOof rewalk robotics, welcome to the show Larry Morning. Thank you for having meit's nice to have you here. So, let's start off by telling our listeners andviewers a little bit about your background and what you've beeninnovating these days. Okay! Well personally, I'm a medical device ky formy career between one big company, Boston, Scientific, which was verysmall by the way when I started and then a few started up since my passion and my driven approach hasbeen with a company called BIA chorbotics and in the end my decisionto do was driven by a couple. Doctors, I spent time with and then a couplepatients the what the fundamental mission of the company is to allowdisable people that are completely paralyzed, partially paralyzed. Anability to walk again and the impact that has in their life is remarkable.So the creation of a new market with the technology that nothing existed andnothing could change with wheel chairs for over two thousand years is reallywhere we are today and we're making progress. So so Larry that's hard, not only creating a technology fromscratch or creating a company from scratch, but creating a whole newmarket. What that? What is that journey...

...been like for you? Well at first, youthink you could do anything because that's the conpetence you tend to havewhen you've had successes, and you forget all the Times you got hittingthe head along the way. Uuthis one was more unique than the others. I've done,though I had really nothing near it to follow. We were when we went to the FDA.We couldn't figure out the pathway, we wanted certain pathway, but there wasno five tk and we had to do Dinovo and we had to create a Dnobo category and nnegotiations with the FDA as opposed to a much larger cagegory and everythingalong the way has been just like that. Everything we've done is the first timeestablishing codes for payments, establishing methods for us in thefield building the emfrastructure, so it's been challenging yeah harder thanwe thought, particularly on the payment side, but it's been worth it so so I, like your humility and modesty,is you kind of just glazed over some of your successes in the past? So justagain, to give a little bit more context. You've had some successfulexits throughout your career yeah. I well, I think the Formmat, a part of mycier was Boston, scientific and I served in every position from thebottom to the top of a division that, at the beginning, was about a ninemillion dollar revenue group and byt. The time I left was six hundred million, so I would the successes that are mostmeasurable are the things I did with that division in all my different roles,which included sales marketing, RND, general management of it so BSC taught me how to bring things tomarket and how to Bot markets. So my successis after that BC deserves a lot of the credit and the people that I formorcolleagues frequently from VSC. Frankly, that came along with me, so we wereable to take a couple of other startups, one that was broken and simply atfollowd the wrong strategy. We got it profitable, we sold it. Those productswere still for so sold today. I'm glad...

...to see that- and I did another oneafter that which also got sold, so I can give more details on those, butthis was my third challenge post BSC, but I'm doing the same thing, I'mcreating markets where way back when Interventional Radiology use of stents.For example, if you talked about a set one thousand, nine hundred and eightyfive people thought that wasn't a very good idea to put in artery it's hard to believe now so y there wasmarket developent work, even though so what do you think you know havingjourneyed through this many times? What do you think the big biggestdifferences are between bringing something, that's disruptive or radicalto market versus? You know an incremental innovation. Well, the market reaction I's easier,doan incremental, because so many things are established and I think inthe early days at BSC, we were able to bring things to market more quicklybecause there were not as many barriers and some barrers are appropriate by theway as the industry's grown for now. Innovation is much harder, an that thereguatory paths are more extensive and correctly generally, I'm not criticism.cripil its just ther the product have got more complex. The payment patternshave gotten particularly difficult. That's been probably the biggestlimited innovation, because that part of the government and insurance systemhasn't figured out how to deal with these things unless you're, really bigso it', Starte, Oy, small company and just the available funding isdifferent. Ow The venture capital days where there were a lot of littlestartups out. There are not so prevalent anymore, so trying tocreate and get it properly funded and for the length of time you have to do.It is longer and harder than it used to be. But the fundamentals heard the same:U He still got Ta be better for patient. You still have to have data. You stillhave to work through the FDA, just maybe a little longer same as he mmasit...

...just their little everything's moreexpensive. It takes longer, but it's still good. So so what do you say to other? Youknow your peers that are in the trenches right now that are possiblyraising money and kind of planning, for you know taking their company from anidea to something that would be commercially viable. Youknow, you know, is there kind of a O, a path? That's distinct or differentfrom a radical innovation that doesn't have a market that you have to createwhere you would say that this path, you know you need to have like ten timesthe funding and plan for ten times the time compared to more of a traditionalmarket. That's already established, I think the reality of it is. It nowbegins at the end of the channel, which, in the end, you should be thinkingabout what you're selling and how you're selling it. But when I was first at BSC, a lot oflittle companies had sales forces and we were able to grow enough to coexist.The consolidation that has occurred and the cost of distribution that hasdeveloped makes it much harder to create a company at the back en thedistribution side path. Someone really has to thinkthrough is- and I remember one other and VennerI worked o said always have your exited mind, even if you know what accent, because you really have to think of make it simple if you're making a hardbell of you know, there's about two companies that are ultimately going tobe in that market, so you're going to have to design and plan at work withprobably working with them someday. If you're creating a totally new marketwhete there is no dominant player and the dominant distribution channel, thenyou have to create one and Rehab, which is you know the world I'm living inright now, O doesn't have the Johnson Johnson'smetrotics Boston, scientifics of the world, it's an industry that is an earlier stage. I would say interms of the advancement of technology...

...so to your question. You've got to really look at where youare, but you do have to pay attention as to where you're going to end up. Areyou going to be a standalone company, and is it big enough, and can you getthat kind of funding, or are you really going to have to think of? Where is thepath I'm going to land at the end of the day, and I know I probably have towork with one of these two players and if that's the case, you build yourrelationships early and constantly say: Hey, I'm going to do this and then yougo. Do it and then we're doing this and then you go, do it and you do morestrategical, lients type approach. I think in the bigger markets answer the question. No, absolutely itdid. I think that's very valuable. So what do you think the the perspective is with the investmentcommunity right now in that path? Are you seeing a lot of investment madewith ideas and companies as complex right?Are you seeing investors kind of steer way of, like Oh, no there's no marketfor this there's going to be this whole regulatory path? Let's just steer awayfrom this type of investment or like yes, you know, someone like yourselfsgot a proven track record for being able to overcome these hurdles, andthat I see the potential for where we could go. Not only changing theindustry, but also you know, having a successful exit in part. You've got toreact to where you can go for money. Well, I did. I take wearchromaticspublic number of years ago, for example, it's because it was probably theeasiest path, even though it's difficult that I spend more money on it.I spend time on that instead of really market development yeah more than I'dlike to, but it was a pathway that was probablymore open to a creative technology that what I was able to deal with was okay.CMS has been much longer and harder than many would have expected. So I was able to raise the money, notnecessarily good terms by the way, but I was able to raise the money to get tothe end point yeah, so you really have to be flexible andwhere you're going to go on this,...

...because I went public when a window opened, butthe five years before there was no window. HMM- and you know right now.Actually, despite Covid, the Marcus have been pretty good for getting some funding but the periodright before and it was bad and I don't know how good it's going to be in thefall. So we w we got up and down over the at. You really have to adjust toyour market, but the funning is out there and you just whether it's strategic or outrightinvestors they can be found. You just have to be prepared to answer thequestions well about an end point, because that's where they're going tojudge it so yeah. So let's just kind of dig into that. Just a little bit. Youknow, Hu, what advice do you have like? What aresome of the important things that you think that they t the innovator has tohave when they are pitching to investors? What are they looking for?What Dar you, when you're developing that presentation an creating thoseconversations? What is it that you're making sure that you're, communicatingand communicating really clearly to be able to you know motivate people tohave the confidence and trust in you that you can do what your say you'regoing to do? I think you have to be comprehensive and it's a hard word touse if you took a classic product development definition and charted itout, and you have a lot of things that range from technology to cost of goodsto scale up to regulatory to clinical to revursement I mean all thosecategorie are going to fall within there yeah when you're presenting a youhave to have those all answered- and I do see too many that come on- they havefantastic technologies. Well, thought out: well develop strong intellectualproperty, okay, but how does it get over here and how much is it going tocost and can it really get paid for and is a regulatory path going to be anextensive randomize, conical trial ors, a a five pink type of things are allyou have to be very well prepared with...

...those answers and most of my early investment. I think wedid that well, and I know where I lost investors, the most and impetely bighigh quality investor that I really would like to have had and they spentlots and lots of time with me and they were really fair and giving it to me.But they didn't invest a number of years ago before I wa public, becausethey were afraid of reimbursement hm. They were right and I was wet. I knewthat was one of my bigger risk yeah, but it was harder than I thought itwould take a tay longer than I thought it would take and they were. They werecorrect in their assessment now interesting. They, I believe, haveinvested since so they've been a late investor, but I couldn't get them earlyso but comprehensiveness of incredibilityof your answers. You can't make things up. You can't be. Hopefully you can'tbe optimistic. Here's what it's probably going to take for stepabcde and if you can't present that in abusiness plan, you'll probably lose them somewhere. Yeah. Absolutely daysof the I don't know, tha todays were ever really there, but I like to saylike long gone, are the days where you could go. Oh well, it's a billiondollar market and all we need is three percent wellt. You still at least accept wellthrogger that out later yeah, it's GE is done. It's so good. Let's get itdone, make it a paralyzed. Man Walks seems,like you shouldn't, be very hard to sell right right, but you had to sellitthe cms, inte governments and andprime insures we're still in thatprocess. So Sio, you talked a lot about reimbursement and cms and howinstrumental that was- and you've got some good news to share with US yeah Iye we worked for many years to build enough data and by the fourth quarterof last year we thought we had enough to justify issuing a separate code forEXO skeletons. So we did the formal application process with Medicare,Medicaid and cms, and it followed with they initiallymade a positive recommendation. They...

...held public hearings in June of thisyear and about ten days ago they issued a formal hicnic code, which is abilling code. That is the start of getting these paid for formally forthis category, so they I particularly gratified they issuedthe code, but it was also important that the insurers, some of themsponsored and spoke, but positively about this. We had the same thing withpatience e, the same thing with users in the public arins. So this is it'sgoing to change, Xis Keleton market. Now, one that's been sitting, it willstart to move and it's good for our company, but it's also good for thecompetition. It's good for alls sure, and this has been a long time in themaking. This hasn't happened overnight to and it really because it was such asmall market. We really had trouble building the day to small initialmarket anyway, that what really helped us was why I didsell six hundred into the market. So I learned and got a lot of that published,but I recognized what the BA did. They took care of soldiers and they fundedthe United States government did a twenty two million dollar expensiverandomized trial, which is just completng a hundred and sixty patients,so with eighty of them with our product and Eght of them in a we wheelchairlevel, one data, so data was a driver at the end of the day, and the Datadconsistently shows the value of walking which is intuitive back when you're onthe early investment said WHO's going to fight about the value Owalkin rightright, who's going to pay for the value of marking. This the real question: Heyit's Dr Roxy, here with a quick break from the conversation. Are you tryingto figure out what moves you need to make to survive and thrive in the newcovid economy? I want every health innovator to find their most viable andprofitable Tibit Strategi, which is why I created he covid proof your businessto the kid. The pipotkit is a step by step framework that helps you find yourbest tivid strategy. It walks you...

...through six categories. You need toexamine for a three hundred and sixty degree view of your business. I callthem the six critical pivot lenses, as you make your way through thiscomprehensive kid, you'll be armed with the tools, cits and strategies. Youneed to make sure you can pivot with speed without missing out on criticaldetails and opportunities, learn more at legacy. Tythan DNACOM BACKLA kid. So,as you kind of indicated earlier, this is a huge milestone that you all haveworked really tirelessly for a long time in achieving, and so what doesthat mean for your company? Is this your fast track to commercialization,or were just some of those other steps that you've got or hurdles that youhave to get through? Well, it's a extremely important step, but there's two or three steps behindit: We've done this exact same process and parallel in Germany. It's just about two years ahead, so wegot a code issued. We then got pricing an general guidelines issued and thenwe started getting contracts. So Germany, if you'R German citizen today,you can get one of these units. Predictably, provided you, you have to go in andshow that you medically qualify. You have to properly train, but the cycle and definitions are allthere, so the paralyzed community in Germany can walk in their community andhome it's good in the United States. We just crossed the first of them steps.We will now set pricing within some of the new pricing rules that have beenput out for durable, Mendaclo equipment. So there's some new good guidelinesthere that thic col work and over the course of the next twelvemonths we will start to get contract, so the United States will becomepredictable and that is the end. Go. Our company started with a paralyzedinventor, a guy named Dr Amitgover, and his passion and drive was to give backsome of the things that he used to have, or others head of their life and we'reactually going to achieve our mission.

At the back end of this, that peoplecan go home, they can stand up and greet people at the door. They can hugtheir loved one standing up. They can walk around the kitchen, theycan walk in them. All I mean it's we're giving something back with them. Theycould stand up and look at their kids and tell them they need a haircutbecause they can see him from the you know, above those are the kinds ofthings and stories that we see which its really huge, and I think that in alot of ways, it ties to the broader mission that a lot of US innovators inthe industry have, and even the work that I do is that you have so manypeople that come up with these incredible technologies that are so needed, but don't have thecommercialization expertis acumen and then their innovation doesn't get inthe hands of the people that need them the most and, and so it's reallyexciting, to see you and the work that you all are doing and have that successto really be able to see. You know not just lives changed because you're generatingrevenue for a public company but patient lives changed by getting thoseinnovations an in really changing their lives in a very meaningful way. That, probably is the thing that madeit easiest for us to fight through this over all these years and ploty base israther passionate because we've gotten attached very much to our customers. Ino listance, I mean we know about their kids, their wives. I think the biggestthing is we don't just make the persons life better. We tend to affect their entire familyright Becaus, they interact differently. They get off painkillers, so they'reable to interact more. They they get more active, their children, see them verydifferently and they chaine. It changes an entirerecosystem, not just a person, so that I think, was the easiest thing to keepus. Why do we keep doing this when we get hit in the head and know we won'tpay for it again...

...and until we had the data and on eposit side, the Ba Sagus first cmsdid give us a code yeah, so I complain about it being slow, but they've got itright, yeahabout that absolutely n, and what an incredible legacy that you allwill leave in really being able to change the lives of so many people tooJon. No, I sell my employees, you know you because each of them have theirparts, including me. We've all contributed collectively. When you see someone walking down thestreet and ythat something we all did together,Yowere yeah. So why Germany Yeah? How did you choose Germany to befirst? How is that part of your you know? Commercialization strategy.Eli've had good experiences in past in Germany was part of it. So but thefundamental reason is they have a particularly good health care system.It's one of the oldest commercial systems. It dates all the way back tobismark and it's well. Structured andstructured has two advantages in one disappantage: it's a lot of paper and a lot of documentation, but theyfollow the rules. So the the German system is progressive,disabled community and I think one of the leading ones in the world.So it was one that I knew how to do it and United States. I sort of knew howto do it, but I would say FDA is pretty clear. You know how to get yourclearance yeah the payment one, because we have a bit of a fractured system.You O cms, the guidelines are reasonably decent. It just takes timeprivate insures that you don't have clear policies right and I do feelthere's some discriminatory practices there, not intentionally, but theperson who can fight can get a device to re to be able to walk again, but that's not necessarily the personwho would help the most all the time, it' so sad...

...and having policies in placed inpredictable ways to make sure the right people are getting it is, is the rightanswer. The Germans are doing that the Va. Does it I think CMS is helping setit up and the private insurers in the US will get there but they're thetheyre, the slowest of the group and that's just the nature of our system. Iwould say, I see CMS ind. The VA tend to look at long term these ar youngerpatients and they think about their health benefits and what this meansover five, ten, twenty thirty years, yeah private insurers tend to look inshorter cycles, and I think that makes it a little bit harder sure. So how doyou think your decision to commercialize in Germany, first or inparallel with the US market? You know what was that data used in your commercialization path inthe US was you were you able to generate revenue, ind sales and so thathelp fun? The work that you were doing here help us understand how that impacted. The work that you ere doinganswers both of the examples you gave are absolutely correct. Initially whatwe did in Germany, because I understood the processes as well, and I had sometalent over there that I had worked with before infor. Many of my employeeshave worked in multiple companies with me, so I know W A my family. It's a lotof Whyi had success frankly, more than anything else, but we were able to thedata and things we built. An systems are built in Germany, we replicated inthe states. So yes, a lot of what we built wasusable across the ocean. Yeah and Germany will be contributing funds andhelping pay the bills before the US does. In fact, it already is at thispoint, so our revenue in Germany has grown enough to wheare. Now it's it. Weare able to use that money in Israel where we development and the UnitedStates as we build the market. That's fantastic! So solary as you think aboutyou, your entrepreneurial career. What...

...are some of the key decisions that youmade that were just game changers for you. When you look back in hindsight ndyou go wow. Maybe I didn't realize when I made this decision that it was goingto be so impactful to what we were doing. help us understand that I migh have been too young tounderstand what I was doing in some of those things, but I would say at thebeginning of my career, I come back to the two people that started BSC JohnAbilian and p Nicholas. They put me in jobs. I didn't really want, and Ilearned more in those jobs and I'll be very specific. My interest is reallyproduct development and I came to BC and for that. Well, for you to work inour marketing and RD departments, we wilt on understand our customer. Theymade me a sales rep and I live. I worked in the field for two years. Iwas number two of the company. I didn't make number one, but I tried, but that period helped me realize wherecustomers are Ilogical, sometimes in their decision making in helped meunderstand a lot of components, and then I went into some more marketingdriven product development typeroles and then they moveed or Andeed I saw inBSC. They chose to push me into places where I didn't plan on going and happen to do a clinical studybutit's, not my career goal, neven sales O creer goal, but by what I would advise others to do, makesure you get yourself through a few different disciplines, because you'llget better overall and put in an organism and building somethingtogether. So I'm given Boston, Sam Etific craditfor that, because they're, the ones who move me around all kinds of differentjobs. Before I was Wer, I was writing a ivision there, so that helped and thensmall companies were just basically. I was able to use those skills and I guess the hardest decision wasnot staying at BSC and doing it. inds three small companies and you've got tohave a certain kind of mindset for that,...

...because it's the funding, ISS different, theinfrastructures different and frank of the works harder yeah. I think I mighthave had an easier path state at Bostin, scientific and I would have beenrewarded and they treated me well, but I' probably had more fun dealing with the problems that I had toface in these three companies up, Tden Yeah spoken like a true serial entrepreneur, so also kind of thinking back. You knowwhat were some of those most challenging moments where maybe youwere one paycheck away? You know from going under. You knowwhat were some of those most difficult moments and how did you overcome them? Well, the paycheck away. One isprobably the most challenging for any of these things. When you do- and I wasjust making that up- I don't think we've been that close,but I guess I wentedto this with no fear of that yeah and if you get stuckin that you're going to make a mistake, it's okay keep doing what you're doingfight the battle. You'll win that one and I have I've, been able to getthings funded, but I've also got things finished. So it was a little bit of aconfidence of keeping yourself balanced to do all theaspects of your job and not one part of it or well. And if you fail ure fail, I'vebeen lucky, I haven't, but I'm not done with this one. Yet so,like Dointt me to it's, going the right way, yeah thethe difference in running somethingsmaller. Is You actually have to do all this stuff? You do in the big companies you just don't have the same resourcee,but all the problems, whether it's reimbursement, pattens, fundraising, personnel, building, aproduct cost of goods collections, data systems, item they're, all there right,ere, better yeah. You've got to get a lot better at having a lot of virttual support earlyand not building too quickly and kind...

...of, like Okayi'll build what I had aBSC. I didn't have that kind of money right right, exactly reality checkreally quick, but they're. All there and frankly, ivebuilt a lot of these things early stage. I used a lot of former BSE COMLEGE INCas who had gone out to do their own things. So my regulatory was my formerregulatory Guiy just had his own firm, Mi Clini Cancer. So there you build aninfrastructure and work with. It is one of the keys that helped me get pastthe points that you were talking about and relative to funding. I had theability to a reach to people I had known in mycareer and you just keep networking till youfind your path and that's the essence of what we did. It's awesome soanything else that you would want to share with our listeners in viewersbefore we wrap up today. Well, I, this is one I've done mostly in theclassroom, if you're an engineer or your finance person or whatever yourrole is, there's many industries out there. Ican't tell you that there's one more roof rewarding than what we do. If you want to deal with the challengesof the methnical device industry, it's worth it. I tend to encourageparticularly the enegineering community and other disciplines to not get enamered with software andother things, which are quite valuable thy the way, but it's a lot more fun, a building,something that works and changes lives and that's a rewarding part of thisbusiness, that's great so Larry for anyone that wants to follow up with youafter the show. How do they reach you? The easiest way is probably just gothrough the rewalk website wwrarcom and I'm quite available inm on linkedin if people search for me there for people that are trying to develop andcreate, I encourage it. I don't mind giving the time people gave time to me and help me, and I owe that to othersWheni, where I can give good advice anywayso.

I guess those are the easiest ways tofind me: I'm not that hard to find. I don't hade all right well, thank you so much forjoining us today. Thank you very much next year, yeuinterested in this too. Bringing these types of things to the public and tothe business community is a valuable service and that thank you so much. Thank you so muchfor listening. I know you're busy working to bring your life changinginnovation to market, and I vowue your time and your attention to save kindand get the latest episodes on your mobile device automatically subscribeto the show on your favorite podcast APP like apple podcast, spotify andstitcher. Thank you for listening, and I appreciate everyone. WHO's beensharing. The show with friends and colleagues, see you on the next episodeof coiq.

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