The State of The Medical Devices Market with Rick Randall, Principal at Riverhead Advisors

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: I thank you so much for tuning in again and I welcome you to go to outcomesrocket.health/reviews where you could rate and review today's podcast because today I have an amazing healthcare leader. His name is Rick Randall. He's principal at Riverhead Advisors. Rick Randall he has spent the majority of his career managing directing and founding early stage medical device companies that have created some of the most revolutionary medical procedures practiced within the past three decades. Rick has a broad experience as a CEO Managing firms such as Target therapeutics innovative devices Tranz 1 and omni life sciences. Businesses under his direct leadership have achieved 1.b billion in value creation from initial public offerings of stock or mergers and acquisitions. Rick has cofounded three medical device companies which include Conceptus, Cardema and Prograft and he has served on the boards of several additional medical device firms. There's no doubt that Rick has that industry leadership that is so keenly sought after in our industry and it's with a warm welcome that I give Rick. Welcome to the podcast. So excited to have you on.

: Thank you so it's great to be here.

: So Rick I wanted to ask you what is it that got you into the health care sector to begin with.

: Yes I always had an interest in the sciences healthcare. I grew up in rural upstate New York on the lake Ontario border. Looking across the water to Toronto and it was a farm community. And my earliest recollection from professional interests was I wanted to be a veterinarian and later on in life when I was in college I moved over to for whatever reason an interest in ophthalmology, optometry but frankly it was difficult enough for me to finance my way through my undergraduate degree. Then to consider how I was going to get through medical school and beyond. I ended up quitting school for a year and a half and working at a General Motors factory just to enable me to finish my last year and a half and get out with only a loss of of one year so that kind that put a damper on on any kind of medical school or thoughts of medical school. But my first job out of college was teaching biology as a biology major and.

: Is that right?

: And I taught high school biology and in a school district outside of Syracuse, New York. And then after two years on the job I was dead set ready to enter my third tenure year. The all important tenure year and I'm kind of about that I called in to a number that I saw in the paper and there were ever times for a medical sales job. Yes and I was asked to come in for the interview. I had no intentions of taking the job. Pretty cocky and pretty sloppy about the interview. And that was moving quite nicely. And then the interviewer turned the subject to the income and what the job was like and the company car and free gasoline and all those things and we.

: All of a sudden and you're like wait a minute wait.

: Wait A minute. The economics kicked in, and then I was dead serious about the interview and somehow didn't blow it and I ended up getting the job. So yes that's how I got into medical technology as a diagnostic sales job first than that I kind of moved up the ladder with medical sales jobs and eventually found I had a real passion for marketing and strategy and moved in-house with C.R. Bard and the rest is history. So that's how that's how I got into the health care sector.

: What a great story and thanks for taking us through that interview. I felt like I was there with you. And now all of a sudden you're interested. So Rick you've obviously been heavy into the industry side of things. Med device a passion that I also share. So what is it that you feel is a hot topic that needs to be on every medical leader agenda today and how to approach it?

: I think the hot topic today for me is is how in the future I'm the prize student beneficiary of this medical device renaissance that I think started in the early 80s and ushered us into the 21st century. And it's been a great ride. We've done wonderful things with technology and the way health care is provided. Now, it's not even a close resemblance to what it was in the 1970s because of it. But the hot topic for me is how are we going to continue in the U.S. to drive that innovation. How are we going to continue to create a pipeline of innovation it's currently at risk. The real risk is in my view due to a material change in which the way startup companies are emerging medtech companies are finance the venture capital world that I benefited by in the 80s kind of the two-fisted look you in the eye venture capitalists who if they liked what you're all about provided you the money to do what you needed to do. That's kind of dried up. Those folks have fled the scene and the life cycle of a healthcare company back then. You know my first CEO job. My assumption was it will take me four years to get the job done the company could be sold or move on to the next. Well now that gestation period of a company to exit is more in the neighborhood of 10 to 15 years and that's caused a lot of the venture folks to flee. So that's that's my hot topic because I love what we do and I want to I want to see this country still benefit as the leader in creating these wonderful devices that we bring to market and I'm I'm a little concerned that we're going to see a slowdown of that innovation which really doesn't benefit anyone.

: I love where you're going with this. And your assessment what is it that has led to this slowdown. Is it the FDA. Is it lack of riders wanting to take risk. What is it?

: The FDA is a part of it venture capitalists about a decade ago summarized that to me and I've been borrowing that line ever since. It's an issue of stacked risks so if you consider when I first was in the CEO position the only thing we really the two things we had to worry about were is our device going to work. And secondly I'm real live human beings. And secondly when we get that device through the FDA? Can we get the FDA to agree to clear the device for commercial use. Those were our real risks and that's why you could take a concept and actually be commercial with the device in two to three years and then be taken out by a larger acquirer in your for maybe even take the company public. Well those are the tip of the iceberg. Today they're stacked risks. And it's taking longer to prove out each one of these risks set. So is the concept going to work? Where am I going to learn we can work in human beings? So there's a process you have to go through to even get into the most lenient countries to test the device. Then the FDA risk is it going to require a full clinical study or a 510 Caywood clinical or straight up 5 10k. And then when you get through all of that which is typically years five or six then can you get the device reimbursed? And I think it's that additional stacked risk of reimbursement in our healthcare system that has kind of caused the venture capitalist to finally give up raise their hands and move on to dotcom or technology plays. And that's that's quite unfortunate. But these stacked risks now have gobbled up the better part of a decade of development. And more importantly exhausted some of the funds that used to be available to us in the health care in the medtech sector.

: That's a shame. It's definitely a shame and fear patient waiting for it technology or if you're a leader at the helm of a corporation waiting for a technology. There's no doubt that it's taken a lot longer and there's really virtually just every year it seems like there's less mass and almost no one willing to form from a venture side back any of these companies up because of that lag time. What's the future look like in your mind?

: Well this is what I'm doing now at Riverhead advisors. I'm I'm focusing my efforts on helping these early stage entrepreneurs. You know I'm a little selective about what I'm helping. What technologies I get involved with but those technologies I believe are going to work and are going to do a service to patients and the system alike. I've been working to really guide them in the right way to approach this so the future to me is first of all I think we're going abroad to cast a broader net as to who can fund these device companies. I've also included private individuals now investor groups for early stage funding. There's what we call family offices which are typically high net worth individuals looking for other places to put some of their billions of dollars or whatever that may be. And what I found is some of those family offices also have a passion for certain areas. Perhaps they've been afflicted in their family with cancer or heart disease or diabetes or whatever. And it may not be necessarily the financial return that drives them as much although that's certainly important as the cause itself and then the other thing I've been doing is I've been tapping into the companies that we in the past would not talk to until we were fully vetted with the technology and all of the all of the issues were dealt and we were selling a lot of product which is the strategic acquirers because I think they're starting to recognize the same problem that we have in financing innovation is going to dry up their pool of innovation which is what differentiates their products and allows them to maintain fairly high pricing in a market because they're delivering unique technologies that have unique benefits. And so most of them have established venture type financing opportunities. So working with the the entrepreneur to cast the broader net and finding other sources of money other than the traditional venture capitalists is one way to deal with this.

: Rick I think you're doing something very unique and you're you're approaching things in a refreshing way. And rather than say hey you know what the well is dry you're looking beyond the well and you're helping entrepreneurs really dr]rive wide and deep into other areas. You listed a couple here. During our conversation so can you give us some examples of maybe some businesses you've helped out in maybe a surprise that happen in the process?

: Yeah I've. There's a company in particular that I'm working with that I'm very excited about. It's a company by the name of RadiaDyne and it's a Houston based company that's focused on the oncology radiation oncology space. It's a company and I give all the credit in the world to the founder John Isham. John was a sales rep himself. He came up through the same the same pathway I did and John had an idea and he felt that radiation oncologist could benefit from balloon type catheters that could be placed in tissue structures to separate them and space those structures away from areas that are being radiated a good example would be for a patient a male patient undergoing prostate cancer radiation that he would have a catheter that would go into the urethra and separate the urethra and the bladder junction and space it by inflating the balloons space it away from the prostate so that as a radiation passes into the body it's mostly hitting only the cancerous tumor and not causing severe side effects and burning to these other viable tissues that are very very important. Well John didn't stop there. He built a nice business. It has made a living for John and other employees. Along the way, he hired a person I worked with at a TranS1, Bret Boudousquie to be the president of the company. But he's developed spent eight years of his life and a lot of his net worth developing a new technology. The Ortrack system which is now just being released to market that enables it's a device that has a capability of loading up the four sensors and the sensors are on these little micro catheters. And so the sensors can be placed in various spots around the area that's going to be treated as both within the tumor or next to the tumor itself and probably more importantly in the surrounding tissues that you want to preserve and you don't want to radiate. And what these sensors do is they measure the radiation real time and they take this reading out into the control room so that the technician and the physician both can be looking at the accumulation of the radiation inforced spots in the body and determining whether they're giving their target dose and not giving too much of a dose to areas they do not want to radiate. So once they're getting these measurements real time, they can adjust the radiation to make sure they're doing what they want to do and they're not doing what they don't want to do and that enables them to be more aggressive with the radiation perhaps reduce the amount of treatments and turn the power up and a whole level of safety to patients who undergo these terrible radiation treatments where they have these burns that could affect them. So what's exciting is that company has been privately funded and now it's time to take advantage of this new technology and publicly funded or funded through other sources. Yes. So rather than just going to venture capitalists which we are doing I I've been working with the company and we are going to some of these other outlets and including potential strategic investors. I've introduced these from the firm to banks. They knew a couple of banks to lone. We've created quite a buzz and I think we're not done yet but I think the financing prospects are going to be very good for the founders and the shareholders who let's face it they took all the risk on this.

: Right.

: And I think it's going to be beneficial to them. And it's going to allow us to get this technology out to the major cancer centers in the United States in a much quicker weaker if it's in a quicker fashion. So there's an example of something how we're putting it to practice.

: Absolutely. And this is now an FDA approved device being used in hospitals today?

: It's an FDA approved device and it also to my other point that I made earlier it also has reimbursement codes embedded in the system. It is now available in one center, Sloan Kettering in New York. And I think they just shipped another unit to another center in Ohio. And there is a stack of hospitals around the country pretty sizable number of very renowned cancer centers that are aware and they're waiting for the technology. So throughout 2018 we're going to see more and more centers have this technology available to them spread out in the United States.

: That's excellent. So Rick appreciate you sharing that very granular and exciting response so listeners Here's an invite to you, if you like what you hear whether it be from a practitioner standpoint, if you're a healthcare executive wanting to differentiate yourself in a way that you are oncologists treat cancer. If you're somebody that has investment capital, I invite you to reach out to Rick and we'll be sharing his his contact information here at the end. But the purpose of the Outcomes Rocket is to do some silo crushing so that the discussions that need to be had are had and that's why we got Rick here on the podcast today to bring this exciting information to you. And so Rick you've learned a lot through the things that you're doing and now you're working on some exciting ventures, the one you just mentioned to us as well as others. Can you share a time when you made a mistake or failed and what you learned from that lesson?

: Oh yes. Unfortunately when you do what I have been doing as long as I've been doing it, those unfortunately do tend to pop up from time to time. So let me take a deep breath here and recollect that experience and in a way where I can painfully share with you. The experience that I'm thinking of is a company by the name of TranS1 which ended up being a it was a we thought was going to be a huge success. It's a great technology, it's a company that I joined as CEO in 2002 and I also happened to be the first employee of the company way back in 2002. At the time I joined, it was a concept it was founded by an interventional radiologist and a business partner and they had the idea of a minimally invasive approach to the lumbar spine and the lower spine to enable surgeons to do a lumbar fusion which is a very common surgery in that part of the anatomy and a fusion that would enable patients to heal very quickly as a matter of fact the ultimate goal was to be able to do something that people just laughed at when we first broached it with them. Outpatient Fusion's. So I joined in 2002 and it moved along very very quickly. I was able to the RMV executive who was working with the company as a consultant at the time and developed some interesting prototypes and I quickly decided I got to hire this guy. And Bob also who I'm still working with today on anotherproject and we hired Bob and we were in the clinic in Brazil with this technology by as I recall by early 2003. I joined the company in June of 2002 and we quickly developed this into a surgery that was working took that data from our own US experience and took the data to the FDA and lo and behold we were able to get a 5 10k clearance for the procedure in the implants and the tools. And we were then starting to commercialize as early as the third quarter I believe in 2005. So it was about as good as it gets. Maybe that should have been a foretelling. And I'm a little bit superstitious about this and I knew it was going so well that I was I was really worried what's going to happen I truly was eventually did it. You'll you'll see in 2005 we commercialize the product in 2006 and 2007 we were seeing rapid growth. There was a kind of a movement taking place with us and around us in the world of spine surgery to move these maximally invasive procedures to a minimally invasive format. So we got caught in that draft. We contributed to that draft and then the IPO market opened up in 2007. So we took advantage of it and we did a initial public offering of stock and went public with the company in October of 2007. And of course it was a very well subscribed very successful IPO. We came in at above the price on the cover all the things that you dream of. Yes. So concept in 2002 public offering in 2005, almost unheard of. And.

: Yeah, that's incredible.

: And then there's the rest of the story. So within six months in early 2008 we learn that the North American Spine Society which was the Surgeon Society of Spine Surgeons that basically were made up our customer base and then some. They had approached CMS and recommended that this approach had its own surgeon payment code. One of the things we vetted early on was can we get paid for this and there happened to be several existing codes covering lumbar spine surgery and we fit the technical vignette of one of those codes. So the advice we got was, you never know what's going to happen and people could come along and say I think you ought to do something differently or it should be looked at differently. But we did fit it, fit the code so we were billing under that code through our commercialization stage. Well, this new code which was granted over time by CMS caused us basically to be put into a Category 3 which is an experimental category. And since most of our patients were covered by private health insurance not Medicare,.

: Yes.

: The adverse effect it had on TranS1 was that our surgeon payments went away. They weren't being reimbursed. I don't know if you could just imagine being the CEO of a publicly traded company and now you find out your surgeons aren't going to be paid for your operation.

: Rick just to level set here you're in a situation where the surgeons are actually trying to make it more defined right? You fitting under an existing code, lumbar fusion of some sort. And now their intent to help actually hindered.

: Well I later learned they weren't really trying to help TranS1. What I what I later learned. And there were hints around this earlier on. What we didn't know behind the curtain was that CMS had already approached the nest coding group and indicated to them that they were growingly concerned that the surgeons being performed under the existing codes the time it took to do the surgeries were not matched up properly with the time that was used in the algorithm that creates the reimbursement dollars.

: Okay.

: In the sense they felt that the surgeons were being overpaid for the amount of work that they were putting into their operations.

: Got you.

: Makes sense because those values and those assessments took place a decade earlier and all surgeries get better the equipment gets better things get faster. So we contributed to this unknowingly because our operation was taking a good surgeon only about an hour. The surgeries were valued at four hours,.

: Got you.

: So roughly put, the powers to be at nest we're concerned that's a little upstart TranS1 was going because if this was widespread we had adopted in a widespread way was going to cause a 75 percent pay cut to their membership. So that was the reason behind them giving us an experimental code so that we could work this through and eventually work through the white. I think they want this to go away. But I'm also very cynical at this. So that was what was behind it.

: Interesting. Thanks. I didn't mean to derail the conversation but it definitely important detail there that I was curious about.

: Sure. And so what did we do about it. Well we had to downsize the company and sales were shrinking. We obviously worked very hard with our surgeon base are fortunately, we had 10,000 operations that had been performed at this particular time. We are able and there were publications in the works so we were able to kind of gather our clinical data, create more clinical data and work within the system to try to turn a Category 3 code into a category 1 code which we eventually did. But we also learned that with the private payers it's very difficult even if you reestablish a new code in a world where they really don't like spine surgery anyway and.

: Right.

: Paying for expensive science spine surgery. It's very difficult to take a non-pay status and move it to a pay status and the company still exists today it's now private and they have been able to establish a code and bring other payers on board. But they're still fighting insurance company by insurance company to do that. So it was a very difficult time in my career. We had a rocket ship to this day. The procedure worked incredibly well. It's one of the best operations out there. If I had to have an L5 S1 fusion, there is only one solution I'm going to see that operation. The company is alive today because there's still surgeons who had great results and they're using it but unfortunately for all the wrong reasons the opportunity really went away and our employee shareholders, surgeons were hurt because of it.

: And so Rick really appreciate that story. A tough one. An exciting one, a tough one. So if you had to share one thing that you learned from that what the listeners. What is that one thing?

: Well there's a few things that if I broke it down to one thing I would say this my first board meeting at the company I didn't know the lumbar spine from the rotator cuff and I had just joined the company and we had a board meeting but I did have an important subject based on my prior experiences with the board. And I wanted it to term you use I want the level set with the board what our expectations were. And at the time I was a growing believer that the public markets are not a good match with single technology companies. There's all the risk is in that single technology and TranS1 was a great example of that. So what we discussed was, Do we really have a exciting product or do we have an exciting company? And we realized we had an exciting product but that's pretty much what it was and that product could be hugely valuable to a larger company that is broader base. So our intent from the very beginning the first board meeting we managed was that we would build the value and look to sell it. Now look to take it public because I had done that before I didn't need that poster on my wall anymore. I just felt that that was the wisest thing to do. We almost did that. The day we closed on our clothes. We accepted term sheets on our last private financing. I think it was 2006.

: Yes.

: The day that then I had promised venture capital we make a decision that day. Out of the blue we got a call from a company that had looked at the company and they made a hundred million dollar offer which the bank who we were working with felt could be easily moved to 125. We declined that because we had put these venture capitalists through this whole process and due diligence to get to where we were that day to make that decision. If I had that win back that would be the easiest decision in the world nonstop. I'm helping the process and I'm allowing the merger and acquisition conversation to take place. If we had stuck to our initial position that we made and took in 2002 at that board meeting, we would have returned a wonderful return to the shareholders at the time for the amount of money put in, for the employees. So that's the lesson learned I believe is we I guess a better way to capsulize that is you really need to be pragmatic about your value proposition at all times. And even though you're in the thick of it and you love what you're doing you think it's the greatest thing in the world, have a sensible balance to the risks that you're also taking by moving forward.

: What a great lesson shared Rick and listeners keep that one with you. And if you're working toward building your company your practice accountable care organization whatever it be. Be very clear about what your outcome is from the beginning and stay true to your true north because that's ultimately what gets you through the thick and help you be successful in adding value to the healthcare system. Rick thanks so much for sharing that.

: You're welcome. Still hurts.

: It's those pains that help us be better right?

: That's right.

: And now you're able to offer these lessons to our listeners but also the people that you work with and in your practice.

: Everyday.

: What would you say So you took us through that dark moment. Why don't you take us to the lighter moments one of your proudest leadership experiences in medical device that you've had?

: Oh sure that's that's a fun one. That would be Target Therapeutics it was my first CEO job in 1989. I was a 37 year old guy who had but you had it I had it all figured out I think until that first day I sat in the big seat. And then said What am I going to do. But it was it was a great experience from that point on. And I was with Target from basically from 1989 to 1997. The last I had a personal reason eventually to move back to the east coast. This was based in Fremont California. And so I was CEO through I believe 1993 and then I stayed on the board through 96 and the acquisition in 97. Target was a company that had developed a very novel, patented micro catheter that was capable of navigating through very small torturous blood vessels. The initial plan for the company was not to develop a catheter but was to develop a new way of treating hepatic cell carcinoma, a form of liver cancer in a way where the interventional radiologist could take a catheter through these torturous vessels into the tumor itself and also go through the venous system into the back door into the tumor and then deploy clotting agents and devices that would basically shut the front and back door. So there was no blood supply coming into the tumor. And what this effectively did was with no blood supply, this growing tumor would then start to shrink.

: Interesting.

: It wasn't a final therapy and it was a palliative treatment but it did become over time very widespread in Asia particularly Japan where it's more prominent as a disease state. And those patients can live another five years of a very good quality of life. And I think they can at that time I believe they could receive up to 2 or 3 treatments each giving them with an additional 4 to 5 years so it was a good thing.

: Amazing.

: But in the United States the market was that large and the clinical pathway was not well-defined. And the company was really struggling. It turned out to be a huge science project and it was gobbling up quite a bit of capital. And the company it was owned by College Incorporation which was one of the materials that was being used to analyze the tumor. So there was limited resources to fund this but at the same time that this research project was ongoing, neuroradiologists working in the same area as the interventional radiologists were picking up these little catheters. They learned about and threading them into the brain and that was creating a nice little revenue stream. By the time I got to the company that was about as I recall about four million dollars in revenue mostly are almost all derived from this Neurovascular application. I joined the company and it was clear to me the strategy going forward was to focus on stroke. I had early in my career earlier in my career I should say I was on the team that developed and marketed the coronary angioplasty catheter which as you know changed the way heart disease is now treated and has become a multibillion dollar industry. So my vision at the time was why can't we do the same thing in the brain?

: Yes.

: And no one was doing it because the heart catheters could not sneak their way up past the Circle of Willis next to your ear into the brain and puncture the brain. Well we had a catheter that would do that. So we kind of jettison the cancer treatment, unfortunately had to let some people go and focused our efforts on the neural application that turned out to be a great thing. Once I got to the company and assessed our opportunity, it became clear to me if we were really going to survive and win, we had to move on beyond these venous malformations that were being treated with our technology that was a small market and a large market, all the customers told me was the cerebral aneurysm. It was a ticking time bomb if it ruptured. The death rate was very high, mortality rate was very high and the only way to treat it was wide open brain surgery which was morbid and not wholly effective. So we gathered the troops and told all the engineers we've got to find a way to fix the Cerebral Aneurysm. Within a few months after that meeting one of our engineers who is working with a neurosurgeon down at UCLA came to me and showed me on my desk working prototype of something he had come up with that I saw firsthand. You know it worked at least in a with an aquarium pump and blue dye going through the tube leaking on my desk and filling a glass blown aneurysm, he was able to block the aneurysm and block the flow of the water into the aneurysm and animal studies had shown that if you do that you could effectively cause the aneurysm to shrink and scar over. So we took that concept to a human outside of the United States at the time. And it worked. And.

: Nice.

: Yeah it's very nice. We were able to take the company public in 1992 even though we did not yet have clearance to market the device in the United States. Around that time there was also a large trial because the neurosurgeons did not give up easily on their technique and demanded a clinical trial where they compared the two methods. And that trial is I think one of the early interim analysis points was halted because the data the outcomes data. This is an outcomes podcast's the outcomes data showed definitively that it was unethical to apply to many of these patients neurosurgery when when this coil did the job and the results were much better.

: Nice. So you're able to just nip it in the bud earlier.

: We nip it in the bud in more ways than one. And we took that as I mentioned the company was public and once we got the clearance in the United States and we brought I had to move to east I became chairman initially and then Gary Bank came in as CEO and we commercialized under Gary's leadership and the stock went crazy and then Boston Scientific ended up buying the company for a little over a billion dollars.

: Amazing.

: The company still now resides with Stryker.

: Stryker right, yeah.

: Corporation. And more importantly aneurysm coiling is the de facto standard of care.

: That's awsome.

: It's also not only did the shareholders do well. Employees did well. We had a great time, that was great bodily experience but there's countless patients lives we saved, outcomes that were much better. A lot of dollars, euros, whatever denomination says because of the technology.

: That's awesome. What a great story Rick got. You're great storyteller by the way. Anybody ever tell you that?

: Yeah. Lot of employees who felt I just probably told them too many repetitive story.

: I love it. Listen what a great story is shared by Rick, a technology that is now being used on patients worldwide. Currently residing within Stryker. It started with a technology that wasn't taking off in our market and a good hard look by Rick and his team to pivot and reapply where it was being used rather than dying on the vine. They found a way and a lot to be learned from that story. I would recommend that you rewind this and listen to it again because it's a really good one. Rick thank you for sharing that one.

: Alan Walker Hey one last anecdotal point today those micro catheters are used globally on a variety of cancers. The original thing that the company was designed to to attack it. The good news is we didn't necessarily pioneer it at the time but it did survive as a as a viable methodology. Now it's universally applied. So it's all good.

: That's awesome. That is awesome. What a great contribution to humankind Rick. Thank you for the work and the tenacity that you applied in that endeavor.

: Well we had a wonderful team that we've been. Many of us have been best friends from those days as you can imagine. So it's a great experience.

: That's outstanding. All right getting to the end here Rick we've got the medical leadership course and what it takes to be successful in medical devices today. The 101 of Rick Randall. So we're going to write out the syllabus with a quick lightning round. I've got four questions for you followed by your favorite book that you would add to the end of the syllabus. You ready?

: OK.

: All right. What's the best way to improve health care outcomes.

: I'm going to focus on early stage companies. That's what's going to live and breathe. My advice there is the best way to produce outcomes is develop a therapeutic technology and a product that not only reduces procedural morbidity and fixes a problem but it also lowers the cost of of care. So patients should feel faster. Your technology should be appropriately priced and you create a value-based outcome if you do that, you have a high probability of winning.

: What's the biggest mistake or pitfall to avoid.

: I've never seen a company take too much capital. You typically need more capital than you think. So under-funding and I think the other thing is to employ a very comprehensive clinical plan as you're measuring your new technologies so that you both measure clinical outcomes and economic outcomes as well because you're going to need both to be able to get your commercialized and find your way into the hospitals to be successful.

: How do you stay relevant as an organization despite all the change?

: That's a great question, I think we typically start these things with a grand vision and then we get mired in the day to day things that you have to tackle. So my advice there is you build a functional strategic plan and you revisit that strategic plan yearly and you're honest with yourself. You're pragmatic,you employ your unaffiliated customers and you change based on the changes that are taking place environmentally.

: What's one area of focus that should drive everything in an organization?

: Kind of ties into the last comment. It's constantly getting customer feedback. Feedback from your employees. Making sure that what you are doing is not alignment with what they feel you should be doing. That's both the visionaries and the visionaries. Because if you only satisfy the visionaries you may not hit the bell shaped curve of humanity that is there to use your product.

: Some great tips there. What book would you recommend as part of the syllabus?

: Oh gosh know this is a bit of an outlier here. I don't know if you'd be part of a syllabus but I'm big on leadership. I don't think you can ever be complacent when it comes to leadership and good leaders are are very important. So a couple books come to mind that are interrelated actually I love the trilogy The Edmund Morris trilogy of Teddy Roosevelt. I thought that the century you know the 21st century was the American century and the rise of America to power. And I think Teddy in his own unique way he was a unique president at the time he came in. There has never been one like him with that kind of background that came into the presidency at least since the seventeen and early eighteen hundreds that had fit that mold. This trilogy covers kind of a rise and fall and really points to characteristics of strong leadership and it's not all good it's it's difficult tough decision making times as well. And the other thing that ties into that is I love the Malcolm Gladwell books and how he makes you think about things. Blink, to me blink, blink told me how I was unconsciously competent. When you're with a startup, you don't have any history. You don't have any clinical data to go on. So you have to make decisions based on very little evidence. Evidence is important but you can't wait for all the evidence to come in. So you have to make some gut level decisions and Blink is all about you know more than you think you know based on your experiences and to trust your gut instincts if you have the right experiences to back them up. So I think Teddy Roosevelt employed those principles. And so those are two books that I find very helpful to me and made me think a little bit differently about how I do things.

: Outstanding Rick. And yeah, these are awesome recommendations. Listeners if you're driving or running or doing something else where you can't write them down don't worry about it, just come back to the episode or just remember to go to outcomesrocket.health/randall. That's Rick's last name. It's R. A.N. D. A. L. L. You will be able to find all the show notes there as well as links to the books and the things that he's up to. Rick, before we conclude, would love if you could just share a closing thought. And then the best place for the listeners could get in touch.

: Sure I'd be happy to and thank you for again for having me join you on this podcast. Hopefully it's helpful to, at least interesting to some people. My closing thought is and I touched on this early so close on it. We've been in a leadership role in United States for some time in the health care segment particularly medical devices and we need to continue leading that way and we need to continue being the driver of game changing cost-reducing medical technologies and to do that we need we really need as a country to come together and devise a new fundamental funding mechanism to enable entrepreneurs to do what they do so well and create those technologies. I would suggest that we we look outside of this country, look to Israel. I've managed a company and Israel. Innovation in Israel is fundamentally critical to them. It's existential to Israel to be able to innovate. They don't have a lot of customers living around them who want to buy from them. So they've got to innovate for markets well beyond their borders and they do a good job of that and they found a way to match venture capital with government assistance and entrepreneurs to find a way to allow innovation to live and breathe and mature. And I think this country should absolutely be tapping into that kind of methodology to replace the old venture capital model that seemingly is broke. So those are my thought I'd leave you with this podcast.

: Some great thoughts and we really appreciate your insights Rick. I know they're going to make a big difference to the listeners. Where would they reach you or follow you if they wanted to.

: Randallrick1 is my e-mail address. It's Randall, randallrick1@gmail.com is the probably the best way to reach me. And we can go from there.

: Excellent. They haven't listeners. Rick Randall sharing some amazing insights and medical device. Rick, it's been a pleasure having you on the podcast and looking forward to staying in touch.

: It's been my pleasure. Well thank you Saul.

Thanks for tuning in to the outcomes rocket podcast if you want the show notes, inspiration, transcripts and everything that we talked about on this episode. Just go to outcomesrocket.health. And again don't forget to check out the amazing healthcare Thinkathon where we can get together took form the blueprint for the future of healthcare. You can find more information on that and how to get involved in our theme which is "implementation is innovation". Just go to outcomesrocket.health/conference that's outcomesrocket.health/conference. Be one of the 200 that will participate. Looking forward to seeing you there.

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