Medsider Radio: Learn from Medtech and Healthcare Experts

From an Idea on the Back of a Napkin to an Eventual $240 Million Exit – The Amazing Story of Sapheon

April 14, 2016 Scott Nelson
Medsider Radio: Learn from Medtech and Healthcare Experts
From an Idea on the Back of a Napkin to an Eventual $240 Million Exit – The Amazing Story of Sapheon
Medsider Radio: Learn from Medtech and Healthcare Experts
From an Idea on the Back of a Napkin to an Eventual $240 Million Exit – The Amazing Story of Sapheon
Apr 14, 2016
Scott Nelson

I’ll be candid. This is an interview I’ve wanted to do for quite some time. During my time at Covidien, I considered myself fortunate to be involved with the acquisition of Sapheon, a startup company that manufactured a disruptive therapy for venous reflux. The more I learned about Sapheon through the diligence process (as well as...[read more]

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Show Notes Transcript

I’ll be candid. This is an interview I’ve wanted to do for quite some time. During my time at Covidien, I considered myself fortunate to be involved with the acquisition of Sapheon, a startup company that manufactured a disruptive therapy for venous reflux. The more I learned about Sapheon through the diligence process (as well as...[read more]

Related Stories

Scott Nelson:   0:08
Welcome to Med Cider, where you can learn from experienced medical device and med tech experts through uncut and unedited interviews. Now here's your host, Scott Nelson. Hello, everyone. It's Scott Nelson and welcome to another edition of Med Cider, the place where I interview Experienced improve unmet tech on medical device, not program. We've got Don Crawford, who is the president and CEO of Analytics for Life medical information technology company that uses advanced signal processing techniques for the purposes of assessing and diagnosing disease. We're certainly going to get into that in more detail. But prior to his role with With Analytics for Life, Don was president and CEO of Saffron, which was acquired by convenience in 2014 and before Saffy on Dent don't have various positions with the guidance Medtronic Devi I on Web in D. He received a bachelor of chemical engineering from Georgia Tech, any MBA from Emory University. So, without further ado, welcome to the call down. Appreciate you coming on.

Don Crawford:   1:15
Thank you.

Scott Nelson:   1:16
All right. So let's let's start with Saffron first. I definitely hinted that what you're doing with analytics from what will certainly get into that in more detail, but Let's start with Saffy on first. As I mentioned, Convenient acquired your company in 2014 for reported, I think, close to $240 million I believe was close to the number. Anyway, that's that's what that's what's that sort of in the public domain. But anyone a fantastic win for you and your company And in my opinion, maybe maybe one of the one of one of the more unheralded stories within within MedTech. So when you finally got that deal done after spending, you know, almost six years with Saffy on, do you recall how you and your team celebrated that win?

Don Crawford:   1:57
Yeah. You know, we were, um uh, really going through a process of the last six months of diligence working Ah ah, working towards a ah final deal and, um ah, transition with comedian. And I remember that in the last month before the deal was finally done. Or actually, I think that we had even signed the agreement that we were still waiting for the final voter. The final of shareholder vote, which is took about 30 days. Ah, we did 1/3 quarter management, um meeting and we took the whole management team, which at that point was based out of, ah, more spill North Carolina. And we took them all back to Sonoma County, where the company originally got started in Santa Rosa. And we had a, um, a team meeting of managers meeting, which we do on a regular quarterly basis. But we did something special, and we invited for a dinner meeting anyone who had ever had anything to do with sappy on consultants, past employees, et cetera. And we did more or less a celebration dinner at the Fairmont in Sonoma. And, uh, we probably had 50 or 75 people attend, and it was really a great celebration for the weekend and even my teammates today that are now scattered. They always, uh, mentioned that weekend when we when we revisit,

Scott Nelson:   3:35
has that's a That's a great story. I wonder how many other med tech companies, you know celebrate, celebrate like that, but that's that's cool. And I I definitely want to dig into into the sad story because it seems like from the out from outsiders perspective, you guys did some amazing things in a relatively short amount of time. I know, I know that somewhat somewhat, you know, you know, it's an opinion, but it seems like you guys got a lot of light budget. Andi, I think, is a fantastic success story. But when you think about your course of those 5.5 6 years, you know, from from when you joined Saffy on Thio sort of the the initial acquisition by Convenient was competing at the time before the Medtronic Medtronic deal, I there may be one or two things that really stand out over the course of that time.

Don Crawford:   4:27
Yes. Um, you know, beating it really was unique and that you heard stories before of people meeting and writing something on the back of the napkin into becoming an idea or a patent. And in reality, um, the co founder, Dr Rod Rabie, who really had the original clinical idea Thio use a tool to glue a leg vein together. That was, you know, the original idea came from Dr Rabie and I remember meeting him for the first time in a hotel in his hometown, and we had dinner and on the back of the placemat at the dinner, he wrote out some drawings and rode out kind of, ah, thought process of what, uh, what he thought this idea could do. And, um, we took that from the back of a napkin to, um, the three clinical trials launching the global operation and ultimately doing a p m A trial. It's a very successful PM a trial and then exit of the company from start to finish with the two co founders involved. So I think that that that in itself is a very, very unique story,

Scott Nelson:   5:43
without without a doubt. And I Fortunately, I've been able to meet somebody, some of that some of the members of the team doctor Dr Ray be included as well. As you know, guys like Monty Mattson and Gary McCord. And you had a fantastic team really, really good people. On a very cool story. I did. I didn't realize that you really, honestly kind of went That Sounds like kind of went from from from napkin idea Thio, you know, Thio successful, successful exit. But when you when you're sitting down with Dr Ray, be at that table, I'm not sure if you remember this or not. But when you when you first, when he first kind of presented. Presented that idea to you? What were your initial thoughts?

Don Crawford:   6:19
Well, I mean, initially, um, I took good on as a consultant. I was just doing Ah, you know, very basic thing that I would do in the corporate medical world. You know, you come up with a new idea in the first thing, you do you learn an MBA school or business school, or if you're out there running your own business, you come up with an idea and you guys just lay out a business plan. Doesn't make sense. Um, first, you know, Is there a need? Well, the market was huge. 25% of the world's population had Venus disease. So boom, that's an early check, Mark. Huge market. Um, the unmet needs, um, you know, the the technology that was being, um, used waas not something that from ah, from a lay person's eye. At least you know, just not being an expert in the field. It just did not. It looked like there was a lot of room for improvement over vein stripping the surgical method and the Oblation methods that have a lot of, um, of side effects and negative downside to it. So we saw unmet need that could be solved with this great idea. And then I looked at the economics. Um, you know, first and foremost, there were a lot of, um ah, companies that were interested in the arena. But really, no, none of at the time that we first looked, none of the companies were owned by major giant corporations were really midsized companies like Angela Dynamics in the at that time. The Oblation company is well, so far back now, I can't even remember

Scott Nelson:   8:03
them. Three

Don Crawford:   8:04
committee in, um,

Scott Nelson:   8:05
the thean us. Yeah,

Don Crawford:   8:08
Venus. So, um, the fact that it really were was ah, uh, the competition was still kind of young. New ideas and younger cos I thought that ah, company like ours or a startup company definitely had a a place to our way to enter the market place. And then we just

Scott Nelson:   8:30
looked at the basics. You know, is this something that could be manufactured, you

Don Crawford:   8:34
know, in a low cost way? And did we see that there's an established market that pays a, um ah ah, reimbursement that would fit in Boom. You know, you go through fiber six list and everyone hit the checkmark box and say, Well, this is a great idea to pursue

Scott Nelson:   8:52
and how much I want to get into. You know, Samore Samore details, Because you make it sound very easy. And I'm sure it wasn't that way. But But you have, you know, incredibly successful story to tell with with respect to Saffy on. Um, but how many? How many ideas do you come across where you're doing Your initial diligence that don't they Don't check all those boxes.

Don Crawford:   9:16
Well, you know, um, there are a lot of ideas out there, but, um ah, a lot of ideas are a neither. The market is unknown. I mean, sometimes you're so innovative and so new that you're really ahead of the market. Um, but, you know, luckily, we were looking at something that really had, oh, an established market. So, you know, if you look at the economics of it and that's usually where I go first, is it Is it being used in isn't being reimbursed? And if those boxes are checked, well, you know, you could almost hit anything into those two, But without the reimbursement or established market, then you know you're really fighting a 10 year battle, not a short battle. Get a device proved.

Scott Nelson:   10:00
Yeah, that's the one of the key

Don Crawford:   10:02
things that I look at.

Scott Nelson:   10:03
You know, those were two really good points. And so let's dive into some of the details on you mentioned that you got you guys, you know, when you know, obtained a c mark. Uh, you know, this This wasn't a just a 5 10 k device was a p p. M. A device and you were able to navigate toast the choppy waters. Which is why I'm gonna ask you a few questions about that because that's certainly no easy task. But let's talk about the funding, because from what I know, based on my research, it looked like you raised around $3 million total or so something like that across it looked like maybe your latest round was a B round. I'm not entirely sure if that's correct, but I guess from a macro perspective and again, this is this is my opinion. But it seems like you guys were really savvy with the way you approached funding the company. And really like I said earlier, getting a lot done in and not not a long period of time in the sea. Mark, that teammate advise you commercialized in Europe were getting ready, you know, probably commercializing you in the U. S. Before the acquisition with comedian, you know? So, Hee, where there were there things that you thought about going into, you know, going into Ah, you know, the funding. The, you know, the funding rounds that allowed you to be, You know, that Savvy. Maybe maybe talk to us a little bit about that.

Don Crawford:   11:15
Yes. So, um, you know, I wish I could say that, uh, I was incredibly innovative and brilliant. And, uh, we have established this new, uh, private funding model because, you know, I had a vision, But in reality, we started the company at the worst time in the history of starting medical device companies. It was in the middle of the, um, the financial crisis 2008 recovery in 2009. And anyone who lived through those days recognized that any sort of traditional venture capital funding, um, and medical especially, um What? We're just not available. Um, so there was no institutional money that you I could count on early stage. Of course. you've heard the stories. You're either too early, you know? Or you're too late or, you know, every excuse you can imagine from the institutional VC investors about why they wouldn't look att Saffy on and And we did talk with, um some, uh you know, mainstream, well known firms, people that we we actually knew through our career between Rod and myself and the the need to go to private equity investors. Private, um, some people would call them angels. I just calm credited investors. We started that pathway. You know, we heard of the famous, uh, friends, families and fools.

Scott Nelson:   12:44
And at

Don Crawford:   12:45
the time, that was the We would go, you know, a month by month and we were out raising. We established a Siri's a preferred series, a price and equity, and we offered it. Ah, of which Rod and I were like, the first we were the biggest shareholder is almost the only shareholders for the 1st 6 months. But that was the way that Ron and I funded the company, and part of it was investing in Siri's a ourselves, um, at the end. Management had more than 10% of the invested funds that were invested in the total investment, which turned out to be right at 30

Scott Nelson:   13:26

Don Crawford:   13:27
$1,000,000. Total investment from start to finish. And we had almost 10% of that was management's money. So that, you know, that is, ah, something you look for when you're out there looking for private investments. If the manager's air in investing into their own company, that's usually a pretty good sign,

Scott Nelson:   13:45
got it. That's Ah, that's such a unique you next door. And I love the fact how you kind of set the set the stage there and and and I didn't even think about it when I was doing some research for this conversation is that that wasn't really incredible, a really difficult time in terms of trying to trying to raise money back in 2000 and 2009. So we need to forget now. But really not that long ago. So let's with regard to raising private money. I'm curious. How did you balance? It? Seems like that would be fairly time intensive versus you know, the traditional path of having you know your Siri's a lead by one of the well known you know VC firms. Instead you raised it through sort of a network of private investors. You call them? How did you balance? You know, spending time, you know, with the necessary dated a task of running, running the business versus you know, what would seem like, You know, a fairly time intensive, you know, uh, fund raising, you know, uh, you know, with with a multitude of different angel investors or private investors.

Don Crawford:   14:43
Well, uh, you know, I mean, the balance is what it wasit was a total immersion. So this is what my job was 24 hours today, and, uh, you know, even at the very beginning, we had a team of people. Rod and I were co founders. We were both involved in the beginning. So we had a network of people network of of successful people and everyone that we brought into the organization you had mentioned in, uh, Gary McCord and, um, uh, several others. But everyone who is became Monty became involved with the company. You know, we all recognize that, um uh, fundraising is, uh is the kind of the poor of the company, and so without that, you can't do the other things, but we really worked as a team. And really, the corporate structure was set up to where we had objectives and goals. Financing was always a part of it. And everyone was involved in being successful at financing. I

Scott Nelson:   15:49
got it. Um, that Z using the analogy kind of everyone's job is to is to sell something especially early on in company. I like you're like the way you're You know, you kind of thought about that in the sense that everyone, everyone at that stage, at that stage in the life of sappy it was It was sort of responsible for trying toe trying to generate some interest in the company. From an investment standpoint, very good. I want to get into it. Oh, some of the, uh you know, the how you what about, you know, establishing that the clinical trials and moving throughout the regulatory process is as fast as you did. But before we before we in kind of the topic on fundraising do you think that's a path in your opinion that Maur early stage device companies should pursue vs, vs, you know, going the traditional route of of trying to connect with well known venture capitals, But instead, Maybe maybe pursuing, you know, uh, a syndicate of different private investors or angel investors.

Don Crawford:   16:49
You know, I think that we've seen more, much more of that occur in the last three years. I would say that I've been watching the, um, kind of watching the industry that this became even in 2012 or so 11 and 12 that became started to resonate. And I know that a number of companies have completed their Siri's A and some into Siri's be along those same along the same lines. So, um, I think that now, although it still is, um, you know, it's, ah, it's brought with a lot of twists and turns, but it can be done and it could you know, we I think there's enough history now to show that that is a method to to use as a, um as a funding plan and a funding source. But you've got to be well connected and understand the nuances of how corporate organizations were. You know, it really comes down to even setting out the first corporate structure, having the right legal counsel for, um uh for setting up your documents, your funding documents or critical. The structure is critical. Ultimately, when you get towards the end or get into later rounds, you'll understand that. Um, you know, the structure that you started with dictates a lot of things. We have to put a lot of thought and, uh, preparation in. Ah, in that, um ah, you in the plan? Or unless you say, the corporate organization, the organizing documents and such. And, uh, that is, uh, just comes with the territory, so to speak. It's different than if a VC throws some term sheets up. They're the ones who want to have, you know, the corporate documents their way. But if you're funding at privately, then really it is the management team that sets the tone that Thea the, um um structure and it It has to be something that is, um, attractive to an investor. Because ultimately your investors are planning on making a multiple return on their investment.

Scott Nelson:   19:13
Yeah, so I guess I guess in summary, the the onus is on, you know, when you when you choose the path that you guys that you guys went down, the onus is is definitely more on you in orderto from that from a term sheet perspective as well. Yeah, yeah, Good lesson. Good lesson to learn. Let's shift Thio, Um, sort of the clinical work and the regulatory pathways that you pursued And let's start, maybe on the regulatory fashion. There's a lot of I think most people in med Tech would agree that the, you know, the FDA is you may be difficult to work with it at times. The regulatory pathways, even even now with the 5 10 K in the clinical burden is a lot heavier than maybe it used to be. Um, but you're like I said before, you were you guys were able to accomplish, you know, a PM today and just shortly after the acquisition with with comedian. So maybe help us or give us a little insight into how your team was able to accomplish so much, you know, in in a short period of time with not a lot of money. Well,

Don Crawford:   20:19
it, um, it came with the recognition for the very beginning that, um, from myself. I had worked 25 years in the implantable device arena. And, uh, you know, when you're involved in the implantable device, Rina cardiovascular devices that, um, you know you learn regulatory and compliance and ah, I've lived through ah, scores of product recalls. So you understand, through, you know, through the Knox of hard life what a regulated industry is requires and so the very beginning. I recognize that what we were doing it Saffy on was an implantable device for putting something permanently into the body and that we needed to treat it from the very beginning with that sort of discipline. Really. And, um, it started from our employee number one, our employee number one waas, a PhD research scientist. Luckily, he had spent a lot of time at Medtronic, so he understood what doing r and D under a, uh under a process was all about. And then, um, we hired a number two employees two weeks later, which was a, uh, a brand new engineer right out of Polytech who was our quality engineer. She had done some, um, summer intern work and worked in the quality department, and we hired her from the very first start of the company to document everything this PhD scientists did, because we kind of know that PhD scientists are not the best documentary. And, um uh, We just took a discipline that we're an implantable device company. From day one, we documented everything. Um and, uh, as we went through on our company process. It is that discipline and documentation that allowed us to even in the P. M. A implant 3.5 hours PM a application. 3.5 years later, some of the work we did in our very first months of the company was so well documented that they were accepted as part of the PM, a application. So, you know, I have told people that you do everything under quality system. You do it right the first time, or else you're gonna spend a lot more money doing it over again.

Scott Nelson:   22:42
That's ah, that's a good lesson to learn that early documentation is not something to be to be quite candid, I wouldn't have expected that to be your answer, but it makes a lot of sense now that you, uh now that you explain it, And when it comes when it comes to the actual p m a. I mean that seems no, maybe not for you since a lot. You know, you've got a lot of experience I mentioned earlier when I when I kinda provided some insight into your background that you spend a lot of time and guidance in the implantable device device arena so you can understand the regulatory burden. But a lot of people you know, obtaining a PM, especially for an early stage company, seems like a daunting task. But I'm not sure I don't have the exact timeline in front of me, But you guys were able to obtain that P m A, you know, in a extremely short fashion. Was there anything? But? I mean, besides the well documented history, uh, throughout Saffy on, Is there anything else that you can kind of pinpoint that lead Thio? You know, switch such quick regulatory timelines.

Don Crawford:   23:38
Well, um uh, we did Okay, So we did have a quality management system from the beginning, which helped with the product development portion, But we also had that same process was in place for the earliest of the early animal work. And, uh, Dr Rabie and Monty, who you had met were, you know, the nor less Our founders were doing the animal work themselves in a universe. The lab that was not GLP. Um but we conducted the study, GLP like and we kept great records of each and every animal implant. So that is what you know, the we went to Oh,

Scott Nelson:   24:22
I think there were 4000

Don Crawford:   24:23
days of animal implants. So we went through 100 animal implant, um, that we were able to do ourselves at the university setting that was relatively cheap because it was not GLP, but later in life. Um, the only reason that we were able to use that data's because we took the burden ourselves to document it properly. And

Scott Nelson:   24:43

Don Crawford:   24:44
that became part of the record and a CZ. We went into the clinical trial work with humans. We worked with top notch investigators. We started off with a group of US physicians that were that had research center in the Dominican Republic. Um, as well, they do research as well as they do offshore teaching of new medical technologies or techniques. And we were able to team up with this group of US physicians and do our first in man work after ah, very exhaustive bench top and animal work. We were able to do that quickly, like in one day. We did eight patients and then later on the second part, we did 30 patients in two days. That's almost, you know, unheard of in US clinical practice. So those were the sort of things have made it quick. And those were the sort of things that, um, we were able to do offshore at a lower price point. And what you would do it in us? Um, clinical trial. This is our pilot work.

Scott Nelson:   25:50
And do you attribute, um, some of that I mean, in terms of being able to execute so quickly, especially when it comes to the clinical trial work? Do you attribute that to just being, you know, really well organized in working with the right physician partners? Or is it does it more have to do with the the disease state in the therapy that you're that you're treating for? And it's relatively easy, Thio, you know, to find patients with that with that disease.

Don Crawford:   26:17
Well, I think that first and foremost that the fact is is 25% of the world's population has the disease, so it's really you know, there are just a Thanh of patients that, um, need treatment, and, um, we don't even come close to, um um even scratching the surface of getting all the patients who need to be treated today, so that makes it really easy. Secondly, from a invasive PM a type class three product putting something in a vein, A disease vein is really pretty low on the totem pole compared to like a, you know, tavern valve or something like that, or some sort of, ah neuroimaging plant. So So we were pretty low risk. And then we could not discount the fact that, uh, are two founders.

Scott Nelson:   27:13
Did all of the animal work close

Don Crawford:   27:16
work closely with the engineers, but they did the clinical part of the animal work 100 animals. So they got the techniques

Scott Nelson:   27:24

Don Crawford:   27:25
and they were able through there, you know, skill level to transfer that knowledge to the Clinton, the actual physicians who did then the human work. They never did any human work themselves. Um, but we were able to transfer that to the vascular surgeons who end the clinicians who would do our clinical trials. There was such a good ability to communicate between our founders and the customers that that that led to, um, easier clinical work and the fact that we knew the patient population that we're dealing with and with Monty and Rod Rabies background we were ableto really focus in on the right. Uh, patient populations, which is the key to all of clinical trials and regulatory commissions, is making sure that you're working on the right group. Start with

Scott Nelson:   28:18
Yeah, that's ah, that those were some really, really good point. So, uh, thanks for coming outlining that, don, I didn't especially regards to the fat. You know, your what you mention about, um, you know, the early animal work that you know, that that that Doctor Rabie and Monty, you know, sort of lead themselves And because it sounds like, you know, listening to here, listening to you explain the story that because, you know, because Rod and Monty were so involved in the animal work, that really and the fact that they had a lot of domain expertise that really translated Well, you know, at a later stage when she got into the, you know, the clinical trial work as well as the regulatory submissions

Don Crawford:   28:55
Exactly. And way knew where there were some of the road. Ah, some of the bumps in the road. We were able to anticipate them and you write them in such a way through the protocol that we we were able to do and we didn't we didn't feel some of the bumps that a lot of people would do if you didn't have that level experience. I

Scott Nelson:   29:17
got it. I got it. Makes that makes a ton of sense. So I want to transition to kind of what you're what you're doing now with with with analytics for life, because it's ah, I don't know a lot about what? You know, your your new venture. I do being a based on some research. I did. It looks like you brought a lot of year your team from your team from Saffy on t kind of this this new company. So before we you know, I guess as a transition from Saffy onto analytics for life, maybe give us ah, kind of an overview of what you're doing. And then, you know, some of the some of the best practices or the key learnings that you experience from your great success story was half beyond what? That you know what you're doing with that or how that's translating into your new you new company, the Analytics for Life.

Don Crawford:   30:00
Yes. Who? Um, Analytics for life is, um, information technology. First foremost. So it's different than the typical single use medical device product that people are probably more familiar with, at least historically. For the last 20 or 30 years, that has been the device industry. But really there, what we're doing is single, you know, they call it a fast type model, but we're really using information technology to look at biological signals or biological information that's coming from the patient and were able to assess and diagnose disease and essentially send that information in a clinically relevant report back to the physician. So it is more on a per test basis, as opposed to single use medical device. Ah, but the information in the the the real product is the, um, the information that we're gathering and, um, processing the information and using big data data sets to compare new patients signals to old patients signals that we know what the outcome was and were able to predict the outcome of the current patient. So it's a different type of technology than, um, you know, catheters and wires. That may be a similar to Saffy on and many of the other devices, but the discipline is the same. Still are. They're considered medical devices, so the instrument that retrieved the data is a medical device. The cloud storage facility where the information is saved is considered a medical device. The algorithm that analyzes the data that you've retrieved in stored is a separate medical device. And actually the report, the clinical report that goes back to the physician through the cloud and into a physician portal is considered a medical device. So those four pieces are separate medical devices that make up the system that allows physicians and patients to get treated faster, safer, quicker and cheaper.

Scott Nelson:   32:19
I got it out of

Don Crawford:   32:21
the nuts, bolts of it.

Scott Nelson:   32:23
And are you Are you producing throughout that sort of supply chain? I guess, for lack of a better description, are those different pillars that you just you just outlined? Are you Are you owning each part of that? So, as an example, you obviously have the, uh uh you you mentioned. It's it's kind of a sass player of software. As a service play on you own the data or producing a clinical report. But are you like, as an example, Are you cruising the device to collect the information from the patient as well? You

Don Crawford:   32:51
know, again, we use a CZ you mentioned we did bring in. Uh, we brought on some team members from our Saffy on days experience. So we did bring on Greg Davis, who runs a new organization called Med Accelerate. That, uh, one of Greg's key roles and saffron waas outsourcing our supply chain. And we really everything that sappy on, um, created or Lessing 95% of everything saffron created was done. The, um, contract manufacturer where we would design process, we would manage the process very

Scott Nelson:   33:29
closely that

Don Crawford:   33:30
we actually use out outsource our manufacturing capabilities. So we're doing the same thing with analytics for life. The device itself. We have designed and tested the device, but ultimately the manufacturer, The assembly is done by ah, third party contract manufacturer. But you know, one that his work works for multiple big menu big medical device companies. But all we do is manage the the quality process of that and the same thing with the cloud so that we were designing the cloud data. We are designing the processes that are used, and we we manage the process. But, um, we use ah, big, um, uh, you know, established companies that are cloud based. For instance, we use IBM to transfer our data to the cloud and, um, IBM equipment to transfer the data in the cloud to the, um, patient we use, um, cloud based, um, algorithms. All of it is is done by people like Apple Corporation is involved with the part of our device offering. Um, Amazon was one of our early, um, cloud transfers, but more, more. We're looking at IBM to being the kind of the gold standard, the the trusted name in the business that we're consolidating our our Elektronik,

Scott Nelson:   35:09
or cloud work with. And then the

Don Crawford:   35:12
instrument is with 1/3 party manufacturer that ultimately we might outsource to, uh, Costa Rica or Ireland as we start building into the hundreds of thousands. But now it's done at a smaller firm.

Scott Nelson:   35:26
Yeah. Ah, and that seems like I kind of want to ask you what's what's next for? You know, um, analytics for life, where you're at and you know where you're headed. But before. Before we get into that, it seems like that that would be a pretty big step. You know, your most of your experiences, you know, is in the traditional device space. You know, you've got a, ah, hardware based product that's either implanted or used on a patient. Not to say that this is what you're doing is not used on the patient, per se, but it seems like you're you're making a pretty big leap. So how have you sort of overcome that? You know? You know, mentally, um, you know, to kind of, you know, make this. You know what it seems like? A pretty significant transition from you know, your your work with Saffy on as an example to now, what you're doing with with analytics for life.

Don Crawford:   36:13
Well, you know, the, um, the products again recognized. I did list four different medical device products now, even though they are I t manipulated in I t delivered being that they are separate devices from a regulatory and a quality standpoint, you're managing

Scott Nelson:   36:33
those exactly the same

Don Crawford:   36:35
way you would any other device. So I do believe the process. The system, the organization

Scott Nelson:   36:41

Don Crawford:   36:42
made Saffy on successful is also leading to an incredibly organized and streamlined process with analytics for life from, um um a, um expert technology standpoint, we did have our legacy team of scientists, PhD scientists and, uh um and, uh, engineers, computer data engineers that are still with the company. But now they're following very strict and very regulated processes because, in addition to the normal safety and efficacy concerns, you've got also got hipper requirements in a lot Maur of, ah, the challenges that come with, um, intellectual technology are, let's, say, information technology and cloud based technologies. But as we recruited some very top notch ah, people along the way with half Aeon, um, we were doing the same things with analytics for life. We did bring in our VP of quality and regulatory. We brought in our VP of manufacturing and business development. But we recruited our, um, vice president of technology, who is expert in, um, Cloud based medical Device Delivery. And we hired this person out of the Bay area, and, uh, he relocated to the research triangle where we're headquartered in the US We actually have a Toronto based technology team and a U. S. Based operational team and, um, we continued to add top notch people. And that's the key to, um, transitioning, I guess the technology bridge at per se.

Scott Nelson:   38:39
But as

Don Crawford:   38:39
far as I'm seeing it, I'm managing it. I think the same way you're managing people to, ah, do great things. And, um and we do it right the first time and follow a very regimented process.

Scott Nelson:   38:53
Got it? And and I'm gonna you know, uh, I'm over over some summarizing your making it maybe meet sound a lot more simple than it was. But from what I from what I just may be, my big takeaway is there. And listening to you explained how you made that transition or, you know, bridge the technology, uh, across the technology bridges you put it is is being able to apply the same sort of processes and being diligent about about establishing systems and processes and also, you know, just get, you know, hiring and gathering that you know, the appropriate team around you to be able to execute on a vision so great, great stuff. So before we kind of conclude that conclude the interview here, Don What What's that? What's next? Randomly looks for life. Where you guys at now? Income. What do you have planned for the immediate future?

Don Crawford:   39:41
Well, we have Ah, um, completed our really our platform instrument, which is the the signal collection device. And we are right now focusing on cardiac signals. When I say right now, that's what we will focus on, at least for the greater part of 2016. We also have the ability to look at other disease states. But right now it's hot. Is Courtney artery disease detection diagnosis and, um ah, you know, treatment. Guiding treatment for, Ah, coronary artery disease is really what's hot for us. And, uh, we did recruit, um, a chief medical officer last quarter and again hiring the right people. We hired an electro physiologist who spent the last 3.5 years as a medical reviewer for the FDA to come in and manage our clinical programs. So obviously, we're going Thio, begin our clinical trial with a well thought out protocols, and we do expect to really do our first human clinical work with our new device with our proprietary device, I would say in the spring, you know, second quarter may timeframe or so, um, and we will, uh, uh, collect, I don't know. 3 to 500 patients. Machine learning. Really? Uh, I can't tell you. It's not, at this point a statistical number per se. But once you gather enough patients in your database, you can create the algorithms that allow you to predict what the next patient's going to do. And we believe that numbers 3 to 500 patients, and that's what we plan to do over the the course of the summer and into the fall will be prepared to discuss the results with the FDA.

Scott Nelson:   41:38
Sounds that sounds really, really interesting. This concept of, you know, kind of the thea wearable, wearable, wearable. You know, wearables within within attack could be being able to collect the data and deliver, you know, deliver results. Certainly certainly a hot ah, hot space right now. So, um, wish you wish you nothing. Nothing but the best with with analytics for life and, you know, based on based on your your fantastic success story with Musashi. And I feel I feel pretty optimistic about what you guys are gonna be able to copy her. So very cool. So it's the last three questions for you, Donna. Kind of kind of bullet point. Sort of questions. Ah, little bit more personal in nature. But I like it's kind of one of my more favorite parts of these these types of conversations because, uh, uh, it's outside of South Side of business, but but somewhat related. So first question, What's your what's your favorite nonfiction business book?

Don Crawford:   42:30
You know, I have to say that I am so engrossed in the day to day and I read so much on a day to day best basis. I'm not a bookworm. I guess that comes with my engineering background.

Scott Nelson:   42:47
Uh, no, no problem. I completely relate. In fact, I've listened Thio Ah, fair number of interviews recently with with really people that I admired respected in this community. They have had similar answers, like I don't have time to read a book, but I love reading, you know, long form, you know, long form pieces online or something like that. But, uh, yeah, I always like to

Don Crawford:   43:08
say to everyone Give me the reader's Digest version.

Scott Nelson:   43:13
All right, so on that note, is there Ah, business leader that you're following right now or one that, you know, one that comes to mind that really inspires you.

Don Crawford:   43:21
Yes, I had the opportunity of, um, attending a luncheon with Jenny Ramadi from Ah, IBM earlier this fall. And, uh, now that we're starting to work ourselves with a lot of the IBM products and I've seen so much Ah, advertisement on the wants and health care system. Um, and the way that Jenny sees the future for IBM is, you know, biggest future for IBM is in the health care arena. May be the largest health care provider, Um, 20 years from now. So the way that she is communicating her vision and turning her vision into really, um re alack shins. And, uh, I'm really amazed it, uh, what I'm seeing there and seeing the transition that IBM go from a hardware to a pure software play.

Scott Nelson:   44:18
Good answer on blast Question when thinking about you know, your med tech career, which way did that? Obviously, we don't have time to get into kind of your past experiences and kind of how you came up through the ranks that companies like Guidant and, uh, Devi I But, you know, if you had a look back and give a piece of advice to your 30 year old self. What would that be?

Don Crawford:   44:41
Um, just be patient first and foremost and, uh, enjoy the winds along the way. That's another thing that Rod and I was staffing on. We recognize this, um, early on and we made ah, um we made a point to really celebrate great the winds along the way and not just focus on the the endgame, but enjoy. We always talked about enjoying the journey. And saffron was a fantastic journey of the people that where where it was involved with, um, you know, we're really friends and and true colleagues that will transcend the lifetime. And we're taking that same philosophy with and licks for life is Thio. Remember that it's a journey not, ah, not ending.

Scott Nelson:   45:30
Yeah, that's that's great advice also come under underappreciate So easy, thio to gloss over the winds to move on to next thing, but definitely something I think all of us, all of us, you take the heart for sure. And like I said earlier, you know, when I intrude, kind of try to provide a little bit of background in regards to sack and it's such a great success story. You know, it's really cool to see what you guys were able to dio in today's, you know, med tech environment that you know, is often criticized for, you know, moving slow. And it's hard to raise money. And you guys were able to do it in in an in relatively short order. So that sze very cool, very cool story. And, uh and I like I Like I said before, I've been fortunate to meet some of your team, you know, members like like like Rod and Monty and great, really great people. So, um, just all around a really cool story. But anyway, that's I think that's it for now. I love to be able if we had more time to get into into a lot more detail. But I think hopefully that provides everyone a good overview of what, What, what you know, uh, least intro to the Saffy on story, and I wish you nothing but the best with with With Analytics for life. And for those listening, all certainly provide links. Thio Analytics for life, the website, um and, uh um, and certainly certainly check that out if you got some time. So, Donald, have you hold on the on the line real quick, but Okay. Thanks again for thanks again for doing this. I really appreciate it. And for everyone that's listening. Oh, God. I've enjoyed reminiscing the, uh, the sappy on story. Yeah, absolutes. It's fun. It's definitely fun. One to talk about. So, uh, for everyone listening. Thanks. Thanks for your attention. And tell the next episode of med Cider Everyone take care.