Medsider: Learn from Medtech and Healthtech Founders and CEOs - From an Idea on the Back of a Napkin to an Eventual $240 Million Exit – The Amazing Story of Sapheon

Episode Date: April 14, 2016

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 StoriesWhy Intersect ENT is an Example of Hope for the Medtech IndustryAre Medical Device Models the Key to Building a Lean Medtech Startup?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used To 

Welcome to Medsider, 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 MedSider, the place where I interview experienced and proven med tech and medical device stock leaders. We've got Don Crawford, who is the president and CEO of Analytics for Life. A 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 analytics for life, Don was president and CEO of Safion, which was

acquired by Cavidian in 2014. And before Safion, Don helped various leadership positions with the guidance Medtronic DVI and WebMD. He received a Bachelor of Chemical Engineering from Georgia. tech and the MBA from Emory University. So without further ado, welcome to the call, Don. Appreciate you coming on. Thank you, Scott. All right, so let's start with Safion first. And I definitely hinted that what you're doing with analytics for life and what we'll certainly get into that in more detail. But let's start with Safion first because as I mentioned,

committing acquired your company in 2014 for reported, I think close to $240 million, I believe, was close to the number anyway. At least that's what that's sort of in the public domain. But, I mean, what a fantastic win for you and your company, in my opinion, maybe one of the more unheralded stories within MedTech. So when you finally got that deal done after spending, you know, almost six years with Safion, do you recall how you and your team celebrated that win? Yeah, you know, we were really going through a process the last six months of diligence with working towards a, a final deal and transition with the COVIDian. And I remember that in the last month before the deal was finally done,

or actually I think that we'd even signed the agreement, but we were still waiting for the final voter, the final shareholder vote, which took about 30 days. We did a third quarter management, meeting and we took the whole management team, which at that point was based out of Morseville, North Carolina, and we took them all back to Sonoma County where the company originally got started in Santa Rosa. And we had a team meeting, a manager's 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 Safian consultants, past employees, et cetera, and we did more or less a celebration dinner at the Fairmont in Sonoma. And 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 mention that weekend when we, revisit.

That's a great story. I wonder how many other med tech companies, you know, celebrate like that. But that's cool. And I definitely want to dig into the Safion story because it seems like from the out, you know, from an outsider's perspective, you guys did some amazing things in a relatively short amount of time. I know that's somewhat, you know, it's an opinion. But it seems like you guys got a lot done on a light budget.

and I think is a fantastic success story. But when you think about the course of those five and a half, six years, you know, from when you joined in Safion to sort of the initial acquisition by Cavidian, what was Cavendian at the time before the Medtronic deal, are there maybe one or two things that really stand out over the course of that time? Yes. You know, it really was unique in that you've heard stories before of, people meeting and riding something on the back of the napkin and becoming an idea or a patent.

And in reality, the co-founder, Dr. Rod Raby, who really had the original clinical idea to use a tool to glue a leg vein together. That was, you know, the original idea came from Dr. Raby, 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 wrote out kind of a thought process of what he thought this idea could do. And we took that from the back of a napkin to the three clinical trials, launching a global operation and ultimately doing a PMA trial,

very successful PMA trial, and then exit of that. the company from start to finish with the two co-founders involved. So I think that that in itself is a very, very unique story. Without a doubt, and fortunately I've been able to meet some of those members of the team, Dr. Rabi-Drew as well as guys like Monty Madsen and Gary McCord, and you had a fantastic team, really, really good people. And very cool story. I didn't realize that.

It really honestly kind of went, it sounds like kind of went from napkin idea to you know to uh to uh to successful successful exit but when you when you're sitting down with with dr rabi 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 well i mean initially um i took it on as a consultant i was just doing uh you know the very basic thing that um i would do in the corporate medical world you know you come up with a new idea and the first thing you do you 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've got to just lay out a business plan. Does it make sense? First, is there a need? Well, the market was huge. 25% of the world's population had venous disease. So, boom, that's an early check mark, huge market. The unmet needs, you know, the technology that was being, used was not something that from a layperson'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 ablation methods that have a lot of side effects and negative downside to it. So we saw an unmet need that could be solved with this great idea and then I looked at the economics. First and foremost, there were a lot of companies that were interested in the arena, but really at the time that we first looked, none of the companies were owned by major giant corporations.

They were really mid-sized companies like Anja Dynamics, and at that time, the ablation company as well. so far back now, I can't even remember them pre-COVIDIA. Venus, Venus, yes, Venus. So the fact that it really was a, the competition was still kind of young, you know, new ideas in younger companies. I thought that a company like ours or a startup company definitely had a place to or a way to enter the marketplace. And then we just looked at the basics, you know, is this something that could be manufactured, you know, in a low-cost way? And did we see that there's an established market that pays a reimbursement that would fit?

And boom, you know, you go through five or six list and everyone hit the check box and say, well, this is a great idea to pursue. And how many – I want to get into, you know, some more details because you make it sound very easy. and I'm sure it wasn't that way. But you have an incredibly successful story to tell with respect to Safion. But how many ideas do you come across where you're doing your initial diligence that don't check all those boxes? Well, you know, there are a lot of ideas out there, but a lot of ideas are either the market is unknown. I mean, sometimes you're so innovative and so new that you're really ahead of the market. But, you know, luckily we were looking at something that really, you know, had an established market.

So, you know, if you look at the economics, and that's usually where I go first, is it is it being used and is it being reimbursed? And if those boxes are checked, well, you know, you could almost fit 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-approved. Yeah, that's one of the key things that I look at. Yeah, those are two really good points. So let's dive into some of the details. And you mentioned that you guys, you know, obtained a CE mark.

You know, this wasn't just a 510K device. It was a PMA device, and you were able to navigate those choppy waters, which certainly want to ask you a few questions about that, because that's certainly no easy task. But let's talk about the funding, because, you know, From what I, you know, based on my research, it looked like you'd 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 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 not a long period of time.

I mean, the CE mark, the PMA device, you commercialized in Europe, we're getting ready, you know, to probably commercialize in the U.S. before the acquisition with Comedian. You know, so, I mean, were there things that you thought about going into, you know, going into, you know, the funding rounds that allowed you to be, you know, that savvy? Maybe talk to us a little bit about that. Yeah, so, you know, I wish I could say that I was incredibly innovative and brilliant. and that we have established this new 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 financial crisis, 2008, recovery in 2009, and anyone who lived through those days recognized that any sort of traditional venture capital funding and medical especially. was just not available. So there was no institutional money that you could count on. In early stage, of course,

you've heard the stories. You're either too early, you know, or you're too late. Every excuse you can imagine from the institutional VC investors about why they wouldn't look at Safion. And we did talk with some, you know, mainstream, well-known firms,

people that we actually knew through our career between Rod and myself. And the need to go to private equity investors, some people would call them angels, I just call them accredited investors. We started that pathway. You've heard of the famous friends, families, and fools. At the time, we would go a month by month, and we were out raising. We established a Series A, preferred Series A price and equity, and we offered it of which Rod and I were like the first, I mean, we were the biggest shareholders, almost the only

shareholders for the first six months, but that was the way that Rod and I funded the company and part of it was investing in Series A ourselves. 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 $38 million total investment from start to finish. And we had almost 10% of that was management's money. So that, you know, that is something you look for when you're out to looking for private investments if the managers are investing into their own company.

That's usually a pretty good sign. Got it. That's such a unique story. I love the fact how you kind of set the stage there. And I didn't even think about it when I was doing some research for this conversation, is that that was a really difficult time in terms of trying to raise money back in 2008 and 2009. So easy 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?

I mean, it seems like that would be fairly time intensive versus the traditional path of having your series A, led by one of the well-known, you know, VC firms. Instead, you raised it through sort of a network of private investors, as you call them. How did you balance, you know, spending time, you know, with the necessary day-to-day tasks of running the business versus, you know, what would seem like, you know, a fairly time-intensive, you know, fundraising, you know, with a multitude of different angel investors or private investors? Well, you know what I mean?

The balance is what it was. It was a total immersion, so this is what my job was 24 hours a day. And even at the very beginning, we had a team of people. Rod and I were co-founders. We were both involved at the beginning, so we had a network of people, network of successful people. And everyone that we brought into the organization, you had mentioned in Gary McCord and several others,

others, but everyone who became Bonte, became involved with the company, we all recognize that fundraising is the core 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 in place. involved in being successful at financing. Got it. That's sort of using the analogy of kind of everyone's job is to sell something, especially

early on in a company. I like the way you're, you know, you kind of thought about that in the sense that everyone at that stage in the life of Sapion was sort of responsible for trying to, trying to generate some interest in the company from an investment standpoint. Very good. I want to get into some of the, you know, the, the, the, the, the, the, the, the, the, the, the, the, how you went about, you know, establishing the clinical trials and, and, and, and, and, and, and, and, and, and, and, and, and, and, and, and, and, and, and, before we, before we, before we in kind of the, the topic on, on fundraising, um, do you think that's a path, uh, in your opinion, that more early stage device companies should pursue, you know, versus, uh, versus, uh, versus, you know, the, the traditional route of, uh, of, uh, of trying to connect with well-known venture capitals, but instead maybe, maybe, uh, you know, uh, uh, you know, a, you know, uh, you know, a, you know, a syndicate of a, you know, a investors or angel investors?

Yeah, no, I think that we've seen much more of that occur in the last three years, I would say that I've been watching the 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 Series A and some into Series B along those same lines. So I think that now, although it still is, you know, it's fraught with a lot of twist and turns, but it can be done, and it can, you know,

I think there's enough history now to show that that is a method to use as a funding plan and a funding, source, but you've got to be well connected and understand the nuances of how corporate organizations work. You know, it really comes down to even setting out the first corporate structure, having the right legal counsel for setting up your documents. Your funding documents are critical. The structure is critical.

Ultimately, when you get towards the end or get into later rounds, you'll understand that the structure that you started with that dictates a lot of things, so you have to put a lot of thought and preparation in that, you know, in the plan, or let's just say the corporate organization, the organizing documents and such, and that is, you know, it 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 the corporate documents their way. But if you're funding it privately, then really it is the management team that sets the tone, sets the structure, and it has to be something that is attractive to an investor because ultimately your investors are planning on making a multiple return on their investment. Yep, yep. So, you know, I guess in summary, the onus is on, you know, when you choose the path that you guys went down, the onus is definitely more on you in order to, you know, from a term sheet perspective as well as. Governance, yeah, corporate governance standpoint. Yeah, yep, good lesson to learn. Well, let's shift to 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 MedTech, would agree that the, you know, the FDA is, you know, maybe, you know, difficult to work with at times, the, you know, the regulatory pathway, even, even now with the 510K, you know, the clinical, you know,

burden is a lot heavier than it maybe it used to be. But you were, like I said before, you were, you guys were able to accomplish, you know, a PMA and just shortly after the acquisition with, with Cibidian. So, you know, maybe help us or give us a little insight into how your team was able to accomplish so much, you know, in a short period of time with not, you know, a lot of money. Well, it came with the recognition for the very beginning that from myself, I had worked 25 years in the implantable device arena. And, you know, when you're involved in the implantable device arena, cardiovascular devices,

that you learn regulatory and compliance, and I've lived through scores of product recalls, so you understand through the knocks of hard life what a regulated industry requires. And so the very beginning, I recognized that what we were doing at Safion 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 it started from our employee number one. Our employee number one was a PhD research scientist. Luckily, he had spent a lot of time at Medtronics, so he understood what doing R&D under a process was all about. And then we hired our number two employee two weeks later, which was a brand-new engineer, right out of Polytech who was our quality engineer.

She had done some 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 scientist did because we kind of know that PhD scientists are not the best documenters. And we just took a discipline that we're an implantable device company from day one. We documented everything.

And as we went through our company process, it is that discipline and documentation that allowed us to even in the PMA implant, or PMA application, three and a half 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 PMA application. So, you know, I've told people that you do everything under a quality system, you do it right the first time, or else you're going to spend a lot more money doing it over again. That's a good lesson to learn that early documentation. It's not something to be quite candid. I wouldn't have expected that to be your answer, but it makes a lot of sense now that you explain it. And when it comes to the actual PMA, I mean, that seems, you know, maybe not for you, since a lot, you've got a lot of experience. I mentioned earlier when I kind of provided some insight into your background that you're,

You spend a lot of time of guidance in the implantable device arena, so you can understand the regulatory burden. But a lot of people, you know, obtaining a PMA, 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 PMA, you know, in an extremely short fashion. Was there anything, I mean, besides the well-documented sort of history or throughout Safion, Is there anything else that you can kind of pinpoint that led to switch such quick regulatory timelines? Well, 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 Dr. Rabi and Monty, who you had met, were, you know, more or less, our founders were doing the animal work themselves in a university lab that was not GLP, but we conducted the study, GLP-like, and we kept great records of each and every animal implant. So that is what, you know, we went through, oh, I think there were 4,000 days of animal implants. So we went through 100 animal implant that we were able to do ourselves at a university setting, it was relatively cheap because it was not GLP, but later in life, the only reason that we

were able to use that data is because we took the burden ourselves to document it properly, and then that became part of the record. And as we went into the clinical trial, worked with humans, we worked with top-notch investigators. We started off with a group of U.S. physicians that had a research center in the Dominican Republic 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 a 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 unheard of in U.S. clinical practice. So those are the sort of things that made it quick, and those were the sort of things that we were able to do offshore at a lower price point than what you would do in U.S. clinical trial. This is our pilot work. And do you attribute 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 and working with the right physician partners, or does it more have to do with the, you know, the disease state and the therapy that you're treating for, and it's relatively easy to, you know, to find patients with that disease? Well, I think that first and foremost, the fact is, is that 25% of the world's population has the disease, so it's really, you know, there are just a ton of patients that need treatment and we don't even come close to even scratching the surface of getting all the patients who need to be treated today. So that makes it really easy.

Secondly, from an invasive PMA-type Class 3 product, putting something in a vein, a disease vein is really pretty low on the totem pole compared to like a, you know, taver valve or something like that or some sort of a neuro implant. So we were a pretty low risk, and then we could not discount the fact that our two founders did all of the animal work, worked closely with the engineers, but they did the clinical part of the animal work, 100 animals, so they got the techniques down, and they were able, through their skill level to transfer that knowledge to the actual physicians who did then the human work.

They never did any human work themselves. But we were able to transfer that to the Vasco surgeons and the clinicians who would do our clinical trials. There was such a good ability to communicate between our founders and the customers that led to easier clinical work and the fact that that. that we knew the patient population that we were dealing with. And with Monty and Rod Raby's background, we were able to really focus in on the right patient populations,

which is the key to all clinical trials and regulatory submissions, is making sure that you're working on the right group to start with. Yeah, that's, those are some really, really good points. So thanks for kind of outlining that, Don. I didn't, especially in regards to the fact, You know, the point you mentioned about, you know, the early animal work that, you know, that Dr. Ray B. and Monty, you know, sort of led themselves. And because, I mean, it sounds like, you know, listening to hear you, 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 once you got into the, you know, the clinical trial work as well as the regulatory submissions.

exactly and you know we knew we're the we're some of the road uh some of the bumps in the road we were able to anticipate them and uh you know write them uh in such a way through the protocol that we we were able you know 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 got it got it makes a ton of sense so i want to transition to kind of what you're what you're doing now with uh with analytics for life because it's uh I don't know a lot about what uh you know your your new venture uh I do be know based on some research I did it looks like you brought a lot of your your team from your team from Safion to to kind of this this new accompany so before we you know I guess as a

transition from Safion to analytics for life maybe give us a kind of an overview of what you're doing and then you know some of the some of the the best practices or the key learnings that you experience from your you know your great success story with Safion and what that you know what you're doing with that or how that's translating into your new company, analytics for life. Yeah, so analytics for life is information technology, first of 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 what we're doing is a single, you know, they call it a SAS type model, but we're really using information technology to look at biological signals or biological information that's coming from the patient and we're 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.

But the information and the real product is the information that we are gathering and 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 we're able to predict the outcome of the current patient. So it's a different type of technology than, you know, catheters and wires that may be similar to Safian and many of the other devices. But the discipline is the same.

Still are, they're considered medical devices. So the instrument that retrieves 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 and 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. Got it. The nuts and bolts of it. And are you producing throughout that sort of supply chain, I guess, for lack of a better description, or those different pillars that you just outlined, are you, are you owning each part of that?

So as an example, you obviously have the, you mentioned it's kind of a SaaS player, software as a service play, and you own the data and are producing a clinical report. But are you, like as an example, are you producing the device to collect the information from the patient as well? You know, again, we used, as you mentioned, we did bring in, we brought on some team members from our Safion Days experience. So we did bring on Greg Davis, who runs an organization called MedCelerate, that one of Greg's key roles in Safion was outsourcing our supply chain. and really everything that Sapheon created, or let's say 95% of everything Safion created, was done via a contract manufacturer where we would design the process. We would manage the process very closely,

but we actually use 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 a third-party contract manufacturer, but one that works for multiple big medical device companies, but all we do is manage the quality process of that. And the same thing with the cloud, so that we are designing the cloud data. We are designing the processes.

that are used and we manage the process, but we use a big, you know, established companies that are cloud-based, for instance. We use IBM to transfer our data to the cloud and IBM equipment to transfer the data in the cloud to the patient. We use, you know, cloud-based algorithms, all of it is done by people like Apple Corporation is involved with part of our device

offering. Amazon was one of our early cloud transfers, but more and more we're looking at IBM to being the kind of the gold standard, the trusted name in the business that we're consolidating our electronic or cloud work with. And then the instrument is, with a third-party manufacturer that ultimately we might outsource to Costa Rica or Ireland as we start building into the hundreds of thousands, but now it's done at a smaller firm. Sure. Yeah. And that seems like I kind of want to ask you what's next for, you know, analytics for life

and kind of where you're at and, you know, where you're headed. But before we get into that, it seems like that would be a pretty big step. You know, most of your experience is, you know, is in that, you know, the traditional device space, you know, where you've got a, you know, a hardware-based product that's either implanted or used on a patient. Not to say that this, you know, what you're doing is not used on a patient per se. But it seems like you're making a pretty big leap. So how have you sort of overcome that, you know, you know, mentally, you know, to kind of, you know, make this, you know, what it seems like a pretty significant transition from, you know, your, you know, you work with Safion as an example to now what you're doing with, with the analytics for life? Well, you know, the products, again, recognize I did list four different medical device

products. Now, even though they are IT manipulated and IT delivered, being that they are separate devices from a regulatory and a quality standpoint, you're managing those exactly the same way you would any other device. So I do believe the process, the system, the organization, that made Safion successful is also leading to an incredibly organized and streamlined process with analytics for life. From an expert technology standpoint, we did have our legacy team of scientists, PhD scientists

and engineers, computer data engineers that are still with the company, but now they are following. following very strict and very regulated processes because in addition to the normal safety and efficacy concerns you've also got HIPAA requirements and a lot more of the challenges that come with intellectual technology, let's say, information technology and cloud-based technologies. But as we recruited some very top-notch people along the way with Safion, we are doing the same things with analytics for life. We did bring in our VP of quality and regulatory, and we brought in our VP of manufacturing and business development, but we recruited our vice president of technology, who is

expert in cloud-based medical device delivery. And we hired this person out of the Bay Area and he relocated to the research triangle where we're headquartered in the U.S. We actually have a Toronto-based technology team and a U.S.-based operational team. And we continued to add top-notch people and that's the key to transitioning, I guess, the technology bridge per se. As far as I'm seeing it, I'm managing it. I'm managing it. it, I think, the same way. You're managing people to do great things, and we do it right the first time and to follow a very regimented process. Got it. And I'm going to, you know, I'm over, over summarizing or making it maybe sound

a lot more simple than it was, but from what I, from what I, I guess maybe my big takeaways there and listening to your, explain kind of how you made that transition or, you know, bridge the technology, you know, across the technology bridge, as you put it, is being able to apply the same sort of processes and being diligent about, you know, establishing systems and processes,

and also, you know, just, you know, hiring and gathering the, you know, the appropriate team around you to be able to execute on the vision. So, great, great stuff. So before we kind of conclude the interview here, Don, what's next for analytics for life? Where are you guys at now?

And kind of what do you plan for the immediate future? Well, we have completed our, really our platform instrument, which is 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, what's hot is corny artery disease, detection. diagnosis and, you know, treatment, guiding treatment for coronary artery disease is really what's hot for us.

And we did recruit a chief medical officer last quarter. And again, hiring the right people, we hired an electrophysiologist who spent the last three and a half years as a medical reviewer for the FDA to come in and manage our clinical program. So obviously we are going to 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 or with our proprietary device, I would say, in the spring, you know, second quarter, May timeframe or so.

And we will collect, I don't know, three to 500 patients, machine learning, really, 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 is going to do. And we believe that number is three to 500 patients, and that's what we plan to do over the course of the summer. And into the fall, we'll be prepared to discuss our results with the FDA. Very cool. Sounds really interesting. I mean, this concept of, you know, kind of the wearable,

wearables within met tech and being able to collect the data and deliver a, you know, deliver a result is certainly a hot space right now. So wish you, wish you nothing, nothing but the best with analytics for life. And, you know, based on your fantastic success story with Safian, I feel pretty optimistic about what you guys are going to be able to accomplish. So very cool. So last three questions for you, Donna, kind of bullet point sort of questions, a little bit more personal in nature. But it's kind of one of my more favorite parts of these types of conversations because it's outside of business, but somewhat related. So first question, what's your favorite nonfiction business book?

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 basis. I'm not a bookworm. I guess that comes with my engineering background. No problem. I completely relate. In fact, I've listened to a fair number of interviews recently with really people that I admire and respect to the business community. They've had similar answers. I don't have time to read a book,

but I love reading long-form pieces online or something like that. Yeah, I always like to say to everyone, give me the Reader's Digest version. There you go. There you go. All right. So on that note, is there a business leader that you're following right now or one that comes to mind that really inspires you?

Yes, I had the opportunity of attending a luncheon with Ginny Ramadi from IBM earlier this fall and now that we are starting to work ourselves with a lot of the IBM products and I've seen so much advertisement on the Watson healthcare system and the way that Jenny sees the future for IBM is the biggest future for IBM is in the health care arena and maybe the largest health care provider 20 years from now so the way that she is communicating her vision and turning her vision into real, real actions. And I'm really amazed at what I'm seeing there and seeing the transition at IBM go from a hardware to a pure software play.

Good answer. And last question. When thinking about your med tech career, which obviously we didn't have time to get into kind of your past experiences and kind of how you came up through the ranks at companies like, you know, guidance and DVI. But, you know, if you had to look back and give a piece of advice to your 30-year-old self, what would that be? Just be patient, first and foremost, and enjoy the wins along the way.

That's another thing that Rod and I with Safion, we recognized this early on, and we made a point to really celebrate the winds along the way and not just focus on the end game, but enjoy, we always talked about enjoying the journey. And Safion was a fantastic journey, the people that I was involved with, you know,

were real friends and true colleagues that will transcend the lifetime. time and we're taking that same philosophy with analytics for life is to remember that it's a journey, not an ending. Yeah, that's great advice. So kind of underappreciated, so easy to gloss over the wins to move on to the next thing. But definitely something I think all of us should take to heart for sure. And like I said earlier, you know, when I introed kind of or tried to provide a little bit of background in regards to Safi, and it's such a great success story.

You know, it's really cool to see what you guys were able to do in today. you know, MedTech environment that, you know, is often, you know, criticized for, you know, moving slow and it's hard to raise money, and you guys were able to do it in, in, in, in, in relatively short order. So that's, that's, that's very cool success, a very cool story. And I, like I said before, I've been fortunate to meet some of your team, you know, members, like, like Rod and Monti, 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 to if we had more time to get into a lot more detail, but I think hopefully that

provides everyone a good overview of kind of what, what this, you know, or at least intro to the Safvian story, and I wish you nothing but the best with, with Analytics for Life. And for those listening, I'll certainly provide links to Analytics for Life, the website, and certainly check that out if you've got some time. So, Don, I'll have you hold on the line real quick, but thanks again for doing this. I really appreciate it. And for everyone this, listening. Oh, go ahead. I've enjoyed remissing the Saffion story. Yeah, absolutely. It's a fun. It's definitely a fun one to talk about.

So for everyone listening, thanks. Thanks for your attention until the next episode of Medsider. Everyone, take care.