Medsider: Learn from Medtech and Healthtech Founders and CEOs - Cultivating a Culture of Continuous Learning and Improvement: Interview with Biotricity CEO Waqaas Al-Siddiq

Episode Date: May 4, 2023

In this episode of Medsider Radio, we sat down with Waqaas Al-Siddiq, CEO of Biotrocity, a cutting-edge remote patient monitoring company focusing on the cardiac landscape. Waqaas has a dual Bachelor’s degree in Computer Engineering and Economics, a Master’s in Computer Engineering from Rochester Institute of Technology, and a Master’s in Business Administration and a Doctorate in Business Administration from Henley Business School. With over 15 years of experience in the technology and healthcare sectors, Waqaas has a strong track record of developing innovative solutions for remote patient monitoring and connected health. As the CEO of Biotricity, he leads the company's mission to revolutionize remote patient monitoring by leveraging cutting-edge technology and data-driven insights.In this interview, Waqaas discusses the crucial role that passion and work ethic play in driving healthtech success. He shares valuable insights into understanding the needs of your target market for effective product development, as well as fostering a culture of continuous learning and improvement within your organization.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.

Don't look for the perfect fit. There is some perfect fit. Find somebody who's interested in and engaged and who's just got the, they got work ethic and they've got interest and they will move mountains for you. But if you're trying to find the perfect fit, you'll never get the right fit. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson.

Hey, everyone, it's Scott. In this episode of MedSider, I sat down with, Kwos Al-Sadeek, CEO of Biotricity. LaQuas holds a bachelor's and master's in electrical and commuter engineering from the University of Toronto, as well as an MBA from the University of California, Berkeley. With over 15 years of experience in the technology and healthcare sectors, Wequas has a strong track record of developing innovative solutions for remote patient monitoring and connected health.

As the CEO of Biotricity, he leads the company's mission to revolutionize remote patient monitoring by leveraging cutting-edge technology and data-driven insights. Here for you the key things that we discussed in this conversation. First, it's vital to understand different user workflows and consider the commercialization aspect of your device during the actual product development phases. Addressing these points early on helps ensure the devices can be effectively integrated into users' routines and increases the likelihood of adoption. Second, when developing medical devices that are used by consumers, you have to cater to diverse

needs, which requires striking a balance between providing patients with sufficient information and avoiding unnecessary concern that may arise from information overload. The best approach is to continuously learn from customers and adjust your message accordingly. Take it into account the various needs of stakeholders. Third, in a saturated market like wearables, entrepreneurs need to focus on delivering clinical value and directing their efforts toward diagnosed patients or those with specific needs. This will help differentiate your products from the competition and allow for maximum impact.

Before we jump into this episode, I wanted to let me. you know that we recently released the second volume of Medsider Mentors, which summarizes the key learnings from the most popular Medsider interviews over the last six months or so. Look, it's tough to listen or read every single Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to medsiderradio.com forward slash mentors.

Premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of Alivecore, and so many others. In addition, as a premium member, you'll get to join live interviews with these incredible. medtech and health tech entrepreneurs. Learn more by visiting medsiderradio.com forward slash mentors. Again, that's medsiderradio.com forward slash mentors. Well, Koss, welcome to Medsider Radio. Appreciate you coming on.

Thank you for having me. Glad to be here. Yeah, looking forward to learning a little bit more about your background and, of course, what you're building at biotricity. So with that said, I recorded kind of a very brief bio of yourself kind of at the outset of this interview. But let's start there. Tell us a little bit more about your professional background leading up to starting biotricity. No, for sure. So, you know, I always say I'm an engineer by training. I'm actually an engineer economist and I have my doctorate in business.

But, you know, I still like the zeros and ones, if you will. And got him I start out doing the big engineering thing at IBM and then got pushed over to AMB and Intel kind of left that joined some investment. banking groups. And really, that's kind of what inspired me to really go into entrepreneurship, because I was looking and analyzed deals. And I saw that, hey, you know, some of these companies are getting funded. I think I have some ideas as well. And so left that. And because I came from the cloud computing space, ended up in there. But I had done some graduate work in wireless sensors and really monitoring remote environments. And that's what got me interested really in,

what does the future of healthcare look like? And so kind of a twisted road. I think all entrepreneurs have a bit of a twisted journey. But that cloud computing piece got me into that connectivity piece because of my background in that intersection of connectivity and cloud. And I started supporting this company called Higgy, which built one of the largest platforms and then was sold over to Babylon Health. And, you know, their approach was really the gamification of healthcare.

And that's where I realized and became very convinced that the future is really in this connected health space. And so then I started biotricity. Got it. And for those listening, biotricity, is it, I mean, I'm looking at your LinkedIn profile now, which we'll link to in the, kind of the summary for this particular discussion. But it looks like, did you, did you start the company back in around 2014 timeframe? Is that when, when everything kind of got going? Yeah, I got my original funding in early 2015. So yeah, that's pretty much where I started. and I'm the founder and I invented the original tech and it kind of, you know, I gave birth to it. Okay, got it. So we're recording this in early, early 23, if you're listening to this,

you know, years later. So, I mean, you've been out it for a while, almost a, almost a decade now. Yeah, yeah, yeah, it takes time to, but especially as you know, when you talk regulatory, talk medical devices, you talk patients, I mean, just that that hurdle of getting a device cleared and getting into the space and then the commercialization piece of it, it takes time. Yeah, yeah, no doubt. I had a had a conversation. just yesterday, another interview that I recorded. We're talking about this very same thing, right? In the device game, nothing is ever short, right?

Even if you're kind of focused on, you know, reasonably short-term projects, I mean, you're talking about a half decade at a minimum. You know, I mean, it takes a while to not only work within sort of the quality regulatory guardrails, but also, you know, when you're changing health care, which I'm sure we'll get into, you know, with what you're building at biotricity, I mean, there's a lot a friction, you know, there's national friction in any startup, but, but especially so in healthcare. So with that said, tell us a little bit more about kind of your company and your products and really kind of what you're building. And again, not expecting you to go too deep or too into the weeds,

but give us kind of the elevator pitch. Yeah, absolutely. So, you know, by electricity, we're a remote patient monitoring company and we kind of defined ourselves like that before RPM became a really a category. So, you know, now that RPM is its own category, I would say we're a digital health and med tech company. And we focus on the cardiac landscape. So really what we saw was that cardiac care was very disjointed. So you have somebody providing diagnostics, somebody providing disease management, somebody providing procedural work.

And really nobody following that patient through that entire cardiac journey. And what's interesting is that that cardiac disease is the number one killer in every country in the world. And so what we did was we built an entire platform. So we can actually track the patient from diagnostics. which is our first product. And then once they get diagnosed, they have some interventional procedure. Then they go into disease management. And then they go into lifestyle management.

So the idea is before you are diagnosed, we have a product for you. When you get diagnosed, you get diagnosed with a biotricity product or a customer of ours, which is a cardiologist who's using that product. And then once you have been diagnosed, we support you through that cardiac journey. And that's kind of the ecosystem that we've built. And that's kind of the vision behind the company without, you know, getting too much into the weeds. And then we are the first company that's really created this product portfolio that can actually map and track a patient through that entire cardiac journey.

Got it. I love the way you from that up, right? Kind of like before, you know, sort of diagnosis before treatment, diagnose immediately after treatment, etc. It's a great kind of like, you know, framework to kind of kind of kind of where your products play. But just to just to help, just to go a little bit deeper on this topic. So biotricity, I'm looking at your site right now. And And for those listening that don't make it to the summary article, it's, it's B-I-O-T-R-I-C-I-T-Y, Biotrity.com is the website. Great, great-looking website, by the way. So I'm looking at, you've got BioFlex, biotress and BioHart. Are those the three primary kind of like hardware devices?

And then, of course, the kind of the cloud side too as well. Correct. Exactly. Got it. Okay. Got it. Perfect. Super interesting.

I think that sets the stage for the rest of the conversation for sure. but give us a sense kind of with sort of your product portfolio. Where are you guys at in terms of commercialization and, you know, regulatory, etc.? Yeah, excellent question. So, you know, we got our foot started in bioflux, right? That's our cardiac diagnostic product. So, you know, we talked about our funding 2015, got our FDA clearance beginning of 2018, spent that time figuring out insurance.

So 2019, we launched a product April of 2019. So we're like literally four years in on that product. And that was really smart diagnostic. So the thesis there was, hey, there's this category of cardiac diagnostics out there and issues happen while you're sleeping. They're asymptomatic. Three o'clock in the morning, you have a six second pause. You're sleeping.

You may not wake up. And so a holter product is not good enough. And this real-time monitor does exist, but you have to have a clunky cell phone. You have this other device. You have to charge two things. And then on top of it, the reimbursement is attractive. So nobody wants to sell the technology. So it's actually inaccessible.

So we came and we said, okay, well, we're going to democratize cardiac telemetry because we think it needs to be available to everybody. And the way we're going to do that is we're going to combine everything into one solution, bring the cell phone technology. So we have our own FCC ID like a cell phone manufacturer, combine to one solution and make this available to every cardiologist, right, so that they can use it and deliver it to the patient. And so that product has been there.

And then what we launched that product is used by 2,000 physicians across 35 states. now. We tracked about, I don't know, probably 170,000 patients on that product up until now. There's probably, you know, forward looking, we'll probably do about 120,000 diagnostic studies this year. And so that was a cardiac diagnostic space. Then what we realized was our customers came back and they said, hey, can you do something about the Holter space? And I said, well, you know, the Holter, we don't really believe in the Holter. And why do you really want us to do this? And so they said, well, it takes us two weeks to get a report back. And I'm like, well, that's interesting.

So somebody may or may not have a cardiac issue. They're complaining. Generally, their numbers look good. So it's like you and I showed up at a cardiologist saying, hey, we complain if chest pain, we'll probably end up on a holter. But I don't want to be in the dark for like a month, right? I'm on the monitor for two weeks. I got away two more weeks for the report.

And so we said, okay, we're going to create a connected holder in a compact form factor. So we created that. that got FDA cleared early part of last year, and it was launched in May of last year. So that was a new product. And that kind of completed our cardiac portfolio. Now, in the background, what we were doing was, and we were building this ecosystem of saying, okay, well, what happens to this patient after they get diagnosed? Well, they have a 30-second ECG that they can collect off of their phone or an Apple Watch.

They pretty much are left to their own meter. There's no glucometer out there because cardiac issues are intermittent. So a data point in a point in time is not very useful for cardiac patient, right? Issues are happening while they're sleeping. So, you know, you can't collect 30 seconds of your ECG while you're sleeping off of your Apple Watch. And so in the background, we were building this cardiac disease management platform when these customers came in and asked us about that whole product. And so we completed that cardiac disease management platform.

we took that technology, we created the bioheart product for pre-diagnosis and post-diagnosis, right? So how do you manage your condition? So if you're at risk, how do I not, you know, fall into the cardiac trap? So is there a product that I can use for prevention? And then if I am diagnosed, what do I do to manage that? So we created the bioheart monitor and that disease management program. And that got launched basically the end of last year at the beginning part of this year. So the commercialization, you know, as you can see, biofluxes the old, the old and tried and true product. And then the Holter product is a newer one that came out.

And then our disease management platform just came out. Now, all of these products are complementary, as you can see, right? It's the same patient at a different life cycle within their cardiac journey. Got it. Got it. That's super helpful. And I love the, I think as I kind of listen to you, describe sort of that story. that product development story and that commercialization,

kind of those time points in which you're commercializing the devices, just the importance of listening to customers, right? I mean, it sounds so straightforward, you know, arguably maybe a little bit, a little bit, a little bit cliche, right? But the fact that you, you know, you simply were dialed into your customer base. And they told you, you know, look, what cost you got you guys have to build a whole, you know, a better, a better holder monitor. You're like, no, I don't know about that.

But, you know, the more you listened, you know, the further that took you down and the development path. So I think it's a really, really useful point. So again, before we kind of rewind the clock and learn a little bit more about kind of key learnings that you've picked up, you know, in your journey building biotricity. Again, for those listening, it's biotricity.com is the website. You can learn a little bit more about the products and the technology as well as the company itself. So with that said, it will cost. Let's go back in time.

We'll frame this up around, you know, 2015, 2016, 17, really that early journey building, you know, bioflux. You mentioned it took about kind of, you know, sounds like about four to five years, right, to go from kind of initial concepts to, to, you know, actually commercialize the device. But if you think back on those, maybe those first couple years during kind of the alpha and beta kind of prototyping days, what, what, like if you had to do it over again, right? What would be maybe some things that you do differently or, or maybe just, you know, in general, where do you think most, you know, med tech entrepreneurs make a lot of mistakes in those very early kind of prototyping phases? Yeah, for sure. So I think that, you know, for us, how I would do it in, and I'll actually break it up into two categories, right? So one is like, you know, what would I do differently? And one of the things that we learned was this engagement with at an alpha stage, we were really a little bit late to get engaged with the customer, right? And so building a smart cardiac monitor to understand the workflow piece of it is, and it sounds kind of like, well, it's obvious, right? But we were so focused on the clinical piece that the workflow piece was kind of, like we knew it was important, but it was not something that was a part of it. So what you really have to understand is what are the users that are using your product, right? It's very,

very critical to dial that. So in our case, we're saying, okay, we need to be clinically great. We know the cardiologist is going to use a product. Let's go build it. And we did, and we did a fantastic a job. And then we went to commercialization and, well, it's actually the nurse that uses it the most. And actually, the problem isn't even the nurse who uses it. It's actually the MA staff who's managing it. So that workflow. So actually, when you look at the product, it's like, wait a minute, there's four workflows here, right? And actually, there's technically five workflows if you really go into it. And the reason is because, well, a cardiologist's workflow is different than a GP's workflow, which is different than an EP's workflow,

which is different than an EPA's workflow. So we were all focused on the, and correctly, you know, clinical, which means cardiologist, electrophysiologist, let's get their product clinically the best. Let's focus on making sure that that is effective. Of course, taking into account the patient as a part of this as well, but I just missed those multiple workflows. So that is something that I would definitely redo differently from a perspective of us as a company. I think what we did really well, right?

And I think this is where what I have seen, a lot of, you know, medical device companies and entrepreneurs and people have asked me, and I said on boards and what they are missing and what I see is that they haven't thought about the commercialization strategy early enough. Because who's going to pay for it? Is the patient paying for it? Is the insurance paying for it? Is it part of a general fee as part of a procedural thing where the hospital is just billing for, hey, I'm building a cardiac procedure. You're a component of the procedure, right?

So you have to figure out what is your commercialization strategy. And in healthcare, it's very interesting because it doesn't necessarily have to be insurance, right? It could be ROI-based, right? Go do this, Mr. Hospital, Mr. Doctor, because you're going to have better patient outcomes, which are going to have less patients returning. And so because of that, you're going to have a cost savings. That's a very different sale than going to adoption saying, hey, as part of your procedure, you're generating this much money.

If you use this and spend this much money on this, you're actually going to, your bottom line on your procedure is going to be better, right? It's reimbursement language, right? So that piece is a big problem. And so a lot of people think, oh, I'll get FDA approval. FDA approval is just a license for you to have a product and that it's clinically safe and effective, whether or not someone's going to pay for it is a whole another entrepreneurial journey. And so, you know, you talked about earlier, it's like, why is it half a decade? Well, there's two

entrepreneurial journeys here, right? And you get the first one and you don't realize about the second one. Yeah. Such a good point. For those listening, I'm sitting here nodding my head, what cost as you're as you're explaining that? Because those are those are such great points, right? And so many of us that are probably arguably maybe a little bit more technically inclined, right? Because we're in the med tech to kind of the healthcare space. You know, it's not like we're just selling a widget, you know, you're so easy to get like into the weeds, right, on the on the device, on the technology, the platform, the system, et cetera, and lose sight of the fact of like, how are you actually going to sell this thing? And, you know, what's, what's, you know, who's paying

for it? What's your channel strategy, et cetera? Because all, you know, to your point, all of that stuff matters, you know, as you're designing your products. But your, your first point about the workflows, that's so interesting because I just, I literally just published an interview yesterday with Ohadirazi. He's the CEO of Clarius, which is a mobile ultrasound. It's a handheld ultrasound device with some cloud connectivity, kind of similar to biotricity a little bit in some regards. And he mentioned something very similar.

He said they went, one thing they did right early on was they went really deep understanding workflows, right? All the key stakeholders that would involve and would touch their product, right? In whatever fashion, you know, it's super important. he stressed the importance of just really understanding, understanding kind of what aspects matter most, right, to each of those stakeholders. So I think those two are really, really, really great points. Kind of transitioning to a little bit to, and it serves as a bit of a segue, right? Because your device is very, it's consumer-centric, right? I mean, it's not just something that's used in a hospital or a physician's clinic.

I mean, this is something that somebody's using at home. And I'm sure, you know, you thought about that. early on, right, as you're developing it's got to look kind of, you know, it's got to be consumer friendly. So talk to us a little bit about that, because that's an interesting kind of intersection for a lot of device companies, especially as consumers sort of take, take more control of their health, you know, if you're not thinking about the consumer and what, you know, how they're using your product. I think you're probably missing something. And obviously, you guys have. So talk us about maybe the importance and kind of what you learned

along the way, kind of living at that intersection, right, of this is a product that is sort prescribed and recommended by physicians, but it's very much a kind of a, has a consumer look and feel too. Yeah, no, absolutely. So, you know, I think one of the things is, and I would say, it's an ongoing journey, right? And the consumers are very interesting because you've got these, you know, you've got the worried well, you've got the people who don't understand anything. And then you got a group in the middle and that have some sort of technical acuity and are willing to try. Then COVID happened and then they got more technically, technically willing to play around with things. But what's also interesting is that given the commercialization timeline, and this is what a lot of

people forget, of your product, your demographics are changing. So, you know, five years is a long time, right? Or four years is a long time. So if, in our case, it was three years to commercial, right? So, but even three years, right? You've got Android versions, phone versions. You've got things changing at that moment in time, right? And so for us, what we always try to deal with in terms of setting, we try to put things into buckets, right? So one bucket is, how do we improve information to the patient without scaring them? Okay, without giving them something that will cause, I mean, they went to a doctor and doctor's like,

I think you have a cardiac issue and they probably showed up their thinking their chest was tight. they woke up in the middle, maybe they had a panic attack thinking they have a heart attack. Who knows what that thought process was? And they show up and they think that, hey, I may or may not have this life-threatening heart issue. So in that moment, how much information do you really provide them that supports a good quality, patient compliance study and all that, but without necessarily giving them a huge amount of concern, right? And so there's an art to that. And we got it pretty good.

We hit the dark board, but we didn't hit a bullseye, right? And I don't think we really are on the bull's eye even today, but we're within one ring or two rings of it, depending on what the context is, because we understand, you know, there are patients that need reassuring messages. We need patients that are like, if they have messages, they get confused. And so there's this arc, right? The other piece of that on the secondary side, because I said there's two buckets, right? The other bucket is how do you actually get the patient on the compliance and the engagement

and the user experience side, right? Because you don't want it to be in the situation where, okay, patient is wearing this device and they're not really engaged on it. They just know that the doctor, a doctor prescribed, and they're kind of like a bystander, right? So if you treat them like that, then your patient compliance, ensuring that you're getting the proper feedback, improving the experience, that becomes very. difficult to do, right? So you're always trying to manage these two buckets, right? Like, how much information do I give, but then I also need to them engage? Yeah, those are, those are really good

points. It reminds me of, I think it was Jennifer Ernst, I believe, that, and she runs Tivic Health, which they have a class two device, but they commercialize it, you know, direct to, direct to consumer. I don't think it requires a prescription. Don't quote me on that. But she mentioned something similar, right? Like, you've got to make sure that your device is obviously, it's user-friendly, it's easy to use, but compliance is key, right? If it's something that people don't want to use and they don't use and they become, you know, they're not compliant with utilizing it, that's oftentimes in most cases going to lead to pretty poor, you know, efficacy, right? So those are, that's a, that's a really, really valid point. I love the fact, too, that you're, you were deep

enough with consumers to understand that if you're delivering, like, information that's frightening or scary or, you know, it's going to scare them. that's a big issue, right? And that's going to correlate to like, you know, how physicians are going to respond to the product too, because if they get a bunch of calls from, you know, that, you know, nine out of ten times are like non-issues, but the consumer, the patient's just scared, you know, that's going to impact, impact that relationship too. Absolutely. And one of the most interesting products for us, which I find so fascinating today, is actually our biohart product, because it really points to this issue about healthcare literacy as well, because that's another

factor that changes the whole thing. So we built that product, like I told you, is because we recognize that cardiac patients really have no tool to manage their condition, right? So because the issue is intermittent and asymptomatic, and actually we have an article on this in Net City about the importance of continuous heart monitoring, where like continuous glucose monitoring is this new thing, which is fantastic, but a glucometer is still a useful tool for diabetic, right? If your sugar is low, you eat something, your sugar is high, you go for a run. But in cardiac issues, the issues are intermittent. They're happening while you're sleeping.

You cannot use a moment in time, manual data collection point. You need something that's continuous. So we built a continuous harm monitor. And we were doing this testimonial things just a couple of weeks ago. And one of the user comes back and they're like, well, I have to open up the app to record my ECG signal. And we have spent so much time trying to explain to the user that it's a continuous heart monitor. And you don't actually have to do anything. And while you're wearing it, it's always recording.

And all you're really doing is going back in time and marking. It's like a bookmark, right? So this user still did not understand it, even though they've been using the product for like a year and a half. So. And then on the other side. side of the spectrum. We have an ER doc who's like recommending this product to his patients for personal management and he understands the whole space. So it's a very interesting thing because

our whole focus, which is very interesting to me is right. Like imagine we built the product to solve this problem. Our whole thesis and our whole point and in one time magazine and all that good stuff. But everywhere where we talk about, we talk about this differentiator of continuous seamless autonomous versus manual. And we have a user and customer who comes back and they're like, I have to manually collect it. And so look at that disconnect, right? And we have as a company, right, and me specifically, every piece of marketing material has focused on this differentiate.

So I find that very fascinating, right? No matter your entire marketing, your entire messaging, everything is around this. this huge point, and yet somehow you haven't articulated it correctly. Right, right. I think it just speaks to this idea of like, you know, always, always be learning, you know, from your customers, you know, you could be, you know, appearingly, assuming you're kind of doing all the right things, right? Like your messaging is on point, it's consistent, et cetera.

But then you, you know, if you're not talking to, you know, to customers and kind of getting an idea of kind of where they're coming from, you know, you very well may be missing missing some major things. But yeah, that's crucial, though, you know, when you're selling a, you've got these two key stakeholders, right, the patients and the physicians and managing, you know, the messaging accordingly, right, to those two, those two ends of the spectrum is pretty challenging to say the least, right? Yeah, no, exactly right. Yeah, let's talk a little bit about, about regulatory, right? Because you, you touched on this, you touched on a couple clearances that you have to date. And so when you think about kind of that journey, right, over the

past, you know, five, six years getting multiple regulatory clearances for your, for your devices. Are there a couple things that come to mind that have been, you know, helpful or maybe that you've learned along the way when it comes to this, you know, this topic of reg? Yeah. So I think, you know, regulatory for us is very interesting because we are innovators, right? So if you think about, you know, we talk about the commercialization journey. We talk about time, right? So, and I'll go back to that just for a second, is because, so we started the product

development in beginning of 2015, right? So we got our FDA clearance at the end, beginning of 18, right? So that's really three years of a true development and, and a device to get clearance, which is actually incredibly fast. Yeah. Comparatively, right? Now, we've shortened that up a bit more because obviously now we have legacy and things like that, but no matter how fast you would we go, we're still looking at an 18 month life cycle. Right? The time you deal with, compatibility, plastic, molds, this, alpha, beta, all of these other pieces that people don't realize. But what has actually fast-tracked us, right? So how do we go and how do we compress our time?

Is we adopted this approach of parallelization, which is, I don't know how widely it's used in the industry, but I don't imagine much because we go to the lab and we'll go to the lab and the lab be like it's going to take nine months to do all your testing and we'll be like why nine months and they said well we have to do this test we have to do that test we have to do these types of tests etc and we're going to uh you know we're going to do this electrical testing we're to do this break you know safety testing all of this so we'll go and we'll say okay well what if you did these tests in parallel and they're like well what do you mean and I said well you can do the safety testing alongside your usability testing alongside your electrical

and drop tests and or some of your EMS testing. And they're like, well, why would you do that? And I'm like, because it's not nine months anymore. It's like four months. And they're like, well, nobody's done that before. And I'm like, well, I'll give you as many devices as you want, but I want all this stuff run in parallel. So the idea of sequential testing, right, which is also a big part of the FDA process

because you need those test results back and based on those test results, you have to finalize your FDA documentation. So that is a big hurdle in terms of timeline that people are not realizing because all of these things have to be tested by independent labs. FD is not convinced about what you do, right? They want an independent lab and they want the report. And so the way to fast track that is to understand which lab testing can be done at the same time. Like there's no dependency. And so that is an arc that we have adopted. I mean, and sometimes we're sending devices. is we have four different labs doing four different types of tests on the same device that all gets put into one filing. So that is a very unique thing that we have been doing. And I think that

that is something that is definitely a way to fast track and improve the regulatory process. Right. I love the fact that you even started, you started out kind of your answer, which is like this story around asking why, right? You went to your test houses and they told you, well, it's going to take nine months to complete all of these, you know, these various test that are needed for the reg submission. And you just asked, why? Why does it take that long? You know what I mean? And I think so many, you know, entrepreneurs don't ask that simple question. I'm like, well, wait a second. Like, why? And then you learned, oh, because they're doing all of these tests sort of in a serial fashion. You're like, wait a second. No, we can, let's do this, like,

these four in parallel, these four going on at the same time, et cetera. And, you know, there may be some risks associated with, like, doing some of these tests at sort of risk if you have your bills done. But you simply ask the question, why? And then, figured out a way to kind of, you know, do everything in parallel to sort of fast track. I love that. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan,

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