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About the Guest:

Sahil Diwan,
Co-Founder & CEO of SafKan Health

Sahil Diwan is an engineer and entrepreneur with a focus on creating greater access to healthcare and healthcare consumerization. He is the Co-Founder & CEO of SafKan Health, a medical technology company with a mission to improve ear care.

SafKan Health’s first product, OtoSet®, is the first automated and FDA-cleared ear-cleaning device. OtoSet® is used by clinicians to treat more patients quickly and safely in lower acuity settings for impacted earwax, the leading cause of conductive hearing loss affecting 35 million Americans. The earwax removal procedure is very common but has seen little innovation over the last 200 years. This has left clinicians with time-consuming, messy, and antiquated options to provide relief to their patients, often having to refer them out to high-cost specialists for additional care. At the push of a button, OtoSet® combines irrigation and micro-suction technology to automatically break down and remove impacted earwax for a quick, safe, effective, and mess-free procedure.

From a young age Sahil’s brother, Aadil Diwan – a Biomedical Engineer who studied at the University of Arizona, has regularly had to seek clinical care to relieve symptoms caused by impacted earwax. Aadil invented OtoSet® to solve his own problem with impacted earwax. He and Sahil then teamed up to start SafKan Health. In just a few years, the SafKan Health team has raised venture capital, run successful clinical trials, secured multiple patents, received FDA 510(k) clearance, and brought a new medical device to market. Sahil and Aadil are among the youngest founders to receive FDA 510(k) clearance for a medical device, having founded SafKan Health in their early twenties.

Sahil is a first-generation immigrant. He studied Computer Science at the University of Oregon.

About the Episode:

On this week’s episode of Entrepreneur Rx, John had the pleasure of speaking with Sahil Diwan, Co-Founder & CEO of SafKan Health. SafKan Health is a medical technology company with a mission to improve ear care with a pair of headsets that clean people’s ears in thirty seconds.

Sahil and his brother persevered for years with the idea of OtoSet®, an automated ear-cleaning device, building prototypes in a college apartment and messaging physicians on LinkedIn. Throughout this inspiring conversation, Sahil details the entrepreneurial process of coming up with the idea, creating prototypes, getting feedback from ENTs, clinical trials, and going through the 510(k) process with the FDA. In addition, Sahil explains why raising money in MedTech is miserably hard and shares several tips for those who might want to venture into this industry.

Tune in to this episode to learn how hard work and persistence made the development of the OtoSet® possible!

Entrepreneur Rx Episode 62:

Entrepreneurs Rx_Sahil Diwan: Audio automatically transcribed by Sonix

Entrepreneurs Rx_Sahil Diwan: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

John Shufeldt:
Hello everybody, and welcome to another edition of Entrepreneur Rx, where we help healthcare professionals own their future.

John Shufeldt:
Hey everybody! Welcome back to another episode of Entrepreneur Rx. Today, I have the distinct pleasure of a gentleman I have spoken to you a few times before, Sahil Diwan is an entrepreneur and has an incredibly, he and his brother have an incredibly cool product device out there that literally will answer the need, or the call, for literally millions of people across the world. Sahil, welcome.

Sahil Diwan:
Thank you for having me, John. Good to see you so quickly again.

John Shufeldt:
Yeah, that was fun. So Sahil was at our office doing a demonstration yesterday, and it kind of blew us all away, and I was a crash test dummy for it, and I survived. So that was a good thing.

Sahil Diwan:
Yeah, thanks for testing it out. It's an experience, right? It's different, it's a cool product to actually be able to try yourself.

John Shufeldt:
It was, it was, I mean, you know, it was amazing. It was not, yeah, it was amazing. And I was telling Sahil before we hit the record button, what a great job he did presenting, and I told him it's one of the, probably the top 3% to 5% of people I've seen do a presentation that was really spot on. So, all right, so Sahil, as I mentioned, there's a lot of people who are going to hear your story, then say, That's the dude I want to be when I grow up. And as you mentioned, you've still got some years ahead of you under your belt, so give people a sense of your background.

Sahil Diwan:
Yeah. I mean, you're the person I look to in that same kind of way. So yeah, I'm early on in my career, so, you know, I'm happy to share the story so far. I guess I'll probably just start from the beginning. So my parents are immigrants, so I'm first generation here in the US. One thing I'll say about that is that the idea of ROI or return on investment is very much hardwired into you from an early stage.

John Shufeldt:
Where did they immigrate from?

Sahil Diwan:
From North India, so they came in the early twenties, you know, started with nothing. It's the typical immigrant mentality, is just come here and then, you know, sacrifice a lot, build up a good life for you and your family, invest heavily in your children and their education, and with the idea of them being able to have the opportunities that they didn't.

John Shufeldt:
Very cool. Okay, so first generation. Where did you guys, where were you, where did you grow up?

Sahil Diwan:
So born and raised in Seattle. So good segue way here, so born and raised in Seattle, was here my entire life until college, and then I went to the University of Oregon, and studied computer science at the University of Oregon, graduated from there. Skipped over a lot there, but maybe we want to go back and talk about the childhood a little bit. But then from there, went down to LA for a little bit before starting this company with my brother in Arizona.

John Shufeldt:
So let's back up. So it seems like this whole immigrant path, you're almost well, first off, you've got to be gritty as hell. And two, like you said, ROI is hard-wired into you, so it's kind of your probably whole mindset growing up as, it's entrepreneurial, whether it's starting a business or just be an entrepreneurial spirit.

Sahil Diwan:
Yeah, I mean, you grow up around a lot of that. You know, it's interesting. So my parents, and my parents came here, my parents have worked at the post office for their entire lives over 30 years. So my dad recently retired, my mom's retiring soon, and, you know, you see them waking up every single day early in the morning to go to work, going and doing that all day, picking us up. And you just see the sacrifice, like you see it firsthand, how hard they're working to be able to provide a much better step-up in life for the children. And then you see it with your family, too, like the wide family. So I have a lot of cousins, a lot of uncles, aunts, and it's kind of like this group mentality of everybody's investing in their education so that they can go off and do something really big and that the parents don't see that return on investment. It's nothing unusual, I think it's pretty normal. But my cousins, I got to see, my brother and I are some of the younger cousins, so a lot of them are a decade older than us and a lot of them became physicians, dentists, entrepreneurs, lawyers. So you're surrounded by a group of people who are working very, very hard, some of which even got like full-ride scholarships to college and whatnot. So you're seeing all these people do that. So, you know, for yourself, you're like, well, I can do that, too. There's, you're just following the path and you're just working hard towards it. I think that's the biggest thing, is that you just realize it's just the hard work and the persistence that really puts you out ahead of other people.

John Shufeldt:
Yeah, it sounds like you were kind of inculcated into that environment, you know, from a young age. Again, like you said, seeing your relatives and watching your parents work so hard and say, I'm not going to let them down there, they're literally killing themselves for me.

Sahil Diwan:
Yeah, yeah.

John Shufeldt:
Very cool. Okay. So why computer science?

Sahil Diwan:
I think I saw your talk, you know, talking about this too. I wasn't a very good student, so, you know, I wanted to be, my parents wanted to be wanted me to be a physician to begin with, but I was always kind of more into tech, to be honest, because that's, but yeah, so I was always more into tech and my dad's actually a big techie. You know, he loves technology and he's always been into it, so we always had gadgets around the house. And I remember when we had our first computer, I'd spent like all day or every day on that thing. I'd basically sleep in that room and be on that computer all the time. So I think that being super into video games, all that kind of stuff really added up to computer science being my path, but I didn't figure that out for a while. It was always more kind of focusing down on the medicine path, but I taught myself to code when I was 16, which is kind of where the cousin influence comes into. So some of my cousins, you know, they had these clients and they were, it was at this time before, like all the, you know, the website building, websites like Squarespace and stuff like that. So people actually had to hire people to build their websites for them. So, and so I was a 16-year-old and, you know, I'd make a bunch of money building people websites and I just learned how to do that, and I taught that to myself. And that's how I kind of got started with being an entrepreneur a little bit and just learning that, hey, you can pick up these skills even outside of school. School was kind of rough for me, I wasn't the best student, it wasn't the environment that I thrived in. I very much liked to learn things by doing them outside of school, that was just how I learned. So I spent a lot of time doing things like that, and that went throughout college too. We were always building apps, building different kind of software that literally hundreds of thousands of people would use. So we were from a young age building things that people were using on a daily basis, me and a few other friends. So that I think kind of lined us up to get to a point of like, okay, now I'm, after college, you're all in on doing a startup, which my parents at first weren't too happy about. My parents, I think, wanted me to go down, Okay, you got your computer science degree. Go get a nice cushy tech job and make a good living for yourself and then get to a stable position and figure out what you want to do after that. Whereas I was like, Okay, well, it seemed kind of easy to get to this point. How much further can it go? And that's kind of why we dived into the startup side of things.

John Shufeldt:
Very cool. So talk about the startup phase, so give us the background of that. I mean, I know the story a little bit, but give everybody the story because it's a cool story.

Sahil Diwan:
It is a cool story. So I was living in LA at the time, working on a few apps and whatnot that I kind of mentioned before after college, but my brother was actually still studying at the University of Arizona. The company is not affiliated with the university in any way, but he was still, he was just still an undergrad there, and he pitched me this idea of a pair of headphones that clean people's ears. And I was like, okay, well, it sounds crazy. I mean, it's, you know, it is a crazy idea and an interesting topic to focus on. But what I did was like, okay, let's get a render and I'll just start cold messaging physicians on LinkedIn, I'd done things like that before. So all we did was write a little Python script and had it go through LinkedIn, add physicians. If they accepted the invite, we would message them and essentially do our little pitch of, Hey, we're developing this product. This is the problem that we're solving, the problem of impacted earwax, which we didn't know the scale of the problem at the time, so we can talk more about that, but we were just trying to solve a problem that my brother had, right? So growing up, he would go to his physician every few months for this ear syringe procedure where they take a syringe, in which you're very familiar with, but you take a syringe and a bucket on your shoulder and you just go at it for 10, 20 minutes hoping that the wax comes out. Even still, they have a very high failure rate. So you're being referred out to an EMT surgeon for micro suction and they'll go under the microscope and micro suction and remove it. But for a very simple procedure, you have to go through this pretty complex process. It's about 35 million Americans that have this issue. It's 1 in 10 children, 1 in 20 healthy adults, and 1 in 3 people over the age of 65, and there are over 20 million procedures performed every year in the United States alone. So a very high volume procedure for a very large number of people, so there was a big market there, and, but kind of still this wacky idea, so the idea was go out, talk to physicians, see if they were interested. Essentially what they told us and they had a very high response rate, which was telling, what they told us is that as long as this is safe, effective, and at a reasonable price point, that they could see it being the new standard of care. So that kind of gave us that initial validation that we needed to go off on this crazy path and build a medical device company in our early twenties.

John Shufeldt:
Now, what was his undergrad in?

Sahil Diwan:
Biomedical engineering. So I'll have to give it to my brother, is that he very much, you know, stuck with what he wanted to do. I was trying to talk him into computer science and kind of on the same path of like, Hey, you can go work anywhere with a computer science degree. You can go work in medicine if you want to with a computer science degree still. But no, he was very focused on biomedical engineering and wanting to go down that path.

John Shufeldt:
Very cool, so he has this idea and you're the software guy, he's a hardware and probably software guy, and the design guy. So tell people how it got started, because I have to say, it's one of the cooler things I've seen, and now that I've used it, it was impressive.

Sahil Diwan:
Yeah, thank you. We spent a lot of time on product design and whatnot, but I think it's a very different story from a traditional medical device startup. We had no idea where to start, so I think this is probably helpful for people who are probably asking, where would I start, too? Particularly if you're just coming out of college. Find a good group of engineers to prototype with is the answer. So my brother and I, after he pitched this idea to me, there seemed like there was something there, and we were like, okay, well, let's put together a small team who can actually start building prototypes that we can then go show to physicians and see if we're onto something. And that's where we went and found a small group of engineers in Arizona that we worked with on a number of different prototypes from the earliest phases. We were literally building, this is where the story is probably very different from other medical device companies, we were building prototypes in my brother's college apartment at the University of Arizona. I'd sleep in the closet and we'd use the living room as the initial office to build prototypes, and we didn't even have an office for the first couple of years. We would just, my brother and I, when he finished college, rented an apartment close to the university and had mattresses on the floor that we slept on, and we turned the living room and put a conference table there, some 3D printers, and that was our office for the first couple of years. So really on a shoestring budget, building these prototypes, very focused on building something that was safe and then also effective into a headset design. So for people listening, the device is called OtoSet is the first automated FDA 510K-cleared ear-cleaning device. The idea is that it automates this ear-cleaning procedure that hasn't changed in 200 years. It uses a combination of irrigation, which is traditionally done in primary care with micro-suction, which is done by ENTs in that setting into an automated device so that the pressures are consistent, the same experience for each patient, which makes it safer and also more effective, and the procedure can be done pretty quickly from setup to clean up in about 5 minutes.

John Shufeldt:
Yeah, it was, it worked pretty fast.

Sahil Diwan:
It is fast, yeah, and I think it's an interesting issue in the healthcare system because you have different types of providers performing the procedure, very different levels of experience when it comes to the procedure, so we wanted to build something that was pretty easy to use, quick to use, and didn't require significant training. So all of that kind of went into the design process from an early stage, but we built a large number of different prototypes before we got to where we are today. And there are so many little details with having to put together a 510K, which is literally this thousand-page document that goes to the FDA at the end of the day, and we had no idea where to start. So we were just very focused on building a good prototype that we could show people to begin with. And I think we got pretty lucky through the process, meeting the right people who could actually help us take this to market.

John Shufeldt:
How long did it take you from when you started to the prototype that you considered workable? So your true MVP?

Sahil Diwan:
Yeah, I mean, I'd say the first year and a half of the company, we were just really young and dumb and didn't know really what we were doing. So we were building these prototypes, they're really rudimentary, and the idea was just, let's go find some physicians who could actually get behind this, so that was the first step. The first step was, get some really early 3D printed prototypes done, go out and start working with some ENTs on further developing it, and getting some ENTs behind it so that people would take it seriously. I think that was the other thing is, we were in our early twenties, who's going to take us seriously with this earwax company and a very young group of engineers building a medical device that they want to take to market. So we got some ENTs behind it, and then our first money in kind of came mid-2018, is when we got our first seed investment. So that is when things actually started to pick up. So we were able to bring people full-time on and focus on this even more. So that's kind of when we really started was mid-2018. We'd gone through an accelerator program called Dream and Health Tech, which was a real game changer for us, honestly. And Dream Adventures, who's the fund that runs that program is still a big supporter of the company today. So that was a real game changer for us. And we, I think early on realized that we were over, we had a lot to figure out, we needed the people around us to help us with that. So Dream, it really provided us with the network of people who built, launched, and exited medical device companies, so we needed those people around. We had no idea how to do regulatory or quality management or anything that we needed to do or clinical trials, anything that we needed to do to get this on the market. So going through that process really helped grow the company up a bit and helped us mature quite a bit. We then raised more seed money to really build out the prototypes, do clinical trials. That was the big next step, was getting enough capital to then actually use this device on patients and the whole process you have to go through to do that, through the IRB submission and writing the protocols and running the actual trial. So we had some great physicians help with those trials too, and that was kind of the next step before you prepare it for a 510K submission.

John Shufeldt:
Very cool, just to describe it to people, say you're wearing ... where I describe it improperly, but it's like wearing a pair of Beats on your head. And there is, you put in room temperature, body temperature, water, in the top part of the earphone, and then it shoots in under pressure, irrigates out your ear canal, and then there's a suction device, a suction to the bottom part of the beats headphone and then that part's removable and you can dump it out. And I was a little apprehensive trying it, only because I hadn't, I haven't had this issue, so having people squirting water in my ear. And what did it take? 20 seconds, did you say, that's the whole process?

Sahil Diwan:
It's yeah, it's a 30-second cycle. And so we've run a number of clinical studies at this point. We did one recently, it was a larger study, and what we learned is that this is, you know, it's a very safe and effective procedure, but more importantly, it's a much better patient experience. You know, we had a very high percentage was nearly 90% who said that this device was a much better experience than what they had done before, if they'd gotten the procedure done before at a physician's office. So that was another thing we cared a lot about, and we still care about today, is how do you continuously improve the device to be faster, to be even more effective, and to be an even better patient experience. That is a never-ending cycle of improvement, and I think that's something different coming into the medical device industry is that things move really slow. We still like to move pretty fast, obviously doing things the right way, making sure you have a robust quality management system and you're testing everything properly, but it's important to take customer feedback and patient feedback and always continuously improve the product. So that's, I think we have a big, as you kind of saw, we have a big focus on the product improvements and the design and the brand that we're building around it.

John Shufeldt:
Yeah, as I mentioned, it's very Apple-esque. I mean in the sense that the design, you could tell the design is very well thought out and very sleek. And so it was, I mean, it was, it was impressive to say the least. The, and being on the other side of that equation a number of times where I'm the one actually doing the cleaning, Oh, my God, this is like, thank God, because that's, you know, that's reason you have ... in these urgent cares or nurses in the emergency department. I do not want to be the one doing this because it is painstaking and tedious.

Sahil Diwan:
Yeah, it's, no, so those are actually good points to bring up too that we're a big learning curve for us. So you know, going through the process you build a prototype so you, you do clinical trials under IRB, you then need to manufacture these, once you kind of get to more of a final design, then that you can go do all the other testing that you need to do for your 510K submission, which is a lot of testing, but I think it's rigorous, but it's really good and I actually really enjoyed going through the 510K process with the FDA. I think it helped us build a much better product. And even though it's a long process, it's capital intensive, there are ways to do it quickly and cheaply, you just have to really know how to stretch a dollar, which we did. So we did a lot with a very small amount of seed capital for medical device company, which is another thing investors always like to see that we're really scrappy, but once you get through that 510K clearance, you now have to start thinking about everything else. So how does this actually, I think you should focus more about it, and we spend a lot of time with ENTs and primary care physicians, so I think we did a good job of this. But this is where the real learning comes in, is you have a first-generation device, now you get this out into the hands of hundreds of clinicians. You have to watch how they're using it, what their feedback is, what the patient feedback is. And, you know, a couple of really important points are, how does it fit into the workflow? They're not going to use it if it doesn't fit into their workflow to get it already, so you have to really focus on that. Clinicians are super busy, it's a new device, it is a pain point, but learning something new when you're so stressed out and overworked all the time is, it feels like a lot. So you need to build everything out from the training materials, the videos to be easily digested, and, so it doesn't feel like an overwhelming task. So huge focus on training materials that we focus on today. How do you get up and running with this device in less than an hour of training, basically? And then again, reimbursement. You have to figure out, all those things start to become much more important as you commercialize the product. We spent a lot of time thinking about it ahead of time. Can't raise money if you're not thinking about those things ahead of time, but getting out in the real world and actually doing it, you start getting punched in the face real quick with different issues and you got to figure out how to resolve them.

John Shufeldt:
Yeah, I've heard that. I've heard that expression before. If you want to be an entrepreneur, you have to just get punched in the face a lot and get back up. What was your biggest surprise in all this? Because it seems like you didn't really start off with this in mind. I want to be an entrepreneur, I want to get punched in the face. But you kind of weaved your way into it, you know, really growing up and then doing computer science. What was your biggest learning on this so far?

Sahil Diwan:
On this company, specifically?

John Shufeldt:
Just on being an entrepreneur, start with entrepreneur.

Sahil Diwan:
Yeah, I think it's a lot harder and a lot less sexy than people make it seem to be. So I think just understanding the harsh reality of what it's actually like to do this, I mean, you'll know this better than most people. I mean, starting a business is brutal. You got to sacrifice a lot to be able to get to a certain point and to go further. So I think just understanding that sacrifice, I don't think I'm the smartest person by far, I also don't think I'm stupid, but I think it's a lot about persistence and going further than other people are willing to go. And being more prepared, I think is another thing. Making sure you're more prepared. You know what the situation you're walking into, you well studied and that you're willing to go further than other people.

John Shufeldt:
What about ego?

Sahil Diwan:
You will have an ego when you go into it and it'll get shattered real quick and then maybe it gets built back up later, you can tell me, but I'm guessing that, right now, I mean, our mentality has always been, let's get the people around us that have been there done that, so we can learn from their mistakes and we can avoid a lot of those mistakes. I mean, we still make mistakes every single day, and you have to learn from them quickly and then learn how to not do them again, but mistakes are a way for you to actually figure out how to be successful, right? So that's the important thing, is to not look at them in such a negative light, but more of like this taught me something and I can get better from it. But yeah, we very much focused on getting people around us who are already very successful, who've been there, done that, who could guide us and provide advice and feedback on literally every step of the way.

John Shufeldt:
Yeah, I think that's funny, one of the things I noticed early on is, if you start in this process, you've got a relatively large ego, it doesn't work well, because getting punched in the face a few times, most people with big egos do not take that well and they don't come back from it or they don't come back from a positive. And it's, you know, that Winston Churchill's, you know, stumbling from failure to failure along your path, and that's hard for people with outsized egos.

Sahil Diwan:
Yeah, I think it's, I don't know, you have to really want to do this. It's more than the money. Like, it's, money's great, I'm sure, but I think it's, you have to really want this to be your lifestyle. I think that's probably the hardest thing. But for me, it's always just been, it's been part of it. Like, I mean, I saw my family struggle. I saw my cousins work super hard, so I never really had a big issue with working really hard or working long hours. I love doing it, so for me it wasn't that hard, but I think that's probably, the piece of advice is that it's not as fun as you think it is. The travel is not that fun, it's, all adds up into something that you have to really want to do.

John Shufeldt:
Yeah, what's, what would you think is the biggest or the most important quality someone could have who wants to get into this?

Sahil Diwan:
Being a learner, just wanting to learn all the time and that being part of your personality, being a learner, being curious, and willing to ask questions. I ask a lot of dumb questions because you have to really understand how things work at their core. You can't just understand it at their high level, you need to dive in deeper and really get your hands dirty and understand it. And I'm a learn-by-doing type person, so rather than sitting and asking too many questions or reading too much, I like to dive in and start getting my hands dirty pretty quick and learn as I'm doing things. So that's just my personality, but I think it's been a helpful trait.

John Shufeldt:
How has raising money been? I mean, I think that's, for a lot of people that has, becomes their ultimate stumbling block. And I again, I'll have to give you credit, you seem to have done it very well, a solid valuation.

Sahil Diwan:
Yeah, yeah, it's, I mean, raising, it depends. I think I can only speak to my experience really in MedTech, raising money in MedTech is miserably hard. I mean, doing a medical device company, I didn't realize how different it is from building an app, right? Like, this is something that is being used on human beings. It needs to be safe, it needs to be effective, if you're selling to physicians, who are the hardest people to sell to, so it's not an easy process.

John Shufeldt:
I mean, it almost needs to be idiot-proof, and I don't mean to call us idiots, but we're not the ones doing it. First off, our staff will do it and they're not idiots either, but I think as you go out to mass commercialization, I mean, you have to have every demographic of patients. You have to connect with them and teach them how to use it. And it's, I think that's going to be an interesting challenge, and ...

Sahil Diwan:
You asked me.

John Shufeldt:
... yesterday, and it was solid.

Sahil Diwan:
Yeah, you asked me earlier what was one of my bigger learning curves. We talked about kind of like the personality side, but one of my learning curves launching a medical device is the focus on training. It's a simple device, it's easy to use, but you still need to have robust training materials that people can go through on their own time. Clinicians are crazy busy, they're way overworked, they're really stressed out, you need to provide an experience that doesn't feel overwhelming to them, but still provides everything that they need to know and that they can come back to. So I'd say that was something I was a little bit more surprised about on the, Hey, this is an easy device, it's a pretty simple procedure, but no, you need to provide all the information so that they can digest and then learn it and practice it. So yeah, I think that's probably one of the things I'd say is, is medical devices are super hard, raising money is super hard for medical devices, but there are clear milestones that you need to hit, and that's kind of the nice thing here. I guess you have that in B2B SaaS software too, but there are clear milestones that you need to hit for investors to kind of unlock the next tier of investors who might be interested. So getting a prototype done, which I think you can do quite cheaply, depending on the type of medical device, you can do quite cheaply with 3D printing today. I don't know what it was like to build a medical device without 3D printing. So that I think was a game changer for us. We could buy a couple 3D printers for $5,000 or $10,000 and then you kind of feel like a software company in a way where you're iterating on product design very quickly, like overnight, right? So you're letting it print overnight, you wake up in the morning, you try that new design out, and then you figure out where to go from there. So that created a really interesting process for us to get quite a ways down the road with very little capital. So we 3D printed devices all the way until we actually had to manufacture it for the 510K submission, for the 510K data, and even still today we do a lot of 3D printing on new devices and whatnot. But, so you get your, you get your prototype, you get your initial clinical data that kind of unlocks your first set of investors that you can really go to, and then you go through the 510K process. Once you get your 510K, you unlock a much larger group of investors that you can go to. So fundraising has become easier, I'll say that, it was much easier to raise the series A, not, caveat is that we're in a recession, so that's the hard part, is to raise during this time, but it feels like it was easier to raise a series A than it was to raise that initial seed capital, at least for me.

John Shufeldt:
Yeah, no, that makes sense. And like I said, you have something you can demonstrate. It's, you can touch it, feel it, you get an idea of the total addressable market. I said your presentation was solid, I can imagine this was a little easier than a little bit of the, not quite pie in the sky because you have something, but I think this is going to work this way as opposed to, No, put it on, it works.

Sahil Diwan:
Yeah, you de-risk the company significantly. I think that's the other thing I realized raising money, is that you might feel a little bit personally hurt when investors turn you down in the beginning, but I think the important part is asking for feedback from investors. I learned so much from pitching investors who turned us down, who then a lot of which came back and invested later. But they're telling you what you need to do because they've seen it over and over. They have this different view of things where they're seeing hundreds of companies and what they're doing, so they have really interesting, a really interesting data set to share with you. So it's pretty clear pathway, you get your 510K, get some early commercialization data, build a significant pipeline of customers that you're going to go execute on. We have a lot of demand for the product, so the Series A is for us to build the team and build the inventory to go out and execute on that.

John Shufeldt:
Yeah, very good. Well, any parting words of wisdom for folks who, as they're listening to this say, I want to be that dude?

Sahil Diwan:
Well, I don't know if you want to be me yet, still got a lot of work to do, but I don't know. I think the biggest thing is, be willing to sacrifice, be willing to work really hard, be willing to work harder than other people, and be persistent. You know, just keep at it, keep iterating, and I think if you focus on that, you'll come across something that can scale.

John Shufeldt:
Yeah, I think those are the perfect analogies and words because everybody says it is a lot harder than you think it's going to be. And I mean, I learn that literally every startup I do because in my mind it's like, Oh, this is easy. I mean, everybody will get this, and it's never easy and no one ever gets it like, I think they should get it. I just get it, and I'm wrong more than I'm right, but boy, perseverance, grit, and that constant learning sort of mentality is crucial.

Sahil Diwan:
Absolutely.

John Shufeldt:
So, Sahil, thank you very much. Good luck in all this, and I know you and I will be connected on it, but amazing job so far, and I expect looking forward to a lot in the future.

Sahil Diwan:
Thank you, John, it's an honor to be on here.

John Shufeldt:
Thanks, appreciate it. Thanks, everybody! It's another great episode. We'll have everything in the show notes, including how to get hold of Sahil if you want to follow along with the progress. And again, I'll, I can't say enough. It's very impressive device and an impressive company. Have a great week, I'll see you back soon.

John Shufeldt:
Thanks for listening to another great edition of Entrepreneur Rx. To find out how to start a business and help secure your future, go to JohnShufeldtMD.com. Thanks for listening.

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Key Take-Aways:

  • It’s important to take customer and patient feedback, as well as feedback from investors who turn you down, to continuously improve your product.
  • Being an entrepreneur is not for everyone.
  • The entrepreneurial lifestyle requires you to be willing to sacrifice and work harder than other people.
  • Entrepreneurs usually stay curious, asking a lot of questions to make their products work.
  • Mistakes are a way for you to figure out how to be successful.
  • Raising money is hard for medical devices, but there are clear milestones that you need to hit like getting your prototype and clinical data, and going through the 510(k) process to unlock a large group of investors.
  • Part of launching a medical device is training care providers with the material they can go through on their own time.

Resources:

  • Connect with and follow Sahil Diwan on LinkedIn.
  • Follow SafKan Health on LinkedIn.
  • Discover the OtoSet® Website!

 

  • To find out how to start a business and help secure your future, go to JohnShufeldtMD.com