HackED! Hardward Prototyping 101

- Welcome, everybody, to the second part of our first day of the design speaker series, where we'll be tackling high-yield topics in both software and hardware applications. For this talk, we're gonna have Dr. Kevin Spencer with us here to talk about hardware. So, Dr. Kevin Spencer is an emergency department physician, mechanical engineer, and entrepreneur. He has over 13 years of experience in emergency medicine, as well as an EMS medical control physician, military contractor, primary care physician, and assistant professor of medicine at Dalhousie University in Canada. He completed medical school at the same university and residency at the University of Ottawa. Prior to medicine, Dr. Spencer also trained at the Center for Emergency Medicine in Pittsburgh as an ENTP, as well as a registered professional engineer with Silicon Valley startup experience in mechanical design and product development. More pertinent to our next hour today is the co-founder of Ring Rescue Inc., a medical device company that formed in 2018 with the goal of being the global standard of care for a very common pain point in emergency medicine. This is the commercialization of a hardware product to solve ring entrapment, which is a common problem in EDs and urgent cares and other healthcare settings. Stuck rings on fingers are a huge problem, both in terms of getting them off but also sometimes saving them when they're of sentimental value. Sometimes it's simple and sometimes it's really complicated that can delay care. This is something that I've personally experienced during my practice trying to remove a very sentimental ring when a patient definitely needed emergent resuscitation. There's also the challenges of harder metals like titanium and tungsten that have not have been very resistant to the traditional tools for removing them. Whether through product design, FDA and regulation, patents and manufacturing, Dr. Spencer is going to share highlights from his journey, starting from Basement, a company that currently has over 17 people and ships products across North America to top hospitals and fire departments. With that behind us, Dr. Spencer, thank you for coming today and the mic is yours.

- Awesome, thanks so much for the intro and for having me here. It's really, really cool to get a chance to connect with everybody and speak about my entrepreneurial and product development journey. Hopefully, everybody here is going to take on a similar path, invent some cool stuff and change the world. What I'll start with, if I'll just share my screen and we'll follow a bit of a slide format here, so just bear with me one second. All right, so I assume you can see this okay? Perfect, all right. So, yeah, thank you again for the intro. My email address is here, so if you have any questions along the way, please do reach out. I'm happy to try my best to answer any questions. So, the goals for today, so the goal is to draw from my experiences with Ring Rescue as the illustrating case study to discuss finding a problem, ideating a solution, and creating the skeleton for a future medical device company and hardware prototyping basics. That's what we're going to go through today. So, the context, who am I and what is Ring Rescue? So, I think I had to thank you for a very comprehensive great introduction there. I'm an ER doc, as mentioned, and I'm also an innovator and co-founder of Ring Rescue. And so, Ring Rescue is a company, it is a medical device manufacturing company. Our core purpose is to be the global standard of care for a common medical problem. We provide the best solutions in the world for suckering removal. And the reason I wanted to start with this slide is because I actually recommend anybody going into the hardware development or startup world, for that matter, whether it's medical device or otherwise, to try and reframe your idea and your path around a core purpose and what you want to do, ideally in a couple key, succinct sentences. If you can distill it down, I really think it helps provide some direction and maybe even inspire both yourself and others to jump on board. So, finding a problem and ideating a solution. So what problem are you intending to solve? This is, of course, the first question you'd ask. Sometimes a problem finds you, sometimes you find a problem. Either way, a couple of key questions you'd want to know going into this. Is this problem large enough, important enough, or interesting enough? And I use those three questions very intentionally because you need motivation to take this on and charge forward. And that motivation needs to be sufficient enough for you to endure essentially the time and personal sacrifice that's needed to see through it. It's easy to get started. It can be a long journey. So just, it's worthwhile asking those questions early on. And if you think the problem is important and you want to go after it, then by all means, get after it, solve the problem. A couple of other things, ask yourself, is this investable? Just be mindful that you will likely need funding at some point to get out of the gates. And you really do want to find out how common is this problem? Who would your customers be? A couple of those ideas very early on, I think will really help set you up for success in terms of what you're trying to develop, what you're trying to solve. So, in our case, so again, we'll use ring rescue as a frame of reference here. So, you know, just standard common knowledge. A lot of people wear rings. Rings are all over the place. Everybody around the world wears rings. They've been around for thousands of years. And we all know as ED docs, fingers can swell for many reasons. Ring entrapment is a common problem. It's definitely a common problem. Sometimes it's mild and sometimes it's quite severe. And it certainly can be a medical emergency with potential for harm, both in ring entrapment syndrome with an ischemic finger and also iatrogenic injury if you mess up getting the ring off with some of the legacy methods out there. So, whatever you're going into, try to frame it up around the scope of the problem and just get some frame of reference built around that as you get going. A really common tip, it's pretty straightforward, just do a survey and ask. This is an example where it was a couple years into my journey with ring rescue where I decided to actually ask ring wearers. And it's very easy to get a survey done. There's lots of companies across the United States that provide this service. It's not very expensive. They have a whole roster of people that are already enrolled with all the demographics. And you just have to figure out what questions you want to ask people. They will pull enough survey participants until they get the number you're looking for. In this case, I wanted to ask people about people who wear rings, their experiences. It took 1,500 people to get 800 ring wearers. And as a result, it works out to 55% of the population. So, you can immediately start building your stats out from there. Then you can ask all kinds of questions. Of course, I asked around their stuck ring experiences, where they went with those experiences, how often it's happening. You can ask whatever questions you want very quickly, very cheaply. Another question you always wanna ask when you're getting started is, why wasn't this problem solved before? If it's a big problem and the problem's been around for a while, why hasn't it been solved? In the case of ring entrapment, what happened is that rings changed, and tools didn't. So, rings used to be gold and silver and traditional metals that were soft and easy to cut. The advent of titanium, stainless steel, tungsten carbide rings, big thing, championship rings, the rings changed, and the tools didn't. As a result, what happened is improvised solutions surfaced using repurposed hardware short tools and other unregulated devices for patient care. And that kind just became embedded in practice. I certainly had shifts in Bill Knight where I'm trying to deal with difficult rings using a Dremel and it's miserable. So, making that recognition really is what led us to decide, you know what, this is something that needs to be evolved and solved better. That's where we started. Another thing you want to know is also what did people do before? So, people did something, and, in this case, there are string wraps, there's all kinds of different contraptions and improvised methods, but you're gonna wanna understand that for your idea. What did people do before and how are you differentiated? I also wonder what's the potential for harm from prior remedies and how can you improve patient safety, and efficacy to the most important things you're going to want to improve upon as you're figuring out your idea and what you want to innovate. So, you know, in this case, of course, there's a lot of safety issues with Dremels and other tools causing finger injury. And so, our goal would be to improve all that. So, if we're going to take on this problem, we wanna solve all these pain points, what we'll call them, and ideally solve them all in one fell swoop into a solution set. And that would be a great goal is to not just incrementally improve things, but really take on the major pain points and create a real impactful change. I think that's your most probable way to get a compelling idea into the prototyping stage and into sort of market level acceptance. So, aim big. I think I like the idea of make your solution 10 times better, 10 times safer than what was out there before. You had me measure that; it can be subjective, but keep the goals large, like that. Small incremental improvements may not be sufficient. Be cautious, in my view, be cautious about low cost, low margin, high volume proposals, because it's just very difficult from the ground up to get there. I recommend just going for bigger impact things if possible. And so having covered all this, let's say your idea is solid, the problem you're solving is sufficient, you have the intellectual property space to operate, and you wanna move forward, which is perfect. So, one last thing to look into before you really charge forward is just get a sense of where the regulatory burden will be. And in the United States, of course, it's the FDA. Class one medical devices are generally quite simple. They're actually exempt from a lot of things. And you really don't have a lot of regulatory burdens in general pursuing class one medical devices. Depends what you're working on. But in general, that's the case. And then a class one medical device is everything from a tongue depressor to a thermometer, which actually might be class two, blood pressure cuff, ring cutter. So, there's lots of examples out there of class one medical devices in everyday use that almost bridge into the consumer product world, but are regulated appropriately by the FDA because they're used on patients. It's pretty straightforward to figure that out. I'll come to that in a second in terms of what the landscape is regulatory wise. One other thing I'd like to point out is IEC 60601. So that's a big, long set of letters and numbers. But basically, what that is, is a medical device standard for electronic medical products. You're making a hardware device that has electronics in it. Just know what that is. It's basically a set of internationally recognized standards for essential performance and safety. And don't get too bogged down with this stuff. Just know that it exists. And when you're ready, Google it and figure out what's involved and how it applies to your product. So, with the FDA, so this is a definition of a ring cutter that is from the FDA. There's a bunch of bullets here, title 21, chapter one, subchapter H, part 880. That looks complicated. It's actually not. You just look at the FDA registry, go fda.gov. You look for the registration and device listing, and you type in what you're trying to do. In this case, I typed in a ring cutter. It tells you everything. So, you can look right there and find out what's out there in that category. Every device and manufacturer that's registered with this product there is listed. You can click on it. You can look up information. It's a great place to start if you want to figure out what people are doing in that space, what other devices in that space look like. So, in the case of our product, so this is a ring rescue kit. It is FDA registered, healthcare cleared, certified to 60601. And the three uniques with our product kit are safe, effective, and easy to use. Those are the three things we focused on. And I can come back to more of the nuances of this later as we're getting more specific into product design. And so, building a product versus building a company, I just wanted to touch on this as well. Often the product idea comes first, and the company building follows. That's sort of the natural progression. The product is more technically focused, but both are equally important. And for us, the compression device was first. And so, what the compression device is, it's a simple, essentially like a blood pressure cuff that applies air pressure to a finger to shrink a finger to make a finger skinnier to get stuck rings off without cutting them. It's a much simpler device. It was how we approached this problem originally. And that really allowed us to understand the space. People are using this product very effectively. It's saving rings from getting cut unnecessarily, which is great for patients. And it got us going. The ring cutter that we developed actually is much more sophisticated. It has electronic software hardware integration. There's a computer microchip in there with a feedback loop. But that was possible on the foundation that we built from the first product. So just keep in mind that you start somewhere, bite off what you can chew, and then build on it from there. And that's just a natural progression that really does, I think, work well as compared to, say, trying to take on too much and maybe taking on something that's less realistic to really cover within the resources and time spans you have available. The other thing I'll mention is don't underestimate the difficulty of building a company. I think many people think early on that the product is the harder part, but it's actually the other way around. I think the company part is probably harder than the product part in a lot of ways. But don't let that discourage you. There's lots of smart folks out there that can help you build a company if you have the foundation of a good product to build upon. So, the skeleton of a company. So, the basics here that you can essentially become a medical device manufacturer or become a company. So first, figure out a name to call your company. Call a lawyer and incorporate it. Get a domain name. Build a simple website, which you can do in a couple of minutes with Squarespace or any other website builder. And now you exist. It's actually that simple. You could do this in an afternoon. You could exist as a company with a website that faces the world and tells whatever you want to say about the stage of the business, you're at. You could literally have this done by tomorrow morning. Starting in your basement is normal. That's where we started. That's where a lot of companies start. Getting one or two partners is normal as well. Just ensure that you have a shareholder's agreement. The longer you put off those types of things, the more complicated it gets. We kind of got lucky and smart at the beginning of listening to good advice and doing this stuff well at the beginning. And it really does, I think, set people up for success. I know lots of companies that didn't, and it just creates a lot of problems. So, food for thought. File patents and IP protections at the appropriate time. You have windows of time from public disclosures. Just know what those are. And don't make foolish mistakes by disclosing early, but also don't get over. This doesn't have to be overcomplicated. Get a little bit of professional advice early on and go get after it. So that covers the first bit of the talk. And then we're going to get into the hardware side of things. But I just want to point out before we go there, we're obviously not the first. Everything around us, the products, technology, services, everything around us that we use daily didn't always exist. People thought of it, created it, commercialized everything, often starting small. And every emerging technology that you see has new tech opportunities in healthcare. And a couple of examples, I mean, the iPhone, the camera display, the small camera chips were used for all kinds of imaging devices, for laryngoscopes, all kinds of stuff. The cameras, the CC displays, the apps. Once the iPhone came out, it changed the landscape of so many technologies. Same with LEDs for pulse oximetry, AI for everything now. There's so many opportunities with AI in healthcare. So, there's all kinds of emerging technologies to create new opportunities in healthcare and for you to innovate new products. And very quickly, there's a couple examples of some really well-known companies that started really, really small. Nike, of course. I don't know if you know any of these stories, but they're super fun to look through. Everything big started small. And I think that's a great lesson for all of us as we're going through the entrepreneurial journey. And I love this Google one. It says Google Worldwide headquarters on the little whiteboard there with some examples of what the Google logo would look like on the other whiteboard. And so, from all this, I just wanted to show a couple of examples before we move on. And so finishing the first piece of this around finding a problem, ideating a solution, and creating the skeleton for a future medical device company, we're going to switch gears and look a little bit into the hardware prototyping basics to help with some of the frame of reference points, and little tricks that I found quite useful along the way. So prototyping is, what is prototyping? We'll start with the definition here. It's the iterative process of creating, testing, and refining preliminary models of a medical device to evaluate and enhance its functionality, design, and usability. It's very iterative. That's really, really important. It allows engineers and designers to explore ideas and solve complex design challenges before moving to volume production or any sort of production. It enables the identification of potential issues and assures the device is on track to meet regulatory safety standards and other requirements. And prototyping is really essential for optimizing the design, for validating the performance, and ensuring that the final product is both effective for its intended purpose and compliant with the medical needs standards. And this is an example of our compression device and the prototyping journey that this device took. And there's a lot of stuff on that table. Each one of them shrunk a finger and allowed rings to be removed, starting from a big electronic device with the three tubes, all the way through a whole bunch of 3D printed prototypes. And the 3D printing actually ends the third unit over from the right. So, all of that was 3D printed all up until the very end, which point we started doing machine plastics and finally plastic injection molding. And the device that we end up with, of course, is quite simple. It doesn't look very complicated, but to get there is a journey. I think that's the case with almost every product you're going to see. And so, the compression device, the way it works, you put it on your finger, leave it on for five minutes, it shrinks a finger, and you take a ring off. That's the idea. So, the basic needs for hardware prototyping, the two most important things, in my view, are some sort of CAD software and a 3D printer. You can just, you basically can do so much with that. You couldn't 20 years ago, even 10 years ago, it was impossible. You had to get machine parts done at an extreme, very high-cost relative to 3D printer, which is basically no cost. And so, depending on what you're working on, if it physically fits within a 3D printer, you can use a 3D printer to almost certainly hardware prototype at least elements of it, if not all of it. The tooling and jigging required to produce it, so much stuff can be done with this. And if you're unfamiliar with what this 3D printers and CAD software are, basically CAD software is where you design stuff in 3D, and this is an example of our dolphin ring cutter in a 3D model. Every single piece, every button, everything on there is a part. You layer them all together. The thing lives in three dimensions. And then you can export the file as an STL file, and you can press print on any component of that. And if it's printable geometry, a 3D printer will print that up and you just start building from there. It's like a Lego assembly from there. And so, what I would recommend, I have no affiliation with any of these companies, but what we use, Fusion 360 is basic, it's accessible, there's all kinds of academic licenses. If you're affiliated with the university, they can probably get it for free by two years. SolidWorks is more advanced, it's kind of an industry standard. Either one, you're going to be able to probably do what you need to do. From a 3D printer perspective, we've got, we've had a bunch of different ones where you currently have a Formlabs printer, which does a great job of stuff. So, it gives you a couple ideas if you want to move forward with that. The other thing I'll actually mention on the printer side, most universities, all kinds of places have them. So even if you don't have one, you can probably export an STL file by email, they can print it up for you for very little cost, almost certainly. So, what's an MVP, Minimal Viable Product? So, creating is fun. Taking the idea out and improving it out is really important. And you can actually start with duct tape and cardboard, lots of things have started that way. Then make it work, then make it great. And so, a Minimal Viable Product is a product that does its intended purpose, in my view. And it solves the problem you're trying to solve. It might be rudimentary, it might not be perfect, but it achieves its intended goals. What I wanted to point out here is just an early MVP for our Dolphin Ring Cutter, which is the device there on the left. And that's actually spring loaded. And it just, it cut rings, it just didn't work. We just, we thought it was going to work and it didn't. And so what we learned is that when you want to cut a whole bunch of different ring types like titanium and tungsten carbide and stainless steel and gold silver, whatever kind of ring and whatever shape you're presented with, you need to essentially get a feedback loop built into the cutting to actually make it work. We just tried a whole bunch of different stuff. And we've got great engineers, we tried all kinds of different things. And what we learned is that this has to be sophisticated, because it's actually kind of hard to do it. And we know that there's tools to cut titanium in aerospace and build aircraft out of. We know that tungsten carbide is in theory cuttable. How do we take those technologies, turn that into a ring cutter? It was complicated. And starting from something you learn, and you iterate, and you grow, and you realize, you know what? Parts of this work well, parts of this doesn't. How do we iterate it? And moving forward, what we ended up with was essentially a hardware device that has a computer in it with a feedback loop to try to cut any metal without heat, so you don't burn patient's fingers. And it actually works really well. But the journey to get there was quite substantial. It all starts with an MVP. And the MVP is really taking the duct tape version and making your idea work in principle, grouping it out, and then taking that and just continuing to iterate forward to the final version you want to get and introduce to the market. So, part of what you also want to understand and look for is the wants versus must-haves. And understand what you're pursuing, the capital or the amount of money that you have to work with, and time you have to work with. The timelines to launch it will really help drive this as well, because you can't bite off more than you can chew, or you just won't get it done. Also understand, is this the only solution for some markets? Is this a new niche, or is there other stuff out there? And get something really, really good built, test it heavily, learn a lot from early users, and then iterate it, is really what I recommend for a hardware pathway. Many ideas die in a lab. Almost no product nails everything on its first pass. And just, I guess, one of the fallacies I've seen is that it always can be better, and it never leaves lab to see the real world, to get real feedback. And that's unfortunate, because the real-world feedback is really, I think, first of all, you can solve a problem better than what other people have done. Second of all, by being in the real world, you actually learn things that you can implement to your next iteration. Product-market fit is extremely important. So just step back for a second. Do you have a deeper superficial understanding of what the market end user wants or needs? Some people do, some people don't. If you're an ED doc, and it's an ED tool for the emergency department, you probably do. But that's not always the case. And so, if you don't, just find somebody that does, and work with them, and get that feedback early. It's often better to design and build the product to fill a market need. But a lot of people sometimes start with an interesting idea that they developed, and then search for a market. And that certainly can be done, it just adds difficulty. So, if there's a market need identified first, and you designed it to satisfy that need, that's typically, I think, an easier path than the reverse. And so, yeah, so with all this, take this feedback, and help that drive your design decisions. Emerging tech implementation. I talked about this a little bit already, but look at how you can implement and integrate emerging technologies into healthcare products. And that's both on the software and hardware side. There's all kinds of stuff out there in consumer products, displays, buttons, microprocessors, all of that has been developed and refined to the point that if it's inexpensive in a toy, you can buy it at a hardware store or at a toy store. The technologies evolved to the point that you could take that and implement that with a little bit of learning and expertise in really unique ways for the medical space. And there's lots of examples of that. And I mentioned a couple earlier. What I like is just LEDs and pulse oximeter using the red light. It's pretty straightforward. Apply a red light with a little bit of wavelength absorption, spectrum absorption type technologies, and you've got a pulse oximeter, which is now in every Apple Watch. Those used to be complicated and expensive devices when they first came out. Now they're pretty much everywhere. You can buy them for like eight bucks, which is super cool. So, all the different technologies that exist in our day-to-day world, always think about how those could be repurposed into your medical device idea to bring that forward. And as I mentioned already, just consider 6061 and other regulatory requirements early in the process. Just know what they are, be familiar with them so you can work towards them at the right time. So, putting it all together. So, identify a you'd like to solve, get some market data on that. That can be a survey, or it could be asking a bunch of friends and colleagues, but start somewhere. Identify in principle how your solution solves the problem better. Scan the FDA site, get a sense of the regulatory category. Class one is going to be pretty simple. Complexity goes way up from there. Class two, three, four. So be mindful of that. Talk to an IP lawyer about patents. IP is intellectual property. So, talk to a lawyer about patents, or at least don't publicly share your idea unless it's protected. Just get some clarity around that before you publicly share it. If you share it under NDA, that's generally pretty safe. But do you want to display it at a trade show or something like that without having a good idea around your IP protection? Be mindful as well, work with universities. Some universities will actually take a claim to IP and others don't. So, you want to be mindful of that going before you put a whole bunch of time and money into it. Understand who else might have a claim to this from the people or the resources you're working with. Learn a good CAD software package or get an engineer that can do this. Most mechanical engineers will have some detailed familiarity with CAD. Get access to a 3D printer and the CAD file is basically printing a document on your home printer. It's that easy. It takes eight hours or something like that, but it's literally press print and that's all there is to it. Build a prototype, test out the concept in vitro, iterate that prototype into an MVP, somewhere along the way start a company and you are now an entrepreneur. And then ask anyone who's ever started a business, they'll probably help you with advice. That's certainly been my experience. A couple final thoughts. So have fun with the journey. Accepted the cost way more and take way longer than you initially think. Build a good company foundation early on, get the co-founder agreements, clarity around IP, clarity around fundraising sources, investor expectations, that kind of stuff. Align with business models that were tried, tested and true. The alternative may create uphill battles. Lots of businesses have been out there and been successful. Look at what they did, follow those models. You're setting yourself up for success. And of course you'll miss 100% of the shots you don't take. So, see where your idea will take you. So that's it for my presentation. I did want to make sure there was time for questions. And also, as everybody's iterating or thinking about their own ideas, this was intentionally fairly broad, but I'm more than happy to share my thoughts and experiences specific to any of your ideas or questions.

- Fantastic. Thank you, Dr. Spencer. And for folks joining asynchronously later on as well, you can see Dr. Spencer's email here that he's graciously offered to us if you have any questions. I'll open it up for any questions right now and I'll kick it off. So, I think particularly those last couple slides in light of your experiences, really gold as far as hardware development in the prototyping phase. One question that I've heard come up from multiple folks working on hardware development is best practices for conducting user testing of a prototype. So how often to do it, how often to iterate based on that feedback. So curious for your thoughts on that and how that played out for you.

- Yeah, there's a couple of nuances that sort of depends what you're building because to test things on humans in the medical context, of course, there's some boundaries there that you want to be mindful of. And in my case for stock rings, as I mentioned earlier, it's kind of unique because there is a deviation normalization into using repurposed hardware store tools for stock rings. And the FDA is very clear, ring cutters are medical devices. There was no finger shrinker for ring removal before. So, we went to the FDA and did something called a 513G, which they compared us to tourniquet devices and said, okay, this is close enough, that works. You can use it for shrinking fingers for removal. So, once you're FDA registered, you are essentially cleared for all intents and purposes to use the product on humans within that jurisdiction. I mean, there may be more nuances to it for sure, but in general, that would be the case. So, if you're before that phase, how do you test it on humans? It depends what you're doing. You're a physician and just make sure you're ethically doing the right thing here. In our case with stock rings, I can test it on mannequin hands. Maybe you want to access a cadaver lab. There's all kinds of different ways you can do this that doesn't involve humans in a lot of cases. Sometimes you have to. And so, the next question, well, is there any potential for risk or harm? Do you need to go through like a study ethics approval, that kind of stuff? You might, you might not. It kind of depends what you're doing. I mean, I cut rings off myself. I wouldn't cut a Dremel, use a Dremel to cut a ring off myself, but I would use my product. And so, you kind of have to use your own judgment, I think, around what kind of human testing is appropriate for what you're developing. And then if it's appropriate, test the hell out of it. Like just ask everybody and get people who have no experience with the procedure to test it, because you're going to learn all kinds of things about even turning your device on or which way you orientate it relative to what you intended. People will hold it upside down. They'll press the wrong things. If it can be done improperly, you'll observe people doing it improperly and you'll be surprised and you'll learn a lot from that. So, I didn't realize that people are going to think that it should go this way. And you'll learn from that, and you'll iterate from that. And so, you know, getting medical hands-on at non-medical hands, family, friends, kids, uncles, grandparents, you know, as many eyeballs and different levels of ability onto your concept, I think, the better for iterating. Does that answer the question, Nick?

- Yeah. No, that's great. I think it, yeah, it is really context dependent, like you're saying. Thank you. Zade, your audio wasn't working. It's still not working. While he's troubleshooting that, I think one other question that comes up a lot is, particularly for clinicians like ourselves who have a product idea but no engineering background, if they want to engage with an engineering partner, what kinds of questions would you recommend they ask to get a good fit and kind of lay that foundation?

- Yep. Great question. Super important as well. You can outsource engineering. There's all kinds of design firms that provide mechanical engineering design support. You just have to pay for it. And if you have a budget, that's easy. You find a good firm, you work with them, and you can kind of stepwise approach it by outsourcing it. If you want to bring a partner in, a mechanical engineering partner, that also could be much more cost effective and efficient. You're both working on sweat equity, but you also want to make sure you find a really good partner, somebody you can work with, you can develop a business with, and then somebody who's actually capable of doing this. And so just like everything else, you kind of like, I don't know, hire slow or fire fast, right? You really want to, if you're bringing a partner in for that, just get references, maybe test the waters a little bit with an early contract or something like that. And then if you feel like you have a great partner, then for sure, that would be the best. If you don't have a technical background in engineering and design, and you're making a hardware product, you're likely going to want to bring an engineering partner in one way or the other. One thing about outsourcing it to consultants and engineering firms, the iterative process can become expensive, and it can spin for a while. And that's something to be mindful of. So, getting somebody in-house who's living and breathing it can definitely help with that. Because you have to, if you have an external consultant, you have to teach them the medical side of it, what they're trying to do, the user side of it. They have to design your testing, your back and forth. This can go on for a long time. And so, if you're looking for simple design, that can be challenging. Now, if you're looking to take your idea, which is an MVP, minimal viable product idea, and commercialize it, that's a whole different thing. There's all kinds of companies that can do that really, really well. They know how to do plastic injection molding. They know how to do design for manufacturing, all that kind of stuff. People can turnkey that. But when you're actually getting the initial concept into a design, certainly an engineering partner that's vetted, that's a good personality fit and, and has the technical aptitude to do this would be good. And there's all kinds of super smart engineers out there. I mean, it wouldn't be hard to find them. You just have to kind of go looking, go by reference as well.

- All right, I'm gonna try my luck again. Is my audio working?

- There you go.

- We got you.

- Perfect. Okay. So more long questions of timing. So, the prototyping phase can be very protracted. At what point do you think it's optimal to start thinking about regulation and funding? Do you do this before you've exited CAD? Do you do this after you've tried it on a couple of your friends and family? When should you be considering that stage?

- Yeah, I think it, it kind of depends on your own interest level and how long you, your interest will propel you to the point where you need to start making some business decisions as well. You know, if you're having fun, you've got an idea and you want to just kind of take it forward a bit, test the waters a bit. I think you can go down that road for a while. But once you realize that, you know, you have an idea, you want to move it forward, you want to start investing your own money into it, your own time is heavily into it, or you're backing off your shifts, or making material changes to your lifestyle around this idea. I think it's important early to understand that because the reality is it can be a barrier. If you're trying to build a class three medical device or something complicated, that's practically going to take 10, 20 years to get 10, 15 years to get the market. And you're just going to, you're just, you're going to need a lot of fundraising. You're going to, it's going to be a long, difficult pathway, which people go down all the time. That's how everything gets market, but it's just getting more involved. And so, if it's going to be more complicated, I would recommend find out earlier, a little bit more about what the barriers might be. So, you can start planning a little bit around how much fundraising and how much time are you going to be putting into this before you get really down that road and decide you may want to back up, or something like that. It's just better going into it with that knowledge. I think the regulatory piece, like I said, it's easy to find out pretty quickly. If you're not sure, there's all kinds of regulatory consultants that are out there that just know the space very well, a quick meeting, a couple hours paid consultant time probably will give you a really good idea of what you're getting into with a regulatory consultant. And there's tons of them out there and people who know the space could look at an idea very quickly and kind of tell you what you're in for, I think. And if you know, it's class one, you're likely to have a lot less barriers. Class FTA is very complicated, and time consuming, costly. I mean, it is for sure, but class one is manageable. Class two, three, and four is going to require a lot more capital for sure.

- Excellent. Thank you so much. In terms of sort of proving your use case to investors, with software, it's so easy to be like, this is what everything looks like. And they can sort of imagine afterwards your pursuit of customers. With hardware, a lot of times you have to actually have your customers first before you approach investors. We've actually, we can build this, and we've done so. Do you have any insights to share about that process from your experience?

- I mean, you can demonstrate a lot of things. It really depends on what you're trying to build. You can usually demonstrate a lot of things on improvised analogs. I mean, you can use a hotdog and if you're a new surgical tool, do surgery on a piece of steak or something like that, right? You're trying to prove a concept for bleeding control, like make a fake blood vessel. There's all kinds of mannequin equipment out there that's used in simulation, high fidelity simulation, and lots of moulage and other things out there that, and then of course there's cadaver stuff as well. So, I think there's lots of ways to prove something out that doesn't require human testing, if you're unable to do human testing, to prove the concept. And if the concept is strong, you can often get seed funding around a strong concept if the market is there and the concept is strong, because there's a lot of programs out there, grant-based programs, 30 or 50k, accelerators and sprint competitions, and there's sometimes university funding and sometimes other just seed stage funding opportunities you can get, or your own money, obviously, is what pretty much every entrepreneur has to do at some point, put your own money into it, to get it to a proved out point that you can present it. And then you're presenting kind of a proof-of-concept idea that this is what I'm trying to solve, and this is how big and important it is I'm trying to solve. This is my idea, and I think this is going to fly for these reasons. I need money to get to the next phase. That's just super common. That's just how everybody does it. Family and friends, investors are usually the first run, angel investors. Yeah, it's the investor piece of getting the capital to proceed is a whole different thing than the hardware design and the product design. It's pretty heavy. There's a lot to it that's heavy, but you don't need to necessarily worry too much about that early on. I think if you can prove out the idea with some of these analogs, you have a good running start to have fun with it, and get people excited and start pitching.

- Great, very high yield. If there are any more questions from the participants, I'd like to move on to a storytelling time that I like to ask speakers.

- I'm actually going to use an example quickly on the hot dog piece. Here's an example. One of the methods people describe for removing rings is using vice grips to shatter tungsten carbide rings, because tungsten is a brittle material that's very, very hard. It's difficult to cut with traditional tools, but because of its brittle nature, if you apply enough force into it, it will shatter kind of like glass and break apart. So, to prove this out, the vice grips method, and then compare that. My issue with the vice grips method is, first of all, you're using vice grips on a finger. Second of all, it shatters into sharp shards that can go into your finger or hit you in the eye, which is not good in healthcare. Third, vice grips are not medical devices, and fourth, a lot of rings look the same. So, how do you know if it's a tungsten ring versus a titanium or stainless-steel ring? Your patients don't know what meds are on. They probably don't know what ring material they have either. And so, I took a hot dog and put a titanium, a stainless steel, a tungsten carbide ring on a hot dog. I took vice grips, and I cracked the tungsten ring, and it shattered and blew up. I did the same thing to the titanium ring, to the stainless ring. It just cinched onto the hot dog and pinched it. The hot dog kind of looks like your finger. There you go. This one blew up, so you kind of got the ring off, but it kind of looks dangerous. The other two look indistinguishable. You basically just cinched on the finger. So, this is why that method, in my view, sucks and why ours is better. That's just an example using technology, like using a hot dog with the technologies that exist out there. Take that concept, apply it to whatever it is you're trying to develop, and say, okay, how do I prove this out? How do I show the storyline by just kind of getting creative with the tools you have available to you?

- I like that. That's amazing for demonstrating value proposition, like just avoiding one malpractice lawsuit from a broken finger is enough to fund 10 years of ring rescue.

- And then, of course, the dolphin ring cutter I used to cut that tungsten carbide ring off of the hot dog quite effectively. That was sort of my mic drop moment in that particular one, so, yeah.

- Amazing. So, having a startup is very scary. And a lot of people get discouraged, especially when they hit a speed bump. Do you have any horror stories you can share from your journey with ring rescue to show us that things can go terribly wrong, but look, here I am.

- Yeah, COVID-19, literally the entire opera world shut down. Like we're in the middle of commercializing our compression device product, and literally patients can't even get in to see their family members in the middle of all this, let alone trying to introduce a new product into the medical device space. So that was like two years of sort of looking around and saying, how do we even sell this or promote it? You can't even travel during that window. So that's a bit of an extreme one, of course, in the sense of that was disruptive across the globe for a period of time. But I guess you just don't really know what kind of curve balls are gonna come your way. And so, I certainly didn't expect a global pandemic two years into my startup. Like that was not expected at all. I was actually at a trade show in Europe. It's a medical device trade show over there. It's one of the biggest ones in the world. And it was just at the beginning, I think it was like this November 2019 or something like that, just when it was holding a start and people are like over there trying to buy a PPE. I'm like, what's going on around here exactly? And then two months later, I'm like, I can't even promote my product anywhere. So, you don't expect a global pandemic or any other big crazy thing. But advice I've received is, whatever you think the journey is going to be, expect it to be harder and insulate from that as much as possible. If you're raising money, raise more than you think you're going to need. You're probably going to need it. If you think it's going to take you two years, expect it probably going to take longer. If you think that your prototypes can be ready in March, add three months onto that. Just plan aggressively and execute aggressively, but also plan around contingencies at the same time. So, you don't get, what's the term in aviation? You want to stay in front of the aircraft, not let the aircraft get in front of you when you're flying.

- I love that. Thank you so much. I mean, yeah, what bigger horror story than the pandemic? So, these are a lot of the questions we collected. Thank you so much for your time. This has been very high yield, particularly since the pool of hardware startups is much smaller than the software starts to come out every year. So, it's definitely a challenging topic, and it's not something that you can find a lot of resources for compared to software startups. For our asynchronous watchers, again, we'll be editing this video, posting it on the website. We're going to have a summary for you with all the salient points. Dr. Spencer, if it's okay, we're going to put in your contact information there. You'll also be present during ASAP this year. So, I'm sure a lot of our participants are going to be passing by to say hello and maybe picking your brain about some things.

- Absolutely. Yeah, no, for sure. Please do come by. We're going to be at ASAP. We'll cut a ring, and we'll talk about all the cool things you have in mind in terms of what you want to develop. And I should bring you back to the COVID story quickly for a second. So as a result of that, of course, it was very difficult to conduct business during that period of time. But you know, turning lemons into lemonade. So, we looked at the problem, we had our compression device to shrink fingers and get rings off of them, cutting them. We realized, look, this solves part of the problem. You still need a ring cutter. You still need a better ring cutter. We were now experts on ring removal at that point because of developing the first product. We had this window with COVID where we can't really do what we want to do. So, we said, let's double down. Instead of just having to compressionize, let's solve this problem entirely. Let's figure out how to make the world's best ring cutter, put it together into a kit. So, it's a full solution, A to Z, get rings off without cutting them, just help patients with their sentimental rings, have a ring cutter that cuts all these problematic metals, solve the problem fully. We took that time, and we built that product out. We went back to the drawing board, re-engineered a new product, added that into the kit, reinvented essentially our whole kit around the full product offering that we have now. And actually, that ended up doing exactly what we needed to and should have done all along. We just, you know, like I said, we started at one place, and we evolved as we went. And you know, that COVID shutdown period actually gave us that sort of concentration and focus to do that. So, I just wanted to point out the lemons to lemonade piece of that as well. And I do look forward to meeting everybody at ASEP and best of luck to everybody with your ideas. I think it's super awesome.

- Quick tip for all the participants who are aiming to visit ASEP. I would recommend you come in towards the earlier part of the exhibitor show than in the middle, because you'll have to fight your way through the crowds. I don't think I saw a busier table than yours last year.

- Yeah. It's fun to show people what you created and see people enthusiastic for it. It really fuels you honestly. So, I do appreciate that. And I appreciate all you guys inviting me to be here and to be part of this really. I mean, I'm an ED doc just like everybody else. Like there's no difference. It's just started doing it and everybody can do the same thing if that's what you want to do.

- Perfect. Well, we're honored to have you here and we're very happy that you joined us for this year's series.

- All right, any other questions? I know we're coming up on the end of the hour period. Any other questions or we'll park them for ASEP?

- Sounds great.

- All right, guys. Thanks again. We'll see you soon. Take care.

- Thank you so much, bye.