Dakota Welker | User Needs, Design Inputs, Verification & Validation の全文書き起こし

joke, you know, you get to choose your 80 hours to work, but there's still like a, like an, a freedom aspect to it or like, you know, and I started studying it and like, you know, it has a-- your, your ceiling is just unlimited and I really enjoy that aspect of it. 00:05:11.541 --> 00:05:15.351 And then as I've gotten into it more and more, I really enjoy the skill building. 00:05:15.362 --> 00:05:21.771 Like it, it helps you build skills in a way that I feel like my day job hasn't gotten in the same, in the same way. 00:05:22.161 --> 00:05:30.531 I mean, obviously I've learned a lot from my day jobs, um, but I feel like entrepreneurship pushes me in like i-in my skill sets and my character. 00:05:30.531 --> 00:05:36.382 It just, it's really developed and forged me as a person, and I've just like really enjoyed it even more. 00:05:36.781 --> 00:05:47.961 Um, I don't know, like would say it's been a progressive interest, increasing interest in entrepreneurship, but I wouldn't say I, I can point to like this one thing that really got me into it. 00:05:49.274 --> 00:05:53.485 When you were younger, you mentioned even being interested in business and entrepreneurship back then. 00:05:53.894 --> 00:06:08.915 Uh, maybe using the, the term business is too much of a stretch, but were there any, quote-unquote, "businesses" that, you know, a lemonade stand on the side of the road, even that type of thing, that, that you started when you were a kid that you, you tried and you were like, "Yeah, I like this. 00:06:08.915 --> 00:06:09.485 This is fun"? 00:06:10.418 --> 00:06:10.807 Yeah. 00:06:10.807 --> 00:06:15.627 So, um, I remember in elementary I was really into Captain Underpants and they 00:06:15.725 --> 00:06:16.735 Oh, nice. 00:06:17.528 --> 00:06:20.757 Yeah, so that was my, uh, fifth grade interest. 00:06:20.807 --> 00:06:25.708 And then they would always make these comic books, and they would sell the comic books. 00:06:26.017 --> 00:06:31.427 So I got really into, like, trying to do that with one of my best friends at the time, and we would try to sell them. 00:06:31.427 --> 00:06:34.387 I mean, he was a better artist than I was, so he always did better. 00:06:34.697 --> 00:06:40.077 But, um, I remember trying to do that and I like, you know, being a creative and, like, making my own thing. 00:06:40.077 --> 00:06:44.228 And then in middle school I, I tried to like a few things, like a, like a stand. 00:06:44.237 --> 00:06:52.637 You know, I would sell like snacks and sodas at garage sales that, you know, my grandmother would do, or I even tried doing like a lemonade stand in middle school. 00:06:52.648 --> 00:06:58.708 And then, um, got back into that, like did some graphic design type stuff in, in high school. 00:06:58.737 --> 00:07:04.497 So I've tried like a series of things and then, you know, I've tried a few things even since as a, as an adult. 00:07:05.968 --> 00:07:07.178 Yeah, same thing with me. 00:07:07.228 --> 00:07:11.168 Uh, I remember in middle school I, I had a, uh, baseball card business. 00:07:11.168 --> 00:07:24.499 I'd go to school and I'd have, you know, 100 cards that, uh, were pretty good I guess, and I'd sell them here and I'd sell them there, and the whole thing went great, and I did pretty well until someone stole all my cards and shut me down. 00:07:24.519 --> 00:07:25.449 I was out of business. 00:07:25.449 --> 00:07:27.288 It was a, it was a sad day, yeah. 00:07:27.338 --> 00:07:29.699 But anyway, it was fun while it lasted. 00:07:30.119 --> 00:07:31.509 All right, let's get back to engineering. 00:07:31.759 --> 00:07:33.899 Um, let's talk about prototypes. 00:07:33.959 --> 00:07:48.538 So you are a big believer in prototypes, and not just prototypes that, that look good but are actual- actually functional, move the, the business forward somehow, a- and maybe even have some element of, of DFM implemented. 00:07:48.538 --> 00:07:57.468 So what, in your mind, what separates a prototype from something that just looks good to something that's actually gonna move the business forward? 00:07:59.601 --> 00:08:00.072 Yeah. 00:08:00.072 --> 00:08:05.041 So to me, a prototype, especially at the early stages, is you're just trying to learn things. 00:08:05.372 --> 00:08:06.502 Um, and that's an approach. 00:08:06.521 --> 00:08:18.201 And I-- There was a book, uh, called"Lean Startup" that I really enjoyed, and I'm, I've been trying to, uh, tinker around with that type of concept of, like, getting something built, keeping things moving, learning from it. 00:08:18.411 --> 00:08:25.081 So to me, it's about having something that's gonna be-- uh, uh, learning something that's gonna be towards your end goal. 00:08:25.252 --> 00:08:33.851 So I think it's about understanding your end goal, what you're trying to go for, and trying to learn as quickly as possible and as effectively as possible. 00:08:34.152 --> 00:08:49.542 Um, so, like, I've had a few times where it's like, you know, you have these inventors and they want this prototype that looks nice to, to an investor, or they had one made in the past and it wasn't quite what they wanted, uh, because it didn't show the functionality. 00:08:49.721 --> 00:08:58.642 So, like, you have to have to show the, like, core functions to be able to show like, okay, what's-- what are you trying to-- what-- how's your product different? 00:08:58.642 --> 00:09:01.672 Yeah, maybe it looks nice, but how is your product different? 00:09:01.961 --> 00:09:09.611 So showing some of those mechanical aspects or, um, uh, electrical or software aspects. 00:09:09.642 --> 00:09:11.812 And I, I'm not a software or electrical guy. 00:09:11.812 --> 00:09:24.261 I do it through, uh, like my, my software skills are AI, you know, prompting, and my electrical skills are, you know, Arduino boards with maybe a few ca- wires, and that's about my capability. 00:09:24.282 --> 00:09:32.892 But, like, the-- you try to integrate with those technolo- those

technologies are also important to, to sell your prototype if you're, like, pitching to investors. 00:09:33.481 --> 00:09:41.432 And if you're not trying to pitch to investors in that next thing, what you're trying to do is show, like, what's gonna work, what's not gonna work, and that's how I, I view it. 00:09:42.811 --> 00:09:47.900 What's the typical, um, what's the word I'm looking for? 00:09:48.280 --> 00:09:53.171 Like, path, I guess, that, that your customers take. 00:09:53.171 --> 00:09:56.191 Like, what, what, what's the, the hero's journey, so to speak? 00:09:56.250 --> 00:10:03.671 Um, are you working with mostly, in your company that is the Think Med Tech, are you working with mostly startups? 00:10:03.701 --> 00:10:05.610 And, like, how do they find you? 00:10:06.591 --> 00:10:09.591 Where are they typically starting that, that you help with? 00:10:09.600 --> 00:10:13.230 Like, what's the next stage that you're typically trying to help them get to? 00:10:14.738 --> 00:10:15.118 Yeah. 00:10:15.118 --> 00:10:23.648 So most, most of the people I get, um, I've had a few people come through LinkedIn, but it's mostly been through Upwork, um, through that freelance platform. 00:10:23.937 --> 00:10:26.197 And a lot of them are, they have no idea. 00:10:26.298 --> 00:10:44.234 Like, they don't know, like, what goes into engineering or product development, and they just have an idea and they don't, you know, maybe they Like they, they have some, the money that they can put into it, and they, and they want-- they're really passionate about their product, but they have no idea, like, what, what the, what to do. 00:10:44.604 --> 00:10:50.624 So, like, I usually go for a four-stage approach, and I'm constantly trying to iterate on it and improve it. 00:10:50.933 --> 00:11:04.594 Um, my goal is to try to be able to have something as much ground, grounding as possible to where they could have as m- set them up for as much success as possible within a budget that's reasonable for them. 00:11:04.823 --> 00:11:10.913 So when you're doing a, you know, you're bootstrapping and doing it out of pocket, you don't have a million-dollar budget to develop a medical device, for example. 00:11:11.183 --> 00:11:17.053 But you may have $10,000 to at least get through to the point where you can have something to pitch to investors. 00:11:17.073 --> 00:11:20.833 And that's what a lot of people end up with, is something they want to present to an investor. 00:11:21.774 --> 00:11:26.903 so I, I'm going back to my four-phase approach, is usually I start out with, like, a documentation phase. 00:11:27.173 --> 00:11:35.964 So that may be developing the products, the problem statement, uh, really defining what they're after, um, helping them kind of get an idea of what market they're after. 00:11:36.014 --> 00:11:42.433 Uh, I try not to go into things that are outside of my expertise too much, but I try to go and say,"Hey, do your market research. 00:11:42.433 --> 00:11:48.933 Make sure you know what you're aiming for," because I don't want you to spend a bunch of money on something that isn't really something that's gonna sell. 00:11:49.053 --> 00:11:51.453 So I always try to en-encourage them to do that. 00:11:51.803 --> 00:11:58.073 Um, give them the differ- kind of give them an idea of, like, what the regulatory, uh, pathway… If it's a medical, a regulatory pathway. 00:11:58.073 --> 00:12:03.774 If it's not medic-medical, it would be like, you know, what's their pathway to get that product out to the market. 00:12:04.754 --> 00:12:07.583 So I guess it's in a way, like, a 1,000-foot view of the roadmap. 00:12:07.984 --> 00:12:17.124 Um, and then I try to define, like, what your user needs, um, and your design inputs are, uh, for medical device, and I do, like, a version of that for if it's, like, a consumer. 00:12:17.484 --> 00:12:19.234 Um, I mostly do medical. 00:12:19.234 --> 00:12:24.833 That's mostly what I've been, I've been able to help, like, uh, physicians mostly is who I, who, who I've helped. 00:12:24.943 --> 00:12:27.203 Probably over half the people have been that. 00:12:27.683 --> 00:12:34.464 Um, and then once that's all done and in place, we start getting into the point where I'll start doing, like, concepts. 00:12:34.464 --> 00:12:36.354 So maybe I'll do some hand sketches. 00:12:36.823 --> 00:12:38.484 Uh, don't look at them. 00:12:38.624 --> 00:12:40.663 They're not pretty, but they get the message across. 00:12:41.104 --> 00:12:55.854 Uh, I may even go into and use, um, a secure AI, uh, to get some renderings, um, something that's gonna protect their information still, but still get some kind of rendering to kind of get an idea of, like, what we're gonna go towards. 00:12:56.224 --> 00:13:01.293 And then I'll go into CAD, and then after that, I'll go into the third phase, which is prototyping. 00:13:01.344 --> 00:13:04.964 So I'll build a few different, a few prototypes and maybe a few rounds of prototypes. 00:13:05.264 --> 00:13:12.333 And then the fourth one's shipping them the prototype, closing it out, kind of getting some feedback from them, and getting into those next steps. 00:13:12.533 --> 00:13:23.354 So that usually gets them to something they, they either can, you know, test on their own or they could present to an investor or, and go to the next phase, the next stage that they wanna go into. 00:13:23.724 --> 00:13:29.224 Um, and I've been able to keep that decently affordable a-and effective, as I mentioned before. 00:13:29.514 --> 00:13:37.615 Um, but I definitely have, like, sp- Started to look at my process and more and more time is being spent in phase one and two. 00:13:38.105 --> 00:13:41.275 Um, especially phase one and really laying that groundwork. 00:13:41.336 --> 00:13:45.806 And then phase two is, like, really getting into more details within the CAD. 00:13:46.225 --> 00:13:50.216 Uh, that way we're spending less time and less money on the actual prototype.

00:13:50.586 --> 00:13:57.535 Uh, still more of an MVP, like 3D printed, uh, something I do in my own shop by hand type of prototype. 00:13:57.535 --> 00:14:01.556 So still trying to keep it low, still trying to get it to there as quickly as possible. 00:14:03.066 --> 00:14:13.576 and I could go down that loop as about, like, thought process about, like, how to, you know, how quickly do you get to the prototype versus how much time do you spend up front, and that's a, balance on its own. 00:14:14.928 --> 00:14:20.969 Some of these, uh, physician inventors that you work with are, are not engineers, right? 00:14:21.278 --> 00:14:27.509 Engineers, I would hope, understand and appreciate the value of good documentation. 00:14:27.509 --> 00:14:36.609 But outside of having that core experience as an engineer, I could imagine that some people might not appreciate the value in the documentation. 00:14:36.609 --> 00:14:53.548 Do you ever get pushback from some of these customers saying, "Why are we spending all the time on, on defining requirements and, and documentation? Just, just put something in, into CAD and 3D print it for me." Or is that not a, uh, an objection that you face very often? 00:14:54.577 --> 00:14:55.888 So I think it depends. 00:14:55.927 --> 00:14:57.258 Um, a-a-and I think part of that's just building trust. 00:14:57.258 --> 00:15:03.837 Uh, part of it's just like, you know, you, you wanna have it to where you build trust with your customer. 00:15:04.758 --> 00:15:11.268 so if they don't trust you, I think that's part of where that like, you know, well, there's a reason why there's documentation and you can explain that to them. 00:15:11.268 --> 00:15:14.317 But if they don't trust you, I don't think that's gonna, that's gonna fall flat. 00:15:14.768 --> 00:15:17.927 Um, most of the time it does okay, especially with physicians. 00:15:17.927 --> 00:15:24.028 They, I think they understand the value of like documentation and laying their groundwork, but I've even had pushback even from physicians. 00:15:24.418 --> 00:15:26.177 Like I've, I've did some testing. 00:15:26.597 --> 00:15:34.028 Um, there was a physician I did some, a prototype for and did some testing, and he wanted me to, uh, not to skip that documentation. 00:15:34.107 --> 00:15:56.817 And then I explained to him, I'm like,"One, I don't actually spend that much time on it. I'm able to actually utilize tools to, to just speak my notes, get it done pretty quickly." But, uh, it's also two, it shows value because the value in that is that it's like it's showing what I did, why, you know, thought process of what I did, wha- why I did it, how to improve on it, and so I don't repeat the same mistakes in the next prototype. 00:15:57.028 --> 00:16:06.538 So in the end, it will save in the long run because if you're just, if you're not taking notes along the way, to me, you're gonna repeat the same mistakes or you're not gonna understand why you made those mistakes. 00:16:07.408 --> 00:16:18.129 There's an engineer that I know and respect a lot who likes to say that the difference between building something in your garage and real engineering is documentation, and I think that's, that's very true. 00:16:18.489 --> 00:16:18.769 Yeah. 00:16:19.999 --> 00:16:24.139 Um, what is-- what's your favorite part of the process? 00:16:24.139 --> 00:16:26.589 I mean, you're wearing a lot of different hats now, right? 00:16:26.589 --> 00:16:28.249 You're wearing the, the business owner hat. 00:16:28.249 --> 00:16:30.078 You're wearing the marketing hat. 00:16:30.078 --> 00:16:31.578 You're wearing the accounting hat. 00:16:31.619 --> 00:16:33.288 Obviously, you're wearing the engineering hat. 00:16:33.729 --> 00:16:34.859 What's your favorite part of it? 00:16:36.306 --> 00:16:42.556 So my favorite part, um, I would say it's just the eng- I mean, of, of course I enjoy the engineering. 00:16:42.596 --> 00:16:46.196 That's-- I really enjoy the creative design and development. 00:16:46.206 --> 00:16:50.635 I enjoy, like, being able to see things go together and work when I build a prototype. 00:16:51.525 --> 00:17:02.035 But I also too, like, I kind of had some enjoyment of being able to educate people who have no clue and kinda seeing that light bulb, and them then kind of like, "Oh, that's really helpful," and things like that. 00:17:02.456 --> 00:17:20.895 Um, so that's, that's also been enjoyable, is just being able to see the client experience of being able to, like, educate them and get that light bulb, or like when they're really happy with their prototype, like being able to see it and like, you know, it's almost like, "Hey, my dream's like here," like, "This is what I envisioned." And so that's, that's been fun too. 00:17:21.215 --> 00:17:23.006 Um, yeah. 00:17:23.006 --> 00:17:24.326 I would… Go ahead. 00:17:25.563 --> 00:17:27.093 What's their path to revenue? 00:17:27.163 --> 00:17:34.772 Uh, I mean, um, uh, a lot of the people you're working with are, are, uh, physician founders, right? 00:17:34.772 --> 00:17:44.522 They don't have, like, a big sales team built out where once the product design is finished, they can just hand it over to the sales team, and they go out and start selling it. 00:17:44.982 --> 00:17:46.512 These are individuals. 00:17:46.522 --> 00:18:01.083 So how do, how do the customers that you work with, these, uh, generally physician-led inventors, how do they bridge that gap between, uh, having a, a product that's developed and then generating revenue from it? 00:18:01.202 --> 00:18:07.113 Is there, uh, one path that you see occur over and over, or has it been a lot of different things? 00:18:09.104 --> 00:18:14.173 I'll say that, like I haven't been able to be as part of that process too deeply. 00:18:14.324 --> 00:18:17.703 Um, but I, I've been able to see a few different versions of it. 00:18:17.733 --> 00:18:22.884 So like within medical, there-- it's really difficult to get into hospitals.

00:18:22.933 --> 00:18:25.784 Um, so like there's different strategies they can do with that. 00:18:25.794 --> 00:18:27.403 Like you have to think about reimbursement. 00:18:27.804 --> 00:18:38.084 Um, some of them will do like a program where like I've seen some startups, they'll, they'll sell a device at cost and then they'll sell disposables and that's where their money and revenue comes from. 00:18:38.443 --> 00:18:47.624 Um, some of them will just, they can just sell, like if it's just something like it's a simple device, they could sell that and be able to do that to, and they make their revenue off of that. 00:18:48.094 --> 00:18:51.473 Um, and then some of them it's, it's a rent, like they may rent a machine out. 00:18:51.834 --> 00:18:59.483 Um, so there's a couple different paths they can choose and I think the important part is just knowing how that's gonna fit into the medical system. 00:18:59.913 --> 00:19:11.594 Um, like some of them it's, you have to understand that like how medical, you know, hospitals do their, their, how they do their, their business, um, and how to get into that business. 00:19:11.624 --> 00:19:19.963 And that's not always as easy and straightforward as just going into Amazon and throwing your product on Amazon and doing typical marketing way, you know, through that. 00:19:20.354 --> 00:19:25.223 Um, so I would say that's what I've seen in, in, in a couple different ways. 00:19:26.576 --> 00:19:38.336 There was a project that you did that I read about, and it was some kind of medical device filter, and you were able to reduce the manufacturing costs by something like 50%, which I thought was incredible. 00:19:38.666 --> 00:19:40.686 Can you walk us through that process? 00:19:40.686 --> 00:19:41.247 What happened? 00:19:41.257 --> 00:19:44.356 How were you able to strip out that much cost from the product? 00:19:45.105 --> 00:19:45.476 Yeah. 00:19:45.476 --> 00:19:52.766 So I'll put this caveat at the beginning, um, that I didn't actually get to see that product go into full force and to production. 00:19:53.236 --> 00:19:57.496 Um, so I'll put that caveat at the beginning 'cause I ended up leaving, leaving before that. 00:19:57.855 --> 00:19:59.655 Um, and it-- but it was close. 00:19:59.715 --> 00:20:07.016 Uh, so that, that was one that was brought to me, uh, and the guy-- there were some guys that already did some research, so I wanna give them credit where credit's due. 00:20:07.266 --> 00:20:10.625 And they started going in through and, and kind of seeing different things. 00:20:10.625 --> 00:20:19.556 And so what the big strategy behind that was just bringing it in-house and working with different vendors rather than the one vendor that you were locked into. 00:20:19.796 --> 00:20:26.826 So, like with that specific type of filter, um, it, it was very niche, so, like they could charge a lot. 00:20:26.836 --> 00:20:33.915 So, like the, the strategy was to bring it in-house, do some, uh, uh, that's own- their own components and do the assembly in-house. 00:20:34.135 --> 00:20:42.855 So that's how they were able, uh, to-- and work with outside vendors to negotiate pricing and, and, and manufacturing strategy and things like that to be able to reduce that cost. 00:20:43.266 --> 00:20:49.286 Um, so that's, that's where that-- that's how they were able to-- that's how that pro- we were able to do that with that project. 00:20:49.296 --> 00:20:55.286 And we got to the point where it was like it, you know, it was, uh, you know, the tooling was made, everything was in, in good shape. 00:20:55.326 --> 00:21:02.286 It just hadn't got to the point of going through the final FDA check marks to get out to the point where it was part of the, uh, market. 00:21:02.395 --> 00:21:07.155 But it was already part, you know, it was something that they, they knew it was gonna sell and that kind of thing. 00:21:07.810 --> 00:21:08.250 Nice. 00:21:08.280 --> 00:21:10.721 That's-- Yeah, we have customers who are the same way. 00:21:10.721 --> 00:21:17.451 They, they have a product, and they have a contract manufacturer who's making it, and it costs an arm and a leg, and they're trying to insource it. 00:21:17.891 --> 00:21:26.070 Uh, we've, yeah, we've developed several machines that allow them to do that, so I know exactly what you mean there, and that can be a huge cost reductions. 00:21:26.320 --> 00:21:37.020 Um, uh, since we're on the topic of medical devices specifically, let's talk about verification and, and validation, which are two terms that are very common in the medical device world. 00:21:37.371 --> 00:21:43.330 But engineers outside the, the medical device world might not be as familiar with those two terms. 00:21:43.330 --> 00:21:51.861 Can you talk about what they mean and, and how they are implemented throughout the, the medical device product development process? 00:21:53.228 --> 00:21:53.248 Yeah. 00:21:53.248 --> 00:21:57.248 Um, I did have one quick note on the medical filter that I think is also valuable, is that 00:21:57.325 --> 00:21:57.934 Oh, please 00:21:58.367 --> 00:22:02.147 we specced it from something that was over-specced for what was needed 00:22:02.317 --> 00:22:03.557 Ah. 00:22:03.857 --> 00:22:07.627 it was specced for the right uh, the right use case. 00:22:07.952 --> 00:22:08.502 Yeah 00:22:09.018 --> 00:22:10.188 and that's also important. 00:22:10.907 --> 00:22:12.228 Um, yeah. 00:22:12.228 --> 00:22:15.038 And then, uh, verification and validation. 00:22:15.167 --> 00:22:22.837 So those are something that's, that's a term that can get a little bit confusing when you're not in the medical device world, 'cause it kinda sounds like the same thing. 00:22:23.147 --> 00:22:33.847 So verification in a nutshell is basically you're, you build something, you, you write an engineering spec, you build it, you test it, you check the fa- fact that you met that spec. 00:22:34.218 --> 00:22:39.557 So it's, um, if you look at the FDA thing, you

got your user needs and you got your design inputs. 00:22:39.557 --> 00:22:41.887 Your design inputs are basically your engineering specs. 00:22:42.127 --> 00:22:43.278 And so you're testing that in the lab. 00:22:43.748 --> 00:22:49.137 Your user needs may be something that's gonna be implemented with the user itself, and that's where you validate it. 00:22:49.417 --> 00:22:54.907 So for example, you may have something that you have an engineering spec that you need a certain flow rate. 00:22:55.048 --> 00:23:03.137 Okay, well that's a verification, and you're verifying that you could do that flow rate, and you're doing that in the la- uh, you know, you're doing that in your prototype shop or your lab or whatever it is. 00:23:03.458 --> 00:23:10.278 But you also need to be able to meet, uh, a certain, um, toxicity requirement. 00:23:10.288 --> 00:23:12.708 So you may take it out and do cytotoxicity testing. 00:23:12.738 --> 00:23:16.387 So that would be a validation of that, that, that user need. 00:23:16.788 --> 00:23:19.907 Um, does that make, is that a good explanation of that, you think? 00:23:20.472 --> 00:23:21.333 I think so, yes. 00:23:21.353 --> 00:23:35.353 You're saying, uh, technical requirements or design inputs are, are matched with verification, whereas the user needs, the, the more qualitative requirements, shall we say, are matched with the, uh, validation 00:23:36.529 --> 00:23:37.049 Yeah, yeah. 00:23:37.049 --> 00:23:41.269 And user needs and design inputs, sometimes you'll get design inputs out of the user needs. 00:23:41.539 --> 00:23:48.759 Uh, but it, at the end of the day, you're validating that you have that user need met and you're verifying that you have the design input met 00:23:49.744 --> 00:24:04.244 Yeah, and user needs and, and design inputs are often, uh, always used in formal medical device development, but they're so practical and, and I'm sometimes surprised that they aren't used more commonly in just general product development, right? 00:24:45.293 --> 00:24:48.373 Yeah, and I've actually been able to use that in things like consumer products. 00:24:48.373 --> 00:24:48.723 I've, I, 00:24:48.850 --> 00:24:49.221 Ja 00:24:49.273 --> 00:24:53.923 it useful and it's, it doesn't have to be as stringent as it is with medical device. 00:24:53.953 --> 00:24:58.763 Like of course, for medical device you have to meet FDA requirements, so you got a lot more documentation and things like that. 00:24:58.763 --> 00:25:09.223 But I, I found it so useful to define like that, and I kind of tweak it, you know, since you don't have to worry about meeting regulatory, I kind of tweak it and fit it according to that product. 00:25:09.223 --> 00:25:11.233 So, excuse me. 00:25:11.293 --> 00:25:18.453 A user need might be, you know, in that version may be like, well, it has to ergonomically, you know, it has to be comfortable for the person. 00:25:18.473 --> 00:25:21.884 So that may, you know, and that's, you know, and that may be

a design input. 00:25:21.884 --> 00:25:29.443 Well, comfortable might mean like it has to meet a certain pou- a pound of weight support or something like that. 00:25:29.783 --> 00:25:33.423 Um, so I've been able to like modify that even for like consumer products. 00:25:34.034 --> 00:25:34.344 Yeah. 00:25:34.454 --> 00:25:35.214 Yeah, that's great. 00:25:35.634 --> 00:25:40.484 Um, do you ever inherit projects from an- another engineer? 00:25:40.484 --> 00:25:51.694 Like, one of your customers comes to you and says, "Hey, I was working with this other engineer or other engineering company, and for whatever reason couldn't get it a- across the finish line. I, I want you to finish it." Is that something that happens? 00:25:52.596 --> 00:25:54.435 Yeah, I've had that happen quite often. 00:25:54.535 --> 00:26:14.045 Um, and you know, there's different reasons why, uh, and but I've been able to like take that and u- usually it's oftentimes just really trying to understand that, that client, um, and what they're after and then, um, just being realistic about what they can achieve with the budget, uh, and, and just communicating. 00:26:14.065 --> 00:26:15.615 Like it's just over-communicating. 00:26:15.615 --> 00:26:25.555 And I think sometimes th- that's seems to be the issue I see, um, is of the big issues is, is one, I think sometimes engineers can struggle with communication. 00:26:26.005 --> 00:26:32.255 Um, and I've definitely had my struggles with it, so I'm not, you know, saying anything bad about that. 00:26:32.265 --> 00:26:34.336 I, I have my struggles with communication as well. 00:26:34.655 --> 00:26:36.295 Um, but that's been able to be helpful. 00:26:36.705 --> 00:26:59.045 Um, the other thing too is not understanding like, um, you'll have somebody that maybe could- wants to- they could do- want- they may want a product that could be done really cheap, so they go to someplace else that ha- that they say can do it for really cheap from, uh, I'm trying to put this, uh, like from a, from like a non-US, um, engineer. 00:26:59.096 --> 00:27:06.865 Well, s- and but they don't understand like, okay, sometimes those guy- l- and there's, there's rooms and there's places for that, so I'm not trying to say that. 00:27:07.155 --> 00:27:14.775 But there's times too, it's like, okay, well, what you wanted isn't gonna be capable with that specific freelancer for that cheap. 00:27:14.995 --> 00:27:24.205 So yes, they could provide you maybe like a, a, a, a d- like a CAD that pr- you know, gives you the kind of the, the look and the feel you want, but you're not gonna have all the detailed engineering. 00:27:24.495 --> 00:27:26.965 That takes from somebody who's got a different skill set. 00:27:27.255 --> 00:27:29.695 And I, I should say that's even with US engineers. 00:27:29.695 --> 00:27:33.765 There's US engi- or that are more CAD-based rather than engineers. 00:27:34.225 --> 00:27:36.765 Um, so I think that's the other thing I've, I've seen, 00:27:37.417 --> 00:27:37.497 Ja, 00:27:37.745 --> 00:27:45.195 that I've had to rescue fr- people from like l- th- those projects where it's like they expected a, a fully engineered product, but they just got the CAD. 00:27:47.034 --> 00:27:50.404 Yeah, that can happen even, even with, um, larger customers. 00:27:50.404 --> 00:28:13.214 We have a, a, certainly won't name any names of course, but, uh, years ago we had a customer who, um, had been around for quite a while and had a, a mature product line and came to us and said, "Hey, we need to develop a, um, a, a new part to this, to this line." And, and so we gave him a quote for it, and it was very clear what the scope of work was, and, and they said, "Yep, great. 00:28:13.214 --> 00:28:13.764 Sounds good. 00:28:13.764 --> 00:28:27.875 Let's do this." And, and we got to, to the end and gave them all the deliverables, and, uh, there were, uh, I think there was a drawing package that, that wasn't in there, and they were like,"Hey, where's the drawing package?" And we're like, "Well, you didn't want the drawing package. 00:28:27.904 --> 00:28:30.544 Like, here's the scope of work that we wrote very clearly. 00:28:30.704 --> 00:28:51.994 You didn't ask, you didn't want the drawing package." So we said, "It's not, that's not, you know, part of the scope." And, and you get to the end, and maybe it's a different person who's managing it at the end than it was at the beginning, and they have different expectations, and communication didn't happen internally, and, and, you know, it, it happens with, with, uh, uh, what's the word I'm looking for? 00:28:52.024 --> 00:28:57.444 Um, individual inventors as well as big established companies that you think would know better. 00:28:57.444 --> 00:29:02.514 But it's a- across the board, communication is always, always, always a challenge. 00:29:03.094 --> 00:29:08.454 What, uh, what's one aspect of the engineering process that you don't like? 00:29:10.767 --> 00:29:13.467 Oh, the engineering, uh, one aspect. 00:29:14.707 --> 00:29:30.548 Um, I know on the, like… It's not the engineering side, it's more like, uh, the, the, the more client relationship is like when you have something and they're unhappy with it, having those meetings are not always fun. 00:29:31.017 --> 00:29:41.557 Um, and I th- I, and I, I would say even in, when you do with engineering, there's just some people management that, that's just hard to, to, to, to navigate, and that's never fun. 00:29:41.817 --> 00:29:59.017 Like, there's sometimes like you, you know, I've had I've worked for, um, that they, they, you know, had a different idea and/or maybe they had a different-- Or they have an expectation that they think I should meet, but maybe isn't realistic for me, and because they're not an engineer, they don't understand that. 00:29:59.327 --> 00:30:01.657 And that's hard to some- to, to navigate. 00:30:02.087 --> 00:30:08.427 Um, and, and just, or even just trying to push back on different

ideas. 00:30:08.427 --> 00:30:20.817 Maybe you're like, I've… Even with other engineers where it's like that idea isn't, you know you've done that before, you know it's the wrong path, and you try to tell somebody else that's the wrong path and try to push back on them. 00:30:21.207 --> 00:30:26.427 Um, and, and then that just, that, that, that conflict, um, with, with other people. 00:30:26.427 --> 00:30:29.357 And I, I understand there's a time and place for it and it's needed. 00:30:29.617 --> 00:30:31.647 That's just a challenge I have with it. 00:30:31.657 --> 00:30:34.677 So maybe not specifically engineering, but more on the people, 00:30:35.122 --> 00:30:35.482 Yeah. 00:30:35.617 --> 00:30:36.217 of things. 00:30:36.842 --> 00:30:41.413 It's almost like what makes it so fun also makes it challenging, right? 00:30:41.452 --> 00:30:46.692 Because the, the fact that it's you're developing something, you're inventing something, that's what's so fun. 00:30:46.702 --> 00:30:49.452 You get to create something that never existed. 00:30:49.692 --> 00:30:56.832 But because it never existed, it's really hard to define, uh, exactly what the expectations are. 00:30:56.832 --> 00:31:02.342 Of course, we do our best job with, uh, uh, user needs and design inputs and, and all these things, right? 00:31:02.342 --> 00:31:14.962 But at the end of the day, uh, even a simple product, when you're developing it, something that has never existed, it's just really, really tough to define everything, and that can lead to some of those unmet expectations. 00:31:14.962 --> 00:31:17.092 And, and sometimes it's maybe a gray area. 00:31:17.122 --> 00:31:24.972 Other times people can just be kind of unreasonable, and, and that's where the documentation really becomes super important. 00:31:25.032 --> 00:31:27.532 And we've had some examples here at Pipeline. 00:31:28.022 --> 00:32:36.562 Thankfully, we've had really good documentation, and, uh, uh, very infrequently, but, but a small handful of times, a customer has come back and said, "I'm not happy because you didn't give me what I paid for." And we can point to our documentation and say, "Yes, definitively, we did give you exactly what you paid for." And, uh, thankfully, you know, knock on wood, we've never had any, any, um, become too big of, uh, a problem. 00:32:36.572 --> 00:32:41.242 But the documentation, like you said, overcommunication, super, super important. 00:32:41.592 --> 00:32:43.482 It's a pain in the butt sometimes, right? 00:32:43.522 --> 00:32:55.172 Like, writing all the things down and cr- keeping this documentation, it's, it's not fun, but it, it… And, and 99% of the time, uh, it's not even needed. 00:32:55.192 --> 00:33:04.612 But it's that 1% of the time when it really is needed, boy, you are, are so happy that, that you did a good job maintaining accurate documentation 00:33:06.017 --> 00:33:06.907 Yeah, absolutely. 00:33:06.907 --> 00:33:14.947 And another thing I've-- that kind of helped me is like almost scaring away some people, like, and just saying,"Hey, this is what you're getting. 00:33:14.947 --> 00:33:30.347 This is how much it costs." And like, you know, since I deal with a lot of early stage people, um, that what they-- it kind of scares some, some people away that would like have like want more for less because they have that maybe they don't understand or, you know, I, I don't know their story. 00:33:30.347 --> 00:33:31.887 I'm not gonna try to pretend like I do. 00:33:31.897 --> 00:33:38.457 But just being really, really well-defined and, and being very, very clear, this is what you're getting 00:33:38.912 --> 00:33:39.262 Yeah 00:33:39.317 --> 00:33:40.987 at the beginning, I think has helped. 00:33:41.027 --> 00:33:47.427 And I've even like tried to sit down and have like a Zoom meeting with them and go through it point by point and make sure they understand. 00:33:48.064 --> 00:33:48.314 Yep. 00:33:48.584 --> 00:33:48.874 Yeah. 00:33:49.584 --> 00:33:53.034 Um, I, I'm curious, what does your, your day look like? 00:33:53.034 --> 00:33:54.604 I mean, you're working a full-time job. 00:33:54.774 --> 00:33:56.274 You, you've got a family. 00:33:56.314 --> 00:34:01.214 You've got your, uh, your, your Think Bed Tech, uh, side hustle going. 00:34:01.724 --> 00:34:06.654 Uh, maybe there are other activities and responsibilities that you have in there as well. 00:34:06.934 --> 00:34:09.574 When are you finding time to sleep with all of this? 00:34:09.574 --> 00:34:11.755 How, how many hours a day are you working on average? 00:34:13.634 --> 00:34:17.183 So, depends on what's going on that day. 00:34:17.233 --> 00:34:21.034 So I probably work on average 60 hours a week, um, 00:34:21.664 --> 00:34:22.144 It's a lot 00:34:22.663 --> 00:34:23.973 yeah, is a decent amount. 00:34:24.023 --> 00:34:27.844 It's, it's manageable, um, but it's, it's a decent amount. 00:34:27.893 --> 00:34:32.403 So I would say one of the big things is, uh, definitely support from my wife. 00:34:32.453 --> 00:34:35.733 Uh, she's been very supportive, so I'm, I'm very happy with that. 00:34:36.153 --> 00:34:39.793 Um, but I'll go back to your original question of what my day looks like. 00:34:40.143 --> 00:34:47.243 Um, so usually I, you know, I get up, I do my morning routine, and then I go to work and do my day job. 00:34:47.243 --> 00:34:50.453 I fit in my, uh, my fitness at my lunchtime. 00:34:50.554 --> 00:34:58.293 Um, and then after that I'll go home after, you know, work ends, and then I'll work on, you know, visit with the, with the family. 00:34:58.293 --> 00:35:05.554 And I have, you know, three little ones, so I help, like, you know, spend some time playing with them, um, or, you know, helping my wife. 00:35:05.554 --> 00:35:09.413 And then I'll go and work, work a couple hours until it's time for bedtime. 00:35:09.413 --> 00:35:16.583 And then when it's time for bedtime, I, you know, help do the r- you know, bedtime routine with the kids and

do, you know, story time and things like that. 00:35:16.583 --> 00:35:25.114 And then if there's a little bit of time left over, um, before we go to bed, I, I try to spend some time with my wife or I may have to catch up on some emails. 00:35:25.143 --> 00:35:26.523 It kinda depends on day to day. 00:35:26.943 --> 00:35:30.723 Um, and then, you know, of course it changes with like kids' activities or 00:35:30.880 --> 00:35:31.320 Yeah. 00:35:31.480 --> 00:35:31.830 Yeah 00:35:31.903 --> 00:35:41.593 where it's like I got-- There's some weeks I have to work 30 hours on my, you know, you know, projects and that's, that's-- and I get very little family time. 00:35:41.593 --> 00:35:45.713 And then there's other weeks I maybe get five hours and there's so much going on with family stuff. 00:35:45.733 --> 00:35:49.283 So it's just staying flexible but also understanding your deadlines. 00:35:50.304 --> 00:35:50.544 Yep. 00:35:50.764 --> 00:35:51.064 Yep. 00:35:51.734 --> 00:35:53.714 All of this sounds very, very familiar. 00:35:53.744 --> 00:35:55.625 I mean, that was my routine back in the day too. 00:35:55.625 --> 00:35:57.844 Although I don't think I had the, the exercise part. 00:35:57.844 --> 00:36:13.284 I… There was a period of time for sure in the beginning of Pipeline where I did not make time for exercise, but it was wake up, work, uh, stop, eat dinner with the family, play with the kids for a bit, and then go back to work and do it all over the next day. 00:36:13.284 --> 00:36:19.644 It w- it, it was a lot, and I'll be honest, I'm, I'm kind of glad that those days are mostly behind me. 00:36:19.644 --> 00:36:26.294 Every now and then, uh, a busy week sn- sneaks up, but, um, I'd say I'm like 45 to 50 hours or so. 00:36:26.364 --> 00:36:32.224 Uh, probably closer to 45 hours right now, and, and that's, it's kinda nice to have a little bit more free time. 00:36:32.375 --> 00:36:36.254 Which leads me to, uh, something else I, I was curious to ask you about. 00:36:36.254 --> 00:36:38.794 What does your ideal situation look like? 00:36:38.804 --> 00:36:48.214 Of course, th- these things are always changing, but, uh, what do you think you would like the future to look like, you know, three, four, five years from now? 00:36:48.214 --> 00:36:51.694 What w- what is it that you're working towards, if you have your way? 00:36:53.065 --> 00:37:03.895 Um, it's probably-- I mean, I really enjoy the place I'm working at now, so I'm not looking to make a, a change to that anytime soon, and I don't feel like my business is where I would want it to be. 00:37:03.925 --> 00:37:10.535 But I'm thinking if I'm gonna move from the place I'm currently at, it's probably into building, into that business full-time. 00:37:10.995 --> 00:37:18.435 Um, and, and then probably doing that full-time for a while and then, know, probably until the end of my career. 00:37:18.505 --> 00:37:19.695 So that's kind of how I envision. 00:37:19.695 --> 00:37:20.835 Of course, things could change. 00:37:20.835 --> 00:37:25.745 I'm open to different opportunities and, you know, life, you gotta just have to pivot according to life. 00:37:26.144 --> 00:37:26.494 Yeah 00:37:26.596 --> 00:37:28.585 but right now I'm okay with where I'm at. 00:37:28.585 --> 00:37:33.105 I, I really, I, I, I just started the place I'm at actually back in February, bounced 00:37:33.214 --> 00:37:33.764 Nice 00:37:34.846 --> 00:37:42.155 um, and really enjoyed it and, um, enjoyed the, the atmosphere and being able to, uh, to develop the products I do. 00:37:42.535 --> 00:37:49.425 Um, but yeah, I think the next move, if I was gonna move out of that place, would be into, uh, my own business. 00:37:49.785 --> 00:37:52.945 Um, and hopefully having more time eventually for the kids. 00:37:52.945 --> 00:37:55.705 They're little, so I don't wanna miss their whole childhood. 00:37:56.275 --> 00:38:05.355 Um, and I, I enjoy spending time with my family, so I try to make that, try to squeeze that in as much as possible while still doing everything that I'm doing. 00:38:06.304 --> 00:38:06.784 For sure. 00:38:06.834 --> 00:38:07.134 Yeah. 00:38:07.564 --> 00:38:07.894 All right. 00:38:07.894 --> 00:38:09.764 Well, well let's wrap things up here. 00:38:09.855 --> 00:38:19.674 Um, I've been enjoying asking all of the guests recently what they're working on that they think someone in the audience might be able to help them with. 00:38:19.684 --> 00:38:28.574 Of course, you've been very generous and shared a lot of great information, and hopefully the audience members will be able to take some of that and use it, apply it to their own work. 00:38:28.964 --> 00:38:40.704 What's something that you're working on, whether it's a, a new technology you're trying to learn about, or a subject matter ex- expert, or a, a vendor you're trying to meet that perhaps someone in the audience listening right now could help you with? 00:38:42.009 --> 00:38:47.519 Yeah, so I got something I'm trying to learn and then I, uh, one of the things I'm working on is networking. 00:38:47.519 --> 00:38:51.969 So, so far as learning, I'm trying to find, uh, something I specialize a little bit more in. 00:38:51.969 --> 00:39:00.529 So I'm learning, uh, C… I, I have a lot of pneumatics and fluids experience, uh, and trying to app- put that application into medical device a little bit deeper. 00:39:00.750 --> 00:39:04.799 So I'm trying to learn CFD, so I'm going through like Simscale type things. 00:39:05.179 --> 00:39:14.569 Uh, so that would be something if, you know, somebody's got some good tips on that and how to d- dive into that, uh, DIY style, um, I definitely would be open to that. 00:39:14.569 --> 00:39:22.429 And then, uh, I've also been working on networking and building relationships, especially within the medical device space within Indianapolis. 00:39:22.759 --> 00:39:27.230 Um, been able to help an incubator and give my time there and build some relationships. 00:39:27.230 -->

00:39:32.789 And I have one that's not medical device, that's more just inventors and hard tech that's another incubator. 00:39:32.799 --> 00:39:40.509 So it doesn't necessarily have to be med- medical device, but that's-- If I had to narrow it down, medical device would be an Indianapolis area. 00:39:40.509 --> 00:39:49.309 That would be, know, if you know somebody that I could connect with that would be a good fit to talk to or I can give s- you know, some help with, I, I would definitely be open to that. 00:39:50.464 --> 00:40:05.654 The, the CFD that you mentioned, it's been a while since I even looked at CFD, but I remember, uh, 10, 15 years ago anyway, it was kind of inaccessible just from a cost standpoint to individuals. 00:40:05.954 --> 00:40:11.804 Um, of course, you've got some revenue coming in from your, your business, so maybe you're, you're not exactly in that position. 00:40:11.804 --> 00:40:22.024 But, uh, are, are there, are there CFD tools nowadays that you can start learning f- uh, whether it's like a, I don't know, a student version? 00:40:22.034 --> 00:40:28.734 Or how do, how do you get your feet wet with something like that without spending an arm and a leg just to start learning it? 00:40:29.847 --> 00:40:35.697 Yeah, so SimScale, and I think Ansys does too, uh, offers some free tools to learn it. 00:40:35.947 --> 00:40:42.817 Now it gets pretty expensive once you get into it and you actually wanna do it for client work, so I haven't figured out how to navigate that yet. 00:40:43.237 --> 00:40:47.697 But, um, far as learning, uh, they have a certain amount of hours, uh, simulation hours you can use 00:40:49.608 --> 00:40:50.259 Okay. 00:40:50.828 --> 00:40:51.398 That's cool. 00:40:51.408 --> 00:40:52.588 That's a great idea for them. 00:40:52.698 --> 00:40:53.168 All right. 00:40:53.918 --> 00:40:54.368 Well, great. 00:40:54.378 --> 00:40:56.958 Dakota, uh, super fun talking with you. 00:40:57.288 --> 00:41:00.348 Anything else that we haven't hit on that you wanna cover before we end? 00:41:02.637 --> 00:41:13.077 Um, I would just say, you know, if you're an, a newer engineer or just somebody who's learning, just like experiment, try different things, do your own projects, do projects for other people. 00:41:13.117 --> 00:41:14.747 It, it'll help you learn so much. 00:41:14.767 --> 00:41:22.687 Like I-- the fact that I'm able to do my full-time job and do some, some work building my own business has really leaped my skills as an engineer. 00:41:23.057 --> 00:41:24.467 Um, so I would encourage that. 00:41:25.536 --> 00:41:38.817 Yeah, even if you continue working for, you know, someone else, the current company or, or whoever, the skills that you've learned doing your own thing are just gonna make you that much more valuable to your, your current and future employers, right? 00:41:39.581 --> 00:41:40.301 Absolutely. 00:41:40.371 --> 00:41:40.771 Yeah 00:41:41.248 --> 00:41:41.538 Yeah. 00:41:41.798 --> 00:41:42.148 Great. 00:41:42.428 --> 00:41:43.058 All right, Dakota. 00:41:43.058 --> 00:41:49.118 Well, thanks again for spending some of your time with us today and, and sharing some of your experience and insight. 00:41:49.408 --> 00:41:57.458 Um, uh, appreciate it very much and, and, uh, we'll, we'll… looking forward to getting this out there so everyone else can hear it. 00:41:58.009 --> 00:42:00.288 Uh, where can, where can people find you? 00:42:00.308 --> 00:42:01.538 How do people get in touch with you? 00:42:02.849 --> 00:42:05.219 Yeah, so you can find me on LinkedIn, of course. 00:42:05.259 --> 00:42:08.269 Um, but my website's thinkmedtech.com. 00:42:08.819 --> 00:42:16.379 Um, just very basic website, but, uh, that you can fi- do contact me through there, but LinkedIn would probably be best. 00:42:16.379 --> 00:42:18.189 I check my LinkedIn a lot more regularly. 00:42:19.250 --> 00:42:19.701 Awesome. 00:42:19.760 --> 00:42:20.310 Terrific. 00:42:20.760 --> 00:42:21.721 All right, Dakota, thanks again 00:42:22.957 --> 00:42:23.547 Yeah, thank you