The Leading Difference
Staci Miller | Founder, Gen UX Consulting | The Intersection of Human Factors, MedTech Innovation, & Building a Resilient Career
Beschreibung
Staci Miller, founder of Gen UX Consulting, shares her winding path from fashion design and psychology to human factors engineering in MedTech. Staci explains what human factors is—through stories from World War II aviation and modern healthcare—and why the FDA now mandates usability work to reduce catastrophic use errors. She breaks down formative versus summative/validation studies, the role of risk documentation (URRA/UFMEA), and why founders should think about usability as early as they think about risk. Staci also opens up about the challenge of starting a second business after losing her first in 2008, how she built Gen UX from $0, and the leadership lessons behind year-over-year growth. Guest links: https://www.genuxconsulting.com/ [https://www.genuxconsulting.com/] | https://www.linkedin.com/company/gen-ux-consulting/ [https://www.linkedin.com/company/gen-ux-consulting/] Charity supported: Feeding America [https://www.feedingamerica.org/] Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com [theleadingdifference@velentium.com]. PRODUCTION CREDITS Host & Editor: Lindsey Dinneen [https://www.linkedin.com/in/lindseydinneen] Producer: Velentium Medical [https://www.velentiummedical.com] EPISODE TRANSCRIPT Episode 081 - Staci Miller [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Staci Miller. Staci is the founder at Gen UX Consulting. Her expertise is in applying user-focused research to develop innovative solutions, and it's essential to the growth of any technology organization. As a detail-oriented and tenacious executive in human factors engineering and UX design, she has a proven record of elevating the end user experience and achieving targeted client outcomes. She has created innovative medtech and big tech solutions through a comprehensive user-centered development process, leveraging artificial intelligence and industry agnostic design tools to optimize products and services. In her current role with Gen UX, she's a key leader facilitating strategic company growth plans and service offerings while managing the capacity and workflow of the UX HF design team. Well, Staci, welcome to the show. I'm so excited to talk with you today. [00:01:49] Staci Miller: Me too. I've been looking forward to it all week, so I'm very excited to be here. And I don't know what the day has in store. I, I know that there was like a, a, a kit that you sent out and I didn't read it on purpose, so everything's gonna be organic. [00:02:03] Lindsey Dinneen: Perfect. Those are my favorite conversations anyway, so I'll take it and run. Some people I know really love to have the questions ahead of time, and others are just like, "Yeah, I don't want to know. I'm just gonna go off the cuff. Here we go." So, brilliant. All right, well, let's start, if you don't mind, by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:24] Staci Miller: That is, those are my favorite questions. So, I have a background in fashion design, psychology. I spent most of my classes in cognitive psych, but it wasn't like a difference of degree, it was just psychology. And then I have a master's degree in human factors and ergonomics. So I went the psychology route and the design route. That's kind of my background. So when I graduated my master's degree, through my master's program, I was able to intern for both years and one was in tech, big tech. I interviewed and landed a, great one year long internship at Samsung, which was actually supposed to be just three months, and I stayed there for a full year. So they kept me through my whole, my whole semester, which is something they don't normally do, which was really fun. I mostly just said, "Hey, can I stay here for the year?" And they're like, "Great, no problem. Sure. We'll figure it out like that seems like a good option. We like you, you like us. Cool. We'll do that." And my second internship was in medical device at a company called Interface and Analysis. My, that was actually my internship. My second one was at Samsung, so I got to really look in like I, I guess you got the curtain. If you think about Wonderland and Oz and the curtain and being able to pull back the curtain between both industries, what did I like better? I ended up liking medical better, mostly because the research was more structured and not necessarily conversations about, "Yeah, so how do you feel about that? Did you like it?" Like to me, that's not really. What I would consider the best opportunity to gain data. Data to me, like there has to be like a clear objective as to what you're doing, the whys behind it, and what do you wanna learn. And I found that in, when I worked with engineers in medtech, they definitely had things that they wanted to learn, whereas in tech, they just had so much money. They were like, "Yeah, let's just see what people think about this." And I'm. Okay. And then when I would be really structured and I was working with people who didn't have backgrounds in research, had very strong, very good backgrounds in design, like legitimately awesome, they were leading the research and they were missing the boat. So the narratives started to be focused on the N of one. This one person said this really interesting thing, so let's base our whole design off of what they said. And I'm like, "Dude, wait a second. Wait a second. All of them said this thing about the design though, and like we have four or five data points about when you ask this question." They're like, "Yeah, but that's not interesting." And I was like, "Okay, keep my mouth shut. I got it. Move on." Like from that moment forward, I, it wasn't like "Staci, don't talk, it was more like this is how we design based on the narratives that we've learned how to, how to research on." And so it wasn't as I would say-- it wasn't considering the actual 360 view of the user. It was considering the really cool thing that happened this one time that was like totally an outlier. And it happened consistently when I was working in big tech. So I was like, uh, medtech, probably more my speed. And then my first job was at Abbott. [00:05:39] Lindsey Dinneen: Nice. [00:05:40] Staci Miller: And I ended up there. Yeah, [00:05:41] Lindsey Dinneen: Okay, great. Well. [00:05:42] Staci Miller: Cool. [00:05:43] Lindsey Dinneen: Lots of questions based on this incredible background. I want to go back a little bit. So fashion design, was this something that you grew up thinking, "Oh, this is what I wanna do and be okay?" Right. All right, so... [00:05:57] Staci Miller: it's all I ever wanted and I did that. So... [00:06:00] Lindsey Dinneen: Yeah. [00:06:02] Staci Miller: That's a, that's a great question. I think that my interest in fashion peaked around when I was 12 years old and during the time, Cindy Crawford and Naomi Campbell, and I was so fascinated by how beautiful these women were. And, and fashion was a thing in the nineties. There was like a lot of Dolce and Gabana around, and I loved it. And I couldn't wait to get my new print of Vogue every, every season. I loved Harper's Bizarre, and I would just pull pictures out of these models and what they were wearing. And then I would start you know, freehanding stuff and things like that. And I think a lot of people do that when they're really interested in clothing and things like that. And if you really think about it, fashion is art that people wear. So I was very attracted to that part of it. And it's all I wanted to do. So after high school, I went to FIDM and studied fashion design. And right outta FIDM, I started my first company in fashion design, and I was a clothing manufacturer, and we had 500 open doors in the United States and in Canada, and I was hoping to expand, but unfortunately 2008 hit and they hit it hard and fast and I lost most of my managing capital in the year that I think was my tipping point. So it was the, the year that I finally got a lot of traction and had a lot of repeat business and a lot of new business as well. And a lot of those new businesses just refused orders. Just from the east coast to the west, and it was just tons of money out that wasn't gonna come in. So there was really no way to, make that work after that, like I lost literally all the money I had in my business in like the span of, I would say three, four weeks. It was just mortifyingly scary. But I was young and people who are young are resilient and they move on and they find a new dream. And it took me a minute, like I didn't really know what the french toast I was gonna do. And I was like, well, I was still planning on staying in fashion and long, short, I was offered a job to do and run production for a one, a different company. So make sure that their goods were produced on time. Deal with the, the timing of all the orders, making sure the product line. So it was basically operations for manufacturing. And I was super excited about the job and I moved back to my parents' house at the time because things were just that tight financially for me. My parents were like, "Yeah, just, you know, come back, we'll figure it out." And I remember saying to my mom and dad, I'm like, "If this job falls through, do you mind if I just go back to school and stay here?" And they both started to laugh at me like, "Your job is fine, but if the sure why, why not?" And they, they thought it was crazy. And then I ended up back in school. So, they were like, "Whoa, that was really insane," 'cause that was in the end of 2008, starting 2009. And so the company rescinded their offer and they were really like, so sad about it, but they went to a market to sell their clothes and they got zero orders that year or something like close to that. So it was just, it was just a really intense time in the fashion industry and I was looking for jobs and I wasn't getting anywhere. So I only had an AA, and at the time that really didn't matter, but I went back to school and I'm like, "If I'm going back to school this late in age, I'm getting a master's degree." I had no idea what I was gonna get a master's degree in. I was like. I like clothes and design. We'll figure it out from there like that. And I was like, "Well, maybe I'll be..." this is crazy. But I was thinking about being a lawyer, like a property law lawyer. So, because when you are a designer in clothing, people can just knock you off. And you've seen that happen like pretty much everywhere. And people can just take advantage of your intellectual property and never pay you for it if they change enough of it. And so I was like, "You know, this would be something I'd probably be good at." So I went back to school thinking I was gonna go into that type of law. I took psychology courses and I took philosophy courses. And philosophy courses really do lean you, get you thinking very specifically about law. That's what philosophy was basically geared towards anyways. And you take these psychology courses and they're about people and how people process information, how people behave based on their behavior and things like that. So I thought the combination would be really good. Well, I ended up not liking, I did like philosophy, but philosophy's "let's think about thinking about it." And psychology is-- which is great. It's great, but psychology is like more applicable when you're interacting with others. And I found it super fascinating. And then I got really into like cognitive psychology and I'm like, "What the french toast am I gonna do with this? I can't do anything with cognitive psychology. Like I need to make money. I'm a grownup. This isn't ah, I'm gonna study underwater basket weaving and come out and go work in communications at Fox." Like I had to have an actual plan. So in my college at the time, there were these classes and they were like introductory to what you can do with your degrees. And that's literally where I found human factors. And there weren't very many schools that did it, but I was taking most of my classes at that point in cognitive psychology, which is how people process information, not their feeling based stuff. Like I didn't wanna have conversations with people about their feelings. Get that off of me. Like that's not, that's not my jam. I'm like, "Sorry, you're sad, but I'm not sad and I don't wanna be sad, so I'm gonna keep, keep going." And I'm like, "How am I gonna work this into my, you know, I love design, I wanna keep that in my background, and how am I gonna, what am I gonna do?" And so the study of human factors really is the intersection of design and research, and how people interact with said products based on the design. And you get to research that. And I'm like, "Sold. Good. I'm, I can do this. This is like this, I didn't even know this thing existed." This is crazy good. And I never looked back. [00:11:49] Lindsey Dinneen: Yeah. [00:11:50] Staci Miller: I got into a master's program the next year. I, and because I was in that specific program in San Jose State, that's why it was so easy for me to work for Samsung because it was in my backyard. And that's why it was easy for me to work for Interface Analysis because Tony was the owner of that company. Tony, he was my professor. So he just was like hiring people and I, I answered his response and I was like, "Hey, I, I'm looking for something." Do you like, he didn't say it was his company. He said, "I have a friend looking" and I'm, you know, like when I know I need to make some money, I'm gonna try to hustle up and make some money. So I'm like, "Hey, I'm open to that." He's like, "Why don't you come by my office and we'll talk?" And I was like, "That's weird." He said It was for some other, I'm like, "Sure, no problem." So I go to his office and he offered me an internship right then and there 'cause it was for me. "I just wanted to see who would respond," 'cause you are the only person that responded. I'm like, "Guess you're gonna hire me then." [00:12:37] Lindsey Dinneen: Amazing. All right. That's great. Thank you so much for that background. And it is so interesting how sometimes our paths are very, very windy to get to where we end up being and we Yeah, exactly. What, what ends up being a really good fit. But, so can you explain a little bit more about human factors, especially, maybe to help folks who have maybe some misconceptions or don't fully understand what it is just in general, but then also relate it specifically to medtech and why it's so important within the medtech industry? [00:13:11] Staci Miller: I can give you a story that probably would do both. So human factors was, was actually founded pretty recently in our timeline of psychology and understanding people. In World War II, there were a whole bunch of fighter pilots ejecting themselves from planes that caused, even in World War II, millions of dollars to produce and nobody could figure out what the problem was. They checked the planes. The planes were operating correctly. They did psychology, like psychological backgrounds on the people who are fighter pilots. I mean, they have to, to get into the military and to fly those planes, you have to be pretty good under pressure. They interviewed them, they were fine. They didn't have any breakdown of stress, and it wasn't happening on a small scale. This was happening on quite a large scale. So they, again, they went, they're like, "Okay, okay." Well, the military went back and " Well, it has to be the plane." So they looked through the plane, wasn't the plane, talk to the people, wasn't the people. So then the psychologist started to ask questions. They're like, "Well, if you're saying that it's not the person's emotional state and you're saying it's not the plane, well then what happened? Something had to happen. Something changed. What changed?" It turned out that the engineers had moved the throttle button with the ejection button in the planes. [00:14:31] Lindsey Dinneen: Oh. [00:14:31] Staci Miller: So the pilots were originally trained to hit the throttle button on the certain side that the throttle button was in the cockpit. So instead of hitting the throttle, because that was their original training, they hit the ejection button. So they ejected themselves out of the planes, which is why human factors was born. Those little changes that people don't understand about human beings. So when we learn something for the first time, because like even if you think about being a kid or being a baby, or learning a really tough lesson, right? You remember that lesson. And so what happens is that's your default setting. "This is the lesson I've learned. This is how I react." Now for that lesson, it doesn't matter if it's like an emotional exchange or if it's a physical one. So because they were taught where the, the pilots were taught specifically where the throttle was in the first place when they were under attack and they were in a high cognitive loaded space, they went back to their original training. [00:15:30] Lindsey Dinneen: Mm-hmm. [00:15:32] Staci Miller: And then the engineers were like, "Well, we told them. We told them." So, so, because they didn't wanna take the blame, right? Nobody wanted to take the blame ruining millions of dollars of planes. So this same type of thing happens in the medical industry. I mean, you can see it pretty easily, right? So you're trained on System X. There's an update, a 510K release to it. The system works differently. Errors are made, people are hurt. [00:15:57] Lindsey Dinneen: Mm-hmm. [00:15:58] Staci Miller: That's how it translates to medical. So aviation was a really big part of human factors and it still is to this day. Like NASA used to hire quite a few of my classmates. And I know that Boeing and a lot of those other, even BMW hire people that do what I do for a living and test the responses during drive time. And if you think about it, if you look at a Tesla versus a BMW, those are very different driving experiences. Like I had to relearn how to drive a Tesla, right? And like it has a one pedal situation. So now when I get into regular cars, I'm like, "Wait, what? What am I doing? What? What kind of car is this? Like how do I drive this thing again?" I know that sounds silly, but it, it's true 'cause you kind of just get used to the thing that you have. And that's exactly why human factors is prevalent in medical device or in aviation or in, you know, like any kind of like navigation systems. The reason the FDA mandated it is because a lot of products were coming to market and there was a very large influx of critical catastrophic errors in hospitals. People were suffering consequences of bad interfaces or lack of instructions on products. I know that there were a lot of intravenous medications given that weren't supposed to be IV medications in like in certain-- yes, you're supposed to inject it, but not. Intravenously and those charged caused people to perish. So that's when the FDA stepped in and said, "Okay, we were asking you as a favor to do these usability studies, but now officially they're part of your risk requirements and they're part of your requirements to get to market." And I think that happened about the time I graduated grad school, around that time. So about 15, 16 years ago. [00:17:50] Lindsey Dinneen: Okay. Yeah. Well that's a fascinating story, and I'm sorry that that is the impetus for the results that we have today, but also how incredible that that is something that's being prioritized and mandated now. And I'm wondering too, when a startup company is developing their technology, how soon should they be thinking about human factors, usability, UX/UI. [00:18:17] Staci Miller: As fast as they're thinking about risk. if you're already thinking about risk at phase zero, that's when you should be thinking about usability and UI and interactions based on user processes, because that's when this kind of conversation really needs to start with regulatory, with your team, with the engineers. So even if you don't have a human factors engineer on staff, like you can find a company that can give you like some fractional support, just, you know, to talk to and to understand what their, what, what their responsibilities are, and what their requirements are to get to market. I have found that a lot of founders don't think that it's a requirement. And I, and I'm really not sure why, but that's been happening a lot lately. [00:18:59] Lindsey Dinneen: Yeah. So because it's a requirement, because you should be thinking about it from the get go, what are some things that you've seen work really well in terms of, putting together this kind of this testing and whatnot versus things that might seem like they could work. Like perhaps somebody feels that they could maybe do some of this testing themselves. You know, just, just things that maybe people who aren't really familiar with all the regulations would perhaps do, and that could cause problems down the road. [00:19:32] Staci Miller: So there's a, these are all really great questions and let's, let's unpack the idea of research, right? So some people think that research is finding out if somebody is happy about a product and would use it, like product market fit, right? Some people do marketing for that, and I can, that's the type of research that is not technically human factors, but it is something that Gen UX can do, right? So it's just research. I, I call it like insert white meat or insert protein. We can do the research, right? So when it comes down to it, there's, I would say that research is split into two buckets, which is UX/UI, which is very popular and people understand that, which is a formative in the FDA guidance and then validation slash summative. So the validation studies are very clean cut. So I'll explain those first. And they are to validate that the user can use the system in its environments safely. So the alpha for that is the user is successful at using this product and the uses, uses and use environments correctly and safely. And this is all based on your risk documentation from your URRA or your UFMEA. Some people use ADFMEA, which is based on design, and I suggest that they don't use that because that focuses more on the system than it does on the user. And the FDA has really cracked down on that. So if you are a founder and you think you can get just one system, ADFMEA, you are probably already starting off on the wrong foot. Make sure you have your own usability. Because human factors work really focuses on two things in the medical industry. One, it focuses on helping develop the device while breaking down risks. So if you have mitigations and your system's designed a certain way to avoid a risk, that's very important, and that's really also usability testing. And I can explain this in two ways. I've worked at Meta, I've worked at Samsung, I've worked at a lot of different big tech companies, and I've worked at a lot of medtech companies. So I think that people think that human factors is different than user research, and they're right. Human factors is much harder than user research. And you really actually need a background in research methods and an understanding of how the application of research works. Formatives can be used for two reasons. One, to support the need of the product in use and to check how people are actually using the system in real life. So sometimes people are really good at thinking-- so engineers are amazing at building systems, right? I can't do what they can do. I'm not gonna pretend like I can. What I can do is help them build it for their end user, because a lot of the times engineers think very differently than the average human being. They're much more educated. Schooling for engineering is extremely difficult. A lot of it's mathematical computations, understanding actual physical properties of things in their environments and how that they work, right? So those are the things that engineers think about all day long. That's fine. I think about the user all day long. So you can create a system that an engineer thinks that is fine, but then the user is " I don't really know how to use this. What are you talking about?" Right? And so that's what user research informatives avoid. They avoid, they break down risk and they are able to help form the product. So those, those user research studies, like before, let's say phase zero to phase four in a market cycle, if phase five is market release, are for those things. And then as you get later in the cycle, you wanna do more rigid research, that's really breaking down the risk and really focusing on the user interactions within the system and med device. And making sure that they're assessing the risk based on your user, but they're very specific to the user interactions that are critical tasks and higher. Or things that lead up to the critical test and come away. So like you have to be able to do the steps before, do the thing that's really hard to do, that could hurt somebody and then make sure coming away from them you don't cause any harm either. That's the best way to look at these types of tests. And we do the exact same thing in validation for systems. So, in software you test to see if the software can do the thing that it's supposed to do. When you check that box, the software does the thing and it did it, and we're good to go. You do the same thing with mechanical engineering. The system has this, this range of motion here and this range of motion here, and it doesn't deviate from plus X to plus Y and therefore the system does what it's supposed to say. So you're verifying and validating that the system does what the system is planned to do. It's really no different in users, it's just that you're dealing with human beings and it's not, it doesn't work the same way, right? Because like people are variables no matter what. And that was really long worded. So there's like tons of different research to do, but if you don't do your summative and you don't do your risk documentation, you're not getting to, you're not gonna get to market approval. Just, there's no way. [00:24:34] Lindsey Dinneen: Yeah. Thank you. Yeah, that is incredibly helpful insight. And you know, so I wanna go back to, you had this company before, right? So you had already built a business and it was thriving, and then unfortunately life intervened a little bit. When you went to start Gen UX, did you have moments... [00:24:57] Staci Miller: Of PTSD? [00:24:58] Lindsey Dinneen: Of, yeah. [00:25:01] Staci Miller: Yes. [00:25:01] Lindsey Dinneen: Yeah. [00:25:02] Staci Miller: Yeah. I had major PTSD. Like I, so the concept of Gen UX was a play on words like, so I'm a Gen Xer, no biggie, but like I think that every Gen Xers, millennials, I feel like both of our generations very much identify with our generation. And I thought it would be kind of a fun play on words to identify to people that are also Gen Xers that, yeah, we do UX work and we're Gen UX, as a Generation X, like it was very important, right? So I kind of came up with that idea, thought it was cute. But at the time I was working for Meta, and Meta had been doing quite a bit of layoffs at the time. Nothing wrong with that, that happens with every company. But I have survived in Medtronic and Abbott and all these other companies. I had survived so many rounds of layoffs. I'm like, "One day my number is gonna be, it's just, it's just gonna happen." So, we started at Meta internally, really like they, they were very open and honest with people. They're like, "This is when this is gonna happen. We are gonna lay off more people. This is when this round is gonna happen. We're gonna lay off more people, and then this is the final round and this is when we're gonna lay off these people." So each of our groups of things like, so it was like engineers, lawyers, researchers. Like we, we had timelines that we knew if, if it was gonna happen, this is when it was gonna happen, this would be the day. [00:26:17] Lindsey Dinneen: Yeah. [00:26:17] Staci Miller: So I started to really think about what that meant, and I'm like, "Okay, well I'm not gonna start looking for jobs right away because I want my severance package." I definitely wanted that 'cause I, and then I wanted a break if I could have it. So I was like, okay. I, in between working at I was working at EDA as a contractor and that was super fun. Like I had my own time kind of, and I enjoyed the work and I got put on other projects whenever they needed me. And it was like, but I was constantly on a project, so I'm like, "I, maybe I'll go into doing IC work by myself" and I'm like, "No, I can't make enough. If I'm gonna do this, I'm gonna build something." And then I'm like, well, I started to talk to my friends every single one of my friends, including Interface Analysis' owner, Tony Andre was like, "Start your own business, Staci. Start your own consulting firm, just do it. Don't even look back. Just do it. People will end up coming to you because you know how to do this." He's like, he's it's, "You know, the first years they are what they are and everybody knows what that looks like. It's, it's rough. You have, it's like a mental game. You're like, I am gonna do this. And you just have to be consistent and can continue down your path. And more and more people will show up." And that's been true every year. But that's how GenX was started. And yes, there was this whole trepidation about, "Am I gonna make it? Am I gonna make it through this?" And I was like, "You know what, Stac, you're starting in a recession in your, in your industry. If you can get it done, if you can get two years in and be successful, you're fine." I'm in year three. [00:27:50] Lindsey Dinneen: Yeah! [00:27:51] Staci Miller: Yeah, I mean, year three, woohoo. And we're increasing 50% year over year in year three, and I started it with $0. So, and I'm not, I'm not saying like a hundred to 50, like $50 to a hundred, we're, we're talking a couple hundred thousand dollars here, a couple hundred thousand there. But it's modest and I do expect that growth, and I do expect that to continue. And the other thing I think about is becoming very malleable in, in your spaces, like what's working for you and what doesn't work for you. But I feel like that's kind of off topic from what you asked. But yeah, I had PTSD gave myself at least two years and I'm like, "I can do anything for two years. If it doesn't work out, you know, like I have everything that I have and I can go back into corporate if I need to." And I really, I really was tripping, like just to be nineties about it, I was tripping. Like I was really like, "You know, I don't know." And my husband was like. He was my biggest cheerleader. He was like, "You've gotta do this. He's you're gonna, you're gonna be able to do this. You have something that I don't have. You're really great at networking people like you." I'm like, "Do they really like what?" And he's, " No, people like being around you. You make friends easy and people really do enjoy being around you and they like know that you're smart and you're gonna be able to do this." So, that's how this all started. And yes, I was really freaked out when I first started, but every day when I had bad days, I'm like, "Everything always works itself out." [00:29:14] Lindsey Dinneen: Yeah. [00:29:14] Staci Miller: "Have you ever not been in a situation where everything works itself out?" "No. No." So I'm like, "Well, if I, if it doesn't, I'll get a new dream, but I don't-- once you hit this, this year, like year three and you know you're still growing, you don't have to get a new dream, you just keep going and you're like, this dream is happening. I'm gonna keep it going." [00:29:34] Lindsey Dinneen: Yeah. What was it like building a team? Did you start off as a one-woman show, or did you have support at the beginning? How did that work? [00:29:43] Staci Miller: So at first, actually my designer's father was working with me and he called me out of the blue and he's " Hey. I have this client, she doesn't have any human factors person working with her, but I know that she needs it and do you wanna talk to her? I know you're not working at Meta," because I put on my, oh. LinkedIn profile Open to Work. So he called me like within two days, like seriously, like people started to call me and that was when I was already like, "I'm gonna do my own thing. I'm just gonna do my own thing." So the universe just brought me a gift, right? And I met this first client and I started to work with her, and at first everything was super cool. The first year it was great, and I really liked working with her, but she also needed a couple of other things. She needed an IFU and she needed design quality assurance. I'm like, "Check, check. I can get both those things done." So I called my friend Maria, "Hey, do you wanna work with me? She's " Hey. Yeah, totally." Because we had already worked together and we knew each other pretty well. So it wasn't like it was difficult to make that connection. And, and she knows my personality. I know her personality, and I know we both work extremely hard and we have that in common. So I wasn't, never, would I be worried about Maria. And then I found I wasn't, I didn't even have a designer yet on staff. And I found someone who used to do instructions for use for a different company I worked for. I called him like, "Hey, can you do this?" He's " Yeah, yeah." So I got all that done for this other client. I'm like, "I can do this. I can do this. I can, I can find people." I know so many intelligent people who love what they do and have a fire for it every day. And then the evolution started to happen. And then I asked someone to work with me to do sales, and then they said, "Yes." And then we started to pitch people that I was friends with and knew, and sometimes they said yes, and sometimes they said no. I think the first year, I think I pitched over like $4 million in business and I got 20,000. No, I got, I got 80,000, something like that. Something, something small and I'm like, "Why am I pitching so much? This is like taking so much time outta my day," that I found someone to work with me. His name was Adam and I still actually work with Adam and he, but he's a big picture guy and he started to work with me a little bit and help me like navigate through some things. Even to this day, we talk and he's not fully, fully, fully on onboarded, but if, if some. Of the clients that he lands do come on board, he will be back on board and he will be working with me again. And then I had a salesperson this last year and I realized just I needed more of a hunter-gatherer. So like we're just going in a different direction, right? So I had that, and then last year my goal was to bring my designer Maddie on full-time. And I was able to do that too. So everything that I've kind of just said, "I'm gonna do this this year, I've been able to do this year." And I'm not taking this lightly. Like I have a board of directors, which are people who are, have different perspectives on finance because that's my weakest link, I would say. A professor at UCLA, his name's Sean Pat, also a good friend of mine. He's on my board. And my brother-in-law and my nephew, who is new in his life and on his journey, is on my board as well, and I kind of wanted him on my board so he can see what it looks like to be an entrepreneur and see what growth looks like year over year because he is already working for companies. He's, he's like 25, I think, and he's already being groomed to be in upper management. He's got upper management written all over him as like the, as like people would say in like cute little circles. And then my my brother-in-law, he is one of the CFOs at Mayo Clinic, so these are people who have some in medical, some in finance, some in finance, in medical, just helping me like grow. I throw things past them and they help, you know, make decisions for the year. And they tell me like, they give me feedback and, and work through things that I'm doing and what they think is right, what they don't think is right. And sometimes I listen, sometimes I don't. You know, like... [00:33:28] Lindsey Dinneen: Well, yeah. [00:33:29] Staci Miller: Just really depends like where I'm at and what I wanna do and where we wanna grow. [00:33:34] Lindsey Dinneen: Yeah. Excellent. Okay. So I'm curious, especially within medtech specifically, are there moments that really stand out to you as just affirming, "Oh my goodness, I am in the right place at the right time." [00:33:49] Staci Miller: Things keep happening, so, every time I speak, like I, I spoke at Project Medtech, people bombarded me. They're like, "We wanna work with you. We wanna work with you. We should talk, we should talk." Anytime I go to a symposium I walk away with two or three leads. People coming up to me, "Oh, do you do this thing? We should really talk. We should really talk." So, just being in the situation like that kind of tells me that I'm in the right direction. And the other thing is we're growing year over year. If you take a 10,000 foot view of where I was year one versus year three now, very, very different. Extremely different. And like I said, I do have, I do have other consultants that work with me. I don't want you to think it's just like a two person shop. It's not, there's other consultants that work with me but they're as needed. They're not full employees, which I think is really helpful in a situation like this. If you're a founder starting up from scratch and you're not, you don't have, I'm not trying to get angel investors. I'm not trying to get people to push money into my company. I am building it literally from zero to whatever it is that I make. And so that, that's a, what I would call like a slow burn of, you have to build your foundation, you have to manage to the capital that you do have, and then you, then you go to the next level and you do the same thing and then you do the same thing. And there's a lot of consistency with the business now, and I see a lot of people targeting me for that consistency. And as, as we are growing, like people are engaging with us on a different level, which is exciting to see. That's always exciting. [00:35:20] Lindsey Dinneen: Yes. [00:35:20] Staci Miller: That's kind of how I know. Yeah. [00:35:23] Lindsey Dinneen: I love that. Awesome. Okay, so pivoting the conversation a little bit just for fun. [00:35:28] Staci Miller: Cool. [00:35:30] Lindsey Dinneen: Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. Could be within your industry, but it doesn't have to be. What would you choose to teach? [00:35:40] Staci Miller: That's a great question. I love, I think it's very important when you do what you do for a living to have something that isn't that for yourself. So I, there's very specific ways as to how I unwind at the end of the day. One of those things is cooking. I would totally do a masterclass in being a home chef. Like I'm, I'm not even a chef like that. I've never gone to culinary school, but I absolutely, I make my own breads. I make chutney sometimes when, when I want some. I would do a masterclass on-- I'm not Gordon Ramsey. I'm not Thomas Keller. Here's what it looks like to be a home cook. And here's the, the five things that you actually need. And this is what you should learn how to make first. Like I remember the first time I was trying to make pasta or something, I boiled the water to death. There was no water left in the pond. Like I didn't even know what I was doing. I, maybe I walked away from it, I don't know, but I destroyed the pot. My mom's " What were you doing?" I was like, "Making pasta." And she's " What, what, what happened? You ruined the pot." I'm like, "I'm not, I just did it wrong." So I would probably do a masterclass in how to just take that first step learning how to make your own food, right? And talk about food 'cause I like food. There you go. That's what I would do. [00:36:52] Lindsey Dinneen: Love it. I love food and I love talking about it. So, that sounds like a great class. [00:36:58] Staci Miller: I would do, I would totally do it. [00:36:59] Lindsey Dinneen: Okay, and then how do you wish to be remembered after you leave this world? [00:37:07] Staci Miller: This might be dating me, but Roy Orbison who wrote the song, "Pretty Woman" that was also in the movie, "Pretty Woman" wrote that he "just wanted to be remembered." And I thought that was really interesting. And I think that everybody knows that song knows that it's the guy like, I don't know if you know like the artist, but I think even to this day, that song, generationally, people know that song. I don't know how I wanna be remembered, but this is how I wanna impact the world. So it's kind of like that, but kind of not. I believe that knowledge transfer is the most powerful thing that we have amongst generations. And I want the next generation to be better than me, which is probably, in my opinion, I'm kind of kind of strict about this, probably a tall order, 'cause I'm like very picky. But, I have mentored and, and taught people my craft, and I want them to be better than me so they can mentor people and be better at this craft. So if I leave one mark on this world, it's that I have taught somebody what I know how to do and I expect them to do it better than me. And I don't mentor just anybody. So if I'm mentoring you is, and I'm putting all this energy into you, you better, you better bring it. And the people that I have worked with and have mentored are doing extremely well in their careers, and that's, that's kind of a thing that I like about, like what we do and how I do it. So I don't know if I would be specifically remembered for that, but I do know that it would move our industry forward and that makes me happy. [00:38:39] Lindsey Dinneen: I love that. That's a beautiful legacy. All right, and then final question. What is one I know, what is one thing that makes you smile every time you see or think about it? [00:38:52] Staci Miller: When I see what I'm building or, or how I'm building it in the future and I really go deep within my, my consciousness about this is what I'm gonna do next. This is how I'm gonna do it. This is what makes me feel really alive. I get so excited. I get like goosebumps. I start smiling. I, I'm a big-- I don't know if you do this, Lindsey, but I do this-- I kind of dance around a little bit. Like I dance when I'm making food, I dance and most people dunno that about me. But I, but my closest friends I remember I was working with this one guy and he looks at me, he's " Do you ever stop dancing?" I'm like, "Nope. Nope, Nope. Gotta dance." So all that stuff like starts to happen. And I just get really excited about the things that I'm trying to build, what I'm trying to master in my own world, what I'm trying to create. And that's what gives me like so much excitement. And then a number two would be my cats, because they're ridiculous and I love them and they give me so much love and they make me smile all the time too. [00:39:52] Lindsey Dinneen: Oh yes, those are great answers. I love that so much. It is exciting to see. Dreams come true. I can totally understand that answer of getting the, the excitement, the tingles, and then yeah, I, yeah, I, I obviously relate to dancing around all the time, and especially like celebratory dances. They're, my celebratory dances are the goofiest, most ridiculous things you've ever seen, but I'm happy! So. [00:40:20] Staci Miller: As long as you're happy, that's all that really matters, right? Like that vibe that you're putting out there and the happiness and the giddiness, like the things that I'm building in my mind, like they haven't happened yet, but I'm dancing like they have, you know, because I hope that they do. Like there you go. And I think that's important. I love it. [00:40:35] Lindsey Dinneen: True embodiment of the vision. I love it. Well, well, Staci, this has been a great conversation. Thank you so much for your insights and your stories, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. And gosh, I just wish you the most continued success as you work to change lives for a better world. [00:41:15] Staci Miller: Thank you, thank you. It was so much fun being with you today. I appreciate this and it was so much fun to talk about. And yeah, I can't wait to see you in the next couple weeks too. So we'll see each other soon. [00:41:26] Lindsey Dinneen: Yay! Sounds good. Well, thanks again and have the best rest of your day. [00:41:32] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.
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