S5E27 Andy Schieber | Work Ethic, Medical Device Commercialization, & Ophthalmology Devices

Andy discusses his background growing up on a farm and how it shaped his work ethic. He talks about his experience founding Engineering Consultants and working with medical device startups. Key topics include challenges in commercializing devices, balancing an inventor's vision with engineering feasibility, and advice for engineers entering the field.

Main Topics: 

• Medical device regulations
• Challenges in commercialization
• Balancing an inventor's vision
• Stem cell and gene therapy advances in ophthalmology
• Advice for young engineers 

About the guest: Andy Schieber is a seasoned medical device engineer and entrepreneur with extensive experience in research and development. He is the Founder and President of Ingenarious Consultants, a firm that specializes in early-stage medical device development, offering services from concept to clinical trials. Andy has a remarkable track record in designing and developing Class III implantable medical devices, and he holds over 40 patents including the Hydrus Microstent, which is a significant innovation in ophthalmology.

He also serves as the Head of Engineering at Rivermark Medical, where he contributes to the development of novel medical technologies. Andy’s educational background includes a Master’s degree in Mechanical Engineering from the University of Minnesota and a Bachelor’s in Engineering from the University of Wisconsin-Stout​.

Links:
Andy Schieber - LinkedIn
Ingenarious Consultants Website

About Being An Engineer

The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community.

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Transcript

Andy Schieber: 0:00

We see plants of all different stages, some of which come here with like, they've already poured the concrete. They already have the rebar in the foundation. And they're asking us to redo the floor plan and it's like, well, it's a little late for that. We can be done, but it's it's difficult.

Aaron Moncur: 0:31

Welcome to the being an engineer Podcast. Today we have the privilege to speak with Andy Schieber, who is a seasoned medical device engineer and entrepreneur with extensive experience in research and development. He is the founder and president of Ingenarious consultants, a firm that specializes in early stage medical device development, offering services from concept to clinical trials. And he has a remarkable track record in designing and developing class three implantable medical devices and holds over 40 patents, including the Hydrus micro Stan, which is a significant innovation in ophthalmology. And he also serves as the head of engineering at River Martin medical, where he contributes to the development of novel medical technologies. And his educational background includes a master's degree in mechanical engineering from the University of Minnesota and a bachelors in engineering from the University of Wisconsin Stout. Andy, thank you so much for being with us on the show today. Aaron, my pleasure. All right. Well, what made you decide to become an engineer?

Andy Schieber: 1:36

Well, it's an interesting story, I kinda have a unique background, I grew up on a farm in Minnesota. So I spent a lot of time with mechanical equipment, driving tractors and, and my head a lot of fascination for these sort of intricate mechanical systems. And most of the equipment even to this day is extremely mechanical, you've got cams, and big rotary arms, and all these things moving. And so I was always fascinated with that. And then I was good at math, both my parents were math teachers. So you know, those kind of two things connected, right. And so that's what kind of got me into the mechanical design, in undergrad. And so that sort of evolved into being sort of an official chemical engineering degree at the University of Minnesota.

Aaron Moncur: 2:26

Terrific. I remember recording one of the very early podcast episodes, it was probably one of the first 10 And I still remember the title of that episode was farm boys make the best engineers. And it I don't know what it is, I guess it's just, you know, it's growing up and like, just fixing things on the flower. But it does seem like, there are a lot of engineers and in ordinate, number of engineers I've met that grew up on farms fixing things.

Andy Schieber: 2:54

Yeah, it's true. When I was when I was young, and I was trying to get my first job, my dad said, you know, just tell him you grew up on a farm, and they should hire you. Because farm kids are hardworking, and farm kids know how to solve problems. And they, you know, they can do things with duct tape, and, you know, wire, you know, whatever. And I always, you know, made fun of my dad for that. I'm like, no, nobody does that. When I tell them, I grew up on a farm that they laugh at me. And so, interestingly enough, when I got my first engineering job, one of the things that my my first boss said, he said, Yeah, Andy, one of the things I like about you is that you grew up on a farm. And I was like, hey, thanks serious right now. Are you just teasing. He's like, I was like, No, I grew up on a farm. I feel like farm kids can manage the startup mentality. And again, I got into startups right away. And so you know, engineering is one thing, but startups is another thing, right? Being able to really formulate a solution without having a lot of resources is sort of inherently part of what you do as a farm farmer. And, and having the not just the engineering and like, we're talking about the technical skill sets that you develop as someone who's on a farm. But there's also the all the other things like, you know, my dad is a biologist and an agronomist, and a, and a business person and attack, you know, he does his own taxes, and, you know, every single thing that you do on a farm is being done by one person, right? So you have this sort of really broad set of skills, that allows you know, somebody who has that experience to become an entrepreneur or become a business person, and in addition to understanding sort of the technical aspects of of engineering, so that I think that that makes sense.

Aaron Moncur: 4:41

Yeah, I'm curious when you were growing up, did you appreciate or just even recognize the fact that you probably, were developing a stronger work ethic than maybe some of your peers who did not grow up on a farm? Yeah,

Andy Schieber: 4:57

definitely. I think even though you know, We didn't, you know, traditionally, I guess, in a historical sense, we didn't do a lot of farm work on, you know, my dad had a small hobby farm, we had 160 acres or so about half of it was cropland. So it was mostly, you know, a single man operation. Although we did help, you know, me, my two sisters helped quite a bit with, you know, taking care of the calves and stuff like that. But I also had classmates in high school who, you know, woke up every morning at five o'clock and milk cows before they came to school. I never had to do that. So there's, there's a range, right? For me, I was sort of, you know, an average or maybe lower than average in terms of my engagement in terms of farm work, compared to the average farm kid, but compared to the kids who lived in town, who, you know, didn't have that, and what did they mow their lawn? I guess that was about it, right? So we did compared to those types of people, yeah, we did a lot of stuff. I mean, we have like, an acre worth of grass to mow. And that's just the lawn mowing, that doesn't count and all the fencing we did, and all the hay baling and unloading hay and feeding calves. And it was one of those things I learned when I when I became a parent. And I was, you know, really reading about, like, how to deal with a toddler, I have a four year old daughter. And one of the things they said was kids view chores as games, and they don't realize it's work. So thinking back, you know, they basically say have your have your four year old help you unload the dishwasher and put the laundry in the in the laundry basket. And, you know, they think it's fun, they don't realize they're being tricked into doing chores. And I feel like a lot of the stuff we did when I was a kid was was not, we didn't see it as a chore. It was fun. I mean, feeding the calves was was fun. We liked doing all that stuff. And we wanted to go out and play with dad and in the barn, you know, we wanted to go outside and do stuff that was especially, you know, boring after a while in the house, you know, in the winter, and we would go out in the barn and it was like a whole playground for us to you know, climb in the hay hay bales and, and you know, and mess around with the cows. And you know, we had a lot of cats and stuff. So it, it didn't feel like work. But it was, you know, later on it kind of segwayed into engineering, it's like I want to do a job that doesn't feel like work. I want to find a job that really is like that. But it feels like I'm playing with stuff I like to do. So that made me it made it made me be able to identify what I wanted to do for work a little bit easier than the average.

Aaron Moncur: 7:28

That's a great insight. So and in addition to the engineering knowledge that you're going to share with us, we've got parenting one on one here as well, for those of you with young kids out there.

Andy Schieber: 7:38

Yeah. All right. It's fun. It's funny. One other little part of that is the the things that you learn when you're a kid in terms of work ethic. Do and this is more about myself and less about my daughter really seem to be difficult when you're a child being told to do something. And I have all these examples I'm running through in my head when when when my parents were telling me, hey, gotta go outside, like when your kid just want to sit in the house and do nothing sometimes. And you don't want to have to do anything. And so there's any schedule, right? Like, oh, you got to do this every day, or you got to do this, these chores, that becomes you know, I guess sort of like this thing that is hanging over you like, Oh, I gotta do all this stuff. I don't want to do this, I want to play I want to do what I want what I want to do. And so what I've what I've found is that has translated into my career. And now that I'm, you know, quote, unquote, older millennial, or whatever, and managing people who are younger than me, I'm just like, I know, this isn't interesting, but just do it. Like, he just can't you just do it, like, just, I know, it's not fun, but but it will be fun when you know how to do it well, and it's easy. And so I think there's a lot of those things that you've learned in doing physical labor, doing farm work, you know, having something at home that your parents, like, my parents didn't really teach me that stuff. They just needed to get the farm.

Aaron Moncur: 9:15

Well, I had a guest on Jim Qusayr, a few weeks back, and he had a really, I think, I think he called it type A and type B fun. I think if I'm getting a right, but the gist of it was, type a font is like you're playing a video game, right? It's fun in the moment and type be fun is it might not be fun at the moment. But looking back you realize, Wow, that was that was a great experience. And I learned a lot and overall, I had a lot of fun. And that's often the case with with engineering work, right? And sometimes it is fun in the moment. But other times like you said, you just have to grind through it and get it done. And when you look back and the project is finished, and you've built this incredible thing, you know, we're extending like, oh, wow, that was really fun. What what a satisfying experience that was.

Andy Schieber: 9:58

Yeah, yeah, exactly. Engineering. is extremely challenging work. So even if you get a fulfillment and an enjoyment from it, it's, it's so frustrating. It's so frustrating, like, why doesn't this work the first time, you know, and, and now that I've been doing this for almost 20 years, it's like, I just assumed nothing's ever gonna work the first time. And, you know, and so, you know, like, you know, obviously we, you know, we're in business, and we're, you know, our goal is always to put together a proposal and plan that, that outlines what we need to do. And, you know, we got to kind of err on the on the side of, you know, having some, some averaging effect, right? Because it's like, okay, if we get everything right the first time we can have it here, or if it never works until 10 times 10, tries, that it might might cost this much time. And try to figure out where that where that average is, without without having started and really trying to figure that out. And it can be frustrating. So, but then after the project's all over, you're just like, yeah, it was easy. That was That seemed like, why did we Why did we figure that out right away?

Aaron Moncur: 11:01

Hindsight is 2020. Yeah. Well, let's, let's talk a little bit about your company engineer. Yes. Tell us how that got started. Sure.

Andy Schieber: 11:10

So I was lucky and fortunate in my career to work at startup companies right from the get go. So I was, was employee number one at my first job while not employee number one engineer number one, at my first job. It was a company of 10 people, mostly senior executive level, medical device people. And then that company ended up not succeeding and and those same founders turned, turned it into an incubator so that I was able to be the first employee at their next company, which was an incubator that spun out companies. And then I went with one of the start the spin outs. So the main spin out that came out of Denali medical was called i vantus, is now owned by Alcon and so that was my experience for the first basically seven years of my career from 2006 until I left I vantus in 2014. To be in that situation, right first employee, you know, ground, ground floor, whatever, design something from scratch, come up with these ideas. We're building the lab out, we're, you know, we're buying equipment, we're hiring people, we're, you know, we're going to clinical trials. And we're doing all that, and then kind of at the tail end of my time, and I vantus, I Ventus had been moving into clinical trials, and they didn't really have a lot of engineering projects. I went to my boss and said, You know, I really kind of want to do some work. Still, and but I'm not I'm kind of I was doing surgical training, I was spending a lot of time in the field, helping out with the clinical trial rollout and training surgeons on on how to use this glaucoma device. And I wanted to get back into engineering. So there was actually a company, a company called Claire Vista medical that was invested with the same investors. And so I actually asked my boss, I said, Hey, I heard about this company, Clare Vista, Star company that that NEA, new enterprise associates had had started recently. And, you know, they're small, they don't have any engineers, you know, can you connect me with them? And he said, Yeah, sure, I'll connect you with, you know, our board member who was the board member over there. And sure enough, that turned into me consulting over there over there one day a week. And the reason why my boss wanted to do that was because he wanted to keep me on, you know, because he knew I was sort of looking to go back to the beginning, right? I wanted to work out an early stage startup, again, I wanted to continue doing that I wanted to be the beginning of a project. And he knew that if I didn't find that at i vantus, that I would have, I would leave and find that somewhere else. And so I started consulting over there, that was my first experience with consulting. So I was going over there one day a week, and kind of fell back in love with like, wow, this is great. I really want to do this, again, this like whole early stage stuff. And I started formulating the idea of doing that as a career. Right. Like, if I was looking for jobs at an early stage startups, it would be extremely difficult because a lot of those companies don't survive. And a lot of those companies have difficulty hiring people. So like, you gotta, you gotta be like the perfect fit, right? So it's really hard to recruit, you know, your one or two or three employees for your very startup, that you're just getting off the ground. And a lot of those companies utilize consultants for a lot at work. So I thought if I could do this on a consulting basis, maybe that would be, you know, career path where I can sort of, you know, kind of a Peter Pan engineer, like, perpetually at the startup level, like never, never growing up into larger, larger companies. And so it took a while to sort of formulate how I was going to do that. But in 2014, when I left I vantus. I had made a lot of connections in the ophthalmology world and I went to a dental A startup company at that point. And so I kind of kept forging those relationships with those with those ophthalmologists. And with those other ofoma companies, I was still doing a little consulting for Claire Vista, they had kind of gone on pause for a while. And I started working on a bunch of other startup projects. And so I started to get a little tiny bit of a pipeline. For fourth consulting work, it was small, I mean, I probably had three clients at the time that was doing on the side, it was it was sort of a a moonlighting thing. And it was only work that I could do like, it wasn't, it wasn't large scale, it was just a pure mechanical design stuff that I was good at, in prototyping and stuff. And I was utilizing vendors to do all that. And then I got, I got an opportunity for a project that was larger. And so this one surgeon came to me and said, We have a project here, that is pretty exciting. And we're gonna license this technology to these investors, would you come meet with me and these investors, and maybe, you know, kick off a project, and you know, we need, you know, X, Y, and Z, we need all these different elements to it. And so I I said yes, without knowing how much work it was gonna be. And then I quickly realized I needed to have other people involved. Because I wasn't gonna be able to do it again, I was fully employed at the time still. So I connected with my co founder at engineering us his name is Randall Takahashi, I worked with him at vantus. At one point, he we worked together there, we had, he had left advantage before me, we reconnected and we're talking shop over lunch. And I said, you know, I kind of proposed this idea of this vision for kind of a startup company, focused Consulting Group. That's a pretty underserved market, most of the design services companies, and most of the engineering companies that are doing services don't really target that market. Because those companies are challenging, challenging, challenging, and timeline challenging. And budget, sometimes they're the, you know, the technology and the problems are trying to solve a really, really difficult. And so a lot of the bigger companies sort of Don't dabble in those smaller projects, as much. And so I thought we had an opportunity to hear would you be interested in in, you know, maybe we should start a company and so, so, September of 2015, which is, you know, we're on our nine year anniversary. Now, this year, we formed in denarius, officially, with that kind of charter, and his background was manufacturing. And so he saw the same vision that I was seeing on the on the kind of the design side and the r&d side, he saw the same vision on the manufacturing side saying, like, yeah, the companies that are in the startup world have the same problems on manufacturing, they don't have resources. And they have a hard time getting stuff done, because they don't have these capabilities. And we should also do that. And we had done that, at that point, we were just doing design services, consulting, but we had this vision for a lab that was going to be a job shop, you know, pilot builds, that sort of thing. And so that was all kind of the framework for what engineering was intending to be in at the beginning.

Aaron Moncur: 18:15

Wonderful. Thank you for running us through that. So it sounds like engineering, this was really kind of born out of your love for early stage startup work. And this is how you get to be a Peter Pan engineer, as you say it. Tell us about the name. That's an interesting name. Where did it come from?

Andy Schieber: 18:35

So so my, my co founders wife, Linda came up with the name, we were bouncing around a bunch of names a bunch of horrible ones. Thank God, we didn't pick any of those. And she suggested engineering. Yes. And I said, What is what is that? She said, It's Latin for engineer. And I thought you would like that, because I was sort of immune to that sort of thing. So I'd like oh, that's kind of neat. Yeah, it has real meaning. But it's also a weird word that people don't necessarily attribute to anything when they hear it, you know, like that. That's what they say about kind of branding. Like, in some cases, you want your name to be clearly obvious what you do, you know, I just got a water heater from the water heater company. You know, so in some cases, that's good branding and other cases, it's like, you know, you make up a word Yahoo, Google, whatever. And, and that you then you make you make a brand out of it that I like the ones that are kind of a little bit of both, right, they have a meaning to them. But on first glance, it's just a random word. And so what so that was kind of the, the underlying meaning there.

Aaron Moncur: 19:39

That's cool. I didn't know the background, or that it was a Latin word, but I know that when I said it, or when I read it, I thought engineer to myself because it kind of rhymes a little bit if it makes sense if that's the Latin form of the word. Cool backstory. Okay, so one of the things that you guys apparently do very well is class Three medical devices. Can you walk us through? Maybe one of the significant challenges a project without giving away any confidential details? Of course, and and how you were able to overcome that challenge?

Andy Schieber: 20:15

Yeah, so class three devices is pretty much what I was working on from the beginning, all these additional devices that I had been working on were all implants. So mostly stents. This is my personal background. At all stents, catheters, the first company I was working for was neurovascular, brain aneurysm products. So that was kind of, you know, where I cut my teeth in the development of medical devices. One of the interesting things about class three devices, as it relates to, you know, requirements as it relates to regulations, is that it to me, it's almost simpler of a thought process. Because, you know, there's, there's requirements, and there's, you know, FDA design controls or whatever, and you just do all of it, you just do everything, and there's no, there's not a lot of thought to it. Sometimes it's just like, it's class three, we just have to do everything. And so where's the where's the FDA guidance for what bio comp you have to do? Okay, we just do everything. Right. And so one of the the things about that as a first experience is that you get experience doing everything, right, you got to do all the different tests, all the different things are kind of the most stringent from an from an engineering standpoint, and testing standpoint, and it gives you kind of an exposure to all the different things. So if somebody comes by and says, Oh, we have class two device, you know, my reaction is always good, what can we eliminate? What can we not have to do, right, because you don't have to do as much for the, the other stuff, it's harder to go in the other direction. You know, I worked with people who, you know, started off kind of in class one or you know, other things. And, you know, they're a little unfamiliar with, like, all the things you have to do and the requirements, so that was easier to pare it down. And so it's just, it's a matter of getting experience with what all those boxes you need to check are. And then once you do that a few times, it becomes relatively predictable, I guess. And

Aaron Moncur: 22:16

for those who don't have experience in medical devices, there's Class One, two, and three medical devices, which each carry a different level of risk for the patient. Class One, maybe like a band aid, right? It's very, very low risk. Class two might be something like a laparoscopic device or a surgical instrument. And then class three is typically or or maybe always, some kind of life sustaining product. So the most risk to a patient

Andy Schieber: 22:42

Yeah, it would be devices that are highest risk, which you know, generally would be things that are treating life threatening conditions, implants, things that are you know, permanently implanted in the body, things that have you know, I guess, scenarios where, you know, syrup, severe things can happen to you if, if something goes wrong. Most of the ones that I've worked on, have been either vascular or ophthalmology. So I've got a lot of experience in like the in the neuro and cardiovascular stents and catheters and then a ton of work in ophthalmology and, and a lot of the ophthalmology stuff is in class three. But I have had an opportunity to work on quite a few different implants in class three devices and in the autumn ology world as well. So it's not life threatening, but it is vision threatening. And so that ends up being high risk.

Aaron Moncur: 23:35

Yeah, okay. Well, you've worked with a lot of these medical device startup companies. And as you mentioned, not all of them stick around long term, right, it's a treacherous environment, and only a few actually make it to commercialization. What are what are some of the key factors that contribute to successful commercialization of one of these medical devices?

Andy Schieber: 23:58

Yeah, that's a that's a challenging question. There's so many different factors that that impact success. I think more to the technical factors than I that I would talk to the other factors because there's, there's business factors, there's, you know, there's a market, there's reimbursement, there's regulatory risk, there's all these different things that will dictate whether you can have the perfect product that works amazingly. And one of these other things ends up throwing you off, right. You know, IP. So there's, there's all these different things that can that can impact you, I think, I'll focus on the technical risks. Generally speaking, you do need to have a good understanding of the market, for your product from a user standpoint, and from a business standpoint, to to properly designing the product. I think one of the one of the issues I see with startup companies that you know, I think they get too far down a path before they really understand those two things. Both you know, what, how the user is going to users how they're gonna interact with it? And how are you know, they're gonna get paid to to use it? Or is the device gonna get sold? And, you know, and because those, those economic factors, and those usability factors dictate your design so much, right? So, so like, if somebody comes to me, and they say, We can sell this device for $1,000, there's reimbursement. And here's the three surgeons that you need to talk to, because they'll tell you everything about how to use it, I would be very confident that I could come up with a set of requirements to design a device for them, right, because I know how they want to use it, the unmet clinical needs. And I also know what my constraints are from from a manufacturing and cost standpoint, right. But if you don't do that, if you don't talk to those surgeons about the use of usability, or use cases of the device, and you don't have the economic factors, and you just focus on the technical problems, and you solve something in a certain way, you could end up farther down the path. And it's unviable from a business standpoint, or it's unviable from a surgical procedural standpoint. And then you have to go back and unravel those things. And you know, people come to us and say, Oh, we're gonna get the cost down, it's like, you guys have already raised $10 million, and you've already done 100 patients, it's a little late for that. Like, it's not too late, but could have been considered sooner. You know, like, I think I always, you know, advocate for taking consideration of the cost of making something right away in the design, you don't necessarily need to hit that cost target for a while. But we see devices, you know, we see clients of all different stages, some of which come here with like, you know, they've already poured the concrete, they already have the rebar in the foundation. And they're asking us to redo the floor plan. And it's like, well, it's a little late for that. We can be done. But it's it's difficult. And so those are the those are the things that really, I think, impact, again, from a technical perspective, because I can't really speak to all the other factors in this question that really dictate whether or not that product is going to succeed through the milestones it needs to effectively in the early stages, and and also in the long run. Right. So like, we didn't talk about, like, the clinical studies and the outcomes, like there's another there's a whole nother conversation about, like, what makes it successful and commercial. Once you've have the design finalized, and you've gone through all the testing, and you're ready to launch it. That's a whole nother conversation. And, you know, maybe that's a follow on question here. But, but, but those are, those are different factors. And that's a different approach to because you don't have as much freedom to change things. And so I've seen products go through all the validations go through the clinical trials, and they succeed, well, and then they get acquired. And then six months later, the acquirer takes the product off the market, and you're just like, we spent years on this, the good, the data was good. Why are they selling this? You know, why aren't they selling this? More? Or why did they take it off market and there was usually something, you know, that changed, you know, market factors changed or business factors change. But, you know, sometimes there's technical things changed, you know, you know, femtosecond lasers come out, and now you don't need this other thing. Right, you had this other thing, and now we don't need it, because there's a new technology that is now better. That's another reason to, to, you know, not be able to predict, you know, whether it's going to be commercially successful or not. Yeah,

Aaron Moncur: 28:31

I, one of the questions I often ask guests on the show is, what are some of the biggest problems that engineering teams commonly fall into? And one of the most common answers is not understanding the problem well enough. And what I really like about what you just said, is, you have elaborated on that, beyond just technical standpoint, right? It's not just understanding the problem from a technical standpoint, but it's understanding the business context around that problem, as well. You mentioned speaking with the surgeons, the physicians early on understanding how they want to use it, you could solve a problem technically, but maybe not hit the mark, as far as the way the specific methodology with which the the surgeons want to use this thing. So understanding the problem is more than just understanding the engineering problem. There's a whole context of different problems out there that are important for the engineers and the team during the product development to understand

Andy Schieber: 29:32

yeah, there's, there's a game theory to it a little bit, as well. I mean, I'm not I'm not that well versed in the game theory. But if you're talking about startups, and like going up levels, like you have to reach sort of a milestone or a threshold, like in your in your achievement, right. So, like, I think one of the issues is you could raise a small amount of money and develop a prototype and and show that to investors. And they're like, oh, That's great, let's, you know, let's invest more money. And then you take that to the clinic and you do some clinical studies. And then they're like, well, the data looks great, okay, let's raise some, you know, let's raise some big money, right? Those are kind of like your levels like that you're you're getting up as you're, as you're sort of verifying your design works, as you're verifying that you can make it as you're verifying that as well as viability, all these stages, right? What I see a lot of companies is, like you said, Get focused on the problem you're trying to solve and all the different elements of that problem. But you also have to make sure that you're solving it just well enough to get to the next stage. Because it doesn't make sense investing $50,000 in an injection molding tool for a prototype, that's going to change in two weeks, right. And you might have a limited amount of funds. And you're like, Okay, I've got, I got this, this pot of money that I need to spend, and I need to play it on certain cards, and I need to pay it on all the right ones. If I put it all in one bucket, and I don't save any for this over here, then I can't get to the next level, I can't get to the next stage. So from an engineering standpoint, it's extremely critical to be quite selective about how you spend that money. And so we're advising clients often about that, like, you know, they come to me, and they say, Yeah, Andy, I don't I only have $5,000 for this project. And I say, Okay, you just want a small little prototype. And they're like, no, no, I want a real full prototype. And I'm just like, well, it's gonna be a little more than that. And they say, Well, I've already spent$20,000 on it, and I'm just like, you haven't built anything yet? Why have you spent $20,000 on IP, you should be, you know, building something, verifying that the design is actually promising. And then, you know, learning from that, and then, you know, patenting and as you go along, right, as you learn more things, you spent your, you know, these are, you know, inventors and people who maybe don't have a full view of the process, and, you know, to go all all into one element, right? And they've got this, it, they're like, Yeah, this IP is really strong. And I'm very proud of it. And I want to develop this further. And I said, Well, it's hard now, because you're not willing to spend what you need to spend on some of these other things. You know, if you would have spent 10,000, AIP, and saved $15,000, for, you know, for a prototype, you'd be, you'd be much farther along at this point. And your pad would be better, too. So those are things that, you know, we talk about constantly, about how much it's about how much where, and when, and the timing of it. And so, you know, sometimes we do some quick and dirty, you know, certain things and in part of the design, and then we do some other things really, really thoroughly, because we know that those are really important to get to the next stage. And then we know we were gonna go back and re address, the common thing that happens in sort of the stenting world is that you spent all your money on the stent, and you don't spend as much on the delivery system. And then you get to the next stage, and then you can work on the delivery system. But I have seen people not balanced that correctly, and maybe spent not enough on the delivery system or none on the delivery system, and then they end up running into problems later. So it's all about leveling up, right and getting to the next milestone and doing just enough to get there. Because if you raise too much money, then you end up deluding yourself too much anyway, and so you don't want to raise too much and run it to optimize that path. Right. And so it's different for every project, though. That's What's complicated about what we do. Yeah,

Aaron Moncur: 33:24

and going back to the IP, something that we've run into is customer will, will get a patent. And, and and then unfortunately, and unnecessarily, in many cases are kind of locked into a technical path that maybe is not the best technical path, because that's how they wrote the patent. When if they would have focused on developing the prototype first and proving out the technology, they may have learned earlier on Oh, okay, path A is actually not the best way to get there. We should do path path B, and then go write the patent for path P. But we have, we have customers occasionally who have a patent already. They come to us, they say let's develop this thing. And we start working on it, we say hey, I know you wrote the patent this way, but really this other way is a better way to do it. And sometimes they say no, we can't do it that way. Because because of the patent, which is unfortunate because it just leads to an inferior product. Yeah.

Andy Schieber: 34:20

And sometimes it's coupled with sort of a non invented here syndrome that you have with really strong minded, strong willed inventors and they have a vision for something and and they want to they want you to carry out their vision in some case, in some cases, they're right minded and they do have an image of vision and we can't, we can't, you know totally understand it. And so one of the balancing acts is when inventor comes to us or an early stage company or a doctor and they have an idea you know, it's important to I hate to say the word humor them, but Sometimes it's like, they don't necessarily have a knowledge of, you know, manufacturing, for example, right like this cannot be made or right now, we don't know how you would make this. But we're not going to, you know, condescend to you about oh, yeah, this is I can't believe you guys filed this patent, this is impossible to make. We want to see the positive of their vision, right and and steer them into a path that we think is viable on the areas of we're the experts. So you're the expert in surgery, surgery, you're the expert in your your field of medicine, and you have this vision for this product. And I'm an expert in design and development and manufacturing and medical devices. So let's figure out if we can't merge these two things together. And that's the best attack I usually take to kind of push them off of being locked into something that like, it may not be viable from a an actual manufacturing standpoint, or, or we think is going to be too onerous of a development paths. And the devices are extremely complicated. And we're like, Well, what are the main key points? Can we dial it down for the first prototype, and we can focus on stuff that we can prove, and we can show and, and generally, they come around, I don't, I don't have a lot of client examples where they were just so hell bent on doing, you know, what was in the patent, or what they had in their mind, they're generally convinced with results. So if they want to have something that's successful, and work, so if you can, you know, work with them and, and acknowledged the, the thought process that they have, and sort of direct them in a in a in a route that you know, will solve both issues, then it's, it's usually, it's usually a great result. I think what ends up happening, which, which I see on the engineering side, and it's part of like the makeup, I guess, I'm an engineer, an engineer is trained and sort of constantly looking for faults. So as an engineer, you look at something and you say, okay, yeah, I'm trying to figure out what's wrong with this, right? Well, it's horrible. It's horrible salesmanship. It's horrible business, right to tell the client immediately when you meet them, how crappy their ideas, but often engineers are unable to, you know, restrain themselves. And the first thing out of their mouth is, well, you can't do that. And so it's a balancing act, right? It's, it's, it's taking on the information like in acknowledging the ingenuity or whatever they're coming up with, and, and also gaining their respect for what we can do without insulting their idea, right. So I think that's what happens when people get locked into a patent is, is the engineer immediately starts criticizing it, and then the engineer, then the client is more likely to hold the tighter and be more defensive. And so we try not to attack Yeah, in those situations.

Aaron Moncur: 37:53

I had an experience many years ago, where a customer that we were working with, we were basically their engineering team. And they sold or they licensed the product we had developed for them to a much larger company, who is going to help take it to the next level, and sell and distributed. And part of that effort was they were going to make some design for manufacturability improvements to this prototype that we had designed for them. And I was in the meeting there as the our customers, engineering representative, and the CEO of this company who had licensed the product he walks in, and there's a roomful of their engineers, right. And this is kind of a kickoff meeting to look at the design to decide, alright, what changes should we make where the what's the low hanging fruit here? And I'll never forget, I thought this was such an astute way to form the conversation, the CEO says to all of his engineers, now look, this prototype that they've designed, this is their baby. So yes, we're going to look for areas to make improvements, but but be kind in what you say and realize how much thought and effort and time that they've put into this, this is their baby. So let's just keep that in mind as we, as we take the next step and, you know, help him improve this for manufacturing and all that stuff. And I thought, Wow, what a great way to, to contextualize this, this conversation. And anyway, that it went well, after that, you know, successful getting it, getting it into mass production and everything that's out there was a great way to frame that kind of conversation.

Andy Schieber: 39:31

That's a good way to think about it.

Aaron Moncur: 39:33

Well, let me take a very short break here and share that the being an engineer podcast is brought to you by pipeline design and engineering where we don't design pipelines, but we do help companies develop advanced manufacturing processes, automated machines and custom fixtures complemented with product design and r&d services. Learn more at Team pipeline.us. The podcast is also sponsored by the way Give an online platform of free tools education and community for engineers learn more at the wave dot engineer. Today we have the privilege of speaking with Andy Schieber. So Andy, tell us a little bit about what what do you see as the the future of medical device innovation, particularly in the areas of neurovascular and a phobic devices, since you have great expertise in those areas? What what changes are advancements should we expect to see?

Andy Schieber: 40:32

Now there's there's some exciting things happening in those areas? I think. Yeah, it's difficult without disclosing confidential information, right. So we do a lot of work with early stage startups that are, you know, hopefully making it to the next stage and becoming successful and, and along the way, we learn about the different areas, and we've worked a lot in glaucoma and cataract surgery, and retinal surgery. And so there's, there's definitely a whole array of exciting stuff happening in those areas. Some of those kind of industries, I guess, in the ophthalmology world have, have had a lot of developments and a lot of successful developments over the past, you know, 3040 years. And so it's in some, some cases, it's hard to visualize what advances, you know, that can be made, I'm not in the IOL business. So I'm not, you know, working on inter ocular lenses, per se, no, there's always advances are going on in that realm. We're working mostly on on surgery, one of the one more exciting things that I've worked on and and I think is, is going to revolutionize eye care is some of the stuff that's going on with stem cells in gene therapy. For retinal diseases, we've we've had the privilege to work on several different devices, for injection, of gene therapy, or stem cells, both in liquid form in in these little polymer matrix devices that, you know, basically regenerate cells in the retina, and in some cases, reverse blindness. Those are pretty science fiction, if you ask me. And, you know, we're just the delivery systems, right, we're working on the needles and the delivery systems for getting the, you know, the treatment to the area, the, you know, the the work that's being done with those, you know, those things are happening at Johns Hopkins, and other universities, University of Iowa, that, you know, is is really groundbreaking University, Colorado, I think, is also involved. So there's, there's multiple universities who are working on sort of that core technology that stem cell and gene therapy, and we're not drug people or biotech people necessarily, were you working on medical devices, but but that's, that's an exciting area that that I'm, I'm looking forward to seeing what happened, what's happening with that in, you know, 1020 years and how that relates to the, you know, those those types of diseases, other ophthalmology cataract surgery is always, you know, a big area of of interest in the industry. I think there's some exciting things happening in cataract surgery and the IOL business in terms of improving the, you know, the procedure and, and my parents are getting close to that age of, of needing cataract surgery and just the, in the period of time that I've been in this industry, you know, cataract surgery has, you know, is is even more you know, smooth and quick and easy. I mean, these procedures take, you know, in some cases, five minutes, and then the firewalls that are being put in or, you know, in some cases, people are insufficient, and is never better than when they get cataract surgery. You know, they maybe wore glasses, their whole lives, and now they're getting these firewalls in their, in their vision is is extremely, you know, crisp. So those are and that's getting better, right, that's, that's improving. Like I said, there's, there's a lot of stuff that's kind of hidden under the confidentiality realm, but there's a lot with a lot of stuff going on in that area. And then the third area that I've had a lot of personal experience with is glaucoma devices device that I worked on the Hydrus micro Stan is, you know, has been commercial for, like almost five years now. And there's, there's more advances, I think, to come in the glaucoma world, more devices that are that are sort of in the, in the pipeline, so to speak, that you know, are going to even more improve the, the guess ease of treatment and reduce and again, one of the things that we do a lot of is reduced the invasiveness of surgery. So you might have a treatment that works, but it's extremely invasive or or very surgical. And I think a big movement in all these, you know, I think the commonality of all these things is that they're moving towards procedures that are a lot easier to recover from a lot easier to perform. and a lot easier to target the area that you need to target without collateral damage, you know, without having a big open surgery in your eye or a big open surgery in your, in your, in your body. So minimally invasive types of techniques, converting this catheter stenting kind of concept from just being a vascular thing to being something that you do in the eye is something that you do in the year or something that you do. And, you know, pretty much anywhere in the body could be a small tube or a small catheter could deliver, you know, the stent or the priest or the, the agents that you might need to do the procedure. Yeah.

Aaron Moncur: 45:41

Great. How about advice for engineers who are looking to get into medical devices, of course, the typical engineering skill set kind of the fundamentals, the core engineering skills are required, but outside of, let's just call it what you learn at school, and maybe even some some basic on the job learning, what do you think are some important skills or behaviors that are important, specifically to medical device development?

Andy Schieber: 46:11

Yeah, I'm a little I can be a little bit of a contrarian when it comes to like paths, right, because I do have a unique path, you know, went from, you know, farm kid to, you know, startup companies in, you know, in, in Minneapolis, business culture, like, couldn't be two different worlds, right, small farming community of 1200 people to, you know, a high, high dollar invested startup community, and, you know, and medical devices. And that's what I recommend, I mean, and you don't, but you don't hear that from people, you're like, Oh, you just graduated, you should get a job at you know, Medtronic, and really cut your teeth on medical devices and really learn about all the different No, you shouldn't, shouldn't do that. You should, you should find a path that allows you to do whatever you want. And make as many mistakes as you can with people that are willing to take risks. And those larger companies in the medical device field, they're making amazing products, and they're doing wonderful things for our industry and for for patients. But they're also, you know, conservatively protecting the work that they're doing, rightfully so, and not necessarily taking a lot of risk to develop some sort of disruptive technology that might cannibalize their own products, right. So you see that happening from, you know, surgeons in from, from staff companies, primarily. And so, if you're interested in medical devices, or if you're interested in automotive, you know, work or if you're interested in any of any area, really, my advice is to get into something that is, you know, innovated, innovative and different than the established industry. And that is, again, a little bit, the opposite of what most people will tell you to do. But I think that's where you will, you will, you'll see some new things because you're, you know, 22 years old, you're just graduated, you have no idea how medical devices are developed, good. You can do things that nobody else would do, because they're, they're tied to what they think you have to do. And I got this lecture from my first boss, I mean, so I got a job offer from Starfire medical, which was a little startup company. And then I got another job offer was an internship with an opportunity to be hired at Boston Scientific, same time. And all the people at the startup company that I was working for came from Boston Scientific, and I accepted the job there. And they're just like, What are you doing? Why are you accepting a job here? I'm like, What do you mean, don't you want me to work here? And they said, Well, I just thought, we heard you, you got a job offer a Boston Scientific? Why would you take that? And I said, Well, I'm gonna do a lot more cool stuff here are tight. And they're like, Yeah, of course, you are, like, well, then that's the answer. But but they but they just, they were kind of used to, like, you know, thinking that, you know, some young person who's trying to get into industry would want to go to the established route. And I wasn't really interested in that I was interested in what the startup company was doing. So I was focused on, you know, what Starfire was doing, I thought what they were doing was really cool. And I walked in, and I saw the cubicles and I saw the big company, and I'm just like, I don't really want to be in this. I'd rather be at this little place, kind of doing little dabbling, and a lot of different things. And what that allowed me to do was obviously, you know, work above, way above my paygrade, from the day from day one, right? You know, being in meetings with, you know, C level executive people, meeting doctors as a 22 year old, doing, why labs and all this sort of thing that you don't get the opportunity to do if you're at the big organization, but it also gave me the opportunity to work on a lot of different stuff. Usually in the bigger organizations you get sort of, you know, pushed in one specialization, a lot of specializations in order to be a efficient, these big organizations need to be specialized. And so you'll be in the remediation department dealing with complaints for three years, you know, like, it's really hard and very competitive to be in the new product development area of Medtronic, like, if you're working in the new technology innovation sector of that company, like, that's elite, you know, people and, and it would be impossible to get into right away, right. And so you're going to be stuck in, you know, the quality engineering department or something for a while. And then you're going to, you know, lose your passion for it. By the time you have enough experience to do it, it's, you know, and I'm gonna say it's too late, but it's harder, it's harder to get that back. It's hard to get that like, you know, we're so sort of naive and exuberant about doing all we're going to change the world, we're going to design new products. Yes. And then somebody hands you an FMEA spreadsheet and says, Here, do this for the next six weeks. You're just like, Oh, I thought we were doing fun stuff. Right. Like, you know, so I think that's, that's my advice, like, and people don't know how to get into startups. And it's, and that's a whole nother question. But that would be my advice, in terms of sort of a philosophy. And then there's, there's specific, I think, techniques and pieces of advice. to actually do that. Well,

Aaron Moncur: 51:23

we might have to have the second interview, where we talk about how to get into startups and get your foot wet in in that area. But let me ask you one more question. And then we'll wrap things up here. What's one thing that you have done? Or seen to accelerate the speed of engineering?

Andy Schieber: 51:42

That's a that's a really good question for us, because it's one of our, our primary goals. You know, we, we have designed our organization to be almost entirely project managed, project based. Most companies have a discipline managed organization, which means you have, you know, a manufacturing department, and you've got a marketing department, and you've got to, you know, an r&d department, right. And the heads of those departments are managing the those Department Budgets. And there's projects that are multiple, multi discipline teams that are, you know, working in all of those departments, right. But the person who's in charge is the is the discipline manager, the, you know, the VP of r&d, he's, he has the power, not the project manager for Project X. As a client based business, we have to be project focused, right, but a lot of project focused businesses that I've seen, are still managed, traditionally. So what we try to do to speed things up is, is to be as project focus from, from an organizational standpoint, as we can, meaning that there should be as little hurdles and restrictions within our organization on the resources that are working on your project. So if you hire us do a project. And we say, okay, these are the three engineers, or there's two engineers, and a technician that we want to work on your project, there should be no hurdles or roadblocks in that, and structure and stuff that's going to prohibit them from doing your work that you want them to do. So a lot of times we you know, we talk about what the queue looks like, and like, you know, how backed up we are, how fast things are gonna take how many hours are gonna take, and the people who have power are the people who are prioritizing, you know, the whole, you know, the whole project, the project list, in those in those situations, like the discipline, like I was talking about, but in our situation is the project people who are in power. So like, I need this stuff done today, this is a timeline we're getting it done today. So it is a it is a is a philosophy and structure of organization that makes everything focused on hitting the client deadlines. So that's kind of the, I guess, the organizational way that we do that, right. So we've, we function more as a resource for the organization we're working for, then as a resource within our organization. So those people are usually working very closely with, you know, the people that are managing now on the client side, or one of us, you know, one of our Senior Principal partners are whatever is managing the project very closely with the client so that everything is, you know, being pushed that way. On the on the ground, though, in within the project. The other way that we accelerate things is, is the, the practical way that we execute each task meeting that we tried to do it a lot of stuff in house, we have a lot of capabilities in house, we have a lot of capabilities in terms of expertise and resources. I mean, you know, we're a small company, we've got about 20 full time people and another 30 consultants, we try to always have the core answers internally and not be relying on a long series of cues from other vendors, like oh, we're waiting for these parts. We're over here, and then we're gonna then they're going through this process over here. You're, then we got to set them up to this test lab and they gotta get inspected over here, then that adds to the timeline, right? So if we can do all that internally as much as possible, then we can, you know, again, we can manage things very dynamically for the client. So that's another way we, we do it on the ground. And then there's a whole myriad of examples I could go through to, to push that point. But that's our focus, right? That's the number one thing that we try to do is be be responsive because dark companies are on a time crunch more so than anything else. Yeah.

Aaron Moncur: 55:29

Terrific. All right. Andy, thank you so much for sharing your time with us today. How can people get in touch with you?

Andy Schieber: 55:36

Thats my pleasure. We have a website Ingenarious.com. We have the ability to quote parts for injection molding, silicone molding, machining and 3d printing assembly waterjet cutting directly on our website so you can see the link there on the front page of the website we are also selling some products now on chamfer that we're manufacturing chamfer is a website that that has a whole catalog of components we're making some components through our job shop on chamfer so there's a link on our website for that and you can see our store there will be in the next few months there will be a few dozen different components strain relief seals different things that are very commonly used in our in our industry that you know, we felt like there was a need to have some off the shelf parts for us. So we we invested in molds and started making some of those parts and are selling them there. And lastly, you can you can find our company or or me personally on LinkedIn. Send me a message. Andy Schieber is my is my name and profile and Ingenarious has a page on LinkedIn so you can find me there. And let me know if you guys are needing are need our help.

Aaron Moncur: 56:54

Terrific. Andy, thank you so much. Again, we'll include all of those links in the show notes, of course, and what a what a pleasure it was to have you on the show today.

Andy Schieber: 57:01

Pleasure was mine. Thank you.

Aaron Moncur: 57:04

I'm Aaron Moncur, founder of pipeline design and engineering. If you liked what you heard today, please share the episode. To learn how your team can leverage our team's expertise developing advanced manufacturing processes, automated machines and custom fixtures complemented with product design and r&d services. Visit us at Team pipeline.us. To join a vibrant community of engineers online visit the wave dot engineer Thank you for listening