A conversation with:
Andrew DiMeo Ph.D

Enabling Evolutionary Design

In the latest episode of the med+Design podcast, we had the privilege of hosting Andrew DiMeo, a fixture in the field of medical device innovation. With a rich background that blends biomedical engineering, design thinking, and entrepreneurship, Dr. DiMeo shared invaluable insights that resonate deeply with anyone involved in medical technology. 

The Concept of Evolutionary Design

Dr. DiMeo advocates for what he calls "Evolutionary Design" in medical device innovation. This approach, distinct from iterative processes, emphasizes the natural evolution of design, allowing for more adaptability and creativity. By using his Strategy tool, DiMeo demonstrates how medical innovators can efficiently trace and manage the development process, saving crucial time and resources.

Impact on Medical Startups

Dr. DiMeo’s personal journey with Novocore Medical Systems highlighted the critical role of efficient design processes in the success of medical startups. His story illustrates how time spent on reverse engineering design controls can significantly impact funding and progress, emphasizing the need for effective tools like Strategy.

Broader Applications and Human-Centric Approach

While primarily designed for medical devices, Dr. DiMeo suggests that the Strategy tool can be adapted for any evolutionary process, indicating its potential across various industries. He also discusses the importance of considering the well-being of all stakeholders involved in the lifecycle of a medical device, from engineers to manufacturing line workers and end-users.

Advice for Aspiring Entrepreneurs

He shares valuable advice for young professionals eager to venture into entrepreneurship. He emphasizes that entrepreneurship should be viewed as a social service, aiming to improve lives and provide opportunities for others. He urges aspiring entrepreneurs to reflect on their motives and the broader impact of their innovations.

The Bottom Line

Dr. DiMeo's insights offer a fresh perspective on medical device innovation, blending creativity with practicality. His emphasis on evolutionary design, human-centric approaches, and the social responsibility of entrepreneurship provides valuable lessons for professionals across the medical technology sector.

As we continue to explore the frontiers of medical innovation, DiMeo's principles remind us of the importance of keeping creativity and social impact at the heart of our endeavors.

Episode Transcript

[00:00:00] Jared Gabaldon: Welcome to our latest Design Inspired Healthcare webinar, where we like to invite medical innovators to share their journey with the greater community. This month we're joined by Professor Andrew DiMeo. He's the Senior Product Manager at Greenlight Guru. He's the former Professor of Biomedical Engineering, Senior Design at UNC and NCSU.

He's the CEO and Founder of Canvas GT, now Strategy. Which was recently acquired by Greenlight Guru where he is developing a medical device success platform that we'll talk more about today. He's been a consultant to many organizations on Design Thinking, Process of Innovation, and Entrepreneurial Mindset.

And he's even spent some time with our Trig team as Innovation and Design Coach as well. So really happy to have you

here, Andrew. Welcome.

[00:00:39] Andrew DiMeo: Awesome. Thanks so much for having me and thanks so much for the like kind introduction here and then the marketing for the event. I was like, who is that guy? I wanna meet him.

You too kind. Sincerely.

[00:00:53] Jared Gabaldon: Oh my gosh. Yeah, I think you're too kind for being here as well, and just in general, I think, a good place to get started would just be like at the origins, I noticed, that you worked in the film industry like very early on Yeah, I think back in the nineties, and what was that time like for you in the New York film industry back then and how did this time set you up for the rest of your career post-grad as a designer?

[00:01:15] Andrew DiMeo: Oh man. It's, it really is the foundation for everything. Especially when it comes to design. I was part of designing sets, being a set dresser and a property person in New York City's film industry. And I really got lucky. I got lucky to work on acclaimed productions like The Sopranos as an example.

And everything from working under pressure to having no ego. It was really about the team. It was about the crew. Like the whole crew does this production and there's a crew party at the end, and so there might be some stars on the stage that get a lot of the accolades.

But I think everyone that's in the film industry really appreciates. The crew that brings something together like this. Just learning about teamwork. It really is the foundation for me thinking in terms of this topic. So we're talking about Evolutionary Design today, right? And so the thing that jumped to my mind was how a script evolved over the course of a show.

So in something like the Sopranos it might take us, I can't actually remember if it took us a week or two weeks to film one episode. It's been so long ago, but I think it was about a week-ish to film one episode. And on the very first day of the shoot, we would get a three ring binder and it was the white script and it was all the pages were white.

And we would read it. We would read it before the first day of shooting, so maybe we'd get it a week before or something like that. But every single day we'd be issued pages. That were revisions. So it'd be like we'd get the blue pages and those pages. You just get a little tiny stack of blue pages and you'd insert them in and replace, pull out the white and insert the blue.

And then there'd be the green pages. And the pink pages. And by the end of the episode, I've got a few of these, like literally in my attic, in a box somewhere, some of the scripts that we worked on the Sopranos, and it would be a rainbow of colors. So it's like the script itself evolved over the course of the episode and so those rainbow colored three ring binder scripts might be my very first introduction to what is Evolutionary Design.

[00:03:32] Jared Gabaldon: That's incredible.

What season did you work on the show?

[00:03:34] Andrew DiMeo: I worked on the very first season not the pilot. Wow. But that very first season, my brother, he was the prop master who hired me. I was the young guy. He worked for, I don't know, the first four seasons or more. There's a little trivia thing, which the production company asked to use our last name as the name of the head of the crime family. So if you look at the Sopranos crime family, Ercoli DiMeo is the head of the Sopranos crime family. . Wow.

[00:04:05] Jared Gabaldon: How cool is that. Yeah I recently watched a documentary about the Sopranos and how it changed the game for the film industry and distribution like thereafter.

But, I digress. I think let's move on now to, after you finished your Masters in Bioengineering. And, just had so much going for you at that point. I feel within five years after graduating, you worked as a Design Engineer, you founded Gilero and the North Carolina Medical Device Organization.

You founded your consulting firm, you started teaching at UNC. It's just so many things going on and was this sort of like the life that you hoped to have lived when you were a kid? And also, what lessons did you learn about client-based services and entrepreneurship during this time as well?

[00:04:43] Andrew DiMeo: The life that I hoped to have lived, I really, I don't know that I knew of any other life. There was a really short period of time, like there was maybe a two year period of time where I was doing a nine to five gig at Alaris Medical Systems as a Design Engineer.

And I think, I'm gonna be 50 this year, and in like my whole entire life. I remember, I was an Entrepreneur when I was a Paper Boy. We could take a half of an episode on my entrepreneurial endeavors as a Paper Boy in middle school, , but from like literally from being a Paper Boy to, working in the movie business to be in a Professor, to starting these companies to where I am today with Canvas GT getting acquired by Green Light Guru.

I've lived the life of an Entrepreneur that whole entire time. So I don't know that I knew or know of anything different. But yeah, when it comes to entrepreneurship and especially entrepreneurship. I'll talk about that more specifically. What I've learned, what I learned then and when I continue to learn and Ty helped teach me this too, is that entrepreneurship is a social service, right?

I think that oftentimes, especially in school, entrepreneurship is taught as, this way to grow scale, big business, lots of money. And I don't see that in reality. In reality, I see people that sacrifice their own prosperity to provide prosperity for others. It's about creating jobs.

It's about doing good. And creating jobs. And yeah I just, I kinda learned early on, and I continue to learn that entrepreneurship is really a social service.

[00:06:30] Jared Gabaldon: You started your career, teaching at UNC and then, NCSU essentially at the same time as your consulting firm, which is really interesting.

And in both cases you're educating people on Process of Innovation, Design Thinking, the Entrepreneurial Mindsets. But I feel like the context in this too is, very different. . And how did you differentiate these teachings where, you're teaching the students versus teaching essentially startup founders or people in various firms.

[00:06:57] Andrew DiMeo: Yeah, that was really important. That was a critical time for me. I was among the very first cohort of Biomedical Engineering faculty that were changing the way that we taught Biomedical Innovation, Entrepreneurship, Design. So back in, 2006, it was the year that I dunno if you're familiar with BME idea the Innovation Design and Entrepreneurship Alliance was formed, about that time.

The Biodesign book that came outta Stanford came out in 2010. So this was the very beginning of this. I'll just sort wrap it all into the word Biodesign. I guess Stanford gets a lot of the credit, but, if I say this Biodesign process worked really well in a bubble, like it worked really well inside this academic setting where you could create this, Hey, we're gonna identify unmet needs in a hospital, and then we're gonna do this, and then we're gonna do that.

I got known for, being one of the innovators of this process. And so I would get invited to do it and of course, consult this practice in many settings from businesses to, Medical Societies, to NIH Grant Awardees, Researchers, just like this huge gamut. And it didn't take me long to realize that it didn't work.

It's if you started with, like pure Bio Design. I would notice that people would just fall asleep instantly. It's Oh, identify an unmet need? And they would just like sleep . We did that a long time ago. And that was also huge in this whole, like how do new medical innovations, how does any innovation evolve? And what does that design process actually look like? And it looked like none of them. And it just taught me that there's these key ingredients in Design, Innovation and Entrepreneurship that gets sprinkled in, but don't happen in any particular order. Seeing all those different settings was just, I got really lucky again, just to have so many different perspectives.

[00:09:02] Jared Gabaldon: Did you ever get to, I think it's just random question, but did you ever get to meet any student later on that, was your student for your Biomedical Engineering classes?

And ended up like working with you in some capacity later on, or you met them at some, firm that you were consulting. You're like, Wow, no way.

[00:09:17] Andrew DiMeo: All of the above, right? I think probably so the students have become, Attorneys, Doctors, important positions at large Medical Device companies. I think one of the funnest was when starting Canvas GT and getting acquired by Green Light Guru. And I was out like pitching for, who are gonna be some of our early adopters. I like started making some cold calls into I won't say the name of the company, but at any rate, basically at the end of the day, one of my former students was the one that I'm pitching to and I was like, man, the tables are like this is like perfect opportunity. Like I would grade their presentations, and tell 'em everything that they did wrong. And I was pretty strict with the students. I was like, man, this could really come back to haunt me. You got the stick to do the grading, but it's at like much higher stakes right now. So that was a lot of fun.

[00:10:07] Jared Gabaldon: That's incredible.

[00:10:08] Ty Hagler: Yeah. I'm sure that your work well prepared them for that moment too.

[00:10:14] Andrew DiMeo: Yeah, exactly.

[00:10:16] Jared Gabaldon: I didn't mean to cut you off, Ty, if you had something before.

[00:10:18] Ty Hagler: Oh yeah. I wanted to drill down. And when you say that Biodesign doesn't work, when you think about the rigor that's involved with Biodesign, with you know, step one through, 57, like do you mind elaborating on that a bit more?

[00:10:31] Andrew DiMeo: Yeah, Biodesign works great in the setting of the way Stanford has its set up or in the way that maybe the programs that emulate Bio Design. It works. It works fantastic. The analogy that I like to use is the book, The Goal by Eliyahu Goldratt. Did I say that right?

I can't pronounce. Yeah, that's good. Yep. In The Goal, you can be running a manufacturing facility and you could take the time to set up the leanest, meanest process in that manufacturing facility. You just can't cut and paste that into another manufacturing facility. It doesn't work over here.

So what I found was Biodesign got a lot of credit, which it should, that they were like cutting and pasting it into very similar looking, factories. And it was running really well and it does work absolutely great. It works as good as the, Toyota production system works in a Toyota manufacturing facility. But once you got outside of that then if you just tried to cut and paste it, it didn't work.

[00:11:33] Ty Hagler: Makes sense. So it's like at a fractal level it doesn't necessarily scale up or down outside of the conditions. It was built within.

[00:11:40] Andrew DiMeo: Exactly.

[00:11:41] Jared Gabaldon: I think, you brought it up before about how, you've worked with a ton of companies. You started a ton of companies, and so is there one sort of product that sticks out to you or one company that sticks out to you that you're just like super proud of that, just hang your hat on, at the end of the day?

[00:11:54] Andrew DiMeo: No, it's the people that have impacted me and the people that I've had the chance to impact. And maybe that's another thing that weighs heavy on me as an entrepreneur and someone, that when I think about this being a social service, right? It's like what I've done in the classroom might have changed the course of people's lives, right?

And that weighs heavy on me. Much more heavy when I convince, a dad with, children to quit his well paying job and join my startup company and then two years later it fails. And they have to, sell their house and pick up and move to a new place. That's for real. That's for real.

That's the stuff that I lose sleep at night. But when I think about. That same person would say that the time that they spent at the company that we started was the most meaningful time of his life and his career, right? And the lives that I've impacted and those people that have impacted my lives are the most important.

[00:12:58] Jared Gabaldon: That's incredible. I've never heard of it, being called a social service before. I love that take. I think it's really interesting. And also, I think I'm sure you've seen it over the past, what, five years or so, maybe even longer. Entrepreneurialism has been like a trend, I guess you could say.

Everyone wants to be an entrepreneur and they don't really understand that not everyone makes it. There's a lot of failure that comes in with being an entrepreneur and not everyone's really ready for that. It's a interesting trend that I hope still continues, but at the same time, people understand a bit more of like really what it takes and it takes a ton out of you and a ton of confidence and a ton of belief and just so much more.

Now we're really getting to meat of this one here. So let's get into the Design Thinking aspect of this. So how does Design Thinking enable Evolutionary Design? But then after that, why should companies consider using it? And then where do companies actually go wrong when they're trying to implement it?

I feel like that's another aspect of it as well.

[00:13:53] Andrew DiMeo: Yeah. So what is Evolutionary Design anyway? And honestly, how should companies use it? I think that Evolutionary Design is how we naturally operate. And maybe in a minute I can give a demo on how we're enabling it, right?

But we're enabling, I think, something that's really natural. The way that I like to think about Design and if you're in the Medical Device industry, the word Design Controls can be a buzzword, right? I ask people, tell me what you think when you hear Design Controls and the answers I get back are like, constrained, constrains creativity it's a process, it's a hurdle. All these like really negative things. That's really bothered me because when I hear Design Control, I hear control something. You control things that are really important, right? You might control a manufacturing process to produce the same output the same way every time.

My favorite example of where does creativity and control and maybe an evolutionary process manifest itself would be in cuisine and food. Think about a five star or Michelin star restaurant. You have to have a creative genius Chef who's coming up with some new dish that is a, new gastro experience and at the same time, they've got to produce this dish over and over again cooked by many different Chefs. Cuz the same Chef's not cooking it every single time and it's gotta come out like perfect. So when anybody goes into the restaurant at any time, they get this five star experience, right?

That's to me, creativity and control, and we want to control how that dish is served every time. So now, How does that dish evolve? What is the evolutionary process? And I think we live it, maybe some of us do in our kitchens and my experience is this. It's like I wanna perfect a pizza.

Every time I make a pizza, I do a little bit different. I do a little bit different and then nail it, just this is the one, this is the one. And I look at my wife and I'm like, What did we. It's like, I think this time we let the dough rest longer. I think maybe we did this.

And it's yeah, but each time we were making pizza, we were making little adjustments here and there. If you look at, a Chef's life, they've got this notebook of going back pages to Wait, I had this many grams of flower. Wait, no, I did this many grams.

No, I did this many. But it was like back there. And then they moved, they've got this notebook and when they nail it, they can kinda like put all the pieces together of that evolutionary process. And then it's like it is controlled, right? That's to me what defines Evolutionary Design and then how can we put that to practice in what we do in innovating new medical devices?

[00:16:50] Ty Hagler: That's such a cool analogy. It also brings to mind what you opened with, the script, and how you'd have rainbow pages throughout the evolution of an episode you've got that latitude to make changes because you're in pursuit of what works. But then you also have a process for controlling communication across a team where each person is worried about execution and getting it right and being efficient. You just made something click for me a unique way there. So anyway I'm excited by that.

[00:17:19] Jared Gabaldon: Yeah. And so did you also have a demo for us as well?

[00:17:24] Andrew DiMeo: Yeah. So I'll show you if I can indulge everybody and share my screen. This is maybe also not, maybe it's also a shameless plug for Greenlight Guru Strategy. I'm gonna share my screen and you guys just give me thumbs up if you're seeing good.

All right. And of course I gotta always redo my Zoom cause I need you guys big so I can talk to you and also look at what I'm doing. So I'm just gonna start here with a Trace Matrix. This might be common to people that have worked in the Medical Device industry, that we've got User Needs, Design Inputs, Design Outputs, and then Verification and Validation.

It looks a little different, the user research and the concepts, because we're really thinking early stage concept development as opposed to maybe a final medical device. And so this might look pretty familiar. This layout might look pretty familiar to people. Those of us in the Medical Device industry who've had to do Design Controls, I like to do them, but for those of us that had to do them and didn't have a good way to do them, a lot of us shot ourselves in the foot by doing this as a stage gate.

In other words, we thought that we had to define all of the User Needs first. Once we had them defined, we could enter into Design Inputs. We're allowed to start brainstorming solutions. After we have defined the Unmet Need and then we can have a design review about the inputs and move to the outputs, and then we can figure out how we're gonna verify and validate things.

It absolutely, positively does not happen this way. I've never seen anybody actually work this way. And so here's the key is the word iterative, right? If you actually read the Design Control guidance document from the FDA they've got this little blurb that not too many people read, which says, in practice this would be iterative.

But I don't think processes are iterative either. Iterative would suggest that we're gonna think of a need and then develop an input, think of an input, then design it, the output, and then verify it and validate it, and then go back and do some more User Needs and more inputs and outputs.

We'd build this up from top left, move across the row and then another. That's how it would build. But we don't work iteratively either. When you're working on a puzzle or something, maybe there's a part of it where you wanna do the border first to define the boundaries, but then that puzzle grows.

It evolves, right? It's an evolutionary process. It's not an iterative process. Nearly all design processes are shown in some sort of flow and some sort of iterative thing. I think it's misleading. I think that we can try to do it that way, but it actually constrains us and we still don't do it that way.

We still don't actually follow that iterative process. What we really do is evolutionary. And so we end up being the Chef that's not the Chef. We end up being the Cook with no notebook. And when we finally get that pizza done, we have to reverse engineer the pizza to figure out how to get to that pizza.

Because we're the Cook, not the Chef. And so I wanted to enable, what we really do. We do evolutionary design. So I'll kinda show you some of the secret sauce in this. This example that I'm showing is Novocore Medical Systems. It's the company that I started with a couple of guys and failed.

And then somebody had to move . We did get it all the way through. Oh man, we got it through a 510 (K) clearance. So I love this as an example because it was an incredibly successful project from classroom to startup company to raising money to getting it through a 510 (K) clearance for sale on the market.

And it was really a funding round that got missed. It was really about market and economics. Which is why it didn't make it. So it's a fantastic example and I'll kind, I'll quickly take you through just a workflow. We might start with brainstorming needs. I put this one in the middle which is enable evolutionary design, so you can read learn more and sign up @gg-strategy.com.

That's my shameless plug, right? And so people might think when we're brainstorming needs. People are thinking like final pizza and people are thinking, like we need flour in an oven that we can get up to 550 degrees or whatever. People are thinking neurologically in tech survival rate, people are thinking highly conductive tubing.

People are all over the map. And the tool that we're providing, allows this left and right brain thinking. We can see things in boards and we can see things in tables. But what becomes more interesting is that we can move between different workflows. We can say, Hey, we're brainstorming needs here, but I wanna start to abstract those needs.

And you don't see the purple note. That was the Enable Evolutionary Design. So what we do to move from one place to another, there's a filter and it's saying, Hey, we had this note board where we're brainstorming needs, and I just wanna see what was on that note board. Keep your eye on all these notes over here.

When I do that, you just get this purple one. I can say this is an Unmet Need and I'm gonna put it here in User Needs. And so we can start to level things by, are they really high level needs, like improved neurologically and intact survival rate? Are they more like a Need Statement? We wanna reduce the time from arrival to delivering the therapy.

Are they low level? Are they ideas? Are they actually technologies. But we're trying to shake out these User Needs. And so that's this process that we're going through. In this case, the table looks different. In this case, the table looks like these different categories.

What I'm not showing you yet, I'm not gonna show you on this board as something that we call Traceability. So we've gone through this process and then. I wanna start building a Trace Matrix. This is what I was showing you earlier. This was the Trace Matrix that looked familiar to you.

But in its board format it looks more like if you're familiar with something like business model canvas, it looks like a canvas with some creative constraints around it where we can put things like User Needs. Again, in this case we might have gone through this work to say, Hey, we've gone through this work to figure out what are the User Needs so I can find just this Enable Evolutionary Design and I can maybe put it in here as one of the User Needs. And then if I turn off all the filters so that you can see everything, one of the things that's really cool is that we can build Traceability right on the board and we can start to see how we can, enable trace. So we're building Traceability like this.

But as far as evolution is concerned I'll go back to just creating some notes.

[00:24:24] Ty Hagler: Andrew? Andrew, could you define real quick Traceability for maybe people that aren't familiar with Traceability and Trace Matrix?

[00:24:31] Andrew DiMeo: Yeah for Medical Device product development, it's a requirement to show that the Design Input came from a User Need. And the Design Output came from that input and that you verify that the outputs meet the inputs and you validate that the final product meets the User Need. So if it's something like a toothbrush, it's like, The user needs to clean the teeth. Does it clean the teeth? That's Validation. The Verification is, did I build something exactly to the specifications of a toothbrush?

This is the requirement that you have to do this is the part of Design Controls that people think, they think this is the controlling thing. But actually what the FDA was saying was control your process. If that makes any sense. Do good design. And so most people then implemented a stage gated process as their controlled process, which created this need input to output.

You could create a controlled, iterative process. What I've never seen before is a controlled evolutionary process, but there's no reason why you can't. It's like the FDA would not say, no, you can't do a controlled evolutionary process. You absolutely can do an evolutionary process, but this is the Trace Matrix.

It's really hard though to visualize this in a table. And this sort of gets to the point of if I show off Traceability here, that this need here, is validated by this to this concept, right? Or this output here is verified by this verification test to this output. This output here.

This output is verified to this input, right? You can see where your holes are in a visual way, right? I can show off for you while I'm doing this that one of the things that you can do is link to anything. So here I've got a meta analysis literature review of this manuscript.

Then I can link to that manuscript so you can link to anything that has a link, whether it be interview notes in your Google Drive or whatever. Of course this purple one here is gonna link to the homepage for Strategy where you get to sign up. Now here's the thing, this is my plug for everybody.

What marketing at Greenlight Gu ru wants you to do is they want you to go to this website and then sign up for early access here. But I'm not a rule follower. So you can either go to gg- strategy.com and then it'll take you to that link I showed you, and then you can sign up for early access or you can just read.

You can just read up there.

[00:27:22] Ty Hagler: Grab a screenshot of that

[00:27:28] Andrew DiMeo: If you can't wait, if you don't wanna sign up, you don't wanna go sign up for anything, you just start using it anyway.

[00:27:32] Ty Hagler: Andrew, you're the master of dropping in a pro tip into your talks.

[00:27:35] Andrew DiMeo: Maybe I've done bad at dropping in pro tips. So , what I wanna say here is I'll use these purple notes just so that they stand out.

What I've seen, like the reality of things is Ooh, I've got an idea. Ooh, I've got an idea. Oh yeah, I got another idea. And let me pop this out. One of the issues that I've had with all of these like visual collaboration tools is zooming in and zooming out to see what I'm trying to look at.

And so we built this side panel so you could see the big picture. But you can zoom in without zooming in, by being able to read what's over here to the right. I've got an idea. Then people sit around, they're like, how are we gonna make that, right?

They're like thinking in terms of inputs and they're thinking in terms of outputs. Then maybe somebody says to 'em like, Does anybody want that? Does anybody care about that? And so then maybe you start doing some user research, right? And you're not really doing any user needs or verification or validation until way you know that it's at some point.

We got something real here. Hey guys, like we should really sit down and define our user needs. So let's define them here. And that's why it's not happening in an iterative way. It's happening in this evolutionary way. Then you can start to be, strategic about, Okay, wait, so how are we going to do this, verification here cuz we gotta verify it to that and we've got to verify this output to that input, right?

So you can start to visualize it here, and then of course it'll start to grow on the table. So this is really the essence of evolutionary. I think that this was the seed that started the whole thing. I'll show you one more thing before we finish the demo because you've seen the output here is this table.

Maybe at some point we wanna do a new thing, which is use a jobs to be done process called important satisfaction to try to see how stakeholders rank or prioritize the unmet needs. I'm gonna spin up this brand new important satisfaction here. And when I add that canvas. What you'll see is all of the notes that we've ever created are over here.

But there's nothing on the board. And again, what I wanna do is I really just wanna go and see those user needs. That's the thing that I want to go and say, How important is this need to you? How satisfied are you by this need being served today? And so when I do that, you can see how this drop down to a manageable list.

Then I can use the side panel to say Oh this, Incredibly important and I'm incredibly dissatisfied. So it's gonna go all the way down here. I can't possibly do that. So we're gonna give that the highest ranking, of course. Then something like little or no impact on the protocol, like you have to do that's table stakes.

Deliver therapy without access to external power. Very important, but I can actually do it today with the methods that they have. I'm not gonna be very specific about these things. I'm just gonna throw 'em on the board. But in this case, the table then provides an opportunity score.

And of course, you can see that this is the highest ranked thing. A lot of people ask me what the formula is, you can find it. I know our friend, Mr. Burleson's on the line, he's got a book called The Statue and the Stone and he explains this in great detail, better detail than I could possibly explain it, and it's even got this formula in it.

But I'm gonna stop there so that we can continue conversation or take Q and A or wherever you wanna take this thing next.

[00:30:58] Jared Gabaldon: Yeah. Absolutely. If anyone has any questions, feel free to shoot 'em in In general, I'm just curious. So how much time does the Strategy product save a med tech innovator or someone that's working on or actually I guess also what does the process look like without this? Cause it seems like this is a great way of keeping everything organized and really front of mind and it seems like it would be really hard without this, but nobody even has this yet. That's crazy.

[00:31:21] Andrew DiMeo: There's two types of medical innovators that I know, I'll just put 'em into two large buckets. There's not two types. There's lots and lots of types, but two large buckets. Those medical innovators that have no idea they should be doing design controls a lot, just don't know.

They're innovating a new medical technology and they just don't have any idea that this design control is a thing. And then there's those of us, myself included, know very well, we're supposed to be doing design controls, but there's just no good notebook for it, so I end up being the Chef.

Not the Chef, sorry. End up being the Cook . I know I'm supposed to be doing it, but I just don't because I'm not going to comply to stage gate. And I'm not going to comply to iterative. I'm just not. It just my life. I try to do it. My life doesn't do it. And so I say, You know what? We'll figure it out later.

Everybody else in the history of this industry has figured it out. And so if you know it's coming, there's this point at which you're like, Okay we have to implement a quality system. We have to implement design controls. This is a requirement that's a three month project. If you had no idea, if like a Consultant comes in and says, Hey, where's your design history file?

And you're like, Who? What's that? Which I see a lot. Oh, that's a nine month project. And pretty much everybody I've interviewed says some, gives me an answer somewhere between three, three to nine months to reverse engineer a design history that they didn't take really good notes along the way.

They didn't build the Trace Matrix along the way. This is exacerbating interesting, by the way, when there's a lot of handoffs, right? Like right now we see a lot of innovation happen in hospitals and universities, and they're handing it off to some startup company, and maybe that startup company is going through lots of turnover. There's the day that the design team has to assemble, and sometimes it's a third party.

There are cases where, like a contract manufacturing firm, is the one that's Hey, we gotta assemble your design history file and. They're trying to reverse engineer something where they're many degrees of separation from where the people that were in the hospital identifying the unmet need, the people that were coming up with, the original concepts, the original, like interviews, observations, all that stuff.

They're literally reverse engineering it. Here's the pizza. It's the best pizza in the world. Figure out how to reproduce that, and it's a long and painful road. .

[00:33:55] Jared Gabaldon: Yeah. I just wanna add, you have a question here from Kahren, Kirsten if you're open to taking the question, be a allow to talk.

[00:34:04] Andrew DiMeo: Let's see. Oh, perfect.

I actually don't have a question. I just wanted to say, I think this is such a cool tool. I really enjoyed watching the demo. Thank you for walking us through all that.

Thank you for Thank you, Karen . Thank you. Thank you.

[00:34:21] Jared Gabaldon: Yeah, it's like you're saving people three to nine months of time in a startup environment. You even mentioned it before, how funding is absolutely crucial to getting nine months of funding.

Wow. Yeah. Actually getting toward finish or getting market, I guess you could say.

[00:34:40] Andrew DiMeo: It impacted our company, Novocore Medical Systems. Myself and the other two founders, we knew exactly what we needed to do. We sat down and took three months to get it done. And we missed a funding round because of time.

If we had gotten done three months faster, we wouldn't have had a failed company. Now, do we wanna point it at one thing? It was this one thing. Reverse engineering design controls. No, but every minute counts. Every day counts. Time counts. And we lost three months reverse engineering our design history file.

[00:35:18] Ty Hagler: Now and to your point, design medical devices take so much time to get through all the different stages that they go through. To your point earlier, if you don't take that time to document as you go, then you have that telephone game of the handoff point from, one set of observations to the next because there will be a lot of different people that touch this thing if it truly, has value and it's gonna benefit and get funding and all of that.

And different people will come in at a later stage and see the predicate work that was done and be trying to interpret it. You want to give them as, as much insight as you can documenting where you are at that point in time. All right. So Kahren has a question. I'll read it off and we'll see.

Andrew, if you can take it. Sure. So can the Strategy tool be used for service development too? And how would that vary? So right now you've got it designed for medical devices.

[00:36:12] Andrew DiMeo: Yeah medical devices is our passion. It's our target audience. We're with Greenlight Guru. We're really focused on the med tech industry.

There's no reason why you can't use Strategy for any evolutionary process. One of the things that I can mention right now is that we're in a beta and we've launched this with what I'll call templates. So there's nine templates that are in there. There's a few that are really specific to medical devices, like a Hazard Analysis, a Risk Assessment, the Trace Matrix.

These are really specific to what you'd be doing for med tech. But then there's other templates in there, like a swap, like important satisfaction which you could use for any industry sector. What is the number of templates we're gonna have where we really wanna listen to you, the beta users cuz we deliberately didn't put a lot of things in there, so you won't see, say business model canvas in there. But if we get tons and tons of people saying, Hey, we'd really like to do business model canvas then we'll put it in there.

So we wanna listen to what the users want as far as workflows, templates, et cetera.

[00:37:20] Ty Hagler: Do you mind talking to what it looks like to add a new template to this? Is that something that like, I guess it needs to happen internally to add a new template?

[00:37:28] Andrew DiMeo: Yeah. Right now our process is we as a team, we call ourselves by the way, the Canvas GT squad. So we hold on to the original name in our squad name. But we evaluate the priority of a new canvas template based on the feedback from the users. And then it's a process of design, right? We're gonna go through an evolutionary process of what is the layout.

I can tell you right now, like our current Trace Matrix or Traceability canvas might not be the final rendition, that is still evolving based on feedback that we're getting. We'll take some time if it's something ready to go, like a business model canvas, that's quick because it's already designed, it's laid out.

We do have to think about how we might want the table to look or what we might want the table to do. Cuz we're implementing both a board and a table for every canvas. Does that table enable traceability? Like you saw? Does that table enable some score producing some output like you saw on importance and satisfaction?

So there would be some work but it's not instant. It's not like we just hit a button and launch it there. We take some time to develop it.

[00:38:40] Jared Gabaldon: I was just curious of your inspiration to create Canvas GT seems like you've done so much of real world experience and was it like you discovered wow, we really need a better process for actually getting something to market and, like tracking all of this or I'm just curious of what was the origin behind that?

[00:38:58] Andrew DiMeo: I think, it was stars aligning every stop I took along the way including, especially at Trig, I'll tell you that story too. Early in my career when I was a young Design Engineer, I went and talked to the document management folks at my company and said Hey, I'm the Design Engineer.

This is the standard operating procedure for design controls and I can't like really work under this system, it's constraining. It really is constraining me, and they're like, Rewrite it, I was like, Oh, okay. So all the FDA cares about is that you have implemented a controlled process that you repeat over time.

So I actually rewrote, the document to make it less constraining, you make it easier to work with. I ended up writing design control standard operating procedures. That was some of my very early consulting work. Was writing those procedures for other medical device companies up to a billion dollar medical device company.

I wrote a design control process for early, early on. I was really impacted early on by one of the brightest, most energetic young Engineers coming to join our team at Alaris Medical Systems.

After a few months he quit and he is, I can't take it, it's like I'm trapped in a box. He was like, felt constrained and he quit. And when I got in front of my classroom, Students at NC State, I was like, We need you. We need your young, bright, innovative minds to be the future of healthcare for our nation.

You have to be creative. You have to be that creative genius. You can't allow these boxes to make you miserable so that you leave our industry. So it was like very passionate about keeping creativity in the process and part of it was just freedom to do so, right?

There's nothing stopping anyone from being that Chef and maintaining that notebook, right? You can do both. But I was constantly looking for ways and I've got some sketches in a notebook from months before joining Trig on this idea of using frameworks to Enable Evolutionary Design.

I wasn't calling it Evolutionary Design at the time. But it really wasn't until when I was at Trig, all the pieces came together. We were doing consulting, we were working with small businesses. We were using other visual collaboration platforms. We were using one called Battery.

We were using another one called Mural. We evaluated all. I was evaluating like dozens of different virtual whiteboards solutions. And it was listening to those that we were consulting with. Hey, we've done all this work on this whiteboard. Can this be our Trace Matrix?

And it was like, Man, it could be like, that would be awesome. Whoa. Could be right. So it's like, you know, 25 years of pragmatic creativity, like all came together with this idea. I feel I'm still at the very beginning of this journey. It's just starting.

[00:41:54] Ty Hagler: The idea of, and you've taught me this, that if you're not having fun designing a medical device, like something's wrong. And it needs to be fixed and you're well on that journey of making it so that the joy of the creativity that you should be bringing to this can also be captured as you go and keep it fluid and flexible, but still at the same time, leave a trail so that other people can follow the breadcrumbs and be able to improve upon your work if they need to pick up on it later.

[00:42:23] Andrew DiMeo: As a Design Engineer, my very first ever job I went and hung out in the manufacturing floor where hand assembly of products was taking place. I would talk to the people that worked on the line hand assembling medical devices and they would talk to me about certain processes.

Were easy, like it made them happy, but certain processes would literally be giving them arthritis. And I'm thinking like what I'm doing in CAD over here can give the person on the manufacturing floor arthritis, right? So how is that improving the quality of life? I would talk to my students about this, this is cradle to grave, improve quality of life.

We want to improve the quality of life of the people that are working at the medical device companies, those people that are on the manufacturing floor making the product wanna improve the quality of life of the people that are using the medical devices, maybe the Doctors, the Nurses, the Caregivers, the quality of life of the people that are receiving those medical devices.

What about me as the Design Engineer? Like, how about the quality of my life? And so can we improve the quality of life of those people that are day to day doing medtech? Can they be having fun too?

[00:43:37] Jared Gabaldon: I have never even thought of that before. Like thinking about the people on the manufacturing line, right? Improving their life. That's incredible. I know we're coming up on the hour and I know there's a whole bunch of stuff we haven't talked about. So I think, I'll just fast forward to our last question and we'll wrap up from there. So I'm just curious of, what advice you have for, the young professional that, wants to become an Entrepreneur and they don't really know where to start, but, they're just really, they're invigorated by it, but they're just raw energy at that point.

[00:44:04] Andrew DiMeo: Yeah. I'm gonna circle it all the way back to being an Entrepreneur as a social service. We want to bring an innovation to the world. That innovation should inherently be something that improves people's lives in some way, you know, makes things more efficient, makes them more fun, but we're bringing something good to the world.

At the same time we're providing jobs for other people. We're creating a place where people can work and become prosperous, have families and insurance and all this stuff, right? It really is about a social service endeavor and be ready that the decisions that you make are impacting other people's lives.

People are quitting their jobs or making career choices to come and work with you. So if this is, Hey, I wanna be an Entrepreneur cuz I wanna make, I would check that and ask yourself why do I really wanna do this?

[00:45:04] Jared Gabaldon: I think on that note, Andrew, thank you so much for coming on. We really appreciate it. Professor DiMeo of Greenlight Guru, just thank you so much for your time. We really appreciate your insights. Thank you.

[00:45:13] Andrew DiMeo: My sincere pleasure. Thanks for having me.

[00:45:16] Ty Hagler: Absolutely. Thank you, Andrew. All right, and thanks to everybody else for joining us, and we'll sign off from there.