Students offer hope for our future. They will be developing products that can save our lives, or at least improve our quality of life. We need to give them as much guidance and advice as possible.
On today’s episode, we have Associate Professor Andrew DiMeo, who shares his mission and what he is trying to do with the biomedical program at the University of North Carolina and North Carolina State University.
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Some highlights of this episode include:
- Andrew’s biomedical product development course is based on quality and regulatory.
- It is possible to be creative and innovative in a restrictive regulated environment, like biomedical engineering.
- Some people believe regulations/controls and the status quo prevent them from getting things done.
- The reasons why controls and regulations are necessary.
- How to prepare biomedical engineers entering the workforce.
- Andrew teaches students by using a real-life medical system.
- Regulations should be kept simple to avoid being too restrictive.
- Andrew describes a siloed world where collaboration is key.
Andrew Dimeo’s blog
FDA Quality System Regulation
The E-Myth Revisited
Memorable episode Quotes by Andrew Dimeo:
“The biomedical engineers are almost like glue. They wear so many different hats.”
“I’m going to show you how you can be innovative and creative within a regulated environment.”
“I can’t tell you how blessed we feel to have the generosity of Greenlight to give the students the opportunity to work in a real enterprise software system.”
Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.
Jon Speer: All right. This episode of the Global Medical Device podcast I really enjoyed the conversation that I had. In fact, I get a little emotional in the middle of the conversation. It felt really good to have this conversation because I really believe in what Andrew DiMeo, the associate professor biomedical engineering at NC State and University of North Carolina ... I really believe in his mission and what he's trying to do and the success that he's been having with the biomedical program at those institutions. I hope you enjoy this as much as I did.
Hello and welcome to the Global Medical Device podcast. This is your host, the founder and VP of quality and regulatory at Greenlight Guru, Jon Speer. I'm real excited about the conversation that we're gonna have today. I'm talking with Andrew DiMeo, associate professor of biomedical engineering at North Carolina State and the University of North Carolina. Andrew, welcome to the Global Medical Device podcast.
Andrew DiMeo: Hey, thanks so much for having me, Jon. It's a pleasure.
Jon Speer: I'm excited about this cuz you and I have had a chance to chat quite a few times prior to now, but I'm excited because of what you're doing. Why don't you tell us all a little bit about your background and your experience and the type of things that you get to do on a daily basis?
Andrew DiMeo: All right. Great. As you know, I'm a professor today at NC State UNC in biomedical engineering. I teach a class called senior design. At the end of the day, it's biomedical product development, innovation, a little bit of flare of entrepreneurship. But it's been a fun background to get me here.
I actually started my career in the New York City motion picture industry designing sets and doing set dressing, props. Went on to study physics and biomedical engineering in college and then went into the industry and worked at Alaris Medical Systems. They're now Care Fusion, part of a BD company. And there I was a design engineer, project manager and learned the whole medical device product development process cradle to grave. It really impacted what I do today. Went on to start my own product development service company called Gilero. They're now EG-Gilero and they're still doing great. And then I started a trade association for medical device companies in North Carolina and that was all prior to coming back and doing what I'm doing today here at NC State, which I've been doing for 12 years now. It's kinda hard to believe that it's been that long.
Jon Speer: I know. Time flies. And maybe it came out when we talked before, but I guess I didn't realize that you're one of the founding principles of Gilero. That's awesome.
Andrew DiMeo: Yeah. Man, those were some really fun days. We were three of us. It was Ted Mosler ... I'll give you ... If you know about Gilero, I'll give you a little clue. The three founders were Todd Korogi, Ted Mosler and Andrew DiMeo. And Gilero is the last syllable of each of our last names.
Jon Speer: And here I thought it was some Italian dish or something. That's really cool. And this was part of what I'm excited about today because when you and I have talked, one of the things that I'm passionate about is trying to share knowledge with people and specifically medical device professionals. And I think it's really important. I've done a lot of work with some different universities, biomedical programs. Sometimes I've gone there to speak or I've shared some content with college students and when I talked to you it was a little bit different. Maybe it's the industry background, maybe it's the entrepreneur background. I'm not really sure. But it was very clear that you structure your program for students in quite a different way. You put a much heavier emphasis on quality and regulatory for students. Why do you think that's so important?
Andrew DiMeo: Well, I gotta tell you this goes back the days that I was at Alaris Medical Systems with Ted and Todd and the team up there. I'll never forget. When I first started, I had never heard of the FDA's quality system regulations. At the time I had a masters in biomedical engineering, went to work for a medical device company and then it was just like read all these standard operating procedures, watch these videos, learn from the FDA. And it was overwhelming but it was just part of the job. To me, it was not that big of a deal but what I'll never forget was a young engineer ... I was a little older, for whatever it's worth. I was a little bit more mature cuz I had done some other things in the movie business and whatnot.
We hired a kid fresh out of school. He came from Penn State. He picked up and he moved to North Carolina, got a car, a place to live. He was starting a whole new life and he was this really energetic, young, creative kid and he was working for the product development group with us. And within a few months just was miserable. It was like he was trapped in this cage. And he hated it. He couldn't stand being in this regulated environment. And I thought wow, this is ... It just was a story that stuck with me.
And certainly when ... I had to maintain a design history file when I worked in those days and then when Ted, Todd and I started Gilero we had to implement our own quality system so we had to set one up. I had this experience of setting up a quality system for a company. And here I am hired to teach a senior design course in biomedical engineering at NC State back in 2006 and I had this ... My mission at the time was give the students the best education in the world. That's what I wanted to give them. How to do it. What was I gonna deliver to them?
I just wanted to give them the best of everything I knew from industry, which included quality system regulations. I wanted to find out what the best academic practices were going on in the world and there was a fellowship program going on at Stanford called bio design, which no one knew too much about way back then. The book hadn't been published yet.
But it was this story about this student that guided me in the importance of hey, I want you to live it now. You're gonna live this in this class. And two things were gonna happen. One, I'm going to show you how you can be innovative and creative within a regulated environment and how badly we as an industry need that. It's sort of like there's a group of people that fit really well into this regulated environment, but they're maybe not the most creative people. And then there's these really creative people that can't stand it and we're losing them and therefore the industry is losing very talented, creative people. And I wanted to be able to say you can do this. You can do both. And if you really do hate it, you found out here before you moved to a whole new state and started a new life.
Jon Speer: Yeah.
Andrew DiMeo: That was the inspiration at the beginning for sure.
Jon Speer: Yeah. And you said something there that I really wanted to add to what you said. Creative, regulated. Sometimes those seem like those are conflicting principles or criteria, certainly in our industry these days. The other thing that I see happening is for those who have stuck with it for a period of time, they get so disenfranchised years later that they lose themselves. They may still continue to go through the motions at their medical device company doing the thing that they need to do but they feel stuck working in too restrictive of an environment, whether that be perceived external regulations that are forcing me to do certain things or just internal processes that we put in place at company. I see that a lot, too, where people just get disenfranchised and they kinda lose their identity but yet they continue to go through the motions. And that's not fun, either.
Andrew DiMeo: Right. Agreed.
Jon Speer: I mean, I've been that guy. There's a time ... I used to work in industry for a large company years ago and I did a lot of work in product development for quite a few years and it's fascinating. When I tell people that I used to get literal cocktail napkin sketches from doctors for concepts and ideas and then I actually would take that and go to the next step, prototype, test, all those sorts of things. It seems like it's cliché but it is real. I've done it. You've done it.
Andrew DiMeo: Yeah. Absolutely.
Jon Speer: I mean, you're doing it now with your students I can imagine as part of the program as well.
Andrew DiMeo: Mm-hmm.
Jon Speer: But then there got to be a point for whatever reason I was trying to climb that later, you know? Just trying to get to that next step and that next step was more bureaucratic. It was more stifling and any creativity that was left in me at that moment of time completely got sucked out of my being and I ended up leaving the company a couple years later. At that moment in time I could not have told you why I left, I just knew I needed to.
Andrew DiMeo: Right.
Jon Speer: Something deep inside said go do something else. And fast forward many years later and starting Greenlight Guru we built this fantastic software platform. And I guess that's my message to folks is if you're in this industry or any industry, it doesn't really matter, frankly, be passionate about what you do. Love it. Embrace it. If you can't do that, then life is just too short.
Andrew DiMeo: Yeah. Yeah. You know what, it's ... I can't agree more. Be passionate about what you do for sure. I think it's kinda funny that here we are, both of us at a point in our career finding ourselves stifled in our jobs for whatever reason and I left and started Gilero and the first thing we did was set up a quality system because we had to. And you left and started a software system for maintaining quality, right? It's almost like the world that maybe caused some of the bureaucracy was also the place to be innovative in, you know? It's kind of an interesting-
Jon Speer: Yeah. I hadn't thought about that, but I always describe myself as a system thinker, you know? I can see flow charts in my mind of all these different process steps. But yeah, that's a really good point. The motivating factor for me to start Greenlight was the status quo of conventional wisdom, it was wrong, and it was preventing people from getting things done. Like I sometimes engineers say "Oh, I hate design controls." And I'm like, no you don't. You hate the process. You don't hate design controls, because design controls is what we do as product development engineers. We're all trying to design the best product possible that is going to be safe and effective for patients. And that's the whole premise behind design controls. So if you hate design controls, chances are the process that you're operating under is the wrong process.
Andrew DiMeo: Agreed, yeah. And or you just don't know why you're subject to this process, right? It's just something that's been put upon you without a particular reason, you know. If we can go to work and know, hey look, do you want your products to be safe and effective for the patients that they reach? Yes, of course I do. Well, we've gotta put some controls around that, you know? And so there's a good reason for these controls to be there, and in fact they're part of what makes the output of, the class that I teach, and companies that do a good job, what makes the output so good is because they're committed to a process of developing safe and effective products, in today's age that lower the cost of care and improve health outcomes also, you know? That's of course extremely important.
Jon Speer: Right, right. Folks I just want to remind you, I'm talking to Andrew DiMeo. Andrew is the Associate Professor of Biomedical Engineering at NC State and UNC, and we're talking a little bit about what inspires of course, but more importantly, what each of us can do to try to help, I guess, elevate the entire industry. We didn't say that yet, but that's really what we're trying to do is inform people about how to operate in a professional manner, but do so that promotes creativity and innovation rather than stifling it.
So, Andrew, I should have looked, but I didn't look and I can't remember off the top of my head exactly how you and I got connected. Maybe it was the universe that brought us together. I'm not so worried about that, but I'm glad that happened. And one of the things that, I don't remember if it was the first time we talked, or the second time, or even the third time, but there was a light bulb that went off for me as you shared some of your story and your background. And the light bulb was, this guy Andrew is teaching and working with students all day every day. And for years, I have been trying to communicate to other biomedical programs, I've been asked what can we do within our program to help better prepare biomedical engineers when they enter the workforce?
And every single time I said to them, you need to do more about teaching quality and regulatory. You need to do more about teaching quality and regulatory. And I spoke with you, you were telling me that, you know? And I was like "Hey, Andrew, I've got this idea. Greenlight Guru has a software platform, and eQMS software platform, that's designed specifically for the medical device industry. What if we work together to put Greenlight Guru in place as part of your curriculum, and enlist your students?" And you loved the idea, and now you've been using the platform as part of your courses now for I guess we're looking at almost two months. I'm curious, how are things going with that?
Andrew DiMeo: It's been just an unbelievable experience. I can't tell you how much, how blessed we feel to have the generosity of Greenlight Guru to give the students the opportunity to work in a real enterprise software system. It's like you can see on their faces that they know that they're doing something that's adding value for their future job search, you know? And so what it's done, when I started this course in 2006, I created a quality system in my head.
It's sort of like, I don't know if you ever read The E-myth Revisited, like when the technician goes to work, they just go to work doing what they do, and all the processes are not written down and formalized. And so the quality system came from my head to the students. Like "You will do this 5 phase process. You will complete all of these deliverables. This is how you will name them. This is how you will revise them." And it worked fantastic for the first few years when the class sizes were 35, 40, 45, 50, but as they grew to 60, 70, now we're at 80 kids in the class, that was not a very scalable thing.
Jon Speer: Wow.
Andrew DiMeo: And then it's another thing to have that's fresh out of industry bringing this to the table. That's been around for 12 years, now you're just like, you know, what you teach isn't taken as literally by the students as something that's important. And so, I've always wanted to make them live it. Like, this is real life. This is living in a medical device company. Every company has a system. And instead of using the system I've sort of ad hoc created for you in my head and experience over the past 12 years, you're gonna use a system that's real. A real quality management system.
And so I create this sort of simulation of a company. You don't come into my classroom, you come into a company. And we have a mission, and our mission is to produce proof of concept to fill an unmet medical need by the end of the academic year. You identify that need in a hospital at the point of care. You propose solutions, you take it through the product development process. This is a real company. And we have real outputs over the years. One of the companies ... we've had five spin-out companies come out of the class. This is not a [crosstalk 00:18:08] class, this is just a regular class required of all students. But the process itself is so rigorous and so good that the output is high quality output. And so, for example, 410 Medical, look it up, it's a company based in Durham, North Carolina. That started as five young women in a hospital meeting a clinician, Doctor Mark Peele, and that was sort of the beginning of what then became what is today 410 Medical.
And so I'm sort of simulating as real life as possible. But what Greenlight Guru has done is turn that simulation up, like an order of magnitude. The simulation is so much more real. You're not using my back of the book, back of the napkin quality system. This is the real deal right here, you know? And it's forced me to up my game too. Like when I said, I'm really starting company. I just got a new enterprise software package. I gotta learn this thing too. And I've been writing up, cranking out new standard operating procedures, new guidance documents, because with using Greenlight Guru we've had to institute some new best practices within our program that works for our company here inside the walls of an academic institution. It's just been, we've all grown for it. I've grown for it, the students have grown for it, it's been really an incredible experience.
Jon Speer: I'm really at a loss for words. And you can see my face. I know that those listening won't see my face, but thank you for sharing that, because I had no idea. I had an idea that it would be helpful, but I really had no idea how impactful that this little experiment that you and I came up with, I had no idea how impactful that would truly be. And I'm kind of emotional right now, but it's a good thing. It's a really good thing.
I'm so thrilled that we've been able to help with that, because we're at a time of a lot of uncertainty, well throughout the world, but certainly in the medical device industry right now. A lot of big changes that are happening, with all those changes in Europe with the regulations, all the changes with ISO 13485, the single audit program, and there are probably a few others. But now more than ever, we need some solid foundation. We need some certainty. We need some clarity. And we need some simplicity, not making things more complicated. There's way too many rules that seem to be put in place, and I get that you need some structure. I'm not saying we need anarchy, but we need some structure, but at the same time it has a diminishing return if it's too rigorous.
The light that we try to shine, I suppose, here at greenlight.guru as well, that let's just keep it simple. Let's keep it straight forward. Let's make it as easy to use as we possibly can, and do so in a way that really helps people understand why they're doing these things, so that's been great to hear.
I know enough about you that, you've probably shared just a small piece of who you are, and what drives you and you're passionate about. I've had a chance to read some of your blog posts. I'll be sure to share that with folks as well on the link that accompanies this. But I know you have a bigger idea. So, tell me, what is your big idea?
Andrew DiMeo: My big idea, it's about collaboration. I think my symbol for is this is, if you've ever been driving down the road and seen a cell tower wrapped in tree branch. Have you ever seen this, John?
Jon Speer: No, a cell tower wrapped in a tree?
Andrew DiMeo: Yeah, keep an eye out. Here, in North Carolina, I don't know if they're all over the country, but you can drive around and you see this tall, tall cell tower and they want to make it a little bit more aesthetically pleasing for the landscape, so they wrap it in, it looks like an artificial Christmas tree wrap. Forgive me for going into this area, but this is just ... I call it my symptoms for a siloed world. This is a world in which we have business people who identify and need and come up with the specifications and the requirements for such a tower. Engineers that build this tower. Designers who come in and, at the last minute, wrap it in tree branch. I just can't help but think, “Why can't all of these folks work together from the beginning and design an environmentally friendly, inherently beautiful, functional, affordable cell tower?”
My message in the medical device industry is, while it's not pretty in, say, telecommunications, it's the thing that's going to make your awesome innovations fail in the medical device industry. We can't afford to wrap it in a tree branch at the end. We, as engineers, need to be working with marketing, with industrial design, with cross-functional teams, the clinicians themselves, and trying to understand the needs from the very beginning. Documenting those needs from the very beginning. Doing a business case, understanding if there's a market, can we reduce the costs of care with a solution. Can we improve health outcomes? What is the regulatory burden up front? And think about all of these things at the very beginning, because this is the only way that really innovative products are going to find their way to patients.
This is what I'm really passionate about. There's no reason why we can't be doing this on college campuses. We've got all the expertise we need here, in a place like NC State. We've got a college of management, a college of design. We've got college of engineering, one of the best in the nation. We've got local hospitals that have so generous to open up their doors to us, hospitals like Rex, and Duke, and Wake Med. All the hospitals are welcoming our students in there and it's just unbelievable the generosity from the community, and companies like yours. We have all the pieces in place, but the silos have to come down. The silos have to come down for people to be able to work together to do this, to together make life saving, life changing products for everyone.
That's the big thing that I think about every single day.
Jon Speer: I don't remember if I've shared this with you, but at the risk that I have just pretend it's the first time you're hearing it. But for those who are listening, I got into the medical device industry accidentally. It wasn't a planned path. I have a chemical engineering degree and junior year, maybe senior year. I think it was junior year, I took ... engineers have to take electives and other engineering disciplines. And I'm like, “Great.” I had some friends that were taking some of the biomedical courses and they're like, “Yeah, you should try it.” If I'm being honest, it was actually because I needed a GPA booster and I heard some of those courses were a little bit easier. But, anyways, it was fascinating. It was like, “Wow, I had no idea.” Here, I'm probably 20, maybe 21, at the time and I hadn't even considered the possibility of being an engineer to design medical devices. The thought didn't even enter my mind.
I was in college in the late '90s and it was the dot com era. If you're a little bit younger, you may not know what the dot com era is, but you can look it up. All these tech companies were starting to just explode. So that changed the job market in a big way, especially for engineers. I remember, electrical engineers, computer engineers, software engineers, I think, they were getting, in some cases, six-figure offers right out of school and it was mind-blowing. Like, "What is going on? This is not real." But the other thing was happening in the chemical engineer job market, there was a contraction. There weren't a lot of jobs available. I had an opportunity to go work at a potato chip factor, but I don't even like potato chips. So I'm like, “Nah.” But I have friends who had opportunities, or had gotten job offers at, a medical device company, Cloak Medical, in Bloomington, Indiana.
They're like, “You should apply, they're hiring other engineers.” And I'm so fortunate that I did, because they took a chance on me. Maybe they just needed a warm body, I don't know, but I'm so grateful for having that chance. Once I understood the impact of what I got to do, one a daily basis, as a medical device professional, and the types of products that I can design, and the impact, and the help that products that I'm involved with provide to real patients all day, every day. I knew that I was never going to leave this industry. I know that even what I do today, that what we're doing at GreenLight is improving the quality of lives. That's why I do this.
Andrew DiMeo: Now you've got me speechless. Well, I'll say the biomedical engineering degree is rigorous in a really different way, because it's so diverse in what you need to learn. But, at the same time, a company, like Cloak, needs chemical engineers. Companies, like Intuitive Surgical, they need mechanical engineers. They hire all kinds of engineers. My phone will ring because I'm the guy who teaches biomedical engineering at NC State. I'll pick it up and it will be, “Hey, we're from Teleflex Medical, do you have any finance students in the class?” They need finance students. So everyone serves a really interesting role in industry. The biomedical engineers are almost like glue. They hold ... They wear so many different hats. They can communicate to different parts of the organization, and they're so good at that.
But the thing, when we get back to this collaboration piece, it's if we can bring these tools of quality and regulatory reimbursement, understanding medical economics, to those that really want to go into this industry. Those that really want to go into this industry, I think, include, not just biomedical engineers, but the chemical, and the electrical, and the mechanical engineers, business students, industrial design students, finance students, art students. They all play a role in the industry. And the more that we can expose them to the regulations that they're going to see, and the environment that they're going to be in, and how important it is to be working with each other now, while they're in college. They hit the ground running in industry and we can make the world a better place.
Jon Speer: For sure. Well, Andrew, this is ... I really enjoyed, yet, another installment in our conversation. I'm glad that we get to share this with the medical device world, and anybody else who might be a little bit curious about the medical device industry. Before we wrap up today, any parting words, or thoughts, or things that you hope that others may pick up from you, and I, talking today?
Andrew DiMeo: Wow. I just want to say, whatever it is that you're doing out there, ask the question, why? Why am I doing this? And have an answer that you can be really, really passionate about every day. Other than that, just thank you so much for your generosity, and working with me, and my students, and giving a new life into the class. At 12 years, we got a nice jolt and it's really nice to get that from Greenlight Guru.
Jon Speer: Yeah. Well, you're welcome. And, folks, I've been talking to Andrew DiMeo, the Associate Professor of Biomedical Engineering at NC State and UNC. I appreciate him sharing some of his insights, and this opportunity to chat, and share that with you today. As we've talked a little bit about today there, Greenlight Guru, you probably heard that a time or two. You may be familiar with what we do, but we have built a world-class, best-of-breed, software platform for managing all things quality. In a way, that makes it, I think, fun. Andrew, I guess, you can share whether, or not, students are having fun using the Greenlight Guru system, but I think it is fun, and it's straightforward, and it's simple.
If you're at a point where you're frustrated with design controls, or you're frustrated with your quality system, or you're frustrated with your CAPA, and you're looking for a better way. I do encourage you to reach out to us, go to Greenlight.Guru. A wealth of information on our website, but if you want to learn more, you can request a demo and we'd be happy to chat with you. As we wrap up, I want to thank all of you for listening and continue to share our podcast with your friends. We're found on the www.greenight.guru/blog. We're also found on iTunes, SoundCloud, and anywhere else, frankly, that you can consume your podcast material. This is John Speer, your host, the founder and VP of Quality and Regulatory at Greenlight Guru. And you have been listening to the Global Medical Device Podcast.
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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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