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Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students learn and understand the importance of quality systems, design controls, and risk management. By collaborating with the Joint Department of Biomedical Engineering (BME) at the University of North Carolina and North Carolina State, Greenlight Guru’s efforts benefit both students and staff.
Today’s guest is Devin Hubbard, UNC/NCSU teaching assistant professor, who describes how Greenlight Guru has made him a better educator for BME students.
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Some highlights of this episode include:
- Students were told what to do, not taught why to control quality, design, or risk. Greenlight Guru solidifies their understanding of the concept to make that connection.
- The Risk Matrix is used to teach BME students which design controls need to be added to manage different levels of risk.
- Devin appreciates the Design Control Matrix because it captures user needs through validation.
- It’s difficult to teach the subtleties of the design and document control process, along with what some people consider unrelated links, such as risk.
- Using a spreadsheet for traceability caused problems for Greenlight Guru’s 510(k)s. It was the driving force behind the creation of Greenlight Guru’s Traceability Matrix.
- University students create a perfect test environment. If a concept isn’t clearly explained, then implementing it in the classroom will be a complete disaster.
- Students, and those who hire them, are impressed by their ability to articulate an understanding of quality systems, regulatory affairs, and risk assessment.
Links:
Devin Hubbard
FDA’s Waterfall Diagram
Episode 61: Helping Prepare Biomedical Engineers Entering the Workforce
Andrew DiMeo
FDA Premarket Notification 510(k)
MedTech True Quality Stories Podcast
Greenlight Guru
Memorable quotes from this episode:
“It’s really important for biomedical professionals to be knowledgeable, and maybe even somewhat proficient, with what a quality system is, what a regulatory strategy is...” Jon Speer
“Working with Greenlight and using the software really allows teaching the regulatory and risk analysis assessment and quality systems a lot easier.” Devin Hubbard
“University students are just a perfect test environment. They’ll break it really quickly, and I don’t mean that as a bad thing.” Devin Hubbard
“I always describe risk and design control - they’re really the same coin, there just two different sides.” Jon Speer
Transcription:
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: For the past couple of years at Greenlight Guru we've been working pretty closely with the joint biomedical engineering departments at the University of North Carolina and NC State. And this started with a connection with a guy by the name of Andrew DiMeo, you might have heard a previous episode on the Global Medical Device Podcast, with Andrew, but really great opportunity to try to help bridge the gap that I've seen and others have seen in the biomedical education. And that is learning about quality systems and design controls, and risk. All the things that medical device professionals need to know about in their day-to-day job. Why not bring some of that learning into the university educational setting? And so UNC, NC State, has been leading the charge. They've been pioneers in trying to do so, and partnering with Greenlight Guru. And I had a chance to meet with Devin Hubbard a few weeks go. Devin is the teaching assistant professor at UNC/NC State joint Department of Biomedical Engineering. And we met a few weeks ago, he said something about how Greenlight has really helped him be a better educator, especially around things around design controls and risk. And I thought, "Wow, this would be awesome to have a further conversation and share that experience with all of you on the Global Medical Device Podcast."
Jon Speer: Hello and welcome to the Global Medical Device podcast, this is your host, founder and VP of Quality, and Regulatory, at Greenlight Guru, Jon Speer. And I'm pretty excited today. I know you all probably think that I say that this is an exciting episode every time we do an episode, at the Global Medical Device Podcast. A little hint I get excited about this stuff. So for me it's super exciting. But I'm gonna say today is special because I get to talk to Devin Hubbard. Devin is a teaching assistant professor at UNC/NC State joint Department of Biomedical Engineering. So Devin welcome to the Global Medical Device Podcast.
Devin Hubbard: Yeah, thanks, it's a real honor to be here.
Jon Speer: And I'm excited because you and I actually had... We've been working together for a bit, some of those who've been listening to the Global Medical Device Podcast, may be following along, might have remembered a story a while back with Andrew DiMeo. Andrew and I agreed a few years ago to partner and explore something with the biomedical program at UNC and NC state. And you have picked up the torch and been running with it now for I guess about a year-ish or so?
Devin Hubbard: Yeah, that's right.
Jon Speer: And you and I had a chance to meet face-to-face a few weeks ago and it was just fascinating. So I guess, tell the folks a little bit about what you do and a little bit about... Because I think the fact that UNC and NC State, at least in my mind, I think of those two schools as kind of fierce rivals especially on the athletic fields. So how does it happen that two schools like that have a joint biomedical program?
Devin Hubbard: Yeah, let me talk about that a little bit. It's actually a really interesting program. So the UNC and NC state joint program has gone back... I mean the history began sort of in the '90s but fast-forwarding into the 2000s. The graduate program became joint in the early 2000s. And the reason I think it makes a lot of sense. So the universities are just about 20 miles apart and at NC State or North Carolina State University, we have the College of Engineering and we have the College of Veterinary Medicine, which is incredible, both of them are really highly-ranked. And over here at UNC which is where my main office is, we have the school of medicine, pharmacy, so we have sort of the Medical Sciences. And fast forwarding a little bit more in a couple of years ago in the, it was 2013, we became joint at the undergraduate level. And I think it makes sense at all, of the foundational levels to combine the two into a single program because of the resources at both campus.
Devin Hubbard: So the real play is that we have an incredible set of resources. We've got physicians in the UNC Hospital network, we've got incredible engineers, over at NC State, we've got an incredible college of veterinary medicine, school pharmacy. So it was really a play to help leverage all the resources and make them accessible to as many different people as possible. So all of the faculty members and students all the way down to the undergraduate level are essentially dual enrollees at both universities. So, I'm appointed at both and all of my students who are undergrads, they are also students at both universities and they have a shuttle, so it's really nice. They can travel and do research at both campuses. And I think where it gets interesting for us today is that the design program is sort of now completely joint. So... And that's kind of where I come in. So my role, my primary role here in the department is that I help run the capstone design course, which we're going to be revamping in the coming years but right now what it looks like in the course that I teach, and I think for the audience listening they may wanna know. We have a two-semester long design sequence, and in the fall, our students are shadowing clinicians.
Devin Hubbard: We have a handful of large hospitals here in the triangle. So UNC being one of those that we work with and we work with several others. And our students go in and they shadow for six to eight weeks in the fall and during that they're beginning their sort of four phase design experience and they're identifying unmet medical needs. We have physicians that have been on board with us for several years at this point, and they sort of understand how the process works. So our students are immersed in the clinic and they are looking for unmet medical needs, they sort of come back, they start building their network, they begin brainstorming to invent a new idea and then they move into verification, validation, and implementation as the semester goes on and as the year goes on. And by the time they get to May, at the very end of it, they sort of have a gigantic symposium, where we invite all their industry and clinical mentors and academic mentors to come see all the hard work that they've put in. And by that point, they typically have or they're required to have, I should say, a proof of concept.
Devin Hubbard: The other interesting thing that I think is relevant for our conversation today is that we also run a quality system in the background, and this is where Greenlight comes in. So historically and when Andrew was working with me prior to his departure, to go work at Trig, he had implemented a design history file over on the NC State side of things. And so when I came on board about five years ago, we had a conversation that went kinda like this, "Hey, these paper DHFs, they're a lot of work. Wouldn't it be great if we could move to something that was a little bit more manageable and easier to share across campuses?" One of the reasons being to enable our teams to be joined? And the first year that I came on board, we had a joint team, and we didn't really have a great way of tracking their progress, and so they actually had sort of separate DHFs, and that sort of forced us into a position to start exploring the options. And I think that's kinda where the story with you and Andrew began.
Jon Speer: Yeah. Yeah. I always... I have to go back to the memory banks to try to recall exactly how they got connected. And, Devin, I don't know why, but for the life of me, I don't remember how exactly. And maybe it's a irrelevant point, I won't spend any more cognitive load, at least in this conversation, on that. But yeah, we did talk a lot about... He... Andrew came from industry first before he was teaching biomedical engineering. And I know one of the things that he was trying to do is reduce to practice, so to speak, some concepts around quality management system and design controls and a design history file, and actually bring those learnings into the classroom setting with undergrads and graduate students before those folks would enter into the workforce. And he shared stories about having a lot of I'll say "paper-based forms" and templates that... And setting up, I don't know if he had SharePoint or Dropbox, but some file tree structure that he had set up, and he talked a lot about how that was really a nightmare to try to maintain and manage on an ongoing basis.
Jon Speer: And it was helping to close the gap a little bit, as far as the theory versus the practice, but there was still quite a bit of gap there. And then enters... In comes Greenlight into the equation, and he starts to play with it and starts to close that gap even further. And then this is where I think you've done a fantastic job of taking that torch, yeah, a little bit further and really solidifying how folks... Students that are learning how to be biomedical engineers... I've been preaching this for a bit, I think, it's really important for bio-medical professionals to be knowledgeable and maybe even somewhat proficient with what a quality system is and what a regulatory strategy is and what design controls are and risk and so on and so forth, so I'm really glad to see that you and the students at UNC and NC State have embraced this notion as well.
Devin Hubbard: Yeah, it's been a really interesting learning experience. I've certainly learned a lot about it, and I think you and I spoke recently about this, but I think one of the things that it does for us is working with Greenlight and using the software really allows teaching the quality management system... Well, I should say more broadly, sort of regulatory and risk analysis assessment and quality systems a lot easier, especially in the context of the sort of subtle links between design and document control and risk assessment, for example. And I can go into that for sure. One thing that I should mention is, up until recently, we just sort of told the students like, "Here's how you're gonna do it," and we never taught them, "What is a quality system? What does it mean to keep document control and to keep design controls? What even are design controls?" We never really... I wouldn't say we went into great detail on that, but I think one of the things that, at least from a... Even just the visual layout of Greenlight, allows a lot more connection building. I should say, I haven't studied this, but my anecdotal observation is at least the students seem to be grasping the concepts a lot more deeply.
Devin Hubbard: And so one example of that, and I think this is something that you and I have talked about recently, is the risk matrix. So one of the things that I've historically found a little challenging to implement is how you teach students who are going through the design process and think... Put yourselves in their shoes. There's just students who have... They're coming to the end of their college careers, they're still learning, they're working on implementing their skills, and now, we're giving them this brand new management system that's requiring them to learn a whole new set of skills. And I think because of that, when risk assessment becomes abstracted from document control and from design control in a way that, I think, it's easy for a student to say, "Well, I'm just doing this for a homework assignment. Check, check, check," right? One thing that I think is nice about Greenlight... And there's many things, but this one in particular is, if you go to your risk matrix, you can see how your design controls are linked to your risk assessment.
Devin Hubbard: So when I have a student or a student team who's going through and evaluating their product idea, we can go through their risk assessment, and I can look at individual elements in the risk matrix. And let's say I pull a single harm out, and say, "Well, this harm is of medium risk." Or, "The residual risk at the moment is medium. So let's take a look at what design controls you have in place to help manage this risk." And then that kinda drives that tangible connection so that I can say, "You need to go back and add a design control," or more importantly, they recognize that they need to go back and add a design control or a set of design controls for a particular risk. And up until this year, we haven't really used that as a tool, and this is the first time I'm seeing our students kind of have that click kinda, "Aha," moment where they recognize that risk assessment informs their design as much as their design informs their risk assessment, at least in the class.
Jon Speer: Well, I think more than the class. And my strong personal opinion is that that's a distinction or a connection that those of us in industry should also be making. And I think, and like your students, this is a problem or a challenge that the medical device industry has faced. We look at, oftentimes, unfortunately, the risk management or the risk assessment type of activities somewhat autonomously from design and development. And I think in large part of that has been driven because oftentimes, you've got your risk spreadsheet that's over here and you've got your design control information that's over there, and there's no good way to connect these things. Sometimes, you get a little cute. You might write a macro or a hyperlink and things like that, but there's all sorts of problems with that. So that's one of the reasons frankly why we built that functionality within the Greenlight workflow is to connect the dots in a way that that's meaningful and that to your point, risk can help drive better design. Or your design can make sure that you're capturing things from a risk perspective. I always describe risk and design control, they're really the same coin. They're just two different sides. I don't know if that makes a lot of sense, but that's how I've kind of conceptualized it.
Devin Hubbard: I agree and I think that I should... Full disclosure here. I've learned a lot of this on the job here. My background is biochemistry and a researcher, so I spent a lot of time doing mechanical and electrical design and rapid prototyping. Before I came here, I was firmly in the pre-design history sort of space. So I think for me even using the software has helped solidify the understanding and the relationship between risk assessment and risk in general and the design process. And from a educational perspective as well, one thing that I appreciate about the Greenlight interface in addition to the link between risk and design and document control is just the layout of the design control matrix. Again, this is a topic that I've had to teach before so how do you teach students the design process? So we use the Stanford bio-design model and we sort of tweak it. But then you look at the FDA's waterfall diagram and so, you're telling students, "well, follow this innovation process," which is pretty much an entrepreneurial process with sort of a twist with regulation and reimbursement tapped onto it.
Devin Hubbard: And then you show them the FDA's waterfall diagram and say, "Well, this is the design process that the FDA wants you to follow". That can be really difficult to connect and they, again, are separated. And one of the things that I appreciate about the layout of Greenlight capturing user needs all the way through validation in the matrix format is that, when I go to teach that in my class, the link is much more apparent because the need-finding exercise that they do at the beginning, for example, of the bio-design process. That is explicitly captured in the user needs, the output from that activity is the list of user needs for a given problem. And so, that is something else that I think I appreciate greatly about the format of the design control matrix and then, the addition of the link to the risk assessment component of things really, I think, helps... I don't know. Make those subtle connections that... Even earlier today, I was on the phone with a colleague and we were talking about this how it's difficult to teach the subtleties of the design and document control process, let alone the links between what some people might feel are unrelated areas like risk, which I totally agree with you is sort of just two sides of the same coin.
Jon Speer: Yeah, I wanna dive into that a little deeper. Folks, I wanna remind you. I'm talking with Devin Hubbard. Devin is a teaching assistant professor at UNC/NC State joint Department of Biomedical Engineering. And we're talking a little bit about how this program has adopted the use of Greenlight to enhance the biomedical student learning with respect to things like quality systems and design controls and risk and document management, and all these things that really are important and foundational to a medical device professional. I wanna remind you while taking this short break too that of course you're listening to the Global Medical Device Podcast and yeah, we've done over 100 episodes of Global Medical Device Podcasts, hard to believe.
Jon Speer: You might not have realized that we also recently launched a brand new podcast. Yes, that's right. In addition to the Global Medical Device Podcast, we are now featuring exciting episodes on the Greenlight Guru, MedTech True Quality Stories. So you wanna check that out as well if you're listening to the Global Medical Device Podcast on iTunes, or SoundCloud, or on the Greenlight blog. Wherever it is that you're consuming it, go check out MedTech True Quality Stories. Some really exciting stories from C-suite executives and other med device professionals and their quest to bringing new products to market, and hearing some real-life stories and some of the challenges and trials and tribulations that these folks have faced in their quest for true quality. So go check that out.
Jon Speer: Alright. I wanna dive back in Devin, to talk a little bit more about design control and I wanna, I guess, peel back the layers a little bit. So you talk about traceability. I'm gonna confess to you, and maybe you already knew this and maybe those listening already knew this as well. The reason Greenlight actually started as a company over five and half years ago, I was struggling as a project manager with this concept of traceability. Not because I didn't know how to do it, but the tools that were out there were... They were poor at best and in fact, I always resorted to a spreadsheet because frankly, at that moment in time, that was the best, most usable way to keep track of this. And traceability hit me front and center... Gosh, this was probably... I was probably 23, 24. Pretty new in the industry at that moment in time and managing a device project and we were trying to achieve 510(k) clearance, and we were about a week away from a 510(k) submission. And I decided... No one told me it wasn't a requirement, it wasn't even really known as a common practice at that era. Granted, this was almost 20 years ago, but.
Jon Speer: I decided to construct a traceability matrix, figuring out what was connected and making sure that we had linked user needs and inputs and outputs and verification and validation. And in doing so, I found that I had some holes, if you will, in information. And specifically, I was missing biocompatibility testing for a particular material that was most definitely gonna be required to support our 510(k) submission. And the fact that I had missed that about a week before our 510(k), not a good experience because that meant that I had to go deliver bad news to my boss, that meant that the 510(k) was gonna be delayed. It meant that getting to market with this new product was gonna be delayed, but it also meant that there was another $15,000 from a budget standpoint that we hadn't allocated in order to conduct that test. I wasn't ever gonna make that mistake again, but over time, over the next 15 or so years, 20 years or so, this spreadsheet to manage information, it breaks down eventually and becomes a challenge.
Jon Speer: The moment you publish a traceability matrix in a spreadsheet format, it's probably wrong. It's just too dynamic, especially at certain stages in development. So that's what drove the creation of Greenlight in the early days. And of course, we've continued to build functionality from then until now. But I love when you shared the other day that you used to teach the "waterfall" diagram. And conceptionally, students were not able to connect the dots as to why this was important. And then you talked about your experience with being like... Can you maybe just elaborate on that just a little bit? I know you touched on it a few minutes ago.
Devin Hubbard: Yeah, okay. And I actually have another comment that follows up in your earlier discussion about traceability. We ran into this issue with traceability matrices where exactly what you were describing happens, it's so dynamic you can't keep track of it. And in a way, maybe university students are just a perfect test environment for these sorts of things 'cause they'll break it really quickly, if that makes sense. And I don't mean that as a bad thing. It's just if a concept doesn't explain exactly crystal clear, then implementing it will be a complete disaster in the classroom, and that's no different for the waterfall diagram. So, in our case, it was sort of, I wanna even say it was almost an after thought. Here's this thing you need to know about and that was as far as it went.
Devin Hubbard: And the problem or the challenge for us was, at the time, the way that our quality system and the documents that we were capturing, and the information we're capturing was formatted in a way that didn't really align well, if you ask me, with that design process that follows the traditional waterfall diagram. And so, when I described what a design review was, from the FDA's perspective, but then turned around and said, "Oh, by the way, in a week, you have a presentation that's your design review, where you're gonna stand up and essentially give a pitch." That's so different and it kind of, I think the disparity between the regulation and what we were actually doing was large enough that it didn't really solidify in the minds of our students much more than just the language. So, beyond being able to say, "Oh yeah, I know what the waterfall diagram is. I don't really know how to use it."
Devin Hubbard: I wanna say that it would have been a stretch to say that they could put that together, the design process with the regulatory pathways. Whereas now, we've reformatted our documents a little bit, but in large part, it's a little easier with the visualization tools of Greenlight having to enter what the user needs are in the design control matrix. In the order in which they go, it's easy to see how a design review inside of Greenlight is different from what we would call a design update, now we changed the language a little bit. So, I think that's the biggest change that we've made that helps harmonize that a little bit. I don't know if that... Is that what you were getting at?
Jon Speer: Yeah, yeah, it's definitely what I was getting at, and I know it's a little bit anecdotal but, and obviously, you have a strong opinion from the eyes of the professor, so to speak, but I guess give a little bit of context. What are some of the things you've been hearing from students?
Devin Hubbard: Yeah, so, I think perhaps another important thing to think about is what we're hearing from the people who hire our students. So, first of all, on the teaching end of things, a lot of what we used to hear was sort of, "Well, why are we doing this? Why am I recording all this paperwork, paperwork, paperwork? It's really burdensome." And I think it does come back to the idea, you've spoken about it in previous podcasts of instead of being reactive to regulation, it's best to just be prepared at all times, and I totally appreciate that. And I think it's difficult to teach in the absence of a good tool for that, and for us, it's Greenlight. And to comment about what we see from the people that hire our students, knowing the language is great. It gets you in the door for an interview, and you can learn a lot on the job, but if we're helping our students prepare and really understand the implications of the entire design process and the regulatory infrastructure associated with that, it helps our students get into more positions.
Devin Hubbard: So, I'll give you some examples. Prior to implementing this, we rarely saw our students go into quality, at least the ones that hadn't been exposed to the design history file. In the last three years, I've seen, I don't know if the percentage is accurate but a relatively high percent of our students will take quality or regulatory positions because they can speak the language. And oh by the way, they've also worked with physicians in the hospital and can speak the language of medicine, and they can also speak the language of engineering, as well as regulatory and quality. So, I think from the hiring perspective, even this morning, I was giving a recommendation for somebody and that came up in the conversation was, "Well, we're really impressed with your student's ability to articulate their understanding of quality management systems and regulatory affairs and risk assessment."
Devin Hubbard: So, I think what we're seeing from feedback for those that are going into industry and from the people that are hiring them is that, understanding this process is not just some burden and checkbox that you have to do for a class, but as this is the way that we document what we do, and it's just part of the whole process. I think it's lowered the, I don't know how to describe it, maybe the busy work factor involved, if that makes sense, or at least the perception of it.
Jon Speer: Yeah. Yeah, it does. 'Cause that's what a lot of, well not just med device professionals in general, but certainly engineers sometimes I think look at things as design controls and some of the things that they have to do to comply with their quality system, as busy work. Yeah, it's a common mindset for sure.
Devin Hubbard: Yeah. Well, one of the things that I think is also interesting about biomedical engineering in particular, and I'm sure there's probably people who will disagree with me on this, but if you compare BME to something like a mechanical engineering or electrical engineering, the foundation of a lot of what we teach in mechanical and electrical is at the end of the day, safety for people. And I find it intriguing that that doesn't really crop up in the biomedical engineering curriculum in general. And it's sort of like this, "Oh, by the way, you need to know about regulation." And that's surprising to me, in a way, because I think one of the defining factors that goes into mechanical, electrical and the sort of what we would call traditional hard technical engineering majors is that the regulatory, well, maybe not the regulatory, but certainly the safety and risk components are just baked into the curriculum. Maybe you're taking a statics course and learning about the failure of a design because of a material selection and that's important in medical devices just as it is in designing a bridge. And yet, I would say that in my experience at least in biomedical engineering programs that is, it's not explicitly tied to the material if that makes sense.
Jon Speer: Absolutely makes sense. As you're describing some of the... And I love what you've shared about the UNC/NC State program because I guess I didn't technically have a biomedical undergrad, I actually am a chemical engineer by degree. But I took some biomedical engineering courses back in the late '90s and I had some friends who took some too. But I would say as far as the courses that we were taking, and that being really applicable to being a medical device professional, product development engineer or what have you, there was a big delta between what was being taught and what was being expected, in practice. But what I love about your program is that you've closed that bridge or you've built a bridge and closed that gap a great deal, the experiences that your students are getting, they're pretty comparable to what certainly an entry-level position is going to be exposed to. So your students will have an advantage, I think.
Devin Hubbard: Yeah, and I think one additional advantage to our setting is that because we're in a university setting, even on the first day of class, I say, "Look, everyone here this is one of your last opportunities if not your last opportunity to try wild things and fail in a safe environment." So one advantage that I think we gain, just being in a university setting and teaching design the way that we teach it is, our students have the opportunity to learn this once, make a bunch of mistakes, and when they leave here, and get hired, they're that much further along in the process, and instead of making a large mistake when they get to where they're going, their mistakes will likely be a little more subtle at least that's the hope.
Jon Speer: Well, unless it's... Engineers are gonna... Well, everyone's gonna make mistakes, it's human. But it's the mistakes in... Like we said a moment ago, about keeping the focus on improving patient safety, and quality of life. I'm paraphrasing a little bit about what you said. I think the sooner that we as medical device professionals can start to wrap our heads around how important that is. I got into the medical device industry, mostly because I needed a job, quite frankly, [chuckle] back 20-something years ago. I hadn't really wrapped my head around the bigger objective, the bigger mission, the things that I'm going to do as a medical device professional are going to have an impact on humanity. So hopefully it's a good impact and not a bad impact. So I think the fact that you're pulling that into the educational environment is huge, huge.
Devin Hubbard: Yeah, I think your point is exactly right, at the end of the day, what our students... If we ask our students why they chose Biomedical Engineering, most of them say, "Well, I just wanna help people." At least that's the most common response that we hear. It's, "Oh yeah, and also, by the way, it's a really fun career." Most of them are saying we wanna help people. And to do so safely, is an important factor, it's the most important factor that goes into getting your device approved for use. And so, that's the mentality that I think Greenlight helps us back up, is we can say, "Well here's how you demonstrate that for this indicated use that you've appropriately documented and taken all the necessary steps to ensure that you're ready to show that your device is safe and effective or at least, as safe and effective as other device." You know?
Jon Speer: Yeah, absolutely. So Devin, I know that you and I could talk for the rest of the afternoon [chuckle] and have a great time. But let's kinda put a wrapper on this episode of the Global Medical Device Podcast, what are maybe a couple of tips, or pointers or suggestions or things that you want our listeners to think about or consider?
Devin Hubbard: Sure, yeah. For those of you that are medical device innovators and especially those that are teaching medical device innovation, I think I would recommend thinking about quality management and quality management systems in your course. I think it helps prepare the students for a career in industry. And particular Greenlight, you guys have been really helpful to work with. And I know that you're working with other universities as well. And I think that the layout of Greenlight happens to be such that it makes teaching some of the very difficult concepts, very tangible and easy in a way that I wanna say is akin to learning solid works if you're an engineer, or AutoCAD.
Devin Hubbard: I think for the people that are in industry that are hiring our students, there's also something to be said that maybe we need to improve our communication between universities and industry in a way that helps make sure that we close the feedback loop to our students. One thing that is important to me is that I'm teaching skills that are relevant to the students that are leaving to go to industry as well as medicine and graduate school. And I think to have that loop closed, I think there's a little way to go yet. And so, knowing what you all want is helpful to us and knowing that our students are prepared for this sort of thing, I think may be valuable to you. So those are the two big things that I can think of that I would want the listeners of this episode to take away. And most certainly, the importance of understanding the link between traceability, design control, document control, and risk assessment, and the tool of Greenlight is an extremely valuable one for teaching that.
Jon Speer: Those are really kind words. And Devin, I guess for those who might be listening who are looking to hire biomedical engineers into the workforce, give us a little bit of an idea, how many engineering students are graduating from your program every year?
Devin Hubbard: Yeah. So, in our program, we have 80 students per campus per year. So that's 160 that are graduating from our program, and all of them go through our design curriculum, so we have four semesters of design. And if we break the percentages down, just over half of them are going into industry. So we have about 80 students that are incredible. I kinda joke with the people outside this university in a way because Biomedical Engineering is one of the most high demand majors at both campuses, and because both campuses already attract some of the best students in the state and in the world, we end up with the best of the best students at these universities. And so, in a way it makes my job easy, but for the folks that are looking to hire, it's you guys, it's a gold mine seriously. We have really incredible students that come through.
Jon Speer: Yeah. And folks, I've had a chance to at least from a distance see and be a little bit tangentially involved in the syllabus of the curriculum. It's top notch. The students coming out of this program, they're coming out with quite a bit of a really hands-on, tangible experience that will make their transition into your medical device company much quicker than may be a traditional engineering graduate so it's certainly worth considering UNC/NC State if you're looking for biomedical engineers. And Devin, I'll include your details and information, and I'm sure that you can get folks that might be interested in talking to some of your students. I'm sure you'll get them pointed in the right direction. Folks, I wanna thank Devin Hubbard. Again, Devin is teaching assistant professor at UNC/NC State joint Department of Biomedical Engineering and I really loved having this opportunity to chat with you on this episode of The Global Medical Device Podcast.
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