Etienne Nichols: 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.
Vernon Baker: In this episode, we talk a lot about implementing a QMS and what you need to do at the very early stages of building out a medical device company. But before we get too far, I wanted to say if you're looking for assistance in implementing a QMS, rook quality system specializes in quality management, system design, customization and implementation. Their experts create tailored solutions that streamline your processes and ensure compliance. So if you're interested in building your ideal qms, contact rookqs.com dot. Hey, everyone. Welcome back to the podcast. My name is Etienne Nichols. I'm the host for today's episode. We're going to be talking to a specific audience. I think it could be applicable to a lot of people, but I particularly want to approach an audience of early stage companies. Maybe the CEO, maybe the founder, maybe someone who needs to hire a quality manager. And this is going to be one of your first quality hires. And so I brought in Vernon Baker. He's one of our medical device gurus. First of all, how are you doing, Vernon?
Etienne Nichols: Good. Great to be with you. Good morning.
Vernon Baker: Great to be with you as well. You've gotten a lot of praise across the company from me. I've heard a lot of good things about you because of your background and the way you hold yourself. And just learning a little more about your background makes it make a lot more sense, just the where you came from and what you've done. And so we were going to talk about all of the different hats you've worn and the tiny companies. I want to get into that. But before we do, let's talk about your background a little bit. You want to just tell us a little bit about yourself, Vernon?
Etienne Nichols: Sure. Thank you so much, first of all, and I am really glad to be with you. I'll try to be brief on the background, but I am a mechanical engineer by training, came from a family of engineers. My dad was in the pharmaceutical industry for many years, and then I've got some brothers that are also engineers of various types. My first couple jobs out of college were not medical device. Worked for the naval nuclear propulsion program, a DoD contractor working on reactor equipment for Virginia class submarines. So totally different, but I guess sharing in what's a regulated industry. But I was living in Pittsburgh at the time, and I met a founder CEO of a very small medical device company, Super Nice guy. I met him at a wedding, and we just hit it off over cocktails, and he invited me to work for him. And so I made the jump. I actually, at the time, it was like, it was a crazy decision because I lost all of my government ish benefits. They had a pension at the time, which is like unheard of now. But, yeah, my wife was super supportive. She's go do this exciting thing, take a pay cut. And, yeah, I started out as a mechanical designer for this really tiny medical device company in Pittsburgh. And it was such a fun organization and experience, and I learned just absolutely tons. So started up just doing cad modeling, mechanical design, autodesk inventor stuff. It was a head mounted display device that, like an oculus rift type of look. So head mounted display that did pupil tracking for mild traumatic brain injury, MTBI or concussion. So just really fascinating to me. Totally new. And then after a couple of years there, my wife's from Minneapolis, and so we were looking to make a move. I took a job at another similarly sized startup just outside Minneapolis, Minnesota, which as was like big kind of med device hub. I was totally ignorant to that at the time, actually. I had no idea. Cause I was still, like, relatively uninitiated. So, yeah, and that's where most of my career in med device has been. I spent nine years there in a variety of roles. I started as like a. I don't even know why. It was like product specialist, spending time working with distributors, more on the business side, traveling, going to conferences, spent a lot of time in the or meeting surgeons who were implanting the device. And then due to the departure of one of the senior engineers on that team, was like, who here is an engineer and can do engineering? Like, okay, I'll give it a try. I'm ready to stop traveling so much. My wife and I were just in the early part of having our children at that point, so I needed to stop traveling to Europe. So then the story from there was stepping into an engineering role, and then engineering is such a generic term. It was like quality regulatory and product development engineering, and then slowly got the resourcing to hire additional engineers for the team. And I had just an absolutely killer, awesome team of smart engineers, and we all just learned from each other and figured it out as we went along, quite honestly. So that's how I ended up in the more quality regulatory space from, like, straight mechanical design.
Vernon Baker: So what were the size of the companies that you worked for when you were working in those early stage startups?
Etienne Nichols: The first one, it was like I said, I think I was like the 6th maybe 7th employee. There was the CEO and founder and then I think there was an office manager, maybe a finance guy and then a couple software engineers and we did use consultants but I think I was like the 6th or 7th employee and then at the second organization I was referring to where I spent most of my time, I was awesome. Maybe like number ten, something like that. We had our own clean room and were doing our own manufacturing, injection molding and so there were a few production people who were working on that. So it hovered around ten maybe at our maximum. We were like twelve or 15 left there and came to GG.
Vernon Baker: So I cant imagine how many hats you had to wear. Early stage especially. But lets say a companys expecting to get into the quality or to really start to ramp up a lot of their quality activities and they hire someone like you, what is it they're looking for or expecting this person to do?
Etienne Nichols: Yeah that's a great question. A lot of things I would say, but the great part is you don't have to be an expert in all of them already. Like one of my favorite things about some I knew about Greenlight before I came here but like even your podcast, not to flatter you but was the not hiding the ball like it's once the information is out there you can find it, you can learn for yourself. And that's how I learned was I learned from consultants along the way. I learned a lot from online content, blog articles. We didn't have chat GPT then, but I probably would have been using it if it did exist. But just learning along the way and collaborating with others who are also learning and just applying critical thinking. That's all. Just to say that no one can be an expert in everything and I'm certainly nothing, but it is good to have a little bit of just enough to be dangerous. Maybe jack of all trades knowledge to at least know where to go or who to ask I think is very helpful. And so core knowledge in the regulation sO 21 CFR 820 and ISO 13485, ISO 14971. So Im talking here about the quality management standard, risk management standard if anyone listening doesnt know those. But like core knowledge in there is definitely helpful and pretty cheap to be honest I didn't have that when I started. I learned as I went but I think it would be a helpful jumpstart for sure. And then the ability to tap into subject matter experts where necessary for sure. When we were doing clinical evaluation or our biocompatibility testing because we had an implant device, having subject matter experts like, I'm not a PhD in toxicology, so having someone at hand to help with those validations, very helpful. I would say a little jack of all trades. I would say it's helpful to be maybe a little bold and not afraid of what you don't know. Eagerness to learn, I think is probably key because there's so much variation depending on your device classification, device design, jurisdictions of sale, whether it's eumbr or I, and be then Brazil or the US, Canada. Like, there's so much to know that nobody can be a pro in all of it, but you need to know where to go and how to get started. So I don't know.
Vernon Baker: I'm glad you brought that up because we have this tendency, especially as engineers, to think, oh, I have to be the smartest one the, I have to know everything about whatever it is we're talking about, when it's actually not possible. And so really you wind up being a specialist in this class three and plan or whether, wherever your is you're talking about. But I suppose if I was to turn this into maybe a slightly different question, you know what, let me go back in time. So you came to this role maybe not with the knowledge of the medical device industry, and you learned some things. And I'm sitting here thinking, okay, what could he possibly have had to learn really quickly? It sounds like supplier management. You have those contractors, those quality plans with the suppliers.
Etienne Nichols: I did not understand conceptually when I started the overall sort of regulatory framework, and I think that's a great place to start. People think it's like looking at a regulation is boring, you know, a good way to put yourself to sleep. But actually I found it almost like someone had put all the cards on the table when I started, like, showed me how the trick is done, because I'd been working with consultants who were quality regulatory consultants, a lot of good people who were very helpful. And then when I started going to the source of truth directly and interpreting it myself and looking at the guidance, I was like, um, this is where they're getting this. This is not. Obviously experience matters and interpretation matters, and that's where consultants can be so helpful. But as a kind of do it yourself bootstrappy small company, you're trying to one, save money and do as much of it internally. And so going straight to the source, whether it's like, just buy the standard, maybe you seem expensive, it's 300, $500. Like, sometimes those are hard to get approval for in a small company. When you're counting every dollar. But I would just say, oh, buy it, buy the guy. Absolutely. Look at the guidance document, go straight to the source and then go to a consultant for interpretation if you need it. But start with a basic understanding. It can get you a lot of the way there. And so I had to learn that the hard way just before I found all, honestly, just like the website, the documents, to educate myself, like, oh, this is where this is coming from. So, yeah, I guess if I were to put that briefly, it'd be like finding the source of truth for the requirement, the sort of show me the shall mentality. And I would say, really, I learned a lot. And it was very humbling. Just in the manufacturing space and in production, by respecting the operators, like learn from them. I had learned that the hard way, probably as like a kind of brash young engineer who thinks, thought I should know things. I've had machinists show me a drawing that I printed out and be like, how am I supposed to put this right angle at the bottom of the hole? And I was like, she put my tail between my legs and went back to my desk and I learned, okay, sure, you got an engineer, but you need to learn from the people who have done it. And so I think spending time on the floor was extremely helpful to watching manufacturing processes work, understanding the key aspects. And that helps with all those other things like supplier management and with kappas and with management reviews, because if you have a real sort of in the trenches understanding of how things work, you're not trying to manage it in the abstract, that you understand the real sort of inputs to a process. And, yeah, I just, I would say I took a long time to learn that and I'm still learning that. But it was, yeah, I would say like a key thing. So I think humility, honestly, is probably better. I certainly, I had to learn that the hard way, but like someone whos humble, ready to learn, but who has a base knowledge in a lot of the core qms areas and is willing to put in the work on the ground level.
Vernon Baker: Okay, you mentioned qms there at the end there, and core QMS specifically. When you think of a medical device company, the size that you were working for, what are those core QMS activities that are going to be likely this persons responsibility from the very beginning?
Etienne Nichols: Oh, yeah, absolutely. Supplier management is definitely one of them. And you mentioned that earlier. Thats huge. I had the analogy once presented to me from a notified body auditor. We were working with TUV Sud or TUV Sud, and the auditor said, imagine a perfectly vertically integrated company that does everything from mining the ore out of the ground, from the raw material. That would be a complete legal manufacturer at some point, and nobody does it right. Maybe the big guys come close, but ultimately, you are outsourcing some of your responsibilities at some level, and you could just move that outsourcing level up to, all the way up to, we're a specification developer working with a contract manufacturer, and the game doesn't really change anywhere or how you manage. That was very helpful to me to hear that analogy, because I thought, okay, this is a raw material supplier for our implant device. If we were making this, what controls would it be under? What controls? We want to make sure that this is high quality. Now they're an external organization that I am not the boss of, per se. We have a contract. How do I pass on appropriately all of their requirements, the responsibilities, and put them in a contract? And that just demystified the whole quality agreement. Quality audits sort of things. It's taking a hard look at. Okay, what are the real concrete risks associated with this? Risks to the patient, risk, first of all, of course, risks to the business in terms of disruption and cost, and then mitigating them as well as you possibly can using critical thinking. So supplier management is a huge one, because circling back to your original question, in a small organization, you might be doing very little to none of your own manufacturing. You have a lot of suppliers, and choosing them is extremely important. Vetting them and getting your supplier controls in place, because for an auditor who, or an inspector who's coming to look at your organization, will quickly see from, like, the scope of your quality manual, you basically outsource all of this work other than the top level responsibility. And that's fine and extremely common. You just have to do it. Otherwise, you know that there's a huge portion of your quality management that is really outside of your organization. So I got tremendous value going on site. Supplier audits, I know during COVID like a lot of that went remote, that, man, I learned things I could not have predicted. If you dont know what you dont know, meeting the quality manager for one of my suppliers or the production manager, and things just come out of the woodwork, issues get resolved that you didnt even know you had, or get nipped in the bud. And I know audits are costly. Onsite audits are costly and time consuming to perform, but when theyre carefully selected, meaning youre doing them for a reason, based on risk, and then well conducted, man, I got so much value out of those supplier audits and learned every single time. And so I love that. But you have to have a good supplier management system in place to do all of that, make risk based decisions, because I don't. But, like, we overhauled our supplier management system from scratch during my time. I think we found ourselves initially doing a lot of things that we couldn't find sense in, like non value added activities. Its disheartening, honestly, on a very human level, and it just feels like a waste of time. Its hard to justify the cost. Top management, which is always a factor in small organizations. And so really thinking through critically, why are we going to do this? What are we trying to achieve? What risk is this mitigating? And then you can answer all those questions. All the other questions are easy then, because, you know, youve made good decisions about the why. And so if top management is like, why are we going to pay for a hotel room for three days and a flight for you to do this? And you know exactly why, because this is the risk to the patient. This is the risk to our business. We've put this through a good process that's leaned out and we trust our decision making, and that's a good argument to make. So anyway, yeah, supplier management is for sure key for the small organizations because they're just not going to be doing all of it themselves, but God bless them if they are doing it themselves.
Vernon Baker: I love that example of the vertical integration and vertically integrated company that makes that. That really is helpful to think about from that perspective. And it's almost like a lot of things are going to stem off of that concept. I used to think supplier management, that seems an external process. How important is that? We got to focus on the inside, get the inside done, and then we work on the outside. But really, you're right. You got to get your arms around the entire process. And if that's a, a way of looking at that, there are other processes that are going to impact that process. Root cause analysis, you mentioned getting those problems solved. So root cause analysis, management responsibility, can you touch on some of those and a few other maybe you think that you would call core early stage things?
Etienne Nichols: Yeah, absolutely. I had to learn what a management review was when I first stepped into this role and how I was going to participate in it. And over time, I think at first, and this was an unhealthy sort of compliance checkbox approach that I think I first had as an engineer when I started learning about Raqqa. And it dissolved pretty quickly over time. And what I mean by that is just thinking like you have to do a management review annually just because that's the expectation. You just check the box, there's a list of inputs, there's a list of outputs, they're listed in SOP and then 3485. So just mention something about those, say no action and move on. And that's not a reflection on my organization, just my like checkbox thinking. And then I really, that really changed because good management reviews, especially in a small organization, are, I really believe are extremely critical to keeping the ship on course. And if you have an engaged executive leadership that both wants to hear and is open to engaging on really concrete topics, do we need more resourcing? How are we going to do this with the resourcing that we have? Is our system effective and then really having frank conversations in that venue? Management reviews are key. And I learned to be probably a little bolder over time and to make it less of a sort of rote exercise of just go through the inputs and outputs and just cut through. Yeah. Where there's nothing sort of interest to discuss. Or you might say a low risk, yes, go through it relatively quickly, address it, but focus on those things that are really impacting safety, impacting the company, the effectiveness of your qms. And so once management reviews are like real in that way, they no longer feel like a waste of time, even if they last two and a half, 3 hours, which they still do because of all those inputs and outputs, you can also split them up and there's strategies to manage that. But yeah, preparing for management reviews, it's really helpful to look at go buys, to obviously look at the standards. Like I said, a source of truth past meeting minutes. Then I think it can be done with critical thinking about what are the hot topics right now in the company, how are we staying on course and being bold enough to address real issues with top management? I found management reviews of extremely high value connecting risk to supplier management. We talked about suppliers, but you talked about other key things. Having a living risk management system that's actually connected to supplier management and post market surveillance. Super key it is. We had old paper systems before we transitioned to an EQMs that one thing just did not correspond to the other. Your risk line items do not. Its work to get them to connect to whats coming in from literature, whats being evaluated in your CER, whats being gathered through all your post market surveillance activities and then relating those back to product development and even supplier management. What are those issues mean about what's happening much earlier on and yeah, it takes a lot of work to keep all those things running and talking to each other. So, yeah, those are all key aspects. Like I said, it's hard to exclude almost anything from what a early quality manager is going to have to do, because they're going to have to do a lot of those things.
Vernon Baker: You mentioned that phrase early on, not hiding the ball, and I appreciated what you said about the podcast and how some of the things that you learned, but I want to hear what you learned about not hiding the ball from your experience as well in Q A, R A. Are there some things that you learned regarding that?
Etienne Nichols: Yeah, absolutely. We worked with, in a small organization, we did use consultants. Some were like materials specialists about the implant material that we were using. Like I said, biocompatibility, but also just to supplement my sort of nascent knowledge in Raqa. We had Raqa consultants, and one of the pieces of advice I received early on was about regulatory intelligence. And this is a not hiding the ball thing or putting all the cards on the table. I had worked with regulatory consultants that sort of just pulled a rabbit out of the hat in terms of an answer, and it was like, oh, how do you, like, how do you arrive at that? And I had one consultant we work with that really put all the cards on the table and helped us establish a regulatory intelligence procedure, which was a new concept to me, but it was, you've used, and I think for sure heard the offense versus defense analogy for Ra and QA. Where does your company, or how does it do, like recon of the regulatory landscape? And so there's changing regulations for sure, like QSR to QMSR recently in the US, but that doesn't happen all that often. But of course, EU MDR was a huge transition in the EU, but then there's a constantly changing landscape of state of the art standards. So FDA recognized standards list, it used to be the EU OJ with all their harmonized lists. Feels like it's a little bit in chaos right now. This consultant helped us, helped me like see all the sources. First of all, told me the concept of the official journal. This was under MDD at the time, showed me the recognized standards list, signed us up for it was like the tech street standards tracker, and helped us develop a gap analysis process to take all this incoming information, regulatory information, separate the wheat from the chaff in terms of what is important here, does this guidance document matter to us and how do we apply it? If it does, what, who do we need to tell? What do we need to do internally and then making the changes internally to our qms as a result of that Reg intel. And, yeah, the not hiding the ball thing is just like showing how it's done. Here's the thinking. I feel like a lot of people, and definitely engineers can relate to, like, okay, here's the source of information, here's how I process it. I have a workflow for doing that. And here are the outputs, just like basic process thinking. And so once you have it, like, almost revealed to you, at least this is how it felt to me once I was shown, like, hey, this is how this is done. Here's the sources of the regulatory information. Here's the newsletters, here's how people find out about things. And that's where a lot of sort of the wisdom and experience of the consultants was really helpful. Just saying, yes, it says this, and this is what it means. But there's a constant influx of even MDCG guidance documents on EU MdR. Knowing where to find those is a huge thing. It's okay. This is what's coming out of the medical device coordination group. It influences how you use Udamed, what the time, how you interpret timelines. Those things are really helpful to read for yourself. And then you can work with a consultant or an expert if you still need help after that. But, yeah, that's what I meant by not hiding the ball is just, okay, this is the process. I can understand at least some of this.
Vernon Baker: The regulatory intelligence is a really good concept, and it's something that, at least in my experience, I don't think I would have seen that very often or known how people put that together. I've built my own type of RSS feed for knowledge.
Etienne Nichols: Yeah.
Vernon Baker: And for incoming things. But how do companies do that? You don't hear that talked about very often.
Etienne Nichols: I had. I have actually not seen it elsewhere in all the companies. I don't know how many companies I've worked with through guru services at GG. Maybe like 50 or 100, it's calling it, at least by that name. I've not seen it very commonly. And so, yeah, our process looked like a list of inputs, so we put directly in our SOP. And if you had a more experienced person than I was at the time, like, I needed a table of, here's all the links. This is like the FDA recognized standards link. Here's the MDCG guidance link. And then we put it. It was like putting them into a hopper, the top of a funnel, input up the process. And then we had criteria for evaluating applicability based on their content. It was a class three implant device. Class three, United States, two b in the e. Some of these guidance documents, just if its for software, it did not apply to us and it goes out of the list. But then some of them were potentially applicable. They get a little closer look and then if they are directly applicable and can impact our product or risk assessment, then they get a full, really clause by clause gap analysis. And we started formalizing those into trace matrices. And again, this sort of level of analysis was necessary for me and my team only because I think we didn't have the experience to just judge it at a high level. I think we gained some of that over time, but it was helpful to just work through those mechanics, work through all the details directly. Like when a new standard came out, I think it was, we went through an ISO 4971 2019 upgrade, I believe it was from 2012, and we broke that thing down, copy and pasted all the clauses into a spreadsheet and did a clause by clause analysis. How do we comply? It was like an audit checklist where it was like, here's the requirement, heres our evidence. What needs to change to just stay on top of standards changes? And it drove some resourcing changes, too, because that was a lot of work to do, and so we needed more people to do it. So all those things are connected together. But yeah, I love the concept of regulatory intelligence. And like you, I have my own input list now. Its like managed through bookmarks and newsletters and things. But for a company, it may be helpful to formalize that process at least a little bit. And regulatory consultants can help distill that for you. If you don't want to have your own internal process to just tell you what matters based on knowledge of your device, but I could be a little more systematic about it. That's engineering.
Vernon Baker: I love that gap analysis in the table with links, especially because if anyone else wants to know where the MDC G's are, those aren't always easy to find. I appreciate whatever stones you want to throw at the FDA. They make their guidance documents pretty easy to get a hold of. The gap analysis is a really interesting concept, and I want to maybe extrapolate that out into a different area of the business. So when you're coming in, there's a lot of things that you don't know, and you don't always know what you don't know. How do you perform that gap analysis on the company level to say, okay, we obviously got to get some supplier controls. How do you know about supplier controls or how do you do the gap analysis to understand that we need a management review, maybe more often than annually or to upgrade our RCA or root cause analysis. What are your thoughts there on gap analysis across the business?
Etienne Nichols: Yeah, if I was starting from absolute zero, the honest answer is I would start by googling it or asking Jeff DPD. But hopefully most of these companies are not starting from absolute zero. That's where like having a document basis of both of the companies I worked for, they had at least it may be, it may have been early stage or it may have been brought over on a flash drive from somebody else's company who, you know, who knows where the qms came from. But I had a starting point and at least from the quality manual on Downdez I was able to see okay, this references this ISO 13485 thing, what is that? I should go take a look at it. Or this 21 CFR, what is a CFR? So starting there. But so honestly, document templates are a huge boost to small companies because it gets them started and then theres a lot of refinement after that and customization based on the organization. Theres tons of customization and critical thinking that has to happen. But just having a starting point like blank page syndrome is rough. Yeah starting with the regulations and standards obviously, and then digging in and there's tons of content out there. Like I'm not flattering you, but learning from ultimate guides and so forth, the definitive guides, like I remember those and.
Vernon Baker: You'Re the author of a lot of that now. So no it's just the company itself. Great.
Etienne Nichols: So no, before I even thought about working at Greenlight, I was like on the blogs and reading the articles and be like oh yeah, okay that makes sense, yeah there's a lot of good content out there. And then direct regulation, source of truth standards, and then online guidance, sources of industry education and training. That was a huge thing, getting top management to really pay for training for us. Like I went through Bumdr training, ISO 1345 training, formal external lecture, BSI and Oriel Stata Matrix I think, and process validation training and a lot of that was born. If you ever need to make a case to top management why some of even those professional development activities are worthwhile, its less expensive to have an internal employee do it than hiring an external consultant. And theres a borderline there. Of course I was not going to ever do our biocompatibility analysis because im not technically expert enough. But for a lot of those topics that we were capable of doing, it was nice to bring them in house, get some external training, get a certification that we could hand to an auditor and inspector and say, hey, this is why we're competent. And not just to get the knowledge. I found those trainings super useful, and you save a lot of the materials and reference them later on. They're like go tos for me, when I have a question or I can't remember something, I've got a lot of old training materials. Oh, yeah, I remember they talked about this. So that's a meandering answer. But training, external training, certainly helpful. Informal industry education, document templates, having a starting point, and then external help. That's part of what we do on the guru services team, is provide this kind of help and guidance to these early stage companies and medium and big size companies, too.
Vernon Baker: Yeah, I've heard sometimes the medical device guru teams been described as the Sherpas that will lead you up the mountain. And so it's always nice to have someone who can, who's been there before and done it and so on. There's a phrase you've used, or maybe an example used a couple times when you're saying, justifying this to management, or if you want them to get on board with this idea or this topic, here's a way to make that case that's a really good. I want to segue into that a little bit and lean into it. Are there communication styles that you recommend? A quality or regulatory person or someone whose boots on the ground making that communication leap to upper management? Any thoughts there?
Etienne Nichols: Yeah, for sure. I think as engineers, or at least for me, I can tend to be a little, maybe blunt and, and maybe not. I think it's helpful to, especially coming into a management review, think about what top management is concerned with and what their goals are. And really you can align on some very basic things that get everybody sort of rowing in the right direction. Because my experience, both at the companies I worked for and in the context of Reichuru, working with a lot of small, innovative companies, the founder, or if the CEO is the founder, which was the case for both of the organizations I worked for, getting the device into the hands of patients and doctors is like a top level imperative. The device has to get out there, and that is not just about quality and regulatory. In order to get there, the business has to survive. You have to be making revenue. You have to keep your costs under control. I think I learned a respect for the seat that they sit in is different than a quality regulatory manager. And so I think if you come in with, hey, I realize that quality and regulatory might not be the center of your universe, and that's okay. It doesn't have to be. I'm not going to try to beat you into it. But here's why. This is important to the business. This is on critical path towards getting this device to market and in the hands of patients or doctors and that they care about, you're speaking their language. And so I think if you can connect, and the good part is that I've learned this is like why like quote TB. True believer in like true quality is that you can always make that argument because it's true. Because it, if you are able to connect the topics and management review to getting this device to market into the hands of patients, a safe and effective device, and the success of the business as well, that's contingent upon those things, then you can really have a good conversation with top management about why these things are important. But it's always going to. For sure it's going to be a negotiation because money is not infinite and it is fungible. So should it go into sales and marketing or should it go into your competency training you want for ISO 1345? Somebody has to make that decision. If your QRA person, your management representative can make their case and it's legitimate, not just tisk, you should. But hey, this is how we're all participating in this mission. We're all in together, then you can have a fair conversation. And top management might not always decide your way. And that's okay too. That's the seat that they're in to evaluate all the data. That's what the management rep is doing, right? Reporting to top management on the suitability, effectiveness of the quality management system. Do that and then have a real conversation about what the outputs are going to be. And I think it'll go fine. You know what I mean? Yeah.
Vernon Baker: This has been a good conversation. We've covered a lot of ground. Any last piece of advice to someone who's looking for someone who has this, maybe they don't have all of the qualifications yet, maybe they still gotta do that gap analysis on themselves. But what kind of person could really fulfill this kind of role?
Etienne Nichols: Yeah, let me think on that just for a second. I think that there's a lot of different types of people who could fill that role and that they're not by any means all my type of person. I was like, learn along the way. It'd be probably you'd get a better, faster jump start if you hire someone who would already learn. But I think an eagerness to learn is critical and a little bit of boldness to base facts brutally but tactfully within an organization. Willingness, willingness to learn and I think a passion, honestly, a lot a passion for the device or product or at least the mission of the company goes a really long way in covering a lot of other ills or gaps in competency and just hire somebody with a high aptitude, humble, willing to learn, and ideally with a bit of experience, I think, and help resource them as they have communication. If im speaking to a founder, listen carefully to the resource requests, doesnt mean you have to grant all of them. But especially if youre hiring somebody on the younger side and probably then less expensive side, then they may need some help. Theyre probably going to need some help, some guidance, maybe some documents, and thats a reasonable request that theyre going to need. If you hire a total pro, maybe theyre coming in with a lot of that, but theyre probably more extensive. Trey? Yeah. I dont know if I have a single piece of advice altogether, but I.
Vernon Baker: Think just from the conversation, it really shows and sheds the light on the communication across departments. I think its essentially you said the Qara has their lens, and this may not be the center of the universe for the CEO. The CEO almost has a kaleidoscope lens. He has to look at all these different things and moving parts. But just understanding why you care about that certification, rice with 1345 or whatever else, to bring those things in house, that's really powerful, I think. And I think it could carry a lot of weight to show that the goal is to move the business forward at the least cost, but with the highest competency. That's really cool.
Etienne Nichols: Absolutely. Absolutely. I hope the conversation was helpful to somebody. And thank you for having me on. I really appreciate it.
Vernon Baker: Well, thank you, Vernon. I really appreciate you sharing your expertise. Those who've been listening look forward to seeing you next time, everybody. Until then, take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.