Episode 367

#367: Interviewing the Interviewer

In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals.

Key Timestamps:

  • [02:15] - Introduction and Etienne’s journey to becoming a podcast host
  • [12:30] - The importance of vulnerability and honesty in product development
  • [22:45] - Balancing quality for audits versus operational benefits
  • [30:10] - Human factors and usability in MedTech product development
  • [37:55] - Simplifying quality management systems
  • [45:00] - The mantra of learn, lead, and love in networking
  • [54:20] - Encouraging emerging entrepreneurs to own their expertise and impact regulations

Quotes:

  1. "The heart of the problem is the seed of the solution."
  2. "Quality management documents should benefit your company first and be audit-ready second."
  3. "Be genuinely curious. Assume the person in front of you knows something worth listening to."

Takeaways:

Key Insights on the Latest MedTech Trends:

  1. Human factors and usability are often misunderstood but crucial in MedTech product development.
  2. Quality management systems should be practical and beneficial for the company, not just for audits.
  3. Networking is more than collecting business cards; it's about building meaningful connections.

Practical Tips for MedTech Professionals:

  1. Be vulnerable and honest about the state of your projects.
  2. Focus on solving the right problems and avoid over-engineering.
  3. Create quality management documents that are easy to understand and useful for your team.

Questions Predicting Future Developments:

  1. How will AI and machine learning shape the future of MedTech product development?
  2. What emerging trends in usability and human factors will impact regulatory changes?
  3. How can MedTech companies better prepare for cybersecurity challenges?

References:

Beginner's Section: MedTech 101

  • Quality Management System (QMS): The system that outlines the processes and procedures to ensure product quality.
  • Human Factors and Usability: The study of how people interact with products to improve design and user experience.
  • Regulatory Strategy: The plan for complying with regulations to bring a medical device to market.

Questions for the Audience:

  • Poll: What do you think will be the most impactful MedTech advancement in the next five years? Email us your thoughts at podcast@greenlight.guru

Feedback:

We'd love to hear your feedback on this episode! Please leave us a review on iTunes and share your thoughts and suggestions for future topics. Email us at podcast@greenlight.guru with your ideas and comments.

Sponsors:

This episode is sponsored by Greenlight Guru. Their all-in-one platform is designed specifically for the unique needs of the medical device industry, helping you maintain compliance, reduce risk, and improve quality. Visit www.greenlight.guru today to learn how their platform can transform your medical device development process.

Transcript
ty manuals I've seen that are:

Devon Campbell: To the global medical Device podcast, where today's brightest minds in the medical device.

Etienne Nichols: Industry go to get their most useful.

Devon Campbell: And actionable insider knowledge direct from some.

Etienne Nichols: Of the world's leading medical device experts and companies.

Etienne Nichols: Are you a medical device company looking to streamline your quality and clinical processes? Look no further than Greenlight Guru. Greenlight Guru's all in one platform is specifically designed for the unique needs of the medical device industry. Their quality management software helps you maintain compliance, reduce risk, and improve quality throughout the entire lifecycle. Say goodbye to the headache of managing multiple systems and hello to a seamless, integrated solution. But that's not all. Greenlight Guru's clinical evidence management software makes it easy to manage your clinical studies, from planning to execution to reporting. With real time visibility and automated workflows, you can accelerate your time to market ensure the highest standards of clinical evidence. And the best part is Greenlight Guru's team of industry experts is with you every step of the way, providing top notch support and guidance to help you succeed. Don't let quality and clinical challenges hold you back.

Etienne Nichols: Visit www.

Etienne Nichols: Dot Greenlight Dot Guru today to learn how their platform can transform your medical device development process. That's www. Dot Greenlight Dot Guru, your partner in medical device success.

Etienne Nichols: Hey, everyone. Welcome back to the global medical Device podcast. I just got on with a meeting that was, I think we just kind of left this on the calendar. We recorded an episode last week with Devin Campbell, I should say, from product. Thank you for being with us today, by the way.

Devon Campbell: Yep.

Etienne Nichols: So we had this already on the calendar just as a plan b. I showed up not expecting, you know, anyone to actually be here, but Devin said, well, I'll let you go ahead and take the reins, Devin, tell us what your ideas.

Devon Campbell: All right, so my idea here was you've been doing this for a little while now since you took over the reins, and you've been doing all these podcasts for the global medical device podcast. And I thought it'd be kind of fun to turn the tables on you. And instead of you asking all the questions, give somebody else a chance to ask some questions and let us, the listeners, know a little bit more about you and about what you've learned through this journey. So, in full disclosure, did not share any of this idea with him before the call. I came up with it over the weekend. I was like, yes, let's do this. It goes spring and autumn and see if he'll jump for it. And he jumped completely for it. So, yeah, that's kind of the idea. With no preparation, you're not ready, and we're jumping launch right into it, and we're going to ask you, ask you some questions. So what I was thinking was, I was reflecting that you've been doing this for a little bit, and I asked you over the weekend. You told me your first episode when you were introduced as a co host was 240. That was a while ago. And your first episode as the host was episode 257, future of cybersecurity. So just dropped 335. So you're coming up pretty close on 100 interviews in a few weeks.

Etienne Nichols: Crazy to think about in that whole hundred.

Devon Campbell: No one's interviewed you yet. So what I thought would be kind of fun is to kind of go through this exercise I call five things. So. And I'm not going to, like, spin me or my company or anything else right now. My company is product. You can listen to other podcasts that I've done with dreamlight, and you can learn about the company and what we do. But if you look at our logo, it's a Fibonacci sequence. So you'll see one small element, one small element of the same size, and then another slightly larger element that's twice. It's one plus one is two. Right. And then the next element is three, and then five. And so it's a fibonacci sequence. It's five elements. Two smaller things, two slightly medium things, but one a little bit bigger than the other, and then one really big thing. And what I would love to do is to go through with you and have you reflect on your last almost 100 episodes. You can drop this whenever you choose to drop it. Maybe it'll be post 100. Maybe it'll be pre hundred. I don't care.

Etienne Nichols: Sure.

Devon Campbell: Just for fun. But let's think through. Like, you've talked to a lot of people, and you've had opportunity to sit and reflect. And I know that when you and I record, when we hit stop and we're done recording, we don't stop talking. Right?

Etienne Nichols: Yeah.

Devon Campbell: We're product development, medical device nerds. Like, we get into this and we keep talking even when the recording stops. So I'm sure you've had really, really cool learning opportunities for you personally over the last hundred episodes. So what I'd like you to do, thinking about the five things spirit, I'd love you to share with me and your listeners. Let's think through product development first. Like developing medical devices. Yeah.

Etienne Nichols: If I could say, just before we go into that, I would kind of like to share just a little bit about how I came to the podcast, because you've got my wheels thinking. But just about that.

Devon Campbell: Hold on, let me, let me. Let me do a better job. Host. No, no, clearly I'm a horrible host. Before we jump into things, I'd love to know a little bit more about you and how you found yourself in this position. And then let's talk about five things that you've learned about product development.

Etienne Nichols: Absolutely. And they may tie together, believe it or not. So my w. My wheels have been turning ever since I got on because I knew that record button was going to be hit. So this is me stalling as I think. So when I came to Greenlight guru, I have to go way back in time, at least for me and my age, it feels like a long time ago. I came to greenlight Guru after being a project manager for a drug delivery combination product company. I loved the job that I was doing. I really did.

Devon Campbell: And at one point, what did you love about that kind of work?

So fast forward a little bit.:

Devon Campbell: Yeah.

t to say that was November of:

Devon Campbell: I remember when. So I did about a dozen or so, maybe a little bit more episodes with John. Right. So I know John pretty well, been on the global medical device podcast several times. But I do remember before you had even co hosted anything, I remember him calling a meeting for him because he and I would talk rather regularly, just text each other and just talk. But I remember him pulling you in. I remember him telling me about you and then pulling you in. I don't know if you remember that conversation, but we had like, this very small kind of like, hey, I'm thinking about doing this one thing and maybe starting to bring a podcast, like co host in. You're going to want to meet him because you're going to want to do some podcasts with him eventually, too. And then you and I got to meet, like, before you even did your first one.

Etienne Nichols: Yeah.

Devon Campbell: Okay. So you brought us to today. Great. Thank you for, for that, for sharing your journey with us. I appreciate that. My favorite part was the crying in your pillow part. I appreciate your honesty and your willingness to be vulnerable there because this is a tough space that we work in. And yeah, there's a lot of times you might want to come home and cry in your pillow and then rally and get back to work the next day. So for all of your listeners who are dealing with hard things in the product development space for medical devices, let's think through, like, help us benefit from what you've learned and what you've had a chance to reflect on over the last hundred ish episodes, and you've had plenty of time to stall now. So I saw what you were doing there. You've got no more excuses. It's time to start talking. So give me, like, like two small lessons. Do you feel like you've learned in talking to all these different people?

Etienne Nichols: Jeff? Yeah. So based on what you said, actually, you kind of already mentioned it. Being vulnerable and going home, crying your pillow, that's a side thing. Everybody deals with things differently, but the thing that I would say was really valuable and that I probably wasn't good enough during my previous leading up to being a project manager was being vulnerable actually at work and not necessarily about your feelings or emotions, although I suppose there's a place for that really being vulnerable about the state of the project. And this is something, I know this probably feels a little subtle or maybe it's hard to value this if you can't really wrap your head around it, but I've talked to regulatory professionals. I've talked to product development professionals, I've talked to CEO's and founders who are going to be talking to investors and so forth. And I've talked to investors actually from that, just a curious perspective, they all value honesty and vulnerability. Now, as humans, we want to be, I want to show you my best side. I want to show you the projects on track.

Devon Campbell: The question is, is it even really your best side? Right. It's a little bit like social media. Like, a lot of people choose to put an imagined version of themselves on social media, but it's not always, it's always like rainbows and unicorns and everything's wonderful. But I agree, like, a lot of times, especially in a working environment, you know, you try to soldier forward and like really make it everything look great and then kind of, you know, fake it till you make it and hope that things kind of come along. And I agree with you. I mean, it's been kind of my experience too in the past, like, and it's my style to be super vulnerable and really authentic and real. It doesn't, it doesn't serve anyone any benefit to parade.

Etienne Nichols: Right. And kind of the flip side of that, when youre talking to your team, ill give you a specific example. I had one time, I remember being in a conference room, we were working on a certain UDI direct part marking, and one of my teammates, her name was Jennifer, she was fantastic. I still wish I had her on my team. She said, well, if I was a doctor, I would want it this way. And I said yes. And in some ways I feel good about this, in some ways I dont. But I said, listen, anything right now we're going with Fred. Is it Fred Crosby's? If I remember his name correctly, quality is free. Author of quality is free. So his definition of quality is it meets the standard. I said, anything above that is gold plating. And so if it meets the standard right now, our goal is to get back on the market so that these things aren't held up. And anything else above that is, is gold plating. And sometimes as engineers, we don't know when to stop. And someone who can actually say, this is our stopping point, I know you want to do better, or I'm kind of applying it as a flip side. So be honest, be vulnerable, say, this is where we are. But as a manager, sometimes you say, hey, guys, we're not going any further past this. Yeah, that's tough.

Devon Campbell: I used the gold analogy as well. In my past, I was running product development for pretty good sized company and I had an engineer working for me, and he had a tendency as an engineer myself, to like, over engineer things a little bit. And I would always have to bring him back. I would. We got to the point where he would start to work on something, and I would just look at him and say, golden toilet. That's all you need to say. And no one else would really know what that meant. But between him and I, it meant like, you've designed a toilet, it does its job. It does not need to be gold, right? It does not need to have all these different fancy things. It has one job, an important job, and it does it really well. We're done. Yeah, right. So whenever we say golden toilet to him, he'd be like, okay, fine. And he would just stop.

Etienne Nichols: You're kind of describing a meta skill, actually. I don't want to go too far down that path. But I remember in my career, we would, we would call something a red couch. If we knew this isn't the place to talk about it, we would simply say red couch. There was a red couch where we would just error grievances. But if we were in a conference room with certain people, you say red couch, and they're like, okay, this is not the place. It's for the red couch. Anyway, it's just interesting. Sometimes it's important.

Devon Campbell: I'm seeing all sorts of hashtags exploding out of the LinkedIn posts that will come from this. I'm seeing hashtag red couch. I'm seeing hashtag golden toilet. People are not going to know what to think. Okay, so you gave me two. Ill take those as the first two, so you owe me three more.

Etienne Nichols: Okay.

Devon Campbell: Following Fibonacci, those first two were of about the same size. Give me the next one. That should be kind of about, you know, the sum of a learning or a reflection from the last hundred episodes or so. Thats about twice as big as those two.

Etienne Nichols: Okay.

Devon Campbell: Twice as, well, twice as important.

Etienne Nichols: Twice. Okay. When I think about product development, because thats kind of what you led with the thing that there's a theme that is recurring over and over. And I don't know how to verbalize this into a single learning, but human factors and usability, it seems to be a continually misunderstood or misapplied or not applied profession in the product development of medical devices. So a lot of times we see a problem, we jump to a conclusion, we go ahead and fix the problem in our mind, and we fall in love with that technology. So a phrase that was instilled in me kind of early on in my career was the. The heart of the problem is the seed of the solution. And if you've heard very many of my episodes, particularly when we're talking about usability, I use that phrase a lot. The heart of the problem is the seed of the solution. When I'm talking to new product development engineers, I always tell them, do not fall in love with your technology. Fall in love with the problem. Just. And obsess about the problem and think about the problem, because as a company. So you could zoom in, you could look at the engineer, but you could talk about the company. If I, let's say I want to help cuts. So I am a three m. I am a band aid. That's that. We are a band aid company, and that's what we do. We make band aids. Well, what if band aids are no longer whatever they're displaced by, I don't know, surgical glue or whatever? Now, are you no longer a band aid company, or are you a wound healing company? You need to focus on what you actually do. So part of the problem is the seated solution is the piece of advice I would give when it comes to product development. Curious, though. It's always my temptation to turn the tables back on you, because that's my comfort zone. But I'd love to hear your thoughts on this.

Devon Campbell: I'm a blank slate. I have zero medical devices. Definitely none whatsoever.

Etienne Nichols: Incredible control. I see.

Devon Campbell: I'm withholding and restraining everything back. So I'll echo a similar observation. I do think that a lot of times, we don't pay as much attention to it as we should. Right. It's kind of like it falls a little bit, like, into, like, risk management side of things, where I see people doing risk management, thinking it's a checkbox activity we do at the end of the process. Right. Same thing. Like, oh, we're getting toward the end, we need to do some human factors, like, oh, well, we probably should do a formative, like, you should have done a form a really long time ago, right? Or, well, we talked to a few users. How can we write that up and turn that into a formative study? But just like risk management, I do see human factors, usability engineering as a critically important, an underappreciated, if I could just be really honest about it, like, aspect of the product development journey. And again, just like risk, they are things that need to be considered very early to help set the stage. So you've got a great product development process to be able to be following and help you bring, not just safe and effective products to market, but products that people love using. It's going to be hard to do to get that if you don't really appreciate the usability side of things and the human factors side of things really, really early. Okay, I just echoed back your same words back to you. It's great podcast host learnings I've been getting from watching and listening. Listening you. Okay, you got two more. Share with your eager audience.

ty manuals I've seen that are:

Devon Campbell: Love it. One of the things I like to teach our clients at product, as we're developing documents, we're an infrastructure for them. We do it in such a way that we want them to be able to be independent on their own, know how to do things, and not like, have to lean on an advisor to come in and teach it to them. We push into, like, philosophically as we're working with them to say, when you're starting to write your own sops and work instructions, you don't write them for right now. Right. Assume wild success for your company, and everyone goes and gets to do wonderful things and new people get hired, or you move up so high in the company. Write the document for a naive, scared, younger version of you who's going to be hired in three or four years.

Etienne Nichols: Yeah.

Devon Campbell: Write the document for them, not for you. Right now, with your knowledge, write what you would be teaching of a younger version of you. It's kind of the same idea, right? Like, make it meaningful, make it impactful, and not just to meet the regulation. Know, to meet the regulations or to meet. Because regulatory told us, we have to do this, we have to do it. And quality engineers said, we have to do this, we have to do it. It's the wrong reason to do it.

Etienne Nichols: Right. And just to kind of, if I could just add on to one of the things you said about as a consultant, when you build out this, you want to do it this way. A piece of advice I would give companies is look for a consultant who's willing to work themselves out of a job as you've kind of described. I mean, you say that all the time. Yeah, that's. That's. My dad told me that when I was a teenager. You know, learn to work yourself out of a job and you'll never be replaceable. It's just like, that doesn't make any sense, but, okay, so I'm ready for one more. I'm ready.

Devon Campbell: The piece de resistance. I've been going, what's the big thing? Over the last hundred episodes or so.

Etienne Nichols: I don't know if this is med tech specific, but one thing I've learned from having traveled, so they've, they've sent me to a lot of conferences now as well. I've talked to lots of people.

Devon Campbell: So I was on the panel.

Etienne Nichols: It was fantastic.

Devon Campbell: That was great fun.

Etienne Nichols: And I've learned that people are people wherever you go. And I'll expand on that a little bit. I've developed a mantra after going to these different networking events, conferences, trade shows, and something that I recommend everybody. It will expand your learning. It will also expand your teaching, which will expand your learning. It's a vicious cycle or that good to great. It's a continuous cycle. So the mantra that I have is learn, lead and love. So I want to learn from those a few steps ahead of me, lead those a few steps behind me and love the people around me. You know, I don't really have room in my life for people that I can't truly love anymore. Like, if. I mean, I hate to say that, but I love people, but I'm pickier than I used to be. So when I network, it's more than just getting that connection on LinkedIn. So what is that? You know, sometimes I think, oh, that guy has so many. He's, he's got so many connections. Well, are they real connections? How many people could he go in person and actually hug and that other person want to have been hugged by him? You know, and I could. I could name off a handful of people, you know, maybe half a dozen. If I really thought about, maybe I could think of more of those people, but people who I would really enjoy. Even if we didn't talk business, medtech never came up. I could go to Minneapolis and find some of those people. I could go to Nashville. I could go to Phoenix, Arizona. Now that having been those, I've had some real connections. Well, how do you do that? Well, there's a couple of things that I recommend. Number one is be genuinely curious. Assume the person in front of you knows something worth listening to. That's one thing. And it's actually something I really respect about you, Devin. I'm. I was excited to get on this call to hear what you would teach me, and you actually genuinely seem to want to have listen to what I have to say. And I'm, like, not sure why, but it's pretty cool. So that's one of the. That's one of the main things I've learned over my travels is to. Is to really, that network is a buzzword, but make friendships. And I think that will go a much longer way than just trying to get your business card and as many of those bowls as possible.

Devon Campbell: Yeah. We like the way we use a similar phrase at product, where we. We like to say that we're heart forward. Right. So we're hands on and heart forward. Right. Get involved, but, like, lead with the heart. Not necessarily just with the. With the mind. Mind will follow with it. You can't go anywhere without it. So I like that.

Etienne Nichols: Yeah.

Devon Campbell: It's a very similar philosophy, I think. And I would hope that you feel that, you know, that you could also come to Boston.

Etienne Nichols: Of course. Yes.

Devon Campbell: Lots of people here for that. Cool. So, I mean, if you, like, reflect on all the things that you've learned and you sharing this last little bit with me, I can see it in your work. Right. I can see it in the way that you ask questions and the questions that you ask of people that you're talking to. It's not just like, I got to do another. I got to do another interview today and. And edit it and publish it and get this out. And you ask questions from a place of caring. Right. And with a sense of empathy for the people that you're talking to, which I think is why you're pretty good at what you're doing. If I could pat you on the shoulder just a little bit there. So reflecting on all of it, and you gave us five things, and I was trying to keep us, like, very product development centric, because that's my happy place.

Etienne Nichols: Sure.

Devon Campbell: So I'm being selfish and wanting to talk about product development stuff, but if we took those guardrails off and wanted to expand on, like, one more kind of idea, and I wanted to be very specific, you can think through different conversations you've had in the last couple of years doing this, doing this work, this important work that you're doing now, which, by the way, is very important. I hope that you reflect and understand the importance of what you do, hosting these podcasts and putting out this information. And John Spear, before you like this, is a great resource, especially for new folks to our industry. And I know, because when I'm on, I get tons of calls, too, afterwards, and people reach out and have feedback, and I know it makes a difference to a lot of people. So I hope that you're proud of yourself for the contribution you're having. So let's contribute just a little bit more. So taking the product development guardrail off, you could talk about risk management. We could talk about, you know, any number of huge topics in our field. Is there a particular thing that you would sit down with an emerging entrepreneur in the medical device space and you just have a few minutes to sit down over coffee and you say, you know what? There's one thing I want you to keep in mind as you move forward on this amazing journey. What might you say to that, to that person?

Etienne Nichols: Oh, man, that's a really good question. And first of all, I want to thank you for the kind words I, I don't always think about. Sometimes I get nervous to think about how many people listen to this podcast. So I don't think about it as much as maybe I should, but I appreciate you bringing that up. It's. And if. If I've done any good, I feel like I've stood on the shoulders of giants like John Spear and others who've come before me. So, first of all, thank you for that. If I was to answer that question, if I was to sit down with an emerging entrepreneur to discuss, you know, one, one piece of advice I would.

Devon Campbell: Give them based on what you've learned doing this work.

Etienne Nichols: Yeah.

Devon Campbell: So many people.

Etienne Nichols: Right. Yeah. And borrow from their credibility, obviously. I mean, that it's, it's been fantastic. One thing that I've learned is, and I'll kind of preface this by saying I've spoken with not only regulatory professionals and product development professionals, but the regulators themselves at times. And I suppose if I was to talk to that emerging entrepreneur, I would tell them, you are the expert in your specific niche, so you need to own that with respect towards everyone else around you. Obviously, what I mean by that is, let's just say, I don't know, I'll use my, I don't want to use the band aid example, but just some example. If you are thinking about the regulations and you're monitoring those regulations, you're building out your regulatory strategy, how I'm going to get this to market. And I think about that as the Stephen Coveys begin with the end in mind. You're building out that strategy and now you work backwards. How am I even going to build the product? Who is this for based on an overarching strategy? Now, you can't know. Sometimes it's like, well, which one comes first? All that said, you think about those things and then you think about the regulations. And don't look at that as, okay, now I have to go, it's electric. I'm going to go do 600, 601. Well, that's not a good example because that, you know, that is a very established standard. There are some things that are still emerging and changing. So you come up against something, you say, oh, why is this the way it is? Well, maybe you are a special case. Maybe, you know, be humble about it, maybe not. Maybe you're just a little bit arrogant, but maybe you're a special case that it doesn't apply or maybe that regulation, nobody's hit on that specific and it's time for it to change. And in the case of cybersecurity, for example, and so rapidly.

Devon Campbell: Yeah, and.

Etienne Nichols: Exactly. AI maturing, machine learning, all these different things. Think about those different things. And the thing that never, until talking to all these people, it never occurred to me that you as a medical device professional and entrepreneur have the ability to make change from a regulatory standpoint. You could potentially change the pathway to market at some point. And so keep that in mind, and I'm going to borrow from what you said in our last episode, stay humble, but also consider that you could affect those changes. So own the product and be the expert in your specific niche and think about that path forward the way you have to to follow those regulations, but also how those regulations could change based on the knowledge, if you apply it the way you should. I don't know if I hope I was able to encapsulate that, but in my mind, I look at the world as it's not set in stone. And so think about it from that perspective.

Devon Campbell: La gray space and a lot of opportunity to do good if you choose to grab the opportunity.

Etienne Nichols: Yeah.

Devon Campbell: So, yeah, definitely expert in your space. I mean, one way to kind of look at it, maybe a different way to say what I think you're saying. You know, you're a subject matter expert in your very specific niche and you are influenced by regulations. We can't not be influenced by regulations in our space. But, you know, maybe, maybe a crude way to say it is like not to be a victim of the regulation, right? To say, oh, I have to do it, this kind of sucks. I got to do this because of this. But it doesn't quite make sense for my little niche. Well, rather than just, well, I'm going to do the best I can. It is an opportunity to make it better and help influence those regulations for the next person that is trying to bring something in your niche, like together, or maybe has a similar problem, but different niche. And there are actually lots of opportunities for people to get involved in helping move regulations forward. Yeah, lots of opportunities to be able to do that.

Etienne Nichols: Yeah. Buried, buried in my assumption or my statement that you should be willing and looking for ways to change those is the assumption that you're reading them and that you understand them. And so that's, that's a piece of advice I give for young product development engineers, is read regulations. That's really where I think you should start. And it's actually how I got my start towards Greenlight guru. I started reading our sops, and I thought, this really required. This seems crazy, you know, I mean, this is going to delay my project by, I don't know, three months, you know, and so I go to the standard. I'm like, it's not in there, you know, and it's intentionally vague and maybe it's there for a reason. That's another, you kind of have to counter that advice of be a rebel with don't move fences, that you don't know why or who put them there. So there's a couple things to think about, but absolutely read those regulations.

Devon Campbell: I used to be one of those engineers, and I'm sure a few of your listeners might remember these days. I would always carry around a pocket 21 CFR. Yeah. In my, you know, little pocket version in my pocket. And when I would butt heads with a less than flexible quality engineer or quality representative on any of the projects I'm working on, say, oh, well, you can't do that because the regulations say so. It used to, oh, it would just get me so wrong. And I would say, okay, well, I'd pull it out and say, show me where the regulation says that. And it doesn't say that. Our sops. Right. Like to your earlier comment, right. Our quality management system, the words on the pages, not the pages themselves, the words on the pages, that's our interpretation of how we're going to meet those that regulation. And that's where it is. So theres the opportunity to make it better. You dont have to necessarily even change the regs. You can change your response to the regulations internal to the company to make things faster, more effective, more efficient, make more sense.

Etienne Nichols: Yeah. That word standard, sometimes I think is overused in our industry to where we only look at it like, oh, what piece of paper is he talking about? When I like to use the classical definition of standard, and that is, that is the normal expected behavior, when in reality it's okay to go above the standard. It's okay to go beyond the standard with your sops. If you have a good reason to do those things, so.

Devon Campbell: Or to go left. You can justify exemptions. Yeah, yeah, yeah.

Etienne Nichols: Right.

Devon Campbell: Well, hey, this was a lot of fun for me. I was excited to be able to spring this idea on you with zero preparation on your part, and I hope that I did an okay job. I think you did a great job answering my questions and had a lot of fun. So I appreciate your willingness to explore this journey with me and to hit record and just leap into the unknown and see where I was going to take it. So.

Etienne Nichols: Absolutely no, you did a great job. If you ever want a job as a podcast host, I'm pretty sure you would be a fantastic host. So thank you so much. Really appreciate it. All right, we'll see you all next time, everybody. 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.

About the Podcast

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Global Medical Device Podcast powered by Greenlight Guru
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 ...

About your host

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Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast