Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about amazing products and technology improving the quality of life. 

Now, there’s an opportunity to take the most listened to podcast in the medical device industry in a new direction by introducing a second voice to the show to share a variety of contexts and perspectives around the why behind what we do that matters.

In this episode Jon is joined by Etienne Nichols, a medical device guru at Greenlight Guru and Jon’s new co-host of the Global Medical Device Podcast. This is a must-listen-to episode, offering details into this exciting news and other key thoughts and observations Jon and Etienne share about the medical device industry.

 

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Some highlights of this episode include:

  • Etienne is passionate about the medical device industry and decided to join Greenlight Guru to help make things better, such as documentation. 
  • Guru Edge: Greenlight Guru is the only medical device system platform for the medical device industry built by actual medical device professionals.
  • Greenlight Guru runs the gamut and covers everything from electrical and mechanical to packaging and production. There’s more medical device experience at Greenlight Guru than at most medical device companies.  
  • In the future, Etienne predicts that data-driven decision making involving patients will be one of the biggest trends or themes in the medical device industry.
  • Jon is anticipating the convergence or blending of technology with everyday devices (i.e., wellness wearables). The lines between what is and is not a medical device are blurry. 
  • The COVID pandemic has created opportunities for innovation in healthcare. Wellness, telehealth, and home-use products have become more common and make patients more comfortable.
  • Etienne has experienced highs and lows with the FDA in the past. Now, he appreciates and is thankful for FDA regulations as guardrails, not limitations, that are flexible and open to interpretation. 
  • The FDA’s job is to protect and promote the health of U.S. citizens. It not only covers medical devices, but many other areas. It’s an awesome responsibility that encourages collaboration and communication.

 

Links:

Meet a Guru: Etienne Nichols

Etienne Nichols on LinkedIn

21 CFR Part 820

FDA - Medical Devices

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable quotes from THIS EPISODE:

“When I came to Greenlight Guru, part of what kind of led me here, was the desire for things to be better.” Etienne Nichols

“No one guru has all the answers on our team, self included." Jon Speer

“I’m excited about all the different ways the medical device industry is going to be improving our lives in the future.” Etienne Nichols

“The more data that can be behind a decision, I love that.” Etienne Nichols

 

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 in companies.

Jon Speer: As I'm recording this today, I think we've done something around 250 podcast episodes, most of them on the Global Medical Device Podcast. A few years ago, we did a series called MedTech True Quality Stories, but it's been so cool. It's been one of the coolest things I've ever had the opportunity to do in my career. I get to talk to amazing people, hear about some amazing products and technology and I get to put it under the bucket of work. It doesn't feel like it most of the time when I'm doing the podcast, but thank you all for... Many of you reached out to me and shared your comments sentiments, and I'm grateful for all of you listening to the Global Medical Device Podcast. And recently it's become clear to me that there's an opportunity to start to take, not necessarily totally in a new direction per se, but to bring in some new varieties, some new contexts, some new perspectives. And joining me on this episode of the Global Medical Device Podcast is a glimpse into where we're going to be going in the future with the Global Medical Device Podcast. And so joining me is Etienne Nichols. Who's one of our medical device gurus at GreenLight Guru. He clearly has a passion for this sort of thing and that was evident to me. And so I've reached out to him and said," Hey, Etienne, will you be more involved with the podcast?" And he's looking forward to it. And he is already starting to schedule some guests and explore some different topics. So it should be fun. I'm going to ride along with him and he's going to ride along with me. So we're going to figure this out. I just wanted to give you, I guess, an introduction, a more in depth opportunity to listen to Etienne Nichols, and who knows, we'll see where it goes. So we're just going to roll with it. So enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast, this is your host and founder at GreenLight Guru, Jon Speer. And joining me is one of our medical device gurus Etienne Nichols. Etienne welcome.

Etienne Nichols: Hey Jon, thanks. Good to be here.

Jon Speer: Et I know you've been on the podcast before and I guess, spoiler earlier, you're going to be on it a lot in the future too. I thought we could use this opportunity to kind of, I guess, hopefully reintroduce folks, listeners to who you are in your background and just riff a little bit about some of the things that are happening and things that each of us are observing in our industry right now.

Etienne Nichols: Yeah. Cool. Well, I appreciate it. And yeah, so we skipped to the end here that I like it. I appreciate you go ahead and letting the cat out of the bag. I really appreciate the opportunity to be on the podcast, to be a co- host and to work with you and work with other medical device professionals. So yeah, I'm excited about the path forward.

Jon Speer: Yeah. And for me, you made that choice pretty obvious because you do such a good job, like creating little videos and snippets and things, you'll put something out on LinkedIn about a new thing that the GreenLight Guru's doing or a topic that you're passionate about. And I don't know if it becomes natural to you, but it's clear to me that you definitely have a passion for doing this sort of thing.

Etienne Nichols: Well, yeah, it's a lot of editing for sure. But yeah, and it's interesting because when I came to GreenLight Guru, part of what led me here was the desire for things to be better as far as like documentation and so forth and just coming here and seeing what GreenLight Guru is doing for the industry, that's really what fuels my ability to go on LinkedIn and post those things, even when I'm thinking," Okay, what's somebody going to think of this," but now if this helps somebody, it matters. And so it makes it a lot easier.

Jon Speer: Yeah. And that spirit that you just described or that thing that interests you about our industry. I mean, I think we have a special team at GreenLight Guru, first and foremost, but I'm especially fond and appreciative of our medical device gurus. And for those listening who may not know, GreenLight Guru, of course we are the only medical device success platform for the medical device industry built by actual medical device professionals. But part of what makes our team special is we have this thing, we call the guru edge and we have folks like Etienne and myself, and probably at least 10 other people that... I lose count these days, and what makes a medical device gurus? These are folks who worked in the medical device industry as product development engineers, and quality managers and quality engineers and regulatory specialists and so on and so forth, who actually worked at medical device companies. So they've been in the shoes that many of you listening are wearing, and they understand the trials and tribulations that you go through as medical device professionals, because we've all done it, and so I think that relatability is important with our customer base and our industry.

Etienne Nichols: Yeah. It's funny that you say that because as you were talking, I started to think, we kind of bear in our body the battle scars of certain situations. When I'm going through the software sometimes, we have the quality events portion of the software and different people like different examples from those, whether it's nonconformance or CAPA. And if they let me pick, I typically say," Well, if you're going to let me pick, let's go with CAPA." I probably have the most trauma related to CAPA. So we can do that.

Jon Speer: Well, I mean, we've all seen things in our career, and this is the other cool thing is no one guru has all the answers on our team, self included and a lot of people are like," Oh my gosh, I bet you've been through-" I say no, I have no experience with that, zero, but I know somebody who does. And so I'll send a quick note, we use this internal messaging tool called Slack. We have a channel just for gurus. I'm like," Hey, who knows about this?" And fair enough, within minutes, somebody knows. And that's awesome to have that expertise. I've said this kind of jokingly before, but I think it's probably true. I don't know how to measure it anyway. So we'll just leave it as something out there that maybe somebody can investigate for us. But I think there is more medical device experience at GreenLight Guru than at most medical device companies.

Etienne Nichols: Yeah. It's really impressive to me. And maybe one of the ways you could quantify that is, most medical device companies are very pointed in a certain specific area, whereas at GreenLight Guru, that's a wide swath. You have electrical, mechanical, the software, just so many different things, packaging, experts, production, labeling. It runs the gamut. So I'm very fortunate to work here. It's exciting to get to learn more of these things too almost by osmosis being with some of the other gurus.

Jon Speer: No, it's fascinating. Every time I get to interact with one of our gurus like, all right, there's an old saying, and I usually butcher these things, but something like it's, surround yourself with people who are smarter than you, and I'm very blessed because I feel like we GreenLight Guru with done a good job of that. And I get to interact with people like," Oh, wow." I remember like when Tom Rish joined.

Etienne Nichols: Yeah.

Jon Speer: I'd done dabbled a little bit in some consulting in the orthopedics base, but here's a guy that designed orthopedic products. And I don't realize that there's always something that's a little bit fascinating about casting a piece of metal that's going to be implanted into the patient for the rest of their life. I mean, my dad, for example, is a recipient of... He had double knee surgery-

Etienne Nichols: Oh wow.

Jon Speer: ...Couple of years ago. And it changed his life. I think that's the cool thing, when you can relate a personal experience, something hopefully nobody we know is going to go through a medical procedure, but the reality is, many people we know are going to go through those and understand the role that a medical device plays in how that can impact their quality of life in a positive way. That's why we do this.

Etienne Nichols: Yeah. A hundred percent. I had a coach at the gym who was getting a double shoulder replacement, well, one shoulder and one partial. And I happened to work at a place where there was another division worked on that side of things, the joints and so forth. So I was actually able to go over to that side and say," Hey, do I need to make any recommendations? Just talk to the director of product marketing on that side." And he said," Well, yeah, there's some good things happening. And they talk to me about a few of those things." It's just, when I hear about those and get to kind of expand my horizon, it reminds me that the future is bright. A lot of times we get sucked into the news and we're worried about so many different things, but really there's just working with all these different companies now, it really does remind me that the future is bright. So I'm excited about all the different ways the medical device industry is going to be improving our lives in the future.

Jon Speer: Yeah, absolutely. And the cool thing is not just, I mean, the gurus that we have, the diversity and the backgrounds that everybody have is really cool, but you kind of hit on this moment ago. But the things that our customers are doing, holy cow, wow. I didn't even think of that. That's cool. So yeah, that's kind of fun for all of us to get that kind of exposure to really the leading edge technology and folks listening... Hopefully many of you are doing some of these fun things too, but there's some really cool things right now that are happening. And I can't wait to hear about some of these products getting to the market. So it's going to be fun time. But I guess with that in mind, as we're recording this, it's toward the tail end of 2021, which I think most people would agree the past couple years have been maybe the weirdest couple years in the history of humanity. But nonetheless, knowing that 2022 is right around the corner, or maybe as this is airing, maybe it's already 2022, but what do you see? What sort of themes or trends or observations do you have as far as what's going on? And I know I'm hitting you very unprepared if we didn't talk about what we were going to talk about. So I'm just throwing this out.

Etienne Nichols: Yeah. My mind's raised in a little bit in a couple different directions trying to think. I would say data driven decision making is going to be one of the biggest things. And it's one of the things that, you know, you can talk about artificial intelligence and some of the different things like that. And that is really cool. It's exciting to hear about those different sections, but the data driven decision making is probably the thing I'm most excited about, its not the sexy, like I said, AI, but it is... I'll give you an example. There's one customer that we work with where they, just to kind of speak in generic terms, just protect the guilty. They are working on a clinical trial where they're actually terminal patients. And so these patients don't really have a whole lot of hope to survive more than a year. So they're doing the clinical trials to make a suggestion on a different off- label drug, for example. And they've had tremendous success. So they put their data into an array or whatever, and it makes a decision for them. It's not that it's doctor making decision, it's looking across a broad, broad swath of drugs that you never would've thought to apply to this specific situation and they're having a lot of success. To me, that sort of thing is really exciting to see, the data driven decision making in different ways.

Jon Speer: That's pretty cool. Hadn't heard about that, but that's really cool. I mean, I like that because I mean, who thinks of that, right? I mean, I hope this comes off the right way, which usually my wife tells me when I say that, but it's going to come off the wrong way. And she's probably right. Well, usually right. But anyway, who thinks, oh wow, there's a patient that has a terminal illness. They have no hope. There's nothing that's going to treat their condition. That's going to reverse this circumstance, but maybe we could give them... Find a pharmaceutical that's not indicated or known or that sort of thing that can make life a little bit better, why not?

Etienne Nichols: Right.

Jon Speer: I mean, there's lot of patients, I mean, sometimes you hear about, or you know a relative or something who maybe late eighties or early nineties and they get a condition and had they been in their forties or fifties, it would've been easier to treat, but because they're a little bit later in life, maybe they're just not able to tolerate the type of surgery and that sort of thing. So this is a really cool thing. Other thing that I'm excited about is, and this has been a theme for a while I think, but there's sort of this convergence or this blending of tech, right? Things that are classic traditional type medical device, very clear cut. I mean that term medical device pretty broadly and somewhat generic at times, but now we have all these tech coming at right? Things that you and I use in our everyday lives that, maybe it's consuming some of our risk space and all these sorts of things, but the lines are blurry between what is and is not a medical device. And I think that's kind of cool in some respects because it's making me a cool patient when I feel like I'm otherwise healthy in some cases, but it's given me information and to your point, I think it feels a little bit like a data driven initiative. I don't know if that's the intent there, but I think that's cool just to see tech entering into our space.

Etienne Nichols: Absolutely. It's interesting. You go into a hospital room and it looks like, depending on the hospital room you go into, it looks like the equipment's been there for 40 years. Sometimes you're like, why haven't things improved? And some things don't need to change. I get that as well, but absolutely, I'm a hundred percent behind if we have the technology to make life more efficient, more productive in so many ways, usually that can be applied to a medical device and make our life a little bit healthier as well. So the wellness products are great.

Jon Speer: You talking about the hospital setting, the examiner and whatever. I'm always reminded of one of our customers. You probably know them, but well, hell I not, I know they have a great story. So the PhotoniCare story, do you know those guys?

Etienne Nichols: No.

Jon Speer: You should look them up, but you have younger kids.

Etienne Nichols: I'm out of loop.

Jon Speer: No, if you have younger kids. This would be appropriate.

Etienne Nichols: Yeah.

Jon Speer: And I forget the name of it. Damn it, that's going to make my story not so good. But what is the device that used for examining the ear?

Etienne Nichols: Oh, not the otoscope, is it?

Jon Speer: Yeah. Yeah, yeah. That's right. Otoscopes thank you. I forgot that.

Etienne Nichols: I don't know how I came up with that.

Jon Speer: Oh, okay. But you said something in a hospital that's been there for like 40 years. Otoscopes's been there for, I think its like a hundred or something crazy like that, now invented and there's basically no tech there, it's just like a flashlight.

Etienne Nichols: Yeah.

Jon Speer: Or less, I mean, I'm overseeing-

Etienne Nichols: Ring with a magnifying glass. Yeah.

Jon Speer: Right. But the guys that started PhotoniCare, sort of their inspiration is the misdiagnosis of ear infections with kids and...

Etienne Nichols: Okay.

Jon Speer: ...The phenomena of the over prescription of antibiotics.

Etienne Nichols: Yeah.

Jon Speer: And when I heard that story, I could immediately relate because when my kids are younger, especially with my son, he had quite a few ear infections and he had to get tubes and all these sorts of things. And I know that the healthcare providers, the doctors, ENTs, et cetera, did the best they could with the knowledge and technology that they had. But I feel company like PhotoniCare is going to change that because they're going to be incorporating video and all these sorts of things into their product. So they've taken a product that existed for over a hundred years and they've modernized it in leveraging tech. So those are cool things too.

Etienne Nichols: Yeah. That's awesome. I mean, anytime you can take the subjectivity out of the equation in a diagnosis, I love that. I don't know if everybody's read or not about the, don't get a colonoscopy after lunch because that's when the fewest polyps are found, that sort of thing. Just we're a little slower after lunchtime. I always try to do things first thing in the morning. But it's because there's subjectivity, you're expecting a doctor to make that call based on a visual. So that's the more data that can be behind a decision. I love that so much.

Jon Speer: Yeah.

Etienne Nichols: You mentioned the wearables, the wellness industry is, I think going to be affected and impacted as well quite a bit. That's exciting to see, because preventative care, there's not a whole lot of emphasis placed on it, but I think there's a lot of space there for improvement too.

Jon Speer: Yeah, and I think the classic wearables are something that you wear on your wrist and resembles, or is incorporated into some sort of watch or something like that. And yeah, there's certainly quite a few products there in that area, but I see other wearables becoming more commonplace. And I think the pandemic is also creating some opportunity for innovation. I think, especially when it comes to healthcare. I mean pre- pandemic, it's not like telehealth didn't exist, but I think it was less common. Especially, like I live a little bit more rural, telehealth would be a huge benefit to a lot of folks who are rural in different parts of the country because we're restricted, we're sort of home bound or home bound more than maybe what we were a couple years ago. So I see wellness to your point. I see telehealth being another area that's grown. Products that are more home use. I could see that growing, which, you know, there's other challenges with that.

Etienne Nichols: Absolutely. So the home use, that's actually one of the company that I was working for prior to coming to GreenLight Guru. They were working on a drug delivery product and the goal was to prevent or help patients who had to go into the hospital to have an infusion and to allow them to have the freedom to do that at home. And its really cool story on their side. It's really exciting what they're doing over there and just things like that, it's really neat to see. I was at a conference actually last well, I started to say last year you mentioned 2022 and it's in my head. I'm like, is this 2022? No it's still-

Jon Speer: Oh yeah.

Etienne Nichols: ...For me. It's 21 right now.

Jon Speer: Yeah. It's still 21.

Etienne Nichols: Got to talk to an inventor. I don't know. He's an interesting guy in a lot of different ways and he's working on a... And has got the funding for, and has a working prototype of a continuous glucose monitor that's non- invasive and he got the idea because his wife nearly died of diabetes and some things like that. So he said, man, we need to be following this all the time. And I just love that stories of people scratching their own itch. And he used that multiple times like," I saved my wife's life and I saved my own life because turns out I was headed that direction as well." So I just think that's super cool to hear those stories as well.

Jon Speer: Yeah. I mean, diabetes, remembering what I started in the industry and probably to some extent, even today that was sort of, if you could come up with a technology to address or mitigate diabetes, I mean, that's sort of a holy grail opportunity and I know there's been a lot of innovation in that space, but I think this is the other thing and your story kind of hits the nail on the head there. But we work in an industry where the people actually care. Okay. Yeah. There's a couple bad apples, but people who work in medical device industry, they care about it. And I hope other people and other industries also care about what they do, but I just feel blessed to do this. And I'm not going to retell this story because you've probably heard it before and plenty of other people listening have heard it before too, but there was a moment in early and I'm glad it happened early in my career where I had a live ball moments like, oh this is why I'm doing this. And I think a lot of medical device professionals that kind of have their own light bulb or epiphany moment where it's like, oh, okay, now I get it. And then once you get it, you can't un- get it, it's contagious in a good way.

Etienne Nichols: Yeah. It's like, there's a line that's been drawn and anything on the other side of that is, you don't want to go there. Yeah. I had a similar in college, maybe a similar situation, I wasn't in the medical device industry yet, but I think it's when caring about my medical devices sort of popped up. My brother had some issues that landed him in the hospital and we were very concerned that he might not make it. He was there all summer long, but at the end of the summer he said," I got to get back to college, so let me out of here." So he just muscled through. He's an impressive guy, a lot of respect for him. But fast forward into my manufacturing career, I would go out to the manufacturing floor. If we had a rush shorter or something of, it was neurosurgical equipment. It was a stereotactic surgical equipment that they used and a lot of workmanship involved. And when we had a lot of orders come in, sometimes we tried to get them through as quickly as possible, but they would see me coming. I'd come out there, I'm like," Guys, I got to make a quick speech." And their like," Etienne's going to go long again." And I'm like, guys, I tell them about my brother in a lot more detail. I'm like," The things that we do matter so much. Okay, you guys aren't building Kia Rios, you guys are building the Lamborghini and so take the time and do it right.' And they roll their eyes at me and they get back to work. But yeah, it matters. What we do really does-

Jon Speer: Well, I mean. Well, so first of all, you're not a brain surgeon, but even more important, you help make the tools that brain surgeons use. So that's pretty damn important. So that's kind of cool.

Etienne Nichols: Residual effects.

Jon Speer: But don't you reach some people in that manufacturing environment for sure. Earlier in my career, I was product development engineer, but the company I worked for, I didn't know this at the time. And actually I kind of found this out the hard way that also meant that I was the manufacturing engineer. Cause we were engineering light, let's just say, we didn't have engineers to fill all the various disciplines within the gamma. We didn't have manufacturing quality engineers. That you were the engineer many times that were going to do all of those things. But I developed really close relationships with the manufacturing departments that built the products that I was designing and not just the ones that I was designing, but the others in our business unit. And this is a trick and I don't mean for it to sound like nefarious or shady. It's quite the opposite actually. So I hope some folks out there listening can take this and apply this. But I found that when you can explain to people what the product does and how it's going to be used and what sort of disease conditions or situations where this product is going to be beneficial, you get a different kind of pride, a sense of ownership. That person now gets a little bit of agency with that product that they're involved with. And I just encourage people to share that with others on your team who may or may not understand that. Just take a few extra moments, just to give them some perspective on what it is that they're doing and why it matters.

Etienne Nichols: Yeah, absolutely. If I go back to that conference, I actually got to moderate a panel with multiple people who had started and sold companies and the piece of advice that really stuck with me that they gave, they said just same thing you said. Just share those customer stories.

Jon Speer: Right.

Etienne Nichols: And I took that and kind of flipped it in my mind. I'm thinking, okay, if a product has impacted me, maybe I should share my story with that company because that could be the difference in-

Jon Speer: Oh yeah.

Etienne Nichols: ...Them moving forward. So I definitely encourage people to do that. Yeah. I know I've heard you talk about the FDA and you say I'm a fan of the FDA and I don't know if you experienced this. I experienced a low to high experience of the FDA. My initial thought, I was like, man, this paperwork, this industry, this regulation. But as I moved forward in my career, I got to the point where I thought," Wow, this actually is a good thing." And I'm actually trying to figure out a way to write this out so it makes sense. They don't put up a speed limit sign. I'm going to try to use this illustration to tell me about whoa, you're way off face. When I was a kid. Well, I call myself a kid. When I was a teenager, I had a motorcycle, it was a fast motorcycle. We would go around curves much faster than we thought. We'd see that speed limit sign. We'd say," Okay, it says 25. That means I can go 40 on this bike." Don't recommend that to anybody. Not a good idea, but this is what went through my mind. When I saw that, I thought, Okay, what the FDA does is they don't put the speed limit sign up. They say the road is curved at a three degree angle that has a certain friction. It has a certain slope, don't fly off the road. And if you're driving a semi, you better go 50 miles an hour. If you're in a sport bike, maybe you can go 40. So that's the way I look at the FDA now as far as their regulations. I don't know. What do you think though?

Jon Speer: It's not so much that they're this putting the speed limit sign. It's almost like they're putting the guardrails up.

Etienne Nichols: Yeah.

Jon Speer: Right. So that you don't slide off that curve and, I'm a little bit older than you, but I started my career in the late nineties. Well, right before I started my career, what we know as commonplace today, 21 CFR part 820, which is the FDA's quality system regulations for medical device, just went into place in the... I think it's 96. So I think we just celebrated like 25 years or something crazy like that, but just went into place. And before that it was like GMP. And so there were regulations, they were just a little more loose, right? A lot more left for interpretation. Although even today, to your point, I think there's still a lot left to interpretation depending on whether I'm driving a semi or a sport bike.

Etienne Nichols: Yeah.

Jon Speer: But the industry was kind of, I was coming into it. The industry was kind of grumpy. They were like,"I can't believe the FDA is putting all this enforcement on us." And so I think that was sort of the tenor or the theme there for a while. And there was not a interactive, collaborative type of relationship between industry and FDA and both sides are guilty, frankly. It was more like this headbutting and it was, I can remember when we do 510( k), we didn't notify FDA ahead of time. We had no communication with FDA ahead of time. We just put together the 510( k) packet and shipped it to them and crossed our fingers and waited. And I don't even think our regulatory team called them after they shipped it to make sure that it was received. I don't know if they had return receipt, but regardless it was very little interaction. It was more of," We're going to send it over. We're going to cross our fingers and wait in kind of this poor and ineffective way to communicate. So that was the beginning. And then within the past, let's call it a decade. I see the FDA has been much more... They've been changing sort of their approach. So there's more opportunity to collaborate with industry. I mean, just a thing, like a pre- submission if you're going to do a regular a 510( k) or some sort of regulatory submission. You can get an audience, you can communicate, you can have a conversation with the FDA ahead of time and think that's awesome and I think that's amazing and I think that's really cool. So yeah, I've seen a huge evolution of FDA over time and I like the metaphor or the analogy or whatever, the riding on a motorbike on curvy road. I think that's good.

Etienne Nichols: Yeah. The other thing, I guess I would also stress because I have conversations with people different times is, the FDA is I am so thankful that they're there. Let me just put it that way. If you know any of the case studies about prior to the FDA prior to certain, whether it was radiological, we're much better off with these regulations. So I'm thankful for that.

Jon Speer: Well, I'm thankful for it and I'm thankful that they are... I think they're still the model that a lot of the rest of the world looks to as far as how to structure and how to effectively monitor and govern medical devices. I mean, it's a tricky balance. I think this is my own personal opinion. I think government works best when you don't notice that it's there, right?

Etienne Nichols: Yeah.

Jon Speer: And I would say generally speaking FDA is sort of that way. I mean, I appreciate that they're kind of a gatekeeper for new technologies. I mean, they have an awesome responsibility, their job, they are a law enforcement agency. A lot of other parts of the world may not have, they may have a regulatory body, but they may not be necessarily a law enforcement agency personally.

Etienne Nichols: Yeah.

Jon Speer: But their job is to protect and promote the health of US citizens. I mean, that's an awesome responsibility and they don't just cover medical devices. They include pharmaceuticals and food and lots of other things. So yeah, the fact that we can design and develop and bring new products to market with that little bit of collaboration with the agency and that generally... They only intervene if there's an issue or a need to, I mean, I don't know. It seems like a pretty good system.

Etienne Nichols: Yeah, absolutely. So didn't mean to go off on that tangent, it popped into my head and I love hearing what you have to say about these different things.

Jon Speer: Yeah. Well, I know we're... I'm just kind of looking at the time here and I know people, well, this feels like a good stopping point.

Etienne Nichols: Sure. No sounds good.

Jon Speer: But welcome. I'm looking forward to working with you more closely on future episodes of the Global Medical Device Podcast, for those listening, Etienne and I've already had some conversations about the direction of the podcast. So I think he'll bring some fresh thoughts and ideas and explore some areas that maybe we haven't done as much in the past, but I know he's excited to put some of his fingerprints on this too, so it should be a good time. So I'm looking forward to it.

Etienne Nichols: Yeah. Thanks Jon. Looking forward to it as well.

Jon Speer: All right, ladies and gentlemen, as you know, GreenLight Guru has a software platform. It's the medical device success platform. It has workflows to help you manage design and development and risk. We've talked a lot about risk today. Etienne and I, on a couple of our stores. And how do you manage that? Well, we also have workflows to help you route documents and records for review and approval, maintain all the versions of those documents. And then CAPA, the dreaded topic that Etienne doesn't want to talk about. Well, we have workflows for that as well as non performances and complaint and audits and so on and so forth. But it's all in a single platform, all tied together. Everything that you do from design and development through post- market, you can connect all of this information together in a platform and it's designed and developed at GreenLight Guru. So it's very easy. Go check it out, www.greenlight.guru. We'd love to chat with you. So if you want to click that button, request that call, then we'd love to learn about what your needs are and see if we have products and solutions that can help you. So very simple. So thank you for listening to the Global Medical Device Podcast. The number one podcast in the medical device industry, and as always I'm guessing I might have to change that line here soon, but this is your hosted founder, Jon Speer and co- host Etienne Nichols and you have been listening to the Global Medical Device Podcast.

 


 

ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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