GMDP-Etienne-Nichols

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves.

The Guru team is comprised of industry experts with a knack for helping companies succeed; each of whom have a specific skillset and knowledge base that companies can tap into and leverage throughout their medical device journey.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Etienne Nichols, a Medical Device Guru at Greenlight Guru, to learn more about his expansive industry knowledge, experience, and passion, of which he uses in his approach to help customers work through the design and development process to bring safe, high quality products to market.

 

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Some highlights of this episode include:

  • Etienne is a mechanical engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience.
  • Also, Etienne has aided in the development of combination drug-delivery devices and managed cross-functional teams to update designs of legacy products. 
  • There’s a whole side of the medical industry that Etienne didn’t ever think about until he broke his arm while in college. He thought about being a doctor, but decided to switch to making medical devices.
  • Etienne believes the future is bright because people are working hard to develop new technologies and bring products to market to improve people’s lives. 
  • By working with gurus and engineers, Etienne has expanded his knowledge of different specialties and niches, including Software as a Medical Device (SaMD).
  • At Greenlight, Etienne looks forward to meeting and getting to know more customers and continue to utilize his skills as an engineer.
  • Once Etienne started following Greenlight, he was curious about its QMS and realized that Greenlight puts the traceability into the traceability matrix. 
  • Etienne understands the pain of following the design controls process in a paper-based QMS environment. Implementing a QMS doesn’t take a long time but requires a methodical approach. Go slow to go fast.

 

Links:

Etienne Nichols

MedTech Innovator

FDA - Classify Your Medical Device

FDA - Software as a Medical Device (SaMD)

FDA - Design Control Guidance for Medical Device Manufacturers

Wade Schroeder (Medical Device Guru)

Jesseca Lyons (Medical Device Guru)

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes by Etienne Nichols:

“I think the best thing for me is getting to see the technology that’s being developed out there and how many people are working so hard to bring products to market.”

“I feel like my breadth of knowledge is expanding just by being around these different people.”

“Greenlight Guru has really put the traceability into the traceability matrix.” 

“I’m a huge fan of design controls workspace for sure. It’s awesome.”


Transcript:

Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: On this episode of the Global Medical Device podcast, I do another Meet the Gurus session, this time with medical device guru Etienne Nichols. Etienne has a lot of experiences prior to joining Greenlight, some in other industries, but to me, that's always part of journey, just learning things along the way that could be applicable to current situation and circumstances. And it was through this conversation, and I talked to all of our gurus periodically but... and then just blessed and appreciate so much how that team has grown and really proud of our medical device gurus at Greenlight Guru today. We have, I think over a dozen as this is being recorded and just to see and hear some of their successes, but how excited they are about helping our customers, medical device companies like you through their journey and how much pride and excitement they have from that. I mean, that's just amazing. So hope you 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 from time to time, we feature one of our gurus as you probably have become familiar. Joining me today is one of our newer gurus at Greenlight Guru, Etienne Nichols. Etienne, welcome to the Global Medical Device podcast.

Etienne Nichols: Thank you, Jon. It's good to be here. I'm excited to have a conversation with you today.

Jon Speer: Absolutely. I guess maybe a good place to start our discussion is tell the folks a little bit about who you are and sort of, I guess, high level overview of your journey in the medical device industry so far.

Etienne Nichols: Sure. Okay. Well, I was a mechanical engineer in college, and I wanted to be a biomedical but I was down that road a little bit already. But what sent me down the interest in being biomedical was I broke my arm in college and the surgeon was really into physics. He talked to me all about the different physics of the implant that was going into my arm and the screws. And he showed me all of the differences," Oh, you're an engineer. You're going to be interested in these things." And it did really spark my interest. So after I got out of the college, I worked as a mechanical engineer for a couple of different industries, aerospace, steel industry. Finally got the chance to be a medical device engineer working at a manufacturing facility. So I learned a lot about different thing, the QMS, product development. I got thrown into a regulatory project, which was really exciting. And then that really sprung me into project management where I started working primarily with product development, even going into a combination device, drug, and drug- delivery device. And that's the point that I found Greenlight Guru. So I feel as though I've dabbled in a lot of different areas, so that's kind of how I came here.

Jon Speer: Okay. And you mentioned before while you were at school, you were thinking about considering biomedical engineering before you broke your arm. What was the drive or the entry there?

Etienne Nichols: Well, so the two different reasons, I had been obviously pursuing mechanical engineering. I had considered going in and going on to be a doctor after that. I was toying with that thought in my mind, but then I thought," Wow, I could really help some people." There's a whole side of the medical industry that I don't ever think about and that's the design of these devices. And here I am already in college to be a designer of things, why not just design medical devices. And so that's really what kind of sparked my interest more than anything.

Jon Speer: Very cool. So you've been at Greenlight now for a few months, I mean, how would you describe or what do you enjoy most about being a guru at Greenlight Guru so far?

Etienne Nichols: I think the best thing for me is getting to see the technology that's being developed out there, and how many people are working so hard to bring products to market. I had the chance recently to be a judge at the MedTech Innovator, which was an awesome experience for me.

Jon Speer: That's cool.

Etienne Nichols: My takeaway from the event... I've talked to a couple of different people about that, but the thing that most everybody is going to hear me say is I feel like the future is bright when I see all of these people working so hard. We hear on the news, all the tough situations that the world's facing, but we don't talk as much about the lesser, not as well known entrepreneurs that are working tirelessly to improve people's lives. So that's exciting to me. It really pumps me up seeing all the technology that's being brought to market.

Jon Speer: For sure. I mean, it's kind of crazy to think about... I mean, I've got a few years on you, but when I entered in the med device industry, I mean, I'm trying to say... I mean, I had a cell phone that it was basically just a phone.

Etienne Nichols: The big brick kind.

Jon Speer: It wasn't quite that big. But when we use a phone, it did got [ inaudible 00:05:38] on it. I think it might've had... I remember my Blackberry, that day's been little bit... I love it [ inaudible 00:05:44]. The phones that we have, and the things that we wear, all these tech devices that we use in our everyday lives, they have some... in some cases, medical purposes, and it's kind of cool to think about the emergence or convergence of technology and med device and all for that purpose of improving my quality of life or the quality of lots of the people that I love. It's kind of exciting.

Etienne Nichols: Yeah. And I guess I'll add, just when you asked the question about what I enjoy about being a guru, that's certainly, probably, first and foremost, it's just so exciting to see that technology like you're saying. But in addition to that, you brought that up about the software as a medical device. That was something that I wasn't previously as involved in. The people I'm working with now, for example, Wade, he's dove right into that to learn software as a medical device, taking courses on that, and he's going to be a cutting edge guy for software as a medical device. And just all of the people I'm working with, they all have their specialties, and they're all really diving into a lot of different subjects that maybe people who were niche engineers might not have ever even considered before. So I feel like my breadth of knowledge is expanding, just by being around these different people, so that's another really exciting thing to be experiencing right now.

Jon Speer: Yeah. When you referred to Wade, you're referring to one of our medical device gurus, Wade Schroeder.

Etienne Nichols: Yes.

Jon Speer: Yeah. So yeah. To me, it's kind of exciting to see, not just the technology, but like you and the other gurus and you have such a great opportunity, I think, to want to let your current skills and expertise shine and be an asset and a resource to our customers. But to your point, Wade is a good example. He's curious about some aspect of the industry, and he's diving in, and he's taking some courses, and getting some expertise in an area that he didn't have so that's kind of cool that... And I think that it exemplifies a bit the entire medical device guru, a group of folks at Greenlight Guru is that... If you look at all of the skills and the expertise we've done when it comes to med device, the group of gurus has done everything you can do. I think that would be... I mean, of course I've got a strong bias, but I think as a customer of Greenlight Guru, that's got to feel good, because I know I've got a team behind me that's already been through the things that I'm going to go through, and that they're a phone call away, so that's kind of cool.

Etienne Nichols: Right, it makes me think when I was leading a project to get direct part marking placed on Class II devices for the UDI implementations several years ago, it was a stressful time. It was a very stressful time for me, because when you're a project manager, you may fall into the trap of thinking," Man, if this project doesn't succeed, heads will roll and things are going to..." And it's possible that people could lose those jobs. It's definitely an impact. But had I back then had Greenlight Guru backing me, I would have had so much more confidence. And while I feel like we did a great job, me and my team, just being part of this machine that backs all these small companies or large companies, any size companies, I feel great being able to do that. I think it's exciting.

Jon Speer: Yeah. That's cool. So I know it's early days in your time at Greenlight, but any favorite customer stories that you can share as far... And don't feel like you have to share who the customer is, maybe just anything come to mind.

Etienne Nichols: Yeah. There's a couple of different... I mean, you're right. And having not been here too long, one of my favorite customers though that I got to have a conversation with, he pulled up his design of early conversations. He wanted to get to know me a little bit. I'd like to get to know him. So we were just having a conversation. He pulled up the design of their product, and he was so open about the way it was designed. We talked about some of the different aspects as to whether you want to can leave or something or not. What are the risks imposed? And that was really fun, because sometimes when you're in an advisory role, you may feel like you're losing touch of the design itself, but those conversations are really exciting. So he and I had a good time exploring that. Yeah. I don't have any specific because obviously, still a little early, but I am excited to start to get to know the customers because that's one of my favorite things about this job as well.

Jon Speer: Yeah. Well, it sounds like in that example that you shared, you got to be an engineer.

Etienne Nichols: Yeah.

Jon Speer: And I'll share a story. Jessica Lyons. So she's been one of our medical device gurus. She just actually celebrated five years, and that was just hard for me to believe. But anyway, when she came in for the interview, we didn't have any gurus aside from me at the time.

Etienne Nichols: Oh, wow.

Jon Speer: We didn't have a customer success team at the time. But she came in for the interview and she wanted to kind of see a day in the life and kind of shadow me. And at the time, I was working with pretty much all of our customers. Again, it's early days, but we had a call with one of our customers, and he started asking questions about sample size for testing purposes and all these sorts of things. And I knew that Jessica has some expertise in that, so I just gave her the phone. And during the interview and...

Etienne Nichols: Oh, wow.

Jon Speer: Because her concern was she really liked being an engineer.

Etienne Nichols: Absolutely.

Jon Speer: And she was worried that if she came to Greenlight, she wouldn't have that opportunity to be the engineer. Yeah, I think maybe a little bit of a bias, but I think the opposite is true. In some cases, I know my career path, I felt like I was spending way too much time updating things like Excel spreadsheets and word documents more so than doing engineering or project management. And that was sort of the motivation that drove me to conceptualize. And I guess to come up with the idea of Greenlight was so that I can actually spend time doing what I enjoyed. And at that time I was managing projects, but I think our guru was getting more of an opportunity to be nerds.

Etienne Nichols: Yeah. I actually think you're absolutely right about that. I am curious, when you conceptualize Greenlight Guru, how close are we from where we were from what was in your mind. I'm sure it's evolved like crazy.

Jon Speer: Well, it has evolved like crazy. The idea that I had was at the time I was doing a lot of consulting with primarily startup, but some small companies, but really trying to help them get products to market. So everything about managing, everything about the product development process, working with suppliers and design firms, and contract manufacturers, things of that nature. But preparing tech files or five, 10 cases, whatever the case may be. But there was this common theme, and it was design controls. And more times than not, the people that I was working with on these projects, they didn't really understand or conceptualize the importance of design controls. And I managed to maintain a spreadsheet, the traceability matrix essentially in a spreadsheet. This is a practice that I've implemented long ago on my career at this point. And I knew that, especially in certain phases of a project, it's very dynamic. Things are very fluid and changing. And so sometimes you're updating that spreadsheet a few times throughout the day. It was not uncommon for me to spend several hours per week just updating that spreadsheet. But it was so important to communicate where we are or what's going on, that it was worth it. And that essentially was the first version of Greenlight was, and then prove workflow for managing design controls while keeping that traceability matrix fund center. I would say all the other workflows that are in the platform, those that evolved and pivots based on things that we learned after. But that design control traceability matrix was the first idea from a product perspective. And I would say where the product is today actually is pretty close to that ultimate vision that I had with that.

Etienne Nichols: Yeah.

Jon Speer: I mean, we constantly are evolving that workflow on the platform. I know that we've got a couple other things on the horizon with that too, but I think it's pretty close today to that vision.

Etienne Nichols: And I don't mean to go too far off track, but what you're talking about, it makes me think of how I found Greenlight Guru. I mentioned wishing that I'd had their content production and all of the team backing me in the past. I actually was... When I found you guys, I was just doing some research and I found Jessica Lyon's article. She had an article on, I think it was DHF, DMR, DHRs. I was just trying to get something to show other people. The external knowledge always seems to swipe people more than your own sometimes, anyway.

Jon Speer: Yeah.

Etienne Nichols: But I was so interested in just the article and the content. I reached out to Jessica and just to say," Hey, really enjoyed your article." I just followed her on LinkedIn and started learning more about Greenlight Guru. And it just was kind of cool to see that I was curious about the product, and started looking at the software. So what I was doing at the time was doing what you said. I was managing an Excel spreadsheet that had the design controls, and we call it a trace matrix as well. But what Greenlight Guru has really... It puts the traceability in the traceability matrix I think, because now you can trace to everything. I'm a huge fan of the design controls workspace, for sure. It's awesome.

Jon Speer: Awesome. Well, I want to focus on and remind you, I'm talking to Etienne Nichols. Etienne is one of our gurus at Greenlight Guru. And he's just describing some about the Greenlight Guru medical device success platform. If you'd like to learn more about the design control workflow or frankly, any other workflows for helping you manage risks in documents, and records, and change, and quality events such as CAPAs and complaints. Well, I would encourage you to go to www.greenlight.guru to learn more, and we'd be thrilled to have a conversation with you to understand your needs and your requirements, and see if we might have products and solutions that can help you. But yeah, you're spot on. I mean, I think that was one of the... I mean, the traceability matrix that I was doing or keeping up to date is... I tried to make it dynamic, but it was essentially a static spreadsheet, and we still had separate documents and records for a lot of the other things. And when you're in a prototype or a mode, heavy prototype or you're doing some preliminary tests and things like that, things are pretty fluid. They change quite often. And that was one of the frustrating things for me about the spreadsheet, the traceability matrix is if I change something in one area, like just say a design input, I probably had to go at least one, probably two or three other places to change it to. And that was the non- value added activity. And so kind of the funny thing is this... I guess a couple of seeds got planted in my brain back in early years. So the first company I worked for out of school, I was a product development engineer and then got involved more in, I guess, engineering systems and processes. But I had somebody, and it was an old school company. When I joined them, the FDA regulations were pretty new, so everybody was trying to figure them out. But there was a comment that I got from a boss once that said," Hey, why don't you figure out a way for all of this design control information to fit on one page." And that kind of stucked with me. And even at that time, I mean, projects that I would manage, we did paper. I had a file cabinet next to me that I had all my projects. And then even the simplest of projects had probably two or three- inch binders full of stuff, just paperwork. That thought just like stuck on my head like one sheet of paper. Now I'm an engineer, and engineers could be contrarian. That's how inaudible to be. And then sometimes even we don't. But I'm thinking," Oh, I can get a D- sized plotter and make it once you... to paper. It just will be the size of a room," right?

Etienne Nichols: Yeah.

Jon Speer: But anyway, that whole idea kind of stuck with me. And before Greenlight was called Greenlight, I was working out. I called it a UniDoc, U- N- I- D- O- C, one document. And the concept is, hey, how can we put all design control information in one place, so that if I update at one place, it changes or goes or where it needs to, it gets updated everywhere too.

Etienne Nichols: Well, I'm sure even early on, the people you were consulting with had to... Well, I don't know how... Did they appreciate it? Were they at the point where they knew the difference, or was that normal inaudible?

Jon Speer: I think there's a similar reaction today. I mean, those who have been through it, they know the moment they see the screen, and Greenlight, they know exactly what it does, without looking into or adding anything. They just know what it does. Right? I think it does bridge the gap and shorten the learning curve a bit for those who are maybe new or to med device. And it is funny. There's a couple of customers that come to mind. Their journey I'm sure has been hard, and I guess level of difficulty is always a matter of perspective, but I know it has been difficult and challenging. But looking through my lens through their journey, it's like what they have been able to accomplish in such a reduced timeframe is phenomenal. And I know Greenlight has played a part of that. But they don't have the other experience in that. That's always kind of interesting is like, if you don't have the context, it's really hard to relate.

Etienne Nichols: Yeah, it's true. And like I said, I was talking to another guru who also managed a trace matrix and at different points in time. Yeah, so much appreciate your... I personally do, anyway. When I look at this, I just think," Oh, man." I've visited with some other engineers who are at different companies now since starting at Greenlight Guru. And I feel like I want to be a walking billboard, because I think Greenlight Guru... I think we're absolutely changing the market in that. We're getting products to market faster, but we're also improving quality of lives with the people who are working in this every day. It's enjoyable to work in Greenlight Guru versus the Excel spreadsheets of yesteryear.

Jon Speer: I think that's... your quality of life component, I mean, it has multiple meanings within the company. I used to say, I'm like a double entendre. And then I learned that's actually inaudible inaudible because I didn't or something risque about it. There's nothing risque about it, so it has multiple meanings. I mean, it's improving the quality of life, because it's helping our customers get products to market for patients, of course. But it's also helping their quality of lives. That was one of the things that for me is... It kind of started getting to a tipping point when I was in consulting is like, I am more qualified, more to bring an offer and an expertise, then it takes to update a spreadsheet. It was like, I want... but I'm spending too much time, not just updated spreadsheets, but just the morass that you go through and of keeping all of these things up- to- date. Because I value the importance of documentation, because I've been on both sides of that equation. Good documentation, not so good documentation. And having gone through those experiences, they definitely formed my beliefs. I knew which one was the preferred option. So I was going to spend the time on the documentation, but I was spending an exorbitant amount of time on the documentation that was taking the way from other skills that I could bring to the team. And I think that describes a lot of medical device professionals, not just product developers and project managers, but a lot of folks are having that experience. And I've heard a lot of people be disenfranchised. And I think the unfortunate thing is that is an outcome of poor attention to detail with respect to our systems that we've put in place. I think we've made things more complicated at times than it needs to be. And then other times that complicated or not, but nonetheless we haven't right sized our systems.

Etienne Nichols: Yeah. And just the fact that what you said about you've felt this need, so you were filling this need to reduce the amount of time spent on that, maybe to improve what you were doing. Just the fact that you having developed a lot of this and then all the other gurus, they're all engineers who are scratching their own itch. This is something we felt the pain of, maybe paper- based or the spreadsheet of a trace matrix. I think that's what really is impressive to me about the company, and the fact that, to your point earlier, the fact that we can help customers having been there, we truly are scratching our own itch. We know why we're doing, what we're doing. And so I think it's great. I'm a big proponent for that.

Jon Speer: Yeah. And for me, it's awesome because then you, and Wade, and Tom, and Jessica, and all the other gurus, you all get to have your... You have different experiences, so you get to bring your sets of experiences and to the team to share. And we all have to kind of learn from that. But all of that, that knowledge finds its way into the product, and so that the next update might have something that is based on some conversations that we've had internal about ways to prove this interface or whatever the case may be. It's like the guru edge, that expertise will find its way into the product and into the workflow, which collectively speaking anything today, as we're recording this, don't hold me to this count, but we have somewhere around a dozen gurus within the company, which is frigging awesome. And I know that it's like unique offering, especially in the QMS software space. Most are so general and generic that they're not specific to med device. Well, we are a hundred percent focused on that device. And we have all of these decades of experience in the form of our gurus who are there to. So like I said, we've got at least 12 as we're talking. I think that's something we don't... and we're pretty modest most of the time. And I think that's one of the areas where maybe we could toot our own horn a little bit more about that.

Etienne Nichols: I love the people I work with, and it's exciting to share in all of this knowledge, and to share the knowledge that I've learned as well over the years. That was one of the things that I found... Like I said, when I found a Greenlight Guru through doing research and coming across the articles. Well, I was struggling with explaining a lot of the design control items to different people, and how things connected. And so when I say struggling, I mean, when I was spending more time doing that, then what I... project management and the engineering. And so that's explaining things to people and really educating people. That was exciting to me and seeing the light bulbs pop on and people really getting it, getting those different connections. That's exciting.

Jon Speer: Yeah.

Etienne Nichols: Yeah.

Jon Speer: All right. Well, at the end, as we're wrapping things up today, I guess, any tips or pointers or thoughts come to mind to kind of wrap our discussion up today?

Etienne Nichols: I'll say one thing just to our customers who are starting out. The thing that I've noticed, just having been on so many different calls, just learning the different processes, what I would say is go slow to go fast. Even in the short time I've been here, I've seen customers come out of the gate hot, they're trying to get through training as fast as they can. Then it's almost like they fall off the radar. Some of them. And implementing a QMS, it doesn't have to take forever, but it does take a methodical approach. So the key I would say is go slow to go fast. And then you can really implement and be strong.

Jon Speer: Yeah, that's really good. And I think along with that, and we realize that it is... You don't have to eat the elephant all at once. So you can take it a bite at a time.

Etienne Nichols: Yeah.

Jon Speer: And I've seen that as well, where customers want to have this mad dash and this rush to get through all the training. Well, in my experience, the training that I've taken through my career is... The training that is the most effective is when it is in sync with when I'm actually doing the activity. It's reinforcing and that sort of thing. Yeah. It's good that people are excited that they want to put all of their QMS in place. And I want you to be excited a year from now. So if you're diving headfirst and trying to do it all within the next couple of weeks or so, you're going to burn yourself out. So, it's a marathon. Pace yourself. That's a really good tip. Well, Etienne, thank you so much. I appreciate you taking time out of your day. I know you mentioned being involved in the MedTech innovator, I'm sure that other forms of content, webinars, and articles, and things of that nature, folks be on the lookout for content from Etienne Nichols, sort of become a hearsay. And so thank you so much for being listeners of the Global Medical Device podcast. The number one podcast in the medical device industry, and that's all thanks to you. Oh yeah. I forgot to mentioned. Hopefully, by now you already figured out, we're on video, so click the subscribe button and the bell icon, and that way you keep notified of anytime there's a new episode. But yeah, we started doing these on video, and I've been having a good time with it. It's a great way to connect with my guests, and hopefully a great way for you to get some of that human connection as well. So thank you so much. As always, this is your host, the founder of Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


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

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