GMDP-Laura-Court-

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a ton of industry experience.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Court, a medical device Guru at Greenlight Guru, about her journey in the medical device industry, which ultimately brought her to Greenlight Guru, and Laura shares some tips for success she's learned along the way.

 

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Some highlights of this episode include:

  • Laura gained hands-on manufacturing experience because she believes medical device professionals can’t design a product well if they don’t know how it’s made or what is gone through to get a product made and put on the market.
  • What made Laura move towards Greenlight? Ultimately, it was her love of helping people and getting out on the floor to help people who make products.
  • Laura sought advice and looked to manufacturers for knowledge to validate products because they knew the systems and processes better than anyone and she wanted to help fix problems.
  • Also, Laura learned that people using products can drastically alter what medical device professionals do.
  • Laura likes being a Guru because she has the opportunity to meet companies and customers, as well as collaborate and interact with people doing and coming out with amazing work and new technology.
  • Greenlight Guru Academy offers courses on risk management, design controls, and document management. Laura believes the educational resource features well-written content that makes the transition to a medical device career easier.
  • Most interactions at Greenlight have been virtual and remote. It takes a desire to learn, surround yourself with smart people, and gain experience.
  • Keys to Success: Use and rely on resources that you can find. You don’t need to know everything right now or be an expert on everything you touch and see.

 

Links:

Laura Court on LinkedIn

FDA - Medical Devices

European Union Medical Device Regulation (EU MDR)

ISO 13485 - Medical Devices

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes by Laura Court:

“I’m a true believer that you can’t design a product well if you don’t know how it’s being made or what you go through to make a product.”

“Ultimately, I just loved helping people. I loved getting out on the floor and helping people who are helping us make the products and things like that. That’s what ultimately drew me towards coming towards Greenlight.”

“I’ve already met so many different companies and just learned about some amazing technology that people are coming out with.”

“I just love the collaborative side of all of it.”


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: I just got the recording of a new Global Medical Device Podcast episode with one of our newer medical device gurus, Laura Court. It was great to connect with her, learn a little bit about her background and prior to Greenlight and working on product development for both small and large companies. And she shared some of those experiences that she's had in her career so far. So I hope you enjoy this Meet The Guru 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, if you've been an avid listener of the Global Medical Device Podcast, especially within the past year or so, you noticed we featured a Meet The Guru episode from time to time. This is a great opportunity for us to share or bring in some of our medical device gurus. That's right. Greenlight, we have a lot of people who work at the company who worked in the medical device industry before they came to Greenlight, which is one of those, I think, advantages. It gives us that guru edge because we've been there. We've done this. We know what you're going through because we've done it before in our careers. And joining me on this special episode of a Meet the Guru is Laura Court. So Laura, welcome to the Global Medical Device Podcast.

Laura Court: Thank you. I'm very excited to be a part.

Jon Speer: All right. Well, I guess a good place to start is, tell us a little bit about yourself, a little bit about your background and your career today, and some of the things that you've done in the medical device industry.

Laura Court: Yeah. So most of my background has been primarily in product development. I love the design side of it, everything like that. I got a degree in mechanical engineering, really loved the human movement, biomechanics side of things. That's what really drew me into medical devices. I did a couple co- ops during college that were in medical devices and everything like that. So my first job, I worked in a fairly technical product. It was a high intensity focused ultrasonic probe. That was a really great way to kick off my career, but it was with a very small company. So I got to get my hands into a lot of different areas, everything from the design side, all the way through to product sourcing, working with manufacturers, everything like that. When I left that company and went on, I went to a little bit bigger company and it was a very different change for me because I was used to a very small company, small product development team. There was only really, two of us on the team, to a larger company where they produced over eight million parts a year.

Jon Speer: Wow.

Laura Court: So I went from a very small, little office to working in a manufacturing plant. There was a press room, an extrusion room, a circuits room, just so much going on, so much more craziness going on. But it was a lot of fun because I got to get my hands then into a lot of different things. There were times that I was crawling through a machine, trying to figure out what was going on, or get different tests set up. So I still got to do a lot of the product design things, but then also got to get my hands into the manufacturing side of it and actually do the hands- on, because I'm a true believer that you can't design a product well if you don't know how it's being made, or what you go through to make a product. So I loved getting that experience and everything like that. But ultimately, I just loved helping people. I loved getting out on the floor and helping people who are helping us make the products and things like that. And that's what ultimately, drew me towards coming towards Greenlight.

Jon Speer: That's awesome. And you probably didn't know this about me. In fact, very few probably do, but both of your previous employers, I actually did some consulting at both of those places once upon a time.

Laura Court: Oh, my gosh.

Jon Speer: Yeah. Yeah.

Laura Court: That's funny.

Jon Speer: So your most recent employer used to be called something completely different back in the day. It's a family- run business, but they were acquired quite a few years ago. But yeah, pretty fascinating. So I'm a little bit familiar. But that last bit that you shared, just about appreciating... Because I too, started my career as a product development engineer, and that appreciation for understanding how the product is built and manufactured and constructed, I think that's really, really important, especially for a product development engineer. But I don't think a lot of product development engineers maybe get that experience. Are there any stories where that really sunk in, where you were like, " Wow, I really need to be paying more attention to this?" Or did it just come natural?

Laura Court: So I guess this is my best learning example that I have is that I was going to help validate a process that was out on the manufacturing floor. And it ran three shifts a day, so we had split it up. One engineer would take each shift and I was going to be working on second shift. And I was still fairly new to the company at the time. Didn't have that much experience within that manufacturing area. Didn't know the people who worked on second shift, anything like that. And obviously, all the guys and ladies and stuff that were working down there knew the system much more than me. They're the ones down there day to day working with the products.

Jon Speer: That's right.

Laura Court: And so I made the point one day, before I even started the validation, and I walked down to the floor on second shift. I went down, I introduced myself to everybody. Explained what I was going to be doing while I was going to be down there. But then also, ask them at the same time, I'm like, " If you have any advice or you know anything that you think needs to be fixed," I'm like, " Please tell me, and I can try and make this better for you."" You guys will help me." And I know I got feedback after we were finished with the validation from a couple of them. And they were just so appreciative that someone took the time to look at their knowledge. And I just laughed when they said that, because I'm just like, " You're the ones working with this every day." It's like, I might know the actual, what's making this piston run for this product sort of thing, but you're the one who can tell the little nuances when things change, what can make a process better, things like that. That was probably one of my biggest humbling experiences almost. It's like, okay, I might know some of the paperwork behind everything, but I'm not the one daily doing it. That's why it's really getting the advice of the people who are making it and then ultimately, the people who are using it can drastically alter what you do.

Jon Speer: Yeah. I totally agree with you. I had an experience pretty early. Unfortunately, it was pretty early in my career where I was working with a large company, although the way we were structured and operated, it really felt many years later I can say this, it felt quite a bit like a startup. The large company that they had different, I guess, pods or groups, business units, or however you want to define that. But the one business unit that I worked with, we had a few product development engineers on our team. We supported a manufacturing department that built the majority of the products for that business unit, but there were no manufacturing or quality engineers. We also served in that role. And I remember a couple moments where I had done some work on hemodialysis catheter and went through the whole design and development process, all the things that we needed to do to get that product to market. Get it to market, and I think within the first order that manufacturing had gotten to assemble the product, they had questions. And who did they come to? Well, they came to me. And it was important for me to have that experience because I realized that just because it was clear here in my head, it didn't necessarily translate into their manufacturing instructions and so on. So I learned a lot through that experience, and feel super blessed to have had that opportunity. I think a lot of product development engineers, they don't get that experience. They don't get that feedback.

Laura Court: Right. Absolutely.

Jon Speer: Yeah. So I know it's earlier days or newer days in your career at Greenlight. But even with that, what do you enjoy most about being a guru so far?

Laura Court: Really, it's been my opportunity to meet so many companies. I've only been with Greenlight here for not even two months yet, but I've already met so many different companies and just learned about some amazing technology that people are coming out with. Because you can only do so much Googling in your free time to figure out what new and exciting stuff is coming up, listen to so many webinars. But this really gives me the opportunity. I get to interact with so many people and just hear about amazing work that people are doing, some work I never would have even thought was possible that people are trying to work on. And I think that's the most amazing part of it.

Jon Speer: Yeah. Anything that sticks out, or any examples that you're able to share?

Laura Court: So there was one company. I won't give any name dropping or anything, because I know they're still working through their process. But it was just an interesting call that we had, because it was very collaborative, because they were trying to figure out how to get up this new process. And they were going to have possibly a couple 100 to possibly a 1, 000 different parts that they were trying to manufacture and get down within their system. And it was so great because I actually got to use some of my previous experience working with the company that had tons of different skews and everything like that. And it was just a great back and forth of trying to think through, what's the best way to do this? How can we organize it? And I just loved that collaborative side of all of it and just trying to help them. And they were bringing their experience. I was trying to bring mine in and figure out the best way to get them started off right, so that they didn't have to go through a lot of those growing pains that I know some other companies have gone through and trying to help them.

Jon Speer: Absolutely. And then I think that's important. And I think this is one of those things that we do emphasize at Greenlight Guru, and I think we can better articulate and communicate this to our customers and to the industry is we've built this purpose- built solution specifically for the medical device industry. The workflows, the verbiage, the terminology, the connectiveness, it's all based on FDA regulations for a med device, as well as ISO 13485 and EU MDR, things of that nature. And I think that's important. But knowing that we have people like you and the rest of our gurus, we have an awesome team of-

Laura Court: We do.

Jon Speer: ... ofwhat people have done in their careers. We have people that worked on orthopedics, electromechanical, software, IVD, audits, regulatory submissions, transfer to manufacturing, all these different sorts of things. So I think that's a wonderful thing that we can bring to our customers and say, " Hey, look, this challenge that you're dealing with, Laura has already done this before and she's going to be working with you." That feels good, right? To be able to help companies through those?

Laura Court: It absolutely does. Even just within our team, my background is so much more in product development, but then we have gurus on our team who are quality- based.

Jon Speer: Right.

Laura Court: Even just some discussions that we have internally with our team, just feeding off each other and learning different processes because it's like, okay, I've helped in an audit before, but maybe I've never completely run one. And I love talking to Sarah or Taylor who have done one, and we just really try and help each other out and learn from each other, too, even just internally.

Jon Speer: Yeah. So I know you shared that one story, the customer with the hundreds of different parts and components. And I know, it's just that we're just a couple of months into your Greenlight journey, but any favorite customer stories that stick out so far? Interactions or seeing... I always think it's great when a customer has an aha moment. It's like, and I had a small part or influence in leading them to that discovery. Anything come to mind as far as favorite customer stories?

Laura Court: So the one with the skews is probably definitely my number one favorite so far that I've had. I've had a couple others where they'll be talking through trying to figure out a process, or figuring out the best way to organize their paperwork and work through a test protocol and things like that.

Jon Speer: Sure.

Laura Court: And I don't know if I necessarily have one exact favorite out of these, but I just love being able to chime in and just being like, " Oh, have you thought about doing this? Or have you thought about adding in this into your protocols to try and help?" Just because it's like, I know you'll get questioned about this in an audit or something along those lines. And being like, " This is a great way to add in, just different statements to help with everything like that." So it's really hard to choose just a one favorite other than the one I already shared, but I just love the collaborative side of all of it.

Jon Speer: All right. So I want to take a short break. I want to remind folks, I'm talking with Laura Court. Laura is a medical device guru at Greenlight Guru. She works with our customer success team and works with a lot of different customers, medical device companies. Probably, it's very similar to many of your companies. So if you're interested in learning more about the Greenlight Guru medical device success platform that's designed specifically and exclusively for the medical device industry by actual med device professionals, where you get to work with people who have medical device experience, like Laura, then I would encourage you to go to www.greenlight.guru. We'd be thrilled to have a conversation with you to better understand your needs, your requirements, to see if we might have some solutions that can help you. Laura, last night, we were in person at an event, celebrating some of the recent success of the company. It was a little surreal for me, and probably for you, too. But for basically the past year plus, all of our interactions as a company, most or all of them have been virtual, remote. Many folks that have joined the team in the past year or so, we've never met face to face. We've hired everybody remote and that was the case for you. So it was great to have a chance to see you face to face, as well as a lot of the other colleagues at Greenlight. But you said something last night that stuck with me. And it was about the Greenlight Academy. This is also something that we've recently rolled out. We have a Greenlight Academy. It has courses that you can consume, some on design controls and risk, document management. We're going to be continually rolling new courses out from time to time, some free, some will be paid. But you said something last night about the academy that I thought was insightful. Do you remember what it was that you said?

Laura Court: So I believe that I was talking about the fact that, so even though I've been in the industry for a while and I'm just learning everything else, I am a full believer that if I had had a platform like the academy with so many of the educational things just so well- written out and just so clear and confident in their writing, that it would have made my transition from school into my full- time career so much easier. Because I spent so much time just trying to suck knowledge out of all my coworkers and sit in on meetings, to try and learn different things and ask as many questions as I can. But having a resource like the academy, I'm going through the videos, even myself still now and I feel like I'm still learning things. That would've just made for such an easier transition coming straight out of school into being the one writing documents and doing different things. It would have been great.

Jon Speer: Yeah. And folks, it's just one of those things that we had built out for internal purposes initially, for what we call Guru Certification. And it was really about trying to... because we have some folks that work at Greenlight that are new to the medical device industry. We wanted to help educate and inform and teach them on the finer points about what it's like to be a medical device professional. So we built out this course. And it's an extensive course. Have you been through that Internal Guru Certification, all of that yet? I know I'm putting you on the spot.

Laura Court: I am a fully level one certified guru so far, and I'm working on my level two certification. So hopefully, within the next couple of weeks here, I'll be all the way through.

Jon Speer: Yeah. But it gets intense. The first couple of levels of this internal training program, it's med device foundational. But then we get into connect into that of how the industry regulations, how that relates to specific workflows. So you're at the beginning of the journey, but keep us posted on how that's going. But as we started to roll this out internally, we started to realize, " Oh, wow, there's an opportunity for us to also deliver some of this information externally." And that's why we've leaned into forming a Greenlight Academy, and offering some of these courses. So to me, the importance of Greenlight is maybe one of the biggest roles that I play within the company is keep that education and information channel active and current and up- to- date. And yeah, this is one of the things that's very important to us is the content that we generate, the guides, the webinars, the podcast. It's really about trying to help teach in a way that's simple and easy to understand as possible. I guess thinking about... you've been here for a couple of months. You've been working with a few customers. You're going through the Guru Certification. You have the prior industry experience. Have you had a chance to think about what things medical device companies can do to be successful? And I guess if we can pull that into those who maybe are customers, what are the keys to success from your point of view?

Laura Court: So my biggest thing that I stress to anyone I talk to is use the resources that you can find. So I'm very much one that I came in thinking I needed to be an absolute expert on everything I see, everything I touch. And that was coming straight out of school, I just have that mindset that I have to know everything right now. And you really don't. It's okay to rely on resources like blogs and webinars, and different things like that. But also, to use consultants. Use, for example, through Greenlight, use the gurus because we've gone through different things like that, and it can save you just a lot of headache and a lot of growing pains of trying to figure things out. If you use people who are experts, and regulatory experts in quality, experts in product development, it helps distribute workloads. It helps distribute the amount that you have to try and figure out, and failures and different things like that. So I stress to everyone to try and use resources. You don't have to be an absolute expert in everything you do when you first start it, but to use it more as a learning opportunity, and those experts.

Jon Speer: Yeah, absolutely. But I think it's natural though, for a young engineer to... Well, I too am an engineer. Engineers, I can say this, and maybe I'm saying it about myself, maybe this isn't typical of all engineers, but those engineers that I know, they believe they are the smartest person in the room.

Laura Court: I can't say I can't disagree on some things for myself as well.

Jon Speer: And even if we don't know something, we're not going to let you know that we don't know it. But sometimes with me, it's like, " Oh crap, I don't know about that thing." So I'll just get through the conversation and then the first thing I do when I'm by myself is I'm looking it up. What is that? And then I find myself going down this rabbit hole, reading all these articles or content, or listening to it and watch a video, just trying to now educate myself on this. And it's weird sometimes, though. But to your point, I don't have to operate that way. In fact, fortunately, I have learned a little bit later in life that I don't want to be the smartest person in the room. I want to surround myself with people that are more intelligent and smarter than me.

Laura Court: Absolutely.

Jon Speer: Because together, it makes a more well- rounded and more robust, and frankly, a better experience for everybody involved. So, yeah.

Laura Court: Absolutely. Greatest piece of advice I got, I come from a family of engineers, and greatest piece of advice I got when I was starting even schooling and starting to interview and different things like that, was they told me, they were like, " It's okay to say I don't know, but I can figure it out, or I can find someone to help you." And that's definitely something that I've carried with me into my career and everything like that. I'm not always the best about living to those words because sometimes like you do, I go through and I go down rabbit holes trying to Google things and figure things out. But I definitely think that's a great piece of advice, because that's what leads you to surround yourself with smart people, because you find somebody who does know those answers and they can help you.

Jon Speer: Right. Absolutely. It's like being a learner. I think that's one of the key aspects that we look for in people to bring to the Greenlight team is, do they have this desire to learn? And I think that's really important if you have that learner's mind, because every day I learn something. I'm sure you're learning a lot. Not just about how Greenlight functions and operates, but every customer that you interact with, you get exposed to something new.

Laura Court: Absolutely.

Jon Speer: Probably on a daily basis. I guess to wrap things up for our conversation today, you opened by sharing that you worked first for a smaller company, and then for a larger company. And in both capacities, were you in product development?

Laura Court: I was.

Jon Speer: Okay. So, can you compare and contrast maybe product development with a big company and a small company? Are they the same? Are they different? And I know you shared a couple of stories that illustrate that, but what are maybe a few key points that folks should think about with respect to product development, based on the shape and size of their company?

Laura Court: Mm- hmm(affirmative). So I think at their core, whether you're at a small company or at a large company, you're still going to have a lot of the same overlap when it comes to product development. You still have design controls. You still have paperwork. You still have the actual design side of it. But then I always laugh and say, when I first started my job, it almost felt a little bit like trial by fire, just because there were so few people within the company that I really got experience in other sides that in a large company, you may not get as far as purchasing, working with contract manufacturers, doing materials selections. Because I know sometimes in very, very large companies, those can all be different departments. But I loved the fact that I got to be all of that wrapped up into one. And even with the second company that I worked for, it was larger, but not absolutely huge. And I still got to do some of that fun work where it's not just sitting at my desk, working at CAD all day. I got the opportunity to see those different facets of what goes into a design. And I think that's very important to do because like I said, when you get out on the manufacturing floor and you have to learn how things are actually put together, it's that same side of it of looking at material availability, material selections. How are relationships going to be with the contract suppliers and different things like that? So I think that all just wraps up into making one really good, sustainable, reliable product. And you need all those different facets of it. So it'll change a little bit from a small to a large company, but I think in the end, all those things need to come back to product development in some way, to make a really successful product.

Jon Speer: Yeah, that's great. That's a great tip. Great tips and advice there. Here's a myth that I've often heard about specifically, medical device product development, but I guess more specifically around design controls. And in some respects, sometimes risk management. I'll often hear or used to hear, it still happens from time to time, but an engineer goes, "Oh, I hate design controls." I know how I answer that question or that reaction when I hear it. I guess I'm curious, what is your reaction when you hear someone say, "Oh, I hate design controls, it's such a pain"? What are your thoughts about that?

Laura Court: Not so much with design controls. I relate more to the risk side when someone says they don't like going through risk, because it is not the most fun document that I've ever written to go through different risks, and think about all the ways that the product you designed could fail. Not many people want to do that because you want to think you've created a pretty safe product. But crosstalk there are always ways that it's going to fail. And I can relate to not wanting to sit down and do that. But at the same time, the earlier that you can do it, the absolute better it'll be at the end, because even just taking during the beginning of the design, just a couple minutes to think through some of the possibilities or some of the design controls that you know you need. And if you do it throughout the process, it's going to save you that six- hour meeting with all your coworkers sitting in a room, pulling out your hair and trying to figure out all these things when it's later on in the design. So taking just a little time and snippets throughout the entire process is going to save a lot of headache in the long run.

Jon Speer: For sure. And I think that's the thing that a lot of folks don't realize is they view things like design controls, and in some respects risk, as impediments to progress, and unnecessary documentation at times. And I'm a big advocate. Start early, do document things because they could be to your advantage. If your reaction is, " Oh, if I make a change, it's too cumbersome. I got to have all these people review and approve." Don't curse design controls, don't curse risk. Maybe reevaluate your practice and your process, because if you have that reaction, " I don't know this," or, " I don't like this," then there's probably something about the practice that needs to be simplified.

Laura Court: Absolutely.

Jon Speer: Because I think when you start to understand the intent behind design and development and risk management, it's all for the purpose of ensuring that products are designed as safely and effectively as possible. And that's really the purpose. And I think when an engineer realizes that, they're like, " Oh yeah, of course. I want products to be safe and effective."

Laura Court: Absolutely.

Jon Speer: All right. Any final thoughts, words of wisdom, hot tips and pointers that you want to share with the listeners about Greenlight, about being a med device nerd or anything else that comes to mind?

Laura Court: Well, I've always laughed and I know I've said this to a couple people, but one of my favorite parts about Greenlight is that it's reducing the possibility of paper cuts. Because I have been that person that sits down and goes through box after box, after box of old paper- based systems, just trying to find one sentence on a paper to validate or verify something. And you just inevitably end up with paper cuts.

Jon Speer: Yeah.

Laura Court: So I am a full fan of going electronic because then I'm not walking around with about 10 Band- Aids on my hands and all these little paper cuts everywhere. So, that's one of my favorite parts of Greenlight.

Jon Speer: All right. You heard it here, folks, Laura's tip: use Greenlight, avoid paper cuts. Laura, thank you so much. It's been great to have this opportunity for me to get to know you a little bit better. I'm sure as you get more acclimated into your career at Greenlight and have opportunities to work with more customers, let's do this again at some point. We can talk about anything that you want to talk about, as long as it relates to something important to the medical device industry. But if you're up for it, we'll do it again soon, okay?

Laura Court: Sounds great. Love to.

Jon Speer: All right. Folks, thank you so much for listening to and watching the Global Medical Device Podcast. If you are watching, be sure to subscribe. Click the bell notification so that you get alerts anytime there's a new episode that goes live. And thank you for just sharing the word about the Global Medical Device Podcast. It's because of you that we continue to remain as the number one podcast in the medical device industry. As always, this is your host and Founder at 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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