#370: Meet a Guru: Jamie Bihary

Jamie Bihary: A big push for why we went into Greenlight Guru was actually a reference from one of our partner companies they had been using. Greenlight had a lot of success, and that was something that we wanted to elevate that system to continue to grow, continue to be cutting edge, and at least follow along with our partners.

Etienne Nichols: Welcome to the global medical device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies. Hey, everybody. Welcome back to the global medical Device podcast. Today with me is Jamie by Harry. She's a medical device guru here at Greenlight Guru. I'm super excited to have you with us, Jamie. How are you doing today?

Jamie Bihary: I'm doing well. How are you doing?

Etienne Nichols: Doing good. It feels like it's been a while since we scheduled this, but can you talk to us a little bit about a day in the life of a medical device guru here at Greenlight Guru?

Jamie Bihary: Yeah, sure. So a day in my typical life. So I am on the onboarding implementation team under Taylor Brown. It's been a pleasure to work with her so far, but typically in, in my day to day I'm working with customers, specifically smaller organizations that are just starting in the medical device industry. Theyre establishing their qms. Maybe theyre starting to put together some materials for their 510k with their design controls and such. So most of my day to day is talking with customers and planning their onboarding experience with greenlight.

Etienne Nichols: Awesome. Are there any things, im always curious, are there things that you run into consistently when youre dealing with those customers, especially maybe at that stage where consistent questions, you get asked things, the common challenges.

Jamie Bihary: Yeah. So I think something common that I get asked is where do we start? When I always lean on following the implementation plan, it's always super important to establish that plan right away. Just so as you've established that QMS later down the line, once you're going through audits, you have a trail that you followed, essentially just outlining how you got there. What did you plan to do, and did you document it the way that you intended? So, yeah, so that's some of the common, common things that I run into is where do we, where do we get started?

Etienne Nichols: I'm also curious about your experience leading up to this point. So I wonder if you could kind of walk us through your origin story and maybe eventually what led you to greenlight guru?

Jamie Bihary: Sure, sure. Yeah. So a little bit about a background about myself. I'm a biomedical engineer by trade, specifically with tissue engineering. So in my past, I did a lot of work with research labs and cell culturing. So that's what got me started in biomedical engineering. Eventually went into the industry and started working with a smaller company that focused on working with biomaterials in the past. So it was a direct correlation to my. To my background. I was able to do a lot of early research and development for that organization. That eventually led me into a quality engineer position where I took a little bit more focus on some devices that are already on the market that we were manufacturing. And a lot of that started playing into environmental monitoring, did some post market surveillance research. So going through the MoD and FDA database, which we all know that that is good and glorious and filled with a lot of details, but boy, it does take a lot of time to go through. And from that experience, we ended up connecting with Greenlight and we started onboarding with Greenlight. Specifically, we were bringing over a legacy system. So a lot of the work that I had helped with that was just plan out some of those details, how we were going to take our existing qms and bring that into an eqms. So that's where I got introduced to Greenlight. And then from there after, I think it was specifically I was talking to Ann Slevin, the head of doc migration. I'm like, wow, she's. She's so sweet. I was like, really looked into Greenlight a little bit more. She's. She was just. She was a lovely person to work with and talk, talk to, and that's what actually brought me to Greenlight. So it's been a pleasure so far. And, yeah, it's a little bit about myself and how I came and connected with Greenlight.

Etienne Nichols: Wow, that's really interesting to know. Does Anne know that she was one of the sparks that, that brought you here?

Jamie Bihary: I think they had mentioned it once, once or twice, but, yeah, no, she was, she's so sweet and love working with her, especially when we have customers that do have that existing legacy qms. It's nice to bring her in to, or bring that organization to Anne. For someone who, who helped me so much, I'm like, oh, yeah, you got a great resource here. So it's a great connection.

Etienne Nichols: That is one of the questions we get a lot is, okay, how long does it take to implement an eqms? If I'm on a legacy system and if you're looking at, or at least in my background, when I previously would look at software or my expectation was the validation is what took a lot, a long time. And all of those activities, getting it up and running and all of that. And then the document migration was a whole other phase, I suppose. And really with green light grew, at least what I've seen, you skip right to that phase, and then you're, you're immediately talking to Anne, who's the working on document migration. Is that, is that what your experience was?

Jamie Bihary: Yes. Yeah. Especially, at least with getting started in the program that they have in place, specifically with O and I and legacy individuals, is we have that welcome call, we get you introduced, and then from there we start talking about validating the Greenlight guru software, which is, we've got a validated test report now, which virtually cuts your time into nothing to validate. Greenlight gurus or our support team and individuals at Greenlight have done a great job with making that readily available for customers. So that when you do have that legacy system, you've got a validated system and you can start migrating those documents virtually. I could say within, within a couple of weeks, you can start meeting with Anne, which it's, it's amazing, especially if you have tight timelines.

Etienne Nichols: When you were working as a biomedical engineer, you were, you mentioned some of the sterility things that you were. Environmental monitoring is there in your past. If you look back, are there any pieces of advice you would give to companies who may be evaluating or needing that system and just how you go about doing some of the activities that you are working on?

Jamie Bihary: Sure. Yeah. So as far as, like, when you're working in a clean room and determining if you even need one at all, you really have to take a look at your manufacturing process and the steps preceding that. So, for example, maybe you are creating a device that has solutions and reagents when you need to manufacture that sterilely. And the reason for that is later down the line if you have introduced any sort of bacteria or contamination, if you were to run that specific device through a sterilization process after it's packaged, you may create endotoxins, which is no good. You would fail an endotoxin test, which, which could make people really sick. So it's really important that you do have that clean room established beforehand so that you can monitor that and bring that device through clean. Cleanly. And then from there, as far as managing your clean room aseptic techniques is huge. Make sure all of your individuals, your technicians, are properly gowning from head to toe. So you might see someone walking around with a bunny suit. They've got the hair net, the mask and you might look funny, but, I mean, it really is to not only protect yourself from the materials, but it's also to protect what you're making. So contamination is huge, especially in the medical device industry, just because, you know, that interacts with people and a lot of things that you can't see can. Can really hurt someone later on. So it's crucial that you have that set up in place so that you can protect others. And then leading into that, you also have an aspect of. You may have that room already established. Okay, I've got aseptic needs. Everything should be good. But you do need to keep in mind environmental monitoring throughout that process so you can ensure that no one is introducing contaminants. So you can essentially check your aseptic gowning. So checking someone's gloves, checking someone's hands, you can do a lot with that, especially when it comes to trying to determine if any contaminants have been introduced into your system. Um, so there's lots of good stuff, but, uh, it's definitely a lot to consider.

Etienne Nichols: I remember when the. The clean room that we had on site, I was always kind of intimidated. Yeah. I'd gown up. I'd do all the things, and then I hope that I didn't introduce anything. And then I remember one time early in the morning, somebody had an issue. I mean. I mean, it wasn't a seizure, but it was some kind of episode like that. And somebody ran in, said, hey, hey, hey. One of the other engineers ran out there, just ran into the clean room. And I. My thought was, oh, they're going in the clean room, but ungowned and all that. But at the same time, that was a situation where you kind of had to. And. But then afterwards, we had to revalidate. And it's a weird deal where, you know, you're like, oh, on the one hand, you have to. I mean, people first, but then. Then getting back up online isn't. Is another thing, but it was one of the things that stands out in my memory. Any stories. I always love to hear people's experiences in the field, any stories that stand out to you as either wins or fails. You know, we don't always like to talk about failures, but. Favorite failures.

Jamie Bihary: Yeah. Okay, well, I guess something that is easily that you can mess up is when you are conducting your environmental monitoring and you're going in and you're. You're pressing your auger plates up against different surfaces, you can contaminate those so easy. So it's so crucial that not only you have a control, a blank control, but you may also do a couple different tests and even retest that area. If. If you feel like, hey, we. That's an area we often clean, we've got the right solutions in place. What happened and why do we see this spike in growth? I. You know, it happens sometimes. You could open up a plate the wrong way and some of that air gets in, you've contaminated it. So that's definitely something. At least I'm sure everyone's done it at one point, but that is something that I remember I had almost no, no, nothing pop up while I was doing anything, except for one plate where I think I had leaned over it for just a couple seconds longer when I contaminated it, which, which can happen. So it's just as long as you're careful. And sometimes retesting is necessary.

Etienne Nichols: If we go back to the quality management system, setting up one of the things that we mentioned validating, we mentioned getting those things up online and the document migration. Can you describe some of the experience? You had? A little bit more detail. You went into some detail about what it was like, but what were some of the pains that you associated with being on that legacy? And let me see if I'm going to buy just a little bit more time and explain why I'm asking this. Sometimes I've been at a company or in a situation where I think, you know, yes, I know. I'd like to get a little bit more cutting edge with our tools that we're using. However, it's kind of a risk, and maybe status quo is okay. You know, what were some of the things that made you realize status quo is not okay or your company?

Jamie Bihary: And, yeah, so as far as the organization that I was with before, a big push for why we went into greenlight, guru was actually a reference from one of our partner companies. So they had been using Greenlight had a lot of success, and that was something that we wanted to elevate that system to continue to grow, continue to be cutting edge, and at least follow along with our partners. So especially you do have the user options for external invitations. So it's nice that you could even be invited into someone else's system, especially if you have a partner system. So it does allow for you to kind of get a glance at someone else's system if you're invited in, which is really nice. And then as far as any pains that we felt going through, we had a big legacy system. It was ten years worth of records and documents and design materials, really. And our system had done really well with all of our past audits. So it was really crucial that we made the transition smoothly, but that we did it accurately. So it was really. Oh, I see a little friend down there. That's so sweet.

Etienne Nichols: Thank you, buddy. My son just brought me some mushrooms. We like to hunt mushrooms on the side.

Jamie Bihary: I love that. So cute. But as far as that legacy system, we had so much documentation and we also had multiple devices, so there was a dynamic element to it where sometimes I see some individuals come in with legacy and they may only have one device, which definitely makes it easier to bring that information over, but you have to create multiple projects. It just adds to that complexity. And I definitely think as far as what our team had focused on as far as our documentation before we brought that in, is very, very visual type of people. We liked everything to be very neat and clean. So as part of that extra step that our team took that you don't have to do was we went in and changed all of the title headers, made all those updates to the revision to start at version zero, changed up some of the naming conventions just so that they would match the new system in the event that we ended up taking some of that information from the boost templates package. So we did a little bit more, a little bit more detail to that, which it was nice that we were able to do that as far as that transition goes, but yeah, so that was as far as my experience with working with document migration and our previous.

Etienne Nichols: QMS system, I can see that paying dividends down the road especially, it probably feels like a lot of work and maybe even nitpicky work at the beginning, but in future audits and inspections, that will make it a whole lot easier and reduce the time spent during that audit explaining, well, this matches because. Or doesn't match because this. And this. The thing that stood out though, what you said, because there's kind of like when we were talking earlier, the status quo. Sometimes we're like, well, nobody wants to stay with the status quo, or at least we think we don't. But when the risk of failure is maybe, maybe too high in our mind, we might justify staying at the status quo. But you mentioned those partners who were pursuing cutting edge, just, just being on the cutting edge. And there's kind of that fear of being left behind. I mean, it's true you could be left behind with someone who is going to go to the front. Is that. Yeah. Anything to add?

Jamie Bihary: Yeah. And it's like too. Like you could stay with a paper system you know, it works. You know, there's nothing wrong with it. But to elevate your system and to take that next step, cut down your time, it really, really helped our team specifically with being able to manage that, especially if you do have a smaller team. You know, sometimes it's hard to read through a bunch of documents all at once and go through filing cabinets. Maybe you can't find things. At least coming from an organization that was a little bit smaller, made it a lot easier to be able to navigate that and manage it.

Etienne Nichols: We talk at Greenlight guru about the guru edge, and when we're talking about that, we're talking about the, I don't know, 20 plus medical device gurus who have industry experience, whether it's sterility, biocomp, UdI, UMDR, all these different spec or, you know, electrical, all these different specialties that, that we see our gurus having. And I know you're part of that guru edge. Now, what's one of your favorite things about being a guru or one of your favorite things about working with customers?

Jamie Bihary: Wow, that's. That's a lot. So, I mean, I think my favorite thing about being a guru is that I have the opportunity to help people and not only help the medical device industry, but to have the opportunity to work with specific customers all over the world. It's very like, humbling and satisfying to know that I was able to help them guide that transition into green light, or whether that was from legacy into an eqms or at least just starting a qms. So it's nice to know that I'm able to guide them a little bit towards the right path to help them achieve their goals. So it's something that in my previous positions, I was more very engineer focused and I had my own, you know, quotas and individual things that I needed to work on, some collaboration between different engineers, but it was very individual and it was more so the only conversations I may have had was with top management when we were planning an audit, or if I needed to let someone know that, hey, there's a GDP error on this document, I need you to correct this for me. And that was to the extent of the conversations that I would have. So being able to come into green light and be able to talk to so many different people, so many different backgrounds and even different sections. So I had specifically only worked with FDA before, and now I'm working with people who are going in the EU. So it's not only given me the opportunity to talk to all those people, but I've been able to learn more myself, which is fantastic. So I really enjoy it and I do love it so much.

what not to say during an ISO: 1345

Jamie Bihary: Yeah, yeah, of course. So as, as far as what not to say, I think the big thing that resonates is saying, that's not. That's not my response. That aspect I don't worry about. But maybe you should. You know, you don't have to own all of that documentation all the time, but you could at least take that information and say, you know what, I may not deal with that specific aspect, but let me pull you, someone who knows more about it. Let me pull those resources so that we can get that, that answered. So I think having a partnered approach to quality, it's not just the quality engineers responsibility. It's the technicians, it's the manufacturing leads. It's manufacturing engineers. Everyone in your organization impacts product quality on some capacity. And definitely having everyone trained on all the procedures, especially that match 13 485, I think that would be, I guess, the most full advice I could provide for people that are going to go through audits and what not to say because you may say that I don't own the quality aspect, but you really do because you act on those procedures, you conduct those. So you do know aspects of the quality. It's okay if you don't know everything. I don't know everything. But let's bring in the right resources to help you navigate what's unknown.

Etienne Nichols: Yeah, that's a really good point. So you made me think of something that it almost sounds like customer service to a certain degree. And we don't think of that auditor or that inspector as a customer. They're not one of our customers, but we are having to serve them. And by serving them well, we're actually serving our company well.

Jamie Bihary: Right?

Etienne Nichols: Yeah.

Jamie Bihary: Yeah. And that definitely leads into internal auditing. And that's so crucial to conduct all the time. You know, not only are you required to do it, but you can take that feedback and what you'd find and make improvements. And I know some people. I learned this from my professor through BSI when I became alert lead internal auditor, that, you know, it's okay to be a little bit nervous, but the auditor is there to help you. They're your friend. They want you to succeed. Yeah. They may bring up things that are uncomfortable and maybe you missed it, but that's okay. As long as you know about it. You know about the issue, you can fix the issue. It's the unknown, unknown issues that could really make or break a business, especially in the medical device industry. So your auditors are your friends. That was one of some of the best advice I had gotten during my time when I took that course through BSI. They're there to help you, and it's okay to be nervous, but they're there to help.

Etienne Nichols: Yeah. Really being willing to accept feedback is important for an overall organization. And, you know, it kind of begs the question, well, how do we encourage people to accept feedback? And maybe training people to really give feedback in a proper way is helpful. You know, I know at Greenlight Guru, I don't know if you've experienced it yet, where at the end of a call I might have someone say, are you open for feedback right now? And if I say, actually, no, I'm kind of having a rough day, I don't know that this is the best day. That's okay. And they say, okay, well, I. Yeah, we'll. We'll come back to this some other time, and. But then when it is time to give feedback or if you are open for feedback, so, well, this is what you did. This is maybe what you should have done, and this is why you would have. It would have been better. So that what, why is really helpful. And I don't know, that just kind of made me think of that with that customer service, the internal auditing and then the less formal every interaction gives you kind of insight into how people would maybe interact with an inspector or an auditor.

Jamie Bihary: Yeah, for sure. And I definitely. I do like the customer. The customer aspect of that is you're not only serving your customer, but you're serving your colleagues and your peers. You want to give your best foot forward all the time. And sometimes you may make a mistake, but definitely having that feedback and that open line of communication to improve is something that's almost invaluable. So if you do have that open line of communication, or maybe if you don't, I always encourage people, open that. Open that conversation. Have that conversation, but maybe uncomfortable. Maybe you're. You're. You're an engineer, like how I was, and I. I was auditing my top management individuals. And that's comfortable. Yeah, you know, I'm going and I'm auditing someone who's the next level up. And, yeah, it's uncomfortable, but let's find something to talk about. Let's. Let's talk about how we can improve and move the business forward together. So it's definitely, definitely something I've learned, and even at green light, too, that the feedback has been fantastic. I know all the gurus want to help customers best way that they can. And the way to do that is make sure the gurus have all that feedback. Just so. Hey, I talked to someone in Samd. Well, maybe someone's not a great. They don't know all. Everything that there is to Samdai. Nice that we can all have that communication just to make sure that everyone's up on the same page.

Etienne Nichols: It really is a deep well of knowledge when you start talking to the gurus. There's no one of us that knows everything, but it would be hard to. To come up with a subject that we don't know something about. You know, one of them. Yeah. So, anyway, you mentioned something there that I wanted to come back to. Oh, top management. When you were auditing or doing internal audit, I got to ask, what were some of the findings that you came up with?

Jamie Bihary: More so findings, I think not so much on the procedure itself, but as we were looking through a couple records, found some GDP errors, so dates written incorrectly. Maybe there was a signature that was missing on a document that was a little bit older that should have been signed sooner. So just smaller things like that where it's a little bit more trivial stuff, but it's kind of nerve wracking to be like, hey, there's a mistake. We need to correct this. And that was something that I eventually got used to and we worked through it and we're able to take some of those findings and those are ones that you could correct very quickly. But it is comfortable to have to go and talk to someone that maybe has been in the industry for 30 years and you're, you're someone new coming into your organization. Maybe you've got, you know, less than five under your belt. And. Yeah, sometimes it's a little bit nerve wracking.

Etienne Nichols: Yeah. That GDP stuff, it really, I remember people would get so irritated when you correct their GDP because, well, is it, is it month, date, year? And is it day, month, year? Is it twelve, 921? Is that September or December? But it's important because if you're going to have potent, let's just say, I don't know, maybe it's a design, a device history record. And, you know, we are potentially going to be having a local recall in the field and we're going to recall everything that was manufactured from September to this date. We don't want to recall more than we need to, so.

Jamie Bihary: Right.

Etienne Nichols: Yeah.

Jamie Bihary: Right. Yeah. And sometimes the smallest things could lead to the biggest, biggest failures just because it's like, wow. Like if you don't have the right data on there or if your eight looks like a nine or, you know, something small like that, I mean, I would hate for the wrong devices to be pull back in that worst case scenario. So definitely good documentation practices is key and it's nice with green light, you kind of rectify most of those just because it's built into the system, which it is glorious. And I love it.

Etienne Nichols: I know we're talking qms for the most part in my, my past was design controls and risk management and, and I love greenlight group for that. I mean, I love it for all of those things. But for sure. Any other pieces of advice, having worked with these different stage companies as they're either coming from legacy documents to an eqms or really just getting started in any direction.

Jamie Bihary: Yeah. So I guess my biggest piece of advice is understand your resources and where you can allocate time because starting a qms or bringing over a legacy QMS, it's time consuming and it's a project on its own. So I think my best piece of advice is know your resources and how much time you can spend and set realistic expectations just so you're not backtracking when it, when it really was a planning error. So that would be my biggest piece of advice is just to, if you do need additional resources, seek out consultants, seek for additional help because everyone around you wants you to succeed. So definitely resources is key, especially in any state, a new qms or a legacy. So that would be my, my key piece of advice.

Etienne Nichols: Yeah, it might be worth just mentioning just to kind of piggyback off what you're saying is a lot of, well, I'm just going to take a step back. So greenlight guru, what even is that to some people? A lot of people don't know. You go to a conference at like the regulatory affairs professional society wraps and they say greenlight grew. Isn't that a media company? You have a podcast, you have a blog, you do webinars, and it's all free. Well, yeah, it is a, it's a sort of a media company. And then you say, well, we also sell software for clinical and for quality management, system design controls, risk management, Kappa complaint handle. Yeah. And then there's the academy. Yeah. A learning center. But then there's that other aspect that's even, flies even lower under the radar, and that's our partner or alliance network.

Jamie Bihary: Right.

Etienne Nichols: You're talking about those different partners. I don't know. Can you speak to any of that? I mean, you've already dealt with some, I would say, but yeah, I mean.

Jamie Bihary: It'S all, it's all making sure that you have the right people involved. And, you know, we do have a partner program that if you are a company where maybe it's just one of you and you need an extra help or you need a recommendations for bringing in that consultant. You know, Greenlight has a big repertoire of partners that we work with that we can recommend specific to your, not only your device, but your specific situation. So it's just important to know that you do have resources available to you and it's more. So just, just speak up and just ask again. That also leads back to the whole auditor thing. Just speak up and ask. And, you know, everyone's, everyone wants to help and we're all friendly here. And no question is a dumb question. And that was something I learned early on. Even in my college career. I was a person that went to office hours no matter what. Sometimes, even if I knew it, I would go to office hours. I remember I was in calc two and I would down and, oh, gosh, calc two would go and I would ask the professor. I'm like, hey, I know this is office hours, but can I do my homework just in here? Why? I'm like, well, what if I have a question? I just want to be able to ask it on the fly. And almost that, that's almost what you have with a guru. Not only do we have guru office hours where you can sit in and work on stuff and ask questions, but you also have your services, too. So if you've got that guru sis, ask that question. Just because it's better to have that answer than to travel through murky waters and hope or guess or question if you've done something right.

Etienne Nichols: Yeah, I'm guessing they would all prefer you not ask any questions about calc two, though.

Jamie Bihary: I would rather take calc three shots. I mean. I mean, yeah, I mean, I could probably figure it out, but that makes one of us.

Etienne Nichols: I passed calc two with an a, but it was a low a and it was tough diffie Q. Anyway, we're getting into the math.

Jamie Bihary: I love it.

Etienne Nichols: Well, it's great talking to you, Jamie. Where can people go to find you and ask questions?

Jamie Bihary: Ooh, to find me. Well, if you're, if you're working with me in onboarding implementation, you've already got me. You can email me anytime, but other places you can find me and navigate if you ever want to connect on LinkedIn. I'm on LinkedIn, but as far as more industry related items, I'm also on assist. So I'm one of the gurus that sits behind the chat sometimes, and I do run some of the office hours with the guru. So you may, you may catch me there as well.

Etienne Nichols: So you're actually talking to real people when you're doing that guru chat in, in the app?

Jamie Bihary: You are. You are talking to real people. The first one, it almost looks like it's, it's a little bot, but it's just to get you started. And then once you submit that question, it goes directly to someone. Live. So cool.

Etienne Nichols: And I've been on meetings where somebody's like, hey, hold on, guys. This person is asking this question and really suddenly they've accessed ten or twelve and we're all kind of chewing on the question and giving them the best answer we can. So it's really fun to see both sides of that, but very cool. Well, thank you so much. I'll put a link to your LinkedIn in the show notes so people can reach out if they have direct questions, especially that you know that unique perspective on being on both sides implementing the software, and now you help others implement the software from the software side. That's cool.

Jamie Bihary: It's a full circle moment.

Etienne Nichols: Yeah. Well, cool. I'll let you get back to it. But thank you so much for taking time out of your day to chat with us today. Jamie.

Jamie Bihary: Yeah, thanks for having me. It's been a pleasure.

Etienne Nichols: We'll see you all later. Take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.