Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru.

Listen to this episode to learn about Ryan's professional journey which brought him to Greenlight Guru and how he's helping companies with design of experiments, design controls, contextual inquiry, FDA QSR and ISO 13485 compliance, protocol/report writing, protocol execution, and quality system implementation and maintenance.

 

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Some highlights of this episode include:

  • Ryan studied biomedical engineering and eventually zoned and honed in on medical device entrepreneurship.
  • After graduating from college, Ryan worked for a startup in Omaha that was a Greenlight Guru customer. Ryan was able to develop a device, get 510(k) clearance, and go to market using Greenlight Guru.
  • Ryan’s first-hand experience with Greenlight Guru not only helped the development of the customer’s product, but boosted Ryan’s personal development as an engineer.
  • To better prepare engineers, reduce the concepts to practice and teach design controls, quality, and regulatory curriculum.
  • Ryan advises engineers to get the knowledge they need to be successful via a foundation of quality. Then, put into practice what you learn to be compliant.
  • Risk Management/Design Controls: Always make sure you know why you are doing things. What’s the purpose? Find value in things and collect feedback.
  • Ryan’s keys to customer success include using Greenlight Guru as a quality system and medical device platform to find early wins and deeper motivation.

 

Links:

Ryan Behringer on LinkedIn

21 CFR Part 820 (Quality System Regulation/Medical Device)

ISO 13485 - Medical Devices

FDA - 510(k) Clearances

Medical Device HQ

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes from RYAN BEHRINGER: 

“I love the entrepreneurship element in the medical device space.”

“I had the pleasure of developing a device, getting  510(k) clearance, and getting to market utilizing Greenlight Guru. It was really instrumental in our development of the product and kind of my personal development as an engineer - gave me loads of confidence.”

“I really enjoy the technical element of things.”

“I always make sure that the things I’m doing, I know why I’m doing them. They have a purpose, and I can find value in those things.”

 

Transcription:

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

Jon Speer: I confess, I am a medical device nerd. I love things like design controls and risk management, the thrill of designing and developing medical device and getting it to market. To me, there's few things that can top that experience. And with that, it's always a great pleasure when I get to talk to somebody who shares in those types of passions. And in this episode of the Global Medical Device Podcast, I speak with one of the newer members of the Greenlight Guru customer success team. I talk with Ryan Behringer. Ryan is a training and onboarding medical device guru. And one of the things that I think is really unique, probably he might be the only person with this distinction is before joining the Greenlight Guru team, he worked for a Greenlight Guru customer who has been a hands- on user of the system for years before he came and joined the team. So his role at Greenlight Guru is going to be extremely invaluable, especially if you are a customer of Greenlight Guru because he's working with training and onboarding new customers, and he's got that firsthand experience. So Ryan and I chat for a bit and share some of the things that we enjoy about being medical device professionals. And I 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 I always love to do special episodes where we get to meet one of the Greenlight Guru gurus sounds redundant, but joining me today is one of our new gurus, Ryan Behringer. Ryan, welcome.

Ryan Behringer: Hi Jon. It's great to be here. Excited to be on.

Jon Speer: All right. You and I caught up just a little bit ago just to get to know one another, a little bit better. I think you shared with me that you're rounding out your first month with Greenlight Guru and that's an end of quarter month, which there's some excitement to see all the new customers that are coming in, but I guess talk a little bit about who you are and your journey and the med device industry that's led you to Greenlight.

Ryan Behringer: Yeah. Like you said, my name is Ryan Behringer. I'm the teams training and onboarding medical device guru, obviously focusing on training and onboarding here at the team. I started out kind of going in an undergrad, knowing I wanted to get into medical devices. I started out in biomedical engineering, found a program at the University of Cincinnati that had a really cool cooperative education element that allowed me to get a lot of really good work experience. As I continued my education and we had a capstone project that was basically focused on medical device, entrepreneurship and very much zoned in and honed in and exactly where I wanted to be. I love the entrepreneurship element in the medical device space. And once I graduated college was able to find myself out at a startup based out of Omaha, Nebraska, and just so happened to be a customer of Greenlight Guru. So I had the pleasure of developing a device, getting clearance and getting to market utilizing Greenlight Guru. And it was really instrumental in our development of the product and kind of my personal development as an engineer gave me loads of confidence.

Jon Speer: Yeah, that's very cool. You said something there that's interesting to me. Interesting, because what I heard you say, you knew that you wanted to be a biomedical engineer like you knew that before you went to school and I mean, obviously you chose that degree program. The reason it's interesting to me is I have a chemical engineering background and I've never worked as a chemical engineer, but I took a couple of courses in biomedical engineering. And they're sort of interesting to me, but I didn't really know much about med device and that sort of thing. So how did you know that's what you wanted to pursue?

Ryan Behringer: I really enjoyed the technical element of things. And what happened was I was in high school. I was on math team. I'd like to do Quiz bowl, Science Olympiad. One year, our science Olympiad topics were around medical device industry. I think it was my junior year when I'm having to apply for colleges. And we do this project as a team kind of, and I got to learn a little bit about medical device space and industry. And before then I knew I wanted to be an engineer, but I just didn't know what type. And then this circumstance comes up. I learned about this and it just clicks in. It makes tons of sense. And it's exactly what I want to do. And luckily enough now that when I was going to college, a lot of universities actually had biomedical engineering programs. It's still rather developing from a undergraduate university perspective is not as widely offered, especially even in the earlier 2000s. Those programs were definitely coming online places and found a right fit and jumped in.

Jon Speer: Yeah. I guess to continue a little bit of my story. So even though I had the chemical engineering degree, I've never been a practicing chemical engineer and right out of school, many listening probably have heard this story, you probably have heard this story too. I know you listen to the podcast, so I'll keep it short. But I found a job with a medical device company as a product development engineer. It was one of the coolest things I've ever done in my life to get cocktail napkin sketches, literal cocktail, napkin sketches from doctors and says," Hey, can you design and develop this product?" And then figuring it out. I mean, that's super cool to be able to do that. And it sounds like you've had some of those types of experiences along the way of your career so far.

Ryan Behringer: Definitely. I think my undergraduate program was amazing in giving you real world experience in actually how you develop a medical device. Our capstones were real found user needs and industry. And we worked with surgeons that had ideas and help them conceptualize these devices. I mean, I'm a senior in college going over to the hospital, catching a surgeon between surgeries to talk about ideas that they have for new devices. And we're putting the other early design controls and presenting just as we're having our own phase review and reviewing designs. And we get to do that during our undergraduate program, which was incredible.

Jon Speer: Yeah. I'm a little bit familiar with the UC program that you had a little bit that I'm aware of it. And it sounds like you would agree with based on your person experiences. And there's lots of great biomedical engineering programs out there. I mean, I put a shout out to my Alma mater. At Rose- Human I know they'd do a great job there too, but the thing that I always admire about the UC program is the cooperative nature of it. A lot of times I've been asked by academic and university institutions who are teaching biomedical either at the undergrad or even at the graduate level, like," Hey, you've been doing this for a long time. What are things that we should be incorporating into our curriculum to better prepare engineers?" I'm like," You got to do more on producing the concepts to practice things like design controls, for example, are super complicated, but also teach your students more about quality, teach them more about regulatory." And it sounds like you got that experience at that undergrad level.

Ryan Behringer: Yeah. I mean, foundationally, my very first cooperative education experience was with the quality engineering team and looking back, I would do it no other way. To me, it was the foundation of all things that I know now and gave me the appropriate context to why we do certain things the way we do them and what value they bring to our businesses. And it has a recommendation for anyone entering the space or undergraduate looking for cooperative education experiences. I think foundationally quality engineering or some sort of quality role is very key to your success. If you want to go into product development or early R& Ds, it's really helpful to have that core knowledge. I think it's core to any biomedical engineer's education.

Jon Speer: Yeah. And I would take that a step further. I know, we at Greenlight and myself personally, I know you've got some experience as well. We do a lot of work with startups and a lot of times these startups are started by an inventor or an entrepreneur. Somebody who has an idea for a product that they think is going to change and improve the quality of life in some way, shape or form. And often, not always, but oftentimes the people who are starting these companies, they don't have that foundation or that knowledge either. So I think it's really key to try to learn or understand or chat to someone like Ryan or me or others on our team. But you had that formative experience as a student, you got that hands- on through the different co- ops that you had, and then you enter the workforce. And as you mentioned, worked with a startup that went from concept to prototype, to submission, to market, imagine there, and I'm sure there are plenty of startups and entrepreneurs and inventors, maybe folks that are pursuing degrees in biomedical engineering, what advice or tips or pointers would you provide them so that they can get the knowledge that they need to be successful?

Ryan Behringer: Yeah, I think as I stated earlier, that foundation of quality can be huge in some ways to start that, it's just go read the reg. I look at the reg every day almost just because I'm curious, I enjoy reading the nuance of it and seeing if I can ever pick up new just tips or just better understanding. And from there you can try to implement into practice knowledge. I mean, I think I have an affinity for seeking out knowledge, but the reason I like to do that is to put it into practice. And I think that really foundationally helps to hammer home the concepts and what you need to do to not only be compliant, but have true quality in your product design.

Jon Speer: I think sometimes the people get, I'm speculating a little bit here, but just from other anecdotes that I have, I think sometimes I read that and it doesn't make a lot of sense to me or I don't know how to reduce it to practice. And sometimes those folks they're like," Ah, I'll just ignore it for right now. It doesn't really matter to me. I want to do this, I got to build a prototype, I've got to do an animal study, we've got to do this, we've got to do a clinical study." And they sort of forget and ignore either consciously or accidentally. But regardless they get to the point where they're ready to go to market and they go to market and sometimes they're like," Oh crap, what's a design history file. We didn't do this. Or we didn't do that." And it's like, there's really no excuse for that. But I think that's a real thing. I think a lot of people are like," Eh, I read the regulation. Ryan told me to do. So I went and read it. I don't share his love for learning and reducing it to practice." What would you say to that person?

Ryan Behringer: I think to me in my design philosophy for medical devices is really integrating holistic approach to the process. I mean, I personally don't know how I could develop a medical device without the guard rails that design controls provide. And the level of closed loop feedback that starting with risk management provides you. If you're doing it as a check back activity, then it will be that for your team. And then you won't find value from it. If there's something that you need to do, I always make sure the things that I'm doing, I know why I'm doing them. They have a purpose and I can find value in those things. And in terms of developing your design inputs and design outputs for your device, if you're working on risk at the same time, those risk items are going to feed into certain design aspects of the device to be it's really about creating that closed loop feedback in its entirety throughout the medical device, life cycle. And then those items that you thought you just needed to do as a checkbox become extremely valuable to the way that you design and develop your devices.

Jon Speer: Yeah. I mean, folks listen I want you to hear this, at least understand conceptually what Ryan and I are talking about. Design controls, risk management, and we'll just pick those two examples for right now. These are must have items or things that you must address during the design and development of your medical devices. And if you look at the activities associated with those topics as checkbox activities, then I challenge you to dig a little bit deeper or reach out to someone like Ryan Behringer or Speer or another Greenlight Guru, medical device guru or somebody else that's been there and done that and understands that so that you can understand how to take that from being a checkbox activity to a value add activity. I struggled with this early in my career to be quite honest with you, a story I'd tell sometimes again, apologies if you've heard it. I remember the first time I needed to do a risk assessment and I was working on a device and we had a designer view schedule and we had different phases and stages. And we had defined criteria of entrance and exit criteria if you will, for particular designer views. And I think this one was around the verification stage or something like that, but I was going through my checklist and I was trying to check the boxes, on my checklist. Yep. Got that, got that, got that. And then I came to the risk assessment and I'm like," Oh crap, I don't have that." And I looked at the counter. I'm like," Oh, it's Wednesday, my designer views on Friday." So I kind of buried myself at my desk for the next day and a half. And I did a risk assessment all by myself so I could check that box, but I did it all by myself. I didn't get any value out of it. No one else on the team got any value out of it because they weren't even involved in that. And so I really missed the message on that.

Ryan Behringer: And it can be tough sometimes when you do have that phase exit checklist that you got to get through, but if you take the time to schedule those things out, make them value add for the business then the time you took to prepare for those things will pay dividends. And the preparation most definitely pays off.

Jon Speer: Yeah. To continue my short story a little bit further. So I do this activity for easily a full day, day and a half of heads down time to get this checkbox. And then we get to the designer view and I had some prototypes built up so that people get involved in the design review process could get hands on. And I remember a company I was working for employee number three, he has a ton of pads, but within three minutes of him having a prototype and the scan, he did something and he broke the damn thing. And like," Tom, what are you doing?" And he's like," Oh, oh, I bet you didn't think of that." And he's right. I didn't. I didn't think of it. So that was kind of a light bulb moment for me. It was like," Oh, I just spent eight to 12 hours of time doing an activity just so I could check a box on the form." And three minutes after I completed that somebody did something manipulating my device in such a way that caused failure and an issue that I hadn't even considered. So don't waste that time again. Let's make sure that we're starting those activities earlier. Let's make sure we're being more collaborative. Let's get value out of all these activities. Nothing is more annoying at least to me to do something where I get no value or if someone else doesn't get value out of it.

Ryan Behringer: Absolutely. I think that sentiment is core to my being. If I don't find value in something I'm going to change it or find a way to find value in it. No questions asked.

Jon Speer: Yeah. Frankly, that's what led to the formation of Greenlight Guru. And folks, I want to remind you, I'm talking with Ryan Behringer. Ryan is a member of our customer success team and he has a training and onboarding medical device guru and speaking of customer success and training and onboarding. Well, first of all, if you're a customer listening, I hope that you found this wonderful resource that we call the Greenlight Guru Academy. If you have not, it's pretty easy to get to academy. greenlight.guru. And I believe you can access that if you're a customer right within the app as well. And the reason I want customers to be aware of this is there are so many assets and materials and resources available in the academy that help you better utilize the Greenlight Guru medical device success platform. Different how tos and videos and all sorts of things that are just going to make your experience even better than what it already is. And good news. Even if you're not currently a Greenlight Guru customer, there is plenty of value and opportunities and courses and materials that are also available to you within the Greenlight Guru academy. We have some introductory courses on a variety of topics, including things like audits and document management and design controls, and risk. We also have recently partnered with medical device HQ and you can access their premium content on design controls and risk. And yes, it's going to cost you a few hundred dollars. I've paid for these courses myself and they are amazing. And I've been in this industry for 23 years. So I would encourage you to check it out whether you're a customer or a listener or just a consumer of our content. I guarantee there is something of value for you in the Greenlight Guru academy. So check it out. Academy. greenlight. guru. All right. So Ryan kind of round out our conversation today. You're part of the customer success team at Greenlight guru. And I know how important and how invaluable that customer experience is. I mean, you've been now on both sides of the fence. You've been a Greenlight customer and user. Now your part of the Greenlight Guru customer success team. Tapping into some of those experiences and I know the Greenlight specific experience are still a little bit fresh, but what do you think are some of the keys to customer success?

Ryan Behringer: To me, some of the keys being really, if you're approaching the platform as a new user, starting to understand where you're going to find those early wins, low- hanging fruit in your system to really get the ball rolling and using Greenlight as your quality system in medical device development platform. I think finding early wins where you're putting in that effort and seeing that payoff will really continue to motivate you to just jump in deeper and take that full, deep dive and really utilize the system to its fullest.

Jon Speer: Yeah. Your experience, it started out, you were very involved in the day- to- day use of the design control workflows and conducting design interviews and risk management and those things. When you were a user, did you have any ahas or light bulb moments that you remember or stick out in your mind?

Ryan Behringer: Oh man, countless. Hope we have a few more hours. I think some of the very early light bulb moments were really around having our designer views and more conventional face exits being on such a small team. It was really my sole responsibility to lead design reviews, phase reviews, to move on to from what you would call your product development phase to your manufacturing phase. And I don't know how I could have done those things without the level of organization that Greenlight provided me just as I'm working through the day to day and product development. The system is really building out the foundations for my designer views, design history file items like that, to where, when I was ready to conduct a designer view it wasn't five days of prepping documents for those reviews, which conventionally that's a lot of times with those items are. Your teams in this phase. And then the whole last week is maybe two weeks is organizing documents, chasing people down, those items and that just never occurred. And it turned that process into the phase was more naturally completed. And we came together and had our reviews. And there's not that buffer time of mostly administrative work that you have to complete.

Jon Speer: Yeah, I can relate sadly to the alternative shared even today a little bit about the designer view experience, but just the preparation that goes typically, or historically that goes into that you create all these different designer, it's a mess. I remember I have it on a conference room table, a stack of packets that was a foot and a half tall so that everybody got their copy of all these drawings and specifications and requirements and all that sort of thing. And I know for a fact that particular thing Greenlight grew and it's going to streamline that activity. And the design review workflow at Greenlight is really about trying to simplify that process and keep it all in a single source of truth and give all of your team members access to the information that they need so that they can make a good review. And I think designer view in general pre or without Greenlight, a lot of times it becomes another one of those checkbox activities. I believe that the experience with Greenlight actually raises the value of that exercise because now you've got everything, if people have questions like," Oh, what about this?" You can interrogate the system and you can pull up additional information, documents, records, and that sort of thing. So I'm glad that was one of those light bulb moments because designer reviews are key distinct moments in time of your products journey and you want it to be robust and holistic and thorough, and you want it to be a little bit challenging, but in a good way.

Ryan Behringer: Yeah, definitely as a team, we very much picked apart our design as you should, and your designer views. And I took pride coming to those being confident that I know you guys are going to pick this apart, but I think we're going to get through it. We did the right things and as a product development engineer and those are the things that I really enjoyed in that process was leading up to that, that point in time being really confident that first try getting through those design reviews because sometimes you don't and you kick your design apart and it's good not making it through a phase. It means you actually utilized your designer view for what it should be, but it's also really inspiring to get picked apart and still make it through because you did the right things leading up to that day.

Jon Speer: Yeah. I got to imagine another awesome moment in your career was getting that notice from FDA that the five had been cleared. I mean, I remember my first letter, I had no idea it was going to be so excited, but for a startup that's like the lifeblood, getting that letter is so key and so important. So how was your reaction about that?

Ryan Behringer: I remember the day fondly. I had been a part of teams in the past on products that have received five clearances, but not as intimate as this and how involved I was in the process. And I was definitely confident, nervously confident going into the process with the FDA and knowing how involved I was in the design and controls process, but it's almost indescribable. And one of the reasons I'm so excited to be here with the team is to work with companies, to get them to that same place. I know how hard I worked to get there. And I would love to be part of that success for hundreds and thousands of more companies. And just being able to contribute to that five, clearance experience or any other regulatory avenues. It's just immensely exciting, rewarding to be a part of.

Jon Speer: I a hundred percent agree. I could not have imagined how rewarding it was going to be with the Greenlight experience. Prior to Greenlight I had been a part of bringing many devices to market, but it wasn't usually a solo or a very specific finite set of activities for a very specific finite project. And then we started Greenlight and there are literally hundreds and hundreds of companies across the globe, thousands upon thousands of people using the platform each and every day and to play a part in all of those companies journey to get medical devices to market and make sure that they're safe and effective and knowing how positive the impact of life is that those products are having for the patients. I can't describe it very well other than what I just shared. It is from a life experience perspective. It's probably one of the most fulfilling things aside from the birth of my children, finding the person that you're supposed to spend life with. Those are probably the only things that would top that at least as you and I are talking. So I can't wait for you to have that experience.

Ryan Behringer: Definitely. I'm so excited to be in those trained onboarding calls, where I see the entire teams on the call and it's three people and their bright eyed ready to go. Just knowing the journey they're about to go on and helping them be successful to have that same success that I had using the platform. It's just hugely motivating, exciting, and definitely we'll be living for those moments.

Jon Speer: I think you have the unique distinction. I mean, of course our other gurus are extremely knowledgeable about the nuances and the trials and tribulations that a medical device company are going to go through and are certainly avid users of the platform internally. But I think you're the only person I think probably in the world who was a user of Greenlight at a startup before you became an employee of Greenland. I think that's a true statement. So you have a unique distinction, so I'm so glad that you're on the team. Do you have any other final thoughts that you want to share with the listeners before we wrap up?

Ryan Behringer: Yes. It's obviously no secret that as a user of Greenlight Guru, I was immensely satisfied with using the product, which is why I wanted to join the team. I had such a great experience with it and found it instrumental to my career as a young biomedical engineer coming out of college. First time leading projects towards five, 10 clearance and found that Greenlight Guru foundationally really gave me the confidence and just the confidence to know that I'm doing the right thing. It gives you the right guardrails and the support from the team. I don't think I would've been able to achieve with the level of success that our team had without using the platform and finding immense value there. I just want to share that value with others which is why I was so eager to join the team. And if I can emulate the experience that I had for new teams coming along and using the product, then I think the medical device industry as a whole will be making great strides and very excited to work with new and potential customers.

Jon Speer: Well, Ryan, thank you for saying so I'm highly confident that you'll do more than just emulate, you know ways to improve and streamline and make that new customer onboarding experience even better because you've been in that seat as that new customer. So I'm sure you'll bring lots of thoughts and ideas and improvements to an already pretty good process and an already amazing customer success team. I also want to thank Ryan Behringer, Ryan is the training and onboarding medical device guru at the Greenlight Guru customer success team. And I'm sure if you're a customer, you're going to be interacting with Ryan here very, very soon. And Ryan, how about this? Maybe in a couple of months or so we'll hop on and do another episode on something that's cool and exciting as a medical device professional. Is that all right?

Ryan Behringer: Absolutely. Yeah. I would love to be back on.

Jon Speer: Okay.

Ryan Behringer: Let's talk about the medical device industry for hours and days and months? I feel like I'm in great company being on the team.

Jon Speer: Yeah, absolutely. And folks, if you want to have the type of experience that Ryan did as a user of the Greenlight platform, it's pretty simple really. Go to www.greenlight.guru and learn a lot more about the medical device success platform. You learn about things about design controls and risk management and document management and Kappas and complaints and all sorts of other workflows that are going to help you to be very successful as a medical device company. We'd be happy to have a conversation with you as well, to learn more about your needs and your requirements to see if we have products and services and solutions that can help address those needs. When you go to the website, it's going to be pretty clear and request a demo. And somebody from our team, they'll be happy to have a conversation with you. And hopefully we have an opportunity to work together and hopefully you have an opportunity to meet and work with Ryan and others on the Greenlight Guru, customer success team. So again, www.greenlight.guru. As always thank you for listening to the Global Medical Device Podcast, the number one podcast in the medical device industry. And now of course you can watch it too, should have mentioned that at the beginning. But if you listen to this and didn't get a chance to see the video, go check out the Greenlight Guru YouTube page, we're publishing all of our episodes of the Global Medical Device Podcast there. So you'll get the video as well. And as always, this is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device Podcast.


ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

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

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