Early in his career Jon was spending too much time updating the team’s Excel spreadsheet which they used to track quality and regulatory-related progress during device development phases. One day he thought to himself “there has to be a better way”, and thus Greenlight Guru was born which simplifies the quality management process for medical device manufacturers. Hear about Jon’s journey from chemical engineer to honorary mechanical engineer to founder of Greenlight Guru. Also check out Greenlight Guru’s The Global Medical Device Podcast.
Pipeline Design & Engineering partners with medical device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, or automation equipment but don’t have the bandwidth or resources internally to develop that equipment. You can find us on the web at www.testfixturedesign.com and www.designtheproduct.com
About Being An Engineer
The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community.
The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us
Early in his career Jon was spending too much time updating the team’s Excel spreadsheet which they used to track quality and regulatory-related progress during device development phases. One day he thought to himself “there has to be a better way”, and thus Greenlight Guru was born which simplifies the quality management process for medical device manufacturers. Hear about Jon’s journey from chemical engineer to honorary mechanical engineer to founder of Greenlight Guru. Also check out Greenlight Guru’s The Global Medical Device Podcast.
Pipeline Design & Engineering partners with medical device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, or automation equipment but don’t have the bandwidth or resources internally to develop that equipment. You can find us on the web at www.testfixturedesign.com and www.designtheproduct.com
About Being An Engineer
The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community.
The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us
Welcome to the being an engineer podcast. Our guest today is Jon Speer. Jon is a chemical engineer and founder of Greenlight guru where they have developed a proprietary software solution to help medical device manufacturers navigate quality and regulatory requirements and get to market faster. And with less risk, Jon, welcome to being an engineer.
Jon Speer:Oh, thanks for having me on. It's great. I've listened to some of your podcast episodes. And man, I, maybe it's the engineering event, man, there's so nerdy and I love it.
Aaron Moncur:There's so nerdy I love that I need, I'm gonna have to frame that and use it as a quote. There's so nerdy I love it. That's perfect. Thank you. Alright, so, Jon, before I get into, I'll say the quote unquote, real questions. I have kind of a personal question, not a personal question. But I don't know something that's kind of fun or interesting. When I was in school, and I'm a mechanical engineer, there was this like running joke or inside joke, predominantly within the mechanical engineers, I don't know if it was shared elsewhere. But the the joke or the universally accepted assumption was that the chemical engineers, they were like cream of the crop. I mean, these guys knew what they're doing. These are the bright guys, then right? Then it was the electrical engineers. And then it was the mechanical engineers, and then down to the bottom where the civil engineers now, truthfully, were you ever in like study groups or things like that? You and your chemical engineer buddies were like, Yeah, we're, you know, we're pretty big deal.
Jon Speer:Truthfully, yeah, probably, you know, I'm sure that happened. I mean, it is it is interesting when you're because the school I went to is all engineers. So everybody's, they're studying some one of those engineering disciplines. And there is this friendly camaraderie and competitiveness amongst the other engineering disciplines. But yeah, I can relate to that analogy a little bit.
Aaron Moncur:Nice. Nice. I love it. So it's not just something insecure, mechanical engineers build themselves. This is some evidence for this, okay. After all these years, get some validation. Excellent. Alright. So Jon, how did you decide that chemical engineering was what you wanted to do?
Jon Speer:One part of it is like, kind of makes sense. And the other part of it, you know, certainly looking back, it's kind of like, that's kind of foolish way to look at it. But the part that kind of makes sense is in high school, I really enjoyed chemistry and math. And I thought, well, that means chemical engineering seems like a right career path or degree to pursue. And, you know, once you get into studying, and becoming an engineer and go into school, you realize that chemistry is important from a chemical engineering, I'm sure it took a lot more chemistry than the new did a chem, oh, chem, P Chem, probably a few other Chem types, which is kind of crazy. But then you learn that, you know, math is really important for all engineering disciplines. But once I got into it, like, you know, just because I like chemistry, and math doesn't necessarily mean it correlates to be a chemical engineer. The other part of it is, you know, engineering was something that was fascinating to me. And chemical engineering looked at, like the average salary of different engineering disciplines. Now, this is back when I'm 1718 years old, and like, oh, chemical engineers make the most money. So that might have had an influence back in my youth as as to why I chose that particular discipline.
Aaron Moncur:Well, that's a great way to go about it. Not that money is the only thing, but that's an important consideration that maybe not all people think about before choosing a career. Yeah, I looked up some stats on the web. And it was really surprised to see that there are only about 33,000 Practicing chemical engineers in the US right now. And then electrical engineering was like 190,000, in mechanical engineering was like 320,000 or something. Why do you suppose there are so few chemical engineers?
Jon Speer:Well, I can, I can always tell you about my own personal experience, because I've never been a practicing chemical engineer. Let's just say I was in the in college in the late 80s. Or I'm sorry, 80s 90s. Excuse me. I'm not quite that old, but late 90s. And there was right at the first.com era. And what was interesting at that time is electrical engineers and computer engineers. They could pretty much write their own ticket come out of school. I mean, I knew A handful of people that we're getting close to six figure entry level jobs right out of school. It's that's really good, good cash flow for a new grad. Yeah, what was also happening in the chemical engineer near and some classic industries were that employ chemical engineers or a lot of food processing oil industry. Pharmaceutical is pretty big with chemical engineering, but some of the opportunities that that I had to pursue from a chemical engineering job perspective, were working at a, an oil plant in West Texas, or working at a potato chip factory in the middle of Iowa. And I don't like potato chips, and I've been to West Texas. My it's probably not the path I want to pursue. Yeah, neither
Aaron Moncur:one of those sounds very interesting. Not to me. No. Well, I was half convinced you were gonna say that most people just aren't smart enough to do.
Jon Speer:Snow. I mean, I've learned Aaron since college that I'll give you a compliment. Mechanical engineers are the most versatile engineering discipline there is. And, and, you know, I guess, how did I get into where I'm at? You know, frankly, I needed a job. And I had friends who had jobs with a medical device company. And they said, they're hiring other engineers, and I can't, but I'm a chemical engineer. And I know it doesn't matter. Apply. And I did and I got a job. And that's sort of how I entered into to the medical device industry, but quickly learned that my mechanical skills were lacking. So I, you know, had to teach myself machining and CAD and a lot of other things that mechanical engineers knew what to do, because this was just part of, you know, how they're wired, you know? Oh, wow.
Aaron Moncur:That's fascinating. So right out of school, you jumped into a company as Yeah, more or less a mechanical engineer and kind of learned on the job.
Jon Speer:Correct? Yeah. Wow. And, and I think it was, you know, the interesting thing is, I wasn't trained as a mechanical engineer, but I did have a pretty good background on material science and and, you know, some systems and processing and things of that nature. So they kind of gave me a different lens or perspective to look at some problems versus some of my peers who were mechanical engineering discipline background.
Aaron Moncur:And that was what, mid 90s?
Jon Speer:Late 90s.
Aaron Moncur:Early 2000s. Yeah. Okay. Okay. How developed was CAD back then? You mentioned having to teach yourself CAD it was probably,
Unknown:that was automatic. Yeah, it was auto CAD. And it was, you know, we, I think we shared we had cat on one computer that we shared amongst, you know, a handful of engineers. I'm fact that right? As I started with this covenant, they were a little behind the times, but this not not too much, really, at that time. I mean, we, we didn't have email. When I first started working. I mean, I had email as kind of a novelty thing in college, but certainly on the job. We didn't have it for the first couple of years that that I worked there. CAD was on a desktop machine, you know, kind of a workstation. Yeah, we didn't have 3d CAD, and we didn't do 3d printing in those days. So yeah, kind of crazy.
Aaron Moncur:It's incredible to think how far we've come. I mean, 20 years is not that long now. Right? And in that short time, it's the tools we have nowadays are outstanding, for sure. For sure. All right. Well, I was gonna ask you what was one of the most interesting chemical engineering projects you worked on? But I guess that that's a goose egg for that
Unknown:one. Yeah, that's gonna be a goose egg. I mean, like I said, I jumped into, I guess, medical device right away. So you know, I've been there ever since and not looking back.
Aaron Moncur:Okay. All right. So you started designing medical devices? You did that for some time? Where did you move from there?
Unknown:Well, I mean, so the first company I worked with, started as a product development engineer did that for a while, I quickly picked up that I had a grasp of systems, understanding how things flow processes and things of that nature. So sort of graduated or migrated or took a next opportunity within the same company to be more of a systems type of role systems engineering type of role. I did that for a couple of years. And then after that, I moved to a product development firms. You know, they did contract development, contract design work, and so got more involved with them, still helping them roll out their systems, processes, procedures, really about compliance and making sure that that they're following all the rules and regulations from a medical device perspective,
Aaron Moncur:getting into processes and systems is that what you found that you really love to do? I mean, it sounds like you you clearly had a knack for it. Were you ever working on processes and systems and be like man I really wish I could just do some design work, we're always it always show me where you're failing in a process environment. And let me fix it. That's what I want to do.
Jon Speer:Well, I mean, I think struggle might not be the right word, but that I still struggle with that today. I mean, some days, I love systems, some days like, Man, I'd love to go back and get get my hands dirty, and start designing and prototyping again. So it's kind of this ebb and flow depending on on sort of the what's going on and where the needs are, and that sort of thing. So I don't know, I, I like both. I haven't been kind of itching. I mean, one of the things I enjoyed, I mean, it's probably a little more systems oriented was project management. So you know, after that, that next career stop. Eventually, I started my own consulting practice. And the primary thing that I was doing in that consulting practice was really, project management. I wasn't super hands on with the design and development products. But I was working with inventors and entrepreneurs and startups who were, and the skills that I brought was managing that whole project process, so that they can get through all the necessary design iterations testing, and eventually get through FDA and other regulatory hurdles so that they can get their products to market. And that part of its fun. So that was kind of a blend, if you will, of kind of a systems approach with being involved with day to day product development.
Aaron Moncur:Yeah, that makes sense. So let's fast forward just a little bit then. And it was a 2013 You founded Greenlight guru,
Jon Speer:correct? Yeah.
Aaron Moncur:Okay. We'll talk a little bit about that. Why did you start the company? What were you doing before then that made you think, you know, there's a need for some kind of software application to manage quality systems? How did that all come about?
Jon Speer:So just immediately, before starting, realize that this is in my consulting practice days, and, and as I mentioned, I was doing a lot of work with, with startup companies trying to design and developing and get their first medical device to market. And a lot of times, in that such situations, I was working with teams who were remote, they were, you know, sort of like we all are these days, but back then that was sort of novel and unique, you know, we virtual teams have sort of, we're sort of at the beginning of that, you know, we had engineers, software developers in some spots, mechanical engineers, and other spots. And so everybody was disconnected. And we had to, we didn't really have great tools to connect people and not just connect people. But when you go through the design and development process, there's a lot of moving parts, especially if there's, you know, software and hardware and mechanical components, they're all moving at different rates. But at some points in time, they have to, they have to come together. And they're really, I mean, I was managing a lot of these details and spreadsheets. And I've spent so much of my time just updating a spreadsheet, like I would get the information from mechanical engineering from the software developer and from the electronics guy, and I'd have to piece it all together. And so I just found I was spending so much of my time, every single day, every week, just updating and merging cells, adding rows, adding columns, and it's like, this is crazy,
Aaron Moncur:you might be working at a potato
Jon Speer:mat as well. Right. And, and you know, and I think even even though I was feeling that pain a lot, and that and that time, I was reminded of earlier days of my career where we were doing the same sort of thing. And I think I just sort of accepted it, then earlier in my career as well, this is just what you do. But as I had a little bit more gray hair on my face and a little less hair on my head and a little bit more experience, I realized that man, there's got to be a better way. So I tried a lot of software tools that claim to do this in. None of them did. In fact, most of them required so much configuration and customization that by the time I would get the tool dialed in that project would have been over or out of that phase. And it's like this, this is just crazy. So like, well, let's build it. Let's build it. You know, there was a point where I'm like, I'm going to teach myself to be a software developer. Let's just say. I'm guessing you've taken a little bit of computer programming or code or something somewhere along the way most engineers have. Yeah, so I got as far as the Hello World tutorial. This is not my bag, not my bag. So But anyway, I networked and I found someone who, who was a software developer who had a lot of experience building companies and software and so we formed a company and that's how we got started.
Aaron Moncur:Wow. Did you need a lot of funding to start that or it was software so there wasn't a whole lot of you know Capital Investment
Jon Speer:a little bit. In those early days, I mean, it was myself, co founder, current CEO at Greenlight, actually David Graham, and then we had to software development resources. And we raised a little bit of capitalists, I'll say friends and family money. But it was mostly just to cover, you know, salaries frankly, in those early days, it wasn't a lot of overhead. In we sort of sublet a corner of an office of, of a friend of David's, and basically, you know, it was pretty low cost operations in those early days. So we were pretty frugal, but able to get a lot out of that a little bit of investment.
Aaron Moncur:And how long was it until you had your, your minimum viable product and you started selling it?
Jon Speer:Yeah, so that happened pretty quick there. Our first MVP is really was really more of a series of high fidelity screenshots, kind of workflow sorts of things. It's more of a concept. And we were able to get a handful of customers that we refer to affectionately as our early adopters, who basically bought, bought into the vision of what we were selling, based on these high fidelity screenshots. That was within six months, four to six months. And then we had our first beta software, probably within a few months after that. So let's call it six to nine months, we had Live software that that were was in the hands of early adopters,
Aaron Moncur:that is really good, very impressive. During the development phase of your software, I'm sure it's always being developed in enhance, but in the early days before you actually came out with it, did you have to collaborate with the FDA to make sure that you had, you know, FDA compliance kind of baked in? Or was it completely separate?
Jon Speer:You know, that regulatory bodies, they're, they're interesting, interesting entities, they're there. I mean, today is different than even when we started the company. They're not historically super collaborative. And they're, they're not the types of organizations that typically will endorse solutions. So the the advantage there, though, is that I had been touched everything up into my career up to this point was experience, it was all based on what's expected. I've been through a lot of audits from FDA and other regulatory bodies, I had prepared personally prepared lots of documents and submissions that FDA and other regulatory bodies would review. So I had a pretty good working knowledge of what was expected. And so that, that, that Guru insight, if you will, that Guru knowledge went into architecting, the platform, you know, regulatory bodies, they're, they're pretty clear about or clear enough about what their requirements are and what the regulations are. I mean, there's a lot left up to interpretation, but the framework of what FDA expects from a medical device company, and what EU and Canada and all these other regulatory agencies expect, fortunately, is pretty consistent in the modern world. And so we're able to use that framework to really build and inform the workflows within the software. Now,
Aaron Moncur:not everyone listening to this podcast is going to be familiar with specifically medical device design. Can you spend just a couple of minutes speaking to a few of the unique challenges associated with that particular industry?
Jon Speer:I mean, no more. One big challenge is the emphasis on documentation, thorough documentation throughout the entire design and development process. And yeah, I know a lot of engineers like, Ah, he documentation. And yeah, I mean, honestly, I'm not I think when a lot of specifically med device engineers are frustrated with documentation, a lot of times, it's because the systems that are put in place, don't always and the criteria and the forms and all the checkboxes that people have to fill out, they don't always add value. And so this is what frustrates engineers. Now, with that being said, there's there's still way more documentation required during the design and development process for medical device, even if you have a dialed in efficient system, probably then there may be some other industries. So I think, I think that's one of the things that's, that's sort of different. And with that, there's also a huge emphasis on risk management, that needs to be documented and vetted and that sort of thing. And, you know, to summarize, or give a little high level overview of risk management, basically, your product is at the end of the day is a medical device that's going to be used on patients. If something goes wrong, what happens and there's an expectation that you think about that and you document that and you make risks based decisions to ensure that that product that you eventually get into the marketplace is as safe and effective as possible. So those are probably the two biggest differentiators I think for from that device product development versus maybe some other industries.
Aaron Moncur:Yeah, that's a great explanation, as you were saying that it is a thought came to me. Is the Greenlight guru software used only by medical device companies, or can it be used by other engineering companies that just need a good quality management system? I mean,
Jon Speer:today, our target market and our customer base, our medical device companies. And I would say that the the, the system is built in a way that provides we like to call guardrails. So there's a little bit of structure there, but it's pretty fluid and flexible. To me and some of my medical device. Peers maybe say, oh, my gosh, really? Did he just say that? There's, there's nothing that's super unique about medical device product development, we use different words. But you start with the user needs, you come up with some requirements, you establish your specifications, you test it, you prove that it works. I mean, that's, that's product development one on one. It's just sometimes med device, we feel like we're a little special. So we create a whole different lexicon of terms to describe those. But it's it's more or less the same thing. But yeah, if you're if you're active in that, theoretically, the greenlight workflows and systems would work for what you're doing to document those decisions along the way.
Aaron Moncur:Okay. Greenlight makes a statement on the website says Greenlight guru is the only quality management software platform designed specifically for medical device companies. That's a pretty impressive statement. And I wondered, were there just is developing a piece of software like this so challenging that it scares the competition away? Or do you think the industry is just still kind of young?
Jon Speer:I think it's a little while I don't know if it scares people away. But maybe a little bit, I do think it is a little, it's still a little bit of a young industry. I mean, somewhat of an interesting statistic, the medical device, industry, regardless of shape and size, a company, it's like something between 60 and 70% are still using paper to manage stuff. You know, it's 2020. That's kind of crazy. But there are reasons for that. And I think some of the reasons have also kept the the state of of solutions designed from that device, really in that infancy. And a lot of it is the regulations, or the perceived obstacles or barriers that one has to go through to use an electronic system. So I think that's a big one a big factor, you know, not to bore you with details, but there are specific regulations that allow shouts that define if you use an electronic record keeping electronic documentation, electronic signatures, you have to go through and do all this crazy amount of validation to prove that it works. And that takes a lot of time. And that's a big obstacle, a barrier to entry for a lot of folks. So we've we've taken that off the table, we do that in house for companies. So that's that's a huge relief to a lot of a lot of folks. The other challenge, I think there's a lot of other software solutions, but they're kind of general purpose, so to speak, or are industry agnostic. And those are okay, but they require to get them dialed in to my needs as a medical device company, I have to customize and configure those platforms. And so that customization and configuration can take several months, I've heard stories of some cases, that even takes a year. So you know, that's usually don't staff, your company with extra capacity just to validate tools and configure and customize tools. So I think that's been part of the the, the lay of the land, so to speak, that has prevented the growth and maturity of medical device, industry specific solutions.
Aaron Moncur:What were some of the challenges that your team had to overcome during the early days, especially developing the software?
Jon Speer:You know, I'll go back to the to the validation side of things. The, I'll say the old way of looking at it, if I'm a med device company, and I purchase, you know, like even CAD, we've talked about CAD earlier, that's kind of a good example. If I purchase a CAD platform or a document management system or some other software, and I'm using that to store my documents, my records, that validation activity would normally take me I'd have to write a bunch of test scripts, and I have to execute those those test scripts, and so on and so forth. Now, again, this is one of the things we do in house Greenlight. But one of the things that that sort of was an interesting barrier to overcome from our software development is, you know, our software development team, their software developers first. And if they had their choice, they would do a release to the customer every single day. Right? Because we're cloud based. So we could easily do that as like, oh timeout. There's this thing called validation that impacts and medical device industry impacts all of our customers. If we release every day, you know, even if we're doing a lot of the lifting and house Well, number one, that would be a huge constraint internally, from a testing and from a documentation standpoint. Plus, some of our customers aren't necessarily up to latest, greatest thinking. So they're still doing an old approach to validation. So every time we release, they would, some customers might say, I have to do a new validation. So you got to stop it with the update. So that's been something that's been a little bit tricky to deal with.
Aaron Moncur:Yeah, if I'm a medical device engineer, and I see new versions of the software being pushed out every day, I'm I'm either thinking, what was broken before that I don't know about or what's changing that I'm going to miss and screw up. Right. Right. So the the software developers weren't necessarily familiar with medical device development and the FDA in the beginning, I'm sure they right. Pick that up over time. Yeah. Correct. That makes sense. Okay. How how do engineers work with your software? So to give us an understanding, what's the workflow of the engineers interaction with the Greenlight guru software?
Jon Speer:Sure. So it really is, it's going to be primarily in the, what we call our projects workspace. So there are specific workflows to document. And this is an FDA term designer med device term design controls, and again, design controls. Think user needs think design requirements, think design, specifications, think verification, validation. But basically, this is constructed, engineers going to enter all of the information of what they heard from the user. What's important from a requirement standpoint, any specific tests and activity, they're going to enter that information directly into the greenlight workflow. And the primary artifact or point of view is this thing called a traceability matrix. Again, this is not unique to med device. But this has become the expected behavior for medical device professional all traceability matrix does is shows the relationship or the flow from the early voice of user that user need, all the way through the entire development process and how things are connected within that ecosystem. So that's a primary workflow that the engineers are going to be entering in and managing throughout the design and development of their medical device. And then there's also a similar type of workflow that does that allows the engineers to capture the risk assessment of their particular device and connect it to design decisions that they're making.
Aaron Moncur:And what are some of the cues if I'm part of a engineering team? And we're maybe in the beginning of a project just getting started? What are some of the cues or signals that might indicate to me that, hey, we need some kind of system, like the greenlight system? What what are the triggers that I should be looking for?
Jon Speer:Yeah, I think collaboration is key. We've we foster that. But in a way that provides a little bit of structure, a little bit of framework. You know, I think I've worked on these projects. And, you know, before Greenlight where a lot of times emails are flying back and forth, or you know, maybe we try to have a shared document on Google Drive or Dropbox. And you know, once you start to get into like prototyping and making iterations and design decisions, it becomes a little unwieldy unless you have a little bit of structure to your information. So Greenlight provides this platform for engineers to collaborate, but do so in a way that provides a little bit of framework around decisions that are being made. So I think once you start to to understand what your your user needs are, what you start to understand what your requirements are, then that's probably a good time to and you start prototyping for sure. But that's definitely a time to start thinking about a solution like Greenlight.
Aaron Moncur:Got it? That makes a lot of sense. Can you share maybe an example a success story of how and we don't need to get like specific into what company was but a company that used your software, and was able to, you know, reduce cost or accelerate schedule or somehow add some value and benefit to the development process with your software?
Jon Speer:Yeah, sure. And, you know, I will if it's okay, there's some case studies on the greenlight website. So if people go to Greenlight guru, somewhere along the top, there's an app Vacation, bar choices, you can go and see some of these case studies. But actually, I was just talking to a company earlier today, they're, they're in Toronto, Canada, Canada, and they started with green live pretty early on in their company. So startup of a handful, I think they might be at 10 or 15 people right now. And they've been capturing their design decisions in the greenlight design control and risk workflows. They are at a point where they're, like, this week, I think he said, planning to prepare a submission to the FDA. So one of the points in time, as you're wrapping up your product development activities of your medical device, there's, there's a point in time where you're going to prepare some sort of regulatory submission. In the US, it's, I'm going to send it to the FDA, and that's basically gonna give me permission to go to market. So I have to get the, you know, the green light, so to speak from, from FDA, before I can start selling my medical device. And there's lots of nuances to this. And I won't get into all the different details. But more or less, I got to get it to a point where a regulatory body says Yes, Jon, you're good to go. And this company that I'm describing there two days away from that, so they were able to do all of the things that they need to do from a design and development. So they're two days away from from submitting to the FDA, hopefully, within a couple of months, they'll get that green light from FDA. So they're, you know, they're at the edge of go on the market. And then with that brings on new challenges, because as a medical device company, I have to establish what is known as a quality management system. And basically, a quality management system is a set of policies and procedures, etc, that describe how I do business, aligning with the regulation. So there's also a, I'm getting super nerdy and complicated on this. So if I, if I'm getting too deep, just this probably
Aaron Moncur:all right, we love nerdy. Alright, so then,
Jon Speer:the other part of this is what I'm going to market, I have to get, I have to basically accredit my, my quality system. And if I'm in the US, that's a little different than if I'm going to Canada or EU. But there's this process called ISO 1345. And ISO 13485, is analogous to ISO 9001, outside the the the med device, and I think, as 9001 might be aerospace or automotive, but don't quote me on that last bit. But basically, I have to have somebody come in and say, you know, yeah, your quality system meets the requirements, you're good, and they, they give me a certification. And that means something. So in some markets, that's required before I go to market, and so this particular company that I'm describing there, they've had the first phase of that ISO certification process. And once we get out of quarantine, they're going to have the final stage. So, you know, it's, it's awesome to see a company go from idea to all the way through the design development, to submitting to regulatory agency to getting ISO certification and, and becoming a real company, as as they've been customers with Greenlight.
Aaron Moncur:That's fantastic. That's got to be very fulfilling and satisfying for you.
Jon Speer:Yeah, I mean, it's and I was telling, the gentleman I was talking to earlier today is like, you know, I live vicariously through through stories like this, because, you know, this is why our mission agreements to improve the quality of life. And the vicarious part of it is, our customers are the medical device companies who are who are bringing life saving life sustaining technologies to the market. And so in this, this particular company, I know what they're doing. I know what problem clinical problem they're trying to solve. And we we played a part of that. So that's pretty cool.
Aaron Moncur:Fantastic. Well, Jon, I won't keep you much longer here. But before we go, if people want to get a hold of you or the company, what are the best ways to do that? And also, I know that you host a podcast or two of your own. Would you like to plug those?
Jon Speer:Oh, sure. Thank you, Aaron. Sure. So global medical device podcast, I assume. Wherever you're listening to this podcast, if you also searched for Global Medical Device podcast, you'll find it and you can just searching in any search engine, you'll find it too, but that's, we get some med device professionals, regulatory nerds, quality nerds, sometimes engineering nerds and we try to talk about med device specific topics of interest. So appreciate y'all checking that out. You can go to the Greenlight guru website, it's pretty easy Greenlight guru that is the domain. Lots of content articles. We do webinars all these sorts of thing and learn a lot more about the company if you want to get a hold of me personally, probably the best way is via email, and my email is J-o-n period S-P-E-E-R at Greenlight guru.
Aaron Moncur:That's very brave. Have you given that your email address here? No, spammers, everyone. Okay,
Jon Speer:it's all good. I read every single email that I get so every day so
Aaron Moncur:happy. That's impressive. How many emails do you get every day out of?
Unknown:Let's just say about 100.
Aaron Moncur:Okay, yeah, that's a lot. All right. Well, Jon, thank you so much for spending some time today with us. My pleasure, really appreciate you you know, sharing your journey through almost being a practicing chemical engineer to to honorary mechanical engineer, and then through the the greenlight development process. Very, very interesting stuff. Thank you.
Jon Speer:Oh, you're welcome. My pleasure.
Aaron Moncur:I'm Aaron Moncure, founder of pipeline design, and engineering. If you liked what you heard today, please leave us a positive review. It really helps other people find the show. To learn how your engineering team can leverage our team's expertise in developing turnkey custom test fixtures, automated equipment and product design, visit us at test fixture design.com Thanks for listening