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What’s the difference between firmware engineering and software engineering? And what do toasters have to do with this? 

In this episode we interview Kyle Matthews, director of Firmware Engineering, and Petek Sener, software engineer, about the differences between their respective fields and tips for new and seasoned professionals alike.

 

Julia: 

I don’t know what either of you do.

Britt: 

Haha, I googled but I don’t know if I Googled right at all. 

Petek: 

I’m curious what you Googled. Were you just like, “Software?”

Britt: 

I first looked at LinkedIn to see what your actual title was. Then I was like, OK, firmware. Then I Googled what FWE is. 

Kyle: 

Firmware engineer. Nice. 

Britt: 

I got mainly interview questions, but they actually were somewhat helpful. And then I just read some embedded software stuff. 

Kyle: 

Yeah, that’s about it. 

Julia: 

We always start off with, “What’s your name? What do you do here?”

Kyle: 

Kyle.

Petek: 

Next question. 

Julia: 

Love it, one word answers only!

Kyle: 

No, I’ll go first. So yeah, my name is Kyle Matthews. I’m the Director of Firmware Engineering here at Blur. I’ve been here seven years now. I think I was like the third employee. And yeah, I joined in May of 2017. 

I joined Blur because I wanted to find like-minded people to learn from. I met Nathan and Scott in the interview, and I immediately was like, oh, this is a great group of people. They’re very smart, they’re very passionate, I could learn a lot here. That was seven years ago, and it’s been… I’ve certainly learned a ton. So mission accomplished. 

Julia: 

There you go. I’m sure [you learned] some things you weren’t expecting to learn. 

Kyle: 

Oh yeah. There’s lots of unexpected things too, and I picked up a little bit of mechanical stuff along the way. I actually originally applied as a mechanical engineer. 

Petek: 

Really? 

Kyle: 

Yeah. 

Petek: 

Oh, that’s crazy. 

Britt: 

What’s your degree in? 

Kyle: 

Biomedical engineering. So yeah, I kind of sidestepped my way into electrical engineering and nowadays more firmware and software engineering just by what I enjoy. So it took me a little bit to find exactly what I had a passion for. But yeah, I kind of lucked into Blur, applied because they had a mechanical engineering position open. mechanical stuff, so I applied. And during the interview, it became very quickly clear. Thankfully, Nathan was on the call. And he was like, oh, this is more, you know, you like doing firmware and software and stuff like that in electrical design. So I kind of did a bit of everything in my previous job. 

Now I’ve sort of cut out the mechanical side of things. I don’t touch too many mechanical things anymore. And I have transitioned fully into the firmware world, pretty much nowadays. I don’t really do too much board design either. Maybe a little bit for projects that are, you know, kind of my passion, which would be small wearable devices. They’re very tightly coupled between the electrical and firmware, meaning the choices you make on your circuit board have, you know, huge consequences for what the firmware needs to look like and they kind of play together. There’s generally a huge dependence on energy efficiency, low power type stuff, and so you have to be to make everything as small as possible and as low power as possible. So that lends itself well to doing both the board design and the firmware side by side by sometimes the same person. 

Petek: 

I’m Petek, I’m an R&D software engineer and compared to Kyle I’m a newbie because I’ve only been here for a year. Blur was super nice, they would let me come in and use some of the lab bench and the spaces and that was when I was in a startup so I was doing, I guess kind of like you, I was doing some CAD design and also the software and I was helping build fleets. 

I remember Kyle was showing me how to actually surface mount solder stuff. So yeah, that’s how I got to kind of see Blur and like the company culture. When I was looking for my next opportunity, I was like, let me see if Blur has a position open. And yeah, that’s how I ended up here. 

Britt: 

So what have you learned so far in your first year here?

Petek: 

Oh, so many things. I think it’s really nice to be able to work with so many engineers that come from different backgrounds. Even when you do different things in a project, even when you just do software, you naturally have to interact with the electrical side or people who wrote the firmware, who did the board. So it’s really nice to be able to go up to that person and ask your questions and kind of learn about what their process looks like and the little tips and tricks that they can give you. Yeah, I think that’s really valuable and something I didn’t have before when I was in a smaller startup. 

Julia: 

What do you want people to know about the difference between the two? 

Kyle: 

There’s sort of a blurred line between them. If you ask five different firmware engineers the difference between something like firmware and embedded engineering and stuff like that, you’ll probably get five different answers. But the key thing for me is for firmware and embedded software, you’re kind of working on a variety of smaller processors, right? When you’re working with what I would consider software, I sort of immediately think of desktop software, mobile apps, backend servers, and things like that have oodles of processing power, for lack of a better term. 

For embedded systems, there’s really, kind of, two different flavors there. There’s one that’s gonna be running on small microcontrollers that are sort of all-in-one systems to simplify it a little bit. They’re generally very small, very low power. They don’t have dedicated RAM most of the time. They don’t have a cooling system. A lot of times they run on batteries and they are just sort of small self-contained systems that may or may not have an operating system, which will be a different operating system than your Windows or OS X or Linux or something like that. It’ll be a stripped down operating system known as a real time operating system. 

So yeah, when I explain this to people, I basically just say I write software that goes on the little green circuit boards that you see. And they’re pretty ubiquitous, like we were kind of talking about earlier. Pretty much everything has firmware in it these days, even for very simple things like a toaster.

There are some toasters that don’t. There’s a very famous mechanical-only toaster. It was made, like 60, years ago. And apparently it’s fantastically good. During COVID, it became popular again and they were selling for hundreds of dollars on eBay. 

Petek: 

Woah.

Kyle: 

But it uses like the temperature warms up some mechanical piece that starts bending or turning or changing properties somehow, and that does the timing. Apparently it makes perfect toast every time. Yeah. But it’s very complicated to build because there’s all these mechanical components in it. And… modern manufacturing processes aren’t quite set up for it, right? 

It ends up being cheaper to put a small microcontroller on there and put a little bit of firmware on there and make a million of those, then it is for a more complicated system. You wouldn’t want a Windows computer in your toaster. 

Petek: 

Yeah. 

Kyle: 

So there’s a cost efficiency there too that differs from true software engineering where you have unlimited computing power, basically. A power budget that is far in excess of what you would have on a microcontroller. You can do a lot more things. It’s a little bit of a different design paradigm when you start thinking about what the system needs to do and how you’re gonna go about doing it. 

Petek: 

Yeah, I’m spoiled over here with all the power and processing. 

When we talk about mostly software at Blur, we’re talking about more like a graphical user interface, so applications you would install, download on your computer. As Kyle works on the firmware, I create these engineering applications so that our R&D team engineers, or manufacturing engineers, or even our clients, because we provide that software to them, can use this interface to be able to talk to their device. So to collect data from your device, visualize it, use it to run tests and experiments with your device, test out the feature. 

Some of these devices go through clinical trials, so you want to be able to have a nice user interface where you can make sure your device behaves the way you expect it to behave, and having a GUI just really speeds up that process. You can just hand it off to someone and they can click the buttons and look at it and it’s a more, like, immediate data processing for them. 

Britt: 

What do you kind of have to know about, when you’re working in parallel together, what do you have to know about the firmware piece in order to be successful in software piece? 

Kyle: 

A lot. 

Petek: 

I second that. 

Kyle: 

Yeah, so I mean the big thing is going to be the communication interface between them, right? So that’s step one, figuring out, well, how are you talking to it? Is it through a physical link like a USB or serial connection or something like that? Or is it wireless like Wi-Fi or Bluetooth? So you kind of start there and then you settle on a communication scheme, right, for lack of a better term. 

For something like a physical serial link, you might have a command line interface, or a more structured interface that’s machine readable, right? Instead of actually typing out like, hey, turn on my LED in normal human readable language, you might have a byte string that’s serialized through some protocol that is more amenable to just using an automated control interface in Python or in some other way. 

Likewise, if you do it through a wireless link like Bluetooth or Wi-Fi, you’ll do the same thing. You’ll settle on, well, what’s the command interface look like? What’s the data that goes out of the device? What’s the data that comes into the device? And you end up spooling up some documentation around that. As you go, you flesh out the documentation more, but you basically start with, can we talk to each other? Once you get that going, then you kind of build on it and riff on it a little bit and start fleshing out, like, a command and response or some other sort of paradigm for how you would talk. 

Additionally too, you know, past the just the raw interface of how do you structure messages to each other, what language are you talking? And I don’t mean language like programming language, I mean, what’s the actual information that’s getting passed back and forth? You also have to know the overall device operating scheme and behavior. So, if you’re going to run, for example, a treatment of some sort, are there some setup steps that have to happen before, during and after? Then you’re going to want to check to have some sort of robust system where you’re checking for errors, making sure it’s in the right state, the data is appropriate and it hasn’t veered off into an unhappy path. That you’re kind of staying on the happy path, and if you do diverge from that happy path, say there’s an error or something, you do your best to bring it back onto that happy path, recover from it, tell the user or the operator what’s going on and things like that. 

You know, every project has bugs. You’re never going to create a project right off the bat that is bug free, but you obviously strive for it every single time. I would say there’s various classes of bugs, but some of my favorite ones are bugs that have sort of complicated interactions. It’s not as much fun when you have a bug that you can just immediately point to, like, there’s the culprit, right? Like, that code was wrong, it needs to be changed, this is how you change it. That’s a relatively quick fix. Getting to that point of finding out where the bug is can sometimes be complicated. 

The more fun ones for me are ones that have hardware or user interactions with them too. Like the user does something that causes some physical interaction that then the firmware can’t quite handle. So there’s this chain of events that you have to walk through and understand in order to solve it. So, you know, another [example] from a low-power wearable device perspective is something like the haptic firing and the device doing something else and it causes the voltage on the battery to dip and you have to kind of work around that. 

For some of our very, very small implantable devices, they have very, very weak batteries. You have to be very careful about how and when you do things because the battery itself can’t even support the processor running for long periods of time because the battery droop gets so low. So those are probably my favorite bugs, the ones where you have power interactions and kind of brown out situations where you have to be super careful about when you’re even letting the processor come out of sleep to run commands and transmissions, things like that, and how do you gate that in a robust way to make sure that you don’t continually bring the system down? Or, more likely, you have some sort of weird edge condition way down the line that happens one percent of the time, right? That’s hard to catch in testing. But if you have a million devices in the field that starts becoming a very large problem 

Petek: 

Yeah, I think user interactions are really hard to predict because as the people who create the software, the firmware, you as the engineer have a very clear idea of what it can do and the order of operations when you’re interacting with it. So sometimes it’s hard to imagine all the various ways that a potential user can interact with it. So then, yeah, you have to get more creative and do things that you yourself wouldn’t normally do just to get to those edge cases of, “What ways can they break my code?”

Kyle: 

That’s a really interesting one, too, with user interactions. You can depend on the user to do the complete opposite of what they were supposed to do. And they will do absolutely anything and everything other than what you planned for them to do. So they stray off that happy path that I mentioned a lot. 

Another fun bug that I had was not really a bug at all. It was more, why are these devices failing in the field? This was before I was at Blur, but I like to relay this anecdote. We had a device that would be, you know, worn on the body and the patients, the users, didn’t really love it too much. It was a very early product, it was a prototype and they were, you know, high school kids. So instead of actually wearing the device, they would fake it. They would stick it in their waistband. 

They were playing contact sports and things like that. We had tons of devices breaking. And it was like, well, why are they breaking? They shouldn’t be breaking. They’re relatively protected. The patients are wearing, users are wearing protective equipment and stuff like that. And it turned out that no, it wasn’t really protected because it was just in their waistband and very susceptible to getting hit and sweat and things like that. And so you had to, figure out and solve the main problem, right? Make it more comfortable for the users, make it handier for the users, and have some design changes around that, but also hardening it for sweat ingress, and things like that, where we didn’t really design for that at the start, but it became very clear when you started testing that the users aren’t gonna do what you want. Pretty much ever. 

Petek: 

Yeah. 

Julia: 

I think that’s why usability testing and getting out in the field and having actual people put it in their hands and mess around with it is so important because like you were saying, they’re never gonna do what you expect them to do. And that’ll show you some weaknesses maybe in your design that you need to fix. 

Kyle: 

For sure, yeah, absolutely. I mean, the overall, a lot of times, it’s not a golden rule, but a lot of times, the core functionality of the device, what you would call kinda like the business logic, the device doing what it was designed to do, spitting out the information it was supposed to do, is somewhat a lot of times a smaller section of the code than handling edge conditions and more likely sort of helping guide the user to a path that is appropriate for the device. I don’t have a great example right now, but defensive code to protect the user against themselves. 

Petek: 

Yeah, put up the safety guards. 

Kyle: 

Exactly. 

Britt: 

They have to, they for sure do that with phones. 

Kyle: 

Yeah. 

Britt: 

You know, my mom, when she can’t do her passcode, she’ll just start smacking it or, you know, hitting all the buttons. 

Kyle: 

Exactly. The users turning their devices off and on at random times, throwing them across the room, not charging them, dropping them into water, all sorts of fun stuff. Not to mention just normal usage flow stuff where they’re maybe clicking a button that you didn’t intend for them to click yet or something like that. So that sort of code, once the user starts getting their hands on the device, there’s sort of an expectation that there’s going to need to be some changes in order to firm things up because you’re always going to discover things that you didn’t anticipate. 

Britt:

So you mentioned hobbies kind of led you to where you are. What kind of things actually got you to get into software or into this field or firmware? 

Petek: 

Sure, so I did biomedical engineering in undergrad, which I guess is like a good starting point because I think with that you kind of taste all different sorts of engineering because you still get a little bit of medical side of things and software side of things and mechanical side of things. Through undergrad I got to work on various design projects, and just through those my favorite part ended up being software. After graduating, over the years that’s just been more the main focus because oftentimes like the user interface is what your investors or end users are seeing. It becomes this valuable asset of how well you can present your device. The focus had been shifted more towards that, so that’s where I directed my energy to. But it also became my favorite part of working on a project, so it all worked out. 

Kyle: 

Yeah, and I was sort of the same way. I had always taken an interest in programming and software development in high school and in college. Those kind of were my favorite classes. I worked at a university for many years after I graduated. And in the course of that job, I got experience with a bunch of different facets of product design. Not purposefully, just by nature of needing to set up a certain experiment and needing a little bit of code maybe to help control it or mechanical design or electrical design to make things a little bit easier. So I started dabbling in that as I was just kind of working as like a lab engineer. 

I kind of really enjoyed every aspect of it, to be honest, but I most enjoyed the firmware and the electrical design. So I just sort of kept expanding on that. Every chance I had for a project to roll a little bit of that in, I would take that opportunity and really sort of focus on that. It sort of came about organically for me. I went to school for biomedical engineering also. I didn’t really like a lot of the things about biomedical engineering, but I did like a lot of the things with electrical and software engineering. I found myself sort of moving towards that direction and after seven or eight years of doing stuff like that in a research setting I decided, hey, I really like product development. That’s kind of what I had come to enjoy most is a new project or a new research project coming in and it needed this little widget. I loved doing the widget part, I didn’t like doing the experiment part so much. So I was like, all right, well let’s see if we can kind of hone in on that and that turned out to be product development. And so I decided, well, let’s look around and see what product development places are around here. And Blur was kinda, even though it was very new at the time and there weren’t too many employees, just talking to them, it was very clear that that’s kinda where I wanted to be. 

So I sort of sidestepped my way into this role by way of doing research-based projects for many, many years. 

Julia: 

Yeah, you’ve been around since the beginning. 

Kyle: 

Yeah, the growth, the growth has been amazing. And just seeing it start from really like four of the co-founders and a couple employees to where we’re at today, it’s really interesting in that the culture has kind of remained the same, right? I explain Blur to people like we’re just a collection of smart people who like doing interesting things, right? We all have that passion for kind of product development in general. 

It’s the type of personality where you’re at a restaurant or you’re walking around and you see some interesting mechanical thing or some interesting product, we’re all the type of people who would then stand around that product for five or ten minutes and likely take it apart and start talking about it, right? Trying to bring interesting things and learn from it. Although everybody’s from different backgrounds, different educations, different specialties, there’s that desire to continually learn and to talk about things, which I find really refreshing and enlightening. You can always learn something here. And that’s, that’s kind of, in my opinion, the best part about being here.

Britt: 

What would you kind of educate the listeners on like different tools, both of you? If you could recommend a starting point for someone who just got thrown into a role that maybe they’re not completely prepared for, which lanes would you probably take them down? 

Kyle: 

Yeah, that’s a great question. So I don’t answer this exact question a lot, but speaking to potential interns, potential employees and things like that, I emphasize the desire to learn as being the most important thing. Because you’re going to start a role, you’re never going to know everything there is. You’re never going to be able to slot directly in and start hammering away. And if you could, you know, that might even be a little bit boring, right? If it becomes rote like that. So you always want to be pushing your boundaries, and the most important thing we look for is that passion to learn and that desire to kind of pick new things up. So when you see something new, you don’t discard it because it’s new and you don’t understand it, you want to dive in. And that’s kind of how you learn and that’s how I learned too. 

I would say just understanding the role that you’re in, what’s expected of you and maybe taking small steps at the beginning to introduce new things. Not too fast, right? You don’t want to rock the boat too much. Let’s say that you’re in a new firmware role. Hopefully you’re on like a somewhat new project not like an established project that would kind of fall under my definition of rocking the boat, maybe a little bit too much if you roll into your new job and you’re like, “I think we should change everything.” That’s probably not the way that you wanna go. But even in the course of starting your new role, you’re gonna come across tons of new things, right? Specific ways that the company does things, development processes and things like that, and take everything in, learn about it as much as you can, and then start integrating it. 

As you go along with this process and you keep learning about things, you’ll settle on things that in your mind seem to work and things that could use a little bit of polishing maybe. And so you polish those things up and then you continually learn and it’s just this gradual improvement process. And it’s not something that happens overnight, it’s something that takes time and desire. So just sticking with it, especially from a firmware perspective, just like software engineering, it’s gone through a great deal of progress even in the last five, ten years. And five to ten years from now, it’s gonna continually explode and improve and make people more efficient. Just being able to write firmware that runs on a multitude of different processors and things like that, different wireless technologies that are starting to come about too. So being able to take those new bits of information in and integrate them is kind of the most important thing.

Petek: 

I agree with that one hundred percent because I think it’s never like, oh you learned it, now you’re a software engineer and you’re done for the rest of your career. I think just teaching yourself the skills to learn is the most important part. There’s always new software, right? Like no two companies do things the same way. There are a bunch of different libraries and packages and different ways of doing it, so you’re always going to be thrown into something that you don’t know and it’s a matter of how dedicated you are and how fast you can teach yourself and start using that tool. 

Even here, some projects needed a database so we had to spin a database. We have a new manufacturing application that needed to talk to a barcode scanner. Have I worked with a barcode scanner before? No. But now I had to figure out how to integrate this barcode scanner into my code. It’s always changing and it’s never the same, which is also the fun part because there’s always something unique in play, there’s always a new challenge. But as Kyle said, I think it’s a matter of you being driven to learn new thing that really makes the difference. 

Julia: 

Amazing. Thanks so much for the interview. 

Kyle: 

Absolutely. I will happily do another episode whenever you guys want. 

Petek: 

Yeah, this is fun. 

Kyle: 

It is fun. It is fun.

Recently we sat down with Elise, Noah, and Dustin to discuss company culture at Blur, their love of cycling, and the flexibility of our team. How do all of these things go together? Well, listen on to find out in this episode of In Focus. 

 

Julia 

Elise, thanks for joining us today on our podcast. 

Elise

Thanks so much for having me, Julia. 

Julia

Happy to have you. All right. So tell me about the cycling culture here at Blur. 

Elise

So, I’ve always been someone who’s biked around kind of casually, but had never taken it super seriously before. I had started biking again, just a little bit like around my neighborhood and nearby where I live for exercise. One time I heard about a bike ride they were going on, so I asked if I could come along. I think it was just a small group of maybe four or five of us that went one morning before work and the main thing I remember from that first ride that I went on with everyone is I was under the impression that the mileage was going to be comparable to what I’d been doing but was truly not prepared for what we were going out there for. 

I had not really done significant gravel biking before and did not realize just how hilly the path would be. And I just remember being pretty destroyed by the “out” of the “out-and-back” path that we took. But thankfully everyone who was with me was really supportive and just trying to make sure that I was drinking enough water and that I was still going and, you know, staying behind if I needed to take a little break. It was just a really nice, friendly, supportive crew and they weren’t, you know, even if I was maybe the least experienced biker at that point, they weren’t out there to really hammer down on their miles. They were down there because it was a fun way to spend some time together and also get outdoors and be biking. And they wanted to make sure that anyone who was interested in coming along was really included in that. 

Dustin

Well, one of the reasons I was really excited to work at Blur actually is when I came in for my in-person interview, I saw Noah with a bike on the back of his car. And so that led to a discussion when he interviewed me, and I found out that there was a whole Blur cycling team complete with jerseys and everything. So I was like, okay, that’s a good sign. I wanna work here. 

Noah

Yeah, I mean, we used to do group rides probably every week. It slowed down a little bit, I mean, especially during the winter when it’s too cold for people to enjoy it as much. But now that we’re closer to the Greenway and a couple of parks now, I’m really excited for as the weather warms up, getting back out there. 

Dustin

We’ve now got a couple of bike storage racks here. So it’s even easier than ever. So the, you know, the Greenway rides, there’s the gravel trails in Umstead. And there’s even the single track and more technical stuff in Crabtree just next to Armstead. So I’m really excited for that 

Julia

Yeah, they used to go like every Friday or every other Friday around three. Get out a little early, go for a two-hour bike ride. I tried it one time… I was very bad. And it was a gravel trail. It was long. I don’t know. How long is that trail? 

Noah

An 8 or 12 mile loop. 

Dustin

You can go as long as you want.

Julia

I think we did the 12 mile loop that day, and my bike was too small, and my tires were kind of flat, and anyways… it was just really not the best. 

Dustin

Well I’m glad that you could, you know, have your first experience six miles from the nearest civilization. 

Julia

Yeah that’s true, that’s true, I wasn’t in the middle of nowhere. It was fun, it was good sort of team building, just pushing each other to do better and beat our own personal bests. Mine was, you know, just making it up the hills.

Noah

One of them is called the graveyard hill for a reason.

Dustin 

We’ve got a bike stand in the office, a pump, we’ve got bike racks. We’ve got a locker room. 

Noah

Yeah, I was a mechanic for six years during college, so I know my way around a bike. Not nice bikes; I’ve patched tires with duct tape and it held for a very long time. So, don’t bring me a bike that’s worth more than like $600 and we’ll be good. 

Julia

I’ll keep that in mind. 

Dustin

A podcast is as good a place as anywhere to unveil this. So Noah Muse and I have been thinking up a new Blur cycling challenge actually. This will be news to you too. Our new building has this huge hill at the back of it that leads into the woods. So we’ve been developing, what I guess has to be the official name now, the Blur Hill Climb Challenge, where you basically have to shoot out of the woods at full speed and try to make it up the hill without stopping, and whoever makes it the furthest becomes the king of the mountain. 

Julia

What if you start going backwards? 

Dustin

Well, you’re wearing a helmet. And we’ll be there to laugh. 

Noah

That’s gonna be tough. 

Dustin

I know. That’s all right. The expectation is not that anyone makes it to the top. But we will see. 

Noah

I think even getting speed coming out of the woods is going to be hard, because even that’s a little bit uphill still. 

Dustin

Yep. 

Noah

Sweet. 

Julia

Well, do you have a launch day for this? Or what’s the plan? 

Dustin

Well, we’re still trying to figure that out, because we’re waiting for it to be nice. We’re waiting for a Friday that everyone’s here and makes sense. He and I were planning on doing some recon, perhaps, next week, just to see how possible it even is. So astute listeners will just have to check back next season. See who the winner is. 

Julia

Okay, well, I’ll be watching out the windows to see if you’re going backwards down the hill. 

Dustin

If you can see someone from the window, it means they’ve achieved, you know, success. 

Noah

Yeah, they definitely won that. 

Julia

This will be a spectator sport for me. I will cheer on those brave souls who dare to, you know, climb the hill. 

Elise

One thing that was also fun about getting more into biking with everyone here at Blur is that they’re not only, you know, excited to go on a bike ride, but are really passionate just about bikes and learning how to take care of them and how to fix them themselves. It was nice to be able to bring in my bike maybe the day before we had a group ride planned and have multiple people here offer to put it on the bike stand that’s in the back of the lab and look and just check and make sure everything’s running well. 

One time I remember someone said, “Oh, I have these old bike pedals, I’m just gonna put them on yours.” And I was really pretty astonished. I was like, wow, that’s just really a really sweet thing to do. That’s just really helpful and kind. And also it has kind of been a fun learning experience where they wouldn’t just take my bike away from me and deal with it. They would generally be showing me like, oh, this is the thing you should be checking. And you know, if you’re noticing this is making this noise, it’s because it’s running is rubbing over here and kind of, you know, general mechanical engineering learning experience of looking at the different pieces and just generally helping each other out and making sure that we can all kind of learn and enjoy things. 

Julia

I think that’s another cool part about working with people who are passionate about what they do. Typically, people who are passionate are also very willing to teach and show you how it’s done. So this thing that is tangentially related to mechanical engineering, it’s just cool that they are kind enough to show you. 

And I feel like that’s part of the culture here at Blur. Everyone is just kind and willing to help out. They’re never holding it over your head that you don’t know something, but really use a lot of opportunities to teach you and show you as long as you’re willing to learn. 

Elise

Yeah, and there’s definitely, I feel like there’s a broad extension of that kind of willingness to teach stuff or to have people learn new things, just even in like… the definitive work culture here. It feels like there’s a lot of, you know, if anyone starts talking to a project manager or a boss or anyone else involved with something and they say like, hey, I don’t really have much experience with this thing, but I’d like to delve more into it. Like, could I kind of learn how to do this? For the most part, you know, unless it really doesn’t make sense in that specific instance, like they’re gonna find a way to say like, yeah, of course you can expand what you’re working on and try and learn this new skill. Just nice to not have super rigid roles and separation of exactly what kinds of things everyone’s in charge of. So we each get to kind of bounce in and out of multiple different tasks and varieties of work that maybe someone in our traditional role at a more corporate place wouldn’t get to touch on. 

Julia

And you had a little bit of that experience moving from the R&D side into quality. Which seems like they would be super different, but I think even in R&D world you touched a lot of quality stuff. So maybe it was a big learning curve, but there was an understanding at least of what quality did. Do you wanna speak a little bit on that? 

Elise

It’s been helpful to have started in the R&D world and to now be in the quality world. I was exposed to our change control process, at least from the R&D side. And I had, as an R&D engineer, gone in and helped out with some manufacturing projects before and transferring things from engineering to manufacturing and different things like that. And so it was definitely a helpful perspective to know exactly what someone on the engineering and R&D side of a project is thinking about and looking at and working with to now be on the quality side.  

I think for me it’s kind of a cool thing because I, maybe unlike some engineers, I’m into, you know, working with words and writing things, and I deal a lot more with documentation now than I used to, but for me that feels like I’m just kind of expanding on a strength I maybe already had. 

Even now that I am officially on the quality side of things, there have been a couple times where we realize on a project, like, oh, we need more mechanical work done on this before it can get released, and I’m still able to kind of bounce back and work a little bit on that end. It’s nice to feel like I have a variety of experience that can still be utilized throughout work here at Blur. 

Julia

If you could describe Blur’s culture in a word or a sentence, what would that be? 

Elise

If I were to just use one word, I would go with communal. Just in the way that it feels like everyone is communally trying to help each other out and gather information and lend a hand where it’s needed. There doesn’t feel like there’s any competition between coworkers. It doesn’t feel like you’re trying to make sure that you succeed rather than someone else. It’s all about just making sure that the project and the work and the tasks are getting through and the products are getting made. 

Julia

One of the things we prize here at Blur is the flexibility of our team. And there’s no better example of that than Elise’s move from research and development to quality. Her mechanical background allows her to troubleshoot manufacturing issues quickly while maintaining quality standards and processes. I hope you got some insight into how we run our team at Blur and what it looks like to have a collaborative environment. And if you caught our enthusiasm for cycling along the way, well, that’s just a bonus and we’ll see you on the trails. 

Today we’re talking about everyone’s favorite topic: failure. What does it really mean to fail fast? How do you learn from your failures and keep moving forward? 

 

Britt

Hello and welcome to today’s podcast. We are here with Andrew and Megan. Why don’t you guys introduce yourselves? Andrew, tell us a little bit about how long you’ve been at Blur and what you do here. 

Andrew

Hi, I’ve been here at Blur for just over three and a half years. It’s a lot of fun. It’s always a learning experience, which I guess is kind of what we’re going to be talking about today. I am the model maker here, which means that I make stuff for people. And when we have a design or something that we need to hold in our hands and see how it feels and looks and interacts with everything else, I’m the guy that 3D prints it or molds it in urethane or silicone or something like that. Then we take a look at it and see what we like and what we don’t like.

Britt

How about you Megan? Tell us a little bit about yourself: how long you’ve been at Blur and what do you do here? 

Megan

My name is Megan Buckingham, I’ve been at Blur for a year and some change. I’m a mechanical engineer. I was in R&D to start off and then I switched over to manufacturing in December, so I guess by now it’s been about half and half. Now I’m sort of between the two. 

Britt

We got her over to the other side in operations and we’re happy about that, but yeah we can’t actually keep her forever because she’s so good at mechanical design that she is whisked away in R&D as well. 

Julia

What does it look like for you to sort of split your time like that? 

Megan

So far so good. I think it really depends on what the workload is for the different clients and where I’m needed and what the other resources are on each project. 

Britt

So today we’re going to be talking about some failures that you’ve had at Blur and how you’ve overcome them. Talking to our audience about how failures can be good. I mean, you have to fail in order to learn and to grow and just sharing some of the things that we’ve seen in the past.

Andrew

Finding the things that don’t work is a good thing, most of the time. Sometimes it’s disastrous, but a lot of the times it’s just progress and figuring out where to go next. 

Megan

Especially in early R&D, one of the purposes of building prototypes in general is to find your failures and pain points and whatnot. All sometimes expected. 

Britt

So what’s an example that you guys can think of that you’ve seen at Blur where you’re trying something in the design process and it just didn’t work, but you learned from it and can now do it better?

Andrew

One thing that comes to mind is just after I started working here, I was working with a two-part foam system. I hadn’t worked with this particular foam before and I underestimated how much I didn’t know about how it was going to behave. So, I designed a mold with very little vent relief and I mixed up my foam and put it in the mold. I clapped it shut, clamped it, and it almost immediately burst in my hands. It cracked in all the places and I was left with foam all over my hands, my shoes, and a broken mold in my hands that I needed to redesign and reprint and go back to the drawing board. And I felt kind of dumb for a second but it was a fairly inexpensive learning moment, so it gave me a little better appreciation for what that foam is capable of. 

Julia

Yeah, and now you’ll never make that mistake again. 

Andrew

Never again. Right. 

Britt

Until the next foam. 

Andrew

Like until a few months later when I was mixing up some expired foam, mixed it up in a bucket on the counter and turned around to do something else. Turned back around to find it bubbling out all over the counter and the floor and I had a little mess to clean up. It was going into the trash anyways, but…

Britt

It wouldn’t be R&D without messes.

Julia

Yeah. I’m imagining that science experiment: elephant foam? They mixed it up in the beaker and then it shoots up in a giant column, that’s what I’m imagining but I’m sure it was much more contained. 

Andrew

I wish it was that fireworks-y. It was a little more boring I guess but still a surprise. 

Julia

Well, Megan, Andrew has shared one of his learning moments, any learning moments from you in manufacturing or R&D?

Megan

Yeah, I have an example that spans R&D and manufacturing, actually. I was working on a product that’s an electromechanical medical device. It has lots of cables in it. It’s designed to be as small as possible as sort of a wearable device. It had many cables in this design, one of which was revised and grew in diameter. And so then we had to accommodate that change in the design. Increasing the clearance holes was a problem, increasing our cable ties for strain relief was a problem. There was hardly any space in the housings for these parts to grow. It should have been an easy change to increase the size, but without any millimeter to spare, ultimately we had to come up with a more complicated solution. 

Luckily we were able to kind of shrink some parts and lengthen some screws and make it work, but it definitely brings to mind that maybe an ideal solution could have been more easily reached if we had just left that tiny bit of clearance in the design in the first place. 

Yeah, there’s really that fine line between making a device as small as possible versus making it too small. So as long as the requirements allow, I’ll definitely be conscientious in the future to add that little bit of space if I can because it’s much harder to later revise a device to be larger rather than smaller. 

Julia

I like that you brought up that example because I think there’s a spectrum when we think of failure. From things like my foam exploded all over the model shop and now I have a big mess to clean up, versus, oh if we had designed this a little bit differently or left some more clearance, it would have been a lot easier to make this change. That’s something you can take into the future, and I think they’re all valuable. When you start to look at [failure] from a perspective of, “How can I learn from this and how can I grow?” and get to that point quickly versus sulking and thinking you can’t do anything, [that’s when it’s valuable]. You just have to keep moving forward and having creative solutions. And I think that’s something that we’re pretty good at and talk about a lot here: there aren’t many things that stop us from moving forward. Sometimes you just have to be a little bit creative in what you do. 

Britt

Yeah, I think that’s one thing that we do well at Blur is, you know, we may come across failures, but then we just keep pushing forward. There’s usually an urgent deadline and you don’t really have time to think about the mistake, you have to think about, “How can I overcome it and still meet the client’s needs and then get there creatively?” It’s not always an easy answer, sometimes you have to really put some thought into it to get there. 

Andrew

Yeah, and that brings to mind a deadline that we were trying to meet. One day, a few years ago, we had a part that we were finishing for a customer that was across the country and we needed to ship it that day. We needed to paint it and fill it with body filler. We were trying to get the shape and texture just right. I had to get the right color too of course. So we were going through this process of applying filler and then letting it cure and then sanding it and then applying filler and letting it cure and sanding it. We were getting a little impatient about how long that was taking, so in order to try to accelerate the cure time of this body filler that we were using, I put it in front of a little miniature personal space heater. It started to cure the filler a little bit more quickly, so we’re happy about that. 

I left it alone for a few minutes and came back to find that part had taken so much heat that it was starting to melt. It was deformed. It wasn’t even deformed very much, but it was deformed enough that it was completely garbage. So not only was that part garbage, but the last three or four hours that we had spent trying to finish that part to perfection was garbage and was lost. We still needed to get a part out to our clients that day and by the magic of having two of them, having a backup, we were able to recover from that and finish the backup and get it looking very good. We did get it out on time but it made us take a step back. Sometimes we are under the wire but we need to remember stuff like when you’re working on thermoplastics don’t put it in front of a space heater and walk away. 

Britt

Yeah, that’s a good lesson. 

Megan

Really putting the thermo in thermoplastic. 

Julia

I’m interested to know if there are any times, not necessarily a failure, but something that could have been accidental worked out in your favor and gave you new insight into a component. Or, it did something that you didn’t expect and then you’re like, “Oh, now I know I can use this for these other things that I wasn’t expecting.”

Andrew

I mean, I work with many different materials and even similar materials might have very different reactions to other environments or materials. So it’s kind of a constant, “Let’s see if this works.” And, “Oh, no, that didn’t work.” You know, and some of these things are very clear from data sheets and stuff like that. But some interactions between different materials, there isn’t documentation for that sort of thing. So it’s kind of a, let’s find out what works and what doesn’t. I’m saying that a lot today, but you know, that’s what I do.

Megan

I’ve also seen instances, specifically with materials, where a client requests a certain material and then maybe for whatever reason it doesn’t turn out the way they expect or they end up with a different material and then they actually like that one better. So a lot of times I think when you make something and actually get your hands on it you might discover, “You know, this isn’t exactly what we had in mind but this actually is really a good solution”

Andrew

Right, sometimes in giving a client what they want you have to sort of read between the lines and hear what they actually want rather than what they say that they want. They might ask very specifically for this hardness rubber in urethane. So, you go ahead and make those but then you go ahead and make one in silicone or you make one in a different hardness and you slip it along with a note like, “Hey try this one out when you get a chance.” Then they wind up loving that one better because it had a feel for what they were interested in. When you work with these materials day in and day out, I just have a little bit more of a feel about how they’re gonna interact with other components. 

Julia

I think that also has to do with really digging down to the root of the problem. Not just with clients, but with users too. Sometimes they’ll say, “This is the problem I’m facing. This is what really is impacting the way I use this product, or this is what I want to have fixed.” But when you dig into it a little bit more, you realize, okay, it’s not the color of this thing, it’s actually, they can’t, I don’t know, open it correctly. Or there’s this little latch that’s really hard. And so I think when you understand that, you can start to present solutions that will actually fix the root of the issue rather than band-aid fixes. 

Megan

Right, like treating symptoms versus treating the illness, if you will. 

Britt

So, Andrew, are there any recommendations that you can provide to our listeners out there, just based on the materials that you have handled so frequently? 

Andrew

I can easily say that silicones tend to be much more resilient than urethanes to a variety of environmental factors like temperature and UV exposure and chemical resistances. Sometimes a urethane is what you want because silicone likes to stick to silicone and doesn’t like to stick to anything else in general, whereas urethanes love to stick to anything. So if you’re doing an overmolding on a cable and you need a strain relief, then a urethane tends to be the way to go. If you’re doing, say, a button pad for a device, it might be silicone that you want so that it can be resistant to any sort of cleaning products. 

Britt

Megan, do you have any tips for our listeners out there? 

Megan

I think one other thing we see, talking about failures or areas to optimize and whatnot, I think a lot of times our clients want to build a prototype. They want it to be cheap, they want it to be fast, and that ultimately is usually some 3D printed parts, those sort of designs. That’s great for a prototype, but sometimes I don’t think there isn’t enough emphasis on future DFM considerations. Sometimes I think if you go down the road really far in a 3D printed design, then if you do want to switch to injection molding or whatnot and your design doesn’t allow for that pivot that can be very difficult. Especially as a financial decision of, “Is it worth it?” and, “When would you do that?” Those are just my thoughts: if you’re designing a product basically from scratch all the way through to production, you kind of have to start with the mentality that it’s definitely going to be production eventually. 

Andrew

If I could add to that, kind of the flip side of that, our engineers and designers of course tend to design for manufacturing and often will send me a part file and ask me to 3D print it. Sometimes I have to kind of come back to them a little bit, I’ve got to push back just a little bit like, “Hey, let me look at your design and talk about a couple things with you.” I could 3D print exactly what you asked me for but you might be really disappointed because it’ll come out slightly different than what you might be expecting. 

Megan

Yeah, it works both ways. 

Andrew

It sure does. 

Megan

Yeah, it’s really hard to 3D print parts that are designed for injection molding and you certainly can’t injection mold a lot of parts that were designed to be 3D printed. Yeah, seen that a lot. 

Britt

It is great that in-house we have a lot of 3D printers so that we can kind of rapidly prototype. But to your point Megan, you have to be thinking long-term. What does this 3D printed part look like for manufacturing? It does end up being something down the road that we have to kind of think through and sometimes it’s good to just get ahead of those decisions and think long term. But definitely agree, like it’s nice that Andrew can spit out tons of 3D printed parts back there and you can start to get a feel for the design and how things are going to fit together. 

Julia

So we’ve talked a lot about failures today. I’d love to hear about what’s your favorite success story so we can let you have some positive time on the microphone too. Like what’s a moment that you’re really proud of where you had a problem that you solved that was really hard but you did it and now you can look back and be like, yeah, that was a good solve. 

Britt

Well, Megan builds robots, that’s pretty cool.

Megan

I certainly am not personally building robots alone but I have been on some robotics projects. I will say it is extremely satisfying when everything finally comes together and it actually works. A lot of steps in between testing all of your small subsystems and making sure those all work, but when you really integrate everything it’s very satisfying. And that first time you turn it on and everything works as expected, those are the really fun wins.

Britt

I can see that. When something’s really hard and it feels like you might not be able to do it and then you pull it off, that’s always a fun win. 

Andrew

Mm-hmm. 

Britt

Well, we have a BlurBQ today, so we’re about to go to that. If you are listening out there and you haven’t been to a BlurBQ yet, you should be reaching out to us because they are really good. 

Julia

Pretty fantastic. Got our own BlurBQ sauce. 

Britt

Yeah and apparently we’re gonna have some BlurBQ biscuits? I think Megan made that up.

Megan

Brisket. 

Britt

All right well thank you both for being here today. We really appreciate it and we look forward to having you guys back. 

Before the holidays, we sat down with Keith Gausmann, one of the founders of Blur, to talk about finishing the year strong, synthesizing what he learned last year, and goal setting for the new year.

A note from the editor: We realized about twenty minutes into recording that we hadn’t done Keith’s intro. With some audio magic, we moved this little sound clip to the beginning. Typically I wouldn’t point this out, but it encapsulates almost too-perfectly one of the themes of this episode: adapt and keep moving forward.

 

Julia

We haven’t actually said who you are yet.

Britt

Yeah, we need you to actually introduce yourself. That’s a good point. 

Keith

My name is Keith Gausmann, I’m one of the partners here. I help run the business, I help run a project or two, and every now and then I do a little mechanical engineering, which I still like to do. Only every now and then, though. 

Britt

Why don’t you tell us also just a little background on Blur and how it got started.

Keith

So Blur started in 2015. There were four of us who started this company: myself, Scott Liddle, Nathan Luck and Jeff Rosino. We were all part of the engineering team at a local start-up company here in Raleigh called TearScience, which was sold eventually to J&J in 2018. We all worked there together for somewhere in the eight year range. We started this off as just the four of us, and over the last eight years we’ve grown into over 50 people. 

We do pretty much everything you need in the medical device space: industrial design, regulatory, ISO 13485, mechanical, electrical, software, firmware, systems engineering, we have a full prototype lab, machine shop, 3D printers, all that good stuff. And then we have manufacturing as well, we’ve done that for about three years with a separate manufacturing facility that’s about two miles from here. It’s really easy to go back and forth when needed. 

We do everything under the sun for a medical device, including writing the design controls when needed, doing all of the V&V testing, prototyping, bread boarding, doing the manufacturing and all the engineering. We can do all or some or even tiny parts of any of that for our customers. It’s kind of whatever the need is, we figure out how to fit in and be a part of our customers team and go from there.

Britt

The number one question I get asked is where the name Blur came from.

Keith

Well, when we were at TearScience, the other three partners and I, one of the things that we didn’t really like was that it was a little bit siloed. You were pretty much told to stay in your lane, and we as engineers don’t really love that too much because we like to think about other things, and make spreadsheets, and show sales people how they can sell better. 

Julia

I’m sure they appreciated that.

Keith

Yeah, they don’t always like that. But it really is blur the lines between all the different disciplines. Our philosophy from day one is hire smart people, bring them in, and they’ll do a good job and also have good insight into other things. Normally smart people don’t just focus on their own little area of the world, they think about other things. If you run a business smartly, you’re going to listen to people when they have comments or thoughts or suggestions about how you market yourself, how you sell stuff, what kind of things you’re offering and how you deal with clients, not just the specifics of a product or the engineering. 

That’s where Blur comes from, and I think we’ve done a pretty good job of doing that. 

Britt

You have, and I feel like every client that has asked me about our name and I’ve told them that, they’ve loved that. It’s been a thing that most people like, that we all work together and we aren’t told to stay in our lane. Thank goodness, because I’m always going in other peoples’ lanes.

Keith

Yeah, that would not be that fun. Again, this comes directly from experience and it’s not that fun to not be able to think about other things. People want to grow and move and do other things with their lives as well, and it gives them the ability to think about stuff like that.

Britt

How do we end the year strong? We try to set expectations with holidays well, but also push hard for our clients. Understand what their goals are for their end of year needs, and then work together as a team to achieve them.

Keith

You know, there’s a give and take. You have crazy schedules and a lot of clients want crazy schedules and things that are right on the edge of being doable, and you always want to go for it. I’m of the opinion let’s go for it, but you also have to realize sometimes you’re not going to make it. But if you don’t go for it, you’ll never make it. So, I like the “Think you can and you will,” mentality, but you have to weigh a bunch of stuff. You don’t want to burn people out, which is a fine line. When you increase your activity and you really go at it hard, you learn a ton. 

This particular client is a really good example in that we had some pretty crazy deadlines, we were doing some things for the very first time. We busted it to meet those goals, and people put in more than they should have. And this time of year that’s tough because everyone’s got family things and you don’t want to be doing that. But the effort that we put in and the things that we learned and the progress we made on the project were hugely valuable. We would not be where we are today if we wouldn’t have gone through that pain, it would have taken us much longer. But now I feel like we’re entering a new year and we’re in good shape. It’s really all about, you want to gain the value and limit the pain, and that’s a fine line. Especially this time of year. 

Britt

I agree with you. We did learn a lot, and we learned a lot in a short amount of time. Sometimes an aggressive goal can help you achieve a lot of learning, which then adds value to future things you’re building or goals you’re setting. 

How would you say you keep the team motivated in those type of aggressive goals when things aren’t always going right and you’re trying to manage clients’ expectations but keep the team moving?

Keith

I think there are a couple of ways. One is you have to keep it positive and you have to add some perspective. Like saying, “All right, what we did from the beginning of the week to the end of the week was we took a two or three day process and turned it into a five hour process. That’s a big deal.” You have to remind people of that because they don’t see it because they’re in it. You have to be able to take a step back, look at something and see the big picture, which is hard to do when you’re in the thick of it. So that’s one thing. That’s like, hey, all this stuff we did wasn’t not worth it. All this stuff actually was worth it, and look at the improvements we made. It will save us from ever doing this again because of all of these improvements, these things aren’t going to take nearly as much time as they used to.

The other thing I think you have to do is be generous. If you ask people to go above and beyond, you have to be willing to do that too. Take your team out to dinner somewhere nice, give them an extra day or two off if they’re working nights and weekends. Those are easy things to do, and they help remind people that it’s a team.

Julia

I think that’s something I’ve noticed here. I’ve never been asked by any of my bosses to do something that they wouldn’t do themselves or aren’t already doing and helping with. As an employee, that certainly helps to keep me motivated because I can see they’re pushing just as hard, they’re working right alongside us, they’re really putting in the work as well. 

Britt

How do you set up for the new year? We’re ending the year now and then we have the holidays coming and then we’re starting out 2024. How do you typically go into each year in setting goals?

Keith

That’s hard. Our business is a little cyclical, we depend on the economy some. You can see a certain amount of work going into the new year. Some of it’s real, some of it you put odds to it: we’re 80% that that’s going to happen, 50% that this is going to happen, and 20% that this is going to happen. Then you try to make plans accordingly to grow and staff as needed. 

Again, you don’t want to be crushing people but you also have to be realistic. You can’t go and hire six people on a whim because you have two jobs that may start in March. That’s going to end in disaster. You kind of have to figure out how to win and get those in the door, start them, and then have your people lined up if you need extra people to do that. Maybe it’s diverting resources from other jobs that are winding down, stuff like that. It’s a bit of a moving target, so that’s not easy. 

Those are the kinds of things we set goals for: how many people do we want to grow into, what kind of areas of the companies do we want to expand? Manufacturing is a good one, that for us, I think in 2024 will be one of the areas that we try to grow. There may be times that we need engineers and R&D to come over and help out as we adjust and try to get the staffing right. 

Britt

That’s the great way of how we do things here. People are willing to pitch in in areas that aren’t necessarily their job role. I think that’s important with a company that’s growing, is to have flexibility and to wear a lot of hats until you understand the current need and something that is going to be needed long term, and to your point staffing accordingly.

Keith

I think the other part of that is fixing known problems in our staffing. So there are different holes that cause pain. For instance, in manufacturing the person that can do a multitude of tasks that everyone is pitching in and doing now but it’s not their core competency, and it takes away from their ability to do what they are good at. It would be like having a wide receiver on your football team and asking them to play running back because you don’t have enough of them. You wouldn’t want to do that very often. 

It’s recognizing those holes and trying to fill them with the right person, not necessarily just a warm body.

Julia

What did you learn this past year?

Keith

In this business you’re always relearning the same lessons over and over again because there’s inherent truth in how you run a business, run projects, communicate with people, deal with people who are poor communicators. You constantly, I won’t say you learn that because it’s not brand new, but you constantly relearn that. And how do you take that and translate it into things that different team members can deal with? They’re all different too. They all need their own level of communication.

I think understanding that that’s more important than ever.

Britt

I think every year we learn even better how to communicate, both externally and internally. You have new projects, and new projects create new obstacles or a miss that you never considered you could miss. It’s not even really a miss at that point, it’s something you now learn from and you try not to miss it again. Those are usually the things I learn throughout the years, and the next year I say, “Okay, how can we ensure that on the next project with an aggressive timeline, we ensure we’re moving fast but we’re hitting all the things.” And that lists continues to grow with each project.

Keith

I’d say one of the other things we’re learning, I wouldn’t say we’ve learned it yet but we’re still learning, is how to communicate our open business model on manufacturing costs. We have an “our books are your books” situation. That’s a good thing because as an engineer that’s always what I wanted from my manufacturers, so we just translated that into what we’re doing because I think it’s fair, it’s honest, and it’s helpful for everyone involved. But when you do that, you get questions on everything. So, you have to make sure you’ve communicated correctly, and you also want to do it in a way that people who are looking at your stuff and other stuff that isn’t so open can compare apples to apples. 

Part of what we’ve learned is how to communicate that openness better, make sure that everyone is on the same page, that they understand what all the line items mean. There’s a ton of information and a ton of data, which ultimately is a good thing, but it can be overwhelming for people sometimes. So, it’s really learning how to work through that with our clients, our potential clients, and communicate it, be clear about it, and make sure that everyone’s on the same page with the different levers that can be pulled and how we can reduce cost where needed, things like that, and being on top of that. 

I think that’s one of the biggest things: don’t just wait for them to ask, just be on top of it. It’s even evolving the open-model forms. I know I’m getting these questions, I’m going to just answer them up front for you so you don’t even have to bother asking. We’ve done the same thing over the years with the R&D proposals thing, making them more open, more detailed, more plans, it always evokes other questions. WE know what those are so we go ahead and answer them up front. You continuously learn that, and it saves effort in the long run.

Britt

What are you most excited about coming up in 2024 for Blur?

Keith

Honestly, I’m excited about stopping spending money on the new building. That’s gonna feel really good.

Julia

Getting settled.

Britt

Getting settled into our new spaces.

Keith

Yes. Again, we’ve spent a lot of money getting this and manufacturing [ready].

Britt

That’s fair. I feel like there has been a lot of growth.

Keith

There has been. It’s really nice and it’s gonna be really good, but I’m gonna be really happy to not do that and have, like, we’re good. We’ve got all the software systems we need, we’ve upgraded all the software, outside of a piece of equipment here and there, we’re good for a little while. Let’s just take it and run and focus on the work for a little while as opposed to all the other stuff. Which has been fun and it’s been great, and it’s really nice, this is an amazing upgrade for all of us. It’s going to serve us well for years to come

Britt

I don’t know if our podcast listeners realize we’ve moved into a new building, I don’t know if we’ve said that on the podcast yet. We’ve got two building and increased our square footage, so that’s been a fun last quarter. It has had us busy in great ways and is good for growth in 2024, which is what I’m excited about. I feel like now we have the appropriate spaces going into 2024 to have new business come in and really grow as a company. 

Keith

Yeah, I mean just getting settled and now using our new abilities and our new space and let’s see what we can do with it. 

Julia

Thanks for chatting. 

Keith

Thanks.

Britt

Thanks for being here, we really appreciate your time. This has been helpful to hear how you look at the company both from ending the year to starting out the new year.

How do you stay positive as a service technician and continue to provide the best possible service for your customers? 

Today we’ll hear some stories from the field, both good and not so good, and learn a few lessons along the way. 

 

Julia

Back with us today is Britt and we’re going to be talking a little bit about some of the stories that come with the service industry. 

Britt

Yes, today I brought Jonathan Manning. He’s been in the service industry for way longer than I have and thought he could share some of his stories on the road and kind of give some tips on what he’s seen out there and lessons learned. So thanks for being here, Jonathan. 

Jonathan

My pleasure. 

Britt

Why don’t you tell the listeners how long you have been in service. 

Jonathan

One way I learned about service, back in the late 90s, I worked with my best friend on his pit crew, and I worked in NASCAR for a NASCAR team for a couple of years. And then later on in the early 2000s, I was working for a company that made industrial equipment, and I did some service work with them. And around 2011, I moved into medical devices and started working for the service department there, and was a field service engineer till 2018 and now I’ve been working at Blur for several years since 2019. A lot of years.

Britt

Tell me, out of the 50 states, how many states have you been to as part of service? 

Jonathan

I was fortunate to see 49 out of 50. I missed out on going to Alaska but I was able to go to 49. 

Britt

Wow, 49 out of 50 states. That’s incredible. And how did you decide who got to go to Alaska? 

Jonathan

Okay, well there were primarily, when the opportunity to go to Alaska came about, there were primarily two of us that were traveling. If a good trip came up it was rock-paper-scissors, and if a bad trip came up it was rock-paper-scissors. I legitimately lost out on the Alaska trip. So I should have gone with scissors, I guess.

Britt

And then what’s the craziest extreme that you’ve gone to from one state to another? Tell us a little bit about that experience. 

Jonathan

OK, well, as far as weather-related, one day I was coming back in the morning. I was coming back from somewhere in Florida, and it was during the winter. I got back into the office before lunch and just happened to run into you Britt and you said, “Would it be possible for you to be in Appleton, Wisconsin,” and I say, “Like when?” and you said, “Tomorrow morning.” I remember giving you a crazy look and thinking, “I don’t want to do this.” I thought about it and decided, okay. So I immediately booked a trip to go to Wisconsin. All I had was clothes for Florida because I was just planning on being in Florida that week and ended up in Milwaukee that nigh. It was like single digit temperatures and all I had was short sleeve shirts. So yeah, that was a quick turnaround trip but it was very cold. 

Britt

Yeah, that happened a lot. So what John was talking about is when you’re first starting a service department and you’ve got a small team and then you’ve got clients calling in, sometimes you’ve got quick turnarounds that have to happen. And yeah, sometimes you’re having to ask people to fly out of Florida and then go straight to Wisconsin, or in some cases, jump on a plane and get to California and then go right from California to Canada. 

I mean, you can’t plan for exactly when service is going to happen, but you can start planning to build your team out to make it the most. less painful process as possible. 

Julia

So Jonathan, did you get a coat when you got to Wisconsin? 

Jonathan

Nope, I just made the best of it. 

Julia

Just toughed it out in your flip flops and shorts. 

Jonathan

Well, no flip flops, but yeah, just dress pants and dress shoes and a polo shirt. 

Britt

I heard about this one time that you had to use a microwave in a hotel. 

Jonathan

Yeah, well, sometimes when you’re planning out these trips for service, you think that you’re gonna be in one place for a certain amount of time and then the rest of the week is already scheduled out. But a lot of times, you have to make changes on the fly. So you pack enough clothes to be somewhere one day and then you add another day’s clothes to it just to make sure. And sometimes those trips end up being extended throughout the whole week. 

So one time it’s the afternoon and I’m out of clean shorts and I wanted to wear shorts out that evening to get something. So you do what every everybody does that is taking an extended trip that’s not planned: You wash your clothes in the sink. I just found out the microwave is not a good thing to try to dry clothes in. 

Britt

What happens if you put clothes in a microwave? 

Jonathan

Well they’ll overheat in places and start smoking. 

Britt

Oh, that’s good to know. 

Jonathan

Fortunately I didn’t set off the smoke alarm. That would have been really, really bad. Yeah, lost that pair of shorts. 

Britt

So not only were you out of clean shorts, you’re down a pair of shorts as well. 

What’s the worst experience you’ve had as far as service and then what’s your best experience that you’d say overall from service? 

Jonathan

Well I always wanted to make sure I was doing a good job for the customer and wanted to be a good representative of the company and have a good first impression. I wanted to leave with the customer having had a good experience and having a machine that’s working. 

I was in Boise, Idaho. I’d left at 0 dark 30 that morning and I remember getting into the office and I just kind of have the shakes because I haven’t eaten anything and I want to get started on this and get it over with. So, I have this machine with probably a 500 to 600 part bill of materials and it’s completely taken apart. All the external housings are off it, all the internal components are out into the bottom to change some CPU components. 

The doctor is coming through the office back and forth which is making me nervous because he’s asking me questions like, “Is my machine ever going to work again?” As I’m getting the thing back together, I have a few small screws that I have to put like a thread locker. It comes in a little one ounce bottle with a small paint brush in it and it’s fluorescent orange. Well, this is a brand new office and they have this bright green colored carpet and bright green colored chairs. As I said earlier, I had the shakes, and I opened this brand new bottle of Threadlocker and it’s like everything happened in slow motion: It slipped out of my hand, I tried to catch it with one hand, now it’s twirling. You can see this fluorescent red liquid going all over the chair where the bottle lands on the chair, bounces up, and then lands on the carpet. I immediately went to the office manager and told her what happened. She brought me some rags and then she brought me, of all things, this stuff that you get in automotive stores: It’s brake cleaner. And all you can smell in the office are solvents. At this point I can’t even breathe. I was able to get most of it out of the carpet, but we ended up buying a new office chair for that customer. 

Britt

Yeah, I remember that call. It was like, “Britt, can we buy them another chair?” and I said, “Yeah, that’s the right thing to do. So let’s do it” But things happen. Don’t feel too bad about it. I remember you felt really bad about it. And I was like, these things happen. Try not to make mistakes, but they happen. And obviously that was a pretty intense repair. 

So probably if it had been a more serviceable device and service had been thought of ahead of time, you probably wouldn’t have had to go that deep into the system and would have had a much faster repair. 

Julia

I can’t imagine that purchase request coming through. I’m just imagining at the office someone would be like, why is someone ordering one office chair? For our customer.?

Britt

For our customer, not for this office. 

Jonathan

Key takeaway for that is always have breakfast. 

Britt

Yeah, that’s true.

Julia

Most important meal of the day.

Britt

And what was your best experience? 

Jonathan

Alright, so best experience was the fact that going to so many different cities, you get to experience the cultures and the food. And my counterpart, Paul, in service, we always kept an Excel database of the best restaurants to go to. 

Julia

Oh, that’s a good idea. 

Jonathan

So I am, I’m a big fan of all types of barbecue. And so I would say a lot of the best experiences, there were many, probably revolved around barbecue. Should I name some of the places? 

Britt

Yeah, definitely. 

Jonathan

So Leo’s in Oklahoma City, Tyler’s in Amarillo, Texas, and Letha’s down in Mississippi. 

Britt

Best barbecue. Good to know. 

Julia

I am very impressed that you remembered those just off the top of your head. And you brought your barbecue skills to Blur. You’re like our grill master here. 

Jonathan

Well, it is a hobby. I enjoy doing it. 

Britt

And then what’s the craziest thing you’ve seen while on the road? 

Jonathan

Oh, definitely that’s easy. I was out in Portland, Oregon and I was driving down to Salem. I was on the five and I saw a motorcycle and a guy had a piece of channel iron strapped to the back of it and had a refrigerator, like a dorm-sized refrigerator, and he was transporting that from one place to another on a motorcycle. I thought that took a lot of skills. 

Julia

Oh yeah, talk about balance. 

Britt

Yeah, that’s some crazy balance. You know. Wow. Yeah, I’m sure you could go on forever. I mean, you’ve got tons of stories there. So, seen a lot of things, heard a lot of things, been to a lot of places. I guess we’ll end with what are some lessons learned, like a few lessons learned if you had to tell our listeners out there that you got from service?

Jonathan

I learned that most people will treat you as you treat them. 

Another thing is airline etiquette: always be nice to the flight attendants and most of the time they will be nice to you.You always want to give up the best seat if you’re on Southwest to the mom that is nervous about having her kids with them when she gets on the plane late. Things like that. And I did learn that the middle seat won’t actually kill you. 

Probably the most important thing though is you always wanna check the mattresses when you’re in strange hotels. 

Julia

Have you found anything? 

Jonathan

Well, I was out in Washington state and it was the only encounter I ever had where I actually saw a real live bed bug. I disappeared from that hotel pretty quick. 

Britt

And then what about lessons learned from, you know, being out in the field performing service? If you were mentoring someone right now, who’s new to service and they’re about to go out on their very first service call, what would you tell them when they get to that office their best thing to think about is? 

Jonathan

Tell them that everything doesn’t go as planned. Be confident in your support group back home. Have numbers of people that have expertise in things that you’re not an expert on, and realize that the worst thing that can happen is you can’t repair the machine and you might get another stab at it. 

Julia

Yeah, I think being confident in your support team is a huge one. The worst thing that can happen in that scenario is you might not be able to fix the problem right there when you’re there, but that’s why you have your support team and the experts that you can rely on and call up. 

Britt

Yeah, well, this has been great, Jonathan. I really appreciate you joining us today and hearing all your stories and lessons that you’ve been able to share with the listeners. 

What are test fixtures and why are they useful in product development? 

When in the product development cycle should you consider using test fixtures? 

We sat down with Nathan, a test fixture engineer at Blur, to understand when test fixtures are needed and why they’re valuable. 

 

Julia

Thanks for joining us today, Nathan. Can you describe what you do here at Blur? 

Nathan

I am our test engineer here at Blur. So I design and develop test fixtures, manufacturing fixtures, assembly fixtures, things like that. I’m also involved with the design verification and validation to make sure that our products are functional and safe before we send them to clinical or to the open market or wherever they may go. And that about sums it up in a nutshell. 

Julia

How long have you been in this field of test fixtures and creating test fixtures, and how did you determine that that’s what you wanted to do as a career? 

Nathan

So, In 2009, when I was 15, I got a job at a third party test lab in Pennsylvania, where I used to live. I started there sort of washing windows, scrubbing carpets, and not so fun things like that. But I was still in high school, so it was okay. They were a very large aerospace test facility, and their market was that they were third party, so they don’t have any weight in whether the results pass or fail which is always what you need at the end of the day to get a system passed for use by the FAA or different things like that. So I’d worked there for a while, I knew the background of where I worked. 

And when I went to college, I got a degree in mechanical engineering. When I got out of college, I was offered a position as a project manager at that business and that would have been in 2016. So I started there and I worked in non-metallics, so composites, plastics, things like that. 

And that’s where I really got into this because, at the time when I got into it, the use of composites and plastics for structural components in the aerospace industry was still fairly new. So it was a new department that we had opened up at the place that I worked and everything there was, at that time, a lot of stuff that they hadn’t done before. So that’s where a lot of the designing new tests and new fixtures and things like that came in because they had 40 or 50 years experience testing metals, but it’s a totally different animal once you get into, in particular, the composites, the carbon fibers, those are very complex tests. So that’s where I got started on it. I did that for five or six years before I came here and now I’ve sort of been doing a similar thing since I got to Blur. 

Britt

Yeah, that’s great. I’ve worked a lot with Nathan, specifically in the manufacturing area with fixtures and yeah, he can come up with pretty much anything. So I’ve definitely had a lot of great experiences with Nathan. 

For our listeners out there though, it would be good to kind of hear your process a little bit. First thing, how do you know when a fixture is needed? Like how does our client know they should be actually reaching out to you for a fixture? 

Nathan

That can vary. Sometimes we are told by the operators who are working with a specific device, to either assemble it or test it, “Hey, this is fairly complicated, it’s labor intensive, it’s not really working out well for us.” So really it’s whenever you make an observation that something could be improved by, you know, minor automation or less human involvement. Whenever you notice things like that, that’s really a good time to consider that it might be a good idea to make a test fixture and assembly fixture, depending on where you’re at in the project. 

Unfortunately, there’s not a direct answer for that. There’s no right answer. It’s really whenever someone observes that something could be improved, that’s the appropriate time to consider investing the time in making something like that. 

It depends on how complex the system that the fixture that you’re considering making is also. If it’s minor, like an alignment jig or a holding jig or something like that, we can come up with something like that typically within a day. It’s not very labor intensive, it doesn’t cost a lot to do something like that. But, if we’re getting more into an automation type thing, that can obviously take a little more time and it’s a little bit bigger of an investment. 

So it’s all about weighing the investment that you’re putting in now to develop some sort of fixture versus, you know, what it would take for someone just to do it. If it’s a, if it’s a small builder, if it’s a minor thing versus a large complex system that is going to take more time and money to come up with. 

Britt

And what’s your process for coming up with a fixture? Are you typically just thinking of it from the user’s perspective and then working through how to make it easier or like what are your steps? Do you draw it out first or do you just start pulling materials and start playing around with things? 

Nathan

The first step for me is I like to see what the problem is. So if we’re working on something in manufacturing and we’re having trouble with assembly, we’re having trouble holding it apart or whatever, I like to watch the process to visually see, okay, this is what they’re trying to do and this is potentially how we could improve it. 

Outside of that, it’s nice here because we have all the materials and resources to rapidly prototype a lot of things. So it’s easy to come up with a simple design to sketch it out, to get it drawn up in a 3D modeling system like SOLIDWORKS. From there we can cut some simple parts out of plastic on the laser and assemble a simple mock jig that way, or we can 3D print something if we think that’s more appropriate. 

Really it’s looking at the process, trying to see what the problem is, coming up with a quick solution to it, and prototyping it to get it in the hands of the people who are using it to make sure that that they see this as a benefit that it’s actually working how they think it will. And from there, after we have that initial prototype, it can be improved to something more robust and more permanent. The first step in the process is to come up with a simple design just to make sure that we’re headed in the right direction and then we can, I don’t want to say complicate it, but we can make it better from there. 

Britt

That makes sense. And it sounds like for the most part, a lot of your fixtures are related to making things more automated or easier for the user. Do you also see a lot of need for fixtures when it comes to electrical testing or in process testing to prevent end of line failures? Where do you see the most fixtures coming out of? 

Nathan

A lot of fixtures that we’re making, at least since I’ve been here related to testing, are life-cycle type things. For most of our design verification campaigns, there’s portions where you want to cycle certain components of the device for the expected life. So, we may unplug and plug something in up to thousands of times to make sure that it’s going to survive what we expect it to see when it’s in service. And obviously, it’s easy to have someone sit there and unplug and plug in a cable 10,000 times, but for things like that, there comes a point where it’s no longer cost effective to pay someone hourly to do that as opposed to investing the time upfront to come up with an automated system for it. 

We have numerous fixtures here that run on linear actuators, things like that, to make repetitive motion automated so that we don’t have to have someone sitting there doing it. And it’s twofold because it saves time, because these are kind of set and forget type things where you set it up, you tell it to go and you check on it when the test is done, once the fixture’s been validated and all that, but it also gets you a more repetitive process where you sort of taking the human error out of the test that you’re doing because you know that it’s doing exactly what it was designed to do every time without fail. So you’re eliminating a variable essentially, depending on what kind of test you’re doing. 

Britt

Yeah, and you’re saving somebody a lot of time from having to do that a thousand times. 

Nathan

A lot of times that somebody is me. So it’s nice. That’s why I save myself some time there. 

Britt

What’s your, a fixture that you’re most proud of? 

Nathan

One of the ones that I did earlier in my time here, it’s basically a cyclic fatigue fixture that takes a round medical device and curls it into a G shape and then extends it back to a straight line. It cycles it that way, you know, a couple thousand times. And then that fixture is also able to take the sensor in a straight line and twist it so it’s like a torsional type test. That one was one of the more complicated ones that I worked on here. So once we got it together, it worked out pretty good. I’m fairly happy with that one. 

Another one that we get a lot more use out of is another cyclic fatigue type fixture that applies a shear stress to a bond line of one of our devices to simulate the stresses that it might see in use. That one involved some usability type testing where we had people wear the device and said, okay, do jumping jacks, do pushups, sit up, stand down and tried to evaluate what kind of stress was actually on that bond line when we were using it. And then taking that and sort of getting a fixture to emulate the stresses that the device sees during actual wear. So that one, the mechanical side of that one isn’t as complicated, but the setup, it’s definitely a lot easier to tie it into the real world use of the device. So that’s another one that I’m fairly happy with. 

Britt

That’s great. 

Julia

Wow, those are cool. 

Britt

Yeah, very cool. I guess my last question I have is just what would you recommend for our clients in that test world or fixture world for them to start thinking of sooner rather than later in their process?

Nathan

I think the earlier that we get started on these, they’re almost like side projects compared to the big scheme of the devices we’re making, but the earlier we can recognize that we need them and we can get started on the development of them, that gives us more time to do some iterations and get a better functioning system. As opposed to, you know, sort of getting it at the last minute and saying, “We need this now, this has to go out, we have to do something quick,” which we’re more than capable of doing, but the more time you have, the cleaner the systems can be, the better they can work. 

I think one of the challenges is that a lot of times with assembly fixtures, we don’t realize we need them until we’re in the assembly process. And there’s two sides of that: On the R&D side, the assembly is typically a little simpler because we’re doing small volumes, but once it gets to the manufacturing side and we’re in more of a production volume, we start to recognize that this could be made, this could be improved, we can make this a little easier. So if we can get it earlier on, it gives us more time to develop it. And on the testing side, it’s the same sort of deal where a lot of times we’re getting into design verification and it’s sort of a rush and we realize that we need this. And again, we’re always capable of getting a quick solution like that, but the more time we have, the better of a system we can come up with. 

Britt

Yeah, that’s great. I really appreciate you being here. 

I think that we can gain a lot from your knowledge. I’ve definitely had to pull Nathan several times to help with assembly for sure in the manufacturing process. The one great thing is having him on site and being able to, as he said, rapidly create a prototype for us to try out and then get into manufacturing quickly and without any downtime. 

I’m glad you’re here today to help educate our clients. 

We’ve taken a few minutes to interview the team members at Blur asking the question, what are you thankful for?

Some answers are silly, some are serious, but all are heartfelt. I hope that as you listen to this, it spurs you to think about your own life and recognize the good in this year. 

• This year I’m thankful that me and my family have stayed healthy. 
• I’m just thankful for the year. It’s gone by so fast. I have a brand new great granddaughter, so that makes two. So I’m thankful for that. Just thankful for that we got all moved into the new facility. Shop looks great and we’re all set and ready to go. 
• Grateful to work with great people at a great place and free food. 
• I’m thankful for the coffee maker. 
• I’m thankful for starting a new job at a super supportive company. 
• I’m thankful for my family, my friends, my health, and all this natural light that we get at our new office. 
• I’m thankful for my family and that we’re almost done with our house renovations. And I’m thankful for your dog Lulu. 
• I’m thankful that my grandma is recovering from her stroke. 
• I am thankful for the new building that we just remodeled and that’s coming along great. And for my dog, Coast. And just friends and family in general. 
• I’m thankful for 80’s hair metal and the better world it has given us to the use of spandex. 
• I’m thankful to work with a bunch of really passionate nerds who are actually really happy to do what they’re doing and help out. 
• I’m thankful for my new job. 
• I’m thankful for a group of co-workers who I enjoy spending time with. 
• So I’m thankful for all the blessings that I have, the countless blessings, including my wife and my soon to be one year old kid. 
• I’m thankful for a really good writing pen. 
• I’m thankful for office dogs. 

As a company, we have a lot to give thanks for. 

We’re thankful for our employees who tackle complex problems head-on and are never afraid of a challenge. Without them, there would be no Blur. 

We’re thankful for the Blur team members we’ve gained this year who bring fresh insights and ideas into the workplace. 

We’re thankful for moving into new R&D and manufacturing buildings that will give us the space to grow. 

Lastly, we’re thankful for each and every one of our clients that trust us to help them along their journey of product development. Because of their belief in our team, we’ve gotten to develop some truly exceptional medical devices that are changing and saving lives. 

From everyone at Blur, a heartfelt Happy Thanksgiving.

Ever wondered what it’s like to intern at Blur? 

Curious what types of projects our interns get to work on? 

Today we’re talking with Anna, an electrical engineering intern, about her experience this summer and the things she learned along the way. 

 

Julia

Anna, thanks so much for coming on the podcast today. Can you tell me a little bit about yourself? What’s your role here at Blur? 

Anna

I’m a grad student at NC State studying electrical engineering. And I was an intern this summer at Blur and decided to stay on part-time to just help out wherever it was needed. 

Julia

So how did you hear about Blur? 

Anna

So during my internship search in the spring of last year, I was just kind of looking on all the basic job sites, looking on Indeed or LinkedIn, and then I actually looked on EPAC, which is NC State’s career development website. I saw a posting for Blur, and then did a little bit of research and thought it sounded like a cool company, so I applied after that. 

Julia

What was the thing about Blur that stood out to you that made you decide out of all the internships you had seen or looked at or job postings, this is the one you wanted to go to. 

Anna

Yeah. So the job description was probably the first thing that led me to Blur because I was like, this sounds like it’s right up my alley because it was relevant to medical devices, which I’ve always been curious about and wanted to work in that industry. But then just doing more research about the company, I kind of found some old YouTube videos that have been posted, introducing Blur and what they do and some of their projects. And I thought they all sounded really interesting. So I just applied and here we are. 

Julia

What areas did you get to work on this summer in your internship? What areas are you working in now? And was there anything that was sort of surprising to you about that or areas you got to work in that you weren’t expecting to? 

Anna

Fortunately I was able to work in a lot of different areas, specifically the research and development area, kind of the upstairs building, but I got to work a lot on one specific project. So it was kind of surprising how much I got to follow that project. I got to see all the different updates and revisions and all of the testing that went into doing everything. And that was unexpected, but exciting.

Julia

That’s cool that you were able to follow a project from the beginning and see its completion through your summer here at Blur. 

Anna

Yeah, it definitely gave me a newfound appreciation for what goes into a medical device, just knowing like how many like hours of work go into even something that seems simple like a software update or a design change and all the testing and of course all the documentation that accompanies it, but have a newfound appreciation for how much work goes into it. 

Julia

So you said you interned through the summer and then you decided to stay on throughout the school year sort of part-time. What made you decide that you wanted to continue working and interning here? 

Anna

I think the biggest thing was probably my involvement in that one particular project, just knowing it was going to be continued and knowing that I had learned a lot about it and felt comfortable with the project to be able to help out more of a part-time role during the semester. But also, I just really liked my time here and the community was great. So I felt very welcome and it was easy to ask to stay on part-time. They were very excited to have me, which was great. 

Julia

We’re always excited to have interns stay!

Julia

Do you feel like your time here this summer, the things you’ve learned, have impacted the way you view your education or even like what you want to do after school? 

Anna

I would say yes, just because I’ve learned a lot that I didn’t necessarily know went into medical device development and design. I think part of that is because my sophomore year, when you’re really supposed to do all the hands-on stuff, was online due to COVID, unfortunately. So I think this filled like a big gap that I had in terms of missing hands-on experience. Now I definitely know this is something I want to do afterwards, and product development specifically for medical devices seems like it’s right up my alley. 

Julia

Cool. That’s awesome that you got to fill that gap here. 

Anna

Yeah, it was unexpected, but I’m glad that it happened. 

Julia

Yeah, good. So what advice would you have for other people in school looking to get into the medical device field or wondering like, am I going to like this? Am I not going to like this? What advice do you have for someone like that who maybe is looking for an internship? 

Anna

Kind of just looking at the job descriptions, they’re all probably going to be similar. You know, the type of job you’re applying for, the job description, they’re going to ask you to do the same thing. So I think just doing a little bit of extra research about the company itself to know if it’s a good fit for you was really what made the difference between my other internships and Blur. And also, you know, I’d always thought I wanted to work at a really big company. And so my internship after junior year, that’s what I did. I worked at a really big company and, you know, I loved all the people and the work, but it was just a little too big. It didn’t feel as personal or have that community that I was looking for. So I think that’s what influenced my decision to look at a little bit of a, you know, more medium sized, smaller company like Blur. 

Julia

And what was your favorite part of your internship? Your ongoing internship, I guess.

Anna

Aside from the festivities, the Blurthday Party happened my first week of the summer and then the Blurbecue happened the last week with the cornhole tournament. So aside from the obvious festivities, I think it was just getting to work with so many experienced engineers and just their willingness to answer questions. I had a lot of questions, so that was great that they were so willing to answer and just let me be independent and kind of do what needed to be done. And then if I had questions again, just ask them. They’ll help me out. 

Julia

Yeah, that is something that we’ve talked about quite a bit on the podcast, or at least I have brought up several times, is the freedom to ask questions and to learn while you’re here. No one’s gonna, like, ostracize you for not knowing something. And I think that’s just advice for people maybe getting into internships for the first time or coming right out of school. You can feel like you need to know everything and that if you ask a question, then people are going to look down on you or think you’re not as much of an expert or why didn’t you learn this in school, but it’s more of a testament to your character and your willingness to learn if you do open up and ask those questions. I find around here people are super respectful and they’re not going to bash you, but they’ll take the time to educate you. 

Anna

That was one of my bigger concerns coming in. I was like, because I did graduate with biomedical engineering in the spring before I started, and I kind of had that concern of, well I do have a degree now, even though I’m an intern I felt that I should maybe know a little bit more than I did. Within my first week, people would just explain stuff, say like, it’s okay if you don’t know how to do this, which just made it feel so much better asking questions. 

How do you design for different levels of technical expertise in a medical device?

When should you translate design ideas from paper into physical models?

Today we’re sitting down with Damein, an industrial designer, to discuss his experience designing medical devices and tips for creating a successful product.

 

Damein

I’m an industrial designer and usability expert here at Blur. I help to bring the voice of the user, their needs and constraints, into a conversation early on so that when we’re designing a product it doesn’t get designed only from the inside out but also from the outside in.

Julia

Have you ever seen a product where that happens, where they don’t start with the user needs and sort of what were the ramifications of that?

Damein

We’ve all seen those things, like when you look at something and think, “This is going to be really nice.” For instance: this microphone. We were just trying to plug the cord into it but the cord plugged into it is sort of cumbersome and difficult to access. That could have been a consideration made early in the process, thinking how does this thing plug in, how does it go together, and how is that experience going to be interpreted by the user? Are they going to get frustrated and just get a better microphone, or are they going to press through that problem and make it work? 

We always want to when we’re designing something, especially early in the process, ask who’s going to be using this thing? How can we champion that user throughout the process so that every step we take and every direction we go we’re always looking back and asking how it’s going to be used? That informs a lot of decisions that we have to make in terms of what shape it needs to be, can a person hold it, can a person operate it, can you reach the buttons, do you have to go back five screens to get back to where you need to be? Those sorts of considerations are really important and you can’t really have those if you’re zoomed in so close to a problem. It’s important to always look back up and ask, “Does this matter to the person who is going to be using the product?”

That’s something that we try to do at Blur and infuse into our design process, having that design consideration for the person who is going to be using the product and not getting too caught up in the technical details and feasibility too early on. Before asking, “Does this work [technically], how are we going to do it?” we make sure first that it will work for the person we’re designing it for.

Britt

And what kinds of questions do you start out with our clients? High level versus detailed to get to what you said, even with plugging in the microphone, what questions could they have asked or thought of to mitigate that?

Damein

When we’re talking to a potential client who has a really great idea, or a technology that they’ve developed, they often want help getting it off the ground. We start with stuff that is super high-level: Tell me about who is going to be using it and what does it do? What are we actually trying to achieve and what’s the goal for the product, and then what’s the goal for the user? Sometimes the user is a different consideration than the person that the product is being used on. Especially in a medical device space, where you have maybe a clinician or nurse or surgical assistant using the device on a patient. The experience for the surgical assistant or the clinician is going to be a lot different than the patient’s experience. Making sure that they have considerations on both sides of the equation [is important]. 

When I start, I start with who is using the product? Is that person, the primary user, also the patient or secondary user? How does that experience go? Sometimes you’ll have a product that the primary user is the patient, but the secondary user would be the clinician who sets it up, hands it to them, and then performs whatever function they need to perform. 

I start with those two profiles and try to understand approaching it with that mindset, and then you look at the workflow. How is that workflow going to go? Do you need to unbox it? Does it need to be paired to something? Are there speakers and buttons? Does it need to be shrouded so it stays sealed and stays clean and sterile throughout the use case? Those are all really important things that we need to know upfront because if you have to put a drape over top of a product, and you also need to have buttons or an interface underneath of that drape, we’re wearing two pairs of gloves, we have a drape, and now we’re trying to push a button underneath of that drape. So, what kind of button is that going to be? It’s probably not going to be a touchscreen, it’s probably not going to be one of those capacitive microwave buttons. It’s going to need to be something relatively chunky that gives good feedback and has a tactile feel so that when you’re pressing it, it’s deliberate, intentional and thoughtful. 

Julia

As you’re designing products for multiple different users, there’s also different levels of technical expertise that you have to weave into these products. How do you balance that? Say you have a user that really doesn’t have much technical expertise on this very technical thing, even potentially life-saving medical devices. I think about an epipen, someone has to look at that and know how to use it right away because there is very little room for error. If there is an error, that’s potentially costing someone their life. How do you balance that as you’re thinking about these questions in the beginning of a design?

Damein

Not everyone has the ability to look at a product and understand how it functions right off the bat. What you want to do is make sure that it’s designed in a way that is intuitive in that direction. If it’s an epipen, one side is always going to be pointy and one side is always going to be blunt, so that makes a lot of sense for [telling a user] “This Side Down.” If you have a basic understanding like me, who’s never used an epipen before, in an emergency I could pick up that device and say, “All right, I know I have to put what’s inside this syringe into this person, so I’m going to stick them with the pointy end.” That helps you to understand how that product functions. Whereas, if it were a rectangular shape or any other sort of shape, it might [spur questions]. Do I do it this way or do I do it that way? Is this like a glowstick, am I supposed to crack it? How does this work?

Designing the form of something can really help inform how a user is going to perceive it and then how a user is going to end up using it. Everyone is going to tackle it for the first time without looking at an IFU. Even though we don’t condone that and we say they should read it, sometimes they don’t. You want to make a product that is going to be safe and effective even if there is an uninformed user. 

Britt

In manufacturing and service, I can think of a lot of things that if I could tell someone what I learned from, I would tell them these mistakes and what I did to prevent that in the future.

Damein

Sure, one thing I would say you want to steer clear of is making assumptions. I know that’s sort of a baseline thing, but especially making assumptions about how someone is going to intuitively use a product. We talked about intuitive use cases where you have a product that looks like it does a function, so form is following function in that case. To me, the designer, the client who had the idea might have had preconceived notions about how if we hand it to a third party, someone who has never seen the device before, how they’re going to use the device. 

We can get the whole way down the process, have a great thing, say, “Look how cool this is! Look how well it works!” and then hand it to someone who’s never seen it before and they hold it upside down. 

Britt

I’ve seen you at Blur give [prototypes] to several different people at the office and say, “Use this,” and they do

Damein

And that is something I really value about being at Blur is that our team operates in a way that they can take a product or project and run with it. You can take this to someone else who has literally never seen this technology before and say, “Hey, look at this cool thing we’re working on. Can you just hold this?” You’ll learn so much, and it’s about that physical interaction. 

You can send out Google surveys, multiple choice questions, but there is so much in the intonation of having a conversation with somebody, watching them hold the product or watching them try to set up the device that is really huge. They’re making a mistake, you’re just watching, and they don’t even know they’re making a mistake. I can then go back to the drawing board and ask questions. Maybe it’s less comfortable to wear it that way, or maybe it doesn’t fit together like that, and make it in a way that it won’t even work [if they put it together incorrectly], so it’s not an option and it’s not a problem.

Julia

How do you elicit the correct emotion from someone? Say you’re using a product and you talked about red as being this very alarming color, this goes maybe more into the UX or UI design, but just being very aware of not just the physical use of something but also how is the person feeling as they’re going through this process? If someone’s using an epipen they’re probably going to be pretty anxious, so it needs to be fairly foolproof in the way that they use it. How do you incorporate that into your design as well?

Damein

In medical devices it’s an interesting issue because you’re dealing with high stakes situations, and oftentimes life-threatening situations, and adrenaline can be pumping and it’s really sort of an intense time, even for trained professionals. On some of the devices that we’re developing, seconds can matter. Getting an infusion on time, moving a millimeter to the right and getting the wrong artery, these are things that are really important. 

[You have to be] cutting a balance between alarming someone and telling them something bad is happening versus alarm fatigue, which is a real thing in the industry where if you’re in an OR, there is constantly something beeping at you. There is constantly something trying to get your attention and flag you down, so you have to be sensitive to that environment and alarm on things that are actually alarms. Not just low batteries. Really sort of playing with that threshold of what is actually an emergency and what is something you can deal with after the real emergency is over? 

When you think about that, you think about, “Do we need to use a red light here? Or would an orange do?” There’s also things you have to do with some regulations, like in 60601 testing you need to be sensitive to what their alert system is and what can and can’t be in that bucket. There’s a lot of different things you have to consider when you’re thinking about how to grab someone’s attention, and what level of that attention you need to grab depending on the class of the device, use case, and the scenarios you’re in. 

Julia

Can you walk us through your ideal timing and timeline for the start of a design project all the way through the end?

Damein

Well, the start is not always the start and the end never ends. Ideally, you would get a cross functional team together: someone who is in the design space and represents the user, someone who is a technical lead, whether that’s a mechanical, electrical, or software engineer depending on what the project’s needs are going to be, and you get the client in the room to lay out the problem you’re trying to solve. What are our goals? What does success look like? We put together a road map of how we would like the project to go. It almost never goes how we want it to go, but we can get close. 

We get that cross functional leadership team together, which is really important because I might not always throw out ideas that are perfectly feasible. If we have someone else in the room to say it might not work, or they have an idea for a different type of technology to supplement what we need to do, it’s important to have that organic transfer of ideas and information. 

After we understand our baseline roadmap, the design team will take that and start throwing stuff at the wall. We’ll have a brainstorming session and start understanding the strengths that we have, the goals we have, and proposing different ideas of how to get there: different technologies, different forms, different things to solve the problems we want to solve. 

We can really explore a large swath of those ideas pretty quickly with fast and dirty CAD models, sketches, renderings, any tool in our tool belt, sculpting foam, and making volumetric studies. We refine it down and I like to see at least five good ideas, usually it’s three, but if we can get five good ideas that go from our most conservative concept that just absolutely solves the problem without taking too much risk all the way to the pie in the sky, something that will shake up the industry or change peoples’ lives.That sort of spectrum is always nice because when we present that to the stakeholders, they can pick the parts they like from each one. They can mitigate the risk with the conservative features and maybe up the perceived value with some of these more interesting ideas on the other end of the spectrum.

Then we go back and explode out what we have. We take the ideas we have, what they wanted, and we put them into new concepts. We push those boundaries to get past the low-hanging fruit, the initial exploration, and into something that is really digging deep and grabbing those good ideas right at the top of the tree. You have to climb high for them, but once we get there we can show three solid directions and the client can pick the one they like the best. 

Then we can move into mechanical design and understand all of the intricacies of how we’re going to design this for manufacture, how we’re going to design it for assembly and get Britt’s team involved. [They’ll tell us] how exactly to set up an assembly line, how many times do we have to flip this thing over to make it work? We can really find some efficiencies in that space, but design sort of tapers off there, where the engineering starts to grow. We have this symbiotic relationship where we don’t really hand it off, but it sort of flows. One process leads into another, so we go from design to engineering to usability studies and then manufacturing. 

Throughout that whole process, there’s designers involved making sure that the vision is maintained, we’re always pushing boundaries and never just accepting the status quo, thinking of new ways to do things and implementing new techniques to achieve the problems we want to achieve. Otherwise, you might get stuck with “good enough” when it could have been a lot better. We never want to be in the position where we’re just settling.

Julia

How do you differentiate between something that is a good idea and something that is a great idea? Do you have questions you ask? I know that’s dependent on the goal of the client, but how do you keep that in mind as you’re having this very exploratory phase at the beginning?

Damein

Sometimes great ideas turn out to be bad ones, and sometimes what you think won’t be good ideas are actually pretty good. 

That’s sort of a non-answer, but it’s kind of a gut feeling when you’re designing something. It’s like, you start sketching something, you start doing a CAD project to understand how things will go together and sometimes something will click. You can feel it in your gut that that is a good direction, and you can feel that flow when you start pushing even further in that direction, and you can come up with something that is, hopefully, really ground-breaking on the other side of that effort. 

Sometimes you’re doing it and you think, this is okay, but I don’t know. You never want to kill something too early because down the line you might want to pull it back up. In fact, right now on a project we’re working on, we’re struggling with how to attach this cartridge to the side of this piece of equipment. We had been doing it one way, but we had to change a couple of things about how they went together. We remembered a couple of weeks ago we had this idea where we would hinge from the bottom. Can we resurrect that? At the time it didn’t make sense, but now that we’ve had these adjustments in the design and some constraints around the engineering, it makes a lot more sense. We can revive that old idea, dig up those prototypes out of the bins on the shelf and now we don’t have to retread that and start from scratch. We have a bit of a leg up. You never really know, sometimes they come back.

Julia

Back to haunt you. 

Damein

Or save you!

Julia

We’ve talked a lot about this exploratory phase and getting a lot of these ideas down on paper. How do you move from paper to where you’re actually getting user feedback

Damein

Absolutely. That’s a really critical part of the process and specifically our process here at Blur. You want to get designs out of your head and into your hands as quickly as you can. That route from A to B needs to be a straight line, if at all possible. So, when you have an idea you might sketch it or do a quick CAD model. Basically, in the ideation phase we don’t restrict designers to make them just do sketches, or just do CAD work, or just do renderings. We want to get any and all visual physical communications out, whether that’s a piece of foam that’s sculpted into a shape, or a 3D printed version of CAD model. It’s really important to get those things into three dimensions so we can actually hand it to that end user, to that stakeholder, and say this is what we’re thinking. If a picture’s worth a thousand words, a model’s worth a million. 

It’s wild, you can have something on a piece of paper but once you hold it in your hand everything becomes so much more clear. You really understand, oh, it looked this big on paper but when you hold it do you really want this thing to run for 24 hours straight? It’s pretty big. Those sorts of constraints become very relevant and very obvious when you have them in three dimensions. 

Really for our process, we try to get things off the page and into your hands as soon as we can because you can make so many more informed decisions about what you’re actually building that way.

Julia

What’s one of your favorite projects that you’ve worked on here at Blur?

Damein

One of the more rewarding projects I’ve gotten to work on during my time here at Blur was a surgical robot that really helped pave the way for a lot of the surgical robotic equipment that is being developed now. What was so interesting about it is there are so many different users, and there are so many different constraints around each user. You have a surgeon, you have a surgical assistant, you have a patient, and you have a scrub nurse, and they all interact with this device in different ways at different times for different reasons. 

The device has three main components: a central unit that drives the instruments, an endoscope, which is a camera on the end of a snakey tube, and an insertion tube or the part that goes into the patient. Our main focus was the central unit and how that interfaces with the endoscope and the insertion tube for the instruments and endoscope. You have three challenging mechanical interfaces that have to remain sterile, that have to be intuitive and usable in almost a blind way because you can’t see what you’re doing when it’s in position, and it’s used by those three users. They all have different needs. On top of that, the whole thing is draped in plastic. So, you have to be able to feel what you’re doing, see what you’re doing, and have the human factors in a way that is always intuitive and easy to access. 

That was a really challenging project, but I think we were able to come up with some really innovative, elegant, and thoughtful solutions for the way that we approached it and how we got those challenges solved for the client. 

Julia

Do you think there’s anything you learned from that project or solutions you came up with that you find yourself coming back to for other projects? Are there any lessons you learned that you can implement into your work going forward?

Damein

I think some of the biggest learnings I gained from working on that project is understanding the importance of working in that cross-functional team. It wasn’t really specifically related to the design, but because it was such a big project there were lots of engineers and designers working on it. We all had to work in a very small space virtually: we’re working on the same CAD models, adjusting the same dimensions. We really had to mind-meld to drive to where we want to be as far as the solution we’re looking for. It really drove home for me our workflow and having these teams work as one consciousness almost, this hive-mind of engineering to achieve a goal. We learned a lot about what works well and doesn’t work well in those challenging, intricate projects that require a lot of effort but a lot of dexterity.

I really love working here, honestly. We have such an amazing team of talented engineers and designers and people working together that it makes it easy to really dig into these hard problems. A challenging project doesn’t feel so daunting when you’re backed up by an incredible team. For me, when a big project comes in the door I’m chomping at the bit to check it out and dig in to see what’s going on because I have someone sitting right next to me, or right behind me, or right across from me who can answer any questions I might have. As a team we can knock it out of the park. That’s been something that’s been really rewarding for me about working at Blur and with this team specifically. 

Julia

We are super collaborative here, which I appreciate a lot as someone who is not on the engineering side of things. I can ask any questions I have without feeling like I should know [the answers].

Damein

There’s a lot of questions I ask that I feel like I should know, but no one ever says anything. 

Julia

Yeah, thanks for sitting down to chat today.

Damein

Absolutely, thanks for having me. 

What, exactly, are design controls?

Why are they important in the world of medical devices?

Today we’re talking with Grace, a mechanical engineer, about her experience with design controls and how to implement them without stalling design progress.

 

Julia

So Grace, what’s your role at Blur and what experience do you have with design controls?

Grace

I’m an R&D engineer here at Blur, so I work primarily on mechanical design. Throughout my time here I’ve worked on several projects that involve design controls, from drafting requirements and user needs to creating design control matrices and then that dictates V&V. Also, executing V&V protocols and writing reports.

Britt

So what are design controls and why are they important?

Grace

Design controls are a road map for medical device development, and it takes a concept and brings it to a final design. It really starts from the beginning of a design and evolves with a device.

Julia

What’s one misconception people have when it comes to design controls?

Grace

That you can start after you’ve already designed your device. I know that Dustin touched on in a previous episode that a pitfall is you’ve only concentrated on the device and then you have to go back and come up with your user needs, product requirements, and the whole process. You could miss something because you don’t have all of those requirements outlined. You’ve created a device where there’s no way to calibrate it, or there’s a part in your device that is going to need regular maintenance and it’s really difficult to access so from a service standpoint you’ve missed something and you’ll have to go back and change things. 

I think it’s best to start after you have some sort of concept, or maybe the client has come to you with some sort of rudimentary prototype. That helps you identify here’s my user needs, here’s my product requirements, I have a handle on that. If you move forward and iterate on the prototype without design controls, you’ll probably end up with something close to the final device but have to go back and generate all of the documentation.

Julia

How do you balance the paperwork side of design controls, getting it done and not letting it all live in your head, but as a mechanical engineer getting the actual design done. Working on it, testing it, and evaluating it. I think maybe there’s a perception that design controls are taking away progress of the device design.

Grace

It has to be hand in hand, where you’re making progress on both sides, not just focusing on the design and you’ll do documentation later. It really impacts the timeline when you have to go back and do all of the documentation when you weren’t trying to keep up with it throughout the design.

Britt

Or even adapting. We had a client recently that came and they designed a device to fit in your hand, and it does that beautifully. Then when they actually put it in the field to test it out, the nurses were actually putting it in their coat pockets because it’s a small device. Now when the nurse bends over, it will fall out because it’s kind of slippery and it’s meant to be a remote control type feel.

We’re helping them come up with a more durable solution now that we understand that they’re not going to hold this and walk around the hospital. They’re going to put it in their scrubs pocket or they’re going to put it on a cart and their cart is also slippery. So then just working with clients to adapt their products and then think through the next risk associated with that. That’s some of what we have to do.

Julia

What does the process look like at Bur for implementing design controls?

Grace

Well, we start by generating a development plan. We work with a client and define the purpose of the device, provide a basic overview of what we want to create, and we break up the design into phases so we have a more manageable timeline. It’s an easier way to manage budget as well. 

Then identify any regulatory standards you want to comply with, that’s really important. Then working with clients to outline the needs of the user, and then after that’s defined including engineers to create product requirements. Think internal hardware, like pumps and sensors, anything that’s important to create a functional device. 

Once you have your user needs and product requirements laid out, you’re going to move on to risk assessments where we’ll identify potential hazards or harms associated with user operation of the device. So, how are you preventing unnecessary exposure to laser or electric shock which is very important to demonstrate to the FDA? 

Once all of those inputs are defined, we’ll go into design and development. Now I’ve got a strong foundation that I can create my design, making sure I’m taking into account the user needs and the product requirements. 

Julia

Having those requirements actually takes some of the fatigue out of making decisions; when you give yourself those guardrails, you can more easily say, “Oh, do we need an app or do we not need an app? Is the user population actually going to use this?” It takes the fatigue out of it, makes it easier to make decisions, and that also helps the timeline.

Grace

I think it helps to involve the whole team, too, so the teams aren’t siloed. You don’t want to say your firmware needs to do this, your mechanical engineer needs to do this, your electrical engineer needs to do this. Once you have an overall idea of how you need your device to work, I think it helps cross-functional teams communicate better so you can move faster in design and development.  

Throughout the process you’re doing design reviews, so have I checked all of the boxes for my requirements? You may change things from your design review. After that you’re going to generate your design control matrix, which is the big document that links all of the user and clinical needs and product requirements and risk to the design characteristics of your device. Say the user needs to use the device in a wet environment, now I need to create a sealed enclosure with a gasket to prevent water ingress. 

From that big design control matrix document, that’s how you generate all of your verification and validation protocols. This is really the final step in your design, you’ve made it, you’re almost there to submit regulatory approval. You have to test your device and make sure you’ve met all of those outputs. 

Like I said before, if you’re trying to create a device that’s going to be used in a wet environment then you would send the device off to a third-party ingress testing. They’re going to test your device, open it up and make sure there isn’t any water inside. 

Julia

How does Blur’s design control system adapt to different levels of technology with different levels of risk?

Grace

Taking risk into account from the beginning of the project so you’re not designing blind to any harms to the user or the clinical environment. So, having a risk management plan to outline what steps you’re going to take throughout the design controls process to identify and mitigate risk and determine who’s responsible for what tasks along the way. Then doing a risk analysis where you’re breaking down every risk associated with the device or process by identifying the intended use or misuse and then the hazards or hazardous situations, and assigning a probability of occurrence. What’s the likelihood of  a fire hazard or electric shock to the user? Taking all of that and putting controls in place to mitigate the risk. Say for a fire hazard, I know I need a fire-rated enclosure. For electric shock, I know I need to design the housings to prevent the user from being exposed to the electronics if they drop the device, things of that nature.

After device V&V, we can always go back and see if there is any residual risk by completing a benefit-risk analysis and maybe modify the intended use if necessary. Throughout the design process you’re conducting risk reviews, writing reports, and ensuring the final design is a low-risk device that is safe for the intended use.

Julia

Having seen a risk document or two, they can be super detailed. How do you know what to put in there, how do you determine that?

Grace

That’s a good question, I think it takes a team to fill out a risk analysis. You’re going to have to lean on the client because they’re going to know more about the environment it’s being used in. 

Also, not just having one person do the risk analysis is very important; one person is only going to think about a subset of the risk, and maybe they’re only going to think about the risk from the electrical standpoint or from the mechanical design standpoint. Having as many eyes as you can look at the risk analysis is how you get to a good document that everyone is happy with, including the FDA.

Julia

We’ve talked a lot about mechanical design and device development on the physical side of things. Can you tell me a little bit about how software and firmware is handled within our design controls?

Grace

Our approach is to separate the software and firmware from the hardware. Software and firmware gets its own development from the outset of the design. 

Once the user needs and product requirements have been established and you’ve created your software and firmware, you generate a product specifications document. You basically describe the functionality of the software and firmware to show how you’ve written it and accomplished those functions. 

Obviously we’re going to have separate V&V protocols to test against the inputs and show that you’ve met your requirements. All of the software and firmware releases are documented; every time you release software and firmware on the device it’s a heavily documented process. Everything is under controls. 

Julia

If you were to sum up design controls and the importance of it in a couple of sentences, tl;dr, what would you say?

Grace

Design controls are important for knowing how the device should be designed and what features you need to include to mitigate risk. 

We talked about having water ingress protection, or being able to pass a drop test to prevent electric shock, or having a fire-rated enclosure so there’s no fire hazard to the user or use environment. 

Ensuring that you’ve included everything that a user needs to successfully use your device and ultimately benefit from the use of your device, because that’s what medical device development is all about.