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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. 

What does it look like when you combine industrial design and mechanical engineering? How do you get out of design ruts and push forward to find the best solution for a product?

To answer these questions, we sat down with Anthony, an industrial designer and mechanical engineer at Blur.

 

Julia

Anthony, can you tell me about yourself? How did you come to work for Blur and what do you do here?

Anthony

I’m a mechanical engineer and industrial designer here at Blur. I work on both of those, so designing the outside of the products as well as the internals and any combination in-between.

Britt

How many years of experience do you have in both of those?

Anthony

Maybe three or four years of purely just industrial design, and then I went back for a mechanical engineering degree after that. My jobs have all been a combination of mechanical and industrial design. So, maybe 13 years doing both combined.

Britt

That’s great.

Julia

What would you say made you decide to go back to school? You started as an industrial designer, went to school for that, and you had four years of experience doing just industrial design. What was that turning point for you that made you say, “Yeah, I think I want to go back to school for mechanical engineering?”

Anthony

I don’t know if there was a turning point. I had considered it when I was in school the first time. I didn’t want to give up on industrial design completely, I like doing both, I just don’t like to be pigeon-holed as just doing industrial design and styling stuff. It just made sense. I’ve always been interested in the internals as well and the development of an idea; more than what it should be but also the nuts and bolts of how to implement the idea.

Julia

Not just making it look pretty, but does it work?

Anthony

Yeah, yeah. It’s an interesting thing that you say that because industrial design can be a lot of things. It’s not always just making it look pretty. 

Britt

That is kind of a cool thing to think about. Industrial design everybody does think of, you know, the creative, the look, the sleek aspects of it. You’re right, there’s also asking if it’s ergonomically correct, how easy is it to use, etc.

Anthony

Yeah, I think that’s a big part of what we do here. It’s a medical product, so the look of it is not typically the driver of the product itself. I mean, it’s important, but a lot of times you have to have something that’s easily usable and meets all the product specs and requirements. It may need to look like a medical device or a well-planned product, or easily usable without having an instruction booklet tell you how to use it. All those are variations on the look, how to design it so somebody can actually use it. 

Julia

And that goes back to something we talked about in Dustin’s interview. He was saying that user needs really need to be the foundation of the product requirements. Everything needs to be traceable back to what the user needs it to do, and that’s the same for industrial design and mechanical design. At the end of the day, if you’re designing something that’s not usable by the person who’s supposed to use it, then you need to start rethinking. 

Anthony

Absolutely, and it’s going to depend on what industry you’re in for what you need industrial design for. There’s industries that really just care about the way something looks, where it’s purely fashion. You may be more budget constrained on your product so you care more about how cheaply this thing can be manufactured. Or, it could be a combination of usability and various facets coming together. You kind of have to balance how much to go into it; what’s the trade off between aesthetics, useability, cost of manufacturing, and everything else there.

Julia

Did getting a degree in mechanical engineering impact the way that you approach industrial design or change it in any way?

Anthony

It did change it. Previously I was able to hand off a design to a mechanical engineer, so I would develop what I wanted it to look like, maybe the skins on the outside and do all of that in CAD, and hand it off to somebody else who did all of the bosses and ribs and mechanisms. I do have to be a little bit more cognisant of how I’m designing it so my pathway isn’t a mess. 

I know the balance so I fight with myself while doing it, whereas previously that interaction was external between you and somebody else and give and take. Some of these products, it’s more of an internal argument with myself and determining the priority of a mechanism versus what I want it to look like. It’s a balancing act. 

I don’t always have the right answer for it and sometimes it may be easier to do that with somebody else. It’s great being part of a team where you can bounce these ideas off of somebody else, but I think I’ve had to be a little bit more aware of that next step that is handing off. 

Julia

What are some misconceptions that people have, either about mechanical engineering or industrial design, that you want to correct?

Anthony

So people typically think of industrial design as just styling, but in school you learn a lot more than that. You learn competitive product analysis, you learn doing some of these ergonomic studies. Obviously, styling is a big component of that. You learn a lot of different manufacturing processes and other things as well, things that people may typically think of being more mechanical engineering. 

It’s surprising a lot of times what people do learn in mechanical engineering versus industrial design. Every educational background is different, so where I went to school was more math based, based on the underlying theory of what was going on with the system. So, fluid dynamics or heat transfer or mechanics, whatever that may be. It wasn’t really practical knowledge in terms of manufacturing stuff, it was the equations that govern things underneath it all so that you could maybe apply that to a real world problem when you need it.

Julia

For your mechanical engineering degree?

Anthony

Yes, for mechanical engineering. For industrial design, I had a lot of classes and background on manufacturing type stuff. So, I learned thermoplastic processing, mold-making and injection molding, processes on sheet metal, die-casting, and a bunch of different production types. That’s really come in handy, having that background. When you get into this niche of product development people expect the mechanical engineers to have a lot of that knowledge from going to school. They think, “Oh, you’re a mechanical engineer, you must know about this stuff.”

Julia

Right.

Anthony

It’s really theory based. You may come into a situation like this where you learn more practical knowledge about manufacturing something from industrial design than you did from engineering. 

Britt

I’ve always been interested from an industrial design perspective how you handle clients when they really want something from an aesthetic perspective that just really won’t work or it won’t meet some requirement they’re looking at. How do you talk them through that and get them to where they need to be?

Anthony

This goes back to one of the differences between mechanical engineering and industrial design, which is the process. As far as mechanical engineering goes, in school you learn about this [process] that’s like, “Okay, I’m looking for this answer, I go through this process, I end up with this answer.” Whereas industrial design is very much a different process. In school I was like, why do I need to go through this whole process? Who cares about the process, the answer is the important part. Why do I need to do all of these derivative designs, all these iterations? It’s not super important.

Today I’ve realized the importance of that. A lot of times these multiple iterations will be great for showing the trade offs to a client. You can do exactly what they want and show them that they can do this, but it will cost them “X,” it’s gonna be way more expensive to develop. It may look great, but you’re gonna have problems with these human-interaction components of it or something like that. So, you can come up with these multiple different solutions to it and walk them through each one of them. 

Maybe I have a different idea of what I think the solution should be, but present it back to them, let them choose. If they really do think this is the most important part, that’s great because they typically know what is the important part of the solution. Earlier in my career I thought maybe I knew what was important, but I’ve come to realize that the client knows more than I do about whatever they’re doing. They’re the expert in that. 

In terms of what they need for their solution, pose it back to them. Make sure that they’re making an educated assessment of what goes into a solution, and then if they’re still set on it that’s the right path to go. 

Britt

That’s great, so we partner with them. Kind of help them get to the best solution for them.

Anthony

Exactly.

Julia

So in that iterative design process, how do you let go of the designs you create and be willing to let them go in the trash? I feel like that’s something that I would really struggle with. 

Anthony

That was a problem when I was younger. I’ll remember this forever: My very first studio professor, my very first project we had, we do these designs, we post them up on the wall, we do a critique of them, or the professor would. The students join in and talk about the good things and the bad things about all of these designs, and I remember being absolutely hurt the first time she did this. There were kids crying in my studio because you had never really had this honest assessment of what you had done. I think she was particularly harsh, maybe compared to some of the other professors, but I think it was a really good lesson and I appreciate it much more now than I did then. 

There is some benefit in being hung up on what you think is the right solution. Maybe your first or second idea is a pretty good solution; you may want to give that more attention. But, at the same time, you can’t fall in love with them. There’s probably a better solution on your fifth attempt, or your seventh attempt, or something like that. If you fall in love with that and you can’t clear your mind of it, you basically keep drawing or modeling the same solution, you’re never going to move onto a different solution or path. 

Julia

What do you do when you find yourself in that spot, where you feel like there’s more but you can’t get the idea out of your head?

Anthony

That’s a really tough question. I think that happens to everyone. What I’ve done is I’ve looked for people that have flashcards or brainstorming processes. I’ve pulled some together over the years of doing this, and I have a list of things I can look at to spark a different idea. Like, make it smaller. Make it bigger. Can you split out the functionality? Can you combine the functionality? Can you reuse a component? Can you do something recycled? All these different things that you can do, I have lists of all of these prompts that I can refer to if I’m stuck or just want to think about it a different way. 

Julia

Where do you draw inspiration from, and if you could describe your style how would you describe it?

Anthony

It’s tougher these days, I feel like I do more mechanical engineering than industrial design. When I did more industrial design I had a reference of pictures that I appreciated, whether it be old stuff or new stuff. 

There was a period of time when I really liked machined metal pieces. So, I did a lot of design that was based off of the details you might see in machined metal pieces. You might see a chamfer or holes for screw heads and things like that. Obviously you don’t have to have that for a cast or injection molded piece, but it still is an interesting aesthetic. 

If you do something like that, sometimes it looks even more powerful because you’re used to seeing it in this reference of being a metal piece. It goes back to the design thing, where maybe you’re not looking for the most beautiful thing but there is some kind of criteria you’re trying to meet with your design itself. Maye you want it to look robust, or well thought-out, or minimal. 

There are a bunch of things that can cause someone to buy a product or interact with a product well. It might not be that you want it to be beautiful, you just want it to be durable, or whatever that word is that makes a person think or realize that there’s more to this product than what meets the eye.

Julia

I noticed you started picking out adjectives. When you start designing a product, do you pick out an adjective and then decide, “I want it to meet this”?

Anthony

I have in the past, but I don’t typically do that now. Typically it’s not a deliberate act to pick out an adjective; as I’m drawing it I might think that it’s not quite the right aesthetic and I want it to look smoother or curvy or more user friendly. 

For a lot of stuff we do here, I don’t want it to look tough. If a user is interacting with a device you want it to look comfortable, or you want it to look user friendly. A lot of those don’t mean completely smooth, but there’s going to be some aspect of, “This thing needs to look like it can fit in your hand” and not just be “strength” or “rigid” or something like that. Probably not an intentional selection of adjectives, but there’s a flow there.

Britt

What’s your favorite project at Blur that you’ve had to work on, or a challenge you’ve had to work through that you’re excited about?

Anthony

There’s one in particular where we did kind of the medical device aspect of it and a bunch of other components to it. We did packaging, we started on the software internally, and things like that. I mean, I didn’t do the software, I don’t know how to do that.

Julia

Yeah, me either.

Anthony

But, it was nice being able to design all the components to go together. Sometimes we may just do the hardware or the hard goods and there may be other aspects of the system that integrate with that that you don’t get to control. But this time all those pieces came together, we did them in-house, and where we arrived with that was a really nice, integrated solution where everything looked like it went together. It fits together nicely.

Julia

I know the project you’re talking about. Yeah, that was very satisfying being able to say we really took our time to make sure that the needs of the user were being met in every aspect of it, not just the device portion.

Anthony

I know I was talking about the design process. You develop iteratively, you make progress by making prototypes, you don’t settle on your first solution. You hold it as a truth as a designer because that’s what’s ingrained in you at school, and I think that’s something that we’re pretty good about here. 

As a company we make sure we roll through the prototypes, you learn by failing in each prototype, and you iteratively improve.

Julia

Yeah, it is very much part of our culture. Fail fast, we want to fail fast because failure isn’t a bad thing, it’s where we learn. If you can translate that word failure into learning, then you can take those learnings and move them into whatever the next solution is. It’s just this snowball effect until you arrive at whatever the final solution is actually going to be.

Anthony

It’s a lot easier now. When I first started off you had to send your part off to some prototype house, and a few days later you’d get back this SLA or SLS part. You pay a bunch of money for it and you hope that it’s right. Now everyone has 3D printers in-house. We have FDM and SLA printers. It’s just so easy to come up with a concept, print it out, test it out the next day, have it in your hand, and iterate off of that. 

That was a problem when I was first starting out, you didn’t have access to getting this thing printed off immediately and trying it out. You basically had to plan to have this thing work right, you take your best shot at it, you hope everything is good, and you send away for it, and you get it back. You didn’t have that many cycles of the iterative process. 

That’s a really great part about having all of these printers on hand; I think the process has improved just because of the technology.

Britt

You can fail fast, you can fail the same day.

Anthony

There have been times when I’ve done that, especially with a small part. You put it on the printer in the morning, it takes a couple of hours to print, you clean it off, put it in your assembly, you make changes to your part, recycle it and you’re going again by the next morning. You’re printing it overnight so you can do multiple rounds a day too. It’s really useful.

Britt

It has been nice here because if we have a long lead on something, for the most part we can find a short-term solution in-house.

Anthony

And it’s expected that there will be some iteration. Your first solution is not going to be a perfect one, and it just takes time. We want to go as fast as possible, but that doesn’t mean settling on the first solution or expecting that first solution to be the right one. It’s probably the wrong one if you go down that path. 

If you pick the first solution, settle on it, do all of your engineering, everything else around that first solution, it takes a lot of time. There’s a lot of stuff that goes into product development, so it takes a lot of time. If you pick that first solution and make sure all of your drafts are right, make sure your bosses are right, make sure your screws and inserts fit, and everything works in the assembly including packaging, it takes a long time. If you come back to it a couple of months later and say, “This doesn’t do everything we needed for it to do and the users aren’t really happy with this,” you’d have to redo all of that work.

On the front end, doing that iteration and the process is where it really pays off. You don’t get too far down the line where you have a massive amount of work to redo at the end; no one’s happy when you do that. If you run with the idea early on maybe you look great for a little while, but when you have to backtrack no one is happy about that. 

Julia

Yeah, client’s never happy about that.

Anthony

No, they’re never happy about that.

Julia

What’s some advice you would give someone who is just starting off in mechanical engineering or industrial design?

Anthony

It really depends what you want to do as far as mechanical engineering goes, that’s such a broad topic. For product development, it’s maybe just tear-downs if you’re naturally inquisitive about how something works. The more solutions you see the better you’re going to be at it. If you’re trying to work in a vacuum without ever having seen these solutions before, everything is going to have to be created from scratch which is really difficult. I mean, it’s difficult to do once, you don’t want to have to do that for everything you’re designing. 

So, product tear-downs for mechanical engineers, the other one is application guides. Everyone wants you to use their product, so make sure to look for their application guide. Injection molding, metal casting, everything under the sun has them; make good use of them. I have a library of hundreds of these application guides on these different processes or materials. It’s easier to just refer back to the file that I have rather than having to scour the internet to hopefully find what I need next time.

Julia

Right. 

Anthony

Industrial design: never stop looking at inspiration. It’s always changing. 

I feel like you can typically identify an industrial designer by the work that they do, there’s kind of a style to it. I don’t know if I’ll ever grow out of the style that I have, but at the same time I think it changes over the course of years. It’s like music, you get bored with one thing so it migrates away. You find something else interesting and you pull those accents into your work. There are definitely visual styles and you maybe combine that into what you do. 

Not working in a vacuum in terms of references; they teach you that in school, but make sure you do that in your work life too.

How do you research effectively when beginning to prototype a solution? How do you know you’ve done enough research to troubleshoot a problem?

In this episode, we’ll chat with Erin, one of our R&D engineers, about her process of finding the best solution through rapid, iterative prototyping. 

 

Julia

Erin, thanks for being with us today. Tell me what you do here.

Erin

I’m a research and development engineer. I’ve been here a little over four years.

Julia

And you started as an intern, right?

Erin

Yeah, not counting the summer I started as an intern, I guess that would be four and a quarter years then.

Julia

Talk about that research part of research and development and prototyping, because I know that’s a lot of what you do here.

Erin

Yeah, definitely! As an R&D engineer a big part of my job is doing research, especially at the start of a project. We’ll come in, the client will have an idea for a concept but there’s a lot of research that has to be done to figure out what components you need, how to source those components, sourcing materials, and finding people that can produce the parts we need. I do a lot of research in my day to day job.

Britt

You’re about to do some research, where do you go first? Google?

Erin

Yeah, I mean honestly, most of the time Google. I try to start out with a broad search and cast a wide net. I’ll see what key words I see popping up a lot and use that to modify my search, and then I seek out experts, whether that’s someone at Blur or someone out in the field for their help. I also keep a log of every person I’ve contacted, what suggestions or notes come out of that conversation. That way I have a log of everything I’ve done and I can go back to that research, or if someone else at Blur is researching a similar part or concept I can go point them to that. 

Britt

It’s great that everyone seems to be creating these libraries that you can reference instead of recreating the wheel every time.

Julia

I think it shows just how collaborative we are too. The resources that we find or the processes we use, it’s not just about us and getting our work done, it’s about saying, “I did this and found it useful, let’s keep it so that someone else can use it because I know someone else is going to run into this problem at some point.”

Erin

Right. Someone else is going to need a camera, so let’s compile a list of all the cameras we’ve used so we don’t have to repeat that work on the next project. 

Julia

Yeah, definitely.

Britt

Do you ever have times where you’re having trouble finding data? Just altogether you can’t find any information, and how do you handle that?

Erin

Yeah, we definitely run into that more than we would like. I think that’s sort of where the testing and prototyping comes in. For instance, if we’re looking for a specific material property that we can’t find, can we get the material in and prototype something ourselves? Is there a simulation we can run with CAD software, find a similar material, and see if that gets us close enough? If we can have a simulation and a test that point towards the same answer, maybe that takes the place of whatever online answer we’re looking for. 

Julia

How often would you say we run simulations here to help in that research process?

Erin

I say we do it on almost every project, whether it’s a finite element analysis (FEA) or a flow simulation. I feel like I’ve done that with a lot of the projects I’ve worked on. We’re always 3D printing components of a device and testing those before we’re going to full scale production. 

Julia

What would you say in your research process is the most challenging part and what do you find the most rewarding?

Erin

I’d say the most challenging part of the research process is if it’s a really specialized component and there’s not a lot of people who make it or know a lot about it, you’re really relying on people to respond to your cold calls and emails. That can be challenging sometimes. I’d say the other big challenge is when a part has a lot of requirements, so it needs to be low cost, high lead time, really durable, juggling all of those different requirements can be a challenge. Or, if you’ve thought you found a new part that would work and a new requirement gets added, you have to go back to your spreadsheet that you’re keeping of all your options and reevaluate that. 

Britt

Yeah, I was going to ask how do you manage that with a client? They’re adding new requirements, how are you able to communicate with them that this new requirement means extra time or extra cost?

Erin

I really think you just have to be transparent with them and say, “We can switch to this part, that’s not a problem, but that may mean the lead time changes, the overall cost of the device changes.” If you’re switching from a smaller part to a bigger part, that housing that it lives in will probably have to change and that part now is going to get more expensive. Understanding that changing that one part can have a ripple effect is important to make sure the client understands as well.

Julia

I think that’s a super important part of presenting anything like that to a client. Having all of those details worked out so you don’t just say, “We can’t do that.” Instead say, “If we do that, here’s what’s going to happen” and then letting them make the decision. At the end of the day it’s their decision to make, and maybe they don’t mind that it’s going to cost more and they really want that specific part or to use that specific process. Definitely make sure you’re getting them all of the information they need to make that decision. 

Erin

Yeah, I agree.

Britt

When you’re first starting to prototype with a new client, what are you go-to initial questions to get the ball rolling?

Erin

When we kick off a design, the thing that I care about most is what function it needs to serve. I’m not as concerned with the overall size it needs to fit within, or if it has to meet all of these certifications. I’m most concerned with function at first. After we have an initial design, the next things I’ll look at are the material it should be made out of and the quantity we’re looking at. If we only need three for some demos we’ll probably 3D print it, if we need one thousand we’ll be injection molding it. And then past that, it’s good to look at usability. Does it need to have a handle, does it now have to fit inside this other part, what constraints does that mean? Also, being aware of color, does it need to be transparent, does it need to be waterproof, biocompatible, food safe, all of that. Those are all important to know, but they’re not the first things I worry about when starting a design.

Julia

How do you know or make a decision that , “Okay, I have done enough research to confidently go with the solution to the problem I’m experiencing in this design.”

Erin

It depends on the test. A test is targeting a specific function, whether it’s usability or waterproofing. Typically there’s a sequence of tests. I’ll start small, like if it’s how two parts interface I’ll just prototype and 3D print those two parts cropped to where that interface is. Once I have that working I’ll print the full-size parts, make sure that works, share it with the client, and have the users handle it and make sure they don’t have any complaints. Past that, what are the differences between the part you’ve prototyped and the production part? If one’s 3D printed and one’s injection molded, is there going to be any difference between them that would cause it not to seal properly, or be waterproof, and making sure you’re confident that despite those changes the design you have will still work. I think that’s when you can check that box that testing’s passed.

Julia

Getting prototypes in the hands of users is so important because, as we have experienced many times, they will give you feedback you haven’t even thought of. 

Erin

For sure, yeah. The earlier the better.

Britt

So you’ve been at Blur for four and a quarter years, what’s something you wish you would have known your first year that you could advise others?

Erin

I’d say just not being afraid to ask people questions. Everyone at Blur is so smart and so capable, so if you get stuck and you can’t solve a problem, don’t spend time just noodling away on it yourself. Go take a walk around the office and bounce some ideas around with people because someone is going to have an answer and it’s going to be a lot quicker than if you were just to sit there alone in your corner of the office.

Julia

Yeah, muddling through it on your own. 

Erin

Right.

Julia

What was the most intimidating part of our machine shop when you first started?

Erin

It’s not really part of the machine shop, but the casting-molding station was really intimidating. At first, just because there were so many components and steps to the process. I was so worried about messing things up. You have to measure stuff initially, make sure you have the A and B components at their correct ratios, degas it and pour it into the mold. Make sure there aren’t any bubbles and put it in this pressure pot; make sure that’s all sealed correctly, which always freaked me out. Then you just have to wait a couple hours until it finishes molding. You don’t know if you’ve failed or not until you take it out.

Julia

I’m sure there were times when you took it out and you were like, “Aww, dang.”

Erin

Yeah, like last month. I had a part that I thought didn’t need mold release, which helps it come out of the mold easily. I went to take it apart and it didn’t move. I was trying to use all these tools to pry it open and it was just chipping away at the tools. I had to just throw it away and start over, so now I use mold release

Julia

As you’re prototyping and testing, what parts of our labs do you use most frequently?

Erin

I use the 3D printer probably the most; right now it’s every single day and I’m kind of hogging it. The laser cutter I use fairly often, that’s really handy when you have larger assemblies that you have to build really fast. I work a lot with the UV cure adhesives, so I am using our UV light pens pretty often. Those allow you to bond things together really quickly, and we have a whole bunch of different UV adhesives for different materials. 

I don’t venture into the machine shop with all of the blades very often. When I first started I was using a circular saw and I didn’t realize there was a safety so I revved it; Jeff was standing next to me and I think I really freaked him out. He was like, “Yeah, I’ll do that for you” and I said, “I think that’s probably a good idea.”

One part that took a lot of testing and troubleshooting and iterating on was we had these two components that had to interface and seal in two different chambers. We wanted that to be done in a single connection so that the user just had one piece they had to connect. We looked at a couple different ways of doing that, either a press-fit, a snap-fit, a press-fit that’s just plastic on plastic or silicone on plastic. 

So, I did a lot of prototyping back in the lab. I would print those two parts on our 3D printers, and really just segments of the parts to speed up the prints and save us some money as well. I’d just print a bunch of different interfaces and see how well they sealed. 

The silicone on plastic interfaces I would overmold the plastic with one of our silicones we have back in the lab and test those. We narrowed it down to three different options, and we’re working on getting each of those full-size parts printed to send to the client. They’ll evaluate each of the three designs and see if there’s one they really like, or if they like all three we’ll bring them to the users and see if there’s a favorite among the users. If there’s not a favorite among the users, we’ll just pick the one that we like the best and will be the easiest to manufacture. That’s been a lot of iterating on and time with the 3D printers and molding station, which has been a lot of fun.

Julia

The benefit to having this in-house prototyping capability is we can come up with a lot of ideas for how to do things. You were just saying, you were just saying you made so many… how many prototypes do you think you made?

Erin

There’s like a hundred different pieces on my desk right now. 

Julia

Exactly, we have all of these different ideas for how these two parts can fit together, but by being able to do this in-house and fairly quickly we can throw out the ones that don’t work.

Erin

And each part is really only about an inch big since I’m just cropping it to that interface, so it’s really not wasting too much material or time to get those printed.

Julia

How long would you say it took you from the time you started 3D printing these up until you had the three core ideas?

Erin

When I am working on it, I’ll print a couple designs one afternoon, test them the next morning, figure out what I don’t like about each design, make those changes, and get them back on the printer that afternoon. So, the iteration cycle is pretty quick. 

Julia

Thanks for coming on Erin and chatting with us.

Erin

Yeah, thanks guys, thanks for having me.