Margaret Koga Ward | Best Practices For Root Cause Failure Analyses

SUMMARY KEYWORDS
engineer, people, working, medical devices, run, device, thought, margaret, career, problem, process, bomb squads, understand, fascinating, woman, company, femoral head, industry, material, questions
SPEAKERS
Margaret Koga Ward, Aaron Moncur

Aaron Moncur 00:14
Welcome to the being an engineer podcast. Our guest today is Margaret Koga Ward, who graduated with a degree in mechanical engineering from Cal Poly and has worked in a variety of industries from airport security to automotive to medical devices, and currently runs her own consultancy. Margaret, welcome to the podcast.

Margaret Koga Ward 00:36
Thank you, Aaron. It’s nice to be here.

Aaron Moncur 00:38
It is. It is so nice to hear her voice. Margaret and I have actually known each other for quite some time what it’s been like, I don’t know. 12,13, 14 years. It’s been a while now.

Margaret Koga Ward 00:48
I stopped doing the math.

Aaron Moncur 00:51
That’s probably a good idea. Okay, so I wanted to start with something kind of fun and I hope my memory is correct here. I think you I remember you telling me at one point that you went to college with Weird Al Yankovic Is that Is that correct? Or am I misremembering? No, that

Margaret Koga Ward 01:10
is true. He was actually a good friend of guy I was dating. And I like to consider myself Weird Al’s first live audience ever. Oh, yeah. Used to go down. He had a show at Cal Poly radio. And he had a Saturday night show the weird owl show. And I used to go down and watch. And I think it made them a little bit nervous. But it was it was amazing to watch. You know, that you could tell you right then you’d have a large following for many years. But it was just me. It was an audience of one.

Aaron Moncur 01:49
How interesting. So you were what in the recording studio or like the radio booth with? Yeah, just kind of watching him do his radio show?

Margaret Koga Ward 01:57
Yep. Yep. Because the the friend of his was one of the technicians that worked at the station. So it was, you know, no big deal for me to go down there. But always wanted to go down when he was on the air. It was just fascinating to watch.

Aaron Moncur 02:12
Got it. How fun. Well, that’s a claim to fame right there.

Margaret Koga Ward 02:16
Absolutely.

Aaron Moncur 02:18
All right. Well, this podcast is about you. Not weird at all. So let’s dive into it. What made you decide to become an engineer? Margaret?

Margaret Koga Ward 02:28
Wow. That’s a great question. Aaron. I always thought I didn’t have a choice. No, I come from a very long line of engineers. On my father’s side. My father was an aerospace engineer. He was one of the guys to get the GPS satellites running. And he did all the algorithms. It’s a brilliant scientist and engineer. His father was an engineer. His father before him was an engineer. And out of five kids and my family. Three of us have or four of us have engineering degrees.

Aaron Moncur 02:59
Oh, my goodness, has the fifth been disowned?

Margaret Koga Ward 03:02
He’s an attorney. So so he’s okay.

Aaron Moncur 03:05
Yeah. I don’t know. Okay, well, we’ll take your word for it.

Margaret Koga Ward 03:10
No, so I was just something I always knew I had an interest in, I like to know how things worked. And it was interesting, because in high school, I wanted to take the, the algebra physics route, and had to convince a guidance counselor that that I knew what I was up to, or I was up against was, it’s still that way, I think, which is too bad.

Aaron Moncur 03:34
Because of, are you referring to gender?

Margaret Koga Ward 03:38
I think it was, I think it was, and this was back in the day, it shouldn’t say but back in the 70s. And she she tried to steer me away from the technical route.

Aaron Moncur 03:48
Oh, how interesting. And I mean, how did that sit with you? How did you react?

Margaret Koga Ward 03:53
like I usually do, I completely ignored her. I was gonna do

Aaron Moncur 03:58
and showed her.

Margaret Koga Ward 04:00
I don’t think she ever looked back.

Aaron Moncur 04:02
So that’s an interesting topic, though, because we’ve never really talked about, you know, women in engineering. We have had one other female guests on the show, which was great. But we didn’t really get into that topic. How, how has it been as as a woman in you know, what is pretty much a male dominated industry.

Margaret Koga Ward 04:24
It has been to use the term dynamic. For the most part, I’ve I’ve never felt any different. But it’s, it’s not an easy path. I always encourage young women to pursue technical fields. And to stay there. We get a lot that start out in engineering, but end up leaving the field after a few years, which is really too bad because I think that women engineers, bring a very different perspective and bring a different way of thinking to the field.

Aaron Moncur 04:53
Oh, that’s an interesting comment that speak more about that if you would, this different perspective that women bring,

Margaret Koga Ward 04:59
I get It stems from a biological difference. If anybody has studied the brains, the two hemispheres of a woman’s brain talk to each other much more than a man’s do. There’s more coordinated activities between the left and the right hemispheres. There’s a cable that connects the two hemispheres. And it’s, it’s, it’s bigger than a woman’s brain, just the way that we’ve evolved. But I think that gives women engineers of, I don’t want to say an edge, but a different perspective, we can approach problems differently, more on a holistic, level versus completely methodical. It should be appreciated. But sometimes it’s questions. I’ve had to explain myself more than a few times, you know, how did you get there? How did you come up with this idea? How did you come up with this conclusion? You know, and I’ve learned to take a step back and not just say, Well, it’s obvious, isn’t it? It just didn’t just popped up. You know, so baby, you know, freebody diagram or, you know, or try to really remember to at least give some indication of how I got there. But I think that we just approach things differently.

Aaron Moncur 06:07
Let me play devil’s advocate here just for a second, how do you know that’s because of the biological differences between men and women, and not just the fact that you’re really smart, and maybe you’re smarter than most people that you, you know, communicate with?

Margaret Koga Ward 06:23
Well, I would hate to give that much credit. I think if you think about the two hemispheres working together, you’ve got the more artistic side working with the logical side. And most engineers are highly logic driven. But I think it’s good to be able to easily access the creative as well. But as I said, it’s it’s challenging to be in the field. Most business relationships are wonderful. But there’s been some some very frustrating experiences also.

Aaron Moncur 06:53
Well, I’m sorry that you’ve had to deal with that. Does that? Do you think it’s changed much over the years? Is it less common now than it was before? Or is it still, you know, more or less the same? No, it’s

Margaret Koga Ward 07:03
frustratingly about the same. There’s been a few in my career. Yeah. Yeah. Where, you know, it’s, I think the biggest obstacle, or I wouldn’t say obstacle, but the biggest insult you can get is that you will end up with men that will say, you know, You’re a strong woman, you know, that right? Getting a woman who’s been in that position shouldn’t

Aaron Moncur 07:25
matter, right? You just good engineer, that’s what we’re talking about, what is gender come into play?

Margaret Koga Ward 07:30
You would never say a man, you know, who’s who’s determined, or who’s opinionated, we got a strong man.

Aaron Moncur 07:37
I’m gonna start saying that now to my team. You’re a strong man, you’re a strong man.

Margaret Koga Ward 07:42
I was gonna say you could tell it to your wife, too. I actually had a, I was working for a company wide. So we had a client. And the client was based in Saudi Arabia, and found out that he was going to be working with a woman engineer was a woman engineer had been assigned to his project. And he called up the president of our company and said, there was no way on this planet that he was going to work with a woman engineer. Oh, my goodness, my esteemed boss said, Well, yes, you are. But it was it was fascinating as the relationship developed. And I think it was probably in the end, one of the best working relationships I’d ever had. So then, and that’s not all, it’s not all hasn’t always been a happy ending. And I would tell any women in this position, that the best thing you can do is to understand that you do bring a unique perspective, it’s okay to have a voice and to use it. But if you do feel that it’s, you know, too much of an old boys network, or it’s an environment that’s a little bit toxic, you know, go out and find another place where it’s not like that, because they certainly aren’t. I’ve run into it a few times in my career, and just went and found a better fit.

Aaron Moncur 08:51
Life’s too short to work with bad people, right?

Margaret Koga Ward 08:54
Pretty much are for them to work with somebody they don’t want to work with either.

Aaron Moncur 08:58
Yeah. Wow. Well, thank you for sharing that very interesting perspective, I would have put money on the assumption that that sort of thing just doesn’t happen as much nowadays, as it as it did, maybe, you know, 20 3040 years ago.

Margaret Koga Ward 09:15
There are some things that have changed when I was a young engineer. It was very, it wasn’t uncommon at all to have somebody walked down the hallway, you know, I’d be deep in thought about something. And somebody walked out, a man would walk down and say smile, honey, you know,

Aaron Moncur 09:30
Oh, no. Oh, God. Furious.

Margaret Koga Ward 09:34
Yeah, so that doesn’t happen anymore. There are still challenges. It happened to me recently, too. You know, it’s too bad. But some men are threatened by a strong woman or woman who’s opinionated or might know more than they do. And the ones that will just treat you like any other engineer, it works out great. But they’re are still those guys out there?

Aaron Moncur 10:03
Okay, well, one project that you worked on early in your career was the development of a mobile X ray machines for airport security, law enforcement and bomb squads, apparel? Yes. What was the research and product requirements like for for that particular project? I mean, were there like certain materials that you needed to optimize the machine for? Did you get to speak with some of these law enforcement agencies? And what was that like?

Margaret Koga Ward 10:33
Ah, but one of the highlights of my career was when I actually got to work for about six months with the bomb squad. Yeah, they had a bunker. It lax, la International. And I got to go there about once a week and talk to them. And that was fascinating. These are some of the most amazing men that I’ve ever worked with in my life.

Aaron Moncur 10:55
Strong Women, would you say? Oh,

Margaret Koga Ward 10:57
yeah, I would say these guys ate meals for breakfast. No, but we Yeah, it was, it was they were always fascinating projects. And when I came into it, I realized that, you know, putting all this this this very heavy equipment into a mobile application, you know, and we would modify vans and carts and trailers, we really had to be very aware of how it was going to be used, who was going to be using it, where it was going to be used, you know, you think about it, you’ve got this thing in the back of a truck. And somebody’s going to be driving it, and how we were going to secure it, how we were going to configure it, whether it was for, you know, again, bomb squads, which were little mobile devices, or a lot of these were customized versions of the screening stations that you still put your bags through at the airport, and actually was on a vacation earlier this year. I was in Egypt. And they had one of the old ones, because the company has been sold several times. But it still said it still had the old company name on it. Oh, yeah, it was great. I was in the Cairo Museum and got caught taking a picture of the security.

Aaron Moncur 12:16
Ma’am, that’s not the merchandise here.

Margaret Koga Ward 12:20
Oh, I got pulled aside and had to stand there and delete the picture and explain what I was doing. Yeah. Oh, yeah. I

Aaron Moncur 12:26
designed that.

Margaret Koga Ward 12:29
Guy didn’t speak much English, or and I my Arabic was pretty sparse. So yeah, I’m good at getting myself in trouble. It was funny.

Aaron Moncur 12:39
All right, I’m gonna nerd out a little bit here and dive a little bit into some engineering details. When you were working at Tech medica, you were involved with the development of femoral head orthopedic implants. And one of your assignments was to identify the root cause for, I guess, some sort of dimensional instability that that your team had identified on these heads? Do you recall the process that you used to uncover that root cause and kind of take us through like, you know, step by step? What What all did that process entail?

Margaret Koga Ward 13:12
Well, we had an issue where we had femoral heads. And if people aren’t familiar with orthopedic implants, the femur is basically your hip and the femoral head is that big knuckle that’s on the side of your hip that attaches to your pelvis. And in a hip implant surgery course, all that is removed, and there is an implant put in that has the femoral head, well, before they put the actual implant in, you’ve got these little trial versions, so you can size it correctly. And, and these are reusable devices. That, that you can size everything before you open the very expensive implant. And we started having some complaints that the sizing wasn’t correct. And we scratched our heads a lot. And I was the some engineers who said, yeah, that’s been happening for a long time. And we just can’t figure it out. Because some of them were getting larger, and some of them are getting smaller. So putting on my my best nerd brain, I did, one of the things I’ve always done is to take a look at the big picture, right? Not just what is happening here, but what are the events that are leading up to, to this happening, and then sometimes they would say we had it, and it wasn’t the right size. And then I use the same set the next time and it was the right size. So we had a lot of variables that were going on and things didn’t make sense. So by taking a step back and looking at the products, looking at the problem from a different perspective. And looking at all the processes, I realized that these went through a steam sterilization cycle shortly before they were used. And if they hadn’t cooled down all the way, which might be the case if they’re running them through the cleaning process. Um, some of them would get bigger, because, you know, he makes things expand. And oddly, some of them would get smaller, which we couldn’t figure out. But it happened to be a geometrical issue. And it was a combination of not just the size, but there was an interior diameter, and how it would expand, some would expand so that the the inside diameter got smaller, and some would expand, so that the outside diameter got got got larger. So it was it was actually a very simple problem. It just needed little bit of creative thinking. And I it didn’t make sense intuitively, even as an engineer that this would happen, we brought a couple sets back through them in the autoclave. And we were able to show that this was the problem. So of course, we couldn’t do much about the design inherently because it was also a material issue. But we could do is notify the surgeons that they might see some some variability, if they were still if they had been autoclaved within the last couple of hours, because it was a combination of the heat and the humidity.

Aaron Moncur 16:08
So what was the solution just to wait a certain period of time after autoclaving? before use?

Margaret Koga Ward 16:15
Yes, and we did find out that some because of the way they absorb the material, some of them would end up almost with a permanent size differential. So we learned to I think the next time we made some changes to the park, we try to accommodate that as much as possible. But really, it was a matter of letting the surgeons know that they might see this variability.

Aaron Moncur 16:41
Wow. Okay, well, I love what you said about seeing the whole picture, right? That’s so important to kind of take a step back and holistically look at what all is going on here. It’s also so interesting that apparently these these changed size or shape in different ways, depending on the device, even though ostensibly all the devices were manufactured the same way. What do you think accounted for why some of these grew on the outside, while others grew on the inside? Was it just completely random?

Margaret Koga Ward 17:15
No, no, it was there was a whole slew of sizes. So the very small ones, we noticed where the material would expand was more into there’s a cutout, you’d think about a hole through the middle of it that didn’t go all the way through kind of a blind hole. So on the smaller sizes, the ratio, the wall thickness was smaller. And so they tended to shrink, such that the inside diameter got smaller, but the outside diameter stayed the same. And then with the bigger parts, the inside diameter stayed the same, and the outside diameter actually grew more.

Aaron Moncur 17:55
Okay, so you were able to predict to some degree, you know, how the geometry was going to change? Exactly. Got it. Got it. All right. Well, you’ve worked in both the automotive and medical device industries, two major industries here in the US and in the world. What are some of the biggest differences that you’ve experienced between the two?

Margaret Koga Ward 18:17
Wow, automotive, if you ever get a chance to work in the automotive field, even for a short amount of time, I would recommend it. It’s a difference of scale. I mean, think of how many, you know, Ford escapes are built. You realize that if you were with a company, and you could save them 10 cents a car, you were a hero, that was huge.

Aaron Moncur 18:41
I’m gonna interrupt real quick, it’s like you. It’s like we had a pre show powwow here because that was literally the next question I had. I remember you telling me that at some point that saving a few pennies, made you a hero. And I was I was going to ask is that an exaggeration? Or is that?

Margaret Koga Ward 18:57
No, no, it is not an exaggeration. But we were we were working with a couple of engine companies. We were working on a camless diesel engine. We we had they’re actually the the technology revolved around these digital latching valves which the valve could stay in in one position or the other position because of residual magnetism. So could stay in either position with no current, which is, you know, pretty unusual. It was developed by an engineer who had worked in the Apollo program. And he realized that this might have a good application for engines. And he started with fuel injectors, and made some very, very efficient fuel injectors, which ended up being used in most of the Ford pickups, most of the diesel Ford pickups and still use this technology. But I was also on the design team for a Uh Uh, well, we were making a camless diesel engine, the thought was you could make a diesel engine run without a camshaft using these valves. And it was fascinating. It was, it was great fun to work with the engineers at the diesel plant. And it was it was a great experience. That was one of my best failures ever. When it was an early prototype, we had a prototype where we were not allowed to make any modifications to the, to the engine, we could find a way to put this little latching valve in, of course, we didn’t have the camshaft, and we were able to show feasibility. But because we were not allowed to touch, make any modifications to the engine block, we knew that they had to run it fairly slowly. Again, this was early concept feasibility. And we were demonstrating it in front of all of the executive members at Ford Motor Company. And it was going great. It was running nice and slow. Everybody was was excited. And I looked and it was inside of a plexiglass shield, of course, and I could start seeing oil dripping. I’m like, Oh, this is really bad. This is bad. A good sign. No, no, because we had a lot of pressure inside of a fairly thin walled device. And it’s dripping. It’s dripping. And anyway, we shut it off. And everybody, you know, was very impressed. Then when the high level executives left the engineers like, Okay, we want to see what this really can do. And they turned up the pressure and turned up the engine speed and it it exploded. It was it was epic. who literally exploded. Oh, it was a great noise. Yeah, yeah. Shot oil all over the place. Again, it was it was inside of a it was it was well contained. And they kind of knew it was going to happen. I certainly knew it was going to happen. But we were glad that it didn’t happen with all the onlookers.

Aaron Moncur 21:54
Did you ever watch the show? Mythbusters? Yes, love Mythbusters That, to me sounds like you know, towards the end of Mythbusters. If they can’t figure out like if the myth is proving to be not true, whatever, they find a way to like blow something up or, you know, destroy something at the end. So glad to hear that you and your group of engineers were able to do the same.

Margaret Koga Ward 22:16
Oh, Adam would have loved it. Jamie would have been horrified. It was great.

Aaron Moncur 22:23
All right. Well, I’ll take a real quick pause here and share that the the being an engineer podcast is powered by pipeline design and engineering, where we work with medical device engineering teams who need turnkey custom test fixtures or automated equipment to assemble, inspect, characterize or perform verification or validation testing other devices. And you can find us at test fixture design.com. We’re speaking with Margaret Kouga. Ward today who among other things, is a consultant helping medical device companies advanced their products from concept to clinical trials and FDA submissions. One of your roles Margaret has been as a or maybe is as a quality auditor. What What’s that been like? I’m imagining one or have two or maybe both depending on the situation. Situations where you walk in and and the engineering team there is like, oh, no, it’s the quality auditor she’s gonna shut us down. It’s gonna be terrible. Or the other one is like, oh, it’s the quality auditor. Let’s Let’s do everything we can and you know, make sure she’s well taken care of. We love the auditors. What is your experience been? Like?

Margaret Koga Ward 23:41
Usually somewhere in the middle? Of course, the best book and let’s take you on a two hour tour of the factory and waste time. That doesn’t work too. Well. No, I’m actually I’ve been in the medical device industry now for over almost 25 years. It’s where I really it’s the industry that stole my heart as much fun as I was having engines blowing up and working with bomb squads. But I’ve worked throughout all facets of medical devices. And I started working for myself about three, three or four years ago now and knew that it would be tough to only make a living as a consultant and contract in contract, medical device development engineer. So one of the things I decided to do was get certified as an auditor and started working for we call them a notified body and these are the big guys. These are the ones that will come in and say you know you have your certificate for ISO 1345. It’s similar to an ISO 9001 audit. And I have really enjoyed it. I don’t get to do it as much because the consulting and the training parts of my business have been going very well. But it is always fascinating walking into the building. thing I’ve been I’ve been part of audits throughout my career. But the the funnest part was to sit on the other side of the table and be the one asking the questions. Yeah. Oh, absolutely, you get ones that just have been told don’t say anything, unless she asks you a question. And that’s awesome. Because I can ask a lot of questions. I think you’re better off talking a little bit more being proud of your quality system, being proud of what you’ve done. Because if you just sit there and be quiet, you’re just giving me a chance to ask a lot more questions and

Aaron Moncur 25:32
great advice. Okay. So the audits that maybe go a little bit easier for the engineering team are the ones where they are excited and share with you, you know, what they’ve done to build their quality system, as opposed to just sitting back and zipping the lips?

Margaret Koga Ward 25:46
Absolutely. And of course, you know, you would have to, to be careful, you certainly don’t want them to overshare. But they should be proud of how they’re how their engineering department has been contributing to the quality of the not just of the device, but of the company itself. And the audits I do, you know, it covers not just the engineering, but you know, purchasing, management, everything. It’s a whole, it’s an audit for the whole organization. But auditing the engineers, I think, is my favorite. Number one, they’re not used to having an auditor come in who, with an engineering background, who has done this, because normally they could answer a few questions and be done. But if I’m the auditor is going to be a much more transparent process. And

Aaron Moncur 26:33
by transparent do you mean difficult and thorough?

Margaret Koga Ward 26:37
Yes, more transparent for me, I, you know, I’m going to look at everything, less transparent for them. Because it’s, it’s, I think it’s a little more, it’s difficult to hide the fact that the engineers don’t understand their role in the quality system. If they do, and they do understand it. And they have been able to develop their products, using the appropriate design controls that are mandated by both the FDA and the ISO certification. They realize it makes good business sense, they have all of the appropriate processes in place, and they should be proud of it. And you know, they should be willing to talk about it, because that, to me, tells me that they’re they’re involved with the process, and they know they understand what they’re doing.

Aaron Moncur 27:26
You’ve done a lot of different things in your career, what do you think it is that that really motivates you? You know, what, what is the? What is it that drives you to go to work every day and do what you do? And if you can think of any, have there been any specific experiences where, you know, you, you went through whatever the experience was, and at the end, you’re like, Yeah, that’s it. That’s what I really love doing?

Margaret Koga Ward 27:52
Oh, gosh, I was you said, I’ve had a long career with a lot of a lot of different companies. I think what really drives me to get up in the morning, and really keep doing what I do. Right now it’s medical devices, is I, I love the fact that what we’re doing helps people, I never wanted to work in an industry where I’ve made weapons of destruction, I I like medical devices, I like knowing that we have the opportunity to make people’s lives better. But it comes with a lot of risks. They don’t always work. And they they don’t always work well. You know that there might be different physiological characteristics or physiological responses. But what I’ve loved about this industry, is realizing how many different pieces there are to the puzzle, not just the engineering, but the quality system, the regulatory aspects and how they really fit together into a beautiful, it’s a puzzle that just that when done, well, you know, you’ve minimized the risk involved to the patient. And I keep doing what I’m doing, because there are a lot of people out there that don’t understand that. There are a lot of people that will decide to take shortcuts, sometimes unwittingly. But I like being a consultant and really teaching them about the aspects of the quality system, and design controls, and understanding the risk and understanding how all of these contribute to making a safe and effective product. And again, it’s it’s it’s a big picture approach. And you have to understand, especially with medical devices, who are your users, how is it going to be used? What is the use environment? How do I want the the user to interact with this device? What are the characteristics that we want this to have? So there’s a lot of planning that has to take place up front. And what I do I enjoy the fact that I’ve gotten to the point where I can understand what’s going to happen downstream. And I like helping companies create products that are safe and effective and help people.

Aaron Moncur 30:14
So it’s not just the fact that you’re solving a puzzle, you know, with all these complex pieces that need to fit together just the right way. It’s, it’s, it’s that, but it’s that plus the fact that the end result is something that helps people makes the world a better place. Is that a fair summary?

Margaret Koga Ward 30:35
Absolutely, you know, very, very much so. And thinking that the biggest aha moment I had, we were trying to develop a device that basically took some very squishy material and used it as filler, into the body, it was kind of a filler material, but it was like, we’re almost like working with jello, and we had to push it. And if you pushed it, it turned from this nice gummy substance to this kind of very flat hard materials, it was an expanded, basically, expanded Teflon was the weirdest material, and we you know, it had to be a small device. And, you know, suddenly Things are getting complicated, we’re looking at, you know, having miniature motors at the end of this device to just start driving the material for because we knew we couldn’t push it. And I got a little obsessive about it, I’m going to admit to that, as a lot of engineers do when you’re working on a problem. And in the end, it just kind of came to me to have a very simple, very inexpensive little drive system that relied on a couple pieces of metal with alternating the teeth that alternated in different directions. You could reciprocate little back and forth motion and just drive it up beautifully. And I think that was really one of the best aha moments of my career, earn me a patent, which I thought was silly, because it seems so simple. But it was again, it was just taking a taking a step back, you know, give your brain a break, sometimes take a step back, you know, remember that there’s probably a much simpler way to do this.

Aaron Moncur 32:21
Let’s dig into that a little bit. That’s really interesting. So you were you’re working hard at solving this problem. solution was not immediately obvious. Do you remember kind of the like the context with within which you had that aha moment? How did you go from being stumped to having this this breakthrough?

Margaret Koga Ward 32:40
You know, like any of us who’ve been engineers long enough, know that our brains are very stubborn, you can’t force them to be creative. You know, brains are amazing, you know, your brain can hate a song, but it will play it for you all day long. So it also sometimes it’s a matter of, of just understanding that. I remember, I just I had to kind of stop consciously thinking about it. But I know in the back of my head, I was always thinking about it. And I, you know, I was probably doing something mundane, actually, I think I was taking a shower. It’s I start to think about it. And I had really kind of let go of the of the complex, and again, started going back to the big picture, what do we want this to do? We’re not going to have a product, if we have to have miniature motors in it. And that just must be a different approach. And I know I was thinking about it and actually started drawing on the walls of the shower. It’s something I don’t remember something. Yeah, I don’t know, there must have been something I was using, I think I think I’d been using a cheese grater or something like that. And just started noodling with this idea, and started drawing on the shower, on the walls of the shower, and came out and I think I was dripping wet and wet and sat down and started drawing things out. And by the next day, started prototyping, it did some proof of concepts. And it worked. It worked great.

Aaron Moncur 34:15
That’s fantastic. It’s so interesting how your subconscious, it really is kind of always working. But you have to give your conscious mind a chance to hear what your subconscious is saying. I’ve found that when I have a hard problem, I have to in order to solve it, I often have to focus very intently, consciously on that challenging problem, you know, spending, I mean, depending on the magnitude or complexity of the problem. Sometimes it’s just, you know, several hours of focused attention but other times it can be days or even weeks or months of focused attention trying to figure out this problem. But the solution doesn’t come you sometimes when when I’m consciously focusing on it. But when I intentionally remove my brain from that problem and go watch a movie or take a shower, or you know, read a book lying in bed at night, that’s when the light comes on. And all of a sudden, oh, I could do this. It’s such an interesting process. It really

Margaret Koga Ward 35:16
is, isn’t it, it’s fascinating, I would find that I’d be, I would be my most creative sometimes out, taking a walk, all of a sudden, everything just starts to fall into place. And it’s usually when you’re doing something like like walking or running, or as you said, watch a movie where it’s just your subconscious brain that has a chance to relax and process or know, there’s not just me, you know, wake up at two o’clock in the morning and realize you’ve been thinking about it. And you kind of lie in bed, and you’re just in a more relaxed state.

Aaron Moncur 35:53
Yeah, there have been studies that show that walking creates or promotes creativity, which I thought was really interesting. All right. Let’s see, you have you’ve done quite a bit of training in in your career, both being a trainer and and being trained it? Is there. Is there some training that you’ve completed, that you’ve received, that you feel like it’s been especially helpful or beneficial to you as an engineer?

Margaret Koga Ward 36:26
Wow, there’s been quite a few. I think my favorite training that I attended, was for it was, I’ve been, I’ve been working on design controls in medical devices for many, many years. And I knew most of it and I thought I really understood it. But I had the opportunity to take a course through a Ami. And it presented the process in a way that was clear cut. It was it made sense, it was a logical progression. And it really helped to fill in the blanks of anything that I thought I wasn’t an expert in. And it made such an impact on me, that actually decided to become a trainer for that organization. And now I teach that course.

Aaron Moncur 37:17
And it’s and what’s courses that?

Margaret Koga Ward 37:19
Well, there’s there’s three courses that I teach. One is the quality system management, which is the overall quality system that’s required for medical device company, both for FDA, ISO and ISO. The other one is much more specific. It’s designed controls for medical devices, which really incorporates the processes of understanding your user and your use environment, introducing risk, what can happen, what are the what are the likely scenarios? What are your hazards and hazardous situations? Identifying your design inputs? You know, what does this have to do not at an engineering level of detail, and then the processes of verification testing and validation testing. And it’s, it’s a process that is used in the medical device industry. And I know there’s similar processes in other regulated industries. But I actually have advised a couple non medical companies about its use, because it really is a wonderful process. But I love being a trainer, because one of the the difficult parts is to really to be able to explain it in a way that anybody can understand it. Because we have people in the courses who may only have one or two years experience in medical devices, and we might have people with 20 years of experience.

Aaron Moncur 38:45
Well, it’s just another puzzle the solution to which results in helping someone right, that’s your MO, apparently,

Margaret Koga Ward 38:51
yes, absolutely. It is, you know, make it understandable. And that’s, that’s very difficult. It’s easy to stand up there and be technical. It’s much more difficult to stand up there and explain things on a human level. You know, if I can make my college son understand that then then I know that we’re on the right track.

Aaron Moncur 39:11
Yeah, mission accomplished. Well, speaking of challenges, what what are some of the biggest challenges that you face? As an engineer?

Margaret Koga Ward 39:20
Hmm. Wow. It’s probably a a personality quirk of mine. I get frustrated when I run into people who will tell you that it can’t be done that way. Because this is the way it’s supposed to be done. We’ve always done it this way. And their minds are not going to be changed. I think I’ve run into that in every industry. We’ve always done it this way. It’s always done this way. We did it like this at my last company. Not understanding that most fields, especially medical devices, they’re always evolving. You know if you did something this way five years ago, chances are, you need to do it very differently now. So I think it’s frustrating for me when people won’t advance their learning or their training, either going to training sessions or finding information online reading the standards and keeping up to date with the, the current expectations. Yeah.

Aaron Moncur 40:22
Can you share? Are there any vendors that you’ve used that you really like? That might be useful for other engineers or engineering teams listening to this?

Margaret Koga Ward 40:31
I mean, vendors like

Aaron Moncur 40:32
you. Oh, no, not Well, I mean, like, like hardware suppliers, or, you know, fabrication shops or contract manufacturers, that kind of thing. Ah, wow. But if you want to include pipeline

Margaret Koga Ward 40:46
pipeline, yes. There’s there’s minor more specific to least recently to the medical device industry. Some of my favorites have always been bare material sciences. I think now, they’re co Vesco they were bought by somebody. If you’re involved at all in medical device packaging, I always recommend clean cut technologies out in California. And none of these people know I’m going to mention them. And I’m certainly not getting a kickback. And then for device manufacturing, or manufacturing services, contract manufacturing. I don’t know I have to remember their name. I’m completely blanking on their name. But there’s a company on the East Coast and the name will come to me in a minute when I stopped trying to think about it

Aaron Moncur 41:36
exactly. Go take a shower and then come back.

Margaret Koga Ward 41:41
Cadence cadence manufacturing, Cadence cadence? Yes, yes. Because they could do everything. I was visiting their facility. And I have a facility that can put a sharp edge on anything, they laugh, including a piece of gum. So that facility was full of anything that you could imagine that’s sharper than sharp, something tiny to these huge blades that are used in the food packaging industry. And I look and there’s the sign for where to go in case of a tornado.

Aaron Moncur 42:21
I can just imagine that flying around in a tornado, it’d be like, yeah, as chopping people’s heads off as it flies around.

Margaret Koga Ward 42:29
They told me they were in an area that really didn’t get tornadoes. But yeah, about down the street.

Aaron Moncur 42:37
Well, what are some of your hobbies? What do you like to do when you’re not engineering things?

Margaret Koga Ward 42:42
Mostly travel. When I became a consultant, I set myself up in such a way that I could travel a lot for work, I love traveling, I love meeting people. My training takes me not only around the country, but around the world, get to talk to engineers and medical device product developers from all around the world. I love that. And when when I’m not traveling for work, I travel for pleasure. So the last few months have been kind of hard, I find myself staring up at it airplanes. But I also like to cook so that’s, that’s been good.

Aaron Moncur 43:22
What are some of the most interesting places you’ve traveled just for personal enjoyment? Oh,

Margaret Koga Ward 43:28
gosh. Again, we’re just in Egypt, Egypt and Jordan, just fascinating. You know, I will tell people if you get the opportunity to go to Egypt or the Middle East, you know, it’s it’s safe. They’re very safe places and the most wonderful people I’ve ever run into in my life. Other than that, places that really I felt like I’d seen something incredible. I would have to put Peru up there, Vietnam, and Cambodia. And I’ve traveled around the world. And those are the places that really felt like I’d been somewhere somewhere very unusual. Yeah.

Aaron Moncur 44:08
Okay. Well, I have to put those on my bucket list. Well, Margaret, thank you for spending some time with me and just chatting. This has been a lot of fun. It’s so interesting that occasionally I will interview someone like you that I’ve known for a long time, but you learn all these things that you never knew about the person. So thank you for sharing all of that. Finally, how can people get a hold of you? What’s the best way for them to get in touch?

Margaret Koga Ward 44:36
Probably the easiest thing is LinkedIn on the only Margaret Koga Ward it’s K O G A and then Ward W A R D or my email is mkoga@teragrammed. It’s teragrammed.com, and teragramed, which is my company name is actually Margaret spelled backwards.

Aaron Moncur 45:06
I never knew that. How did I not know that?

Margaret Koga Ward 45:08
It’s not obvious, is it?

Aaron Moncur 45:10
It is not. No, I always looked at that. Name it. That’s an interesting name. I wonder where she came up with that. Brilliant,

Margaret Koga Ward 45:19
Big picture. You have to know things backwards and forwards.

Aaron Moncur 45:23
That’s wonderful. That’s just terrific. All right, Margaret. Well, thank you again, for sharing some of your wisdom and going through some of these great experiences that you’ve had. Thank you very much.

Margaret Koga Ward 45:35
Thank you, Aaron. It’s been a pleasure and take care. It’s wonderful talking to you.

Aaron Moncur 45:43
I’m Aaron Moncur, founder of pipeline design, and engineering. If you liked what you heard today, please leave us a positive review. It really helps other people find the show. To learn how your engineering team can leverage our team’s expertise in developing turnkey custom test fixtures, automated equipment and product design, visit us at testfixturedesign.com Thanks for listening.