Revolutionizing Orthopedic Care in Low-Income Countries, Part 3 of 3
**Note - please excuse the typos. This transcript was automatically generated.**
Hetal Baman (00:00:01) - Two weeks ago on the Global Health Pursuit podcast, we spoke with Signs founder and president Dr. Lewis Zirkle. Last week, we spoke with Jeanne Dillner Signs CEO. And this week we get to speak with signs very own engineering manager Terry Smith. Today we're diving deep into the engineering of it all. Now, I'm not going to bore you with all of the technical details of the engineering world, but I really did want to know how Terry and the science team work together to create orthopedic implants and instruments that serve patients in populations that don't necessarily have reliable electricity and places where the infrastructure may not be the greatest. Now, according to the W.H.O., about 1.3 million people die each year from road traffic crashes, and more than half of these deaths occur among vulnerable road users, pedestrians, bicyclists and motorcyclists. On top of this, between 20 to 50 million more people suffer non-fatal injuries, and many of these people incur injuries that are disabling, to say the least. As the engineering manager, Terry, speaks to us about how science design process to create trauma implants and instruments is so different than the norm.
Hetal Baman (00:01:31) - He speaks with us about how they work with surgeons from all around the world to create better products and implement relevant education so that each side surgeon is able to optimally treat their patients. So how do they begin to create devices to serve these patients? Keep listening to find out. Before we get into the episode, here's a little bit about Terry. Terry joined Sign in January of 2017 as the engineering manager responsible for developing and maintaining sign products. He brings a broad background in product design, product development program and project management in the aerospace, renewable energy and instrumentation technology with experience in small and large organizations allowing him to navigate the challenges and rewards of startup companies and corporate organization. Prior to joining Sign, Terry held leadership positions at the Boeing company Infineon Corporation and Bruker. Throughout his career, he has worked with domestic and international teams and customers to turn ideas into designs and products. Terry is an inventor on four different patents and earned his Bachelor of Science in mechanical engineering from the University of Wyoming. My name is Heather Baumann and this is the Global Health Pursuit.
Hetal Baman (00:03:02) - Hi, Terry. How are you?
Terry Smith (00:03:04) - I'm good. How are.
Hetal Baman (00:03:05) - You? I'm so great. I just want to mention that, you know, I've been looking forward to this interview so, so much, not just because I have a background in med device and orthopedics. But because when I first heard about sign, I want to say like 3 or 4 years ago, you know, I learned about the unique angle that you guys take. Your team has taken to. Not only design and manufacture implants for low resource areas all around the world, but honestly, like the fact that you guys really get the surgeons involved from all around the world, it's it's truly I think it's really, really inspiring. So with that being said, I want to welcome you onto the podcast.
Terry Smith (00:03:55) - Thank you. Yeah, no, I'm very excited. It's always like I said, it's always fun to share about saying their mission and the work we're doing.
Hetal Baman (00:04:01) - Firstly, I want to learn about a little bit about you and get a little bit of a story behind how you got to sign.
Hetal Baman (00:04:09) - Yeah, tell me a little bit about yourself. Sure.
Terry Smith (00:04:11) - Maybe I'll give you the kind of a big picture and then I'll zero in on sign a little bit and relationship we had with sign overviews. I have a mechanical engineering degree from University of Wyoming. My career is really well spanned decades now, which is kind of scary to say that out loud, but it's kind of come in three phases where and it's all been really related around product development or research. So I've been really fortunate, super blessed career started in aerospace, you know, structural design on, on essentially military airplanes.
Hetal Baman (00:04:45) - Okay. That's very different from what you're doing now. So I.
Terry Smith (00:04:48) - Have this, yeah. As I talk a little bit, you'll see that I had this huge diversity large companies, small companies, startups and now a non-profit. But so did structural design work at Boeing for a number of years. I have out of that there was 3 or 4 patents, some of that work. It's kind of fun to walk into a Air Force museum and see an airplane that you actually have parts that you design.
Terry Smith (00:05:10) - Oh, so cool. So it's really cool, right? I mean, it's just like every one of my projects that I've worked on over the years seems is like a dream job for for some people. So I feel really, really blessed and fortunate to have the career that I have. So after spending about 16 years in that space, I decided to move to a smaller company and that was again aerospace related in that we were working on deep space electrical power generators for deep space probes, and that lasted a couple of years. There were some contracts there and the CEO at the time decided that technology could be used also be used in renewable energy space. Okay. And so we were headed down a path for a few years on developing a renewable energy product, and we didn't quite hit that curve right. It was our timing was a little off. Our cost structure wasn't quite right, but the technology ended up still exists. And there's a couple of companies that are using it, one for a cooler application and then another is like a remote power and compressors for compressed natural gas.
Terry Smith (00:06:09) - So those those are going up. Probably the coolest thing out of that is when I first started that company or I started at that company, there was like 35 of us, right? So I go from this company of 200,000 people where there's, you know, I can just go to the.
Hetal Baman (00:06:22) - You know, what your job is, and you go in and say, well.
Terry Smith (00:06:25) - And then I have this list of experts, right? So if I have any question on any topic, I can go to the internal phonebook and find some technical fellow that's that person that has been doing this for years. Right? And so then I go to this 35 person startup where you had to do everything right, literally everything. So anyway, but that was that was very fun. There's kind of the unique story out of that particular group was we delivered for these electrical generators to NASA in Cleveland, Ohio, at the the Glenn Research Center, and that was back in about 2004. Time frame three of those engines are still running and they haven't had any maintenance done on the engines.
Terry Smith (00:07:04) - The test stands and all of that have broken and fixed. So the it's been probably a year and a half ago since I've talked to one of them, but they're still running. And that was the intent. Right. They needed to have 20 or 30 year lifespan. So they're they're pretty close on that. Anyway, that was kind of fun. Then I switched from that into I kind of went into this technology space and that was part of it. And then I had another opportunity to work for a company and we did handheld x ray fluorescence instrumentation.
Hetal Baman (00:07:31) - Okay, Moving into the health space. Okay.
Terry Smith (00:07:33) - That's actually not what. No, no. It's more of a quality. It's more of a quality inspection tool. So it looks like this is Star Trek. Literally, it's like a little an old Star Trek phaser looking device, our first one really to kind of look like that. And so it's a little x ray and a sensor in this handheld device. And if you want to know what a metal alloy is, you can place this against that.
Terry Smith (00:07:55) - You pull the trigger, generates this x ray. If you had chemistry and you remember your valence electrons, the x ray NOx. Yeah. Really? I don't remember that really. Seriously. I had to read all of that. And so anyway, but it'll tell you what that alloy is, right? Or if you want to know the actual chemistry, it'll give you the chemical makeup of the alloy and that those are instruments that are used, quality control people will use them. So if you order. So we actually have several here in the building. So when we order raw material, we want to know that what what was shipped to us is what we ordered.
Hetal Baman (00:08:27) - Right. Right.
Terry Smith (00:08:28) - You have material search and it comes with. All of that. And they're serialized, right, particularly for implant materials. But we have had an instance where we had ordered an alloy called Nitric 60 and they shipped us 17 for for an instrument, which would have been a very big deal if we would have made.
Terry Smith (00:08:43) - Oh, wow. If we would have made parts out of it and shipped them right. That's a huge deal to not. Yeah. And so, so that device is used to just kind of part of that quality inspection. And so that was kind of a fun job to have for a while that I had in all of these. I've been really in engineering management, right? So I had a team of software engineers and electrical engineers and mechanical engineers developing products around that. And then, you know, I'm going to roll back just a little bit. So the company that I worked at where we were doing the deep space power generation and the renewable energy at that time, I had had one of the engineers had left us that was a cyclic company. So we hired a lot of people, laid off. A lot of people hired people, right. We were in that in that mode. And one of my engineers that let go, he says, I fired him. Really? It really didn't happen that way.
Terry Smith (00:09:35) - It really didn't happen.
Hetal Baman (00:09:37) - You're like, it's just semantics. Whatever.
Terry Smith (00:09:40) - Well, he had an option to take, you know, to take a package to leave or try to stick it out with this and hope we raised money and then not have any. You know, the potential was he was going to continue to have a job or we weren't going to have money. And we're all looking for jobs. Right. And so he chose he chose a package so that he had some you know, essentially was.
Hetal Baman (00:09:59) - And then he said that you fired him.
Terry Smith (00:10:02) - He works for me again now. So it's like.
Hetal Baman (00:10:04) - Oh, wow.
Terry Smith (00:10:05) - Yeah, that's a whole story. So he came to work at Simon and so we met Sine and Dr. Jekyll, our founder and CEO, kind of through that relationship. And also I was working with Gene Donner and the CEO on an economic development committee where we would do manufacturing expos locally and sine always had a booth. And so we kind of started supporting them. Like they would come over to the engineering team that I was running and say, Hey, like, like lunch and learns.
Terry Smith (00:10:33) - And they'd explain to us what they were doing. And they had a couple of engineers at the time working for Sine, and we would try to help them out with ideas, right? Or analysis, whatever we could do to give them a hand on their projects. So we did that for quite a while. And so and then at one point I got laid off in between jobs and I'm talking to Jeanne, the CEO, and she's like, We need you to do an internal manufacturing audit. And I'm like, Gene, I know. I know nothing about what you're doing, right.
Hetal Baman (00:10:59) - About med devices.
Terry Smith (00:11:00) - Devices, you know how to do an audit. And so I happened to have a colleague, the next colleague, that she had done that for a while. And so she's like, here, Terry, I'm going to give you the crash course. And so he came to sign for about six weeks and got paid like minimum wage, right? I mean, it was nothing.
Hetal Baman (00:11:16) - And when was this?
Terry Smith (00:11:18) - This was back in about 2011.
Terry Smith (00:11:21) - 2012.
Hetal Baman (00:11:22) - Okay.
Terry Smith (00:11:22) - So about, you know.
Hetal Baman (00:11:24) - And how big was signed back then?
Terry Smith (00:11:28) - There are probably about 25 people.
Hetal Baman (00:11:29) - Okay. Yeah. 20.
Terry Smith (00:11:31) - Yeah. They were just trying to get to ISO 1345 Okay. They'd had a couple of countries that said, Hey, if you're going to ship to us, you got to be ISO certified.
Hetal Baman (00:11:39) - And what is ISO for anybody who hasn't, who doesn't know?
Terry Smith (00:11:43) - It's an international standard that's used a lot for products and it doesn't matter whether it's a medical device or there's if you have consumer products, it's generally European standard. A lot of US companies follow them. And so it's really a quality standard. And so it's like if you're going to develop medical devices, 1345 is required by a lot of countries, health industries. It just tells you how to set up your quality management system and it's really how you manage the organization, how you how you procure products, how you qualify suppliers. It gives you requirements around. It doesn't tell you exactly how to do it.
Terry Smith (00:12:22) - Well, let me just step back. I saw in the ISO 101 is you tell me what you're going to do, right? So you write down your processes of how you're going to do your work. Then you have to go do it and then you have to have the paperwork that tells you that shows that you did what you said you were going to do. And that's that's ISO in a nutshell, right? That's really what it is, you know? You know, tell me what you're going to do. Go do it and then show me that you did that in an audit. And when it comes to developing and releasing a medical product, particularly for us in the orthopedic world, it is they give you there's a section called Design Control, and it really parallels closely what the FDA requires. And those two are starting to merge. Now, FDA is starting to really kind of take on that ISO 1345 and they say they're going to harmonize it. You know, they've been seeing that for years.
Terry Smith (00:13:10) - But in the end is for sign, we are we are registered with the FDA as a as a medical device manufacturer with the 1345. We have to do design control, what's called design control. And and again, it's just a it's a way of a formal process to get requirements for your products then. It's a way of you map out how you can trace how those requirements go through your design process and how you're going to test to make sure that what you it's called design verification. The design that you did is what you said you were going to build. And then you have to do the validation side and hopefully we'll talk about that. Yes, but which proves that what you designed is what the user wanted, Right? Right. It's really it's really that's the basics of it. And there's a lot of there's a lot of paperwork involved sometimes.
Hetal Baman (00:14:00) - Oh, so much paperwork. I know. I so like verification is more like in-house testing, mechanical testing, all of that stuff. And then validation is like, is it going to work in the user's hands? You know? So that's essentially in a nutshell what verification and validation.
Hetal Baman (00:14:16) - I remember like back when I was in school, there was a lot of confusion around like, what is that?
Terry Smith (00:14:23) - Even in industry there still is, right?
Hetal Baman (00:14:26) - Oh, interesting.
Terry Smith (00:14:27) - You know, so because they don't teach you this isn't something you learn in college. No. Unless you unless you have a really special class. But for the most part, you don't.
Hetal Baman (00:14:35) - Yeah, right. Yeah. So what sign does is design and manufacture implants and instruments for orthopedic trauma injuries within low resource areas around the world. I wanted to talk to you a little bit about kind of the medical device orthopedics world in general and how what you're seeing year after year is just like a technology upgrade. You know, you're getting better and better and better and then it's like, you know, the device needs all of this electricity and then all these wires and all these all of these different things that you might not find in a rural clinic. So at sign, what have you seen that is very, very different than, you know, other medical device companies? And what is the process like for you guys? Sure.
Hetal Baman (00:15:32) - Sure.
Terry Smith (00:15:33) - So. I think in the US markets because the medical devices are so competitive, they have to have a unique selling point, right? So there's this, you know, the US side and so that unique selling point, you know, so they're always coming up with unique ways of doing things. And it's that like, well, ours is a little bit better than yours because of this, right?
Hetal Baman (00:15:54) - This one little aspect of it. Yeah, it.
Terry Smith (00:15:57) - May be right. And so a good example is so we treat long bone fractures, right? So the tibia I start down at the shin bone, so the tibia, the femur and then the humerus, which is in the arm. And so that's what our primary goal is, is because overseas in low resource settings, when those are fractured and they don't heal properly, then that is literally a poverty is a break away for a lot of these people. Right. And so if they can't get treatment and it doesn't heal correctly, they don't work.
Terry Smith (00:16:25) - And then, you know, it could.
Hetal Baman (00:16:26) - Be they can't go to school. They can't work. There's a mental health problems, all of these things.
Terry Smith (00:16:31) - Yeah. And in some and in some countries and in some settings that it's literally a death curse to them. Right. Because. Right. They just they can't make a living and they won't eat. And so then they're reliant on the charity of others. So we have a universal mail, right? So here's a great example. We have a couple of different types of intermediary nails. And so for the audience that doesn't understand what that is, it's a it's essentially a stainless steel rod. And the surgeon is going to place that rod down the center of the Bone Canal because his goal is to stabilize that fracture during healing. And then he attaches ILC attaches. He interlocks that that rod to the bone by putting in bone screws and the ends of this stainless steel rod, there's holes. And so he has to put bone screws through the bone into that hole in the rod.
Terry Smith (00:17:14) - But he does that in this in a low resource setting. Our system is set up to not require an x ray machine and surgery. Right? And so that's kind of a unique part of it. And there's a lot around why we have to do it that way. And in the US or in Europe, what a surgeon will do is he'll have a real time answering machine in surgery. And so when he places that that nail down the center of the Bone Canal, he sees where the where the holes are and that end of that, he'll know where to make an incision and where to drill a hole so that the the bone screw can go into that.
Hetal Baman (00:17:45) - Yeah, they're able to take a picture every five seconds to be like, okay, this is exactly the right place. I'm in the right place.
Terry Smith (00:17:51) - Right? And so our system is you attach a nail to that, to a targeting system, and it's placed down the center of the canal. And then on the outside of the patient, the surgeon will know using our alcohol, you know, if you're a woodworker or have done anything, it's really like a drill jig, right? It's a little jig that tells them where to make an incision, where to drill a hole, and then they can blindly place that screw into that the end of the nail and interlock the nail to the bone.
Terry Smith (00:18:19) - And so that's that's what our product does. And so and.
Hetal Baman (00:18:24) - They're doing this without x ray technology or any of that.
Terry Smith (00:18:27) - Yeah, they're doing that. They'll have the, you know, they have to have an x ray to understand what the fracture is. And so. Right. And so that's they'll do a pre-op X ray, but a lot of times that x ray machine is in a different part of the hospital or a different part of the hospital campus, like literally across the campus, you know, And and or we had one one surgeon, he was working at a hospital where he had he didn't have an x ray machine. So they had to get their x ray to another clinic. The other clinic didn't have orthopedics or surgery capability. So they would the patient would bring their x ray with them to his house. Oh, wow. It's super crazy. So back to like, what's the differences between us? And so we have one nail that, you know, and it could be used in the tibia, the femur or the humerus, and it can be used on the right hand side of the body or the left hand side.
Terry Smith (00:19:18) - Oh, wow. Okay. And it can be used, say on the in the femur. It'll either come down from the top of the hip, it'll or it can be used and that's called anti grade or it can come up from the knee bottoms up into the knee in. That's called the retrograde approach. And we can use the same nail to do what's called a retro calcaneus fusion, which is the way to fuse the ankle. So if you ever really, you know, a low tibia fracture or the calcaneus, you know, fracture, that's pretty bad. Then you can you can you can fuse the ankle together. And sometimes that's required so that single nail can do all of those, right where like I said, here in the US or in Europe, they're going to have a unique nail for each of those applications, right? Or maybe 2 or 3 unique nails depending on the type of fracture. Our goal is to be very universal in our approach and then but also do the resource appropriate design, right? And so it's really understanding what's going on in those in those hospitals and and the breadth of the hospitals that are surgeons work in is huge, right? So on one side, there may be university teaching hospitals in the larger cities in Africa and Asia, and they're reasonably modern, right? They may or may not have a work access to the working calm in the hospital.
Hetal Baman (00:20:39) - Calm is the x ray.
Terry Smith (00:20:41) - Yes. Yes. Is that real time x ray machine that's used in surgery and for a variety of reasons, Right. Maybe they don't have the maintenance crew there. Right? They can can maintain it or they save it for surgeries that absolutely require the use of the CR. And they know that with our equipment, they don't have to they don't have to have it in an operating theatre that has the right. So they may, depending on their surgical load, on their hospital, they may choose to not use that operating theatre. So that's one extreme. And on the other extreme is, like I said, a hospital that may not have an x ray machine in the facility and the the patient has to bring an x ray with them. And so it's that whole spectrum there that we have to do a lot of. But overseas, they don't have the same power quality. And so that's really hard on this electronic equipment. And so they just don't last as long in some of these countries.
Terry Smith (00:21:32) - And like I said, they don't always have the train maintenance technicians there to do the maintenance. The long term, it's on the equipment. So that's yeah, so that's the challenges that that our surgeons and hospitals face. And so our goal then is of course, to try to get out of this. We're trying to address with a universal design, this huge spectrum of use cases, right? And so that's the fun and the challenge of some of the work that we get to do. Right. And I would say in the early days, you know, Dr. Surgical, he had in your interviews, you just learned that he's he is like the most compassionate patient advocate you'll ever meet. And so he had spent a decent amount of time collecting used medical equipment and teaching surgeons overseas. And he did that for a number of years. And on a visit, there was a patient that that they kept walking by him and the surgeon that he'd been working with for several years. Right. And he didn't that that particular patient was in traction and he'd been in traction.
Terry Smith (00:22:35) - So finally, doctor said, why aren't we treating this patient? And he's like, Well, he's in traction.
Hetal Baman (00:22:40) - So when you say traction, what does that mean?
Terry Smith (00:22:42) - So they'll take and attach a weight to a leg via There's a couple of ways to do that. Sometimes they'll actually put pins in and attach a weight to it and they they take the fracture and they're trying to stretch it out and align the bones. Sometimes when a patient has a fracture, the muscles will contract and the bone ends will overlap and not aligned. And so they they put them into traction. That is a method to try to to heal bones, but it usually doesn't work on the femurs very well to get them to align that whole story with this particular patient was made. Dr. Zurcher realized that the work that he had been doing of donating like used US medical equipment, was it resource appropriate design because they couldn't use it. It didn't have it goes back to their they didn't have the right arms, they didn't have the right equipment.
Terry Smith (00:23:29) - And so he had spent a number of years doing this effort and realized that it was like it was for literally for not. Right. Yeah. And so he'd helped some people, but he. And so then you realized that he had to start sign and had to do a design of a implant system from scratch that was resource appropriate.
Hetal Baman (00:23:47) - So I mean what he was doing back then was just like, you can say that it was almost like not sustainable. You know, like there would be some some cases where it would work out. But then, you know, you use this one donated thing and then it's done.
Terry Smith (00:24:03) - Right. Right. And then you hope that you get more of the same. Right. Implants to go work with the rest of the surgical instruments. Right. So that led to the formation of sign. And so he in the early days of sign, he was a voice of the customer, right? He was the voice that he would he would travel like once a quarter for a week or two weeks.
Terry Smith (00:24:21) - He'd come back. He had a whole list of ideas and things and challenges that they faced. And then at that time, the engineering team would just iterate on those designs until we developed our our email system that we have today.
Hetal Baman (00:24:35) - So, okay, so that's a good point. I was going to ask you, like what was your starting point? You know, did you have like a nail that you had from like a different medical device company and was like, okay, well, we're going to use this as our starting point and then we're going to start like designing down to become universal.
Terry Smith (00:24:56) - Yeah, let me I'll try to get through that in a, in a concise manner, right? Yeah. So there's one thing about sign that I find extremely fascinating. It is extremely providential. They are things that happen at sign for no. Like if you look at it externally and you're like, how did these people come together that were not associated with each other? And things work out to one of those fortuitous and providential moments was a gentleman.
Terry Smith (00:25:24) - Dr. Jekyll befriended a gentleman by the name of Randy Huebner. So anybody in the orthopedic world that knows Acumen, Randy was the founder of Acumen Mechanical Engineers. Super. Great guy. He's on our board. He's like one of our guest engineers, to be honest. He does a lot. He does a lot of work. But it's super fun to work. It's super fun to work with him.
Hetal Baman (00:25:42) - The honorary engineer.
Terry Smith (00:25:44) - Engineer. Yeah, he's really an engineer at heart. And so it's fun. Anyway, so Dr. Drew contacted Randy and they became friends out of this. And so Randy actually did the initial they had at that time, assumed had a humoral male to treat the humerus. And so he did he did a basic initial design for for sign. And it included a little bit of the instrumentation. And then from there, that kind of led to the creation of the rest of the sinus system and the sign email system, I should say. And then it's things progressed. Yeah, there's so much I could cover here.
Terry Smith (00:26:21) - So part of the thing that you mentioned this early on in our conversation about our access to science surgeons and our ability to communicate with them and right. So a lot of that is facilitated because we have a surgical database. And so what we require of hospitals that are participating with this and is that they fill out case information. So the surgical database is a long bone trauma database. Right now, there's over 200,000 cases in there. And so we asked that the surgeons fill out information about that surgery. We need pre-op and post-op X-rays. But the important thing is to follow up. What we really want is the follow up, because then that's really that is like the report card for the surgeon. And it's a report card for assigned, right? Because you see in there, we get to see like, was the training effective? You know, how good was the surgery? And then what were the results of that surgery? And you get a really good indication of of our devices doing what they need to be doing.
Terry Smith (00:27:24) - That's evolved over the years. And so but a lot of that surgical database also provided an avenue for us to provide training to the surgeons because doctors reviews every case.
Hetal Baman (00:27:36) - And I mean, you even said that before, like he literally reviews every single case.
Terry Smith (00:27:41) - We will comment on cases and sometimes the surgeons are emailing and asking questions. And so it's really that mentoring. It was like a mentoring tool, right? That's evolved over time. And we have you know, we have some board members that are also doing case reviews and we have some of our because we're going to be in 2024, it'll be 25 years.
Hetal Baman (00:28:02) - Yay.
Terry Smith (00:28:03) - Right?
Hetal Baman (00:28:04) - Wow.
Terry Smith (00:28:05) - It's super amazing, right, that it's been that sustainable. So we have mentors now. Some of our surgeons, you know, like literally the mentors have become the teachers or the students who become the mentor.
Hetal Baman (00:28:14) - Right, right, right, right.
Terry Smith (00:28:16) - So they're reviewing cases to and they're doing comments. So it's kind of fun to watch how this is going to become a little bit more distributed and not just, you know, focused on Dr. Jekyll and his ability.
Hetal Baman (00:28:25) - You're just going to do this forever. It's okay. Well, it makes.
Terry Smith (00:28:27) - It sustainable, right? That's right. That's really what it is. And that's the goal, right? That's the whole goal to do so. Yeah. So anyway, that is another that's an aspect of the training and but it also gives us a lot of feedback in the engineering team. You know, it takes some time to go study cases and get through it because it wasn't the database is not structured for us to do research on. It's really was structured around the report card, which is, All right, It just it means that there's some great tools now that we can use and we can look at cases. So so we review a lot of x rays and then there's a whole part of the FDA and ISO that's called post-market surveillance, where medical device companies need to monitor their devices and while they're need field use. And so this is a great tool for us to do that. And I don't I don't I'm not aware of other medical device companies that actually have this level of detail at this magnitude of information.
Hetal Baman (00:29:18) - So even for like, yeah. Post-op and yeah, that's, it's, that is really huge. I think, you know, when you think about like if you're an engineer and you're listening to this, you know, the engineering process within the orthopedics or med device in general, you know, you have a whole design control process where you go from inputs to outputs and, and you got to do like your verification and your validation. So how is it different from like a regular design control process? Because first of all, you can't just like call your doctor just randomly and be like, hey, like, I need you to come in and like, you know, let's talk about like voice of customer and then and then iterate and, you know, your validation, like your validation testing where you want to. Get this equipment right in their hands and, like, check off the boxes. How is that different from, like, a regular design control process? Sure.
Terry Smith (00:30:19) - In the early days, in your early days, they didn't know a lot about FDA.
Terry Smith (00:30:22) - They didn't know a lot about stuff. And they'd just doctors. They would design a couple. Yeah. And then the doctors were going to take it on a trip and use it. And so. Oh, wow. So it was like prescribed. Essentially, it was prescribed devices, right? What they were doing at that time. So the doctors would talk to surgeons ahead of time on the trips. What kind of cases do you have? And then, you know, he would take nails, implants, maybe a few instruments that they talk through what might be needed or based on the previous trip. Like if I had this instrument that was slightly different. And so that's how the system evolved in the early days. Now that the I'll say the email system is fairly mature and it's got a lot of feedback on it. The way it works is we'll get whether it's through the database, through email conversations or the one thing I haven't talked about is we do an in-person conference once a year on those really bad Covid years.
Terry Smith (00:31:15) - Yeah, we do an in-person conference and. It used to be that we would have like 120 or 130 surgeons that would show up at our headquarters in Richland, Washington. So it's out in eastern Washington. And then it's like it'd be four days of surgeons giving lectures like they would do presentations they'd have to apply to do. Here's the abstract, send it in. Doctors and the science team would approve them. Then they'd group them together based on topics. And then so it was a lot of peer to peer learning between the surgeons. But in that, what the engineering team would get was you start hearing the voice of the customer, right? Right. So then that would lead to conversations during lunch and breaks and in the evenings, like, hey, you know, sketches like what do you need? You'd also we would do we do surveillance training on this on the system, on the different approaches. And so engineers do well We get to do all of that training with those surgeons. And, you know, sometimes it's super fun when you have a young resident that's come over from from another country and they really don't know the system.
Terry Smith (00:32:23) - And you get a trainer and then you'll have a mentor there. You have somebody who's done maybe a thousand surgeries. Wow. And you look at their name card and you're like, oh, yeah, yeah, yeah. You need to be teaching, right? And you're right. Not me. Right. It's pretty intimidating. But then they're like, you know, they just they're really good because they're very respectful and they're like, they just interject like, Oh, yeah, but if you try this, you know, So they would. So it's pretty fun to listen to them. And then out of that and of course, if as an engineer, you're just like, we're just it's a dream, right, that you have all of these this huge customer base and you hear the voice of many customers.
Hetal Baman (00:33:02) - Do you see a difference between, like from one country to another country or like, you know, between cultures as well? Like is there is there maybe a difference in the way that. I don't know.
Terry Smith (00:33:15) - There are. There are some. There are some. Yeah. Sometimes the bulk of our surgeons are native to their countries. Right. Okay. But we also have a lot of us surgeons and or like Italian surgeons, there's a couple of Italian surgeons in Kenya, but in particular the US surgeons, some of them maybe are going over because they're doing it's a mission trip for them, but they're over there six months out of the year or three months out of the year, or they're over 2 or 3 years. And then they then they have to come back and do US boards and work in the US for a couple of years and then they go back, right? And so some of them have dedicated their life to to helping the injured poor, very much like doctors, but, but they're living overseas and doing that. And so sometimes the US surgeons, particularly ones that travel over there, they they can be a little bit like I like my way of doing it, you know. And so they have they have adapted our surgical technique to a method that they have.
Terry Smith (00:34:10) - And so, you know, and so sometimes it's like, well, we, but we designed it to be used this way, right? And so you end up in discussions and that's all right. That's all right. Right. And so because sometimes we find better ways or different ways of doing things. So that's probably one difference where like particularly in Asia, they're they are like super respectful and they're very good at following through the technique. They're very good at. You know, you have to listen very carefully for them to tell you that they don't like something because they don't always they're not black and white and telling you that. Right. And so we give them permission. A lot of times like, I need you to tell me what is bad, What is, you know, I.
Hetal Baman (00:34:48) - Know, right? It's it's.
Terry Smith (00:34:49) - Okay. Like, what is it that isn't working for you? Like what? Because I can't fix it unless you don't tell us. Right? And so. So sometimes you have to give them permission to do that.
Terry Smith (00:34:58) - And I would say the African surgeons come and some of them were very like, once you have that conversation about, you know, you have my permission to tell us, right? Because they also don't want to tell you that something's I don't want to say wrong, but it's like.
Hetal Baman (00:35:12) - This sucks.
Terry Smith (00:35:14) - We could do it differently, right? You could make it better and you could do it differently because they they understand. They understand what we're doing right and how we're helping people. And so, you know, and we have some great examples of stuff where we've gotten feedback and it's driven changes in our design. We have a we have a linear clamp that's used to like clamp the bones together to help in what's called the reduction. So aligning the bones up and, you know, we went through a whole, you know, the design verification and validation steps and then the surgeons started using it and and a couple of them were like, hey, the handle is too small. I need to put more pressure on it.
Terry Smith (00:35:53) - I'm using it. It was designed for long bones, but they're like, I'm using it in pelvic surgery and I need a longer grip and I need to do this. Yeah. And so can you change the shape of that handle so it doesn't hurt my hand so much. And so it's just something really simple. That's that that ergonomic side of it where they actually expand the use of our devices. And so then we go back and we make an iteration on it. So, you know, that's, that's that's part of what we get to do with them. And so our. When we do our bench testing, a lot of times it's with sawbones. They're foam replicas of bones. Doctors will do the surgeries with us. We worked out a technique with that with this in-person conference. Then we try to do all our new devices there. Usually we have breakout sessions where engineers, we're showing them all the new devices. But again, it's really like we're capturing feedback. We're like watching them how they use it, you know, because we try to you try to make your devices very intuitive on how to use.
Terry Smith (00:36:47) - And so you're showing that. And so you'll see like, oh, they don't understand, right? Whatever it is, our western way of thinking.
Hetal Baman (00:36:57) - Right, Right.
Terry Smith (00:36:58) - Is it maybe like the way that they were, they don't have that experience or that, So we have to think about it differently. And so then you watch them and it's like, well, okay, why don't you pick it up that way, you know? And how did you handle it? Why was it that you did that? And so some of it is, is it's just they were taught a certain way. And so then it makes us have to think about that, how we do our devices slightly differently. And so that the other thing that we actually have had this in the last five conferences is we've had bio skills labs. So it started out where we had a company and I'll promote a surgical training institute and, and they're out of Vancouver, Washington. They show up with a semi tractor trailer and it has eight surgical stations in it, right? It has slide outs.
Terry Smith (00:37:46) - It slides out to be a triple wide. They have eight surgical stations and then they were donated specimens. And we did three days of essentially cadaver training with these surgeons from overseas. And so that's another way. So now we're going to do the validation set, right? Yeah, right, right. So super fun. And since then, we've actually been able to remodel our building and we actually have our own bio skills lab now. And so we commissioned it last fall. We had a conference and we've kind of shrunk, decided to change our annual conference to be more like 30 or 40 surgeons. It's a little more, a little smaller, a little more intimate. But again, we had eight BioShield sessions in there, a couple spine sessions with some spinal surgeons and doing spinal trauma initial training and then and then all the Longbow training. So we are in there. We have a skin graft system we're working on right now. And so we were in there with the surgeons, like practicing and having them tested, giving us feedback, Oh, if you can change this.
Terry Smith (00:38:48) - And so part of that started in, in a breakout session where it was a benchtop benchtop testing. Yeah. And then we had a chance to move it into the lab and had them use it with the specimens and give us feedback. And so, so we have this really unique opportunity of how we get to do our verification and validation. And so or maybe we have a board member that's, that's visiting or sometimes local orthopedic surgeon and ask them if they can they can do some work with this and do the verification, the validation side of it. Yeah. So anyway, super fun that we have the access to these surgeons that is.
Hetal Baman (00:39:21) - I think that is so cool. I just want to ask you, like, how cool is it for you to see Sine evolve over the years?
Terry Smith (00:39:30) - You know, it's really fun because in the early days I didn't have a ton of exposure to okay, so I didn't ever finish my story, right? So I did that short part time stint with sign back about 11 or 12 years ago.
Hetal Baman (00:39:43) - Oh, right, right, right, right.
Terry Smith (00:39:44) - And then after that, the company that I was working for that did the little Star Trek handheld X-ray fluorescence, we would sponsor tables at their fundraisers. Okay. So and I knew two of the engineers here had worked for me in the past, So it was always fun to show up and and kind of talk to him at the fundraisers. And then Gene, the CEO and I like I said, we are on this committee together. So I'd see here 2 or 3 times a year outside of assigned. And then one day I had my job that I had was a super good job, but I was ready to move on Culturally. There was a lot of is ready. I was ready to move on from from a corporate culture, quarterly profit standpoint like you get in if you ever into that you know engineering's a cost center and it's just like they were going to save their way to prosperity. They didn't they weren't they didn't know how to sort out and do a product and sell products.
Terry Smith (00:40:37) - Well. So to and so anyway. So it was it was I was kind of looking and this she called me up one day. She's like, hey, I think I need to we're making changes in engineering department. Are you are you interested? You want to come talk to us? And I said, Sure. She goes, okay, well, we need you. Why don't I meet you for dinner? And and she had like, she had an auditor that was in the building that day that was. And she goes, I want you to meet Sarah, our internal auditor, and. All right, I can do that. So I go to dinner. Well, it wasn't just Gene and the audit, it was the rest of the management team.
Hetal Baman (00:41:11) - Oh, my God. It was an interview. It was. They ambushed you.
Terry Smith (00:41:15) - Right? Well, and I knew, you know, I kind of knew most of them, so. Anyway, so they had that conversation led to a job offer.
Terry Smith (00:41:23) - And so I walked away from a corporate corporate world. It's to come join time. And that was six years ago. And don't regret it one bit at all. Great. I'll have a different retirement. Probably what it would have before, but whatever I have, I have so much more satisfaction in what I'm doing and the impact that we're making. So anyway, it's yeah, that's part of my I mean.
Hetal Baman (00:41:48) - I can see it in your face. Like, I mean, six years, it's not like you're a new engineer and you're like, Oh, I'm so excited. It's just like, it seems like, you know, every day is just like a new adventure.
Terry Smith (00:41:59) - It is. It is totally a new adventure. Part of. That's Dr. Jekyll. Part of that stuck is he is he is an entrepreneur at heart. And and he just will be like, yeah, okay. I know you guys are working on this finished because I need to go to the next thing and Right. And so we're always he's always challenging and pushing us and that's contrary to an engineer, right? We like to be very sequential and work through a problem.
Terry Smith (00:42:22) - Right. So that's it keeps us on our toes for sure.
Hetal Baman (00:42:26) - It's like almost like a startup environment.
Terry Smith (00:42:28) - It is a lot of ways in a lot of ways.
Hetal Baman (00:42:29) - Yeah, it is.
Terry Smith (00:42:31) - And wow. Yeah. So what else?
Hetal Baman (00:42:35) - I mean.
Terry Smith (00:42:36) - I could go on for a couple of hours.
Hetal Baman (00:42:38) - I know, but I really, I really want to close this interview by, you know, asking you what what's in the works for sign, you know, what are you most excited about for the future?
Terry Smith (00:42:49) - You know, there's. There's a couple of things there. I think one of them is we've had about four years ago, we met a couple of spine surgeons at the Canadian Orthopaedic Association conference. And so Dr. Strickland, Jeanne and I had gone up there and we did some Sawbones training to session during their conference. And so there was a young surgeon there. She was just finishing. She was just starting her spinal residency. Supriya Singh And so she kind of reached out to us like, Hey, what would you ever, you know, we've been thinking about spine trauma and like, we would like to learn about your model and what you do, that's fine.
Terry Smith (00:43:35) - And is it could we do something with spine that has evolved into there's a whole spine team surprise on there. Another doctor and I always been terrible at pronouncing his name. Another Canadian spine surgeon. And then we have a Dr. Mike Cassia that's out of Indiana. He's on our board. They are like they're like the core of this team. And then we have another surgeon, Saraya Karolyi. She's at his back in New York, another spine surgeon. And she's she's actually been acquainted with Dr. Jekyll for years. When she started medical schools, like she reached out, she's good friends with one of our spine surgeons in Myanmar. Dr.. And she's traveled over there a couple of times anyway. So that kind of those four are starting to to develop with some neurosurgeons a plan to do spine trauma. Oh, wow. And to to the goal is to to set up a couple training hospitals in Africa and in Asia. So right now there's Kenya, Tanzania and Nepal. Are the are there places that they're initially targeting? And so it's really to go in and treat thoracic lumbar injuries for the most part and then have rehabilitation on the on the backside.
Terry Smith (00:44:55) - Right. They don't they have to have all of that. But it's really to set up a residency program in those countries so that they we have a Nepali surgeon and a Kenyan surgeon that are doing their their spinal residency in Canada at Western. And so they're going through, and I should say, their fellowship. It's really a spinal fellowship there. And so from has been able to get that coordinated with with the university there. So then they will go back to their countries and then they will start a program, their fellowship program at those hospitals in those countries. And it'll be like 1 or 2 fellows a year. And then the key there is going to be like, can they get implants at a quality implants at a reasonable cost that's sustainable, right? And so there's a whole like a couple parallel efforts there. Can we find the right quality of implants from that are cleared with the FDA? That's kind of like one of the requirements we want because you know that they've gone through the appropriate testing and then and is the the right cost structure.
Terry Smith (00:46:05) - So there's also an effort of doing some conceptual designs of pedicle screws right around that. And so that's for me, that's super exciting, partly because my grandmother was paralyzed and I saw the struggle that she went through back in this 60s and 70s. Right. Which I think is some of those countries, you know, their medical capabilities similar to what we had back in those days in some ways or maybe less. And so having that ability to to get treated for that spinal trauma is kind of a big deal. So that's one that's one aspect there. You know, we're trying to it's getting treated separate from the long bone efforts. So so they have to raise their own funds, right? We're nonprofit. So it's like we don't want to take away from the long bone because then that becomes an opportunity cost for who we who we can serve, right? And so they're working through all of that. And it's super fun to watch them. It's a they're very passionate, very obviously, extremely intelligent. So for me, it's like it's fun to work with all of these people that have extremely articulate and that make me think differently.
Terry Smith (00:47:12) - And, you know, so they raise you up, right? That's really the cool, that's the cool part. And with it and even overseas, the surgeons overseas, these guys are incredibly good surgeons.
Hetal Baman (00:47:23) - When you think about it, right? Like these surgeons are doing these surgeries and these types of conditions where like they don't have the the x ray technology and all of the flora, they don't. Right, right, right. And that's what we see sometimes in the US hospitals where it's like, oh, I'm not really sure. I'm just going to take a picture here or I'm going to take a picture here and you're not able to do that. So it's so.
Terry Smith (00:47:47) - They become very, very good surgeons. They're very tactile oriented and some of the you see. Looking at x rays and you see the huge defect maybe from that injury and then what how it turns out and you're like, this is amazing. It's totally amazing. So that's fine. I'm going to go back spines. One of the aspects I'm pretty excited about to see where it ends up.
Terry Smith (00:48:08) - We have a new system. We're going to launch a skin graft system that's will be the summer and we'll we'll get that out into the field. So low cost, when you see a lot of the road traffic accidents, there's a lot of pretty severe soft tissue damage and skin flaps and the ability to to take a skin graft and cover it up, some of those damaged areas is pretty important. It'll also probably get used in a lot of burn victims. You see that in a lot of the countries where they're using wood and cooking fuel for cooking. There's a lot of there's a lot of pediatric burn patients because they don't a child reaches up and grabs a pot and boiling water or something, you know? So you see you see a lot of that. And so that's another one that we know would be super impactful. And then we're also doing dabbling in infection control and infection prevention, which is for engineers, is like totally weird, right? But, you know, a lot of our cases show present late to the hospital.
Terry Smith (00:49:09) - Right? So most of these countries, they don't have the emergency services like we have here in the US. So, you know, you don't call 911. They're not showing up in minutes and taking you to the hospital. And so some countries have it in some larger cities, but not in all cases. And so in some cases, they may be days to weeks or months after the injury that they have the ability they save money to pay for the trip to the hospital. Right. Right. And so they present late to the hospital and some of them are going to be infected. And so you're like, how do you help them? And without, you know, the surgeons obviously have a lot of antibiotics that they can use. Some of them are easier to access in some countries than others. But but then, you know, that antibiotic resistance, right? That whole you know, there's a lot of infections that have resistance to antibiotics. And so if you keep adding antibiotics and it's really hard and that and you just keep promoting that, that antibiotic.
Hetal Baman (00:50:05) - Resistance.
Terry Smith (00:50:06) - So we have a couple surgeons at Avastin. They're using UV lights. So a lot of times that's used in the US to try, but they're disinfecting whole rooms with lights, right? It's a couple of the surgeons have handheld and they're they're using it as a prep before surgery. So the skin area the local area and we've reached out and talked to experts in the light field and skins and dermatologists. And so, you know, there's a there's a gentleman from the UK that had worked at Harvard and the doctor there, and he I mean, he's published hundreds of papers, right? And so we just call them, email them and call them up. And half the time they answer and then we get to talk to them, right? And so so you also don't become very bashful at signing, right? And then you explain what you're doing. And usually a lot of times we see people are like, Oh, yeah, absolutely, we want to help.
Hetal Baman (00:50:57) - And yeah, how could they not?
Terry Smith (00:51:00) - Yeah, yeah.
Terry Smith (00:51:01) - So the infection control and infection prevention is one. We have another company called United Guardian. They make a product called Pectin. It's been around for years since the 50s. It's actually it was it's considered an over-the-counter antiseptic. Okay. It is very similar. It's like a very strong decon solution, which is essentially a chlorine based, but it's a more neutral. A lot of it's used a lot for installation on bladder infections and things like that, urinary tract infections. But a lot of orthopedic surgeons use it as a rinse out before doing, say, a total hip or told to me. And it's that last chance to to to kill any.
Hetal Baman (00:51:41) - Kill any.
Terry Smith (00:51:42) - And so that we have a surgeon in Uganda that's doing a clinical trial over there and comparing it against the standard that they use, which is like an iodine based product, like a Betadine, right? Or they use acetic acid a lot of times or just sailing rates. Right. So he's doing a clinical study with that. We have a nice relationship with United Guardians where they're they will either donate or at cost, depending on how much we're buying.
Terry Smith (00:52:10) - Another company called Bio Composites out of the UK, they make a calcium sulfate product called Stimulant. And so there are some US surgeons that and and technique that they will use where they'll mix antibiotics into that calcium sulfate. So if you have a large bone defect or infected bone, they will you can make antibiotic beads out of it and place it in that that surgical site or they will actually fill the canal partway with it and press the nail in into that. And then it provides additional support and then that sulfate will reabsorb over time. And then with the antibiotics there, it's really localized. And so you're not treating the whole body with that. You're treating that local infection site. So there's a risk there in that approach. We have a couple surgeons that are starting to use that and bio composites have donated. Sort of the stimulant product to us with that. So so that's kind of another fun part that we're doing where, you know, because it's an extension of some of the issues that we see in the field with some of the surgeons and that, you know, and like I said, when when you have an open fat fracture that has presented late and they haven't had medical treatment, it's going to be infected.
Hetal Baman (00:53:15) - Well, yeah, just to explain, like an open fracture is essentially when the bone sticking out of your your arm or your leg. Right.
Terry Smith (00:53:23) - Right. So that's kind of what's in the works right now. And and we have lots of other little devices that we're working on. A lot of times the one thing I didn't really talk about is one of the challenges that we face in time is are we manufacturing house? But we also have some times where we need to go out of house and do use contract manufacturers. So it's finding, you know, sometimes our production volumes are low. And so you're trying to like have a design that's low cost, right? But a lot of times low cost designs come with volume because you can do manufacturing processes that that allow that are less labor intensive. Like if you're stamping products or injection molding, the cost usually comes down. But you'd need to do a lot of volume with that too. So that's one of the challenges, is trying to get to a design that's the right cost structure so that we can treat a lot of patients with them.
Terry Smith (00:54:18) - Right, right. And and that's kind of been my career, right? Small volume, cost pressure. Lots of cost pressure on it.
Hetal Baman (00:54:25) - Cost pressure. Right.
Terry Smith (00:54:26) - Right. I mean, that's my corporate lingo. I can get a lot of cost pressure. Right. And so which is really what it is. And so as a nonprofit, we're trying to treat more patients, right?
Hetal Baman (00:54:34) - Oh, my gosh, this is so cool. This is so, so, so cool. I, I didn't even realize the amount of work that you guys are doing. Thank you so much for what you do and your time, Terry.
Terry Smith (00:54:46) - Yeah, no, absolutely. It's like I said, it's super fun to tell people about sign, you know, because in the orthopedic world, you know, a lot of the doctor's peers who quite frankly, are retiring and not showing up to their orthopedic association meetings as much anymore. Right. You know, they signs well known, right? But with the new generation of surgeons, particularly, I think that were less known.
Terry Smith (00:55:08) - And so that's going to be that's part of the the opportunity. And the challenge is to get some education there. I think overseas in a lot of countries, we're very well known. I had an African surgeon that said, you know, orthopedic trauma in Africa would not exist without that surgery. Wow. Right. That's huge. That's a huge statement because doctors are provided all that training, provided equipment and training residency programs are set up in these hospitals and they cycle through like in Tanzania and Kenya and Ethiopia. They cycle some of the larger university hospitals. They cycle a lot of residents, and those residents go off to rural hospitals and eventually they will there's a certain percentage of them that become sign surgeons, right?
Hetal Baman (00:55:50) - And they will dedicated sign surgeons. Wow, that's beautiful.
Terry Smith (00:55:54) - Yeah. I mean, we could have we could have we could do episodes on certain surgeons, right? There's some.
Hetal Baman (00:56:00) - Well.
Terry Smith (00:56:01) - There's a couple of Italian surgeons that would be super fun for you to talk to. Yeah. And the innovations that they're doing.
Terry Smith (00:56:05) - One in particular, he's developing a phone app to do follow up with.
Hetal Baman (00:56:11) - That's great. Oh, my gosh. Okay. Yeah, we just. We got to stop. We are out of time, but thank you so much for your time. Thank you for listening to this episode. If you'd like to learn more about today's topic and guest, head over to the show notes linked in the description of this episode. There you can get access to resources, links and ways you can get involved in the pursuit for global health. And if you love this episode, don't forget to write me a review on Apple Podcasts and rate the podcast on Spotify. It helps me get in front of more people just like you, and continues to elevate the causes we are so passionate about. I'll see you in the next one.