podcast_Delta-Development-Team

There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings.

In this episode of the Global Medical Device Podcast Jon Speer and episode cohost, colleague and medical device guru Wade Schroeder talk to guests Monti Leija and Robert Futch from the Delta Development Team, manufacturers of ruggedized thermal systems that specialize in military applications. 

Listen to this episode to learn about the Delta Development Team’s journey designing their latest product, the Autonomous Portable Refrigeration Unit (APRU) that provides a cooling and heating systems for extreme environments.

 

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Some highlights of this episode include:

  • APRU is medical refrigeration for medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications.
  • APRU applications include military operations, disaster relief response, and emergency medical systems (EMS) because the device meets AABB guidelines and FDA regulations.
  • The military provided end-user feedback on how it wants the APRU to function and perform. Therefore, the APRU is unique because it’s small and runs on a battery that can be charged.  
  • Power of Innovation: The biggest power consumers are refrigerators and air conditioners—both require refrigeration.
  • Obstacles and Challenges: Every time somebody goes through the medical device journey it involves learning and becoming aware of regulatory guidelines.
  • Recommendations: Find the right consultants, team members, and standards management tools. Wade Schroeder, Greenlight Medical Device Guru, has been a major asset to the Delta Development Team by providing regulatory guidance. 
  • Testing Methodologies: Motivation is to meet extreme environment requirements and standards. Some manufacturers choose to not meet some standards to make mobile medical devices that don’t work as well. APRU is the new standard.
  • Root Cause and Right Configuration: Make minor adjustments to prototypes to reduce complexity, cost, and failure points via due diligence rather than rebuild.

 

Links:

Delta Development Team

Autonomous Portable Refrigeration Unit (APRU)

Monti Leija on Linkedin

Robert Futch on LinkedIn

Meet a Guru - Wade Schroeder

World Health Organization (WHO) 

FDA Rules and Regulations

AABB Guidelines

ISO 9001 

ISO 13485

ISO 1971

IEC 60601

2021 State of Medical Device Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes from this episode:

“They were looking to build a device that would keep whole blood cold for a duration.” Monti Leija

“This device, why it’s special or it’s different is the fact that, one, it’s small compared to devices out there. It runs on a battery, that’s kind of the second important thing.” Robert Futch

“What if they can just treat you on site? What if they could bring the blood to you? Then, you’ve got a much better chance of surviving. But what’s missing from this equation is how do they get the blood to you safely?” Monti Leija

“Our device is the new standard.” Robert Futch


Transcript:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: This is a pretty exciting episode of Global Medical Device Podcast. I get to talk to the Delta Development Team, where they share a little bit of their story of developing their new product, the Autonomous Portable Refrigeration Unit or APRU for short. Be sure to check them out, deltadevteam.com, and enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to another exciting episode of the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. Kind of excited about this one because I get to talk to one of our Greenlight Guru customers. Today I'm going to be talking with Monti Leija and Robert Futch. Both are with Delta Development... or, Delta Development Team rather. Gentlemen, welcome to the podcast.

Monti Leija: Thank you.

Robert Futch: Thanks for bringing us on today.

Jon Speer: Absolutely. Also, joining me is going to be one of our medical device gurus at Greenlight Guru, Wade Schroeder. Wade's been working pretty closely with the Delta Development Team. Wade, I want to make sure that you get a chance to say hello to the listeners as well.

Wade Schroeder: Hello everyone. Yeah. Thank you, Jon, for including me as well. It's been great working with these guys, so I'm excited for this.

Jon Speer: All right. Monti and Robert, we're going to certainly dive into some details and learn a lot more about this real exciting product that you're launching here in a moment. Before we do that, do you mind giving a little bit of background about yourselves and a little bit about the Delta Development Team?

Monti Leija: Yeah. Sure. This is Monti. A little bit about myself is, I was in the army for a long time. I retired maybe four or five years ago and went on this contracting work, supporting still the military in tactical medical training. That is my expertise and some prolonged field care. As we went along training, I ran into some guys that now we formed the Delta Development Team. They were looking to build a device that would keep whole blood cold for a duration. They brought me in and asked me some questions on if this was feasible and would the military use it? With all my experience, I was like, " Yeah. They would use it. They would love it. They need it right now." I said, " Where can they go buy it?" They're like, " Well, we haven't made it yet. We just have this idea."

Jon Speer: Awesome.

Monti Leija: Anyways, that's how we started out, was they wanted to make a refrigeration device, but they didn't know how it would be applied in the military setting. That's the piece I brought with it.

Jon Speer: Well, I appreciate your service, Monti, and thanks for that background as well.

Robert Futch: He's got about the whole story there. Was Bill and Chris and I that started in 2018 and we saw a few tendrils of interest from SBIR projects and proposals going out, but nobody had really made it all the way yet. Nobody had developed this device to the level that the customers were looking for, and so that's what we set out to do back in 2018. Through a mutual friend, we found Monti here and that completed the team.

Jon Speer: Robert, I'm a little bit curious about that. The way you described that, or the way I heard you describe it anyway, it's like you were just constantly looking at all these SBIR requests and you kept seeing the theme. I mean, it was probably a little bit more complicated than that, but is that more or less how you decided to dive into this particular product area?

Robert Futch: It is. I guess it's a combination of a lot of themes that came together. Bill and I worked at another refrigeration design company. I was there for seven years. He was there for a little bit longer and so we had a lot of experience in medical refrigerators and their applications with vaccines, including vaccine distribution with the World Health Organization. We were already familiar with the whole process of keeping an eye out for more SBIRs and proposals from the World Health Organization. That's when we started seeing more of this trend from just looking for these vaccine solutions, to also looking for blood transport solutions.

Jon Speer: Okay. Terrific. We might as well just, I guess, dive right in and talk about your new exciting product. We can chat about the finer points and details regarding that. I guess, tell me about this new device that you're on the cusp of launching, or maybe you already have launched, and now it's just time to continue to spread the word. What is the name of this new product?

Monti Leija: It is the Autonomous Portable Refrigeration Unit, the APRU. Around here, we just call it APRU to shorten that. This device why it's special or it's different is the fact that, one, it's small compared to devices out there. Runs on a battery. That's the second important thing. With our end- user feedback with... Of course, that's the military, going back and forth with them on how they want this to function and perform, it's special in the sense of a regular refrigerator if you can imagine any refrigerator you have out there, you can't just throw it in the back of a vehicle. You can't just throw it on a helicopter and drive out to the desert or into the Arctic on a military mission and expect it to perform. What we've done is we've miniaturized this refrigerator so that you could put it on a helicopter, a vehicle, take it anywhere in 115 degree heat, dust, rain, on a boat with water, and it will still function. Really, it's designed for military operations and it could run on a battery, right? Because when the military goes places, they don't always have somewhere to plug things in. It'll run a battery for a few days until they can find a place to charge it, or they just plug it in the vehicle if they have vehicles.

Jon Speer: Well, that's pretty impressive. I mean, I'll be honest. I don't know a ton about refrigeration, except that I think I've heard that in my home, the refrigerator is the largest consumer of power in my entire house. I don't know if that's accurate. Of course both you guys can fact- check me on that one, but that I do think this is accurate. A refrigerator requires a lot of power, and so the fact that this product that you've developed can run for days on battery, that's pretty impressive.

Robert Futch: That was one of the major innovations. I'll say, you're right. It's probably one of the biggest power consumers actually in your house. The second biggest is right outside your house. That's the air conditioning, right?

Jon Speer: Yeah. Both require some sort of refrigeration of some sort.

Robert Futch: Exactly.

Jon Speer: Give me a sense of how big this product is. I mean, what kind of footprint we're talking. I mean, granted, I'm gathering Monti, it's not the same size as the refrigerator in my house because that's impractical for storage and transport. What kind of size are we talking about?

Monti Leija: I would say a medium small to medium toolbox that you carry your tools in, that you could physically carry yourself. One person can carry this. It's only 30 pounds. One person can move it around. I think it's a 17 by 19 inch, 10 inch complete.

Robert Futch: We started with was we showed a concept of it to the 48th Rescue Squadron here in town and they said, "Hey, can you make it as small as an ammo box?" That was our starting point.

Jon Speer: All right. I have a pretty good idea for some of the military uses for this, but I guess at the risk of not just making assumptions and letting our listeners know, what all would the military use this sort of device for?

Monti Leija: Well, specifically the military wants to use it for carrying blood products on missions closest possible to the injuries because we know that the sooner our casualties get whole blood, when they've been bleeding a lot, the better the outcome. It makes a huge difference to get blood products on your casualty as soon as possible. That's one. The other use would be something, they could put their vaccines in there. They could put temperature- controlled medications like rocuronium as well. There's other medical products they could put in there but the military specifically is looking for a reliable way to keep their whole blood at temperature until needed and anywhere in the world. This is ready to go to the Arctic.

Jon Speer: Wow. I mean, I can't help but think in current times we're all still dealing with the global pandemic of COVID-19, as I see the product as I watch the short video that's on your website... And folks, by the way, you can check out more about the Delta Development Team and the APRU product. You can go to deltadev, D- E- V, team. com. That's all one word, no spaces, no hyphens. Then if you want to see the APRU unit, just put a/ APRU at the end of that, but deltadevteam.com/apru. As I look at this, it seems though that there might be some sort of application in our current normal non-military needs of the world today too. Have you thought about those potential applications with this product?

Monti Leija: Yes. Where actually today I just shipped one out to a government agency supporting the Navajo Nation COVID-19 response. I just shipped one out there for them to put it through its ropes to give us feedback. They're going to be using it to carry their samples back to the lab for testing.

Jon Speer: All right.

Monti Leija: Then the other use is EMS as well is really interested in our product because it meets all the AAB guidelines and the FDA regulations, which there is very few, if any devices, that meet all those intents. Anyways, EMS is also looking our way, even though they're carrying their whole blood actually now in different types of devices, they don't really meet the regulations like ours will.

Robert Futch: There was one thing I wanted to share here is that it's not just this interest in the military, but there's been some experiments around the country right now, notably in San Antonio and Houston now, where they've just started experimenting with bringing blood to people in need. A little bit of background is that normally if you get in some kind of serious injury, the ambulance comes out, they pick you up and they try to stabilize you. Then they hope that you survive on the way back to the hospital, right? The new plan is what if they could just treat you onsite? What if they could bring the blood to you? Then you've got a much better chance of surviving. What's missing from this equation, now how do they get the blood to you safely?

Jon Speer: Right. For sure. Really cool. All right, so gentlemen, when you came up with this idea and you decided to pursue this, what did you know about being a medical device and FDA regulations?

Monti Leija: We're still learning so not much initially.

Robert Futch: That's a big one. I'd say our foremost expert here on the regulation was Bill when we started. Bill had previously been through ISO 9001 regulation for their medical device manufacturing facility, but had never done ISO 13485 or they never did 14971. This was a totally new world for all of us where we had to really quickly come up with this whole quality management system and find a way to manage all of this regulation from all of these different standards organizations. I don't think we realized what we got ourselves into when we started.

Jon Speer: Well, that's usually the case. I think every time somebody goes through the medical device journey for the first time, is like, " Oh my goodness." Now that you've done it, I mean... or in the process of doing it, I guess I'll bring in Wade on this too. Wade, you've been working pretty closely with Monti and Robert and the rest of the Delta Development Team. What are some of the obstacles and challenges that you saw as you were working with them as their medical device guru?

Wade Schroeder: They tackled really a lot of it very well. A lot of it was just being aware of certain things. I think a lot of our conversations, even recent ones have been around, what else should I be watching out for? Or what's a good way of doing this that we haven't thought about yet? Different things like that. Becoming aware of a lot of it has been a lot of what I've seen, but I'll pass it over to you guys. What recommendations would you guys give to other people that are in a similar situation?

Robert Futch: Well, I think we've definitely found the right set of tools to make this happen, both in terms of finding the right consultants, finding the right team members, finding the right standards management tools. Of course, Wade, you've been one of our major assets getting all of this together. The only way that we could have brought all of this regulation together and actually completed all of this now in such a short amount of time was to have all the right tools at hand.

Jon Speer: Folks, I want to remind you I'm talking with Monti Leija, he's the CEO of Delta Development Team. I'm also talking with Robert Futch. He's the CTO at Delta Development Team. Again, you can learn a whole bunch more about their APRU unit by going to www.deltadevteam.com/apru. Talking a little bit about their journey as a medical device company and getting ingrained and in doctrine, so to speak, into all things FDA. They've been a Greenlight customer now for a bit. Encourage you all, whether this is your first time or you've done this many times before, the Greenlight Guru Medical Device Quality Management System (MDQMS) software platform is designed to help you. It's designed in a way that helps you be as efficient as you possibly can be by incorporating those must- have criteria from a design and development standpoint and risk and document management, as well as all your post-market needs. If you're interested in learning more about how we might be able to help you, go to www.greenlight.guru to learn more. Request a demo. We'd be thrilled to have a conversation with you to see if there might be something we can do to help you. All right. Gentlemen, I guess talk about this journey a little bit more. When you started, obviously it was an idea. Robert, Monti, you talked about having this idea and finding each other and figuring out a way to design and prototype and eventually reduce this to practice, but that's just the beginning. You talked about meeting the AABB regulations and FDA regulations. I assume that somewhere along the way, there were different submissions that involved government agencies in some way, shape or form. Talk a little bit about that experience.

Robert Futch: Well, we've got our FDA registration coming up here and I can tell you one thing is that I feel well prepared for it now. It's been a long learning journey, but because we've had the right tools at hand, I can confidently say that we're well prepared for FDA inspections and for the FDA registration of this medical device.

Jon Speer: Okay. What was maybe one of the surprises? I mean, of course, learning about design controls and risks, I'm sure that was one, and what a quality management system is. Although one of your colleagues, as you mentioned, had the 9001 experience, so there's a lot of parallels between that and 13485.

Robert Futch: Right.

Jon Speer: As you started to really get into this, what were some of the biggest surprises that you encountered that you weren't anticipating?

Monti Leija: Well, I say on my part is talking to the end users and then taking out the device because we had our ideas and they give us their ideas. Then we made this prototype. Then we took this prototype out to them and said, " All right, play with this." They're like, "Well, we would like it to do this. These are our real challenges that we face." Most of these devices, these mobile devices and these other ways they carry whole blood, they work very well in 80 degree Fahrenheit weather there. Everybody performs pretty well, except for when you get to 110 Fahrenheit, then it crushes, all these devices. We've really pushed our standard or we've really pushed for this device work at 110 Fahrenheit where most devices are getting crushed with the heat and the sun. I guess that's one of the big learning points we took away was, how are these other devices doing this? They're putting it in their marketing and they're posting it. Then comes to find out they're testing at 80 Fahrenheit, like the optimal temperature to test these things to get their number. The guys were taking these devices out to Africa and they're like, " Hey, this thing is not even lasting four hours. What's going on?" Then we go find out why it is. What we're trying to do here is really expand the amount of time they have autonomy to hold their blood in Africa, right? In the places where you don't know what kind of power you're going to get. It's unpredictable. It's austere, and that's what we're designing to.

Jon Speer: That's interesting to me because I mean, I don't want to say it's easy, but it seems like it would be relatively easy to design a product for ideal conditions. I'm not asking you to speculate why others didn't tackle this challenge before. Maybe it was because the criteria and the requirements were just too stringent, but it seems to me that ... I mean, you've fallen into sort of a sweet spot, Robert. Maybe this is the whole motivation to begin with is that you the needs for those extreme situations and extreme environmental conditions. Talk a little bit about some of the testing that you had to do. I mean, were there standards that already existed for these? Did you have to come up with your own methodologies?

Robert Futch: Yeah. Well, I think there's two parts there. It's that we wanted to go the difficult route, the one that nobody has completed yet of meeting these extreme environment requirements. Also, we're going the difficult route of meeting all of the standards, right? There are some standards for mobile medical devices like this and people just are choosing not to meet them right now because they can get away with devices that don't quite work as well. We want to go the more difficult route of actually having a device that meets the standards so that our device is the new standard.

Jon Speer: Terrific. Wade, I know you've been working with the guys very closely through all of this. You have that electrical engineering background as well. Did you get involved with some of the IEC testing and providing advice and recommendations to them?

Wade Schroeder: Yeah. We definitely talked about that. Robert and I got into 60601 quite a bit there.

Robert Futch: Yeah.

Wade Schroeder: Yeah. It definitely brought me back to my electrical engineering days. I enjoyed that and it was a great opportunity to use my experience to help these guys out. They've just been phenomenal. The amount of work that Robert does between each meeting that we have once a month, it has just been absolutely impressive.

Jon Speer: Because I've developed products that, to Monti's description a moment ago, were really designed to work in ideal situations, 80 degrees or what have you. I've gone through the IEC 60601 battery of testing for a device that doesn't have these extreme conditions. I know how hard it is to get a product through the testing just for those'simple' circumstances. My goodness. I can't even imagine how complicated this was with the extreme conditions you guys were dealing with.

Robert Futch: Well, you're right. We just got done with the 60601 testing on this device and also IEC 61010. We did both of those for this device. Of course, what's the number one surprise you always run into is electromagnetics, right?

Jon Speer: Yeah. EMC is a beast. The last product I worked on, I think we had the... And this is nerd talk for a moment. I may sound like I know more than I'm talking about, but bear with me for a moment. The inside of the enclosure had a nickel paint for conductivity, but then we had the entire electronic package all wrapped and kept on tape it. I don't know how we got everything into that container, but that was one of those scenarios that we found out after the fact very late in the process. How did you avoid these gotchas? Because if you have your form factor already pretty well defined, it's got to be an ammo box. It's not like you can make it the size of a large cooler. How did you deal with all of these different design challenges?

Robert Futch: I'd say that was one of the major surprises because we're mostly mechanical engineers here. We've got some electrical and material science as well. You could tell that most of us were excited, " Ooh, let's build the box, let's design what it's going to look like." Then we get to the end and we're like, " Oh yeah, we have to do EMC testing." Of course that's in our design controls. We were somewhat prepared. We had our electromagnetically protected screen overlay and we had some idea of what we might need. All right. We showed up to the first day of electromagnetic testing and they tell us that we've got some areas of the spectrum to work on, but we came back with what we called our EMC ultra- unit. It has every possible EMC protection you can think of, probably like your device, right? We wrapped the whole thing in the EMC tape. We had the EMC shielding connectors and the paint that you were talking about. We did the whole thing, right? Even after all that, it still didn't pass. Now every time you get into EMC, we're pulling our hair out. " What is this?" You come to find out that it was just a data speed issue is the bond rate on one of our devices on the board. Just changing the speed just a little bit was enough to flatten out the entire spectrum.

Jon Speer: Wow, that's awesome. I mean, so a minor code change in the firmware is way better than having to go do a rebuild.

Robert Futch: It is. Right after that, we went through and then we were like, " Okay. Well, do we still need the EMI paint?" Take that out? Nope. It still works. We take out the shielding connectors and it still works. We take out... So we got to go down the list and eliminate all of these protections that we had in there beforehand just in case we needed them, which was a huge benefit for us because it reduces complexity and costs and failure points, where we didn't need all of these other EMC protections, because we found the root of the problem.

Jon Speer: Yeah. I love that, Robert, because I think a lot of times companies are just putting tape and suspenders and belts and all kinds of things to try to get through that but I don't think they do the due diligence in actually getting to that root cause. To replay what I heard you just say, you found that root cause, and then you were able to back off until you found the right configuration of everything. I got to imagine that there was probably some challenge in this cause... and Monti didn't say this exactly but what I heard is you would build some early prototypes, you would field test them, get the feedback. You had this form factor that your users are pretty comfortable with and so now you're fixed to that footprint, so to speak. Did that create any unforeseen challenges as well?

Robert Futch: I think it's difficult. You have to either come up with the box first or come up with your EMC design first, right? It's a chicken or the egg situation. The way that we started was we did have this form factor and something that our users really liked. It fits in their helicopter. It fits in their Humvees, it fits in their ambulances. Then we did leave room for the electromagnetic solutions, not just in the physical form factor, but in the price as well. We had already talked to our customers about, " All right. Here's what we expect the price to be." If we had to make some huge changes in the EMC components, then that would be a bit of a surprise to the customer later if it was a much bigger price, right?

Jon Speer: For sure.

Robert Futch: In addition to being bigger.

Jon Speer: For sure. All right. Let folks know where you are. I mean, it sounds like some units are out in the field or are about to be sent to the field, but where are you in this journey to commercialization?

Monti Leija: Really close. We are very close. We're looking January/ February to have our first production models actually out. That's how close we are. We've got all our prototypes. We have a prototype that's going up north of us. We have one that's actually in training right now in Wake Forest Special Operations. We're going to send a prototype out to Afghanistan for more end- user feedback. I don't know how much we can change on what we have on our prototype right now, but we are getting a lot more data from our end users.

Robert Futch: These are our validation events, right?

Monti Leija: Yeah.

Robert Futch: All right. That's a big part of the whole design control process, validating at the end. We're doing that at... We've got a lot of opportunities to do that at this event in Wake Forest and Afghanistan and with the Navajo Nation. I feel like we've got a lot of opportunity, maybe more than is normal, to be able to validate our product really well.

Jon Speer: All right. Any other things about Delta Development Team and the APRU unit that you think is really important to share with listeners that we haven't covered so far?

Monti Leija: Let's see, we've covered pretty much all of it. Just know that this is designed to withstand rigorous military operations, is the whole design behind this. This effort's been going on for almost over two years, right?

Robert Futch: Yeah. I think we're-

Jon Speer: It can be dropped from the C- 130 with a shoot on it and if the shoot fails to deploy you're still good?

Monti Leija: Yeah. You will. It might crack, but it's-

Jon Speer: It's pretty rugged.

Monti Leija: Yeah. It might crack, but it's still going to run. It's still going to function. It's still going to-

Jon Speer: That's cool.

Monti Leija: It's still going to keep everything cold until you can get back and tape it up or get it replaced, but it's still going to run if it gets damaged. It's not going to be any issue. crosstalk.

Jon Speer: I guess that's the ultimate drop test.

Robert Futch: It is. Yeah. We did some drop testing already, but it was only from a few feet up, but we are expecting it to be able to survive paradrops as well.

Monti Leija: Yeah. Some of our end users I just talked to last week, they're excited that it is air droppable. The other thing they're looking at is as the military moves forward with a lot of this drones, the big drones, the little drones, that they will be able to put this under a drone or on a drone, however they want to do it and be able to ship this blood out as far as the drone will go. That's another big benefit we're looking at where they can have all these APRUs charged, ready to go. Then when they get the call, they just got to go link it up onto the drone and send it out.

Robert Futch: There was one thing, I don't know if you guys heard about the... It was the very first transport of an organ. I think it was in Boston that happened. You guys hear about that?

Jon Speer: I did not. Go ahead. Please tell us more.

Robert Futch: It was the very first transport of an organ by drone. I'm pretty sure it was Boston. I have to go find the article again, but they transported it in a cooler, just with ice in it, right?

Jon Speer: Yeah.

Robert Futch: We've got this interesting mix of high tech and low tech right there.

Jon Speer: I mean, if this becomes more common, it seems like you have the ideal product for those types of needs as well.

Robert Futch: That's what I'm thinking. In the future where this becomes more prevalent, where people are flying drones between cities or around cities, and they need a high- tech solution to keep the organs cold in transport, this is exactly it. We're already prepared for the future.

Jon Speer: I have a twisted sense of humor sometimes, but I was just thinking Amazon Prime for organs with drone delivery, right? Maybe that's in our future. Gentlemen, how can I, and how can Wade and how can our listeners at the Global Medical Device Podcast, what can we do to help your cause?

Robert Futch: Well, we're trying to start making people aware of the technology that's available right now, where previously people weren't thinking about providing blood in the field, just because it wasn't technically possible. Now that we do have the technology there's also the policy change, the procedure change, all of that, that comes along with the new technology and the education around people being able to give blood in the field in order to save more lives. It's a lot more than just the technology that comes along with it. We've got to bring out the education and the policy changes to make this possible to stay more relaxed.

Jon Speer: Awesome. All right, folks, this is your challenge is to spread the word about the Delta Development Team's APRU device, just to create awareness because I can imagine there's a lot of other needs beyond those we've just talked to. Wade, since I have you on this episode as well, you and I have chatted. All good things, Robert and Monti, so bear with me for a moment. You've shared how every time you get off the phone with these guys, how excited you are because of how they take the challenge on. Some of the things they know, some of them they're learning for the first time, but to your point earlier, they do their homework. They do the due diligence. They do the work. What attributes, or how would you describe the things that the Delta Development Team has done really well and turn that into tips and pointers that others should embrace as part of their journey to bring new medical products to market?

Wade Schroeder: Oh, man, there's too many to count. I guess, to think of a few, just willingness to take on something new has been really impressive. Every time we talk about design controls and risk I mention something else. Verification validation comes to mind when I mentioned how to put a protocol together and then put it on a report and Robert's like, " Oh yeah, that sounds great. We'll be right on that." It's the willingness to do new things and do what's right. Don't look for the easy way out and do the right thing, I think has really helped these guys be so successful and meet their timelines. One of the things that I think is so impressive about them, it was about a year ago when I started working with these guys. They had a really aggressive timeline with this, and I was impressed that they've been able to keep that timeline pretty much to the T. Whereas a lot of other products I've worked on in the past and I've heard about in the past, it's really hard to keep that. I've been really impressed with that.

Jon Speer: Monti and Robert, as you've shared more about the Delta Development Team story and the challenge that you set out to tackle, it's inspiring to me that you just didn't accept status quo for this particular product space. That you realize that the challenge that you were facing had never been tackled by anyone before. It was really aggressive and I can imagine it was pretty trying and frustrating at times, but you stuck with it and you built something that's really an awesome product. You're to be commended for that. It's inspiring as I said.

Monti Leija: Yeah. I'd like to add to what you guys are saying, and I'll give you the reason why we are pushing so hard, is because our end users, specifically the military special operations, they wanted this device two years ago to start making a difference on the battlefield, right? To start saving lives. Every day I came into work, I was pushing these. I'm like, " They want it right now." Rob's like, " Impossible. They cannot have it right now." I'm like, " Right now." Then three months later, I'm like, " Is it ready to go? Let's go. They're ready for it. They want it right now." He's like, " No. Nope." I mean, the biggest reason why we really pushed this hard is because we know it's going to make a difference and they want this product right now, like two years ago, but we want it right. I think Wade, you said that. We want to make sure this is a good device, very reliable device. Last thing we want to do is send this device on a battlefield and the blood goes out of temperature range, and then it's no good. Now the person that donated the blood, they donated it, that's lost. The casualty that needed it, that's lost. The medic loses confidence in his ability to save his casualties because something happened with the blood. I mean, there is the device itself, but then it's the purpose of we want to be able to save some lives, but we also want to make sure the blood actually is good to go when they get there. I just want to add that part.

Jon Speer: I love it, Monti and I think that's a great-

Monti Leija: That's why it's rushed.

Jon Speer: Yeah. No. I think it's a great way to wrap up this episode too. It's really about improving the quality of life. That's why I get up every day excited to be a part of the Greenlight Guru team. I know that's a big part of why Wade is here, is we get to work with companies like the Delta Development Team who are out on a mission to build products and technologies to save lives. This is really awesome. Help me in thanking Monti Leija, CEO, and Robert Futch, CTO from the Delta Development Team for joining me on this episode of the Global Medical Device Podcast.

Wade Schroeder: Thank you guys.

Monti Leija: Thank you.

Jon Speer: Folks, as I mentioned, Greenlight Guru is here to help. You've heard from one of our medical devices gurus, Wade. Hopefully you know a little bit about the Medical Device Quality Management System Software Platform. It's the only medical device quality management software on the market today. It's been designed exclusively and specifically for the medical device industry by actual medical device professionals like Wade Schroeder and myself, as well as the rest of our other Gurus. Be sure you go learn more about how we can help you by visiting www.greenlight.guru. As always, thank you so much for being a loyal listener of the Global Medical Device Podcast, the number one podcast in the medical device industry. As I mentioned, a few moments ago, you have some homework to help the Delta Development Team spread the word, get the awareness out about their new APRU product, so share this with your friends and colleagues. As always, thank you. Until next time, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


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