Regulatory Consultants and What They Get Wrong | Thomas Moore, PhD

You can’t outsource judgment, but you don’t have to do it alone. If you’re navigating go-to-market decisions in a regulated space, work with Bill through MESH as your fractional CMO.

Talk with Bill at MESH. https://meshagency.com/about-bill-schick/ 

About this episode: Early-stage medtech founders often treat regulatory strategy as a checklist item. That mistake can cost years, capital, and credibility. In this episode, I sit down with Thomas Moore, founder of PTL Solutions, to understand why regulatory strategy is actually a business roadmap and how founders can engage with it intelligently without outsourcing their judgment.

Follow Thomas: https://www.linkedin.com/in/thomas-moore-phd-40016753/
PTL Solutions: ptl-solutions.com

00:00 Defining Regulatory Strategy 
01:13 Thomas Moore Background 
02:23 Why Regulatory Strategy Is a Core Business Tool
05:41 The Problem With Checkbox Regulatory Thinking
08:49 When Regulatory Consultants Miss the Mark
10:58 Why Founders Must Stay Engaged in Regulatory Strategy
12:26 What Investors Look for in Regulatory Planning
14:25 Can Founders Build Their Own Regulatory Strategy
16:14 Where MedTech Teams Get Stuck
21:18 The Must Have Elements of a Strong Regulatory Strategy
25:56 Why Regulatory Strategy Is Not a Linear Process

Regulatory strategy is often framed as a compliance hurdle — something to outsource, check off, and move past. But as Thomas Moore, PhD explains, that mindset quietly introduces risk across the entire business.

With over two decades in medical device development, Thomas has seen what happens when founders receive a beautifully written regulatory document they can’t defend, explain, or adapt. In this conversation, he reframes regulatory strategy as a living roadmap — one that connects product design, clinical evidence, quality systems, investor confidence, and FDA credibility.

This episode is especially relevant for early-stage medtech founders navigating limited budgets, compressed timelines, and high stakes. Thomas shares why founders don’t need to do everything themselves — but why they can’t afford to be hands-off either. From pre-subs to predicate strategy to “spinning plates” across functions, this conversation gives founders language, structure, and confidence to engage regulators and consultants from a position of clarity.

If you’re building a regulated product and trying to move fast without stepping on landmines, this episode will help you think more clearly about where regulatory fits — and why it’s inseparable from business strategy.

🎧 Subscribe to LifeSci Continuum for founder-level conversations on commercialization, regulation, and building durable life-science companies. https://meshagency.com/about-bill-schick/

#MedTechFounders #RegulatoryStrategy #LifeSciences

Transcript

0:00

It's not just a regulatory discussion. It's a business discussion."My design is right here right now. What if I add a feature? Or what if I remove a feature? Does that actually get me to fit into another category?" And again, like I said, it's a trade-off. Have you ever felt like building a regulated device is less of a plan and more a bunch of plates spinning while someone else throws wrenches? Yeah, I've seen that too. Welcome to LifeSci Continuum. In today's interview with Thomas Moore of PTL Solutions, we break down what a regulatory strategy actually is. regulatory strategy as I look at it is really a core part of a medical device company's journey. They can use this as a tool to help map out the entire development process and establish what evidence they need to generate and why they need to generate it and for who they need to generate it. Why checkbox thinking kills companies and how regulatory decisions ripple into product, your business model, and go to market. at least see how far you can get. mean, there's a big difference between bringing a tongue depressor to the market and a heart pump. You're gonna fall somewhere in there, right? The more complex the device, if you're a de novo and there's nothing out there to base it on, you're probably gonna have more questions than somebody who has a smoking gun predicate. Alright, let's go. Well Thomas, thanks for hopping on with me today. Absolutely, it's my pleasure. Thank you so much for inviting me. For the audience, give us a little bit of background on you. What are you doing these days? I've been working in the medical device industry for about 21 years and even my whole journey to getting there was a bit zigzaggy. Started as an aerospace engineer, then a mechanical engineer, then an FEA analyst and finally moved into med device. And so did some work for some big corporations, did some work for some startups, did a master's and a PhD in there. And then in 2020, when the pandemic hit, I pivoted into freelancing and essentially started what is PTL Solutions today and um grown it into uh what I like to think, I mean, I think we're an all in one at this point we have pretty much every resource a medical device company could need. We have design, development, software, hardware. We have clinical, regulatory, quality. We have commercialization reimbursement. We help out with a lot of different areas. We've grown from being just me to a team of around 25 that are, you know, some people are what I'd consider core members of the team that are, that are engaged every day and then there's other members of the team who come in on very specialized projects, but I'm really happy with, with how it's kind of shaken out as we've grown. It's really nice. For the conversation today, I think with all those things in mind, the focus really is on regulatory strategy. You and I have talked about that quite a bit. It seems like a lot of startups and early stage companies certainly run into challenges here and they don't necessarily have the experience to know um exactly what to do. So, from your perspective, give me kind of a quick overview. of what a regulatory strategy is and you know maybe what that looks like and then we can talk about some of the broken parts. Yeah. Sure. No, I mean, a regulatory strategy, as I look at it, is really a core part of a medical device company's journey. They can use this as a tool to help map out the entire development process and essentially establish what evidence they need to generate and why they need to generate it and for who they need to generate it. I mean, a good example is when you think about like clinical studies. Sometimes you want to generate that data for a regulatory approval reason. Other times you want to generate it for a marketing reason. Sometimes you want it to inform your design. So there is lots of different reasons why we collect that information. When it comes to the regulatory strategy, it was a bit of a pet peeve of mine when I started this company that people would develop what I was calling, I looked at it like a regulatory assignment. And I saw a number of examples of this where a company goes to a consultant asks for advice or, know, helped me build my reg strategy. And they just respond by saying, oh, your device is this, you do this, you do that, you go to market. And even from the very beginnings, I was always using this, word holistic. Like I think about developing a medical device, you can't just do it in a silo, you can't do it by itself. And so when you, when you build out a regulatory strategy, when you're looking at the pathway, you're going to follow you, look at your product code, your reg number, for example, in the US you look at all the testing you're going to have to do to get that device to market. If something changes. from a, let's say a clinical use perspective. You are doing user interviews and you find that your users feel, this feature is not really gonna be that much benefit. You know, we go from an 80 % improvement to an 85 % improvement. Well, do you really wanna go through all the trouble of adding that extra feature, especially if it moves you into a higher risk classification? So I always looked at that reg assignment and thought, well, that's not very helpful. Because if you look at the holistic approach to developing a medical device, You want to understand if I develop a 510k exempt version of my device or a 510k traditional version or a de novo version, how does that impact my business? How does that impact my users? How does it impact my reg pathway? You want to look at the whole. And so I always felt creating a reg strategy document that actually includes, if possible, as you know, like some devices, you're just stuck with one pathway. But if you can assess all that and really have a, basically like you have a pathway with contingencies. that help you to understand like if you pull on this lever or push on that, you know, push on that button, it changes your pathway a little bit and it changes your budget, changes everything, right? So I always thought to myself, this reg strategy document, I feel like it's underestimated just how important it is, not just from a reg perspective, but from a business perspective. So I think that's a really good point. And often some of these things can um be sort of check boxes on the road to commercialization and just kind of, guess, underappreciated for the relevance or how important they are. If you can, can you share an example where there was really a disconnect between what was really needed by a particular company or device, obviously confidentially? Yeah. And also... where they were as far as an internal state of their regulatory approach maybe was. So one thing I just wanted to touch on that you just mentioned was the whole, idea of a grocery list. I mean, literally yesterday I was, I was presenting this, this workshop that we do on the reg strategy development and like how, how to do it yourself. And one of the things that came up was the idea that a lot of people look at it like a grocery list when you're developing a medical device, you know, just check, check and we're done. And I kind of the analogy I used and somebody really liked it yesterday. Um, it's like the idea that you're really spinning plates. So you get your, you you study the clinical use case, you spin that plate, you get it going, then you get your design going, you spin that plate. And ultimately you want to get everything spinning. So, you know, everything is perfect in sort of that equilibrium. And so, so yeah, I just, I wanted to just add that because I think it's really important for people to understand that it, again, like I think I said it already, but you can't really do this in a silo. You've got to look at all of the different, all the different ways. So. When it comes to the regulatory strategies, mean, we've seen, feel like sometimes it's almost like a disconnect and it sounds awful to say it and I can't prove it, right? But you see things that companies do and I just, I just questioned the value because some companies charge a lot of money for these regulatory strategies, but I've seen a company where they basically a quarter of the report was all about the like the physiology and like the anatomy and like, certain conditions and just this very detailed write up on the medical condition. But I just felt it was odd because the authors of the document were writing it for somebody who was much more much more trained than they were on the medical side of things. So it's like, did I just pay for this company to write to do this write up that had no, you know, I knew this already, you didn't have to write this all in here. Kind of strange, right? And then another one where basically we saw a lot of just copy paste from the FDA website. This one client I was working with who had kind of employed me as more of a product development person as opposed to a regulatory person at the time. And so we had asked this company to put together a reg strategy and twice they came back. They just really just copied and pasted one section of the FDA website, which took up about, I want to say like a third of the report. And then another third, then they redid it because we were like, well, no, no, that's not what we want. And then they just redid it and copied another section of the FDA website. And so it is what it is. It's hard to know why these, people do what they did, but ultimately it was just not what they were looking for. And so I find the biggest gap sometimes is the client and the consultant just, they just don't connect and it's, it's really hard. to get the value out of that report if, the, sometimes the client doesn't know really what to ask for. And then the consultant tries to give them what they think is the right thing. And so you can't really call anybody a bad guy in that situation. It's just, it's really hard to connect. And that's, that's where I see the value in what I'm doing because not that I'm doing it better than everybody else. It's more just, it's like when you go to a training course for anything and I'm I'm sure you've gone to a training course for software before where you sit down, you spent two days intensively working on a piece of software, you learn how to use it, then you don't touch it for two months, you come back to it and it's like, what did I just do? You have no idea how it works. I remember I can do a thing. I can't remember how to get there. Thank God for Google. And so in this case, you've got this beautiful reg strategy document that's written and it's given to somebody who may have trouble interpreting it or doesn't connect the dots down the road. Like if I say, you've got to comply with 6601-1 or one of the 6601-1 standards, it may not be meaningful to you. But if I tell you, okay, this is how you build a regulatory strategy, go to the FDA website, you hunt this stuff down, you find these product codes, you find the reg numbers, you find 510k summaries. You dig into it. You're starting, you get more of an appreciation for it because you're in the thick of it now. And it's, and it's, uh, it's like you have, you're accountable, right? Where's it easy when you just receive a report from a consultant and it's okay. reg strats done. And then, okay, now we go find a test lab that can do the 6601 testing that we need done. But if you now, if you have to go defend that in an audit. I feel like it's gonna be a lot tougher for the company that just kind of took a very hands off approach to the ones who rolled up their sleeves and said, I'm gonna do this myself or I'm gonna do as much of this as possible myself, right? What you're advocating for really is that the people within the company, even when using a consultant and a specialist to help them along, that they be actively engaged as well. They can't treat this as a, know, set it and forget it, just walk away from it. Yeah, I mean, especially because I with especially with a regulatory regulatory strategy, I mean that that forms the basis for your roadmap and you're going to present that roadmap to investors. So, I mean, very early on, you're going to find out if you can't defend this. I mean, you're not not going to raise money, not be able to defend it to FDA. Like it's a lot of a lot of reasons why it's not a great idea. And I mean, I would say a lot of our customers get get involved, get pretty engaged with it. And it works out really well that way. Right. So it's. um I think it's a positive all around when they do have that level of engagement. So I was at a pitch event last night actually. And the panel had probably 10 experts on it. And these founders would get up there and pitch their ideas. And easily a third of the questions from the panel were relating to FDA current conditions, what their regulatory strategy was. And to have that be seen sometimes is just something to check off the list and moved on from, I think, is not doing a service to the business and the future of the company. Very much, very much. And I mean, as much as the reg strategy is important, one of the things that I feel like is being missed or lost is when you're building this reg strategy out, it's not enough to just say, okay, I found a 510k summary. I found my predicate. Boom, we're just going to do what they did. One of the things that I see people miss and it's not because they're incompetent. It's because a lot of people don't even know it exists, right? That's the MAUDE database where you can actually see what's going on uh with your competitors' devices or maybe similar devices, maybe devices that are apps or maybe devices that require cybersecurity, you can look up to see what's going on and really understand where the FDA is picking at, you know, or the threads that are going on when they're reviewing a submission, right? And so it's some of those little details that obviously a lot of people who've never worked in this space don't even know, but it's such an important, I mean, it's important for two reasons. Number one, you're demonstrating to the FDA that you've looked under every stone. but also you're demonstrating to the FDA that you've got a heightened level of credibility. Like if you had the foresight to go and say, okay, we're not just gonna send a V&V in, we're also gonna show you that we went the extra mile to make sure that device is gonna be extra safe. I mean, that's really gonna speak volumes to how serious you're taking your device, right? Right. And just for those of us who don't know better, why is it so important that we make those two points to the FDA early on? It's kind of like establishing, when you're establishing a relationship with people, right? I mean, the better, the more they feel they can trust you, right? The better that working relationship is going to be. I always think about it, like somebody said this to me very early in my careers, you know, if you're, if you're making a medical device, um, you should be asking yourself, would I, would I let my grandmother use this device or my grandfather use the device or loved one? You always have to have that level of care in there. And so if you can demonstrate that to a regulator, I mean, it just, it's gonna make your life a lot easier. this. We've talked about bringing in a uh consultant like you've described, but what about founders who might be considering just working on their own regulatory strategy? Can they do it all themselves? Like, I don't have any experience. Should I just get going on it and start building it all out myself? Or what does that look like? Ultimately the answer, like every answer I give to everybody is it depends. And everyone loves to hear me say that, but really it's, like, you can get started on anything. And I think it's just knowing where to look. I mean, we work with a lot of companies who are going to the US first, um, bringing their products market first in the FDA database has a lot of information that you can use. so, um, I mean, you can just, you can go there and start searching and there's a bit of like, You know, there's the tricks and the tips that you have to understand, but you can definitely start. where I see the companies and it's like common across everything, right? Like everybody can work so far until they get stuck. And then maybe they don't know how the FDA is going to react to a decision or they're just not sure how to do a certain task. But that's what I encourage people to do. It's like, be brave, find out, dig in, right. And, start trying. And if you get to a point where you're stumped, that's where you start asking people. And maybe you're like, What I see is like, you can build 80 % of your reg strategy and your pathway, right? Then you're saving 80% of the money you would have spent with a consultant doing the whole thing. So take a shot, right? And at least see how far you can get. I mean, there's a big difference between bringing a tongue depressor to the market and a heart pump. So you're going to fall somewhere in there, right? And so the more complex the device, if you're a de novo and there's nothing out there to base it on, you're probably going to have more questions than somebody who has a smoking gun predicate, right? Right, way I think about it. can really tackle most of it is what I'm hearing you say. Where do you see the common challenges where founders or small teams get hung up and they get stuck? uh of devices that are either brand new or bringing brand new technology and so maybe they fall between a couple of predicates or maybe they're a de novo and then they're trying to find a way to bring themselves back so that they can find a path to market that is simpler or less challenging or less expensive. And so it's really in those shades of gray where people have questions and uh we engage with them to try to help get. answers there so they have clarity and sometimes it's just you know what there's there is no no 100 % guarantee answer here we we have to move with FDA and ask that that question to get clarity on that one little point does that make sense? It does. it does. You know, and going kind of back back to the other side, what do you think are the no brainer things that they could tackle that they just maybe they think they need a consultant for, but they simply don't. It depends, right? question. Yeah, exactly. mean, when you think about the different types of devices, I mean, right now we have devices that can include AI. Um, so, and then, and then software. And so you might have devices with an app. So it could be a lot of cybersecurity as these new types of devices are coming to market. I mean, the FDA to a degree is, is learning about them as well. Right? Like if there's a certain device has never come to market before or very few, and there's going to be differences between them. So they have to understand how do we review these? or not review them, how do we ensure that enough testing has been done to ensure safety and advocacy, right? And so the things where I kind of, I kind of take this approach where it's like, it's a giant puzzle, okay? And what we're gonna do is we're gonna find all the pieces and we're gonna try and put it together. And so the first step is finding all those pieces. So let's look for product codes. And so the way you can tackle that is by going to the FDA website and doing a search for the different, product code types. can do, you can search for a descriptive term to see what comes up there. And then you can also look at devices that are competitors of yours and start targeting it that way. So you kind of attack it from multiple angles. So you start to find some product codes, start to find some reg numbers with definitions, and you can start to see where you may or may not be a good fit. And the other thing to think about is you're doing this, it's like, okay, my design is right here right now. So What if I add a feature or what if I remove a feature? Does that actually get me to fit into another category? And again, like I said, it's a trade-off. So it's not just a regulatory discussion, it's a business discussion. If we go 510k exempt first and then go 510k traditional, is there an advantage there or disadvantage? We have to understand that. But ultimately, to answer your question is there's a lot of pieces to those puzzles you have to find, to the puzzle you have to find. And so I mean... you can easily search for these things. And I do a combination of Googling and going to the FDA website to start finding some of this stuff. And as you build the puzzle out, you'll start to see, like I use this case study when I teach this, where there's a company that is um trying to get their reg strategy put together. And so they look for a product code and they find a product code that very closely matches their device. But then they go look for... what devices are within that product code family? And there's, think seven and six of them are pre 1992. There's there's, if you look for it, I think a summary, there's nothing there. One of them is from, uh, two to, want to say 2002 or something, but when you click on that one, you can find a 510k summary and they actually put a lot of detail into it. So it, it was able to help that company put their reg strategy together. But it's, it's like luck of the draw. Like sometimes you look and there's nothing there. and so you, you really have to now take more of a common sense approach or look for devices that are maybe similar to yours, like devices that have software. You can look and see, what did they have to do? And you can, you can still piece it together, but it just gets a little more complicated. And so like sometimes I think of it like almost like a card game. It's really the luck of the card to get. And so there's only so much you can do sometimes, but it's really a matter of trying that's. really how I kind of boil it down to seeing how much you can build. And then when you get to that point, you're like, okay, this is, think we've found as much as we're going to, let's see who we can bring in to just take a look at this and give us their thoughts, you know? And I mean, there's a lot to be said for networking. And I mean, I know I'm going like totally off on a tangent here, but there's so many people out there who've developed medical devices. And I've found a lot of them are more than happy to give you a little bit of time and, you know, talk through it with you and help you, right? So. It's really important. mean, the network at Boston, think is great. There's a lot of people there who you can, who you can chat with and they're, they're willing to give you a little bit of time and, and help you like give you that little boost to get a little bit more forward, right? Yeah, exactly. And I think that's an important note. And it's tangential, but I think it's important that ah the community is really supportive. ah I think if you're in the tech space, it's a different animal entirely, where it's very cutthroat and things are super secret. ah But in this space, the community is really, at its core, more interested in helping uh move medicine and health care forward. ah by extension, I think most of the people are ready, are really willing and open to talking and sharing their experience. So I think that's a good point. Sort of going back to that, the regulatory strategy though, um what do you think are the must have components? And this is this, maybe this feels a little dry and obvious to you, but if I'm just starting out, I want to know I have to... At least have as a starting point this this and this give me a a sort of a minimum and maybe it's a depends but you know, I imagine if I'm just spinning up and this is kind of ground zero. Where do I begin? What are the basic elements? So, I mean, it kind of goes back to what I was saying before around it's a holistic process. So one thing you want to establish in that process of building out your reg strategy is what are you claiming, right? What's your indication for use? What's your intended use? Who are the patients you're testing, you're using this on? What's the environment, right? You want to understand those things. And then... you then, those are the things you use to help you, I mean, obviously you wanna understand your competitors as well, cause you wanna get that information that's gonna allow you to start doing that multiple angle attack on finding the information within the FDA database. um I think it's really also important to understand how this device is gonna be used in the clinic. And I know this sounds like I'm not talking about regs at all, but it's really because, When you get to that point where you have to start saying to yourself, okay, if I follow this pathway, 510k exempt. If I follow this pathway, I'm a 510k traditional. But the version of my device that allows me to follow each of those pathways is critical because it's, you know, that determines your classification. But then from a business perspective, you have to understand, if I'm going to be a 510k exempt version of my device, does it add value to the healthcare providers, to the patient? Or... enough value that they're going to buy it and adopt it. Right. And so those are really key things. mean, understanding your design as well. And then the challenge, the cost to changing that design from being the 510k exam version to the 510k traditional version. What's the impact on your business there? All of those things weigh in. And I feel like, you know, you want to have all those plates spinning before you go to the FDA website, because then once you get there, it helps that decision-making process, right? And sometimes it makes it just very, very clear. This path is the way we have to go because nobody cares about the simpler version of our device. Or alternatively, adding that extra technology doesn't move the needle enough for people. So why would we spend another million dollars to get that version of the product on the market right now? Let's just get this version on, right? So I feel like those... those are the things that I would want people to come to the table with. Like let's just say for argument's sake, I was building their reg strategy completely. Then those are the things I'd want them to come to the table with really clear answers on. And if they don't have those answers, we figure it out as we go. And it's like, okay, I've gotten this far, but now I need you to tell me which market are we going for here? And once we know, then it's like, okay, so this is your reg strategy. You're like, this is the product code. This is the reg number. Maybe this is a predicate, maybe not. But ultimately it helps us determine the V and V and that's the piece that they also need to get out. It's more of an output of this exercise, but that's what you really need because that's gonna define, right? The timeline for your project. mean, if you have to do biocompatibility, cybersecurity, all those different parts of the V and V process, like what does it look like? What is your, if you have to do a comparison to a predicate, well, what is that gonna look like? How challenging is that for you? ah Cause ultimately it determines your budget and your time, which are as you can imagine, pretty big inputs to what you want to raise. Even a small team, your timing is limited and you either need to be super, super agile or things, you know, things tend to stack up and extend. With all of that, ah I really like the spinning plates analogy because I think that some of the thinking is either it's like a, it's like a grocery list, like you said, or it's a, you know, a linear timeline. We'll do this. And then we'll do this and we'll do this and we'll, you know, let's start thinking about regulatory down, you know, down the road somewhere. And a lot of the conversations I have are you should have that part of your initial business strategy. Going back to the spinning plates. em I think that, you know, small teams need to, to understand that any one of your plates could bump into another plate and send it sailing. And you have to be really open and flexible. And so that's why I like your, Holistic view of the whole thing, you know, and it's not all bad. Sometimes opportunity just presents itself It's almost a happy mistake. um but taking into account all of these things all the time um You know talk about that a little bit more and that kind of you have to have more of a flexible view of this Rather than a strict fixed linear approach was just laughing to myself, I thought you were gonna ask me, like, tell me how exhausting that is. Well, you could talk about that if you want and then we could bounce over to um the other. But yeah, it really is actually super exhaust. Yeah. So one of the things we talk about when I do, and this is a little bit of a pivot, but one of the things we talk about when we do the quality, this quality workshop we run, where we help people learn how to implement a quality system, quality management system, is the idea that you don't want to do things like all or nothing. Like we don't say, okay, today we don't have a quality system. Now we have the full thing kicked off that just doesn't work as you can imagine, especially with small teams. And so similarly, when it comes to the whole. Um, you want to baby step your way into this, you know, for a number of reasons, you want to gradually adopt culture of quality, this culture of working within an environment where you're developing a regulated product, right? Um, the overhead increases, obviously for the team, the burden increases for the team, but you don't want to go from zero all the way. so like same thing with when you're thinking about all of these things, like the. Like I have a slide that I show people where I just put up the word chaos with a question mark and it feels like chaos because you have to manage all of these things. But it's like you do it almost like a sprint approach. Like it's like, okay, we've, we've got this idea for what our device is going to look like, what the adoption is going to look like, what quality is going to look like, what the design is going to look like. Okay. So let's start here. Let's go. Let's do two months of work, three months of work. Now we get to here and it's like, we've learned a lot in those two months. I mean, sometimes when you, you know, sometimes people think of it at like moments in time and it's like, we, okay, stop here. We freeze. Okay. Look at everything assess. Okay. Now let's go do some work. And then we get to another two months later, three months later. Okay. Let's reassess. What did we learn about the product development process here? What did we learn about designing this device? That's going to impact our users is going to impact our reg strategy. Like maybe we dreamt up a concept and we realized, Holy cow, we're, trying to invent something that's just really complicated. Like let's. the scale that back, it's just going to be too much for us. They change the design and that impacts changes on other things. So it's very much like when you think about it, when you think about kicking off design controls and you go through the phase gate process and you have design reviews, we encourage a lot of people to just do really good engineering best practice, right? Write everything down, version control your design as you're testing it. But you know, keep doing wholesale design reviews so that you understand the impact of decisions you've made. as you move forward on the rest of the business. And yeah, it is exhausting, but it's like, I look at it like, uh know, if you have a strong plan and you have some strong contingencies, it's gonna help you keep moving forward as opposed to getting to a point where you realize, no, we made a mistake here, how are we gonna fix this? And then you're just stuck, you know? Like you don't wanna be. A lot of what's driving all of this is just really de-risking the entire program. Thomas, thank you so much. That was great. Thank you, Bill. I'm really glad I came on this and I really appreciate the opportunity and it was a good discussion. I really enjoyed it. It was great. Awesome. Well, have a great day. If you made it here, thank you. If you haven't already, like, share, and subscribe to the channel. If you want to learn more about this topic, I expand on it below as well as in my LinkedIn newsletter. That's all for now. More soon.