The Founder’s Playbook for Med Device Engineering | Tim Looney

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President/CEO Tim Looney (Northeast Biomedical) breaks down the engineering plan founders actually need (DHF, phased reviews, and right-sized documentation) to move faster without tripping FDA/CE. We cover startup blind spots, big-company constraints, and how to “do it right once” so you don’t pay for DHF remediation later.

Tim’s LinkedIn - https://www.linkedin.com/in/tlooney/ 

00:00 Why med device engineering fails
00:16 Who is Tim Looney
03:04 What founders miss in early engineering
06:11 Why the FDA rejects “it’s all in my head”
08:13 Hidden tests and documentation you must plan for
12:24 Move fast the right way
15:53 How phased engineering speeds up approvals
20:23 How to avoid costly founder mistakes
24:44 Why the system blocks unprepared founders
27:11 Case study on fast clearance done correctly
 
In medtech, “move fast and break things” breaks people. Tim Looney leads Northeast Biomedical, a product development and contract manufacturing firm that lives where speed meets compliance. In this episode, Tim explains the engineering plan most founders skip: phase-gated reviews, checklists that prevent “oops” moments at submission, and documentation that’s lean early but complete enough to avoid costly DHF remediation. We unpack startup blind spots (biocompatibility, shelf-life, packaging, verification), how larger companies get stuck in resource bottlenecks, and why the fastest path to clearance is often meticulous—just not bloated. Tim also shares a class-III European dossier story that moved in weeks because the package was complete, plus practical guidance for early founders on prototypes, notebooks, and IP strategy. If you’re building the next device, this conversation is your map to “right the first time.”

 https://meshagency.com/fcmo-fractional-cmo-fractional-marketing/

#MedTech #MedicalDevices #GoToMarket

Transcript

0:00

If we have a bad day and a product goes poorly, someone is going to be injured. The company that we work with invent or whoever it is, will hands down be the subject matter expert. But they don't fully encompass all of the tasks that has to happen because it's outside of their expertise. I'm Bill Schick, fractional CMO, host of life's AI continuum. Today I get a chance to speak with my guest, Tim Looney from Northeast Biomedical, where he breaks down landing engineering for med device projects. What you don't want to do is you don't want to go towards regulatory approval and get there, and they'd be like, where is this test? Or did you consider this? Did you consider that? And what we're trying to do is we're trying to get through faster by not forgetting things and making sure we include all of the steps, understanding what founders actually need, what is planning phase reviews, and right sizing your documentation. If you want to see that you're monitoring the right things, and if you walk in and go all up here, don't worry, I make it the same every time. It's not going to fly. And really understanding how sometimes it can feel like you're moving a little bit slower than you'd like to, but you're actually moving faster than you would otherwise. Thanks for joining. Let's go. So, Tim, thanks for hopping on with me today. Thanks for having me. For the listeners who don't know you. Give us a little bit of background on you. Well, that's a long, long discussion. I don't know if we have enough time for that, but my background mainly comes from, you know, I was trained as a mechanical engineer, and it had kind of an interesting career. You know, I started off in design engineer, started designing equipment, machinery, robotics and that type of thing. And then 20 something years ago, I switched into medical device. And because I was always drawn to that, because it's kind of a neat thing, like you're actually making something to help somebody. So I've been working in that field basically ever since then. The company itself was started actually 14 years ago this month. We are a small product development and contract manufacturing company, so we focus on working with other companies that either have an idea or need some help or design that needs to be fixed or some sort of challenge. And what we do is we put engineers in our systems to work for them, as a fee for service type of operation. And we also will produce, you know, finished grade devices. So the companies quality system is ISO 1345 certified. So we have to go through some pretty rigorous things with that. And the biggest thing like we work with a wide variety of different companies. It mostly involves some sort of disposable and some sort of durable goods. And we that could be electronics, that could be a catheter that usually pair them together, some sort of sensor. Yes. We've been at it for 14 years with about 25 people here. We're still looking to grow. We're taking on some more space. It's, it's fun because we get to work with a lot of startups that are have interesting projects going on. We also balance that office. We work with a lot of bigger companies that just don't have the resources for the time that they need. They're usually under some sort of deadline or some sort of crunch, and we can help them with that. So that should probably cover you're looking back on, on the last few years. What are some notable projects that you've worked on that you would you would be able to talk about? So some of our stuff is highly, confidential customer. We've had some really interesting things, and I'm trying to think of some of the more interesting ones. We've worked with one company with the technology that is a it's a feedback loop for, depth cutting. So the first product that they put out was for toenail drilling. So for to treat toenail fungus, it would drill through the toenail and it would have this feedback loop built in that would stop the toenail or stop the drill before it started causing a lot of pain. And so what they would do is they would drill an array of holes, and then they would fill the toe nail full of, anti fungal medicine and make it instead of taking a pill. Then they expanded that same technology to create a cranial drill. And so the cranial drill will drill into the skull and then it will stop before it creates a plunge injury. So that was a really fun one. We've worked on a lot of different, catheters as far as urology catheters, a lot of coronary catheters with ultrasound arrays in them. One of the other things we're trying to think of, some of the other ones, even to robotics and equipment. I mean, we have a product line that we make for a company that we designed and developed here. That's for biotech. It creates immunoassay material from blood, from animal blood. So we've been making those for a number of years. And that it's just kind of an interesting like wide spectrum of different things. Right. So so you work with a variety of companies from the sort of the individual entrepreneur all the way up to a larger company that might be developing new products or expanding their product line. Part of the reason that companies come to you is that you have a pretty robust engineering, you know, and planning process. Tell me a little bit about that. Yeah, it's interesting because that's like I was about to say before I forgot, it's a, you know, we are never the subject matter expert. The customer always knows what's going on. But what we do is we do bring a process. Most companies, especially startups or physician adventures or even larger companies, don't understand what it takes to all the steps they have to do to put the product on the market. So we've developed this with, with, you know, consultation from a regulatory group, from our quality group, from our engineering group. And we've developed our what we call an engineering plan. And that covers all of the steps that that happen from the beginning to the end of what it takes to bring a product to market. And it's flexible enough that we can do it for a wide variety of different products. And we can also come in or out, depending on the fix, because some companies are looking for, hey, we just need to reclassify this. We need to retest for this particular indication for use or other people where we just need to focus in the beginning. And then there's the hey, we have a clinical trial. Our designs are done. We just need you to make up, you know, 500 units of this so we can go to trial. So it's been pretty helpful. It's not perfect, but it's, one of the things I think that when you meet these a lot of these especially smaller companies do not fully understand the depth and complexity of what has to happen. We've met plenty of physicians that will tell you. Oh, yeah, the design's done like. Great. Can we review it? It's up here. And I'm always like, that's fabulous. The FDA is going to love that. So let's dig in to that point for a moment for let's be explicit. What is the problem with carrying around your your plan in your head? Nothing. If you want to keep it secret. The issue really only arises if you want to have somebody else help you make it. And it's really only issue if you want to submit it for regulatory approval. You can't go to market whether it's in Europe. I spent a lot of time working in Europe, a lot of time working in the United States. You can't go to market with if you go to the FDA. Well, let's see what you have because they want to make sure that it's safe and effective. They want to see that you've tested things. They want to see that you're monitoring the right things. And if you walk in and go, yeah, it's all up here. Don't worry, I make it the same every time. It's just it's not going to fly. There's no way. I just want to be sort of the contrarian here. But that feels like a super obvious thing. But I imagine that you're talking about that because it's often not as obvious as you would want it to be. It's never as obvious as what what you would think. And the problem is, is that I'm not trying to belittle the people that have these brilliant ideas, because oftentimes it's a wonderful idea, but it's a regulatory hurdle that's been put in front of us because, I mean, if if we have a bad day and a product goes poorly, someone is going to be injured, hopefully not severely, but it's possible. So it does take a little bit of education to kind of convince them, like, all right. So you don't want to have to do that. If we sell this company, you're going to have to pass this information along to someone else. So it's more about recordkeeping and building value and looking for the next step, the larger volumes, the other manufacturers, that kind of thing. Right. That makes sense. So what do you think? You know, maybe focusing on startups for a moment. Because I imagine that larger companies probably have a little bit more of a process in place to some extent, looking at maybe a startup or a, you know, solo entrepreneur. What do you think are some of the the key things that they often miss? They just don't they just don't get on their radar. It's the level of of detail that has to go into the design, the level of documentation, inspections and that type of thing. They just don't fully understand the implications of what they're trying to do, whether it's did I get this test, compatibility, shelf life, package testing. There's all these things that we've accounted for that most of the time. They just don't care. We have we're working with a startup now to position it better, and he's a very reasonable guy. And he was looking at us. He's like, I want to make a change. And we're like, okay, that's going to take a little bit more money and a little bit more time. It's generally acceptable. That's. And then he came back to me and he's like, I just want to talk to you about this. He goes, I was looking at the budget and how much budget we've spent, and we should have plenty of money left over to to work in this design change. And I was like, well, let's go through our engineering plan. Let me explain to you this test, this test, this test, it's all accounted for as far as costs. And I go and he goes, oh wow. Well that goes my that was why you're asking for my money. Because I was like, you know, it's just there's things that they don't understand. I mean, we've done this numerous, numerous times. So we understand what's going on, and can anticipate what the FDA wants. We can anticipate what all the changes would be. Did they miss anything in their engineer? Because our focus is on the engineering planning part of this. I mean, there is a funny story for that is that they had us do some initial work about six years ago, and we had just implemented our system and they they said, alright, here's some work. We have to go to an animal, you know, pre-clinical study, we'll call it, and we'll say animal. We're gonna have to go to a pre-clinical study. Then we need to get these prototypes produced. And this was, this was kind of interesting because, you know, here we are, we're at the study and it's not too far from here. And they look down and they're like, yeah, we need to do this, this and this. I was like, okay, hold on. I'm going to run back to my office. We're going to make something really quickly, and we're going to come back and use it in the, in the, in the preclinical study. And this is kind of a little bit of odd thing is that they decided at that point that they were going to deviate away from our system and go to another company that was slightly bigger at the time. And then they came back, and now we were doing a ton of work with them because our system has matured over the past 6 or 7 years, obviously, like anything would. The other company did horrible work for them and we came back as a much trusted resource. And so now they brought us our biggest thing. They're like, this is the pivotal moment for this company. You have to do this design and take it to market. One of the things that we do is we focus on the process. And that's where our development plan came from. The company that we work with, company inventor, whoever it is, will hands down be the subject matter expert of what they're trying to do, of that technology, of that procedure, the disease state, whatever it may be. But they don't fully encompass all of the tasks that has to happen because it's outside of their expertise. Whereas what we can provide and we do this all the time, is that we provide kind of reminders and building blocks in our engineering plan. Like, don't forget, we have to test this. Oh, great. Because what you don't want to do is you don't want to go towards regulatory approval and get there. And they'd be like, hey, where is this test? Or did you consider this? Did you consider that? And what we're trying to do is we're trying to get through faster by not forgetting things and making sure we include all of the steps. And oftentimes they're like, oh, we've heard about that. And some of the companies are more sophisticated than others. But oftentimes, especially with the startups, they are looking specifically at that one product as like their next best thing. They haven't done this millions of times. So that's one of the things is we bring structure and like a checklist of things that should happen. And in some cases you look at our checklist, you're like, I don't need to do that. I don't need to do that. And when we look, we decide, we talk about it, okay. We have the provisions not to put that, but we've addressed it. And so there's nothing left behind. There's no missing bits. Also from what I've seen as well, is sometimes, you know, up front without a lot of experience and careful consideration, I think there's a sense of just moving really quickly. Let's move fast and break things, in an effort to accelerate the process. But what you're saying is by taking a step back and kind of systematically going through all of the possible, places that might need to be looked at and removing those, rather than just not being aware that they exist at all. It does actually help you get to market faster because you don't run. You don't run into those those surprises later on in the process. Yeah. One of the things because of, you know, we've been obviously I've been at this for a long time, but one of the things that we have spent a lot of time doing, which is kind of it's a difficult it's not a fun task. It's called def remediation. Design history file remediation where we never fake data. But we'll find out later that they should have done this or should've done that in their effort to get to market faster. And as long as you have that data with, we'll call it current correct dates and things like that, the FDA or the notified body will be happy. So that's kind of the forensic side of things. It's just much better and faster cheaper to remember it to begin with instead of trying to backfill it in. Now the FDA is involved or upset. You have so much time, letters, recalls like none of that stuff. You don't want to do any of that, right? So you just in getting ahead of it, rather than maybe crossing your fingers. And, you know, we'll deal with that when we get to it sort of thing. That mentality, I, I've seen that a bit. And we try to avoid that where we can. Yeah. It's just making them aware, and they can choose not to do things. They could say, you know, I don't think we need to do but compatibility, that's a discussion. But then it was just kind of. So that's maybe on the smaller business side, the startup side, talk a little bit more about, a more established, company and how, maybe where they struggle a little bit with the sort of this engineering process and how you, you know, you help them there. Yeah, there's there's multiple aspects to that. But most of the time it's resource constraints. We've had customers get notified by the FDA that they require some additional testing. Testing wasn't completed. And now that they're on the notice for they have 60 days to complete the testing. Okay. Well, we at one point can direct, let's say, 15 engineers to start running some tests, solving the problems that they couldn't normally handle without the extra influx of help. We've had this on numerous occasions with customers where they'll be in the building are people in the building, and then they're just one big happy team moving forward, trying to get things done. In larger companies, innovation tends to be more difficult because it's, it's there's not constraints, but I call it corporate inertia, where it's just harder to move a bigger boat to line up than it would be a small, smaller boat, a little bit more versatile, more steerable, that type of thing. So we can add that, bring that to the table, whereas we're not constrained by the oh, you have to have 15 signatures. We'll have the same thing certified, audited everything. But it's just much faster. Talk a little bit more about your approach when we spoke about it last. It's it's really a phased approach helps you maintain speed while staying compliant. Like what's what's maybe special about what you're doing. We try to account for all of the things that have to happen, which is good. So like I said before, not to sound like a broken record, but nothing's left behind. Nothing's forgotten. And we have design reviews at each the end of each phase and reviews. So in a checklist, all these things need to happen for us to move forward. At this point. It keeps us accountable, keeps the customer accountable. And makes sure that when you're at the end product is going to be as complete as it possibly ever could. But then we also have the ability to add resources that don't need to be like, if you're working for a small company and you've got a complex thing, you end up with three engineers, whereas we could end up with some of this engineer's time, some of this engineer's time, and some of that engineer's time. But they're not sitting around waiting for for you to give them more work. We could have put them on some other project until they're needed, and then we pull them back. And so that that also helps with the speed. If I'm trying to build my own engineering plan. Do you have recommendations to me on how I can help, design or build my process so that it strikes a good balance of remaining compliant, but also moving as, as reasonably quickly as as we would want to. Yeah. I mean, I never try to talk you out of making your own plan. There's a lot to it. I think there's probably 6 or 800 lines of items that need to be done, and some of those could take a minute, some of them could take a month. But just being complete. So there's a lot of research and FDA has a lot of good guidance on what to do, but you're going to have to read it, understand it. There's some decent books out there, but design is a one that's it's popular. I actually used to use that in one of the classes, actually. I still use it in one of the classes I teach. To kind of give people the framework and then build from that, but it really comes with experience and understanding what what is required. What class do teach? I teach about, okay. So I am an adjunct professor at, UMass Lowell. Okay. I currently only teach in biomedical engineering. I teach medical device design, too, and computer aided design design for medical devices. But previously I've taught, new product development strategy through the the business department, through the MBA program. And then, I used to teach mechanical engineering technologies to teach drafting class. But I've been doing it this January, be 28 years. I think it's really interesting. Who who typically like at what level are you teaching? Are these are these kids still coming out? Are these, you know, grown ups with a lot of experience? Is it a variety? What do you see in those classes? The business school tended to be and the engineering technology, which I probably gave up 4 or 5 years ago, tend to be slightly older experience trying to make, you know, get to the next level. The biomedical engineering students are the ones that I work with now. And, a lot of them have focused on trying to do medical device design as a, as a concentration to their, to their studies. And for me, it's, it's a fascinating thing because I have an opportunity to have 214 week sessions with these students. And typically, if we're looking for people, we start them off as they're seniors, juniors, the seniors, in college as technicians to come in. And it's in addition to the big show. So I think at this point, we probably have three quarters of our engineering staff is from that school that has come through an internship program through, there's a math life sciences center at the local in Massachusetts that we, we partner with for making that happen. That's great. That's that's the best interview process. Let me tell you that the caliber of staff members we get out of that is Barnard, because it's you talk to somebody for an hour, you don't know. You talk to somebody for 14 weeks every week. Sometimes they're having a good week. Sometimes they're having a bad week. You start to understand, well, you have a lot more good weeks or bad weeks. Yeah. You get to really know the people. Yeah. Very nice. Okay. So back to looking at developing an engineering plan where we're advising kind of, you know, smaller startups, entrepreneurs on, you know, what the process looks like. What what recommendations would you make to them or advice would you give them, to see this process as the, you know, the mechanism for success as opposed to, unnecessary evil? Let's just say a firm, what was that, a burden? Yes, exactly. Like, this is the thing that gets you, you know, to the end as opposed to, you know, a roadblock. It's a great question. The challenge with that is it does take a lot of education. I mean, a lot of what we do is educate. And sometimes if they do come in, they see it as a burden or a roadblock or something where they just want to move faster. It's on my staff's responsibility to educate them on why. And what if they skip that? What are the implications if they don't do a complete job? What are the implications? And it really doesn't take too long in most cases. And it's also a good indicator as you're starting to discuss a project with the customer. I mean, we don't take every project, and if they can't be, I'm not trying to say brought around or, or anything, but if they can't be enlightened, get coached to the point where they're like, oh yeah, we need to do that. I understand. And then they're not going to have everything, but then they will be like, okay, I well, I have to trust your expertise with this. And we've it's it's basically unfortunately part of the sales process is you have to kind of talk to them. We always have a technical person in the room for every initial meeting, just to make sure that things are going to, you know, that they understand what's going on, what the implications are, and things like that. And we're not trying to make it slower. We'll actually make it faster, but that you just have to understand that we know what we're doing. Right. What do you think has been the the hardest one, convert, maybe someone who really, really felt like they didn't have to do all of the work. But you want them over? I was going to say there's some we haven't won over. I'll quickly tell you that, because it was. It's been kind of funny. We talked to this one physician inventor. I won't say what he was working on. But he's like, I've got this. It's done. And we're like, okay, this is what we need to do in order to put it on the market and produce it. Oh, well, I don't need to do that. Okay. And so then he went away for two years and he came back and he said, I've talked to eight different people and they've all given me your name and number. He's like, I already had your name and number. And I was like, okay, but as I tell you, we should talk. And we're still that's still in the process. But it does happen quite a bit, especially with people that are real research based. They won't see a lot of the value in the documentation, and they're like, I can make that. I'm like, yes, you can make that. But we have to teach other people how to make that so that you don't have to make that. I'm trying to there's been a lot, some we never convert. We try really hard. And those, those projects tend to take longer in and, you know, just become more arduous because it's not necessarily, you know, it's just harder to to get it moving and to finish up all the things we need to do. There's one one doctor I've worked with for years on and off. And he always tells me that you don't have to do that, you know, not do that. And then I'm the first one to say, yeah, you do. I started off consulting to him. This goes back a long ways in my previous past. He then hired me as a VP for his company and I continued to argue with him. The only one of the company without I them about cutting corners for six years, and then immediately hired me for his next company, as a consultant. And we spearheaded most of his initial design on multiple different products, both, disposables and durable goods like electronics based. And but I will probably get a text message from this weekend asking a question. So he kind of has come around. That's probably one of the biggest ones. And this is a relationship going on spend 15, 18 years? Yeah, I think I think some of the the thinking we have as entrepreneurs is we see something and it just seems really obvious and easy to us. And, that sometimes that can overshadow the reality of bringing a device to market, especially in a system that sometimes we assume that because we're, you know, we're part of the system, it would just be really easy for us to bring it into the market. But the system's really designed to keep us out. It's designed to and people don't think about it that way, but it's designed to protect people. And the way that you do that is you default almost to no. And you have to get through the barriers. And that's where we feel bogged down is with all of the resistance of that. So yeah. So my job is to not show you that it's bogged down, that there are things that you have to do and to show you the quickest and most efficient way to get past them, because the thing with a lot of these, like it's a it was a little bit easier in Europe before the regulations changed, where you could call and be like, hey, this is what we're trying to do to the notified body. We're trying to get this through. What do you want to see? I'd like to see X, Y, and Z. And so with the FDA has come a long way. But originally you'd go in and you'd be like, I want to do this. And they'd be like, no, we want you to do this. But now they're becoming more collaborative, especially with next February coming. We'll see how that goes. Where they combine the two systems. But it is it is a negotiation to find make sure everybody's boxes are checked. Things are tested. I mean, we have gone and changed the indications for use to make it a little bit more acceptable. You still want to be able to control the market. You still want your product to be able to use for the disease. State that you want, but you sometimes have to change the way that you get there right off and then adapt to it. Talk about that a little more. Can you dig into that, or do you have a story that you could share with us? I have a story from Europe. It's probably a few years old. So we're working in a coronary project. This was back before it was MDG, medical device guidelines, before it became the regulations, before the big regulation change. And we were working with the notified body, and we happened to be working with the head of the of of this joint regulatory association. And we had a class three product. It was a coronary device device. And we're collaborating with him like we're going to do this, we're going to do that. And so when it came out, you know, a dossier is probably 2 or 3 phone books there. It is a significant undertaking to get a full design history file documented in enough detail for him to be happy. From the time first submission to the time that we were able to we got market, a market clearance was two weeks for a class three product because we had spoken to the notified body the entire way through and he looked at it and he just actually he did this. He goes, he put his hand up on the, on the stack of paper, which is like this. He goes, is this everything I want to see? Yes. All the tests pass. Yes, yes. Okay. Give me two weeks and then he went and said to to k back and said, hey, I really appreciate what you did. You've made my job much easier. He goes, can I use your documentation package, your design history file, as an example to other companies for what I want to see? Wow. We're like, sure, please don't show the actual test details, but you can you can show the layout extra. The format you could use like this would be great so that I can tell people, if they want to get their products to market faster, follow this this plan and just put putting put the pieces together. And I am a happy man. It was fun. So capturing capturing the documentation as you go, I think would be a key part of success. So even if you're, you know, alone or early stage, just making sure you're documenting everything as you go, even if it's before bringing you in, right? Yep, yep. And we'll want to review that. But the challenge here and this is where it takes experience. You don't want to over document in the beginning. You don't want to under document in the beginning over document. It's going to take you too long under document. We're going to go back and we're gonna have to figure it out and fill in the blanks, which is going to happen anyways. But we're happy to talk to people in the beginning and say like, all right, this is what we're thinking, and we'll talk to people like, here's our plan to put it forward, here's our engineering plan filled out, and they'll come back like we're going to take the first phase and do it. We can we'll talk to you at six months. We'll bring back what we have and we'll make sure that we have what you need. Sure. Not a problem. Happy to work with you. Do you think there is a rough, a bit of guidance that you could provide somebody just starting out? Maybe they're too early for you and you could give them, just a quick suggestion on a rough ballpark of what the right level is for them. Yeah, we do try to do that. Oftentimes, like one of our first steps when we speak to a company is, well, they come through or they have a project. Yes. And unfortunately, due to the, the startup nature of a lot of the things we do, they're pre funding, but they don't know what to ask for, for funding and what they need to do without talking to us first. They just have a technology concept. But there's not even a fully fleshed out product. So we will work with them in the beginning. Then pair off things. You do this, will we? We'll do this later. We even have certain instances where we're working with a surgeon. He's like, I will run all the animal labs. I will make sure that I will do. I will do the surgeries myself. Fantastic. You know, it's all we build. A team with them is an integral part to it. Okay. And you, you basically assemble the rest of the players. Yep. To get this thing going. Okay. That makes perfect sense. If and I'm going to I'm going to ask it again though, I would want to try to be a little bit prescriptive. And maybe we can put up some some rails here for you. I'm speaking to that. That listener who is is they're still early and they feel like they're not quite ready for you. Let's say they're maybe, you know, six months or a year out from working with you guys. What level of documentation would you like to see? Within, like an ideal client moving forward. And I'll say that's a tough question to answer. We have come and worked with customers with literally napkin sketches, the need to look like this somehow to people that have working prototypes, that they have early test data or benchtop data. For us, we can work with either. Obviously, there's more front end work if we're getting a napkin sketch. I mean, we've had several companies show up with a patent. I got a pat, can you make this? Yes. It's going to take a minute. Right. I imagine I don't have a patent yet. But I'm beyond, thumbnail sketch. I can think of a client of mine who, was literally building things in his garage, and, he's past that. Well, past that now, but that's where he was. He was at his own, you know, prototype. He was talking to an IP attorney, but he wasn't there yet. He was. He was. Well past that thumbnail sketch, so he was pretty far along. And he's probably within striking distance of of coming your way. Do you think there are any specific, things that he should have ready for you when he shows up? It's funny because we get this question all the time. What do you want to see? And the easiest answer is everything. But that doesn't help. It's not like it's not a helpful way to explain it, but we would want to sit down. We want to see the prototype. We want to review it. If there's any notebooks that you used at that point, it's mostly background information. Shockingly enough, we end up being involved with a lot of IP generation as well. We're not attorneys, but we can take something and really define and refine the claims. We can help look at different embodiments. We can get involved with a lot of that stuff working with the attorneys, set up, help them work on their strategy. You know, we should have rolling provisionals. We should do this. We should do that. And it's just a lot of things that they may not have thought of. But we're fully capable and get both of those things like, and we get this. It's practically done. I just need to make one change to here's the very beginning. Just have an idea. We prefer the from the front. Like the fun stuff in the beginning, right? Right. The ideation. Oh, that's the best part of typing. Yeah. Oh, yeah. I mean, we'll do all stages, but I mean, in the beginning the company was formed for the first probably 5 or 6 years, just on the front end work, just on the early R&D stages, because it was before we got our ISO certification and we weren't making human grade devices. And then we've added talent to the team in order to bring the manufacturing side of things up. And when I say we do manufacturing, our goal is to launch early product, get you through your clinicals if needed, and then help you scale, and then we will stay on as a as a approved supplier while you go to the big Flextronics and the big dogs of the world that aren't as efficient in the hundreds and thousands, they're more efficient than the tens of thousands of millions of parts. If you had one piece of advice for somebody just starting out, they they had they they were just hit by this idea. And they were they were just ready to go and they're going to go out to their shop or they're going to go do whatever it is they do that to get it going. What would that that piece of advice be? Find a mentor. Find someone that that knows you or would like to know you, that's intrigued by what you're doing and can share their experiences with you while you're going through it. Because they will live vicariously through you with inventing cool things, and then you will be able to absorb information, background, and strategy from them. It's a my mentor that has, counseled me never to work for another big company again, was the assistant dean of engineering when I was an undergrad student decades ago, and I still talk to him. Tim, thank you so much. You've been great. All right. Thank you. I appreciate it. 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.