What No One Tells You About Going to Market Commercialization Pitfalls in MedTech

Hello and welcome. My name is Shawn Smith. This is Medtech leading voice, Webinar. What no one tells you about going to market medtech commercialization pitfalls with experts, Rene, Franz and Michelle Lott from Leanraka. I'm delighted to have them here today while we're waiting for everyone to join. I'm just gonna run over a few quick housekeeping announcements. let's see. a recording and slides will be available tomorrow. It will be emailed to everyone. Please use the Q. And a button for questions for Renee and Michelle. Questions that you have for me should go in the chat and use the chat for comments.

If you would like a certificate of attendance from today's meeting. Please put your name and email address name as it should appear on the certificate and email address in the chat, and we will make sure that you get that probably by the end of the week. We create this manually. So please be patient. As I said, today's subject matter. Experts are Michelle Lott and Rene Franz from Leanraka, and I would like to make a special announcement on behalf of Medtech leading voice exchange. Many of you have seen my post this past couple days. Last Friday we soft launched a new program. It's the only network for medtech product and service providers where your expertise matters. If you're interested in becoming one of the 100

founding members, please write 100 or founding member, or something in or Mlvx in the chat, and I will contact you, or I will put a link in there as well. So that's exciting. And now, without any further ado. I am going to turn it over to our expert speakers. Thank you very much. Please take it away.

Thank you, Sean, thanks everyone for joining we're actually doing part 2 of innovation to commercialization. And Michelle and I are going to briefly introduce ourselves, and then we will jump into what we covered before. And then today's talking points. So Michelle.

So I'm Michelle. I'm the principal and founder of Lanariqa. I've been in the medical device industry for about 20 years now. I've also served as an FDA FDA industry representative on the Fgmp. Advisory Committee. We make a joke that I am a Master Grief Counselor, because people have a lot of feelings, mostly difficult ones to deal with in this whole process of getting to market, and my partner, Rene here comes in and kind of takes the baton and handles kind of the business and commercialization side of those those same things.

Thanks, Michelle, so a bit about my oh, sorry! Go ahead.

I was like. Take it away.

Okay. bit about my background. I've been doing medical device product development and commercialization for over 30 years. And I've helped bring to market in various stages from a sketch on a napkin all the way through to getting a device into the end. Users hands over 200 medical technologies. it says, Don't shoot always the messenger, and you'll get a better appreciation for that today as we go through this presentation. But there's just a lot of tough messages that we have to deliver to clients. And part of doing this seminar is to help you actually think through some areas so that hopefully, you won't have to go to Michelle's grief counseling.

So what we previously covered. And this this prior webinar is available, I think you can just drop in the chat if you'd like access to it, your email. But we previously covered product development creating a business plan, regulatory strategy, 101 and prototyping and manufacturing. And we ran out of time. So today, we're going to just briefly revisit concept to commercialization ready set, maybe market launch knowns and unknowns, basically how to sell your product and secrets to success. So, too little too late, Michelle, do you want to take this one.

Go ahead!

Okay, so this is really the roadmap from an idea which could be a sketch on a napkin all the way through to getting your 1st sale and scaling, and what usually happens is folks come to us right when they need their clearance with the FDA, or perhaps Europe, and say we need it now. Well, there's a lot of stuff that has to happen to get you to that point. So we always say, Well, this sounds expensive, because look at all of this work to the left of FDA clearance that needs to be done before that happens. So the reason it's expensive is we all jump into this time machine and help you build this information retrospectively. So again, we covered everything left of this and our prior seminar. And now we're gonna jump into market clearance.

and it is not in many cases the beginning or the end of the race. It's the beginning of it. So most average tech startups come to us. And they think that that whole list of activities they don't always realize they have to do those. So they come to us thinking they have very little left to do, and they are ready to launch. And the reality is in the real world. They're not able to launch, because there's so few of those activities completed. And so that's where the commercialization piece comes in, too. You think about building a house. The foundation is critical. So you need to be thinking about your foundation and your whole commercialization plan right from the start

ready set. Maybe. So what we want to talk to you about today. And this is so important, even before you begin your product development journey is thinking about. Okay, I do have this idea. How do I really validate it. How do I know if that idea is worth pursuing and then upfront teasing out? If it's just an idea or a viable product? And this is really important, because it will save you a lot of time. And you and any investors you bring to the table a lot of money. And so we're going to share some examples with you of devices that we've worked on and opportunities that we've. We've helped people work through. So in this process, you really need to be thinking about the following 5 questions you need to ask, do the users need it? We'll have examples of that. Is it appropriate for your target market?

Can you even manufacture it? Can the users actually use it? And is it at the right price point? We're going to share some examples with you now and again. These are things you should be thinking about right in the beginning, as you start your product development journey. So here's an example of a product that had a viable market elsewhere in the world. It was a mobile app that you could use to scan your skin to say, Okay, this lesion or this mark might be skin cancer. And then, if you thought it was skin cancer, you could then maybe be moved up in the queue to see a dermatologist. So they approached us and said, Hey, would you help us commercialize here in the Us. So the 1st thing that we did is we went to dermatologists

because they wanted this to be a medical device, and they wanted it to be reimbursed. And the dermatologist said, Well, that's great. But can it identify the cancer? And will that be in place of actually doing a biopsy? And their answer was, No, those are not the claims that we want to go, for we just want it to say it might be cancer. It might not. So in the market they were selling in. That was very much needed, because sometimes it could take a year or more to see a dermatologist. But here in the Us. Dermatologists are widely available. So we saved them quite a bit of money and headache upfront by saying, Hey, we talked to the folks that would use this, and there's really no market for it here unless you want to make the claim that you're equivalent to a biopsy. And they didn't.

And this is why we call Rene. Don't shoot the messenger.

Yeah, sounds good.

Saved them a lot of money, but it was hard to swallow. At the same time.

Very true. The next 2 examples Michelle and I worked with with both of these companies. The 1st was essentially a radiation seed that went into the eye to treat acute, wet, macular degeneration. It was initially designed over in Europe, and the technique that they used was called subtenens anesthesia. So you had to put the patient under anesthesia, and that is how you had to insert this bead. But their target market was the Us. Where the surgeons who were trained to do this did not know how to do the subtenens technique. They used retrovulbular block. That was their conventional technique. So it was very, very difficult, if not impossible, for that product to be adopted here because of that.

And Michelle, did you want to comment on that one.

Just that. They're the target user for this was different, that the that you know would explain the surgeon versus the the interventionalist.

Right. So in the second example, here we had worked with a company that had a great alternative procedure to what was called the cox maze. So the Cox Maze procedure is done by cardiothoracic surgeons. They crack open the chest and they go in, and they basically surgically cut lines in the heart to stop irregular electrical impulses that cause atrial fibrillation. The problem was the device that was designed by this company was intended to be used by surgeons, but it was not part of their standard technique. They designed a minimally invasive device that would pop up into the chest cavity. The chest cavity remained closed, which was foreign to the cardiothoracic surgeons.

And so they had a tremendous amount of trouble getting that adopted. And, in fact, that portion of the technology never went anywhere. And this, I think, was a 60 million dollars investment. So another example of really understanding the end user of your product and how they literally operate in their space. And manufacturing. You might be thinking, Wow, I'm thinking about developing a product. I'm thinking about the end users and how it would be used, and that just seems too early to be thinking about manufacturing. But it's not. You need to be asking yourself right up front. Is it even possible to make this.

and can you scale it up? So here's an example of a device that used strontium from disassembled Russian bombs. And it had a very specific half-life, and essentially there was a limited supply. So it ended up that they could only make a limited amount of their product because they could only get a limited amount of the strontium that was needed. Another example of manufacturing and thinking it through was a device that had to have ph paper incorporated into it. This device is successfully on the market. Now, that being said, as they went into the manufacturing process, they had to take into consideration the Ph. Paper that was being inserted into the device couldn't be exposed to light, air.

or humidity, so that had to be assembled in a controlled chamber that really affects your product development, your planning, and also the amount of money that you raise, because that affects the manufacturing process. And on that subject we mentioned this before in the last seminar, but really wanted to touch base again on the prototyping. It's really important for commercialization to get that key opinion leader or just end user feedback, because sometimes it's hard for people to visualize your concept until they get it in your hands. So it's a very valuable step in the process. But what we want to emphasize to you is, let's say, your concept. You've actually done 3D manufactured prototypes. They are not sufficient for verification and validation testing to support your final product so many times. The materials that are used for 3D printing are very different. If you have a molded product, and you're actually going to to have a molded product scaled in the manufacturing process.

So just keep in mind that the results of the user feedback again, are really helpful, and we do recommend doing this step. But it can be misleading, using 3D printed prototypes because you're not going to be able to in the majority of the cases, take them through the regulatory process. and also the materials that are used many times are different than the final product.

And so the impact that this has on your usability testing for the FDA is, you know, this would be considered like a formative usability input where you used it to iterate different user features of the of the product. But, like Rene said, while there are some materials out there that could make it through the FDA process. It is going to require a lot of biocompatibility, validations, a lot of process, validations for the consistency of both the material and the process. So there's there's a lot. People I find, that people especially that are kind of new to the industry are thinking that.

Oh, wow! I'll just 3D. Print this until we have enough revenue to buy molds or or whatever. But it's also it can be more time consuming and more expensive to actually do all the work that's needed to validate the 3D manufacturing process.

Yeah. It's a really good point. Michelle. And also, you know, just to close this out a beautiful prototype that you might be able to print, you might not be able to manufacture it, or at least manufacture it at the price point that you need to be successful in the market. So to wrap up this section, just thinking about assessing the opportunity. How do you assess the market needs before you invest? Those were the 5 questions that we started this section with, really take the time to think those through. And then we're going to talk about this here in a few minutes. But adoption itself of your product. It can be challenging regardless of cost. We say here because it's hard to beat free. That'll mean more to you here in the next few slides. But that's a really important piece, because you need to plan. For once you do have your market clearance. You need to be realistic as to when you think you're going to have your 1st sale, because that affects your fundraising.

You also need to be worrying about your costs now, because it's just too easy to over design, and one of the other really critical inputs into your trace matrix should be your target cost. And it's important to know what the market will bear before you even start designing the product because it is easy to over design and then have too high of a price point. So, asking yourself, you know the questions also is what I'm making better. Is it cheaper? Is it up against what might be perceived as free in the market? And so, you know, challenging your assumptions, thinking those things through and also knowing, you know hopefully, some of you now are kind of rethinking or thinking more in depth about your product development journey. So know that pivoting during that process is not a bad thing. It's actually expected. And you know, for the most part, no one really gets it right on the 1st try, so don't beat yourself up if you have to pivot and take a different direction.

So the knowns and the unknowns, this part's really critical in terms of your commercialization journey after you get market clearance, or even before, as you're looking at how much funds you need to raise till you have your 1st sale. So we're going to talk about choosing your own commercialization adventure. There's known problems and known solutions. There's known problems and unknown solutions, unknown problems and known solutions and unknown problems and unknown solutions. And that sounds like a lot of gibberish. But we're going to go through each one of these, with some examples so known problems and known solutions. Once you get your market clearance, these are the easiest to bring to market.

But you have to keep in mind. Your solution needs to be less expensive. It needs to be cheaper, better, or preferably both. So what's an example of that? That would be like a feeding tube or a Foley catheter, something that hospitals know that they need, and they're already buying known problem and unknown solution. This one has a longer sales cycle. And the reason is, clinicians know that they have a problem. But you have to take time, and it can take a couple of years or more to generate awareness around the solution itself. So we're going to talk about a couple of examples. So the example on the left represents an Iv bag. So published studies report that up to 50% of all Ivs placed have some sort of medication error.

And despite investment over the past 20 years in smart pump technologies. Those rates, those error rates, remain the same. and other published studies report that up to 58% of errors with iv medications are related to the fact that people don't know it's flowing through the line. So they have a known problem. They know they have iv medication errors. They know that those rates are still really high, but they don't know that it's because of the little known fact that there's people just don't know what's flowing through the lines. So there's there's the perception right now, because they either don't label lines or they use tape and marker that what they're doing is free, despite the high error rates and what it costs.

But there's product out there that will allow you to id those lines in a very simple way. So clinicians will know what's flowing through the line, and it will take time for that to be adopted, because hospitals are pinched for pennies, and they see the cost for this up against free. It's not so. This is what we would call a value proposition sale. And again, it can take 5 years or more to build the value and get the clinical buy-in to actually get sales. Another.

And Rene, you and I see it often where there is like, people know that there's a problem. But it's an underreported problem, because nobody wants to take responsibility for misplacing a feeding line versus a drug line or drug line versus, you know, different the different drugs into different locations. So. And we've worked on several products like that, including, you know, a nasogastric, a device to check. If a nasogastric tube is correctly placed because who's going to admit that they put the tube in the baby's lungs and caused a pneumothorax.

That is actually a great lead into this. So that is, that falls under the category of what I call an unknown problem and an unknown solution. So, as Michelle mentioned, we worked on this product together, and what was interesting as we approached the market was when you go to place a feeding tube, or at least years ago they would use a method called auscultation, so they blow air bubbles in the tube, and then they would put the stethoscope over the stomach, and they'd listen for sounds, and they thought if they heard the sound they were in the stomach. What they didn't realize they didn't even know there was a problem.

But 30% of those tubes that were placed using air bubbles were not in the stomach, and there was a high percentage of those patients that actually had them in the lungs and drowned. And the reason that they didn't know that they had a problem was, as Michelle said, the errors weren't reported, but even worse when a patient died from a feeding tube that went into the lungs and they were fed in their lungs. It was classified as the heart stopped, so they didn't in pathology, say the lungs were filled with fluid. The cause of death was the heart stopped. So it was really a process. I'm going to take you through the journey of what it took to get this product to market when you have an unknown problem and an unknown solution.

2,003, the Uk. And the Us. Recommended against the use of blowing air bubbles into nasogastric tubes. By 2,005. The Uk. Was using Ph. By 2015 we were working with this company, and we started educating people here in the Us. We had the only FDA cleared Ph indicator for nasogastric tube placement. So we worked to change clinical practice and awareness. Here in the Us. And globally. the product launched, and by 2,018 there were new standards. There was a national recommendation to use Ph. 1st here in the Us. And not to use auscultation. yet it took from then till 2021, and beyond to actually get successful traction with this device. So why are we taking you through this journey? Well, if you have a product like this, where people, it's not a reportable incident, people don't realize that they have an issue, and

you know that there is one, and you have a solution for it. Be prepared for that commercialization journey to take you 7 plus years till you're recognizing revenue. And again, that's why, people say, Don't shoot the messenger. Did you want to add anything, Michelle?

No, thank you.

Okay? And this final category, I'm sure you know, you guys, none of you are are in this. In this category. However, we do occasionally encounter folks that have great solutions, but they don't know what the problem is that they're trying to solve. And this is really the most difficult one, because sometimes folks get in their head oh, well, I'll just create the solution, and the people will come. Somebody will need it and they really.

You know, find a problem. I'm gonna create a solution and find a problem.

Yeah.

Yeah. And then the other think, have we see? you know, practicing clinicians that think that they're solving a problem in their own practice that everybody's got. And that's not necessarily the case. You do. You see what I'm saying like? Because they have this problem in their practice? They think that adoption is gonna be, you know, a no brainer. And it's not necessarily for other clinicians in other areas.

Yeah. yeah. So in this case, you know, you really need to ask yourself, is this really even validated? What's the problem that I'm solving here. and do other people have it. So this is of the 4 categories, the absolute, most difficult to get to market, and they usually actually don't for that reason. So, jumping into.

Before we, before we jump into the next part. May I interrupt for the poll? Let's see launch. So just launching a quick Poll feel free to talk over me, Rene. That are over the poll. But we just yeah would love to get your feedback. So please participate if you can. And I'm done.

No, that's great. And just another comment on that poll. Depending on where you are in the product life cycle, you know. If if you want to schedule time with us after this, because we're just scratching the surface of these topics, it's helpful for us to know, too, where you are when you put time on our calendar, so we'll have the right resource available from our team to meet with you.

Yeah. Just write time on calendar or time in the chat, and they'll reach out.

Thanks, Shawn, all right. So now let's talk about when you actually go to sell your product and let's talk about hospital purchasing systems. So the known problem with known solutions. We also call those me, too, products. Those are typically the simplest to be adopted by Idns. Idns are integrated delivery networks. It's basically hospital systems. It's more straightforward for a hospital because they're already spending money on it. And they know that they need it. That being said there are certain hospitals, and we'll talk a little bit more about Gpos or group purchasing organizations that are very compliant with their group purchasing organizations. So the only way to get your me, too. Product sold is to be on a specific Gpo

new innovative products. We talked about this, that life cycle of getting something new and innovative to market after you're cleared is at least in some cases 5 to 7 years. And you really need to work a strategy around your trade shows really working to make those as valuable as possible for your business, because they're expensive, but they're one of the best ways to get clinicians away from the clinical setting where they're distracted and really focused on your product and your technology setting up clinical evaluations. Those are key getting papers published and developing your key opinion leaders. And then, if you have, let's say, a known problem with an unknown solution or an unknown problem with an unknown solution working with organizations that set clinical and patient safety practices like we talked about with the Ph indicator.

So really, also thinking about when you're setting up. If you, if a clinical study is required, and or you want to do a clinical study that's purely focused on commercialization. taking the time to ensure that whatever claims you're making your regulatory and your reimbursement align with those, and they align with the market and the end users of the product.

And this is really important because each one of those stakeholders is going to want to see something different out of the clinical study. So what the FDA needs to to prove for safety and efficacy is different from what you need to prove for reimbursement purposes is different from what the stakeholders and key opinion leaders want to see. So it's really important to be aware of all 3 of these as early as possible, so you can get the most utility out of whatever studies that you do it. It may seem more expensive at first, st but in the long run it is going to be, get your product to market much more efficiently.

Yeah, think about that time machine. You don't wanna have to go back and recreate this. So other considerations and this relates to manufacturing and thinking about this, about your sales plan upfront. If you want a Federal contract, you want to be eligible for a department of defense contract in the us. The product has to be manufactured in a free trade country. So this was the map of free trade countries, you know, a few weeks ago. I don't know if that's changed. There's been a lot going on. But just keep that in mind upfront, too. You want those contracts you have to manufacture in a free trade country

intellectual property. There's a whole strategy around this, and we don't have time in this webinar to really go into details, except for the fact that it's important to protect, early, reevaluate and protect often. And so one of the strongest intellectual property portfolios that I tend to see would be 1st getting utility patent around your concept. You know, if you can protect the concept of what you're doing that has extreme value. And then, once you then create your device. then have design patents specific to how you've designed your technology. So the utility patent. Think of it as an umbrella that sits over the concept and the design patents roll up under that umbrella to just allow additional layers of security around this technology or this concept that you've created.

Some folks don't want to disclose anything at all. So they hold trade secrets so that might be something like the Coca-cola formula. It's not patented. It's held as a trade secret you have to think about whether there's utility in that for you or not. And then there's always trademarking. That's really important, too. If you have specific names and or designs that are really critical for your market success.

And so problem, I see, is that people come to me with a patent, and they think that they're through the design process because they were issued a patent. But then that causes further problems, because sometimes some of the things that they put in their patents, they don't realize how difficult it is to bring a device to market with those particular features, and if they don't bring it with those features, they're outside of the scope of the patent. So this is another area where regulatory and commercialization and legal need to work together on the IP and the claims you're going to make. And for me. One of the products I worked on was a a mask that had a kind of a see-through plastic part over your lips, so people could still see you talking

particularly important for deaf people, or maybe the dentist. But this particular person put in their patent that they had to have an antimicrobial coating on the mask, and they did not know that the FDA, when you have antimicrobial coatings on breathing pathways, wants to see about $500,000 worth of biocompatibility, testing alone. So.

Yeah. And you know the other side to that coin, too. Is that a lot of times? You know, you've taken maybe 5 or 10 years to get your product to market. You've received feedback from from key opinion leaders and from the market. And so you've made different design iterations, or you know, corrections to your design. And so it's so important to go back and revisit what your initial claims were, and ensure that they cover the actual device that you're bringing to market because you may have to file additional patents also, in some cases, if it's taken, you, you know, maybe 10 years to develop your product. The patent life is 17. That only gives you 7 years, and if it's taken 10 years to develop and it's 7 years to commercialize, you've already exceeded the valuable life of that patent. So it's important to have a strategy where you're constantly checking in and building on your portfolio, because this is one of the areas that investors look to to make sure that you have adequate coverage.

So speaking of investors, there's a number of different ways that you can actually help get money to get your technology to market. One of the easiest and quickest is friends and family also. Sometimes Sba loans, and that's usually precede money. and the issues with friends and family can be that, you know, you're being diluted right up front. You're giving away equity with Sba loans. Of course you're going to have to pay that back, but there's no dilution there. A 3rd way that you can go into. You know, the precede area is with grants. That's non dilutive. But grants can be difficult to get, and very time consuming to apply for.

But once you get through that initial. Oh, go ahead, Michelle.

I was like speaking of different stakeholders, and what they want to see again, to get grants from Nih or the sbir, or any of those I-corp any of those types of grants that stakeholder group wants to see different things as well out of the deliverables and expectations for what you use the money for, and how you use it, and how long it takes to pay to.

Yeah, yeah. And you know, sometimes people will contact us early in that process, too, and ask us to help them map out a regulatory strategy, because they'll need to. You know, they'll need to at least have that in place, or an idea of what they're going to do before they can actually be awarded grant funding. And then there's you know, the option of angel investor.

Renee.

What go.

Renee. Somebody mentioned somebody mentioned in the chat about asked about part acting, and we would. Would we consider that.

Yeah, you know, we.

Want us to think about private equity.

Yeah. So private equity, that's also an option. It's it's been typically more popular for companies that private equity groups that want to acquire a number of different companies create kind of this conglomerate that they eventually go off and sell. So that that is, that is definitely an option. And we're seeing it more and more for like service companies. More, you know, for Med. So if you're a service provider in Med Tech. we're seeing it. We're seeing people being approached more and more by private equity, private equity in med tech, like, if you already have your product in the market, and private equity is looking at acquiring a company. Typically, then what they're doing is coming in buying the company, you know, getting another set of companies attached to it and then going for this very large multibillion dollar exit.

So, as you look at, we're talking about pre-seed funding and the different avenues for that. You could also possibly do crowdfunding for that again, you're trading. You're trading equity. So there's always trade-offs. But then, as you start to advance, you can look to angel investors, high net worth individuals venture capital. And just briefly, the difference between them is typically a high net worth individual and angel investor. Many of them know your space. Well, so they're not only investing in the technology, they can actually be a resource to help you navigate a lot of these pitfalls that we've been talking about.

and then venture capital. That's an option, too. You typically see that though, when you're going for your series, A, your series, B, they'll want to take a lot more equity. And what you will find is not all, but many Vc firms. It's very time consuming to manage the relationship. So as a founder. You'll typically spend a lot of time managing the Vc. Rather than focusing on the company. So that's just something to keep in mind and then exit planning, knowing your end game right up front. And you know, planning. For if you know you want to be acquired or licensed, or build a business that you want to grow staff and lead. That also determines what type of investor you bring in. And for sure, any investor pitch deck that you put together always always talk about your exit strategy and what is in it for the investor.

And you'll also, if you're going the investment route which most people do, you need to be aware of what's required in due diligence. And so it's essentially a process that investors use to make sure that what they're putting their money into has a solid foundation and can produce results. So there's a number of areas. There's financial, legal, operational product and and human capital and depending on where you are at in your product development journey. In this the requirements and things that they look for are very different. Did you want to comment on that, Michelle?

Yeah, and just don't underestimate the importance of doing regulatory at the same time as all of this, because I have worked on more than one remediation project where I had to work with lawyers that resulted in the company who purchased the bigger company that purchased the company I was working at sued the original owner because they misrepresented the regulatory portion of the due diligence, and at the time that this company bought the other company they did not have enough background or knowledge to know. They're just like the guy filled out the checklist that they sent him. He did not. He was not straightforward on it, and only somebody with a very technical background, like, you know, myself or my team would have even known to ask questions about the information that he submitted. So it's just another thing that's just so many things that's important to think of early and often to avoid you getting into those stages of grief of anger, denial, and bargaining.

Yeah. And then you're in the market. You've got investment and you're selling. But just keep in mind that you're actually never done. You're going to get feedback. You know, things are going to go wrong. Product may not work right. There might be quality issues. And you have this ongoing list of questions that you need to be thinking about. Okay, I've had to make a design iteration. Now, does my Ap cover. It? Does this even covered by my current regulatory claims is now the market still interested in going in the same direction? And do I need to scale manufacturing, you know, and or reduce the cost of the product to be successful. So really, you know, leverage your groundwork. We're talking so much about planning, and you know, not going into that time machine and having to recreate things, but also just be prepared that this is, it's a living process, and you will always be going back and and making changes. And.

Michelle, I don't know if you want to add anything to that.

No.

Okay. so secrets to success. defining your target market early to ensure a complete regulatory strategy and incorporating all of that input into the trace matrix, which was part of part one of the series is really really important. That's the foundation for your product filing your IP to ensure you're protected early. And as we talked about reevaluating that often Michelle touched on this, aligning your regulatory path and reimbursement, strategy is critical and establishing your commercialization plan right up front and really thinking about, you know. who's gonna use this product? How are they going to use it? What's my sales cycle so that

you raise money and always raise more money than you think. You initially need.

And then that's back to the importance of having that regulatory and reimbursement strategy drafted out very early. Because I see people take the regulatory strategies we make and put them into their pitch deck so that they can tell the potential investors that hey? We really know how much you know, close to how much time and how much money that this is going to need. Because we had a 3rd party professional. you know, sketch out what you know this process for us, and more realistic time and cost. It also builds credibility with investors, especially investors, that know this market well.

So I have a question. It's sort of a general question. But in terms of timeline, you know the from the very fastest to the least, fastest. You know. What would you say? The average timeline for bringing a device to market in the Us. Is.

I mean, from my perspective, the quickest I've ever seen something happen. It was for a class one Gmp exempt device. and it was kind of a me, too, product. And it took less than 2 years. That's the quickest I've ever seen. Cause that regular.

They if it's who I'm thinking about. Even they were in denial because they they thought that they were Gmp. Exempt. And so, therefore they don't have to do anything but register themselves, and I told them I'm like, no, your contract manufacturer has to be registered and listed as well, even though, that they don't have any obligation under the Gmps. They still have to pay that money every year. and so he's like, no, I get it through. I've gotten it like this for years. It's fine, you know, that's not a thing. And then the very next shipment he gets, he It gets stuck in customs and Stockton costume for like 2 weeks

while we get the contract manufacturer registered so. I'm sorry I've got to jump. Rene can take it from here with any more questions, and if you've got regulatory questions, feel free to reach out to me, and I'll follow up with you.

Thanks. Michelle.

Okay, hold on.

We're basically wrapping up. Now, I just wanted to make everyone aware that we do have some free downloads for you to help you basically build that foundation we've been talking about. We have a regulatory pathway assessment. We have a business market assessment. So those are tools that you can use to start planning early. you can follow us. We we post a lot of information to to help you out in this process, and we also have a new product, too. It's called lean launchpad, and it's a preset amount of consulting hours every month where you have access to people on our team that have regulatory experience, quality experience. And this is global

sterilization, biocompatibility, product development, electrical safety and commercialization. So it gives you access to these experts for a couple of hours each month to really help you plan and avoid a lot of pitfalls that we've been talking about. So.

If you're interested in learning more about launch, please just write launch in the chat, and we'll make sure that somebody follows up with you. About that, and he is sorry. Didn't interrupt.

Yeah, no, no, that's perfect. Just wanted to know, you know, at this point I think we have what 12 min left. Are there any questions.

Let's see there there's a comment. Too much capital can lead to spending inefficient if inefficiency often referred to as burning cash comments.

I mean, that's true. If you raise too much money, there's always a balance there. And there's always a balance, too, of, for example, with manufacturers. There are some manufacturers. If it's a scale of one to 10 that are a 10, they're extraordinarily expensive. They're good, but they're extraordinarily expensive, and then there's manufacturers that you can go to that are more like a 5 in terms of expense. They're still very good, very reliable. But you know, for example, I've seen people go and have molds made for production molds cut from from steel for similar products, where they paid anywhere from $50,000 for that mold up to 2.2 million for the same mold. So yes.

having too much capital, can make you drunk and disorderly, and maybe not pay attention to the best, getting the best value for the services. We've seen that with regulatory, too, we had one client that had come to us after spending $200,000 with a very good but high priced legal team, and then came to us for the same amount of work we could have. We could have gotten them to where they were at for about $10,000. So you're right. Good advice, just really be careful. One of the reasons we call ourselves lean is we like to take you through the leanest process, both in terms of time and cost, to getting to market.

So we have another question. And this is about State level registration sales, tax regulations, Secretary of State registrations, etc. In my experience, these cause significant delays. Do you see this too.

So you know, typically, gosh, did this slide get cut out of here? I I had a slide on paths to market, and yep it got cut. So one of the things I didn't touch on is when you go to actually sell your product here. I recommend going through a distributor and or a strategic partner that already has all of that infrastructure in place here in the Us. So, and and it also makes your life easier because they're likely already registered. Well, they are registered and credentialed with the hospital systems. So yeah, my advice is, don't hire your own sales team right out the gate. Because what's important is the reach and frequency into the market. You probably need 30 or 40 sales reps out there to do a good job representing your product. You're not going to be able to afford that as a startup. You're also not going to be able to afford to keep up with all of this licensure is, what with local state and hospital bodies.

Interesting. Next question is in the medical device product development phase. So they're in product development. It's often impossible to predict the timelines when each milestone can be reached. True, how should one approach this when speaking with investors, promising them too much, can set the company up for failure, but being realistic might be a negative message, and investors will not invest any thoughts.

It's a great question. Fantastic question. It is really a balancing act. I personally prefer to be realistic. because at the end of the day, you know, especially if you're working with investors that know this industry. Well, that gives you credibility. And so I've seen. I've seen people go both directions. Working with some folks now where you know they were over, promised and under delivered, and the investors are really angry and the leadership team is at risk of not being the leadership team anymore. So it's

you have to do some soul searching. That's my recommendation as to who you want your investors to be. How long you want to stick with the process. and how much money you want to raise, because I really do believe, and I because I've seen it happen a lot, if you are not honest about it, and you're the one leading the company when you go into the next rounds, because you're going to have to do additional rounds. There's a good chance you're going to get diluted significantly. And it's just something.

I think you brought up a really good point about investors who know the industry. So if you're going to friends and family, they might have unrealistic expectations. If you're going to an Angel investor group, for example, that reviews 50 to 100 applications per month. They know Bs when they see it. You know they're they're aware of the fact that You know what? What a reasonable timeline looks like. You know, in my experience, companies that say, Oh, in marketing we're not putting any money towards marketing. You know that I immediately am like, Okay, well, how is this going to happen? You know. So I mean when when you're dealing with people who know, then it's a lot different than dealing with people who don't know.

That would be.

But honesty is always the best policy. Okay. Well, it looks like oh, no. Sorry. Oh, dear, this is hard. Okay, from your experience. What is the current average timeline for a de novo clearance.

Okay, that is a really good question for Michelle. Oh, Celine, I I spoke with you and Ben yesterday. It's nice to see you on this webinar. It's a great question. I'm actually gonna note that you asked it, and I will talk to Michelle and get back to you.

Okay? And then the next question is as a startup. Do we need a distributor when we are to try to market with only a few hospitals. How how do we register to sell to hospitals?

That's a that's a very good question, too. So every hospital system has its own kind of qualification process. So if it's a large Idn. You may have to go through, you know, 5, 10 pieces of paperwork. You may have to pay $50,000 a year for the privilege of selling to them to become a qualified, supplier other hospital systems like community hospitals. They'll they might ask for. You know, what's your regulatory clearance? What type of insurance. Do you have? You know, some very basic questions they're they're easier to actually sell into. So it's going to depend on the hospital system. Even if it's a few, whether they're part of a large Idn, if it's a very compliant idn.

or if it's a smaller community based hospital, that's why I tend to like to go through distributors because they already have all of that paperwork in place. All the logistics are handled for you.

Great. Okay, it looks like we're about out of time. Again, a couple of reminders. If you're interested in learning more about lean launch. Please write the word launch in the chat. If you're interested in learning about more about Mlvx, please drop Mlvx in the chat, and, Renee. It's been a pleasure, as always, and thanks to the audience for the fantastic questions, and everyone who attended and gave up an hour of their time. Thank you very, very much. Oh, there's going to be a brief survey at the end of this. Please fill it out. Love to hear your feedback. Thank you.

Deshawn. Thanks. Everyone.