COMMERCIALIZATION PITFALLS featuring RENAE FRANZ

Good morning!

Morning. I'm promoting you

Thanks.

Maybe one of those plans co-host make co-host

Co. Host has been made. Dr. Lang is here today. I love that

So while we're while we're getting started. Had a all hands on meeting with all 5 of my full time part-time employees today. And we've knocked out a plan for bringing this into a nice landing 10 x and we're gonna be interviewing all of the speakers, publishing all of those things, talking to the sponsors, and oh. recruiting and planning each session, and doubling down on every single thing that needs to be nailed down in the next 6 weeks. So rest assured that we are on the job and working diligently with the decided purpose of

Making this as successful as possible

Yay!

So we will be doing all of the emails and recruitment that we can on that note.

You will do a fantastic job

Those of you who are thinking about inviting a startup?

Okay.

To attend. Please feel free to contact me, and we can make special arrangements. We want to make sure that we have 10 or 15 startups there, some investors there, some highly skilled professionals such as yourselves, there, some vendors there, but not vending, and the and and regulatory and quality people who want to learn and contribute. I went to make a pitch for the fact that we're doing a lot of interactive sessions. I've been working with my team on making this a workshop or a retreat, in a sense, for people who really want to take their networking and

Say the next level don't say to the next level

To the lower level and

Don't say any level

To the refrigerator. Are you happy? we're! You're right, Joe. You're right. We should avoid cliche language. Stop sounding like chat. Gpt. So

You know where Bruce is today? He looks like he's in an Mc. Escher hell.

He is, he's actually trapped in a more

That never ends and never starts.

Correct, and T. Usher was all black and white.

It's a virtual clean room

Oh, okay.

So one of these days when you're when you're real short on finding recruits to come in and talk about what they do and how it might apply and get an advice from people. I'll sign up and talk about our clean rooms

Alright that works. Michael, we haven't seen you in a month of Sundays. Give us an update with your mute off

That's always helpful. Thank you, Joe. It's always good to be back. I know it's been a long

It's sharp

What was that?

You're looking sharp

Thank you. I appreciate that. Yeah, I got a haircut. I get here about about once a month

Alright!

Yeah, yeah. So yeah, I guess I'll give you guys a real lowdown. So as Joe knows. But a lot of other people don't know, we've developed a new positional, obstructive sleep apnea device that fits in everyone's ears. And we are staffing doctors right now. And right now we're on the fundraise. So that's where the company is at. That's what we've been doing. Yeah.

Looking good. Where are you? With regulatory

Oh, we're all I mean, we're set for regulatory. We're just waiting to get the funds to actually do the 510 K. We've got 2 people that are interested in working with us. They say it'll probably be about a hundred to 120 days. Cross your fingers

And we got 2 raise at this point

About 300,000 get going.

Do you have a lead investor? How much have you raised so far

Oh, we're just. We're just starting up again. So no, we do not have a lead investor

Well, I hope you don't have any pitfalls that Rene identifies

No, Nope don't know of any pitfalls yet, actually, though

It's always about

I should tell you. We've we've actually been tested for over 200 days, the latest version. So 200 nights across 6 people. So it's working great. Now, we just need

You're one of those 6

Oh, of course, of course. Yeah, yeah.

That's interesting. I'd love to hear about your experience with it, but

Yeah.

Maybe in another week, Miss Franz. they loved you so much. They had to have you back immediately.

It's been a month

That's an idiot in

Yeah.

FDA. Terms

That's true. And in actually being able to sell your medical device terms which we'll all talk about here in a in a few minutes. Thanks for having me. Thanks everyone for for joining so

What will your talk title be in a few weeks?

Wait a minute. I thought, I'm talking today.

Oh, you are! But now I'm talking about in person in California when you're with us

Oh, I'm gonna be leading a. I'm gonna be leading a workshop on basically a lot of what we're talking about now and working through both the pitfalls, you know, talking about things that can go wrong, but also giving you the tips for success and how to strategically navigate through those

Hey!

You know, based on real world experience, not chat, gpt experience. Chat. Gt, Gpt does definitely has its place. But it's never brought a medical device to market before. So not yet. It will someday, but not now.

You have slides to share with us

I do, I do so. Michelle and I were on a couple of weeks. It was actually exactly a month ago. It was February 21.st And we really talked about the pitfalls from concept to commercialization. And we talked. we focused in that session on product development. You know, really the importance of identifying user needs function needs regulatory needs upfront your regulatory strategy, all the things that can go wrong and then design for manufacturability. So we've covered all of that. Any of you who are interested in that information? We have a masterclass that we did early February, and I guess I don't know, Joe. Should they drop their name in the chat? If they want access to that to get more information? Because I'm just gonna talk about commercialization today I'm not gonna touch on those things.

By all means, if there's anything you want as a follow up, just communicate it. And Shawn has been doing a great job with you guys with your outreach and your marketing communication

Yes.

So he's your guy to make sure you get what you ask

Okay. great. So now I'm gonna I'm gonna jump into commercialization. Many people who are new to Med tech. And and you know, I think there's what 18 people on the call. I'm not sure what your experience is, but what I find working with most startups that are new to medtech is, they think I have my market clearance. I've just spent 5, 1015 years getting my product to market or getting it developed. I have clearance. And now I've I'm at the end of this race, and the money is just gonna start flowing in. I am here to tell you, and and I hate to be the messenger of this. But for most people I would say 95% of medical devices. Getting to that point is not the end. It's just the very beginning. And we're gonna talk about why and the ways that you can navigate the pitfalls and successfully get your device

to be in a more accelerated timeframe, and being successful, actually generating revenue. So I don't know why I'm having trouble here we go all right. So one of the really important pieces which I think everybody knows is having a sales strategy. So even when you're in the process of doing product development, you know regulatory work, you need to be thinking about. How am I really going to sell this product and start forming relationships with entities that you think would best represent it in the market. The other thing that you need to be doing. And it it sounds like I'm sorry I missed the person that was just talking at the very beginning, who was talking about the sleep apnea device. It sounds like you've kind of already started that journey working with with entities to test the device. So you start to build champions and key opinion leaders early.

So what does it look like then to open up a sales channel in the medical device world. And I'm gonna mostly focus on hospitals, because that's where most of the revenue goes. But if you have questions about acute care, long term care home health. I'm happy to answer those as well. But much of the sales process that I'm going to talk about also applies to those organizations. So when you're a startup and you have limited funds. My recommendation is not to go with forming your own sales organization. Why is that? It's really expensive. You're going to commercialize here in the Us. We're a big country, and one of the keys to successfully selling is having good reach and frequency. And so, in order for a startup to have good reach and frequency with their own sales organization. You're looking at hiring a minimum of 10 people

better off having at least 30 people. So you think about the salary of 30 salespeople, which is probably around a hundred 1,000 a year now, plus commission plus their travel, plus the other piece I'm gonna talk about is credentialing because that actually plays into some of the other things that we'll be talking about later. The credentialing process for them. So it used to be 30, 2530 years ago, when I started in this industry, you could just walk into a hospital anytime, anywhere talk to a clinician. They like your product, they place an order. It is not like that anymore. And one of the things that has really become prevalent in the past decade has been this credentialing process. So for a sales rep to set foot in a hospital. Now they have to be credentialed with

some, you know, usually multiple national organizations. but also many hospital systems are requiring additional credentialing and money out of your pocket to allow them to set foot in your hospital, so it will cost you thousands of dollars a year and a lot of paperwork for each rep on top of their salaries. If you try to do this with your own sales force. So what I recommend for a startup is one of the 3 things go with a distributor, a 1099 sales representative, or a mixture of the 2. And we'll talk about that here in a minute, or a strategic partner. So a distributor for those of you who aren't aware is somebody that not only sells your product, but they also warehouse and ship it for you. So why is that important? Well as a startup. You know, it's really nice to have an organization that

1st of all has to buy the product and stock it. So you get some initial orders from them. At least, that's my recommendation. When you set up the relationship is to make sure that they buy a certain amount of product. So they're invested upfront, and you get some sales. But then they do all the transacting on your behalf. So, in addition to sales reps needing to be credentialed vendors also now have to go through a credentialing process. And for some hospital systems, you know, not only is it a lot of paperwork, but also it can cost you upwards of $50,000 a year just to have the pleasure of being able to sell to them. So that's really not an expense that you would want to take on, I would imagine, as a startup unless you're flush with cash. So distributor handles all of that for you. They're going to sell the product. They're going to warehouse it, and they're going to invoice for you. So the way that distributors are set up here you can either have a master distributor that covers the whole Us.

Or regional distributors that you can piece together for your sales organization something else that I strongly recommend before you actually launch your product in your vetting sales organizations find one that's that is a specialty distributor in your niche. So what do I mean by that. Well, if you have a product that's focused on the Nicu, for example, you want a specialty distribution organization that calls on the Nicu. You don't want to be sending a general surgery product in with a Nicu sales force. It sounds pretty basic. But it's it's really important. The other thing that you need to be thinking about with distributors, and this also plays into maybe bringing in some 1099 sales representatives.

I strongly suggest having them break out in your contract by region minimums because you well, 1st of all, I guess I should back up. My recommendation is with a sales organization, even though it might be uncomfortable at 1st to make them exclusive, but give them minimums and and break it down by region. And the reason that I recommend going initially with exclusivity is, it takes a long time to get your 1st sale. It's very expensive for the distribution organization to do it. And guess what? If they're not exclusive. They're not going to put the time and effort in it, because they could put 2 years into the sale, and then someone else could come out from underneath them and steal it. So they're gonna work harder for you if you make them exclusive.

But the the balance to that is you need to put boundaries around it and say, Okay, I'm going to make you exclusive and depending on the market, and we'll talk more about this later. You may want to. Say, we'll negotiate what those minimums are, because you might have a product that a hospital's never bought before, so it's difficult to negotiate those upfront. or you may say you're going to have to sell this amount in the next 6 months. so there's some flexibility there. But I strongly recommend whether it's a distributor. Sales represent sales. Rep. Do it by region. Because again, this is a big country, and here's a pitfall I've I've seen happen where you you negotiate exclusivity with the distributor, and you have a couple of regions that are performing well. You always have your key performers, and then you have some that are just bottom of the barrel.

and if your agreement covers the whole country with one minimum. you cannot get out of those bottom of the barrel, and that but the bottom of the barrel sales reps may be in highly populated regions, like New England or California, where you really want a high performing sales rep. And so, if you do your minimums by region, you have the flexibility, as you revisit the contract, and I recommend doing, maybe putting it in at least every 6 months in the beginning, and then once a year, once you're established to say, you know what New England's not performing. I I want a new sales channel there. And that's where you have the flexibility to say, okay, I'm either gonna bring in a regional distributor or I'm gonna cover that with 1099 sales representatives.

So that's that's a really important piece. I've had to go through that before with clients and it's really painful if it's not spelled out, especially if this distributors, just performing well overall, but not performing at all in key regions. So talked about distributors 1099 sales, representatives. So 1099 sales representatives. Will sell the product for you, but they will not warehouse it, they will not invoice it. You pay them less of a percentage than you would a master distributor. But you're still gonna have to find a place to warehouse and and actually ship and invoice your product. So you know, some folks like to put together a 1099 sales force to cover the entire country.

I recommend actually going in with distributors that can warehouse and invoice your product, and then, where they don't have coverage, or where I mentioned, they might be failing in areas. Bring in a 1099 sales rep to cover those areas. The 3rd way to sell your product is for a startup is to find a really good strategic partner. So let's say, you have a really novel wound care product. And you find someone like I'm just gonna throw it out there. St. And they they're already selling into wound care. They have the right call point. Your product is different enough that they're interested in selling it.

And it also is exciting to the sales reps because they're typically going in and talking about the same things all the time. So you're giving them a new product to sell in a space that also can become for you a strategic exit. So if it looks like there's a there's a company out there that's playing in your space that you think. Yeah, they could really benefit from being my distributor. Essentially. I would work to get into those companies and see if they'll sell your product, and then eventually they may become your strategic exit. Partner. Any questions about these sales channels before I move on to the box movers

Rene, can I? I'm just gonna give some color commentary on like the the quality side of this

Yeah.

Well, 1st thing you know, you brought up all the different States. It's important to know there are states that require you to list your device in their state. So these are things that need to be thought about and planned for, and the right time to do. It is in your initial design planning is to define all of your distribution options and make sure your quality system can support all of those. you know a project that you and I worked on back when we were in industry together. You know I had one of the sales reps. After we had gotten clearance for his device, he said, he's like I was like, where do you want to sell this? And he's like, you know, globally.

Well, okay, that ship sailed, you know. So, and all of these people are also considered your like are your suppliers. So they all they need to be on your supplier list and depending on what they do, you may need to also audit them and do performance reviews, and you for sure need to train them on your complaint process so that they know what to document and and elevate. So these things aren't just important from a commercialization in a business. But they're also important from a quality and regulatory perspective

I like the globally answer, where do you want to sell? You know

Everywhere to everyone. I want to put the caveat. I'm only talking about the Us. Right now. I am not talking about other markets, but But yeah, it's true. I want. I want to sell everywhere. Well, that's a whole different story. Well, spend 8 h talking about that

Excuse me, can I have a question

Sure.

I tried to raise my hand, but I couldn't find the little icon

Oh!

So I just wanna make sure I understand what Michelle Lott is saying. So as a manufacturer, if you already registered with FDA. And also you have all your product, including model listed on your listings. Does that include all 50 States? And then, when you find a distributor, say they are in Florida, and then, if they do decide to market your product. should they also add that model on the listing? So I'm not quite sure how and how detailed, to what extent the listing need to be done from the the manufacturer side and the distributor side

Yep. I could just clarify something up front when I'm talking distributor here. I don't mean like a contract manufacturer that might either hold the product and ship it out to your sales. Distributor I'm talking about the the actual sales distributor themselves. So, Michelle, that might play a part in how you're gonna answer

So Michelle, the FDA does not require any of these people to register and list themselves, but they are suppliers to you. so so you're as long as you have your listing, your contract manufacturer listing. If your company, and if your company is based outside of the Us, then you need a Us agent. That's that's all you need. And the rest of this is controlled through your supplier controls and verifications

Okay, that makes life a little easier. So

Yes, exactly.

Okay. Thank you.

Thanks, Michelle and Michelle. Any other questions before we we move on to what I affectionately call the box movers. Okay, so a lot of times folks will come to me and say I'd really like to have Cardinal Mckesson, one of those big companies sell my product, and we affectionately call those companies. They're very important to hospitals, for just in time, delivery and inventory management. However, they sell thousands and thousands of products, and to have them be your only sales presence would not benefit a new product. That's, you know, not a me, too. That needs a lot of time spent on it with clinicians in the market. So the way to work with the cardinals and the Mckesson's when you're a small company and you're launching a new technology is to work with your specialty sales organization. However, you've set it up. We've talked about that already.

and then you put the onus on them to actually, when they sell the product, be able to sell it to Cardinal and Mckesson. So Cardinal and Mckesson, you know they can manage that inventory in and out of the hospital, and that comes out of your distributors margin not out of yours. So any questions about the box movers, cardinals and Mckessons. Okay, so now we're gonna talk about the actual healthcare system structure, which is primarily when you're talking about hospitals, clinics, outpatient surgery centers, idns or integrated delivery networks, which would be, you know. Maybe in the East there's Wellstar. There's Sentara out here in the West. We have Kaiser, Saint Joseph's banner. Those are all integrated networks, and they're

they're they behave very differently. But it's important to understand how each one works and how to navigate through them so that you can successfully get your product sold the other piece that's important to understand, and it rolls up under ideans would be group purchasing organizations. So a lot of times people will come to me and say, Oh, I I really need to get on Health Trust right away or vizient, and that may be the case, especially if you're what I call a me, too product. And we're gonna talk about that more here in a minute. But when I say me, too, I don't mean that you're not special, you are, but the hospitals already buying a product in that category. So

it would probably benefit you to be part of a group purchasing organization because they give priority to the products the hospital does that are on their Gpos and the Gpo. That is the 3 biggest are Health Trust, viziant and premier, and the biggest, most compliant one is Health trust. So if you're a product you fit into a category that hospitals are already purchasing, and you're trying to get into a Health Trust account. You're gonna have to be on that. Gpo. so what does that look like? So again, if you're this what I call a me, too, product. So maybe you are an enteral feeding tube that has some additional benefits or a wound dressing that can show you can heal a wound faster and better. Antimicrobial products. Hospitals are already buying those. And it typically is a lot easier to get into an integrated delivery network or an idn. That being said.

it's still a long process. So why is that? Well, I talked about how, years ago you could just pop into a hospital meet with the clinician. They liked your product. The next day you'd have a purchase order. Well, now, we've come a long way. and if somebody's interested in your product. You 1st has have to develop a champion within the hospital, and you really lean on your sales organization for that. And one thing I didn't mention about the sales organization. But this is this is actually something that I do. That's very successful is when you get your sales organization put together, you identify your top 5 people, you can do that by either asking the sales or leadership. Hey? Who are your top 5, or you'll get a sense as you go through training and you work with them.

But the reason you do that is because you need to have these champions that are out there that have good relationships with these hospitals that can really get you in the door, and you will find when you can get out, and you travel as much as you can with these top 5 sales folks like to show off. So they're not. You're going out to travel with them. They're gonna get you in front of as many hospital leaders as they can, because they wanna look good. And the other thing that happens is you're the expert on the product. Even if you have a specialty sales organization, they they have a number of products in their bag, and they're not going to necessarily focus on your product unless you're out there with them, and you can show them how they can make money because they're coin operated. So

picking your top 5 and really nurturing those relationships helps you as you go into these hospital purchasing systems. So you've got your top 5, you're working with them. And you're going into these idms. The 1st thing you're going to need to do is work to get on value Analysis committee. So that's what almost every hospital, now that's large takes your product through so depending on how urgent they perceive your products need to be. This is where the timing comes in in terms of your turnaround on sales. It could be. It takes you a month to get on value analysis, or it could take you 6 months.

So now you've got your hospital champion working for you. You've got your really good sales rep, and they're working for you, and they're they're pushing the hospital as much as they can. Let's say, 6 months later you get on value analysis. And they like your product. And they say, Okay, now, we want to do an evaluation. So now they have to organize that. Get some cases through. Irb, that could be another 6 months. So now we're at a year. They do the evaluation, and in many cases you have to get back onto value analysis that could take another 6 months. So what I'm telling you here is, don't be frustrated when you get market clearance, and you think you're ready to sell, and it takes you 2 years

for a me, too, product to get your 1st sale. I had a I had a client in Texas, got the Mayo clinic on board, took a couple of years. They got their okay to sell this product to all the Mayo clinics and it took from the time the hospital said, Okay, till they got their 1st purchase order a year. So the bureaucracy with these Idns, especially as they're growing and buying more hospitals is just making the sales process more arduous. So that's what it looks like to get in with the me, too. Product. If you have a new innovative technology. And when I say new and innovative, I mean something that the hospitals never seen before, there's no direct replacement for it.

It's at least 5 to 7 years, and there's a lot of things that you need to do right and right away to be successful, getting it to market. So in that case, you need to think about the fact that, okay, I have this new innovative product. And I'm going to use one that we worked on about 10 years ago, and it was to confirm enteral feeding tube placement as an example so enteral feeding tubes. For many years the standard was to blow bubbles into the tube and listen with a stethoscope over the stomach to determine whether it was in the stomach or not. and published studies were showing that up to 30% of those tubes placed with that method, especially in kids, were not in the stomach.

and a high percentage of of people, unfortunately, were, were dying from it, but when they did autopsies they wouldn't show that they died from a misplaced feeding tube. They would just say that the heart had stopped. So we had to work to change global and national policies, to have standards that then we could go into the hospital with and say, Okay. no more. Blowing air bubbles into feeding tubes. Ph is now the gold standard, and guess what? We have. The only FDA cleared product that uses Ph to confirm nasogastric tube placement. So we had to work alongside of doing trade shows, clinical evaluations with key opinion leaders and interested parties to create global and national alerts and standards around this issue. And I'm telling you this because I work with a number of

people, particularly in the patient safety space that have phenomenal products that we know will really change and save people's lives. But hospitals are so strapped for cash right now that unless you are a product that they're already buying, and you're replacing something that they perceive as free. You will have. Your adoption will be more than 5 to 7 years. It'll probably be 10 years or more, and you might be out of the market. So it's really, really key that you develop those relationships. And you develop a whole strategy, globally and nationally. That says, Hey, you know there's warnings. Don't

don't use auscultation, don't you know. Blow air bubbles into the stomach and use ph that's 1 example. So any information

Before you go on from a regulatory perspective. The top one. Me, too, means you are substantially equivalent. which means that it's going to be likely a 5, 10 k. Or even 5 10 k. Exempt. When you say innovative, the FDA immediately thinks de novo. So it's like this real tightrope. And this is why it's so important for regulatory marketing to align very early in the development process over claims, because usually. as soon as they get clearance marketing. People start throwing out all kinds of wild stuff like better than twice as fast like all these things. And then the FDA does troll the the Internet and websites to see what people are doing with their claims and promotions.

It's just

Another example of how you guys really have to work together to be successful in the market, and that regulatory is your strategic partner and not a necessary evil for you.

Here's your site.

Yeah, I can actually attest my very last FDA inspection, which was last February. No, January. Excuse me. And they actually looked at social media. They were looking at my social media procedure. They were looking at social media posts. They were asking questions about social media. So if anybody has any doubt that they're trolling. I can attest that they're actually doing it. We spent an hour on it

Yeah, thanks for that, Michelle. This is a good ad. So other considerations and this is actually something you need to consider early on in your design phase, as you look for contract manufacturers. If you, for example, want to sell your product with the or to the Department of Defense, it has to be manufactured in a free trade zone. So we've highlighted here the current Free trade zones. And that's really important.

Used to be. We have no idea what's happening now with the Free trade zones

Exactly right now. These are free trade zones. I don't know if that's gonna look like next week or next month. But it that's really critical. Because, let's say, a lot of your strategy was is to sell to the Department of Defense. But you're making your product outside of a free trade zone. You're gonna have to qualify a whole new contract manufacturer and go through that process because they will not buy that from you.

Renee. You mean the manufacturer putting together, but I can get parts from China

It. Yes, that's a good clarification, Joe. You can get parts from China. Pakistan, you can get yourself even. But your final assembly packaging needs to be done in a free trade country. Yeah, any questions on on this piece? Well, you guys are awfully quiet. Intellectual property. This one's really important, definitely protect early and often. And there's a strategy to it. So there's really 4 ways that you can protect your technology, you can, you know. Go with what I call the umbrella, the utility patent that covers the basic concept of it. That's the strongest. You can go with design patents. Design patents are great. Once you

hopefully have been able to get a utility patent because a design patent then solidifies, okay, this is exactly what the design looks like, and nobody can copy it. Then there's trademarks. Those are important, especially when you're building a brand to trademark it. And then the last piece would be trade secrets. So there are certain things that you may decide. They're important enough. I don't want to go through the patent process and teach people how to do this. We're going to maintain this as a trade secret. So you need to be considering all 4 of those things as you go through protecting your IP,

something that I want to note that I've seen is an issue with people who start their medical device journey and design a lot of times do the right thing and they protect the design right up front. Well, as you evolve in product development, you get feedback from key opinion leaders. That device. 99% of the time is going to change somewhat and a lot of the time it changes significantly enough that by the time you go to launch your product 5, 1015 years later, those patents and that IP does not cover the device that you're launching. So I I can think of at least a handful of times. I've worked with a client where we were getting ready to launch, and I said, Oh, can I take a look at your claims and the claims were so different they were different enough

that we were about to launch a medical device that was so different that the IP wasn't going to cover it sufficiently. So we had to file what's called a provisional right away before we, because it's 1st to file. Now, it's not 1st to invent. So we had to file provisional. Make sure all of that documentation was in place and then launch the product. And, Kevin, I see you've got your hand up

Yeah, I just wanted to comment on on the patent decision as far as when do you file? It's also sometimes, though driven by the financing needs. We had that ourselves where one of our early angel investors basically was pushing us to file. And it's actually kind of hurt us. I think we filed too early where we're now trying to race to come up with additional filings to cover us. Because, you know, we've we've basically lost 10 years on our patent life. Along the way, because it's taken us a lot longer than anticipated to get to commercialization. So that's something that's also, you know, has to be a discussion on the financing side.

But I think it's also. I think people's thinking on patent versus making something just trade secret is, is also being affected just by the way, patent litigation is happening right now. And it's it's quite frankly, a lot harder to defend a lot of things, anyway, just because of the way the patent courts are working

Yeah, yeah, thanks for that, Kevin. Nelly. I see your hands up

Actually, Michelle's gonna know exactly about this story. So I actually had a client who thought they could. So what they wanted to do is they were. They were literally giving their IP away, and I begged them. It took me months, and thank God, I actually got through. But they were going to let their contract manufacturer release the designs, file the 510 K. And then they thought, oh, a year later we'll file the 510 K. Ourselves. And I'm like you're losing your entire. I mean, I can't tell you how many times I got on the phone with Michelle, so don't short circuit yourself trying to get to market

thinking you're going to be able to recover your IP by putting it into the contract manufacturer. You're you're doing this, and I'm like, seriously ask Michelle. I was like. I am I crazy? This is the wrong

Yeah, she she did. We did a lot of reality checks on that one like, who who's the crazy one in this relationship?

Yeah, seriously, they thought.

Case it was not Nelly

In most cases it's me. But yeah, you know, this is like, I can't. Yeah. So be careful on your IP, trust the people who are telling you how to protect your IP, because you could give it away and not know you're giving it away.

Yes, and actually, to add to that, Nelly, I had. I've I've encountered situations with clients where they've turned over. They've said to their contract, design and developer. You're you're registered as my specification developer. You're registered as my contract manufacturer. You own my design history files. You own all of this. and then trying to pull that out if the relationship goes sour and you don't want to use them is a nightmare

I actually as the call, as the management rep from all my clients, because they all outsource design, control, and contract manufacturing. I make them. Whatever that contract manufacturer releases we release in house, they hate it, they go. Nelly cost me. I go. I don't care you. I go. Do you know how many divorces happen between contract manufacturers and manufacturing companies. I go, they go. No, I go. It happens all the time, and then you lose your information because they own the documentation you don't. The I mean it's the one thing I fight with my clients the most on is is that I make up. I make them set up a dual dock control system when it comes to that

That's spot on. That's exactly what they need. The other thing that I've seen happen we're getting a little off track because this is an IP, but it is part of making. Your device is, I've seen people enter into relationships with contract manufacturers, and they spend hundreds of thousands, sometimes close to a million dollars on their tooling. and they don't identify in the supply agreement right up front like who owns what tooling. So they go to move away from that contract manufacturer and the contract manufacturers like. -Oh! That's ours. Well, now, they've got to go spend all that money again for tooling, and so you need to call things like that out in your supply agreement. It needs to be in a living appendix that you can update every time you build new molds or tools, make sure that you own them as the company and the

So what I do is I have the client purchase the tooling, put it on their equipment form, and then do an internal transfer on loan that way. We have internal documentation that shows that that tooling is owned by the company, and it gets labeled with our calibration. But then we transfer responsibility of the calibration and maintenance to the Cm. Until and then until we return it back. Is that a good method, or do you like the

Yeah, yeah. As long as is it spelled out in a contract, and both parties agree that that's

I don't think we we do. That's not one thing. I I think I'm gonna update that. I don't think we've actually filled that out. But I think that's thank you. That's a good ad. I've been doing it through the equipment procedure, not through the contract, but

Yeah, I do supply agreement. And then the the quality agreement. Michelle, I'm sorry I keep

Not to beat a dead horse here, but I might have mentioned. You need to think about claims early. You need to think about product features early, and how they impact your regulatory strategy in this particular example with patent. This was a customer that she got a patent before she even knew what was required for her device, and in her patent they wrote in that it had an antimicrobial. but barrier to it for this mask, and FDA said or not, FDA, but she couldn't bring it to market, because a mask that contains a microbial thing has about $500,000 worth of biocompatibility testing so. But she couldn't take that feature off, because then she would not be under her patent, and then, if anybody could copy it.

so she's stuck, because from a regulatory perspective, she built in something that wasn't even needed. She just put all the bells and whistles in her patent, and now she's been unable to bring her product to market

Bruce, you're off camera, but I'm wondering if, as a clean room person, you have anything to add here he may have stepped away. So let's continue unless he shows

Okay. yeah, that's another really good point. And that actually is where? You know. Let's say you have that baseline IP, like Michelle's client had. And you realize that the product that you're bringing to market like you're not going to do the antimicrobial thing if you have the funds and the opportunity to do so. It would work with your patent attorney to come up with a subsequent, you know. Follow on patent filing. That's more specific to the design that you're actually going to be bringing to market. But again, do that before you, you actually put your product out in the public domain, because it's 1st to file, not 1st to invent

any other questions or conversations about IP from a commercialization perspective

Think I can add a little bit to it. It's not only that you lose some years when you file, and you're not ready yet to market. but also on the other. On the end of your patent. If you're near the 25 years, it becomes less valuable because it becomes easier for other parties to infringe like, for instance, our product is, is way old. But even before the patent was ended it was infringed by an Austrian party, and it was too costly to go to court to to fight them for just one year of production. So in the end of the the IP the the patent protection.

It wasn't as strong as more as it was in the beginning.

Yeah, and actually thank you for bringing that up. Because if you do have the funds and the ability to continue to protect your product along the way you may be able to avoid like that what the incident that you guys got into with the patent expiring? Because if you if you're able to change the features just enough and continue the patent process. In some cases you may be able to extend the life of the protection every time that you file and are granted the patent. But it's

That's what we're doing right now. We're we're adding more patterns to it. Yes, and that works

Yes. Yeah.

Could I ask a question? This is Paul. I see this workflow. I love this slide, and I was just wanting to ask, how do you? You? Because you know with with what Michelle is doing as an offering allow, how do you help a 1 of your clients stay in sync with all the regulatory and compliance guidelines. Is there a are you? Is there an platform checks and balances a gantt chart that is productized into an offering, and then you get like a checklist. We're doing this first, st second, 3, rd 4, th 5, th and all the moving pieces. Simple thing, hey? You know, they get a new sub, a new supplier for a good, you know, with my supply chain background, right? They get a new supplier for a component

that suppliers gotta now do the documentation and stuff. How do you all keep track of all that for your clients? How your clients keep track of that? Is there a framework of like a platform, an app, or something like that.

Michelle, do you want to answer that

I'm sorry I didn't catch it. What was the

So basically, how do we? How would we at lean help keep a client compliant all the way through, like they've they've launched their product. Now they might be facing supplier audits, supplier changes

I think that this is one area where Lane really stands apart from a lot of other firms is that if you engage us very early, and I mean very early. and we do an initial regulatory pathway assessment. It can inform the whole rest of the process, not just the from the regulatory perspective. But you know, Rene could read that Rpa. As the business and commercialization side very early on, and she immediately has insight to the the rest of these areas that need to be covered. So but me getting Renee's feedback from the business side and mine from the regulatory, it is going to be the the fastest and most accurate way to get to market.

Does that make sense

Is, and that's that's the question. Right from the regulatory standpoint. Are you offering that cause? You have it in your mind, and you've got a is that document functional, operational? Is it a platform, or they keep coming back to you? How do you, monitor? Do? Are they staying in compliance, especially when you know on the commercialization side, right? Because they somebody down the line and say, Hey, I need need a new supplier, and just want to go to make sure they don't delay the production, but not keep track of the regulatory. How does how does that follow through? Is there? How is this checks and balances happening. Are you doing? Are you doing reports? Are you doing all regular audits, or are you? Is there a platform? Is there, or is it just documentation that you are then having conversations with clients about

So usually. And this is not what should happen is but usually what does happen is they get that rpa, they value the Rpa. Then they go out and raise funds and show that Rpa. In the due diligence, but unfortunately they will go away, and and you know fundraising can take forever. And at the same time they've been making. They're moving to what they think is their prototype because they don't have money. They only invest in that product side. And so then, by the time they come back to me, we they have made changes that totally invalidate the rpa, that they

raise money. So it really needs. The best clients that are most successful are consistent communicators about where they are not only in the investment process, but what did they do? And it doesn't mean that I have to like spend a lot of time or their money on it. It's just just tell me, you know, so it's so

Do you offer them? A a timeline, a a schedule of

The the Rpa. The Rpa. Generally maps out what should be next steps and and flow charts of how to interpret the FDA requirements for whatever their their product is. We also include a lot of technical information, like all of the standards that we are aware of at the time that could apply all the guidance documents. So they are informed from a technical perspective, so that as they're moving through that process that they continue to like, say, look at those standards and put those in their design inputs or plan with their marketing people of okay, here are boundaries. And all these guidance and standards.

But we recently launched a new program that's called Lean Req launch and we also have a lean Raqa learn. But in the launch model we're offering a certain number of hours with any of my experts that they need to talk to a month, and it has a couple of other features, and for, like, you know, less than a thousand dollars, they they. That's a way that I think that people that startups can engage because it's not expensive. It's not going to break their bank, but then they get the the advice they need when they need it, and they're paying for it. you know, every month. So why not? Why not talk to me, you know, because I made it affordable

Yeah, because you got new people new in new staff, right? New vendors, all kinds of the so moving pieces during launch

Exactly. And that also happens a lot

Well, I mean

Like the the people who were there when I did. The initial Rpa. Are not the ones they've moved on. And now we've got all kinds of fresh blood that have no idea about the history. And aren't art shared, and the the CEO didn't share the Rpa. With them. So

Yeah, I can see breakdowns. You know. You, the the supply chain guys will have product coming back because packaging into didn't withhold. You need that feedback. Right? You need that information in the iteration. They go back. They change the product here. There. What have you? Yeah.

It. It sounds if I'm right, it sounds like you're also asking about, you know, post launch, when you're actually selling what type of support we could offer

Right? Right? Right? Right? I just

Yeah, because

You're at this point. You're trying to get. You need the feedback from the field. You need the feedback from the new employees

And you're gonna be making stay in compliance. Exactly. So. We can support you with the program that Michelle, you know, mentioned. But also, we offer fractional quality support. So we can be looked at as a part of your quality team and we can help be integrated into your processes and let you know as you go along. Oh, you're you're getting into trouble here. You need to do this. You need to do that. So that's another option, if you need us. More involved

It's similarly, we build into that price. 1st off you get all the cert, the support and implementing services that we can offer. You could also get services from Rene. And I'm sorry I lost my train of thought

And the commercial

I get the range of services like you're moving more front end

So we're trying to like build in time for, like them to call us and whatnot, so that we're so that they treat us like we're part of the team, and they have to talk to us every month at least once a month, because it's built into

That's the cadence I was looking for. Yeah, it's top of your top of mind, right, Toma. Top of mind awareness

Yes.

Risk management has gotta be. It's like an education cycle. Right? You gotta stay. Yeah. Okay, got something I can chat with you about later. Appreciate it.

Yeah, yeah, let let's meet you and Rene talk like, maybe

I heard that expression before. Toma

Yeah, top of mind awareness.

Anyone else. Yeah, Paul, you're making shit up

No man. Well, I do, but

Is there anything else for? Talk about just wrapping this up and

I? I have a quick question. Sorry. I always ask questions at the end. So when you were talking about the 1099 contractors for sales and exclusivity. I think that's an excellent idea. But how enforceable is it like? What is the have you come across cases or where they were not actually exclusive, and the cost of litigation for that anybody can answer the question. But I'm just curious. The pros and cons, like the pros, are excellent, but what would be the cost associated with the non? The breach of contract

Okay? 1st of all, I want to make sure I understand the question correctly. So when we talk about like a 1099, or distributor being exclusive, I mean, the manufacturer is only selling that product through that entity, not reverse. is is that find on that

Sorry I I'll refund the question I'm asking about the idea of having the sales. I maybe I misheard it, but I thought you were mentioned having sales team, some of them be 1099 contractors and fill out an exclusivity and then give them minimums that they have to sell. So if they breach that contract, what would be the cost for the organization? And is it worth it for them for that risk?

If if you make somebody a 1099, you can't really demand exclusivity from them. It's it's sort of a violation of the idea, they become a full time, a de facto, full time employee. When you demand exclusivity of a 1099, if you demand hours. If you demand this if you demand that. So you really need to be careful with with 1099 Si don't think you'd have a lot of recourse in that event.

So. And when I was talking about exclusivity I meant from I'm selling a product into the market so that 1099 person is guarantee. I'm telling them, you know. George, you're the only one selling into Alabama. I'm not gonna let anybody else sell into Alabama, George, it's just you. So any work that you do, George, to gain business is is all yours. But you're gonna have to sell at least a hundred $1,000 worth of product a year to maintain that exclusivity. So that's different. That's different.

Yeah.

Than what Shawn is talking about. So when I say exclusivity, it's exclusive to the company. Penetration into a region

Okay, okay, that makes sense

It's an excellent question. Yeah, thank you. Thank you that I'm gonna be clearer about that. Next time

Thank you for clarifying. Thank you.

Yeah. And as the resident sales guy, if I could, Patricia, it's a great question again. And Kevin, it's your point is very really important, because, like, you take states like California, they're very strict about the relationship and what you can and cannot do with your 1099 s. Cause. They, the State wants to get their taxes. But managing Full commission reps is really an art form. There's a lot of risk in doing it. The cost effectiveness is that it really works only when you support them right and give them give them the support they need, like materials and training and stuff for that, and then they can. And like Rene was saying, you they can maintain the exclusivity exclusivity.

if the the revenue and the models are there, because if they don't deliver, then it opens up very quickly, and you should keep them on a very tight leash.

Yeah. Yep, I know at the top of the hour I'm just gonna go through this super quickly. Secrets to success. Define your target market right up front. So you're addressing all your regulatory. Your product needs even your marketing and your sales IP to ensure you're protected early and reevaluate. Often, like we talked about, align your regulatory path and your reimbursement strategy. We didn't talk a lot about that that happens pretty early on. We talk a lot about that today, but that's really critical. For those of you who sell devices, you know, one of the 1st things you're asked is, okay. What's the reimbursement for it? What's the code? What do we get reimbursed?

Establish your commercialization plan and and work it? And then I always recommend raising more money than you initially think you need, because this whole process is just more expensive. It's like a house project you're like, oh, I'm gonna go change that door out. I'll be done in 3 h and 9 h and 10 trips to Home Depot later. There you are, similar with with medical devices. Thank you. Everyone. Any other questions.

Oh, but a statement! I seen a few comments of Thank you. This was great, etc, etc. So I knew that before you started, but I didn't know that you knew that. So thank you for that, and I hope folks can join us next week. We have a new guest. She's a friend I met about 10 years ago at Daniel Crafts event in in the Hotel del Coronado. Her name is Dr. Amy Baxter. and she is going to talk about her product, about resolving back pain, but also knows quite a bit about. And we'll comment on changes that we can expect from FDA and the National Institute of Health.

which I think will be highly relevant for

No, I know we are past 12 o'clock. But can I have one quick question, please?

What does the team think? Should we let Michelle Mitchell talk or

Yes.

Thank you, Sean. The last thing Renee mentioned is the reimbursement. So now I have a question about that. So, for example, like for pressure, injury, care, lymphedema, and then lymphedema, not have reimbursement for a few years, and then, I believe, last year, January, they started that. So now a lot of people are trying to get the code ego 6, 5, 0 to 5, 2. But whose responsibility to tie the code with the product is that a manufacturer or the the distributor, because they are asking each other so who decide what code go, with what system, what product

You are asking such a good question. And this is, it's a complex response. I'm going to oversimplify it for now. But I think we might benefit from a regulatory reimbursement kind of combo on this on this channel here soon. So typically when you're going through like the regulatory process, if possible. We advise that you align your regulatory claims with product codes that are already reimbursement codes that are already out there, so that you know when you launch the product, it can be reimbursed. In the meantime, there are ways, let's say you have an innovative product, or you have a product that there's not really a reimbursement code for the indication for use. There are ways to work with with Cms and actually work to have a code established for it, a specific indication

Well.

But but and it's typically done, it's not done by the distributor. It's done typically by the people who are the the actual creator of the product, the company that's trying to bring the product to market

Okay, because this product exists in the market for a long time and because there was no medicare reimbursement code for some time. So nobody's really interested. And now, suddenly, because I think Cms or Dhs, I'm not sure which one they published this guideline as to what code requires, what specifications. And now, suddenly, there are 3 codes out there. And everybody's interested in this particular 2 products, actually. But they want the many contracting manufacturer to say product. A, go with this code product. B, go with this code before you can provide us all the necessary reasoning, for.

you know, satisfy the reimbursement code. Otherwise we we're not considering it. And so now we're trying to fit the product into the code. So it's kind of hard to justify, because. you know it could. It could range from $200 reimbursement to $4,000 reimbursement. So there's a huge gap. And you don't wanna you know, I just don't think we we should overstay our product. Try to get the highest reimbursement, because I just personally, I don't think that's right, so that there's some work need to be done. That's why I'm asking this question.

Yeah. And you cannot tell a hospital or any entity that's buying the product. Hey? Here's a code you can get reimbursed. You cannot say that you can say, here are a number of codes that may be used for this procedure. And you know you need to validate through your processes here at your healthcare system as to what you're able to get reimbursed, for, you'd be so careful about that. Okay, the other thing you is really important, too, is work with your your sales team. If they have people in the field. They have customers buying the product. And they're they're trying these different codes. See if they will give feedback to say, Oh, yeah, I use code 8, 5, 7, 3, 4, and it actually reimbursed at $300 when I used it

Okay. Thank you.

We'll get their feedback. Yeah, yeah, you're welcome. But then

Thank you, everybody, for letting me and ask the questions

Anytime, Sean, you had something in the chat for folks, and I think we'll conclude there

Okay? Yeah. So we're doing a new webinar next week, part 2 of getting your product paid for so more detail on you know, reimbursement codes market access. probably worth attending. I'm also going to do a post today on a 10 x startup challenge. This is to induce more startups to attend the event. What we will do is we will write a feature article in medtech leading voice about them. In advance of the event. And then, you know, heavily discounted pricing is available for startups, because we want to make sure that we have a nice balance of startups in the room. But we can. We can talk about details about pricing offline. I wanted to. If you know a startup. That is a good candidate for possibly going to 10 x and they would like some exposure they would like some media exposure. Please. I'm gonna share this

with you, and then you can just put them in touch with me.

Yeah, Sean, I do. I'd like to have a conversation with you on the

Okay, do you know my email, or how to get a hold of me?

I'll find you on on slack

Okay, good as Joe knows I'm terrible on slack. But

Sorry then I don't

I will. Just put my email in the chat right here. Sorry everyone Shawn. I know we're up

And then I had a question on the 10 X discount on the hotels. What's the cutoff on that

It's typically the 1st week of April, actually. And every year I'm like. no, I really need more time. And they usually granted, but depending on occupancy. Sometimes they get a little persnickety. So I just put the link there. I would suggest anyone who's even thinking about coming to go ahead and book a room because you can cancel it like the day before. That way you'll be guaranteed to get the good pricing. They do cut it rather significantly. So I suggest you take advantage of that

And any of you that are thinking about attending. If I can push you over the edge by offering you a medtech leading voice interview. Then please take me up on that. I am always interested in learning about what people are doing and sharing it with the audience. So if we can, you know, figure out a way to make that work? We'll make that work. Okay, that's it for me.

And me. Thank you all, and we'll see you next week bye, for now

Have a great weekend

Jill Mitchell slapped me, slap me so I can. I can continue. Got a conversation with you

Okay, I'm very bad with slack, too. So

Okay, well, we'll email me. Then

Okay.

Joe, I'll start a new call. Michelle

Don't do it, don't do it now.

My one o'clock, so

All right.

Beautiful.

John, we can stay here

I'll just

Okay.

Thanks. Michelle

What are we doing?

Hi Michelle!

Hi! Where'd Michelle Mitchell go?

I kicked her out. You out now, too, so

Oh, you meant not we stay in, Pop. You're

Hey? If you like, you're always

I'm good. I'm just

Alright!

Love you guys.

You, too, bye. and it's just us

Okay. God, yeah. So many, so many things going on. Had to bring 5 people into help. Sort it out. So the answer to your question is, yes, I will use. And yes, I have talked to my team about using Ann, you know. As you know, from working with me. My brain functions differently than other people's does, and

A little challenging for your teammate here

Yeah, I know. I know it's been challenging for you, and I apologize for that. However, you know

Well, that's why I wanted to really reemphasize the the. This could be your most lucrative revenue stream. I made a hundred $35,000 in my best year. Doing this, I mean cleared it as profit

So. Yes. I mean, I know that we've we've talked about, you know, transitioning, you know, next year. And you know me potentially taking this over

I hope, because I don't want to do it much longer. I mean, I really, honestly, I Friday mornings, I'm like, okay. But

Well, I I've I think that that is an interesting option. And we'll definitely give you an answer so that you can announce it at the event. you know.

If you don't, it dies.

I know I know, and the

It's so consistent with what you're doing. I mean, your your business now is what my business was

You have.

Potential for sponsorships and revenue from ticket sales, and it also boosts your visibility as a marketer. I mean, it all worked

Okay, so I have to update you on a few things. So Christian, the owner is not coming. Maria is not coming. I'm gonna keep them on as sponsors, and name only just because

That they will give you money to do so.

No, but I mean, just because they're my clients. With their question about owners. I think I I saved the Owner Institute deal. So they're paying 7,000 a month. So that's 84 grand a year

Yeah.

Okay. I want to keep them

Yeah, I would.

And so what I did was I offered them a month or 2 free to get us aligned with the new salesperson. Now, what we're not doing in that month or 2 is work. What I'm doing is collaborating with them on building a plan to move forward to support them. And so the contract is paused. The retainer is paused for up to 2 months, right on the condition that it's restarting right, and they don't have the internal resources to do the kind of marketing that they need to be doing. However, the sales guy is new, and so he really kind of needs to dig into

aligning, marketing and sales so that they're not doing duplicative work or work that isn't helpful. And so he and I are gonna work that out. That's that's on that point. So that's the reason why I'm not, you know, gonna just. you know, spitefully strip yoner's name from the event. But, Christian, yona, you know, is is not coming, because whatever which is fine, so what I wanted to align with you on is the keynote speakers, because we really only have 4 speaker from the stage slots on on the agenda as it is right now, like you're the dedicated speaker you're up there for half an hour. You're gonna talk, and I know one is Anthony Chang.

I believe

It is.

Okay, I want from my side. Bradley.

Anthony has to speak up first.st Usually at the the 1st day

1st 1st day. I'm fine with that. He's great. He's a great speaker, he's, you know, important name and you know, really good. Who else did you is? Do you need

Mauricio

Mauricia, now

And Gunter, if he comes, deserves his own speaking spot as well. I I don't know how committed you are to only 4

I'm I, you know I can figure it out if we need to squeeze in another speaker. We squeeze in another speaker, and we squeeze something else. You know I'm the. As far as I'm concerned. The agenda is still relatively fluid. Right? Yeah, right up until the day of So, Gunter, if he goes. When do you think

What does?

What does he talk about? Who is he?

He's he was my very 1st client. He's this, probably among the smartest people I know. He's read the entire Accountability act, and he gets hired out for 10 grand a day to teach entire sales. Forces like Roche hires him, and Baxter hires him to come in and help salespeople

A sales pro

Yes.

Awesome. I love that. Okay. Well, let's find out if he's going And just, you know, Making sure that everyone that was promised speaking slots. What do we call the the interviews that you do

Best friends.

Fast rounds, making sure that those are filled, and then the the sessions, the the workshops are going to be. I'm working with my team to develop these out so that they open an envelope. They get an assignment. The workshop leader leads them through the assignment. Everyone in the group gets introduced, they do a brainstorming session on the topic. They capture all their ideas. They put them all together. All of this is recorded on somebody's phone for an AI report afterwards. But they're also going to do a live post on Linkedin from their session. So group Panda group, you know, like, like each group is gonna have a

Oh, I used to need I forget even what the app was called, but there was a special app that I paid for to broadcast, live on Linkedin? Is that still required? Or does Linkedin now support, live broadcasting

You need a streaming, yeah, to to broadcast live

Right.

You need a streaming partner.

So would, when you say they would broadcast, live on their

No, it's it's it would be they would do a post. So the post would be like a short video or a bunch of pictures, or and then an AI generated thing like this is this is what we did in our group. So it's like this, and then if all the participants support it, then there's going to be this huge viral effect of

Right.

All these people on Linkedin saying, This is amazing. This is the best conference I've ever been to

Right.

I've never been to anything like this before in my life. We're learning so much

Yes, yes, I got it.

Okay, so that's like 16 fold. Right?

By the way, are you gonna do a daily post for Michelle now? The countdown that she's doing, because that's what we did years ago, and it was a great hit

Countdown, post

Yeah, minus whatever t minus whatever. No, I wasn't talking. Well, you can do it for us. But she recently posted something that was like a countdown. Had to. She did it for Mdr. Before this was like a Qsr. Or something. Do you

She's got. She's got this new course coming

That's not it. Let me look. Hi! This is Leslie. No, I think I'll do it once a week. It's the Qmsr countdown. Will you be ready? 328 days left On my screen

Yeah, I think Frau made that

Well, this is Leslie. I think I'll do it once a week.

Yeah. But I think fraud made the graphic

I also, bye, have that thing that I put in the 10 x planning the Al Franken thing. Have you watched it? No share my screen again

Oh, I did see the Al Franken thing

I think that just classy and great, and a great way to promote our stuff. I haven't made it. I'm not gonna make it. If you

Right. I know Junior needs to make it

I don't know how you prioritize the work, but I put that up there

It's it's it's in the chat. Where is it?

In the 10 x premium

Okay. Yes.

In 10 X planning team. It's the very top thing. If you use the starring system

Okay.

Do you use stars? No, you don't. So I just right click on Star Channel or star. You do it for people. Then there are ones that I just write too infrequently to have starred

Is it worth reaching out to Dwayne Mancini with any help on trying to recruit startups for this or not?

Yeah, potentially. Yeah. I mean. get them a deep enough discount. Just check that. He doesn't have something going on at the same time. And he might see it as competitive

I got it

Trying to attract the same audience. We are, I mean, in terms of startups

Okay, I don't. I don't really wanna have anything to do with them. I I sorry. That reminds me. So

You want me to ask him

So maybe you could do this.

I'll ask him unless you tell me otherwise.

Yeah. Ask him. I mean, you have a good relationship with him. I don't know him. So is 2 people. the guy with the long beard. Is he coming

The guy with the long beard

Yeah, looks like, zz, top.

Oh, you mean Justin, if you give him a speaking spot. if you highlight him and he gets a video out of it, he'll come

I'll do it, Justin Bushka, so I'll reach out to him and all

Okay, and I'll get his money.

And you get his money. And then the other one was the guy with the school. That's sort of competitive with Michelle. The guy was all over Youtube, but not all over Linkedin

That's accurate.

Rob Packard.

Yeah, he's on

Okay, so I'll if you reach out to him I will coordinate with him on the promotion, because what I want to do for each speaker is, create a 2 page Pdf. Which is like an interview with them I'm speaking at, and then have them publish this on their linkedin so that people can read the interview and and then we'll also publish the interview. or at least a link to the interview. But Show it would be, you know, figuring out what his topic is gonna be what he wants to discuss, because I mean, he can talk about just about anything. 1st of all.

as far as I can tell anything regulatory, related. And the second thing is, you know, just because I've never spoken to him, just for you to make that introduction

I'm sorry I'm multitasking by writing Duane. Who am I introducing

You're introducing me to Rob Packard and saying we would like to feature him and

Yeah, that's easy.

And figure out what his topic is. Gonna be, and I will connect with him next week

Okay.

speaking of trump fans, Nelly Bushman has signed a small contract with us

Oh, good!

It's the least amount of money that I've ever worked for. Probably

A month.

Not even

500 a month.

Yeah.

And what are you doing for her

We are gonna produce an ebook guide, promote the guide and do a webinar. Oh, but it's a 6 month contract no. 3 grand. That's about all you'll get out of it. I I realize that. You know some. You know it. We're we're gonna do the appropriate amount of work. You know. My my team is is got some of these things down to a science where they're not, you know, putting in long hours putting together a guide. She is gonna

participate lead one of the workshops. And you know, I just think that is important to how do I put this

Winter's, a definite.

Great. What is his last name?

Vessels WESS. ELS.

And that's pronounced with a V

Oh, it's wet, wet! It's wessels, but it's German enough that you kind of

You kind of fudge it

Yeah. Butter vessels. I don't know what you said exactly.

It. So where does he live?

I lose track. I think he's in Tennessee now.

Okay, that's fantastic. So likewise reach out to him. Introduce me, and we will feature him

Yeah, you get your content info to him. Sure share contact done. Oh, share with Gulcher

So met this kid it! And at the wraps meeting his name is George Kwasinski. He's like 24 years old and has a startup that's similar to Jesse Chen in the sense that you know it's all data and it's run off of. He did this presentation on FDA warning letters at the thing. I'll send you the article that I wrote about him. Anyway, I'm trying to get him to come. I think I'll talk him into it, probably not going to

By the way, it's the 7th he'll do the Wednesday, and I never charge him

You never charge

Good job.

Yeah, right? That's fine. So he would speak on the 7.th Is that what you said? 7th speaker? Okay? yeah. So this kid is amazing. He's 24 years old. He's a founder, and he's like, you know. just I asked him. There. I was like, you must be an oldest child, because no youngest child is ever gonna do those? What are you, Ciao?

He and his child

Yeah, how? How did I figure that

As well

I'm youngest, you know. I was like I was like, you know what I was doing at 24, not not starting a company

Got it

Were you? What were you doing at 24,

I was working at. No, yeah. I was working at Marine, Midland Bank and applying to Wharton. and in September starting Warden as one of the 10 youngest in the class

Oh, congratulations! Didn't know you went to Wharton. How do you feel about the 160 million being there? You go 100. So my theory is, everyone that's connected to University of Pennsylvania, even if they voted Republican, has kind of been like turned on to Donald Trump's 100

Very much.

100 and 75 million dollar. We're cutting you off because, you know, a trans swimmer. or whatever it was.

You know.

I think that

Although I do have a friend that is a staunch well, I have 2 grants that are staunch Republicans who like we're all over the Dean back in. I don't even remember what it was now, where deans of schools were getting in trouble for anti Semitic stuff, or I don't remember

Well, as I said to Mike, you know, if it weren't the Trans. People in the locker room it would be the support of Palestine, or it would be the, you know. Oh, you know, research on abortion, or I don't know some, you know something that doesn't fit with their. you know. Agenda, you know, basically enemy of Donald trump, for whatever reason. And they would just find a way to But we'll see I'm predicting a Mussolini like ending to the whole thing where he gets dragged through the street and hung upside down by his own people.

It may take a few years to get there, but

Would that be before or after our death?

Well, I'm not planning on dying, no matter what he does. I'll buy a gun before that and kill other people. I don't

And we'll perish at the hands of someone with a gun

But I'm not. I'm not. I'm not gonna go down without a fight. I'm going to take out at least a hundred Republicans before I go down

Are you gonna be like we're a bomb or something

If I have to, I mean

Explosions! Scare me.

If it, if it, if it, if it really comes down to life or death. Joe, I'm I'm willing to take out as many as a thousand people, including children. The way that I look at it is you know what what they should do, and you know, don't quote me on this because I will, I will deny it. But they should really start just targeting the family members of the Republican Senators and just start killing them

Sure.

You see the logic? It's

I like it.

And drug cartel logic.

I like it.

But it's like, Okay, you won't do this for your country. But you might for your family. Let me get this. Okay. I got a phone call

You have to take it

Now it went to voicemail. I don't know who it is. It, said Hannah Mitchell.

Yeah.

Which is strange. I'll call them back if it's important. So yeah, that's that's my theory is just start taking out their family members. And you know. this is like my approach to the Nra, just like start killing all their vice presidents

I'd like that

You know. You believe in guns. Here you go

Yeah. Gone away. Is there anything else we need to cover? Because I got some trading to do do so. You didn't answer. Do you have anyone that you talked to this week that I can put in yellow on our spreadsheet

Explain the color system to me. Again, yellow means what

Yellow means. We've talked to them, and they expressed interest. So it's a matter of following up. So are you coming? Are you coming? Blue is. I'm coming, and I'm like, so can you pay? Can you pay? Did you get your room

Coming!

Means they have paid, and that still leaves the. Did you get your room? Did you get your room

What what color is paid

Screen

Green is paid equals green. Yes, I have talked to people, but I do need to update

If we do it. Now, just tell me who they are. Just give me links. you know you love me, and we're gonna talk for another 15 min, anyhow. So just multitask. Come on, Shawn, I know you can do it. I wanna be where the people are. I'll entertain you. I wanna see? Wanna see him dancing, strolling along down those. What's that word again? Street? Try continue

Me. You're good singer. I'm not a good singer. Sing

Up where they run up, where they stay all day in the sun, wandering free. Wish I could be part of that world.

David Fillmore cannot come. I'm not sure if we have him listed as a speaker or not.

I will. Yeah.

Did Kevin same pay his invoice? I know you invoiced him

I did, and I don't think yet, but once it's invoice, it's like I'm good

Okay, so

We don't have speakers for April. By the way, we have George the week after Amy, but

Yeah, I don't have any trouble getting speakers. I will. I will line up the rest of them. I just one of the things I wanted to ask you, is there anyone that you promised speaking to before? 10 x, because otherwise I'm gonna just double down on the rest of the people. So Dale Gallagher, president of cognant cognition, is coming. He's he's a yes, so we should get paid by them.

Let me sort by 1st name, because we're dealing with people that okay? So who did you say

Dale, Gallagher.

No, she didn't. But that name let me just double check something

Well, that's that's the cognition person. So we had somebody

I had. Who's a who is Edward Doherty?

Edward Doherty. I'm gonna talk to him. He is the one. So he's on the list in yellow or whatever color it is for we're still trying to talk him into it. I'm doing 2 free webinars for him, so he better fucking come and So George Kwasinski, KWIE. Sinsky with an with a C.

Token, Linkedin

Yeah, I'm gonna have to call you back. Okay.

George, what to spell it? Oh, I found it a WIE.

Yeah.

Young kid.

Yeah.

And and you said, he's he's coming

No, he's a person that I talked to, and I'm trying to talk him into coming

Oh, well, he looks too young to want to pay

Well, he's the one with the startup

Yeah, I don't see in pain. But okay.

Well, I told him 500

Okay.

I mean, I'm trying not to let people in for free, because I don't believe that people value things when they get them for free

Right.

And

Okay. Oh, let's let's stay active on on slack. If you'd be so kind. And

Bye.

I'll I'll make sure that Annie's roped in, and and we get this by this time next week we will look at the spreadsheet together and feel really good about it.

I love you. Bye, bye, thanks, Joe.