Roadmap for Successful MedTech Concept to Commercialization Mapping the Journey and Pitfalls from Ideation to Commercialization

Hello, and welcome everybody to the medtech leading voice. Lean Raqa Webinar on concept to commercialization with Michelle Lott and Rene Franz from lean riqa. I'm excited about this topic today. Run through a few housekeeping notes which I'm going to paste into the chat in a moment. Please feel free to use the Q&A button rigorously throughout this webinar to submit any questions that you may have for either of the speakers today. Also, there will be a recording available to all registrants. As well as the slide deck tomorrow. We will send an email to all registrants tomorrow with that information in it.

there will be a short poll during this about 10 min in there will be a survey after the call. We ask that you please participate in the survey to let us know what you think and provide feedback and direction for for future topics. It's very important. Let's see those of you who aren't aware of the 10 X Conference. Rene here is going to be speaking. She's going to be leading a workshop and participating in panel discussions. So you're going to get a sneak preview of that. Michelle is going to be out of the country, otherwise she would be joining us. Along with many, many of your other. Mlv. 100 favorites.

let's see. At the end of this call. We are going to introduce a new program from Leanra, Qa. And I hope that you stay on the call to learn about that. In the meantime we're going to go ahead and get started, Michelle, why don't you introduce yourself? And then Rene? And then you can bring up your slides.

Sure. So I'm Michelle Lott. I founded lean Reqa about 15 or so years ago, and we specialize in helping startups and small companies bring their products to market, not only from like a regulatory and quality perspective, but also through commercialization and market analysis and business activities. With the help of Renee, who is my the general manager of Lean. but has over 30 years of experience in product commercialization efforts. So, Renee, if you want to expound a little bit.

Sure.

You know.

Thanks, Michelle. Thanks, Sean. Thanks everyone for joining. I'm Rene Franz. And, as Michelle said, I have over 30 years of medical device, development and commercialization experience. And I've helped bring to market over 200 different medical technologies over the years. And what I hope you gain from today's session is really an understanding of everything that can go wrong in medical device development and all the ways that we can help set you up for success so hopefully, those things don't go wrong.

Fantastic. Let's get started. Feel free to bring up your slides.

Can everybody see my screen? Can you see that Shawn.

Yes, yes.

Okay, wonderful. So I don't think we have to spend time on this. We've already done our introductions. So agenda, we're gonna talk about product development and business planning. That's really key. And of course, regulatory strategy is a huge piece of that prototyping and manufacturing. And then, finally, when you're ready to launch your product commercialization. So I'm going to turn this over to you, Michelle.

Okay. so most of our, this is your typical process of bringing a product to market from early concept development all the way through FDA and into commercialization and scaling. Our most of our company customers come to us a little too little too late, and they come and they say, hey, we need you to file a submission for us now. We're ready to go to market. and they have not contacted us early enough in the process, because they think this sounds expensive to do regulatory or some of these commercialization services. But what they don't need realize is that all these activities need to be done at key points in this life cycle to avoid a lot of mistakes or oversights that will cost time and money.

So instead, you know, Rene or I will have to get in our time machine and essentially reverse engineer some of this dark or most of the documentation retrospectively. And you know what that really is expensive to not plan for these at the right place at the right time. So you could go. So this is another common mistake, we see is that the average tech startup specifically with technology that spun out of a university, they come to us and they think that they are, say, 80% done with the activities it takes to bring a medical device to market, and that they only got have 20% or so left to go.

So what we what in reality, in the real world, it's the opposite. They have 80% left to go complete. And they're only about 20% done. And so we end up with a failure to launch so.

Sorry, Michelle, did I go too fast?

No.

Okay. So that's where where the butterfly effect comes into play. And I'm imagining sorry this is advancing on its own. But I imagine most of you are familiar with this, where a butterfly flaps its wings in one part of the world, and a tornado occurs at the other part of the world. And so that's what we really want to help you avoid. And so there's a number of tools and planning that you can use to help put you in the right place. So one of the foundations is what we call a trace matrix. And it's really the building blocks of a cross functional tool that you use to engage engineering. regulatory and quality and clinical, because that's really your foundation of the bricks that you're building. But you want to pull sales, finance, marketing and executive leadership into it. I'm going to show you the trace matrix now, and I'm going to give you some examples of why that's really important.

So this is an example of a trace matrix. This one is very simple. In a more complex device you may have 40 to a hundred pages of requirements. But we're only gonna focus on 6 today to give you an idea of what could possibly go wrong and get you thinking about ways to design your device. So these things don't happen to you. So you'll identify the user need the requirement type. I won't go too much into this. But there's design inputs, outputs verification validation. And the status. So the 1st one that we're going to focus on is identifying the temperature range. So not only identifying the temperature range in which you use your device. But the temperature range in which your device is stored.

So why is that important? Well, the examples that I'm going to share with you today actually are from a very long time ago, because I don't want to compromise any client confidentiality or any devices that are currently on the market. So this occurred over 30 years ago. I had a purchasing agent working for me, and she thought she was doing a really good thing saving us money. She changed a power cord out just as we were rolling out a whole series of whole blood collection devices throughout Canada. So the last province that was rolled out was Ontario, and they were the lucky ones. or maybe the unlucky ones, to get this new power cord.

So the new power cord comes in and we start getting phone calls. Our power cords are falling out of the wall. Well, what the heck is going on. We have implemented this February we've implemented across the entire country of Canada. Nobody else is complaining except for Ontario. So I had up there with the Director of quality to see what's going on, and guess what I see, these power cords that are a hard, plastic blue. The old ones were more of like a spongy, gray silicone, and in Canada for their mobile blood collections they actually store their equipment overnight. So it sits at negative 30 to negative 40°C. Then they pull it off of their bus, and they bring it into a school or a fire department, and the cords didn't have time to heat up, and the

purchasing agent didn't think to clear it through engineering to see if this less expensive cord was actually going to function in the intended environment. So what was happening is, the cords are falling out of the walls. The entire province of Canada, who gets 80% of their blood from mobile collections, actually had a blood shortage over the period of one to 2 months, that it took us to figure this out, and they had to import blood in from other regions. Another really important consideration is identifying the way that the device may compromise a medical therapy. So again, I'm going to go back to my blood collection and processing days where we had a trip scale. And this one was not. It wasn't A/C powered or battery powered. It was literally a mechanical scale that had a flat spring in it. We were having trouble with this.

the spring migrating. So somebody in production had a great idea to put a drop of our TV in which is like super glue, but never validated it. So it was never tested. So guess what? We implemented 300 of those devices at the American Red Cross in Philadelphia, and we were overdrawing the blood donors. And there's 2 reasons that that's serious. One. If you overdraw a blood donor. Most importantly, you can make them sick. And that was happening, and 2, the units that were overdrawn had to be thrown away because they didn't have the right mixture of anticoagulant to whole blood ratio, so they would clot.

So, Rene, is it? Is it fair to say that these are all things that weren't fully thought through when the product was initially designed and therefore weren't in the original trace. Matrix.

Exactly. Exactly.

And but things that were should have been easy to to know or define. If you kind of peel peel the onion, if you will. On the on all of the layers of the use, environment, and oh, etc.

Exactly. Exactly so on that same topic, you know, identifying the countries where you're going to use the device. So why is that important? Well, if you have a device that uses A/C power, you probably know that the Us. Is 1 10 voltage. Europe is 2 20, Japan's 100 and all the other countries fall somewhere between those 3, and they require different A/C power, actual outlet receptors. So that's really critical. The other thing that's critical to consider when you're going into other countries is the demographics of the people. You know. Some countries people are smaller, larger than others. So, taking all of that into consideration.

Butterfly effect had a device. It was actually a handheld radio frequency sealer that was used to seal the aliquots of plastic on blood bag for Hla typing or for blood matching and typing. And the problem was the device was designed basically for the engineers who were mostly men with larger hands. And when we went to implement the device, and we were implementing at that time in Asia. Their hands were so much smaller that when they went to actuate the device, the magnet at the very bottom that was supposed to engage the radio frequency. They couldn't close it because their hands were so tiny so they couldn't activate the radio frequency energy so they couldn't seal the tubing.

So we actually had to create what we affectionately called the J. Screw. Because we discovered this in Japan to allow for people from all different countries, all different size hands, to be able to use the device effectively.

The meanwhile, on the regulatory side, you know, we have seen, you know, recently, with the the evolution of the European Medical device regulations that are still evolving. We have kind of seen a change in the trajectory of what markets to enter. First.st It used to be that people perceived that Europe was a lower barrier to entry. It was easier to get your product into commercialization, and they would go to Europe first, st meaning that you need to take considerations like the electrical issues and others, and different test standards in consideration in Europe. First, st while you were doing clinical trials in the Us. But now the Europe is going to be the one that is leading the way in requiring clinical trials. And then, whereas FDA is working on a lot of different pathways to market that don't necessarily require as extensive clinical trials anymore.

So from a a planning purpose, from a regulatory perspective, these are, you've got like a switch in your strategy, which is going to be a switch in the type of information that goes in 1st into your trace matrix for a regulatory requirement. So an example of that is in the for, like in the FDA, you can see all of the standards, the product specific standards that are required for infusion pump on the left for entering the Us. Market. But if you look up, you know something similar in the EU standards database

1st off they have a different harmonization process, so the version that they have recognized or harmonized may or may not be the same version as the equivalent standard in the the Us. And that is recognized as consensus standard. And then there's even more, because, you know, you've got your product specific standards like what we just looked at, which, you know, could be like the insulin pumps, cardiovascular implants, spinal implants that are very product specific. But then you've also got concepts that that span horizontally over, like many different device types. And so it's really important to know all of those technical specifications like right up front, because all of these standards are going to

specify particular test methods, particular acceptance, criteria, and all of these things need to be put itemized individually in your trace matrix right from the start. So your your regulatory plan and strategy significantly drives the standards that you select which should drive a lot of your test specifications.

So going back to that trace matrix in addition to all of the different regulatory and consensus standards that you wouldn't, you do need to integrate into this. You also need to. If you're designing a device, identify critical dimensions. And you really need to do that upfront. And and here's why? Well, I guess I should take a minute to explain what a critical dimension is. It's a measurement that directly affects the devices, performance, and functionality, and not a lot of people think about that initially, when they're designing a device. So what could possibly go wrong? Well, we had an instance going back to that radio frequency sealer, we had a critical dimension that we didn't even know we had. And so when the jaws of the sealer come together with the radio frequency energy. If there's any sort of gap

that radio frequency energy will spark. So what happened? We sent sealers to the Cord Blood Bank in Singapore and they lost 10 units of cord blood because we had a critical dimension that we did not know about, and it was off. So what was happening is, they were applying the radio frequency energy to the tubing. The device was sparking because the 2 jaws were not meeting evenly and they were burning through the tubing. So not only were 10 families affected, you know they were saving this cord blood for a reason, but also each unit of lost cord blood cost the Singapore Blood Bank $50,000 each.

So identify your critical dimensions upfront and make sure that you actually do your Qc. For those as you're bringing the products off the manufacturing line. So another critical user need is really understanding who your targeted patient population is. So in this particular instance, we had designed a whole blood collection device again, going back to that analogy where we're mixing whole blood with anticoagulant. But we wanted to get away from grams and move to milliliters, because most of the world outside of the Us. Was collecting in milliliters. So in order to make that calculation, we had to include in the formula, the specific gravity of blood. So we looked up the specific gravity of blood here in the Us. Which worked great, and the device was working just fine here.

but then we went to Japan with it, and guess what we were overdrawing our donors again, and could not figure out what the heck was going on. Eventually we learned that the specific gravity of blood in specific patient populations is different. So we needed to take into an account where the device was being used, and how we needed to adjust the specific gravity of blood so that we could accurately collect a unit of blood and and not harm somebody in the process.

So, Renee. I think this is probably a good place to stop for one of our poll questions.

Okay.

Ron, if you wanna pop pop that up. you're on mute.

Sean, you're muted.

Sorry about that. I'm back. The I mentioned at the beginning of the call that there is a certificate of attendance available. If you would like to get the certificate of attendance, please put your name as you would like it to appear on the certificate in the chat along with your email address. Both of those are required in order to receive the thing, and we'll try to get it out in the next 48 h we've launched the poll questions. So, please, there are 6 questions in the poll. And so we're going to let this run for a while while we continue to talk, I would mention that on the 25th of this month there is going to be a new cyber security webinar with Jose, and I'll put details that in there and then. The last thing that I'm gonna say before I turn it back over to our speakers is at the end of this call. We're launching a new beta program. And if you would like to receive details on that information, I'm gonna go ahead and put that link

in the chat shortly. But please stay on the call because we're gonna introduce that. I don't think I have any other announcements. we'll try to get all to all of your questions. There are a lot of questions submitted already. And so yeah, thank you. Everyone.

Thank you. I'll keep going here. So another important piece to identify is, who is the targeted clinician or end user of the device. So why is that important? Well, here's an example. Michelle and I actually worked on this technology years ago. It was actually a brilliant and minimally invasive way to treat atrial fibrillation. So for those who are refractory to other treatments and would typically go in for what's called a cox maze procedure performed by typically a cardiothoracic surgeon where they go in, and they crack your chest open, they open up your chest cavity, and they literally surgically cut lines into your heart to stop the aberrant electrical pathways. So the technology

that was really innovative was not having to crack the chest open. They would pop in through the xiphoid process just right here and under the sternum, and they would, in a minimally invasive way, access the chest cavity and do what was called an epicardial ablation. But all of this had to be done in a closed chest cavity, using fluoroscopy. Well, that's something that a cardiac electrophysiologist is used to doing, not a cardiothoracic surgeon. So the effect was they were targeting cardiothoracic surgeons who were not trained to use a minimally invasive procedure, and unfortunately, after about 60 million dollars of spend this product did not successfully launch into its initial intended market.

And Renee, if I can point out, you know, one other aspect, you know, that's significant about the regulatory path is that that's a whole entire different. You know, user skill set process procedure. So you have a whole different range of human factors to consider as well. And you know the FDA wants to see that you have thought through the the process. The user, you know, in this case, obviously, it's going to be just primarily the doctor, that's using the device. But in many devices you could have the doctor. You could have a nurse. You could have. Possibly the patient.

Remember.

Chairman. Yeah.

I mean.

Care. And so even with that, you could have even different use environments all for the same. And these are things that need to be thought through, you know, systematically, when you're, you know, during early product development. And then now, the FDA is also expecting a good bit of a bit more out of human factor studies in in devices where they didn't previously ask for them.

Yup good point. And then the final piece that I'm going to talk about. And again, this is not an exhaustive list of everything that goes in the trace matrix. There's a lot of other things that that do. But these are just the highlights. Really think about your product cost. I mean, you may be designing the Porsche of medical devices, but your customers may only be willing to pay for the Ford focus. So that's a really important piece to consider. So everything that we've talked about, plus more in the compliance with standards needs to be a part of this. We're going to talk about a lot of other things this morning. But, if you have any other questions about this, or feel like you might need some guidance in this area, feel free to put time on our calendar.

Another tool that we're going to share with you. After this is our business market assessment tool and what this is going to help you do is look at each of the markets. Like, as Michelle said, Europe now has become much more difficult to enter from a regulatory expense. I was, gonna say, expense. It is from an expense perspective as well as typically your price point for your product. Lower. So it makes sense for you to look at each of the markets that you're thinking of entering. Look at what your potential your market potential is in terms of devices sold, and what you think you can sell the device for. So those are your pricing considerations.

And then the flip side of that look at your cost considerations and regulatory and product development is a huge piece of that. So we have a great tool for you to use that can help you do a deeper dive and assess whether it makes sense to enter one particular market over another. And then, finally, there's the business plan. I'm not going to go into a lot of detail about this, because this could be a whole 2 day seminar on its own. But make sure that you have a business plan that you're taking into account your market size and segmenting your market. What's your clinical strategy? What does your competition look like? What's your regulatory and reimbursement strategy? I think it's really important if you can, to align your regulatory strategy with

your with reimbursement. So you know, at the end of the day the device you're getting cleared for. And in the product code you're getting cleared for can actually be reimbursed. Once you go to market, what are your financial projections look like? How are you going to commercialize? And then how are you gonna exit? Those are all critical elements to a business plan that we can help you with. I'm going to turn it over to you now, Michelle, to talk more about regulatory strategy. unless this is this is a place, Sean, where you want to stop and do a poll question.

No we ran all the poll questions. They were. They were all together. If you want to go over them, we can show them again. Just let me know.

No, I think we're good. I just wanted to make sure you were clear.

Recap at the end.

Yeah.

Okay.

So choosing the right pathway can be a little like choosing your own adventure. It can range anywhere from a walk in the park where you could be 5, 10 k. Exempt, and maybe even good manufacturing practices exempt. It can be like a half Marathon, where there is a good bit of training and preparation. But overall, you know, it's it's attainable. And this is similar to the 5 10 K process. or it can be a little bit more rigorous, and it could be like training and preparing for a marathon. If you have a new or novel technology or a new or novel intended use for a particular technology application.

and then it could get to where it has the rigor of an ironman endurance competition, where it is for the pre-market approval process for the highest risk devices. Okay, next slide. So in the FDA structures, their products using a risk-based medical device classification with class one being 5 10 K exempt products. Class 2 require a 5, 10 K between class one and class 2. These make up the bulk of products about almost 80 to 90%, and about 10% or less, or or class 3 pmas.

And then there is. There's a handful of devices, though, that are remain unclassified for various reasons. But what is important is that, regardless of the classification or requirements or exemptions of your product, every product is subject to an element of general controls and then class 2 products are also subject to special controls, such as a 510 K submission, a guidance document, maybe a post approval study and then pre-market approvals require the the Pma. These are for products usually that are high risk life supporting life, sustaining products.

whereas the moderate risk devices for Class 2 are like infusion pumps, surgical masks and class one include, like handheld surgical instruments and gloves, and like bandages. go on, Renee. So long story short, in all of those controls and submission requirements and their exemptions is, there's a number of permutations that could apply to your product. And it's really important to know that in your windows of when you're exemptions could apply if they apply. And if you have exceeded what the FDA intended for those exemptions, and therefore you need to either apply one of those good manufacturing practices, controls, or put it in a submission where otherwise you might not.

So so the butter, if you could go back to the the butterfly slide so for for me, where I have seen this go wrong from a regulatory perspective, and you end up in the butterfly effect by not understanding these controls and exemptions. I have seen people that were argued with me that they're if if we could just stay on the other slide, please. I have seen. Had customers argue with me that because their product was Class 1 5, 10 K. And Gmp. Exempt that their contract manufacturer didn't need to register or list with the FDA.

And that customer, you know, continued believing all of those things until his product got stuck in customs about 6 months later, and the FDA was holding his. The product hostage until its contract manufacturer was was registered. And then I've also seen customers say that they didn't need to submit. A 5, 10 K. And the FDA came their their problem through some sort. This is very far exceeds the exemptions that we called out in the regulation. And so now you have to stop marketing this product. Some of them even had to be recalled, and then the the client had to put in a 5, 10 k.

Sorry. Continue so for the regulatory path, you know. You usually, when people have a newer novel technology, they may think that they need to go into submission straight to a de novo that incorporates all of the features that they intend to that they want in their final commercialized device. however, that a step-by-step approach could be better where they start with a 5, 10 k. And then gradually increase technology and indications until they have got. They've got a series of cleared products that, and then go for that higher de novo. And that's because sometimes it can be like almost like putting blinders on the FDA, because you've got a cleared product which the FDA has already defined as safe and effective. By the by, the fact that it has a clearance.

And then so by the time you get to a de novo you can focus a little bit more on those things that take it into that new and novel versus You know all all the other things that you had to approve from a technology perspective along the way. So next. So this also has got some implications for what that looks like in terms of time and money. So if you get a 5, 10 k. Even if it's not for the full gambit of features that you intend to commercialize with, you can at least start marketing your product for some applications, and possibly, you know, start making some level of revenue.

And this also keeps your fees, you know, kind of at an incremental basis. so as opposed to. If you just go straight to de novo, you know, the not only is the FDA fee significant. but also the amount of time and money is going to take a lot more time and a lot more money. And you know, sometimes maybe getting a 5, 10 K. Along the way is a quick win to show investors or the market that that you can do this and you're making progress. So next.

So, to sum up the different types of submissions and cost and time frames the 5 10 K, which is the submission type for class 2, most class, 2 devices and a few class, one devices. It's it's in the ballpark for like a low technology around 5, 1,500 pages, and then but if it's got like software, hardware, electrical safety compatibility, you know you could be upwards of 6,000 or more pages by the time you get all your reports attached. The review time for a 5 10 k. Is the clock time, for FDA is 90 days. We are typically seeing that these are taking about 200 250 days.

So, and I'll just quickly go through the De Novo and Pma realities. The clock time for de novo is 150 days, and those are actually taken more along the lines of 400 and Pmas. The FDA clock is 180 days. It's taking more like 800 days. So for 5, 10 k. You say you got market clearance de novo. You can say you got market clearance, or that you were granted, but only in the circumstances that you end up having to actually submit a pre-market approval. Then that's when you can say FDA approval or approved. Okay.

If I could just interject here in terms of you know, you're doing your business plan. You're projecting to investors, your time to market. It's really important to know the reality of how long it's taking to get these clearances, because that really affects the amount of money that you raise and the expectations as to when your product's actually going to land in the market.

Okay, good. So here I have seen some customers that were adamant on going direct to Delvo that didn't appropriately communicate and plan with the FDA, because they thought that they fully understood not only their technology, but FDA's perception of it. And it was a technology where they could have built subsequently on some previous both, they had had a previous de novo and some subsequent 510 case, and they could have used those initial clearances to build incrementally, but they added a new anatomical site that they did not, and they made assumptions about the FDA

and the FDA, you know, essentially disagreed with the assumptions they made about fitting into the De Novo path, and what the requirements were going to be, and they ended up, you know, not only spending a lot of money a lot of time. and then just arguing for a really long time with the FDA because their strategy was not lined up with this kind of more stepwise approach to get FDA's kind of gradual buy into this new anatomical location. Sure next. So I think this next one is, is a big one, and I think it's a big one for for both me from a regulatory perspective, and then also from for Rene, from a business development and commercialization

perspective. And that's unsubstantiated claims. Claims really have to be substantiated with data. And you have to understand what constitutes a claim. If you make just an assertion that your product is twice as fast as, or preferred over better than reduces this. I even had a client one time that that their marketing logo says. Stop this condition. And the FDA considers all of those claims that has to be substantiated. And they're like, well, show us our your data that this stops that altogether.

So ideally, you know, you understand. You work with the the sales and marketing team in advance of a submission, and you include all of those claims in, perhaps, that the instructions for use, or the labeling that you you turn in with the submission, and then that way. You know the FDA has looked at it in some level, and that they that you're not going to get in trouble later in the market. But I have seen it where people made claims and assertions even that beyond the initial say, intended use or patient population. And FDA said, You know, time out you have exceeded what we intended here, therefore we feel like that you have resulted in reclassifying yourself often up, classifying yourself.

To. I have. I've seen it where there was a particular help application, where one type of technology was, a class 2, 5, 10 k, and at some point they made a design change, and then subsequent marketing claims, and between the technology that they changed to and the claims, they became a class 3, Pma. And it was an implant. And so they had the FDA sent out like a a whole press release about people who have these implants and what they needed to do to coordinate with the company and their their physicians to get those those hips Redone.

so.

So in in addition to that. that when I work with clients, another place I see people get into into potential trouble is the device isn't even cleared yet. They have it up on a website. They might have videos, and they might already making be making claims about it. Then that's also not okay. So you need to be really careful about when you start making claims and how you make them.

and you know, when Renee and I, worked at a the same place in industry, many many moons ago. But we would take our teams and sit down and script out. What did the engineers or the sales teams want to say about it? What could we do internally to do testing or whatnot to validate the claim, and then we would write a paper with the study or the validation attached, and then we would put that into document control. And then sales and marketing had a whole range of terminology that we worked around that

that report or that assessment

Yeah. So we only have 15 min yet, and we have a lot left to cover. And I think there's some questions, too, thinking, maybe the did. You have a butterfly effect for this.

I I do. We can go on them.

Okay. All right.

No, this is it. So? This is the hip system that I was talking about. Yeah.

Yeah.

And it's a biggie.

Okay, so prototyping and manufacturing again, being considerate of the time we have left, we still have to get through this and commercialization and answer your questions. Just a couple of things when you're working with a device, you know, rather than let's say it's an AI software platform. A really good idea is to get a 3D. Printed prototype at least made so that you can test the device, you know. See if it works the way that you had intended. Make sure you get it into the end users hands. If you can get some key opinion leader, key opinion leaders involved, you know. Survey them, start to get their feedback.

That being said, a 3D. Printed prototype is not sufficient for verification and validation testing, and in no way, unless you're making like a custom dental implant, and they all have to be 3D. Printed. That's a whole other story. but in no way. If you're going from 3D. Printing, let's say, to injection molding. Should you consider a 3D printed product, your final product. And there's a lot of reasons for that one. If you're going from 3D. Printing to injection, molding, and your device requires biocompatibility, testing. Guess what? Those are. 2 different materials and processes, and you're probably adding some coloring. If you're going from 3D.

Printing to your final device that all has to go through biocompatibility testing. And if your device is sterile. You then, after you do biocompatibility testing have to pardon me, you sterilize the device, then go through biocompatibility, testing to see if it passes the other issue when you transfer a design from a 3D. Printed to an injection. Molded part is that there tend to be dimensional inaccuracies. So the way that 3D printed prototyping works is it basically is layering one dimension over another, while injection molding is basically flowing plastic through almost like a port and into a mold that you've created. So I've seen a lot of times where we've had beautiful 3D printed prototypes, but we go to manufacture and injection molding, and the walls are just way too thin. So a lot of times you do have to think about design for manufacturability as you move from prototyping into your final injection. Molded plastic part.

And you also have to be prepared that the FDA is going to ask for like, how does the unit under test compared to the unit. You intend to commercialize.

Exactly. Yeah. So the other thing I just want to mention here, too. And I had briefly touched on this before. But you know you're designing to the Porsche, and your market will only pay for the Ford focus. You really need to be thinking about your manufacturing costs every step of the way as well, and the ease of actually fabricating and assembling your final product that's really critical to successful market launch. And sometimes you do have to redesign. We don't want you to do that. So you need to be thinking about these things early on and incorporating them into the trace matrix.

So this next one is a little bit of a sticking point from a regulatory and quality perspective into commercialization. I see a lot of startups and small companies that in development partner with manufacturers that they think have the technological capabilities to produce their product. But they have never made medical devices before. and they don't have an adequate quality management system. So they make assumptions that their contract manufacturer is either going to be willing to and able to put in a quality management system and register and list with FDA, and then they end up with a manufacturing partner that's in commercialization that does not have

the requirements that they need, and then they have to source other suppliers, because the the who they selected is not capable of meeting FDA requirements and costs. So this one's mine like this was my 1st recall I ever had to manage as a regulatory person. So in this one basically had the butterfly effect at every single level of from the the molded component, where it specifically said on the print, that flash was allowed in an area that happened to be a mating surface, and it prevented the press fit. Then, in the assembly process.

They. It was too complex. They had a pokyo tool, and it wasn't being used because the flow wasn't right. And then one more Renee, and then at last, that the Erp system did not have all of the components entered correctly. And so I had product in the field that I had to recall that I didn't even know contained this component. And so, as soon as I did the recall, I had to the next day resend out all the letters, all the notifications about additional products that we had to manually go through every batch record to identify that lot was used or not. So lots of lots of it was a whole

butterfly effect storm on that one.

Commercialization. I know we don't have a lot of time. So I'm just gonna quickly run through this piece. So market clearance, everything that we have just talked about is critical to lay the foundation for your device. But it is not the end. In most cases it's just the very beginning. So I'm just gonna talk about some of the the things that you need to consider in the commercialization process. A really big piece of it is your sales strategy. So if you're a startup. I don't recommend hiring your own sales organization, the reach and frequency, the amount of sales reps that you need to adequately penetrate the Us. The amount of requirements that are put on them now by the different hospital systems is just exorbitant. The cost and the time. It really doesn't make sense for you to do that. So there's 3 different ways that I help folks penetrate the market here in the

Us. You can work through a group of specialty distributors, they can be regional. We can patch together a really good group of distributors that focus on your therapeutic area and and get them to sell your product, or we can work through a master distributor the other way. That you can approach the market here is through a conglomeration of 1099 sales representatives. So those are independent sales reps. They sell your product, but they don't warehouse or invoice. So in that model. You would have to have either a distributor or a warehouse here, and the capability to invoice. And there's some complexities around that. And

you know, if you want to learn more, you can put time on our calendar. And then, finally, there's strategic partners that you can work through. It might be a large company that sells similar product, and they may want to augment their portfolio with your product. They've been selling, let's say, an enteral feeding system for years, and you've got a new great twist to enteral feeding product. and they've been selling the cake. You're now the icing, the part that gets their attention. So sometimes you're a great fit to go right into the market with a strategic partner. Once you establish your sales organization, it's important to understand who you're selling into. So I'm just gonna touch on hospitals. There's a lot of different networks that you sell into here in the Us. But for the sake of time I'll talk about integrated delivery networks. Those are hospital systems like Banner and Kaiser that we have out here here in the West.

And then, of course, there's many other systems like Baycare, you know, out in the East and others. But essentially, when you work with an Idn, you either have to understand that they basically insist that all of their hospitals use a specific technology, and in some cases they allow the hospitals each to independently decide. So it's important for you to have an Idn strategy based on how they work with the market. It's important that you get Lawson numbers. Whatever numbers are required in order to get into their system. And it's important that you understand how to work with value analysis. And that's a that's a critical piece

group purchasing organizations. I'm going to talk a little bit more about that on the next slide. And then the final thing I just want to talk about are what we affectionately call in the industry box movers. That would be your Mckesson, your Cardinal. They're great for just in time, warehousing and delivery, but they are not the folks. If you are coming into the market with an innovative product. Their sales reps have a catalog, this big. They are not the folks that are going to go and spend the time that you need with clinicians to really get the message across. They literally just move boxes from the warehouse

to the hospital. So when you're going into a hospital purchasing system. You have to understand. If you are a Me too, product, meaning you are a slightly better enteral feeding tube. Or maybe you're a little bit less expensive. Those are typically much easier to adopt for an idn. They're more straightforward for hospitals because they're already buying them. So there's a place for them in their system. The strategy here is to get on a group purchasing organization. And in this case, if you're going to get on any. Get on Health Trust. That's the largest and most compliant one in the country. So for me, 2 products, Gpos, are a huge part of your strategy.

If you're coming to market with a new innovative product which I'm imagining most of you are buckle up. It is at least 5 to 7 years after market clearance, and sometimes longer before you really start to penetrate the market, because what you have to do is convince a hospital that is pretty much broke now, coming out of Covid to spend money in an area that they've never spent it before, and as much as a clinician loves your product, and as much as everybody tells you. It's the greatest thing since sliced bread. They cannot get it in unless you've done a series of steps. So get out to those trade shows. Get those clinical evaluations done really prove the value in the clinical setting. Publish papers develop your key opinion leaders, and work with organizations globally and nationally to set standards, other considerations. If you want to sell into the Department of Defense, for example, your device has to be manufactured in a Free Trade country

or in the Us. And then finally, here's an area. I see people get into a lot of trouble, and it's IP, so protect your IP early and often there's 4 ways to protect utility. Patents are the strongest. They cover the concept design patents cover the actual device that you've created. Don't do a design patent. If you don't want to teach people how to do what you're doing. keep that as a trade secret. and then there's trademarks. And then finally, in the interest of time, I see Sean's joined. Take the time after you. You're right. When you get ready to launch your device to do an IP review and make sure that your claims actually cover the device you're launching. You might spend 10 years in development. You may have protected that product 10 years ago. Now you're hitting the market, and you've done your voice of the customer, and the device that you're bringing to market is completely different in some ways

than the device you originally started with. Make sure that you're protected. When you enter the market. The market is 1st to file with IP not 1st to invent. So that being said. Here are Michelle and my secrets to success. Download our trace matrix and we're going to send you the business market assessment tool. File your IP to ensure that you're protected and make sure you reevaluate, often define your target markets and ensure that your regulatory strategy is a part of it and incorporate everything you can into that. Trace matrix, establish your commercialization plan. That's your roadmap. And we didn't even get a chance to talk about funding. That's a huge thing. But raise more money than you initially think that you need. Don't keep going back to the investors. You do all those things, and you're living in a world of

butterflies and rainbows. Hopefully, not the butterfly effect.

Awesome. That was a wonderful presentation. Thank you both. We covered a lot of ground today before everybody drops off the call. I want to take a moment to talk about a new Beta program from Lean Riqa, called Lean Launchpad. This program is designed, specifically.

Can you? Forward? Yep.

Yeah, specifically for you all on the call who are looking for lean, affordable consulting as a service really. Is how I like to think of it and it allows you to predict the cost that your support is gonna cost you in a much more transparent way to get the support that you need when you need it. Not when you don't need it. So avoid hiring people in advance, and I hope that many of you will at least inquire about how lean launch pad can work for you. There's a landing page set up which provides more details. So please take a look at that. Feel free to scan this QR code down here in the corner with your phones. Go there right now.

And please talk to us. Michelle and Renee and the team at Leanraqa is here to help you succeed in the market. I hope you got a lot out of today's session. Please complete the survey. Those of you that have submitted the things either by email or by in the chat for the certificate. You'll receive those in 48 h or so, and I wish everybody a great day. Michelle. Renee want to say goodbye to everybody.

Bye. Thank you. Everyone.

Really appreciate your time that you spent with us today.

Thank you all.