Device Innovation to Commercialization, Phase 1: Concept

My name is Sean Smith. And… I'm going to be off camera today because there is an internet outage and I am using a hotspot on my phone, so I apologize for that. But I'm excited for today's Qual Innovation to Commercialization Phase 1 Product Conception with Rene Franz. and Michelle Lott from Lean Raqa. Let's see. Let's start with the housekeeping announcements. The housekeeping announcements are this webinar is being recorded and will be made available to all participants 24 hours after the call.

Joe Siegrist, slides and recording. If you would like a certificate of attendance, please put your name as you would like it to appear on the certificate in the chat file. Along with your email address, name, and email in the chat for a certificate of attendance. Please be patient about getting the certificates of attendance, because we make them manually, And let's see. The next thing is upcoming events. Oh, well, first of all, use the Q&A function to ask questions of the speakers. Or the chat, but preferably the Q&A. Yes, hi, Michelle. And.

Then… the last thing is upcoming events. Are going to be dropped into the chat. Join us this Friday for the Human Side of Risk. And I don't remember what's coming up after that, so it's going to be put in the chat file. And I think that is it. I'm going to turn it over to Renee and Michelle at this point. Welcome.

Yeah, thanks, Sean. And, we sure appreciate all of you joining today. I'm Renee Franz, First, I'm actually going to let Michelle start this, because she's the founder of Lean REQA, so I'm going to turn it over to you to introduce yourself, Michelle.

Okay. I started, Lean REQA about 20 years ago now, and And I started it to help small to mid-sized companies find their path to market as easy as possible. I am a regulatory and quality expert. I served as a FDA GMP advisory committee member. And then finally, I'm a master grief counselor because people definitely go through all the stages of grief and loss as they're coming to terms with their path to market.

Thanks, Michelle. So Michelle and I have a long history of working together here at Lean. I help out as general manager as well as I help our clients through the product development and commercialization process, which we're gonna talk more about today. But my background, I've been doing medical device development and commercialization for almost 35 years now. And over the course of those years, I've helped bring over 200 different medical devices to market in various stages. And the reason that it says don't shoot, always the messenger, is because I'm the one that has to tell people that come to us

That say, hey, we've got this great idea, and we're gonna be to market in 6 months, and we take a look at the whole plan, and it's more like 3 years. So, we are going to help you in this webinar really, get to the foundation of what you need to do. when you're in what I call phase one, the conception stage. So, this webinar will be really critical for you if you're new to med tech, and you're just trying to figure out, hey, should I even try to commercialize this medical device? Or, you're in the trenches of design development, or even commercialization, and you've hit some… some, some struggles. So, you can hit reset and go back to the basics, which is what we're really going to be focusing on today.

So we're going to look at from Concept to Commercialization, because you always start with the end in mind. The questions you need to be asking yourself in terms of commercialization right up front to see if you have a viable product, what product development questions you need to be asking yourself, and then give you some tips on secrets to success. So when clients come to us, the average tech startup believes that they're here. It's that, boy, we're going to be to market in six months, and then they want to shoot me because I tell them it's three years. Because. Really, this is what it looks like in the real world. So what we're going to talk about today is laying the foundation with some tools.

Being, a trace matrix that we can share with you. If you're interested, you can drop your name in the chat with your email, as well as some really important foundational questions to ask. But before we talk about that. Let's look at the whole medical device process from conception, which is the idea, all the way through your first sale and scaling, which we're going to call adulthood in the series. So, there's a lot of activity that happens here, and most people, when they come to us at Lean, RAQA, are here. They say, we need to do this now. And we say. Boy, that sounds expensive, because we're gonna have to take you back in this time machine and build all these other activities retrospectively.

So, our goal today is to work with you and say, hey, let's just build a foundation. You're right here. Let's talk about identifying user needs. This trace matrix that I referenced. And aligning your regulatory and your reimbursement strategy so that you can secure the funding that you need to be successful. Michelle, did you have any other comments on this?

No, you nailed it.

Okay. So, what we're going to talk about next is first things first. How do you even validate that you have an idea that's worth pursuing? And how do you, right from the start, tease out if it's just an idea or a viable product? These seem like really basic questions, but they are truly the foundation of building your medical device. Do the users really need it? We're going to give you an example of somebody who came to us. And we helped them figure out right away that there wasn't a market for it here in the US. Is it appropriate for your target market? Can you even make it? Can the users use it? This is really critical. We're going to spend some time on this topic.

Is it at the right price point? You need to consider pricing right away, because you don't want to build something that then you price yourself out of the market. Do you know the regulatory path, and do you know the reimbursement path? How in the world will the end user pay for it? So an example of the first question, do the end users even need it? We had a client that had approached us from outside the US. They had a really neat app. And it could, by scanning the skin, tell you if you may have skin cancer. So, they wanted to come to the U.S. with it. our first step was we went out to dermatologists, and we went out to general practitioners and said, hey, would this be a useful tool for you in your practice? And they said, absolutely, if it could actually replace a biopsy.

So we went back to the, to the developers of this technology and asked them that question, and they said, no, it's not designed for that. It's just a screening tool to say you may or may not have cancer. So… We were able to save them a tremendous amount of money by saying, hey, there's really not a need for this here. There's a need for it in your market, because there's long waits to get into a dermatologist, and it can… this technology in their market could put them further up in the queue, so they're seen sooner. But there's really no need for it here in the US because we have generally wide access to clinicians that can help diagnose whether you have skin cancer or not.

This… these two examples are related to, can the end user even use it? I cannot emphasize how important this is, because with both of these companies, Michelle and I worked with them, they spent millions of dollars developing phenomenal technology that at the end of the day, the end users couldn't use. They weren't trained in the procedure. So the first one that we worked on was actually a treatment for acute wet macular degeneration. It's just a condition in the eyes that can make you go blind, which is serious. And the technology was placing radiation beads behind the eye. And all of the development work was done in the UK.

And it was done with clinicians that used a very different technique. It was called some tenons anesthesia. They then threw the ball over to the US, which was their target market, and the clinicians here were trained in a very different technique. It was a retrobulbular block, and it was so different that they had trouble, and in fact. Did not adopt this technology because it didn't fit into their clinical flow and how they were trained. The second one was a treatment for atrial fibrillation, and it was fantastic. It allowed you to remotely go to the exterior portion of the heart in the chest and use radiofrequency to burn heart tissue to stop an irregular heartbeat.

The problem was their target was for surgeons, cardiothoracic surgeons who like to crack the chest open and actually surgically work on the heart. So after about$75 million developing this phenomenal technology. The end users never adopted it because it was outside of their capabilities and how they were trained.

And who would have thought that cardiothoracic surgeons wanting to do surgery? Yeah.

Exactly. So, you know, this is… I can't emphasize enough, you know, products that are developed, it's a great idea. I can't emphasize enough talking to clinicians about the workflow in their environment. and how they might use your device, and asking them up front. And I actually want to show you a device, Michelle and I worked with this client, too, that nailed it up front. So, this product that I'm going to show you, SplashCap, was developed by an emergency room physician. who got tired of taking a syringe and filling it with saline and irrigating wounds. It was time consuming and all the splashback was, you know, contaminating and dangerous. And he said, God, there's got to be a better way to do this. So as a clinician, he knew that he needed to just create something that went right to the source of saline, which he did.

attach it, it fit any standard saline bottle at that time, and clinicians could immediately start irrigating. So this is definitely a success story, because it met the clinical need, it fit the clinical workflow, and it fit all of the existing Saline bottles, which was the technology at the time, that it needed to connect to.

And then Baxter ups and goes and changes their… the pitching on their screws on the top of the bottle, and… There was a big part of his market that was… that he had to make adjustments for after he was in successful commercialization, because the market around him… products around him changed.

Yeah. Yeah, good point. So the tools that we're going to introduce to you here not only serve you during the concept phase, but once you reach adulthood and there's changes in the market. you're gonna come back to these tools, like the trace matrix, so that's a good point, Michelle. So on the topic of can you even make it going back to those radiation beads, they were made from disassembled Russian bombs that had a very specific strontium half life. Well, you can imagine going to scale with something like that. How do you… you know, at some point, you might run out of disassembled Russian bombs with strontium at the right half-life. So you need to be thinking about how in the world am I going to make this device up front?

We also had another client that had incorporated pH paper into their device. Which was great, but during the manufacturing process, and this had to be part of the very beginning concept, they had to think about, how am I going to protect the pH paper from light and humidity and any kind of environmental exposures? So, you know, from the commercial perspective, it's really important to be asking yourself those foundational questions and assessing those market needs before you even start investing your own money. Adoption itself, and we'll talk about this more in the later phases, but it can be challenging regardless of cost, because sometimes it's hard to beat what clinicians see as free. So we had a client that had an IV line labeling system. It was fantastic.

But, you know, most hospitals don't even label IV lines. But they also know that they have high IV medication error rates. So bridging the gap between saying you have these high IV medication error rates that relate to line labeling, which is you're not doing. And getting them to purchase something, and getting them from free to buy, is another hurdle that you need to be thinking about early on. We mentioned worrying about costs now, it's too easy to over-design. I worked on a biopharm product, it was about 30 years ago, and it was going into biopharm processing. our cost to make it was $2,000, and the most the market would pay was $2,500. So we actually never launched it and had to go back and redesign.

And then you need to be thinking about who will pay for the device, and that's a really important piece of reimbursement. So now we're going to talk to you about the tool that you'll use to not only incorporate answers to the questions we laid out there from the market and commercialization perspective. But also from product development. So, when you're using this tool that we're going to introduce to you, the trace matrix, which leads to your product specifications, it really is a cross-functional exercise. You need to be including folks. You don't necessarily have to be paying them yet, there's lots of incubators out there and innovation groups that will help you with this, but you need to be including folks with medical device, executive leadership.

Marketing, sales, finance, regulatory quality, reimbursement, clinical and engineering. Because this trace matrix is really key to building the foundation for your device that will set you up for success when you go to commercialize. So this is just a snapshot of what a trace matrix can look like. And again, we're happy to share a template with you. Just drop your name and your email in the chat. But this is in no way an exhaustive list. But we just want to highlight some of the user needs that are really critical that you may not even think are important. So the first one is identifying the temperature range.

So, not only identifying the temperature range that you're going to operate your product in, but also the temperature range in which you're going to store the product. So, I have a story. This was from over 30 years ago. We were launching this whole blood. collection device in Canada, and we had successfully gotten into and trained every province except for Ontario. Ontario was the last to go. And they started calling with all these complaints about their AC power cords falling out of the wall. So why is that significant? Well, in Canada, at that time, 80% of the blood was collected on these mobile collections. It was wintertime, and they were storing these devices

outside in these vans that sometimes reached negative 30 to 40 degrees Celsius. So we had to travel up there. And the first thing I noticed was that the power cord was different. So the power cord that we had used all throughout the rest of Canada was this gray silicone spongy one. And I noticed that this one that was falling out of the walls was an ice blue hard plastic. Okay. And when we looked at. the product specification for that cord, it was at a much warmer tolerance than what this product was being exposed to. So this was a miss on our part, because we didn't put into our trace matrix that everything in the device, including the power cord, had to be able to be stored at a temperature of negative 40 degrees C. So, our purchasing person.

didn't get that memo. Now, the engineers, when they were designing, knew it, and probably just said, hey, we're gonna use this cord. And then the purchasing person didn't have a spec for it, and she found an opportunity to save money, and went and bought a different one. So, this is an example of how critical it is to understand your environmental storage and operating temperature. So, the reason this has a blood drop with help is because it took us a month to figure this out in Ontario, and they actually had a blood shortage in that region, because they couldn't use our device, because the power cords were falling out of the wall.

So who would think that switching a power cord would cause a blood shortage in the province of Ontario, Canada? That's how significant these details are. So the next consideration is identifying where you're going to sell the device. That affects so many things. You know, selling here in the US, it's 110 voltage with a very specific plug, but if you're headed over to Japan, for example, it's 100 volts and a very different plug. So keeping that in mind if it's an electrical device is really important to design for or include in your, in your trace matrix right up front. It's a business.

One of my favorites is that your marketing team can't take the standard approach as marketing teams want to do, where, like, one time I asked a client, like, where do they want to sell this device? Oh, you know, globally. effort. Alright, well, there's a ton, obviously, of just even logistical, technical differences in geography to geography, but every one of these have their pretty much own unique regulations on way to bring products to the market. And not insignificantly, a whole set of fees. that are both upfront and recurring. So there really needs to be some careful thought from the both the sales side and the engineering side and marketing to to properly access all of these markets.

Yeah, well said. And that actually leads to this example of a, it was a handheld device for sealing blood bag tubing designed, you know, for the global market. And it worked great in the US and Europe, and it got to Japan and it didn't work. And we eventually figured out that. that the end user was a Japanese female, and her hand was so much smaller than the rest of the world that we were selling into, so we had to make a product adaption. We called it the J-Screw for that particular market. Michelle, I'm going to let you take this one.

So, from a regulatory perspective, that we used to always hear, pitches, like, from Angel and people looking for venture funding, that their plan to market access is going to be to start with the EU first. Because it was more based off of technical performance standards and specifications, and the U.S. had a reputation of requiring not only a lot of clinical trials, but very extensive ones with, like, long endpoints. So people used to bring their product to market first because of the ease of entry in the United States and save the US for later.

But now, with the entry of MDR, we have seen a shift in that, where now EU is the one that's requiring, not only trial data and extensive trial data, but even on something that is a little bit more of a commodity product. The fees can be, like, anywhere north of $100,000 to $500,000 for your initial CE marking process, and not to mention the ongoing regulatory cost. And so we found the US going… trying to go more towards a technical specification route, and shorter endpoints and predictor endpoints. So these things have, really had an impact on not… the regulations have also had an impact on your marketing commercialization strategy.

Yeah, and so…

First, we've got our next poll up, so if everybody can… Participate in that quickly. And you could go on Renee.

Okay, I was just gonna add that, you know, experienced medical device investors, if you tell them you're going to Europe first, they will not fund you, for all the reasons Michelle just said. So, continuing on with this, Michelle, did you want to go into more detail? About those consensus standards that you'd be required to meet in the U.S. versus what Europe requires?

Yeah, So, you could see in this particular… this on the left is an example of, the product code description right now, the FDA's website, and it has, and it has recognized consensus standards that are. That that device is subject to. And so this list lists out all of those standards and the guidance documents. And you can know this right up front, just by knowing your regulatory strategy, and then you can immediately start feeding the requirements in these recognized consensus standards and guidance documents into that trace matrix that Renae was talking about, because I've also seen, customers

put this off too, too late in the process, and try to test it, like, kind of almost in reverse, instead of building it to be compliant, and ended up having to change their entire device design. And then similarly, the European Commission also has a, and there it's called a harmonization process. As opposed to the recognition process in the United States. But… and they take even a stricter line of this, of they pretty much want to see these tests done. And, applied and succeeded 100% in full. And the FDA does have some local room for you to explain, you know, why you did or did not, or why a particular standard wasn't applicable.

Okay. So.

Yeah, and so I think this fits into that when we showed you that whole product development timeline and where we said, hey, most people come to us when they want their device cleared, and then a lot of times they have to jump in that time machine and go back and recreate and redo testing to these standards that their device may or may not pass, and that can be very expensive. So, it's important to plan for this right up front, and know the markets you're going into. So… You know, these needs that we've talked about, and so many more. are really critical, and, you know, if you have additional questions, you know, feel free to put time on our calendar. We do offer 30-minute, you know, touch-based sessions with folks for no charge.

So product development. This is really important to understand as well if you're new to MedTech. So if you have a low-effort, low-complexity product, it's still important to do that trace matrix, because we talked about all the things that can go wrong if you don't think about, for example, temperature range. But the complexity definitely increases from a wheel, which is standard, to a rocket ship, depending on how much effort, how complex your device is. And the… then that, equals the requisite planning and resources that you're gonna need. So just know that if you're, for example, going to spend time on that trace matrix, if it's a really simple device, you know, it might only be a few days working with some experts, but if it's really complex.

Like a cardiac ablation system, you need to spend a lot of time in this concept phase. And this may seem… this usability engineering standard may seem like it's a little bit too advanced for concept. But the IEC 62366 is all about guiding you through understanding your product in its intended environment, and how the end user's going to interact with it. So it's really critical, to do your homework up front, and take time to understand this early on.

Well, and the use specification should be set, like, very early before your even risk analysis or other design inputs. You know, so that that user specification is really kind of the first step after initial feasibility, at beginning this process of populating the trace matrix, and then leading the next stages of design and development.

Yeah, yeah, exactly. So, you know, even be thinking about, you know, understanding all the accompanying information with it. Contraindications, you know, areas you know your device can't be used in, that should be, called out very clearly in that trace matrix, right, from the beginning, and again, you know, identifying the specific condition, how long the device is going to be used for, the patient population, and then other things, like, if it's disposable, what are you going to do with it afterwards? That's really important, too, to identify right up front. Michelle, did you want to unpack this one a little bit more, what's meant by intended use?

Sure. And this is really kind of the underpinnings of the regulatory strategy, and it's the core concept at underneath the the basis of the FDA regulations. And this can be… it refers to your objective, intent, or purpose, which can be shown by your labeling, your advertising, your oral or written statements, your implied or expressed claims, your website. you know, things that you say or do in conferences, and so you can, Renee, you can go to the next slide. And so, you can view it a little bit like the umbrella is your overall intended use statement, and then you have specific indications for use that fit underneath that, and that these can include a specific target population, a duration of use.

or a particular set of anatomical sites. And the way you design each of these could radically… especially adding claims at any of these can radically change, both your regulatory, pathway, and then claims can also end up being marketed at, adulterated, product. adulterated and misbranded after the fact if you haven't accounted for these properly in your FDA submission.

And going back to some of the, you know, examples we gave you earlier, thinking about, like, who is your target population? Right up front, knowing who that is. Is it going to be, you know, a child, an adult? In our case, was it going to be people in the U.S. versus Japan? How long is that device going to be used for. You need to know these things, and where on the body is it can be used? It needs to… you need to identify that right up front during the concept stage. So the different inputs for usability engineering, and we've talked about this, but high level, get the user profile, or will a nurse be using it, a doctor, a respiratory therapist?

And then talk to those people. You know, in addition to talking to key opinion leaders, that's fantastic. They can help guide the process. But oftentimes, they're more risk takers, and so it's also good to talk to the general population that would use your device to get a broader understanding of how it might be incorporated into your practice, because you don't want to be, like, that cardiac Ablation technology that was absolutely a phenomenal product, but was landing with surgeons that, hey, as Michelle said, what do you know? They want to do surgery and crack the chest open. Like you don't want to be in that position.

Think about, like, the frequently used functions of the device. Think about the patient demographics. We've touched on that. And then also, how is your device going to either be compatible with and or rely on other medical devices?

And this is really important post-COVID, is because, you know, everybody's trying to have home health care and, like, what wearables, what, what tech… what would keep somebody out of the hospital if they could do it at home. Usability is… is such a big focus of FDA now. And they actually just released a new guidance document. a few months ago with, and also updated the E-Star template with a lot of new and additional, very specific requirements around the usability. So just… just know that this is a very hot topic with FDA at the moment.

And I think it makes sense. I think you build a much better medical device when you consider these things right up front.

Interesting side note from yesterday's webinar on sex bias was that in usability testing, they often don't differentiate between men and women in the results. And then, so women tend to have smaller hands, tend to be… have less physical strength than men do, and so if the device relies on one of those features, and that gets sort of miscoded in the data, you know, sort of overlooked, then the FDA is now coming back to people and asking for, well. Let's see how your data is substratified by men and women using the device, and are they able to use it equally well?

And that is, that is an emerging trend at the FDA.

Well, and that kind of goes back to the example, Sean, earlier we gave about that handheld device that, you know, I helped bring to market 30 years ago, and It was designed for, you know, male hands in the US and Europe, but when it went to be used in Japan, it was used by women who have much smaller hands with less hand strength. So yeah. Makes a big difference. So here's a, here's another tool. that you have, the use-related risk analysis, and, you know, what order you do this in, whether you do your trace matrix first, and then jump to this, or do this, and then incorporate the information into your trace matrix.

This is another important tool for you to be able to go in and really, assess how the end user's gonna work with the device in any kind of Errors they might make, and any kind of hazardous conditions they might be in. Did you want to add anything to this, Michelle?

No, but just this whole… the concept of the URRA, it's… well, it's not new. This is a part of that, guidance document that the FDA said, and they very… they mentioned this tool very specifically, and actually these columns came out of the contents that they, in that guidance document, said that they expect to see at minimum for a URRA.

So, boy, we're doing pretty well on time. Do we have any questions before we jump into secrets to success? Especially in this phase.

So Patrice asks. While reading your slides, I wonder if you can provide a clear definition of intended use versus intended purpose and indication for use. I think I probably covered that one with the concept of the intended use kind of being the overarching statement. And then the… the very specific indications or narrowing of that use would happen below it. An example, and so, Patrice, I don't… I'm not in the IVD space. But for a medical device, it might be… look like something. Like, this, unit is for interosseous access when intravenous access is not possible due to damage or, you know, loss of bloom or something in an emergency environment.

So that's interosseous access. That's your intended use. But then they go on to say for less than 24 hours. So that scopes your contact duration, which in turn scopes your biocompatibility testing that's needed. So again, just defining that one thing, you immediately define some specifications that go with it. For your biocompatibility testing. Then, you can, say it's for, interosseous access in the femur and the tibula of adult patients, and it's for… and in pediatrics, it's also for, say, the humeral head.

So, there we have all three. We have. Indication for use for contract, duration, for, general… for. populations, specific populations, and anatomical sites. So that's a good… that's a good example of how all these can roll up. And then. The other thing to think about in your claims and marketing materials is that you even have to think about things if you just say, does such and such twice as fast. or user-preferred, or any of those types of trying to do any type of comparative, to other, products on the market. Those also, are considered, you know, implied claims.

So.

Yeah, and I would even say include those in the trace matrix. You know, that's why, you know, you involve your marketing and your sales, experts right up front, because they may say, hey, I can't sell this unless it's twice as fast. Build that in to your trace matrix, and then design and test for it, so you can back that claim, if you really need to make it.

And then in the chat, we have in the too little, too late slide, you have VOC after the first prototype. How do you recommend instead persuading leadership to seek out VOC ahead of ideation? and user needs development. Should VOC be one? Of the first things you seek out, or should it be performed until… should it not be performed until after a prototype? That is…

That is an excellent question. And I would say, you know, you do a VOC light right in the beginning. So, and maybe we should actually put that in there because we were talking about those questions that you need to ask, like can the end user even use it? You know, what's the target patient population? All of those things are, you know, those are questions that you should be asking up front, and they're more of a VOC light to even understand if this is a viable product. And then the next stage, which we're calling birth, is when you're actually prototyping this. And that's when you would do a more formal voice of the customer, you know, where you gather key opinion leaders, as well as average users, and, you know, you gather as many as you can, whether you do it at a conference, like a trade show, where they all gather. Maybe you have a product that's specific to nurses, so you go to a nursing meeting.

and interview people there, or survey them at your booth, or you can even engage a group to do, like, an email survey. So that's when the more formal VOC would occur, but I agree with you, a VOC light, right in the very beginning, based on those questions we talked about. Appropriate, and we should probably add that to our slide deck.

And then how do you… how do you expect FDA to submit a URRA to a separate report by a lab or manufacturer? It's… Typically, a part of the whole risk analysis process, the upfront preliminary hazard analysis, I have always, in my documents, blended the usability and preliminary risk analysis together. Into one activity, and so the… the big thing, and you should download the… a copy of the most current E-Star, and look at specifically the human factors. requirements and the way that they want it uploaded. A separate report is not necessarily required, but you do need to, for sure, point to exactly where in that report your URRA activities are documented.

So. Okay, that is…

Is that it for now? Are we caught up?

Yeah, so can we go back to the summary slide a few slides ago? Will you email the presentation to us? Yes, you will get a copy of the presentation afterwards. And…

Summary slide, I'm not sure which one that is. Umm. Can you give more information?

So…

We'll keep moving on until we get more clarity on that. Okay, secrets to success. So, as a reminder, the questions to ask, do the users need it? We gave you that example on that, skin screening technology, the skin cancer screening technology. Was it appropriate for the target market? Right off the bat, that answer was no. Can you even make it? We gave you examples of products, you know, in particular the one that was made with the, strontium from the disassembled Russian bombs. that has a limited amount, of material that you could actually use to make your product. Can the end users use it? We gave you examples of that. Is it at the right price point? Do you know the regulatory path, and how will the end user pay for it? Again.

Going back to these very basic questions and to the other person's point of, gosh, we need to do some sort of voice of the customer right up front. This is part of that voice of the customer light. So, the secrets to success… Really defining your target market, as we've been talking about over and over again, is so important. And a big piece of that is ensuring that you have the right regulatory strategy. And incorporating that into the trace matrix. And I would take it a step further, too, and say, also looking at the reimbursement strategy. And some sort of health economic, model, you know, preliminary up front, because it's… you know right away that there might be a minimal viable product that you could come to market with from a regulatory perspective that has a reimbursement code.

go to market, perhaps, with that first. Use yourself as the predicate, do a health economic study, and then use, you know, continue to add on, the claims that you want to make over time. And we didn't really touch on this, but, you know, if you do find at the end of the concept stage and conception, you're like, hey, I really have an idea here. File a provisional. The world now is first to file, not first to invent, and you can always file a provisional, and over a course of time, as you flesh out what the device does, convert it to a non-provisional, essentially a patent.

And this can be really tricky in early stage. ideation, because you want to convince the Patent Office that you are unique and novel and deserve to be protected for it. But you want to convince the FDA most of the time that you fit in what's called the 510 process, which is based on substantial equivalence. That you're… that… that the differences in your product don't raise new questions of safety and efficacy. So, you're telling the story about how novel it is on one point, and you're having to tell the opposite side of that for the FDA, that, oh no, nothing really new to see here. So that this is another thing that's important to like stay lock lockstep.

Yes.

Yeah. With their activities during development.

Well said, Michelle. We already talked about aligning your regulatory path and reimbursement strategy, and establishing your commercialization plan. I mean, at the very least, at this stage. be thinking about how you're going to sell this product, and what you eventually want to do with the company. Do you want to exit to a large strategic partner, or do you want to actually produce and sell this product over an extended period of time? Think… always thinking of the end in mind, and that will… That will really be important as you move to the next phase, which will be birth, that we'll talk about in a separate webinar.

And then, finally, raising more money than you initially think you need. So, by going through this process right up front, using that trace matrix, asking yourself all the questions that we've laid out there. And… and… Honing in on what the device needs to do. And then figuring out what that's gonna cost, raise more money than that, because it always takes more money and more time than you anticipate. And then additional questions to ask. Who's part of your team? I can't emphasize enough having folks on your team that have medical device experience. Especially in regulatory and reimbursement, that's absolutely critical, but also in terms of, commercialization experience, because it's…

It's a wild world out there. One of your biggest challenges, you know, even if you develop a device and it gets cleared, the biggest hurdle is actually getting it commercialized. So work with the right people up front. Like I said, there's incubators. There's innovation groups available to people all across the country. Then ask yourself, you know, how complex is the device or idea? Where do you start first? We talked about that. And, do you actually understand the product you're making? And that's the IEC 62366 standard. And really take the time to go through those questions. And populate the inputs into your trace matrix.

So, this was Phase 1, conception. We will have, as we said, four more. webinars, taking you through the whole life cycle of a medical device into adulthood, which is actually when you're… when you're selling the device at scale.

Okay.

We have a lot of tools for you, you know, we mentioned the Trace Matrix, we're happy to send that to you if you drop your email in. to the chat. We have a regulatory pathway assessment model. We have a business market assessment model, meaning, hey, it helps you understand the, you know. the volume of product that you're forecasting to sell versus the cost to get it to market. And then we have a QMSR checklist, and you can actually go on our website and get access to these free guides. Also, another program that we don't have a slide for, but might be helpful to those of you who are new to MedTech and are in the concept phase, we have a program called Lean Launch, and it gives you up to 3 hours a month

of high-level consulting time with one of the experts on our team, so anyone that… anything from regulatory quality, biocompatibility, electrical safety, to product development through commercialization. So, it's a great tool for those who want help navigating the complex Process of getting a medical device to market.

And it provides just a general reality check to make sure You know, certainly in three hours we can't do it, you know, providing deliverables, but it definitely gives you a reality check and gives you an early warning of things that you also need to think about and include in your next steps. So, do we have, So, thank you. Jenny says that it was a brilliantly simplified… see, it's lean.

I'm not.

overview of very complex process. I'm looking forward to the continuation. Yay. Thank you.

Oh, thank you!

Yep. Is there any last thanks, Chris? Very nice job. We appreciate you all, and I know some of you are frequent flyers to my webinars, and I sincerely appreciate all the support I've gotten from you guys over the years. So, any… any last questions, or… comments, or…

One thing I'll throw out there is if there's something you would specifically like covered in the subsequent webinars, please let us know. Drop it in the chat, send us an email, and we'll make sure to include that.

Yep. All right. John?

Fra I think we lost Sean.

Okay.

All right, well, thank you everyone.

Yep, have a great day.

Hey.

Hey!

What happened?

Well, we're done.

Oh, we're done, okay. Sean, had a… The internet was gone. I mean, it was pretty good.

Yeah, yeah, did,

Are we still alive? Oh, we're still live! Oh!

Well.

Guys, thank you so much for joining. : I really appreciate it. : Sean had a problem with his, with an internet, so I really… I want to thank you guys for joining, and I'm gonna send all the certificate probably end of the week. And we're gonna send the trace metrics, too. Thank you so much, and have a good day.

Thank you, take care.

You too, bye-bye.