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Friday In-Focus · 26 March 2025

Getting Your Product Paid—A MedTech Commercialization Roadmap

Tatyana Staneva and Edward Dougherty use a fictitious MedTech startup to show how to build a US market access strategy and an investor story that gets a product paid.

Sean Smith, publisherTatyana Staneva, founder and director of clarity for action; clarity expertEdward Dougherty, medtech advisor; advisor to masschallenge uk cohort companies9,545-word transcript

Summary

What the session covered

This second part of a two-part webinar, hosted by Sean Smith, uses the fictitious Munich-based startup NeuroVita Medical to apply the recommendations from part one. NeuroVita has a wearable, AI-driven headband for non-invasive neuromodulation aimed first at migraine and later at chronic pain, and it wants to enter the US market to attract investors. Tatyana Staneva and Edward Dougherty recap the company and its investor feedback before moving into practical work. Edward Dougherty focuses on US market access strategy. He explains why companies must understand the clinical practice flow and site of service, because payment is tied to where care is delivered. He covers patient demographics—US migraine patients tend to be younger, have lower income, are about 75% women and cluster in the Midwest and Southwest—and how that affects insurance, including employer plans, self-insured large employers, Medicare and Medicaid. He then discusses competitor research, reimbursement through coverage, coding and payment, and building an evidence cascade for regulators, payers, clinicians and other stakeholders. Tatyana Staneva turns to investor communication. She argues that a solid strategy and financials are prerequisites for a good story, and describes a layered playbook for gathering product, competitor and funding insights. She distinguishes story from narrative, explains the standard pitch structure and urges founders to make slide titles convey the whole story. She also stresses engaging the right investors and balancing detail against strategic importance.

The slides

The slides

Slides coming soonThe deck for this session is not on file yet.

Take these with you

Six checks

Map the care pathwayBefore positioning a product, trace where US patients start, how they are referred and where care and payment occur.
Profile patients and insuranceUse geography, age, income and insurance mix to decide where and how to focus the US strategy.
Build competitor profilesPull information from company, FDA, ClinicalTrials.gov, press and customer sources to understand rival products and reimbursement.
Plan coverage, coding and paymentTreat coverage, coding and payment as separate workstreams, including diagnosis, procedure and product codes.
Create an evidence cascadeDefine what each stakeholder needs to hear and build studies that expand the evidence over time.
Assemble a layered playbookGather product, competitor and financial detail, pressure-test the timeline and budget, then test whether slide titles alone tell the story.

Transcript

Full transcript

Edited for readability: filler words, false starts and Zoom housekeeping removed. Times run from the start of the recording.

00:02
Sean Smith

Hello, and welcome everyone. My name is Sean Smith, publisher of Medtech, leading voice, and I am here today with Tatiana Staneva and Edward Doherty for getting your product paid. I'm really excited about this is part 2 of a two-part webinar series. I'm going to put the link to part one. In case you missed it, you can watch the recording there, and if you want the slides, just ping me or either of the speakers, then see, we have a few housekeeping notes. The housekeeping notes are, please use the Q. And a button for any questions that you have feel free to submit questions throughout the webinar. We'll try to get to them at the end. They have a jam packed slide deck today. Which was going to be available for download along with the recording

00:55
Sean Smith

so in case you missed today's call or want to go back and watch it again, you'll have the opportunity to do so those links will be sent in an email 24 h from now. But if for any reason you don't get them feel free to reach out to me. Second of all, there's going to be a certificate of attendance available. If you would like to get the certificate of attendance, please put your name as you would like to appear on the certificate and your email address in the chat. So the chat is for requests to me the Q. And A is for asking questions of the speakers. that will be helpful. There will be a poll about 20 min into the call with some questions, and there will be a follow up survey. Your feedback is very much appreciated. I would also say that if you're asking for a certificate I'd really love it. If you share your certificate on Linkedin and let the audience know about this helpful webinar that's good for us, it's good for you and

02:07
Sean Smith

yeah. So on that note. If you missed part one, I'm going to put the link to that in the chat. I'm going to also put some links in for upcoming webinars tomorrow. Lean Qms. Sign up, then next week, part 3 of 3 clinical webinar with yoner Institute, Dr. Bettina Martin, which is furano regulation. Yeah. So with that in mind, I'm going to go ahead and turn it over to our speakers, and I'm going to ask them to say a little bit about themselves. Tatiana, why don't you start

02:47
Tatyana Staneva

Hello, everyone thank you, Sean, for setting this up for us. I am super excited. I was super happy last week. And this week I'm even more excited because we get to show you well, the deep dive into our recommendations for last time. But me, I am the founder and director of clarity for action. This thing right there, my company and I call myself a Co. Advisor and a clarity expert, because this is what I do for my clients. I basically help them get strategic and financial clarity so that they can build and innovate in healthcare and life sciences. I am Bulgarian and German. I live in London. I have a very diverse, eclectic kind of career, having spent time in automotive, and then inform my life sciences for a long time. And now doing digital health biotech med tech all sorts of consulting for small companies and big companies. Yeah, and that's me, I guess, in a very small nutshell, and super excited to be here, as I said.

03:51
Edward Dougherty

And I'll just say I'm delighted to have the chance to work with you again today. Tatiana and Shawn. Thank you for your hospitality and hosting this this Webinar series. My name is Ed Docherty. I sit in Washington, DC. And for the last 30 years I have been working on helping Med tech companies get their products to market and then get their products paid in at an amount that is consistent with the value that the product brings Tatiana and I met about 6 or 7 months ago. Both of us are advisors to companies in the current cohort for mass challenge Uk and have had the chance to work with them. So if you're joining from mass challenge today, shout out to you, and just want to thank you all for your joining us today, and hope that you find the discussion really, really very interesting.

04:54
Edward Dougherty

So I guess, Tatiana, we turn it over to you to to start

04:58
Tatyana Staneva

Yep.

04:58
Edward Dougherty

In the slides

04:59
Tatyana Staneva

I will do that now, and I will share in a moment. Okay, I hope that it is now visible on your screens.

05:25
Sean Smith

Perfect Florence

05:28
Tatyana Staneva

Right. So excuse me, let's dive in straight away. So

05:35
Edward Dougherty

I'm sorry I'm not seeing the the slides. I don't know if

05:38
Sean Smith

I am.

05:39
Edward Dougherty

Are you?

05:40
Sean Smith

Yeah.

05:41
Edward Dougherty

Okay. Got it. I got it. Sorry. Go ahead. Very good.

05:46
Tatyana Staneva

Right. So we have an agenda which is basically a continuation from last week's. We are going to briefly show you who Neurovita medical is this fictitious company that Ed and I created for the purposes of this webinar, and then we're going to go straight into actioning the advice that we shared last week on a very high level. So it will be Ed, talking about the market access strategy and how to basically improve neuro, Vita's thinking and strategy. And then I will talk about investor communication, how to tell a story and basically how to engage investors in a hopefully more successful way again based on Nerovita's example. So getting your product paid, that's what we're going to talk about today. And

06:30
Tatyana Staneva

just a quick recap of neurovita medical they are a Med tech Startup, founded in Munich in 2022 by Dr. Anna Fisher and Dr. Lars Becker. They are focusing on non-invasive neurostimulation. They have developed a basically excuse me, a wearable headband which provides non-invasive neuromodulation and is AI driven and is for migraine sufferers@firstst But they also want to open this device later on for chronic pain. It has position, connectivity for remote monitoring and and basically on a smart app to a company. So that's neurovita. They are. Their plans are to enter the Ux Us. Market because they think it's bigger, and this will make them more attractive for investors. However, the investors are not committing yet. They're giving all this kind of very diverse feedback. And we covered this in the previous session. So you can have a look there. But basically it's ranging from very general to super specific.

07:26
Tatyana Staneva

We, Ed and I gave very high level recommendations last time, and we looked at this fictitious pitch deck, or an excerpt of it, and I highlighted some quick fixes to improve the investment story, which are, you know, to start with the strongest point to address the weaknesses head on most importantly, tell a story which shows a level of digestible complexity of your product, and also your strategy, and, if possible to demonstrate the product to bring it to the meeting. So that's very, very high level. And I will go into more detail, into the homework that you need to do in order to craft this investment story and how to engage investors. But before I do that I would like to hand over to Ed, and he will walk you through the improvements to the market access strategy itself. Excuse me. And this is the market access strategy is basically the

08:19
Tatyana Staneva

biggest part of the homework that I just mentioned that you need to do, because without a solid strategy, it is simply impossible to tell a good story. So it over to you

08:33
Edward Dougherty

Thanks, Tatiana. So my summary comments for last week were really related to how Nerveda was positioning itself in the Us. Market, and ensuring that they were as effective as they could possibly be. both in their fundraising efforts, but also in their actual activities, their strategy and tactics to bring their product to market. And what I noted last week were 3 things that it's very important to focus on the clinical practice flow of medicine in the Us. Because that really determines where your product will fit and how it fits into the routine practice. Second, is to understand what the patient demographics are, because they tell you a lot about how to focus your strategy when you're bringing a product to market, and I'll spend a bit more time on that

09:28
Edward Dougherty

today than I was able to spend last week. 3, rd that relationships are so important and taking time to build on those relationships and invest in them in the Us. Market builds advocates for you as a company and for your products as well. And so that becomes critically important. So if we move on to beginning to do research into the elements that you need to understand, to put together an effective market access strategy. As I mentioned a moment ago, the 1st thing is to understand how medicine is practiced in the Us. And, as you all know, there are different patterns in different countries.

10:20
Edward Dougherty

On where a patient starts if they need to see a physician where they're referred to, how they're referred, and then where the services are provided. So here in the slide, you see, a very simplified clinical treatment pathway for someone with chronic migraine who is seeking some relief. Where does the patient start? And then how is that person referred through to eventually getting a therapeutic response to the pain that they are experiencing. Why is that important? Because what you notice here, for example, is in these 4 steps. That treatment is essentially provided from the physician's office. Advanced imaging services certainly are provided at an imaging center. But the point is that there really is no engagement with a clinic for treatment of migraine here, and so that affects the time

11:23
Edward Dougherty

of positioning for your product. And then how that product is going to be paid in the Us. Payment reimbursement is tied to the site of service in which the the service is being provided, and so it's important to know where that is. 1st piece, second piece. Tatiana, if you'd go on to the next slide, please. is to understand the patient demographics. Now, in this case, patients who suffer migraine in the Us. Tend to be clustered geographically, as it turns out, in the Midwest and Southwest, they tend to be younger. Between 18 and 44 years of age.

12:10
Edward Dougherty

and they tend to have a lower income. And about 75% of them are women. And so why is that information important? Well, geography, as you'll see here. can sometimes be very important to you. So here this map is intended to identify sort of a clustering, if you will, of where people with migraine happen to live in the country, I guess I'd say it appears that there are a couple of states where there tend to be more people than in other States. And so, for example, Oregon or Alabama, West Virginia, Vermont. In this particular map, now sometimes you see a different type of clustering that is perhaps more dramatic. So, for example, with stroke, you see a much more geographic focus on where people with stroke tend to live here. Not so much.

13:19
Edward Dougherty

But even still, there's important information that you can learn. And if, for example, you are looking at where to identify sites where you might do a clinical trial. For example, in this case there are 2 very well regarded sites. one in Oregon, the Oregon Health and Science University Leading Hospital for Research, where many clinical studies are done. Similarly, the University of Alabama at Birmingham Hospital is one of the premier institutions in the country, and a very influential place. And so. if you're looking to identify places to cite your clinical studies, oftentimes matching them up with

14:10
Edward Dougherty

areas of the country where there's greater density of people with that particular condition can be a very helpful way for you to work on clinical studies and identifying investigators. Now, the next thing that the demographics tell you is what kind of health insurance the target patient population is likely to have. Now we noted before that the population for migraine tends to be a younger population, and so that affects the type of insurance that they have. The current slide is sort of a very, very simplified map of a very complex health insurance system in the Us. In fact, we have multiple systems, not just one, as many countries do. And I think you know the best way to describe it is essentially the health insurance coverage in the Us. Is about half

15:13
Edward Dougherty

government and half commercial related health plans. So people who are of working age in the Us. And that is 64 years of age and younger typically get their health insurance through their employer and their employer shares the cost of the health insurance. The interesting thing to note there is that larger employers, namely, those with 500 employees or more, typically self-insure for their employees, meaning that they carry the financial responsibility for paying for those benefits that's important to know, because

16:00
Edward Dougherty

that gives them the flexibility really to design health insurance benefits that will be most helpful to their members. Now go back to the patient demographics and note that migraines often cause absence from work. That's an issue that has real impact on employers. And so employers are certainly incentivized to want to be able to provide benefits to their employees that will improve their health related to migraines which will improve their attendance at work so important from their perspective. Another part of the population gets their health insurance through government programs. Medicare and Medicaid are the ones that you hear about most frequently. Medicare is for individuals who are 65 years of age or older, those who have disabilities and are on end stage renal disease.

17:05
Edward Dougherty

Now that particular program, the Medicare program is not so much implicated. It's not a focus for a strategy for entering the Us. Market. That's focusing on the migraine market because migraine patients tend to be younger. However, the Medicaid program is likely a very important one for developing a strategy around a program to address migraine younger population with financial needs and a larger number of women in that program. So knowing patient demographics gives you a sense of where to focus, because that ends up helping to determine what type of health reimbursement these individuals are going to receive.

18:01
Edward Dougherty

So having that information. The next important piece of of research to do is essentially to look at whether there are any other companies that are currently in that space and how they're doing in that space currently. So why do you do that? Well. sometimes it happens that bringing a new product into the market, your competitors have really already kind of set the roadway for you to be able to follow, and it ends up being a pretty easy pathway for you to come to market. They've done all the hard work already. There are other times where that's not possible, and you have to kind of develop the pathway yourself, or at least understand what the hurdles and opportunities are in that environment. Now, if you look at the migraine treatment market in the Us.

19:05
Edward Dougherty

Especially the non-invasive market, it ends up being a pretty difficult market to enter and to be successful in. Now we've identified 3 competitors that are on market. And then Nuravida, our company is the last column there in the table. And what we've tried to do is to line up our product, the Nuravida product against the other competitors on a range of issues to see where we stand, and the extent to which there are similarities or differences that are important as we bring our product to market. Now. just kind of highlighting a couple of issues here on this slide product, a. What's perhaps most different about them is the fact that they have an over the counter product, whereas the competitors have only prescription products available for the non-invasive treatment of migraine. So that's potentially a differentiator for them.

20:18
Edward Dougherty

and something that they can really perhaps, focus on as their segment of the market. If you will. If you look at product B, they're an important issue that we'll address is the cost of the product. and the fact that what they charge for is not just the device itself, but also what they call a stimulation package. And so essentially, every time you need to apply electrical stimulation to treat your migraine symptoms. You use one of those stimulation services out of the package, and then you renew the package as needed. So that's an interesting sort of different way to to make your product available and to price it for the marketplace.

21:14
Edward Dougherty

Now, product C has taken a different approach altogether. They're really focused on pricing. If you look at their their retail price. It's very high, $2,000 higher than any of the others. but their approach in differentiating has been to offer discounts like a 60 day trial period at a very low price that leads customers to have access to additional discounts down the road. So we see 3 different paths to differentiation. What does that offer for neuravit. Well, we see that the product is itself different, in that there is an AI component which none of the other products have.

22:02
Edward Dougherty

and in many ways. The other factors related to our product is pretty. They're pretty similar, not much differentiation there. But if you go to the next slide, you see that when we look at how each of these companies are facing reimbursement, you begin to see some important differences that can, in fact, be instructive for you as a new company entering into a competitive environment. So back to product A, you see that they don't have any reimbursement at all. So all of their products that they sell are going to have to be paid for by the patients who want to use them themselves. Now.

22:51
Edward Dougherty

one thing that they have done to try to help their customers. Their patients is to make their product eligible for purchase through health savings, accounts, or flex, spend accounts. And just tag that for you. Because if your product is potentially eligible for purchase through one of these programs, it can be a way to really incentivize your customers to use your product. These programs are essentially pre-tax programs that employees can enroll in with their employers. That takes money, that the employer would pay the employee and puts it into a fund that the employee can use for health related purchases. So if there's no reimbursement using a fund like this could be potentially valuable. Lots more information and detail about those things.

23:57
Edward Dougherty

Product. B, what do we see there? Well. they have been able to successfully get some coverage from some payers. It's not universal, but they're in the process of beginning to build a track record with payers to have their product reimbursed by payers. That's positive, and every success kind of builds the story for the subsequent success in getting coverage from the payers. Also note that they have been successful in getting their own code that facilitates the process of payment for their product. And that's helpful product. C. Still, very early in the pathway toward reimbursement.

24:48
Edward Dougherty

Not very much success at all. So, you know, be interesting from a competitive environment to know what they're doing and what's not working because it could help us as we enter the market or Nuravida as they enter, to ensure that they plan for some hurdles that they can overcome them. Now one of the questions that came up last week is, how do you get that type of competitive intelligence? Certainly there's some information that's easily, publicly available. But there's a lot of other information. That is not so. How do you build a profile for your competitors? And you know there is a strategy to do that. And the way I describe it is essentially like pulling a thread out of a piece of fabric, if you will, and you just have to keep pulling on that to get the information and to put together the profile that you're looking for. So, Tatiana, if you just go back to the previous slide for a moment, please. I'm sorry

25:53
Edward Dougherty

the other way. Right places that you could look at a company website, FDA website, clinicaltrials.gov press releases. There are all sorts of sort of nuggets of information here that can be very important in putting together your profile of competitors, and if you would advance, please to the next slide. Additional sources to take a look at would be, for example, the trade press. I've listed there a couple of sort of the Daily Newsletters that I look at every day. You probably look at a number of these as well. Again. They offer pieces of information that you can put together to build a profile for

26:37
Edward Dougherty

your competitors. Finally, I would say, talk to your customers or your potential customers to ask them how they're interacting with your competitors, with their products. And what new product features and components your competitors are bringing to market, because that can be pretty helpful as well. So so with that sort of research as kind of the 1st step in developing your strategy, the next becomes well. Who are the real stakeholders here, or to describe them another way. Who are the audiences that you need to be communicating with? And how do you do that? Ultimately, as we mentioned last week, you might think about developing what I refer to as an evidence cascade. What that means in my mind is identifying who the stakeholders are who need to hear about your product

27:35
Edward Dougherty

and then to determine what it is about your product that they need to hear. So, for example, regulators like FDA are interested in knowing and seeing evidence to demonstrate to them that your product is safe and effective. Payers are going to be interested in different information. Does that product provide real benefit for patients at a population level key opinion leaders might be focused on improving the standard of care, practicing clinicians, optimizing the practice flow and so forth. Each of them have a little bit of a different perspective and from an efficiency perspective. What you want to be able to do is to put together one story, if you will that addresses the interests of each of these groups.

28:28
Edward Dougherty

So, Tatiana, if you'd go on to the next slide, please, I've tried to identify what an evidence cascade might look like. And here I'm proposing a real world example of a company that is currently in the process of developing a cancer screening test and what they have done is they have developed a series of studies, some that have been completed, some that are still ongoing, some just being initiated, that over time begin to provide evidence to address each of the audiences that they're interested in communicating with. So again, you see, 1st of all, they need to demonstrate that the product is safe and effective. And they want that data for FDA

29:20
Edward Dougherty

payers are interested in things such as real world data and registry data. So not just how the product works with a very small, well controlled. patient population in a clinical trial, but how the product performs in the real world, among many patients without that kind of controlled environment. And if you go through each of these steps, you see that they are essentially expanding their story over time to ensure that they are effectively communicating the value of their product to each of the audiences that they need to be communicating with. I just think it's a very impressive example of having thought, through the value that an evidence cascade can bring

30:09
Edward Dougherty

to the marketplace when describing your product. If we, if we move on. Then, once we've completed that research, we can begin to put together the strategy that will drive access to your product in the Us. Marketplace. So you know. Importantly, we'll want to think about reimbursement. Will you be able to get payment for the use of your product? Now, there are kind of 3 concepts that we refer to when we think about reimbursement in the Us. The 1st is coverage, and essentially, that is the policy that payers apply to your product and other products in that category. And essentially, the decision is, will we pay for it? Will we cover it, or won't we?

31:03
Edward Dougherty

And you see here a listing of the types of language that they use to describe products that they agree to cover, based on medical necessity, or those that they decline to cover, because essentially they choose that they decide, based on the evidence that they review that the product is not medically necessary, and to the great irritation of many of my clients. Some coverage policies will conclude that their products are, in the eyes of the insurance company, experimental, investigational, or otherwise unproven meaning. The evidence is not yet strong enough in the eyes of the payer to go forward and cover the product. So coverage is the 1st thing

31:55
Edward Dougherty

you go to the next slide. The second piece is to be able to have appropriate coding that is used to essentially implement the coverage policy. So you see here on the left. This is an actual form that healthcare providers in the Us. Use to essentially submit a bill to the insurers to pay for the services that they provide, and there are a range of specific codes that are used that need to be paired in the payers systems to allow payment to be made. The 1st is related to the patient's diagnosis. And so here is an example of an Icd-ten diagnosis code related to migraine. The second would be the procedures that are performed to provide care to the patient. And you see here we noted in the clinical practice flow that patients

33:05
Edward Dougherty

seen in the physician's office and are cared for there. There's also imaging that is done, and those procedures are all described using cpt codes. Finally, we're talking about non-invasive devices that are used by patients to manage their chronic migraine. And here there are particular product codes that are used to identify these devices for payment. So we've got coverage. We've got coding. The last piece to reimbursement is to understand how the product is going to be paid for. Now I sort of like to sometimes describe this as like purchasing a seat on an airplane. You know, the person sitting next to you may have paid significantly, more or significantly less than you did. You're all going to the same place.

34:04
Edward Dougherty

But the way the payment is made can be very different. There are essentially 3 systems that are used in the Us. The oldest system is the so-called fee for service system. A provider. A doctor submits a claim with a code on it, and that code describes a service, and that code unlocks a payment. The problem with fee for service is it sort of encourages providers to provide more services because they'll get paid for those services? I would say, though, that there's been a transition, and that now I think the most frequent model that we're using is a essentially a contract discount model where providers and payers enter into agreements together, and if the services are provided by in network providers.

35:01
Edward Dougherty

then the payment is made at a discount. So that's the current system. Where are we going? We're going toward a value-based system where essentially, the providers are focused more on preventive services than they are in actually providing more expensive downstream interventions if you will. and so positioning your product in a way that brings value to the system that improves clinical outcomes in the near term and reduces downstream. Cost is very valuable to some payers, and can be an attractive way for you to position your product for payment in the marketplace.

35:51
Edward Dougherty

So if we move on now and kind of go back to how all of that planning actually impacts the company's timeline and fundraising abilities, this is the timeline that we showed last week that Noravida brought to investors, and if you look at it essentially looks like it's pretty aggressive that they have perhaps tried to do too much in too short a period of time, and that they may not be successful. Having done the research, that and the planning that we've just talked about ends up potentially changing their roadmap and their timing. And if you notice the difference, it could be as much as a 2 year difference in when they might be able to bring their product to market. That's an important detail to know. Obviously, before you present your timeline and your funding request to investors.

36:57
Edward Dougherty

So just one last piece here would be if you go to the next slide. There was some question about how you come to the number that you want to actually request from your investors as you describe your process. and you'll see here, and in the next slide that our conclusion was essentially that neuravit sort of didn't take the right approach to putting their budget together, and that taking a more bottom up approach would be much more successful way for them to ensure that they have not under estimated what funding they're going to need. So having the type of strategy and having done the research that I've just described. There, I'm going to turn it back over to Tatiana and ask her to focus on how you engage with investors, and I think before you do that, I think, Sean, you probably want to mention this poll here

38:07
Sean Smith

Yeah, if you guys would please take a moment to fill out the poll question, it's just a few questions. I'll leave it running. And Tatiana. You could go ahead and and start, and this will run for about 2 min.

38:25
Tatyana Staneva

Very good oops too fast. Right? So all this work that Ed was talking about is essential for everything that I will talk about now, because without doing the work on the strategy and also on the financials, you cannot build the story, and the question is, what makes a good investment story. Excuse me when I ask founders about their biggest challenges. What I usually get is these 3 things fundraising growth or sales and then skills and team basically help to execute. And finally, all of these can be solved with storytelling but not just storytelling. It's the work that goes into the storytelling to get the strategy and the financials right? And so that's why it's putting the 2 together. What Ed was talking about until now, and what I will talk about now. So

39:18
Tatyana Staneva

what makes a good investment story? 3 things you need to build a layered playbook. That's the 1st thing it's the most work that you have to do, and then you need to craft the story and the narrative, and then engage the right investors. And when you have these 3 together. What I see happens with startups is that they have funding momentum and the same works. By the way, also for customers. So it's not only it's not only investors. This is essentially, if you need to sell anything to anyone. Not very true, you need to tell them a story so that they can relate. Now, what is this layered paybook that I'm talking about? This is a checklist here. The goal is to gain strategic and financial clarity. Why do I say clarity, because.

40:03
Tatyana Staneva

as you notice from Ed's presentation just now, everything is so complex. And he didn't even talk about the product complexity. He only talked about the complexity of the Us. Landscape when it comes to building a market access strategy. But the same is true also for your product and for everything that you need to tell investors in order to convince them to to invest. So first, st you need to get clarity. And the 1st thing is to basically understand the investor feedback. Then this goes back to you know, we said, it's very general. It's very specific. What does it mean? Then you need to talk. Then you need to actually lay out the full product complexity so that you can see the the strengths and the weaknesses of your product and fill in any knowledge gaps, especially when it comes to competitors. As in the case of Neurovida

40:56
Tatyana Staneva

you also need to understand financial implications of the roadmap. This is what Ed talked about. And finally, you need to put all of this together into what I call the layered playbook. So, for example, for Neurovita, we mentioned last time that one of their seemingly differentiating factors is the AI. That's their strongest point. So they literally need to built lots and lots of information about this? AI? What data was it trained on? Why is the algorithm so much better? What is their special expertise and skill set that that has gone into it. How is it applicable to the Us. Population, basically anything that you can think of? You need to to start layering these details in somewhere where you can easily pull them and talk about them when necessary. Same is then true also about the weakest points. So the competitors

41:45
Tatyana Staneva

you would in the case of Neurbita. It's basically that the market is overcrowded, as we just saw again in the refresher. the slide from it with the competitors as many. And this is actually true for the migraine market, and we didn't even pick all of them. So it's a it's a very complex kind of endeavor to go and understand what they're actually doing. And it starts with figuring out what are the right criteria that you need to compare yourselves against. So That's all the work that goes into this kind of layered playbook which is designed, or it should be designed to gather all your insights and all your understanding. And it's especially true, I find, for especially helpful for founders who have a scientist, a scientific and a tech background, but also for everyone else who comes from business and understand how the business game is played, so to speak. It's very helpful to have it all kind of

42:39
Tatyana Staneva

clear in front of you to know what you need to pick when you start building the story. When you start building your pitch to investors. And there's 1 very important thing here that I put at the bottom. You need to at the same time also balance your effort for detail versus how important is this thing that you're layering right now, or which you're collecting information on in the context of the overall strategy. So if it's not your strongest point, and you just want to explain every single detail of your device. Then maybe it's not worth the effort, but it is. It is your strongest point in the example of near with that would be the AI then. Yes, put all the effort in. So that's what I mean by by balance.

43:22
Tatyana Staneva

Second bit is how to craft the story and the narrative. And the goal here is to build a connection. It's like I said. It's the fundraising. It's like. It's a sales process. You need to convince somebody to buy literally by your company. And because of this you need to kind of convince them that your company is what they need, so you need to somehow resonate with them and and give them what they are looking to buy effectively. And the way to do this is to tell them a story because the story allows you to connect and makes everything very compelling and credible and hopefully memorable, because even if investors don't invest, decide, maybe they decide not to invest in you.

44:00
Tatyana Staneva

but if you're memorable, if you impress them with something they will for sure recommend you tell the investors that that's super helpful. And that's actually what happens with successful fundraising, that it's not so much having a list of these investors. These are the investors that I think will invest in me. But mostly okay. I'll start with this list, but then they will recommend me to the to the right ones to invest in my company. So the goal here, how do you build this connection is by picking and choosing from your layered playbook into into a story. That is, yeah, that somehow addresses the the needs of the investors. So they need to feel

44:37
Tatyana Staneva

the power of your yeah investment proposition. So I talk about the storytelling, and everybody talks about storytelling, and people might wonder, why is it important? Well, 1st of all, what is it? It's it's the art of shaping and delivering a story and doing so in a meaningful way, in an engaging way which will resonate with whoever is listening. So it blends. The storytelling blends both the story and the narrative. So the story is the description of what happens. whereas the narrative is the structure that you put this stuff that is happening into, and it it benefits the story and the storytelling benefits a lot from you. Know how you, how you, what tone you choose and what detail you you present, and the voice and the structure, and the motion, and the rhythm, and everything that usually these are words that you would use to describe a book not so much a fundraising pitch.

45:40
Tatyana Staneva

But it's they're super important, because this is how you get investors to care. And yeah. to get them interested. So a typical startup story, you might be asking yourself already, what is that? There is a typical startup story. And the difference, of course, is that all startups are solving different problems. But there is a kind of like a structure. To this. The startup is solving a big problem. So in the case of neurovita, it's they want to have a treatment for migraine, and they want to be with less side effects and more accessible, and all that, and also providing a real time adjustments through the AI element. So

46:21
Tatyana Staneva

the startup is solving a big problem for the benefit of the patients or the customers. And the rest of the story is that this startup is now asking investors to embark on a quest with it through trials and tribulations, just as it happens in films and in books and everywhere, through milestones and through successes. And it's go all the way to the happy ending, which is, of course, the successful exit. This is this is the story. the narrative at the same time is it's something that we all know. It's a very standard structure. When it comes to pitching for fun, for funding. It's a problem solution business model. Go to market market size, competition financials, funding asks team, it's it's always the same. It never changes, because this is what is important in terms of arguments.

47:08
Tatyana Staneva

Marrying the 2 together is is is what will create an engaging story, and of course, how you deliver it will make a difference, too. But in order to kind of craft this story and the narrative into something that you can then tell in a very engaging way is by picking and choosing strategically from your layered playbook. So if you don't have all the facts and the strategy and the financials, and all of that that Ed talked about in the 1st part. you are not able to basically tell your story. Even though you have the narrative, the narrative is there the problem solution, the business model? But you don't know what to put into it and how to?

47:49
Tatyana Staneva

Well, yeah, highlight. The things that matter, for example, how big the problem is that you're solving, you might say, or you might promise very big returns. This might be also emotionally important to the investors. Actually, we know that it is So you need to. You need to pick. And if there's 1 thing that I hope everyone on this webinar will take away from the session today is this, if you read the slides, slide titles alone when you read them in sequence. Don't pay attention to anything that else that's in the deck. Those like titles should convey the entire story at a very high level, of course, without the details, but it should be, it should be possible to read and and convince, convey the message that you that you want to convey

48:36
Tatyana Staneva

and I will at the end. I don't know if you will have time to go through this, but I have actually taken the fictitious which deck of neurovita that we showed last time with their storyline. And then I have created another storyline to show how it can be done. And to illustrate this point here. So your goal, like, I said, is to show the investor how you will go together through these trials and tribulations, developing the product, betting, the competition. hiring and firing, because that's what you need to do in order to build an excellent team which will deliver, and then, of course, overcoming regulatory hurdles to market access. All of these are the ups and downs, ups and downs that you have to convince the investor to go on a journey with you in order to then get to the part where you actually hit the milestones and get the successes. So you launch a great product.

49:29
Tatyana Staneva

You deliver immense value to your patients or to your customers depending on what it is, and you generate the revenue, you make the profit. And you finally realize scale. And all of this basically brings you to this exciting exit that, you know, satisfies the needs of the investors and also the founders. So this is this is the the job that needs to be done here. And it's it's quite it's quite a lot of work that goes into it in terms of what I call the homework. Now. once you have created this story, and again you have to fit it into the 10 or 15 pages, or whatever you have for the fundraising pitch. Your goal is to then go and sell it right. You literally want to sell your company to investors. They're going to take a stake. So it's not only going to be you owning it. So you want to sell. And how do you do this? Well, you

50:24
Tatyana Staneva

1st of all, with the new example that we gave last time. If you're getting all of this very confusing feedback. You need to understand why that is so. This gives you clues about your outreach. Whom have you spoken to? Who gave you this feedback? Why, they gave it to you does have anything to do with their focus. Maybe some misalignment of between their investment strategy and and what you what you're proposing, or yeah, what you're proposing to deliver for them. So you need to identify your ideal investor. So that is a bit of a like kind of desktop or other research to look into what investors are out there. And again, this can be very complex, and a lot of work can go into this, and I would again say that it needs to be balanced. So you don't have to create lists and lists of I don't know 303,000 investors that might potentially be interesting or to start with and then trying to narrow them down to the

51:24
Tatyana Staneva

I don't know 2 or 3 that will invest in you. No, that's not what I'm saying, but you do need to think about how to focus your search from the very start, so that you are able to target your outreach, get some feedback, understand what? The feedback where it's coming from. Improve your story. So do more homework potentially improve your story. Then go back to those investors, get more feedback and do this repeatedly until you actually hit the right investor that will invest in you, because you might get lucky, and you might find the investors which will give you money right away. But that's not usually what happens and what I see when I, when I work with founders, is that it's kind of like a little bit of a spiral. It's again iterating, as

52:09
Tatyana Staneva

usually is the case with startups, with anything you have to iterate with. hypothesis of who your real, who your ideal investor is. And then, adapt to the feedback, or maybe discount the feedback if it's not relevant and go find another investor. So once you have kind of done this gap analysis between who you think your ideal investors and whom you're you're reaching out to. Then you can. Then you can identify who it is that you really should go after and then use the right channels for effective interest and the right channels. There can be many channels right? You can do cold outreach. You can do. Go through your network. You can go to events, and so on.

52:54
Tatyana Staneva

They can all be right. It's you have to again experiment and and see what will actually produce well, commitments and further further recommendations or further introductions to someone who might be a better fit for your company. You need to tailor the pitch and you also need to build relationships as you go through this. So you know you can engage with, and get investors as early as you can and Adapt your story. Adapt your investment proposition as you go, and the key here. I think with one thing that I see founders not do is to follow up relentlessly, or rather the ones who manage to fundraise successfully. They follow up and follow up and follow up and follow up until they get a no, but actually, what I also see is that investor never say a no, it's never final. If they give you a no, it doesn't mean no, it usually means not now.

53:48
Tatyana Staneva

So there's definitely a benefit in engaging with them. Now. I'm have a lot more slides here to talk about how you can drive maximum impact. And what you need to show investors. And then this is the basically the story before and after the new Vita example which you will be able to read. But we are very behind our schedule, and I want to leave 5 min for questions. So just a quick, quick slide here to show you topics that we didn't cover in this webinar. So from tactical and strategic to financial. We can talk about operationalizing the strategy. We can talk about negotiations with regulators and payers or with investors depending on what it is. We can talk about building financial models. So putting all of these things when you estimate the funding, ask into an actual model with a P. And L and a balance sheet and a cash flow, and a runaway, and all of that. But

54:44
Tatyana Staneva

please let us know if that is of interest, and call us if you get stuck. and yes, we have, I think, 5 min now for questions and answers.

54:56
Sean Smith

Okay? Well, the 1st question that, I'm gonna answer is, yes, it is possible to get the slides from part one of this series, and I happily send them to anybody that pings me. And 2 please explain. Pm. Pm. Method, who is considered member

55:19
Edward Dougherty

So I think that question is for me, and it's related to payment methods for covered services. And so the term Pmpm. Means per member per month in a value-based payment system. Essentially, a payer looks at what it costs them over the course of a year to take care of a group of patients. And so if you are able to address that amount and help a payer essentially spend less on that population of patients on a monthly basis. Then you will be very attractive to the payer for that, for relationship with your payer and using your product

56:14
Sean Smith

Fantastic. I'd like to remind everyone, if they would like a certificate of attendance to please put their name as they'd like it to appear along with their email in the chat and ask you to share that on Linkedin after the fact and comments would be helpful to us. Let's see, for every exit strategy. Is it advisable to know how the product is going to be paid? What is the opinion of the panelists to be the best approach for attracting a nice exit. There's more to dive deep into most promising market opportunities to show that you have done your homework and understand the intricacies, or to diversify a little not to miss that investor in a different market area. Like when you have a device that might have a slightly different angles for cardiology, neurology, neurophysiology, etc.

57:14
Sean Smith

Ps, I love the research stakeholder slide. So was that

57:27
Tatyana Staneva

What is most helpful for exit? Or is that the question? Because it was very long, is

57:31
Sean Smith

Yeah. So I guess for every exit strategy. Is it advisable to know how the product is going to be paid? Okay, that's not really a question, what is the opinion of the best approach to attracting a nice exit? And then the may offer their, you know, should they diversify? Or should they dive deep into the most promising market?

57:57
Tatyana Staneva

I can give a a i can share my take on this. usually, I mean, exit is important because investors want to make money. But there's so many factors which influence the exit that it what's important, in my opinion, or in my experience, is that there is it is possible to exit. So there is some potential acquirer of your company, or it is possible to ipo this. But you know it, it shouldn't be something that I don't know. It's a business which will only generate royalties. Nobody will ever want to buy it, and will lock investors forever into your investment. That's not good. I don't think this is the case ever with Med devices, I mean, there's so many big companies that they will likely be an acquired, but you also have to do homework here and and figure out if there is one.

58:43
Tatyana Staneva

when it's always premature to talk about exit. I don't know which stage this company is at that raised the question. But it's it's mostly, I would say, premature to talk about exit when you're in. I don't know seed or series, a and so on. And you haven't developed the full potential. Because what matters is that investors satisfy their to satisfy their fund? Math and fund math is a very well, we can explain it as well, but it's not something that you can influence. and you have a chance at at satisfying it or solving the equation of the found math in a good way, if you are very profitable. So that's I know I'm not

59:24
Tatyana Staneva

very specific. Answer, but it is my experience. So ed, I hand over to you to add

59:31
Edward Dougherty

Well, I was going to ask you the same question. You know what's. I'm not sure that there's 1 strategy that works in every situation, and you know the other thought I had. Tatiana was, you know, in communicating with an investor. You have multiple meetings with them over time for the due diligence process. Correct. So kind of like the question. If you start in one of those speed dating environments, you know where companies get 2 min to pitch their their idea to try to have initial meetings with investors. How do you block out that communication from? You know the very brief communication to get their interest, and then build out that communication.

1:00:18
Edward Dougherty

providing appropriate detail

1:00:22
Tatyana Staneva

Yeah, it's a i. I say, it's it's not a negotiation, but it is a negotiation, because everything you say can be well, helpful or not helpful. Reviewing our position and getting the interest. I, with the exit specifically, I'm just going to quote Guy Kawasaki, and it's not a 100 accurate quote. But he basically says, if you, if you talk about exits, or if any investors ask, ask you about exit in the early stages. Neither of you have a clue. What you're talking about. That's his quote, not mine. And I can just share that from my experience. And I've worked in mergers and acquisitions which is not the same as startups. But it is about buying and selling companies.

1:01:00
Tatyana Staneva

I agree. So, yeah, yeah, that's all I can say

1:01:07
Sean Smith

In my experience working with startups. I think that I say, if you're too focused on the exit, you're going to miss the show and

1:01:17
Edward Dougherty

Well said.

1:01:18
Sean Smith

The so on that note. I would like to thank all of the participants, the speakers, and the excellent for the excellent presentation and slide deck today. This is a very interesting topic, and I hope that we'll have an opportunity to continue the conversation in in the coming days. You guys want to say goodbye to everyone

1:01:46
Edward Dougherty

Yes, thank you. Please contact us. If you have any questions

1:01:51
Tatyana Staneva

Yes, please reach out. It's been a pleasure, and I had a great time designing this, and even though we couldn't say everything that we wanted to share. We've done our best to really deliver something of value. And I hope that it is going to be valuable, too. And yeah, like, I'd say, reach out

1:02:06
Sean Smith

Thank you both. Take care!

1:02:10
Tatyana Staneva

Bye.

How to cite this session

Smith S., Staneva T., Dougherty E. Getting Your Product Paid—A MedTech Commercialization Roadmap. MedTech Leading Voice, Friday In-Focus, 26 March 2025.

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