US MedTech Market Access Strategic Outlook 2025

Hello, and welcome everybody to 2025, Us. Market access strategy for medical devices. Our speaker today is Edward Doherty, and also Richard Paquette. and I'm going to put some housekeeping announcements in the chat. 1st of all, the slides and recording will be available tomorrow. Those wishing to receive the certificate of attendance today should provide their name and email their name as they would like it to appear on their certificate in the chat and or they can email me. I'll put my email in the notes. Make sure you subscribe to medtech leading voice and medtechleadingvoice.com and save the date for next week's webinar. All that information will be in the chat as well as registration link.

Without further ado. I'm going to turn it over to Richard to get us started, and I'm gonna paste the notes in the chat right now.

Thank you, Sean. Well, Hello, everyone. Thanks for joining us today. We're very pleased to be sponsoring this event. If you're unfamiliar with the Owner Institute. We're a consulting firm, dedicated exclusively to supporting the medical device community. We have a team of over 200 consultants worldwide, and we work work closely with medical device manufacturers to navigate the regulatory process and develop strategic plans to to bring their products to markets globally beyond consulting. We provide innovative tools to automate post-market surveillance and regulatory compliance as well as digital transformation services

and educational resources. We're excited to kick off today. The 1st in a series of sessions that go beyond traditional regulatory topics. focusing on market access and reimbursement strategies, which is a critical piece of the puzzle when bringing a new product to market. With that I'll toss it back over to Sean and introduce Ed.

So we're chatting before the call and take it away. Ed.

Good morning. Good afternoon, I guess. Good evening to those of you who are joining us. I'm really very happy to be able to be with you today to talk about one of the important issues that I'm quite passionate about in the work that I do. I have been working with medical device companies for just over 30 years as a consultant to assist with reimbursement and regulatory issues in the Us. I do a lot of work now with companies that are based outside the Us. Who are planning to enter the Us. Market, to introduce the dynamics in the market, to familiarize you with the opportunities and the risks that you face there, and to put together a plan that will

lead to your success in interacting with FDA to get 5, 10 K. Marketing clearance or pre-market approval for your device, as well as getting payment for the use of your device in a way that is consistent with the value that your device brings. I think we work in one of the most exciting sectors of the marketplace, and I'm just really delighted to have the chance to talk with you about it today. So What I think I'll do is begin with my slides, Sean. That's what just kind of go right into that. Share my screen with you all. And why don't we jump in?

All right. I suggested to Sean that if you have questions that come up during the presentation. Please. Put them into the chat. I intend to kind of speak through rather than break for questions. but would really like the opportunity to engage with you after the presentation, and to take any questions that you might have. I'm also available, after today's presentation, to meet with you to talk about particular issues that may be of importance to your technology, that you might feel uncomfortable addressing in a group. I often do that, and would be pleased to have the opportunity to meet you and to talk more with you about the important work that you are doing.

I'll just start by saying that this navigating the New World, I think, is very appropriate in a number of ways. I remember one time when I was beginning to do a presentation on accessing the Us. Healthcare market was actually way back in 2015. I was teaching in Stockholm for a week with some entrepreneurs in the Med Tech sector, and that was a time when we were certain that Hillary Clinton was going to be elected President of the United States in 2016, and nobody thought that Brexit was ever going to happen. Well, I think we all know that now. What we didn't know then is that things can change, and when they do change, the environment that we work in also changes. And so my objective today is really to to try to

give you a sense of where we are, in the Us. And in the Us. Healthcare market. As a result of that, and then to help you begin to think about some of the concrete steps that you should be thinking about planning to take in the coming year. As you prepare to launch your medical technology in the Us. Healthcare market. And so, specifically, I'd like to talk a bit about what has happened in the Us. Over the course of the last year, and particularly since the November general elections here. I'd like to talk a bit about how all of that is affecting regulators, FDA, how that is likely to affect payers, and

how it will likely affect your eventual customers in the Us. All of that, as a way of inviting you to think about how you might set forth some of your key priorities in your agenda for 2025. So let's get started there first, st just to maybe highlight. What I think are some key themes that are likely to emerge over the course of 25, and through to 28, and the next general election in the Us. These things, I think, are themes that will affect us as they continue to roll out. The 1st one, I think, is, we're going to see increasing vertical integration both among payers and among providers. I'll talk more about this later on. But among payers I think we're going to see an interest in continuing to purchase primary care practices to purchase

drug distributors and drug benefits, managers and so forth. I think you'll see a continued sort of acquisition of a range of services, so that at the end of the day, at the end of the year individual insured, individual people in the Us. Are likely to interact with only one or 2 major payers. Similarly with providers that we'll see an increase in integrated delivery networks which pull together. Really, every health related service that would be of importance to you from cradle to grave.

I think we're also going to see some increase in venture capital activity. I know the last several years have been pretty tough for a number of my clients, perhaps for a number of you as well. And I think there's there's some indication that changes in the financial environment that result from the new administration would likely trickle down to a greater enthusiasm in investments and likely some more movement of cash particularly focused in Med tech areas and innovation in in healthcare in particular. in terms of sort of specific thematic focus. I think we'll see a greater focus on drugs and on reducing the huge expenses that Americans have to make every year to purchase the drugs that they need, and getting access to the drugs to improve their health. I think Med tech generally is sort of less politically sensitive

in the Us. And I would expect that to go forward. My sense is that there tends to be pretty good bipartisan support for medical technology innovation. That's a good thing. And I would expect that really to continue and maybe to to grow. You know one of the questions that I have been getting from my clients outside the Us. Since the election is what I think the impact of tariffs are likely to be on access to the medical market and the cost of Med tech products that are coming into the country from other places. My sense at this point, and you may have this sense as well. Is that right now the discussion around tariffs is really a

a tactical tool that the President elect is using as a negotiation cudgel if you will, and that at this point I think many of the tariffs that have been discussed are probably more of a threat than they are a promise at this point, but to the extent that we can predict anything that's going to happen in the trump administration over the course of the next 4 years. I think it's a question and issue that will continue to come up. And as a result, I think a lot of chaos is going to take place over the course of the next couple of years, certainly over the course of 25, as we begin to negotiate, perhaps, some significant political and policy changes related to every part of American life, healthcare being one of the critical parts of that.

So let me talk briefly, if I may, about the changes that we anticipate in the Federal Government the executive branch, as well as legislative and judicial branches I've put out for you here. Just a top line. Org chart of the nominees for management and oversight of health care. In the Us. At the Federal level, beginning in January, so just a number of weeks away from now President Trump or President-elect trump, has nominated Robert Kennedy to be the Secretary of Health and Human services. His background is as an environmental lawyer. He's been a big critic of the various health related agencies in the Federal Government, particularly critical of ties that FDA leadership have had with industry, with the drug and device industry. He's also been a critic of vaccines.

and is very interested in things like dietary supplements and nutraceuticals. So I think you'll hear a lot of discussion that he would drive if he is, in fact, confirmed to his office. That will address a number of these issues. Now, as I said before, not necessarily targeting Med Tech products and innovation directly, but that will certainly be the environment that we will be facing now. The nominee for Commissioner of the FDA is Marty Mccary. He is a chief of surgery currently at Johns Hopkins University. He's a very well regarded surgeon. He has been a Fox news contributor on a number of occasions. Fox news, as you may know, is

a more conservative news network than other networks are in the Us. He has sometimes criticized FDA as operating more like the so-called crusty librarian than anything else, and by that he means the librarian who gets angry at you when you take out books, or you want to take books out of the library. So he is interested, apparently, as he says, in opening up the agency and making it more responsive to the interests of industry, including accelerating the review and clearance or approval process

for new products. We'll see for the centers for Medicare and Medicaid services. The major Government payer, Cms. Dr. Mehmet Oz. Has been nominated. He ran for the Senate in 2022 in Pennsylvania. He is a transplant surgeon by training, and is referred to often as being a so-called celebrity physician. He was a daytime television host in the Us. For a number of years known for pushing or endorsing a range of health related products.

some of which really have no science to support their use, and so that positioning has raised some concern for some people looking at him. Coming into this position, he does not have any government experience. but he is interested in a couple of policy issues. One of them is, he's a great proponent of Medicare advantage plans. We'll talk about those in a few moments. He'd like to see all medicare beneficiaries enroll in medicare advantage plans which are private insurance plans for medicare beneficiaries. So an interesting thing to consider. He also has a lot of concerns about Medicaid. As you may know, Medicaid is the health insurance

that is available on a needs basis. So for those who do not meet the Federal poverty level for income are qualified for Medicaid. He thinks that the Federal Government is paying too much for that. It's currently a health plan that is jointly funded by the Federal Government and the State governments, and he generally liked to see the States take on more responsibility for carrying that expense. Dr. Dave Weldon is named to be the director of the Centers for Disease Control and Prevention. He is an internal medicine physician in private practice, now in Florida, former Congressman. Interestingly, he's been a real critic of the public health infrastructure in the Us.

Very, very engaged in the covid vaccine discussions as well, and has been cited as someone who perhaps promotes misinformation about public health related to vaccines and other sorts of things, and there are some who are concerned about his taking over responsibility for a public health Agency. 2 other people who are not directly involved with healthcare, but whom I identify here. The nominee for Secretary of the Treasury is Mark Rowan. He is a big investor venture capitalist big in deal making. And so, you know, there's some thinking that there's going to be sort of an enthusiasm and and a movement toward increased investment in new opportunities and so on. So potentially a a positive business environment. As a result, final person is Brad Smith.

who is currently leading Doge, which you may have heard as the Elon Musk and Vivek Ramaswami, the Look, they're looking the department of government efficiency. Some people comment that. it's kind of crazy that a department focused on efficiency needs 2 people to to run it. But there you are. The interesting thing is that Smith is also a healthcare entrepreneur, and so there are folks who think that there'll be a big focus on actually beginning to look at the structure of the healthcare environment. Interesting stuff. If we go on and look at Congress just a few comments there. The current 118th Congress has a lot of unfinished business. They are planning to recess at the end of next week, but they still haven't passed a budget for fiscal year 2025, which began on October first.st

And so we're expecting a continuing resolution through March of 25, which will maintain funding for the government at current levels until the new budget is approved in the current budget and moving into payment for healthcare. In 2025 physicians got a 2% cut in their payment, which has been an issue that we will see reverberating over the course of the year there was some discussion that Congress would not implement that payment cut, but so far there's been no movement on that issue as well. On the other hand, in the hospital outpatient area, we're seeing that there's likely to be some increased payment in advanced imaging in particular, so good news in that front. There will be a cap for seniors in their out-of-pocket, spending on drugs next year, making drugs affordable.

But also there is some push from Congress to force some of the vertical integration that I was mentioning a minute ago to not continue so. For example, that pharmacy benefit managers. Pbms could no longer be owned by health insurance companies. That's the thing. Interestingly. When the new Congress takes their positions in January, they will have a look back period that allows them to remove any final rules by the Federal Government that have been approved within the previous number of months. That Congressional Review Act. It ends up being something that allows a new administration to sort of claw back policies that they don't like from a previous administration, which is why you may have noted that agencies like

FDA really pushed to get some of their final rules out and published before this look back period, so that they would not be the subject of potential return. On the court side. The Us. Supreme Court last year struck down what's been called the chevron deference in Federal law. Essentially what that means is a deference to institutions within the Federal Government that set policies. So we should probably see more litigation related to policies by Cms or policies by FDA that would no longer require the courts

to essentially recognize the expertise that the agencies bring to the table. So it will be an interesting kind of mix. Finally, I'll just say the national mood. If you might have heard the Merriam-webster word of the year for 2024 is polarization. I think it's fair to say that we, as Americans, are very highly polarized, and there's quite a bit of anger. You have a mood of people saying, just fire everybody, and let's start over again. If you've also been following the recent killing of Brian Thompson, the CEO of United Healthcare, the largest health insurance company in the us

interestingly, the response to that in social media and in the news has been that there are people who are really sort of happy that the leadership of health insurance companies are beginning to take some heat, obviously a terrible thing, but it is definitely an indicator of where many Americans are with regard to their health care and their ability to have health insurance. Let me sort of look a bit, if I may, at the us. Healthcare ecosystem, and what I think all of this means for the system itself. I'm going to start with FDA, and kind of go around the circle here.

I think people at FDA are anticipating a fair amount of disruption with the change of administration and with the way in which some public health policy may be implemented through FDA. I wouldn't be surprised to see departures from the agency, and unfortunately, a lack of some important expertise. Certainly the department of Government efficiency Doge is talking about cutting, funding across the Federal Government that could affect agency funding agency funding is tied to staffing and adequate staffing is something that FDA has not had in a long time, and staffing levels can affect timelines for regulatory review and clearance. So that could be an issue.

We've also noticed that. As the new Congress comes in. That there will be strong Republican oversight of the agency, and so I would look to see increased direction from Congress to the agency to operate in a perhaps more efficient manner than they have before. There are a number of rules that were published, and could well be questioned as a result of the change in administration, the so-called lab developed test or Ldt final rule which FDA implemented to begin to regulate these lab developed tests

as devices rather than exercising discretion over these tests as they have up until this point. I think there's going to be a general sort of push and pull between politics and science, and what I mean by that is that there will be significant pressure on the agency, I believe, to approve products that have some sort of public appeal. and perhaps not focus so strongly on science to go back to the Covid epidemic. There was a lot of push and pull in the 1st trump administration about FDA's need to ensure safety before they would provide access to vaccinations and other treatments for Covid. So I think we'll see that continue

from the payer perspective. I think that changes in the government are going to result in reducing the strength of the medical safety net for people. With regard to the level of health insurance, they have the level of coverage that is available to them. I think that is going to be a challenge for a number of folks, particularly on the lower end of the income scale. As I mentioned with Dr. Oz previously, I think we'll see an increased push toward privatization in the Medicare and a move toward Medicare. Advantage plans. Interestingly, I think we'll also see an expansion of the transitional coverage program that is currently in place for medical devices that have been granted breakthrough designation, essentially allowing them to be covered and paid by Medicare immediately after they receive 510 k. Clearance or marketing approval. So that's an interesting thing.

I mentioned physician payment being down. And I think we'll continue to see that, too, if we look on the provider side, I think we'll continue to see provider consolidation as well. Hospital and hospital systems are growing larger, consolidating as a way of managing expenses. and I think that there is going to be additional pressure on these institutions in contracting for payment with healthcare payers. What does all that mean for you. I think it's going to be a favorable environment for big companies. There have already been the Ceos of Pfizer and Lilly have already flown down to Florida to have dinner with President elect trump to sort of talk about their thoughts with regard to drug development.

I think the growth and the continued sort of M. And a activity. Consolidation is going to make it harder for some smaller companies to access their customers. The the payers and providers that you're going to want to be interacting with. And so I have some tips on how you might continue to or plan to address that as you move forward again, I think the big focus is going to be more on drug prices and probably less on the cost and payment for medical technology. But we'll see all of this affects patients, obviously. And I think that there are going to be challenges in access to care, and that that will become a big sort of public

conversation that I expect to continue, and could lead to some Congressional activity as we go forward.

Did we break for a second and do the poll? Question.

Absolutely.

Are you seeing the poll? Questions.

I am. Yes, so if I could invite you all just to take a minute to respond to this these 2 questions here 1st about yourself and then a bit about your organization.

Well, there's actually 3. Oh, there are okay. Sorry, folks. I didn't scroll down. You're free to continue while they, while they complete the quiz over the next or the the poll over. The next minute or 2.

Sure, all right. So I wanted to transition into talking a bit about some of these impacts specifically for regulators and for payers and some tips on how you might be thinking about responding to issues that are being raised by them. So. as I mentioned before, I think we're going to see a real struggle at FDA between what qualifies as good science and how we can get products approved and cleared for market as efficiently as possible. I think that's going to play out and continue to play out over the course of the next couple of years. So what do you do to respond to that push. As you are beginning to think about bringing your product to market in the Us.

To me it goes to planning for what you'll hear FDA talk about quite a bit, which is the total product lifecycle Tplc. and it's been, I guess, a habit of many of ours to focus on evidence, planning and risk management, and so on, really, at the beginning of the process for bringing the product to market, but less focus on what evidence and support the product will need throughout its life cycle. And so I think. taking that broader view about the evidence that will be needed to support access to your product over the lifecycle is going to be important.

where do you start? I think you start that discussion with with your Q sub or your pre-submission meetings with FDA to get a sense of what types of evidence they will require in order to clear or approve your product for market. But I would view that really as the starting point for your evidence development plan that you should build on to begin to also consider how that evidence is going to be viewed by payers, by providers who will be learning about your product and wanting to potentially adopt it for use. There's going to be an increased focus on digital health. I think that probably goes without saying. And there's been some interesting discussion over the last couple of months about the definition of medical device in the Us. Statutes now, and essentially, a sense that the innovation related to devices is going way beyond what the current definition

of medical devices can really capture and and appropriately regulate. So I think, we're going to see a lot of movement in that area and efforts by the agency to expand, how it thinks about these products. What I think that means for you is that there's an opportunity for you to educate the agency about products in the digital health space products that have artificial intelligence or machine learning as part of the product. I think there is enough of an evolving understanding of these devices, that you have the opportunity to describe the product that you are bringing to market, and to propose how it should be regulated and defend that you have absolutely the ability and authority to do that. And I would say, entering into robust, robust

discussion with FDA on these types of issues is important. Frankly, they may disagree with you at the end of the day. but it's up to you to defend the plan that you put forward, and it could be sort of a learning experience for you and for the Regulators as you begin and continue your discussions with them. I've seen in a number of occasions where the reviewers, participating in a pre-sub meeting have come in with one perspective on the level of evidence required to clear a product for marketing, and left the conversation an hour later, being persuaded that another approach proposed by the manufacturer was actually acceptable. So definitely consider that as you're planning for these interactions.

You are certainly aware that in the Us. We are going to be transitioning to a new quality system away from the current system that is provided for in part 8, 20 of our federal regulations, and harmonize in 2026 with Iso, 1, 3, 4, 8, 5. Now for many of you, particularly outside the Us who are already certified for 13, 4, 8, 5, or in the process of doing so. That's good news for you. But I think that focus

for companies that are not familiar with 13, 4, 85 could potentially be a challenge and sort of one of the key suggestions there would be to think more about risk management across the product lifecycle. Again, many companies tend to put their put together their risk management program for their submission to FDA that focuses really on design of the product, but much less on what happens with managing access to the product across the lifecycle. Finally, you know, on product claims. Again, I think there could be some shifting in how we balance safety with access. And so I think the best way to think about addressing that is, to plan, to engage with providers and with patient groups

as early as you can in your development process, to to hear what is important to them, and to ensure that your product addresses needs that they have raised and articulated let me go on. Yes. talk a bit about payers. Now, if I may. This is crazy for people who live in a single payer system. But just to sort of describe the Us payer environment at a very top level. Essentially, people in the Us. Are divided 50 50 between government insurance and commercial insurance or private insurance. If we look to the right of this slide. We see that just about everybody in the Us. Who has

private or commercial insurance has it through their employer and large employers, meaning companies that have more than about 500 employees typically are self-insured, meaning that they carry the financial risk for the health benefits for their employees. The self-insured companies have a lot of flexibility in establishing benefits for their employees because they're paying the bill. Essentially. So, they're not constrained by coding. They're not constrained by coverage determinations. They evaluate new products and services based on how attractive the benefit is for employees

and how a cost saving access to that technology could be. So when you're looking at a self-insured market thinking, think about the types of benefits that will retain employees. For example, expanding healthcare for women is one area that is very important, for some employees and employers, as a result, are responding to that. We also see a range of models that self-insured employers are looking to now, and so one is the center of excellence. Model Walmart is a great proponent of this, where they are driving their employees to the best

place in the country to get the type of treatment that they need. So they'll fly you from Arkansas to Ohio, for example, to have surgery at the Cleveland clinic, if that's the place that is the best for orthopedic surgery in the country, in their view. And so that's an interesting model. They're also increasingly looking at digital platforms to provide benefits to their employees. and are taking what's called a virtual 1st approach to healthcare, where you have to meet with a clinician through telehealth first, st and be evaluated before you are invited to an office visit in an effort to keep costs down. On the government side the innovator there is the Medicare

Advantage market, which, as I mentioned before, is private health insurance for medicare beneficiaries, individuals who are 65 years of age and older, those with disabilities and those with end stage renal disease. And so again, the strength of the evidence that you provide for scrutiny by payers here is going to be a critical asset for you to have an interesting thing to remember, though, is, if you are approaching a Medicare advantage, plan to talk about covering or paying for your technology. they are typically paid on a a value based

platform, which means that they receive monthly payments per member per month. For the services that they provide. And that's how they do their budgeting for paying for healthcare services, typically what they're looking for when they are looking to adopt new products or technologies is a return on their investment of at least 3 x. And so having the evidence to be able to demonstrate that is critically important. So at the end of the day I would recommend that you focus particularly on the type of reimbursement that might be available to you through Medicare advantage plans and through self-insured employers.

They have the flexibility to cover the products and services about which they view to be valued. I'm gonna move on and just sort of look at the map here for a minute and and ask you some questions like, Well, where do you start so assume you are a newer company coming into the Us. Market. You can't attack the entire market all at once, can you? I'm not sure you can. And so trying to identify places where you can focus where you can establish sort of a home base if you will, for your company and for your technology can be very important.

Once you have that strong center, you can grow from that through referrals and other influence patterns that we could discuss. How do you choose those? Well, for example, if your product is focused on treating heart disease. if you are interested in addressing stroke hypertension, things like that, for example, you might focus on the Blue States that I've identified there Tennessee and Alabama. Why, well, these States are in what is considered to be the stroke belt in the country, and in fact, these in particular are known as the stroke Buckle. On that because of the high volume of stroke in these parts of the country, but you also have Vanderbilt in Nashville and the University of Alabama at Birmingham, very well regarded health institutions that are innovators, and are focused on supporting new technology, great places to consider starting. If that is your focus.

perhaps you have a technology where you really want to engage with provider innovators. And maybe you are looking to institutions in the country that are known for innovation themselves, and who are leaders in innovation. So, for example, you might look at some of the gray States like Massachusetts, where Mass. General Brigham is operating, or Cleveland Clinic in Ohio, or the Mayo Clinic, or the University of California. Health systems in San Francisco and San Diego are well known as being leaders in innovation and healthcare. If you have a virtual product, a virtual physical therapy product, for example, or other types of products? Where is virtual healthcare strong in the Us.

Well, intermountain healthcare in Salt Lake City, in Utah and Ochsner healthcare in New Orleans. in Louisiana are 2 places where there is a great focus on these types of products, and maybe an area where you would be particularly interested in focusing your time. And then you know the traditional focus on medicare beneficiaries. If your product is really intended for people who are 65 years of age or older. You go where the retirees are, for example, and that would certainly include Florida, could also include places like Illinois or New York, where there are high levels of retirees as well. So I'm inviting you to think strategically about these issues because they can be so important for how you begin to block and tackle your approach to the Us. Market.

Alright! Let me move on now to really my last slide, and to spend a little bit of time talking about this, because what I've tried to do is to sort of build the environment for you. So that then I can say, All right, let's start the planning process for 2025 and beyond. if your product is planned to come to market in 25, or 26 or 28, you should be working very carefully, beginning early in 2025 to plan out the process. So how do you do that? Well, I would say. start at the end. So start at the date where you expect that you are going to get your clearance or approval from regulators, and that you'll be ready to commercialize your product in the Us. Whatever that date is. Then work backwards to January 2025, and within that timeframe begin to prioritize all of the tasks that you need to undertake and successfully complete.

How would you do that? 1st plot your regulatory timeline? You know where you are in terms of preparing for your submission. If you're actually going through the review process, and when you expect to get clearance or approval. then overlay onto that your market access, timeline, and see where there are synergies between the 2. Many clients operate these 2 processes independently, separately. And, in my view, that's a bad thing, a question for you. Do your regulatory and market access reimbursement consultants talk to each other. They should advise you jointly about opportunities to put both of these important timelines and processes together, so that you can gain gain time and manage resources effectively and efficiently in going through the process.

Let me just go through quickly. You know, as I was thinking about this earlier today, I think I could put a red box on each of the things that are on this timeline. But what I've intended to do is to sort of lay out the life cycle, if you will, of product development and commercialization in the Us. Let me land on a couple of important things. Can you describe your product and the unique value that it brings to the market in a very few sentences, you would not be surprised. The number of innovators bringing new products to market who cannot do that. and so focusing on how you are addressing an important unmet medical need is a critical thing.

Do you have a clear return on investment that you can speak to? If you don't. You will not be effective in communicating with payers or providers about your product. What is your evidence development plan? You should begin to think about your evidence, planning as early as your preparation for your pre-sub meeting with FDA, and then using that to build out your strategy for the evidence that payers and providers are going to be looking at as well. If you are a smaller company or a startup company, have you begun to? Prepare your quality system? If you haven't, you should. There is no

thing worse that I can think of than having to go back after you've been going through the product development process and then try to document in a quality system format that to document all of the work that you've done. It's a huge waste of time and a huge frustration for the people on your team who are involved in that? Have I talked about evidence? I hope so. And I think that at the end of the day, as I've said, it is the most important asset that you have beginning to socialize that evidence with the relationships that you have among clinicians. Key opinion leaders and patient groups is important. If you have few contacts or relationships with these groups in the Us. Now developing those relationships should be a high priority for you, because developing good relationships like that

takes time. And you need the time to develop the relationships that you're going to draw on when you bring your product to market publication. Planning is another thing that I think about a lot. Again, evidence should not be just for FDA clearance or approval, but ongoing communication about the value of your product as it matures in the marketplace. Last comment. when you get to market and begin to interact with payers. You are going to find that there are going to be challenges. You're going to find that you are not going to be covered or not paid, particularly if you are still in the process of developing evidence to support using your product.

you got to keep working on the evidence development. But you also need to track and appeal every denial that you receive for reimbursement for your product. You need to support your provider customers in seeking that. And you need to know everywhere and every time your product is not approved for reimbursement, because that gives you an opportunity to communicate with the payer to get the patient and the provider and the payer together to talk about it, to talk about the value that your product will bring to them. That is an ongoing process, I call it. It feels like hand to hand combat.

It really does. It will take time. But over the course of a year or 2 or 3 you should expect to be to to see success there, and that is quite important. So I'm going to stop at this point. And turn it back to you, Sean, to see if there are any comments or questions that we might discuss in the time we have remaining.

Yes, thank you very much. That was enlightening, and very, very, very, very helpful. I particularly before we anybody who has any questions, please submit them in the Q. And a. Or in the chat. That's fine. In the meantime, my question to you is, if you can elaborate for us on Roi, and what that means in a medical context. I know what it means in a business context. However. when we're talking about human health. It's a little hard for me to wrap my mind around how one demonstrates an roi on a heart catheter.

That's a really good question, Sean, and I think the answer is that Roi is going to differ by product type, and it's going to differ by customer type if you will. And so, what are the most important things that people care about improved health outcomes and reduced cost? If you can demonstrate that you bring both of those to the table. That's really good, and that's where you would start building a return on investment. So if you're communicating with or beginning to negotiate with a Medicare Advantage plan. It will be important for them if you can identify a subset in their member population who will benefit most from access to your technology. Say you have a problem with managing osteoarthritis.

or they have a problem, and it's costing them a lot of money because their people, their members, are being undertreated and their pain is poorly managed, that pain treatment is expensive for the Medicare advantage plan. And so if you can bring a solution which ends up saving downstream cost for the plan. Then that is a an important return on investment. And so you come to the Ma plan. And you say, let's start negotiating. I'll offer the product our product to you at a reduced price for a year. Let's do a pilot program together to study the outcomes of your members who are using our product. But what do we know? We know that those payers don't want to invest a lot.

And this program upfront. So you have to offer the program in a way that's going to be affordable for them. And they need to see that level of return on their investment. If you can't make the numbers work that's going to be a problem, and you're interacting with the payer in that regard.

We have a question here. Regarding market entry for devices like advanced dressings in chronic wounds in the Us. FDA payers, evidence needs satisfied with clinical trial evidence built with an EU population, for example.

Yes, you can use evidence that you gathered through clinical studies in the EU and present them to FDA to payers, and so forth, providers as well. That evidence is persuasive. Obviously the evidence has to have been collected in a fashion that is consistent with the way FDA presented. I'm sorry evidence presented to FDA would be, it has to be well presented, and to the extent possible. The population in the EU needs to reflect the demographics of the Us. Population

for whom this product would be used. So the population for advanced wound care in the Us. In terms of race, ethnicity, age, and so forth. You would need to be able to demonstrate some of that if you can, or if you can't. then have some either post-market studies or pre-market review that would allow you to collect data in the Us. To validate the data that you've already collected in the EU. That's a very persuasive approach for Regulators and for payers and providers.

Interesting. I have another question, and that is surrounding clinical evidence. And the European emphasis on clinical evidence versus the Us. Emphasis on predicate devices existing technology. And then I want to shift gears a little bit and talk about the Cms prioritization of paying for fewer doctors visits doing more managed care, virtual care, chronic care, management, prioritizing other aspects.

and moving, moving away from in office visits and reimbursement to physicians with all that in mind follow, follow this complex question is software as a medical device. And of digital monitoring, and all of that sort of thing. I would see an opportunity, with the emphasis of Cms to move in the direction of more software, AI based devices. And I think that the Vc. Community also has an appetite for that. I don't know. There's question in there somewhere.

Let me just sort of, I guess, react or respond to that because you've raised like 5 really important issues. I think in that. Okay, with regard to AI definite interest in the investor community, in among regulators and among payers as well, I think there's a broad promise that AI is going to solve every problem that we have. and that is, I guess, both a promise and a concern that we should be thinking about with particular regard to AI questions like, does the AI evolve? Do you have a change plan in place that can be presented to demonstrate safety of how the AI is being used within the technology.

Digital health products are becoming a greater focus for payers and are beginning to be reviewed by tech assessment groups about their relative value. So, for example, the Peterson group is a relatively new group a year or 2 years old that is now doing tech assessments on things like digital therapeutics for diabetes and hypertension, and so on. And so, if you look at the type of work that they've done, you can see the kind of evidence that they require to be able to agree that the digital therapeutic is bringing value for money. And so we're seeing sort of a greater focus there at the end of the day. Even if you have a 510 k.

Cleared product where you don't need to submit clinical evidence as part of the pre-market review for FDA. You're going to need clinical evidence anyway. And so, using some plan to begin to capture that evidence is going to be really important. I'll go back to my comment a moment ago about working with a payer to gather the clinical and economic evidence that you need is a cost, effective way for you to capture that evidence. And if you're working with an influential payer group. for example, Kaiser Permanente, one that many people are familiar with. If Kaiser finds that using your technology using your software product ends up saving money and improving health outcomes of their members. That is a real.

important stamp of approval that you take to other payers who are considering using your product.

Well, I'm afraid we're out of time. There are a few more questions we will follow up afterwards. Please complete the survey which will pop up on your screen automatically, or at least be included in the follow up email again, the recording will be available. The slides will be available tomorrow. If you would like a certificate of attendance. please feel free to email me. My email address is Sean at bear to b 2 b.com. It's a up here in the the beginning of the chat, and I want to thank our speakers. Particularly, Edward. Thank you very much, and Richard as well, for your time and an excellent presentation. Today. I really really got a lot out of it, and I hope everyone else did, too.

thank you, everyone, and we look forward to seeing you again next week for article 10. A thanks. bye, bye.

You all.