Etienne Nichols: Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

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From idea to postmarket. Check it out at www.greenlight.guru.

hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. Today I want to talk about just kind of the reimbursement landscape and how it affects different regions of the world.

With me today to talk about this is Karen Deep Singh Badwal, who is a seasoned quality and regulatory consultant specializing in software as a medical device and artificial intelligence applications.

And with over a decade of experience, Karen Deep has been instrumental in guiding medtech companies through the intricate, intricate regulatory landscapes across various markets. He's also the host of the Medtech Podcast where he delves into the journeys of industry leaders and the evolving dynamics of the medical technology technology sector.

So I'm excited to have him on. If you've ever, if you, if you follow very many people in the, in the space on LinkedIn, he is probably one you've come across.

He's a very popular and well known name in medtech. So thank you and welcome to the show.

Etienne Nichols: Karen Deep thank you. It's always a pleasure to be back on.

Karandeep Singh Badwal: So when we talk about reimbursement, why, what, what's, what's the point of even talking about reimbursement when it comes to medical device development and design? Because early on we're developing a medical dev, do we need to be thinking about reimbursement?

Etienne Nichols: So being someone who's in regulatory, I always had that bias of saying regulatory first early on in my career. Then I started speaking to people in reimbursement and just generally from the business aspect, you know, for example, if you can get regulatory approval, that's great.

You know, it means that you've worked very hard towards it. But if nobody's going to buy your device or it's not an economically viable, then you don't have a viable business and that's what you need to look for.

Of course there's exceptions to this. For example, if you're a charity or not for profit, that's a completely different story. But most people in this games are effectively a business and they want to get some sort of money out of it.

So reimbursement is key. You know, you might have everything, and I've seen it before with some of my clients where, look, I say great, you know, you're definitely going to get regulatory approval.

The clinical data exists, you're doing everything right, but you don't have a profitable business. And if you don't have a profitable business, then it's not worth pursuing because the last thing you want to do is invest millions into a company, get your regulatory approval and then find out you're not making very many sales.

Karandeep Singh Badwal: Yeah, and it's an interesting thing because when I think about sales and reimbursement, they're closely tied together.

You could have a great sales team, but you have no way of making money because it's not set up for the hospitals to pay you. And so sometimes I think in this industry we get a little bit caught up in the terminology reimbursement just by itself.

How will you get paid, who is going to pay you and through what means will they pay you? So I, I wonder if you could maybe guide us a little bit through the different major markets like the us, Europe, Asia.

So just some of the maybe high level differences in how those reimbursement systems are set up.

Etienne Nichols: Sure. It's an interesting point that you bring up there, Etion as well. Depending on the jurisdiction that you're in, you may have an insurance based system like the us, you may have a government based system like the EU and some parts of Asia.

So it can vary effectively, but it's very important that you consider it. And this, aside from regulatory, also might be a deciding factor of which target, which target market you're going to have first.

You know, it's always the debate of US versus eu and some argue that the US is easier from a regulatory standpoint, but from a reimbursement standpoint it may make sense to go to the EU and vice versa.

So these are definitely things we have to consider. So like you mentioned, we could break it down to the three I'll be discussing today. So that's the us, Europe and Asia.

Now when it comes to the us you know, you primarily got things like Medicare and Medicaid effectively when it comes down to reimbursement. Whilst private insurers can sometimes set their own policies, this can vary accordingly.

And there's three key elements that you have to consider here. When you're working with the US there's coding, so that could be CPT and HCPCs, which I'll get onto in a minute.

Coverage and payments. So CPT stands for current Procedural terminology, which is basically like a physician billing code. Think of it, a code at which they can work out how they bill.

And HCPCs, which is healthcare Common Procedure Coding system. And that covers everything from medical devices, drugs and supplies. It's not specific to medical devices, also drugs and supplies. So those things that you need to look into.

And that's basically how it works in the U.S.

now, sometimes, especially talking about my sand and AI background as well, AI based radiology tools sometimes struggle with the Medicare system because it requires both clinical and economic disorders evidence before coverage.

And especially when you have a new technology, there may be clinical data available, but there may not be any real world evidence or economic evidence to prove that it's actually going to be viable because it's something completely new and it's maybe not been used before.

Now when it comes to Europe of course is, you know, the EU is quite harmonized, but we also need to remember how it differs, you know, from the U.S. the U.S.

is one country where the Europe is made of a set of different countries. And of course each and every country has its own different set of requirements, but there is a lot of harmonization.

So every company, sorry, every country has basically its own assessment system when it comes to reimbursement. So for example, Germany has what's known as nub, which is hospital specific reimbursement programs which allow new medical technologies to come in.

There's also dega, which is basically, I'm not going to talk about that, how to pronounce it, but it's to do with digital hubs and software medical devices. So it allows prescription based digital tools to be covered.

And there's also the EU HTA regulation which aims to sort of harmonize the reimbursement system. So there are talks in Europe as well to try and harmonize them. So the issue that companies are going to have, especially startups, you know, when they get their CE mark approval within the eu,

okay, that's great. But then they now have to navigate the separate reimbursement processes within each country. It can be a little bit of a pain point for that company as well because okay, great, you've got your CE mark, you can legally sell.

But from a reimbursement standpoint, if you want to sell in France, if you want to sell in Germany, the systems are going to be different and it may be difficult getting approved in each and every jurisdiction that you want to go to now, when we get onto Asia, of course,

now that is a highly fragmented market. What do I mean by that? So when it comes to Japan, they have something known as foreign average pricing. So it's a reimbursement system based on the average price of devices in other countries.

Now you can see et on where this causes an issue. If you have one type of device and there's one sort of price that is average around the world, yet your device costs three times as much from a reimbursement standpoint, it may not work for you.

But however, on the other hand, if you've come up with something that's basically a third of that, then it can work in your favor. So the issue you have is a set price or something that may work in your favor, may not work in your favor.

China basically has what's known as a volume based procurement. So the government contracts often drive down the cost and that can make pricing negotiations quite tough in that market. And in Korea as well, they have something known as a national health insurance service which sort of controls reimbursement.

So the real issue here is basically when it comes to reimbursement, it's a completely different minefield to regulatory. And it's something that you need to think about at the start.

And that's also going to drive in terms of which jurisdictions you target first. Or in some cases it may be that you don't go to that jurisdiction at all because unfortunately, although you'll get the regulatory approval, there may be some demand from a reimbursement point of view.

It may not be profitable or economically viable for you. And I think the step in the right direction here is what Europe is doing with the HTA regulation is having some sort of harmonized reimbursement for the whole of Europe.

And I think that will make a big impact in terms of how companies target the EU market.

Wow.

Karandeep Singh Badwal: I thought I understood a certain amount of reimbursement, but you covered a lot of ground, especially the, the particularly about Asia and how I like that idea of that strategy. If you have a third the cost, you know, the at the average price could make you a lot more profit or increase those margins compared to some of your competitors.

That's really interesting and I'm curious and maybe this is just feel free to punt if this is, you know, not really in your wheelhouse, but who typically covers the reimbursement strategy or whose job is it to establish this in a typical medical device company.

Etienne Nichols: So in the same way that you may have a Quality or regulatory consultant or health economics consultant. And sometimes it could be the people that work in health economics, sometimes they do a great job of reimbursement.

I. But my personal recommendation is find someone that's worked in that jurisdiction before, ideally with your types of products, so they know how to negotiate with different types of governments.

Because, you know, the negotiation tactics you may use in Asia may not work in the US and vice versa. You know, every other country in the world has their own way of doing things, and you want somebody who understands the system.

So my view here is have some sort of reimbursement expert that may also be the health economics consultant that you have on board. But like with any job that you want done properly, you know, go and speak to the guy or the girl who's been doing this for years on end in that particular jurisdiction,

they're going to guide you the best way.

Karandeep Singh Badwal: Yeah, that makes sense.

Okay. I don't want to get into politics necessarily. However, being in the United Kingdom and me being in the US this year, I feel like politics is going to overlay a lot of every conversation, a lot of conversations we have in the quality and regulatory space for medical devices,

particularly with the change in administration in the US and all of the different things that are happening,

as well as around tariffs and so on. And I'm wondering if you have any thought or if seen any trends on how companies are going to navigate this way or that way or become more segregated to one region based on the amount of just the cost associated with going to other countries.

I don't know if you have any thought on that or any. Any guidance on how companies can navigate some of those particular, you know, governmental difficulties, as they are today.

Etienne Nichols: So if you went back to last week, we'll probably comment on the FDA layoffs and how people reinstated. So I'm glad that happened. And Etion, it's very timely that you bring this podcast on because as of today, the UK Prime Minister has actually abolished the nhs, the national health system,

and is looking to have a complete shakeup. So that's another thing that's happening around the world.

Karandeep Singh Badwal: Yeah.

Etienne Nichols: So at this moment in time, it may work to our benefit, it may not work to our benefit. So nobody really knows. So again, particularly when it comes to a political climate, it's just kind of build that within your business strategy.

You know, bear in mind, again, I hope this never happens, but, you know, things like wars happen across the world, there's political changes, there could be new leaders coming in, and all of this affects Your company.

And these are things that you need to account for. So have a bit of leeway for that. And that is why I say, you know, avoid just having one target jurisdiction, of course have the main one that makes the most sense for you, but anything can change tomorrow.

So, you know, always have a plan where maybe there's another jurisdiction you can target. Things are always changing around the world and particularly with the FDA layoff of a lot of companies who think, you know, we want to go to the US and then if you've only got half the amount of assessors,

that's obviously going to increase the amount of time and then it may be that you go back to the EU again. So my view, of course, is in your regulatory strategy.

Yes, of course, have a primary jurisdiction that you want, but due to the unpredictability of the world, whether it's a political standpoint, regulations, etc. Have other jurisdictions that you also have in mind should your first plan not work.

Karandeep Singh Badwal: I think that's good advice. You have that primary, primary region you want to go to. Maybe there's a list of others. And excuse me, if you go through that list and you say, okay, this is what our anticipated margins are going to be in this region.

This is what our anticipated margins in this region. We can be profitable in these different regions. Whether it's we're going up against tariffs, whether we're going up against regulatory difficulties, timelines, et cetera, we could still be profitable.

But then there may be some that are going to be below that line. You say, okay, well, I'm going to cross that region off for now for these reasons. And if you document those reasons, in this industry, we're all about documentation, you may be able to circle back and bring that region,

region back up as things change. Because it seems the only thing, the only constant is change at the moment. So. And maybe it's always been that way and I'm finally old enough to recognize it.

That being said, I know you already mentioned some about software as a medical device. You already mentioned some about AI and your experience there. Are there any unique challenges other than the ones you've already mentioned that these technologies face in the current reimbursement frameworks?

Etienne Nichols: Yeah, very much so. Number one, could be no established billing codes. And you know, we can go also back to the FDA 510k product codes as well. When a newer technology comes along, you often go down the de novo route and it can of course exist a billing code as well.

If there's a new type of technology There may not necessarily be a billing code that exactly is right for that particular type of product that you're going to come into as well.

The second one of course is real world clinical and economic evidence, because this is something quite new or maybe there's not a lot of it on the market. How exactly do you prove any cost effective proof?

Because there's nothing else currently on the market. And in terms of real world data, this can be limited to none. So that's another issue that you may face as well.

Another one of course is when you have these issues where there's no real world clinical or economic evidence, this can potentially delay your reimbursement statutory. So this can take potentially years.

So for example, people say regulatory can take years.

Reimbursement can also take years as well. So that's something you have to consider. So it's very, that's why I say it's very important at the start to figure out how long this is going to take.

So, you know, if you're still in the baby phases of your company and you're not going to make a product for four years from now, brilliant, you can go out and collect the clinical data.

The last thing you want to do is, right, get to that point and think, ah, we don't have any clinical data for regulatory and we don't have any for reimbursement.

What do we do now? And etion, despite the education and the great platform that you have, it's far more common than we actually should be. You know, there's a lot of information out there, but then sometimes companies, you know, they delay the regulatory, they delay the reimbursement, which is understandable,

the raising funds, you know, marketing, etc. But it's a mistake that they often make. So this is quite common and you'll see it as well. You know, a startup may get FDA clearance but then realize there's no real reimbursement pathway, which goes back to what I was saying earlier as well.

And this, you can actually see this as well. So if you go into the FDA board database, there'll be products that get their 510k and never hit the US market.

Now in some cases, you know, some Companies get a 510k because they're easier to go to other parts like Asia and other parts of the world, Africa, et cetera, because once they've got that 510k, also some parts of Saudi Arabia.

But you also see companies who get the 510k try to sell their product and then realize it's not economically viable, and there's no reimbursement pathway. Now, luckily, with education out there, you know, companies are taking the regulatory reimbursement pathway a lot more seriously.

But this still happens to this day. You'll still see companies get their regulatory approval and then realize that the reimbursement's just not working for them. And then, unfortunately, these companies folded.

They may have a fantastic product that's going to go out and change lives, but if they haven't got money in, then they can't keep making these products. Right?

Karandeep Singh Badwal: Yeah, that's absolutely. I mean, I totally agree with you. I know you kind of are a big proponent of beginning with the end in mind. You know, I quote Stephen covey in the 7 Habits of Highly Effective People.

Begin with the end in mind. How are you planning to get paid? And you have to really build that in. And the other thing I think about is you. You mentioned baby companies, and you might have mentioned this at the very beginning, but when I think about reimbursement strategy,

if you explore that early enough in the product development cycle and you. You kind of extrapolate out to the nth degree to when you're actually in the hospital and you're selling and you recognize this isn't viable, you could actually go back, change your indications for use, change some of the things in the design itself and be more profitable and maybe a slight change.

Would you agree with that or elaborate? What are your thoughts?

Etienne Nichols: Yeah, very much so. So I remember when I first got an exposure, I was speaking to a reimbursement consultant, and they said the same. I was always like, no regulatory first, no reimbursement first.

And the example that they gave me, Etienne, exactly how you just explained it is depending on the indication the claims you make for your product, you may be suitable for a different reimbursement code.

And it could be the difference between getting a hundred dollars for it and 700 for it just by making a few simple changes. And as you highlighted, Etienne, if you build that in from the start, saying, okay, these are the two potential codes that we can go through, but if we change some claims and indications,

we can go for this one, which seems more profitable and more in line with what we want to do. If you do that from the start, you know, it's like a domino effect.

You'll save thousands, hundred thousand, maybe even millions of dollars in the long run.

Karandeep Singh Badwal: Yeah, okay, I want to throw something else at you then. So in the US we have every. Well, everyone has their acronyms. It's just the industry, it's not the US But RX versus otc, prescription versus over the counter.

There's different ways to get to market. Have, do you have any thoughts or advice,

personal feelings about going straight to the market as far as going straight to the consumer versus going prescription first? And I might think of something like a blood, a blood pressure cuff or a CPAP machine and so on.

Does it make sense in your mind one way or another or have you thought about that sort of thing as far as, you know, when it, when it comes to going straight to the consumer, selling on Amazon versus trying to sell to a hospital?

Etienne Nichols: Again, I'm not the reimbursement expert here, but to me it makes sense to go down the prescription route because then you're selling through a general practitioner or a physician, somebody who understands this product inside out and is going to allocate it to the right people over the counter.

It's just your average Joe. You know, maybe that's just a bandage or something like that. But whereas your prescription is something that's in the system and if a physician sees that this is a particular type of thing that they need, they can prescribe that to you as well.

Also, by going in the prescription pathway, it's kind of you can pay yourself to real world competitors. You can build that data from there to be clinical data existing on there.

So I really think etn, it depends on what your device actually is. You know, it may make sense to make it over the counter, something just like wound dressing or a bandage, 100% that makes sense.

But if something is very, very complex and requires the needs of a physician, you're probably going to be going down the prescription path. Right?

Karandeep Singh Badwal: Yeah.

Real world evidence. You've mentioned this multiple times in health economics that's increasingly important. What are your thoughts on how people should integrate these elements into the product development regulatory strategies?

Etienne Nichols: So the easiest way will be post market surveillance. So as part of your post market surveillance you should be getting real world data. What are your competitors doing? What are things happening in the industry?

And this is, and again this is me being slightly controversial here is I don't consider the EU MDR to be a new regulation. I think we've mentioned this before in the past life.

I call it the MDD plus. And there's a lot of people that say that to me too. It's, it's basically was the old MDD with more responsibility and things that companies should be doing anyway.

I mean to me post market surveillance is a complete no brainer you should be out there on the market trying to find out, okay, what are the methods of which my product might fail?

How are the other products out there performing on the market? Bring that evidence in and then come in and improve your product. I mean that's just basic, basic business, effectively not even medical devices.

You know, what are the potential ways that my product or service can go wrong and then what can I start doing to bring that in? And then you might preventive action.

So I think the best way of doing that as well. Also there's a lot of platforms out there as well that share sort of clinical evidence, etc. But also have someone clinical on your team looking for clinical stuff.

I mean you wouldn't hire a guy in sales to go out and look at literature because that's not really their forte. And again, so if you have a clinical team or you have a clinical expert, have them go out and get information on these sort of things.

And that's really the best way of doing it is implement it in your post market surveillance. So it's built into your quality management system. It's something you're going to be talking about on your management reviews.

Don't just rely on, you know, we're going to find out passively. My view is make it part of your post market surveillance. And also when it comes to the EU MDR under Article 10 9, there's also this requirement for, it's called a strategy for regulatory compliance.

Build that into there that you will be looking for real world data, you will be looking for these different ways in terms of information you can find and also state the methods that you're going to use.

You know, whether that's signing up to journals, whether it's using experts and then you can build that in your strategy for regulatory compliance report. That is the best way around it.

Karandeep Singh Badwal: That makes sense. It's,

it's funny when you mention that when you talk about all those different things, post market surveillance,

I just keep going back to the phrase begin with the end in mind. You have to have the whole picture really in your mind or on paper somehow with an understanding that yes, we're going to, we're trying to solve this problem.

These are the indications that we want to solve. This is how we want to get paid. This is how we're going to make sure that what we've accomplished, you know, all these different things.

Do you have any suggestions for companies just to keep all that straight and really to understand that they have met all of the requirements all along the way? Not Just from a regulatory standpoint, but from a business standpoint and understanding all of the requirements that are going to be needed to be profitable.

Etienne Nichols: Yeah, effectively we could take like the Agile approach here. So when it comes to agile, we have a couple of week check in. So you don't have checking points. It's very easy to get bundled down with your work, you know, and this is the mistake that companies make.

Our QMS audit is going to be due in a couple of weeks time. Drop everything and let's do QMs straight for two weeks. If you're using QMS right from the start, you should be audit ready all the time.

And that's what any good auditor or anybody would tell you. Hence why in the EU we have the concept of what's known as the unannounced audit. You shouldn't be audit ready at any given time.

Yes, of course it makes sense to prepare, to have resources, make sure there's people available on your team, but you should be ready for this all the time. So my view here is always have stock points.

And I think one great way of doing it. Of course I go back to the management review and Etienne, you may have seen this too. If you look at your typical company after another doing a management review once annually, which in my view is not enough, do them more often.

Why not have a monthly annual review and then what you can do in your procedure and the way around it is you could say something like, we're going to have at minimum once every year, a management review.

But why not have 12, why not have 15? It leaves you open. It means you're still following your procedure. And the beauty of a management review, you've got all of the heads there.

You've got the head of quality, you've got the head of R and D, you've got the design and development team all in one room and they can speak to each other.

In any business, it's very difficult to get a lot of people together in one room. And that is the beauty of the management review. And there's nothing in the regulations to say that in your management review meeting you can't talk about other things.

You can't talk about general business. Why not? You know, if you've got all these people in the room and you want to spend another 20 minutes just talking about general business metrics, reimbursement, I say, why not?

All the people are there in the room. You've got the greatest minds in your company get together and discuss these things. Don't just think that, oh, we're just going to do the minimum for regulatory.

You can also do extra things and if anything, you're going to impress the auditor because it shows that you're being proactive.

Karandeep Singh Badwal: Actually, I want to, I want to touch on that just a little bit deeper. Previously, prior to qmsr, the quality management system regulation that FDA has pivoted to, used to, it was QSR then this is coming from 21 CFR part 820 and apologize for throwing all of the word salad or Alphabet soup at you.

is being harmonized with ISO: 1345

Now, you mentioned the management review.

Of course you're going to talk about all things quality, all things regulatory, and really cover the gamut. And you want to be thorough. And I agree, more than once a year makes sense.

Your leadership team is probably getting together more than once a year, at least a quarter, most likely monthly, if not weekly. I mean, it's just the way business operates. But they don't always talk about those quality and regulatory things.

Now, if you were to roll that into that maybe monthly, quarter or quarterly business review and you do talk about those other things, do you recommend actually including all of that business discussion in that management review or.

I can just see, I can just hear companies telling me, well, I don't want an auditor knowing about our inner workings or the, the struggles that we're facing in these other areas.

What are your thoughts there?

Etienne Nichols: My view here is you don't have to show that information to them as long as you take the exercises in terms of what's written, the regulation and the standard. And the way that you could do that is you just show them the part of the meeting minutes which go towards whatever your quality of regulatory that you're having.

And the other bits you can have redacted, you can do that. And I've seen it with companies sometimes, you know, for example, if they're showing training records of an employee, they may say, hold on a few minutes, we're going to remove private information like their name, address and telephone number,

which is not required. So that'll be the best way around it. So that's a great point that you bring up Etion as well. You know, a lot of people under CFR 820 just to say, yes, we've had a management review meeting, but they don't have to show the minutes.

But then in my view is probably the minutes went up to scratch in a lot of companies. And of course under ISO 1 through 4 or 5, you now have to show the minutes so people take it seriously.

And the classic I can Give is Class 1, Class 1 software as a medical device. So particularly someone in my background as well, you know, companies that are going from MDD to mdr, they were required to have technical files and a partial QMS and things like that.

Were they up to scratch? In my opinion, no, not really. And it's not the company's fault. It's because nobody's ever assessed it. If you don't assess something, how do you know you're up to scratch?

And it's kind of like you go for your driving license, there's somebody there, you have to pass a driving test, there's a standard. But if you just say to anyone, hey, you know, just jump in a car and you can go driving, how do you know you're up to scratch or following the rules?

You wouldn't really know until someone assesses you. And I think that's the best way around it. So my view here is you can redact information if it's got nothing to do with the requirements of the regulatory policy and there's nothing wrong with that.

So you might have a different section of your management review where you minute these things and then you can leave that out during audit time.

Karandeep Singh Badwal: The phrase, I don't know who I'm quoting here, I don't know who this comes from, but what, what gets measured gets managed. And I think that's accurate. You know, if, if you're not paying attention to anything, of course it's going to start to slip and you stop really caring about it too much.

So I'm, I, I am on the fence as to whether I like that the FDA is now going to be reviewing management review. I'm, you know, I,

I guess I'm a product of my country in that we have a very much an independence and anonymity, you know, mindset. So there's. Whether that's good or bad, you know, we can make that argument.

I always love talking to you though, Karen Deep, because I feel like we have the quintessential UK versus American when we have these conversations. And I love that because I, you kind of raise my awareness to a global view and I really appreciate that about you.

And actually there's something about that that I wanted to mention.

Your take on, on the EMDR is different than a lot of people that I mentioned. And it's interesting because you are in that situation. You're in the U.K. i know, okay, the U.K.

has its own thing going on, but you are surrounded by EMDR and your take is that it's MDD plus. And so I really appreciate that because it's a different perspective than, than a lot of the ones that I am familiar with when it comes to reimbursement.

Do you see it as a similar situation? And can, can we go maybe I don't want to go too deep because I think sometimes we lose people. But the pros and cons of the different types of reimbursement as it relates to the U.S.

i don't know if you have any particular examples about how the EU performs its reimbursement through the government spending or the US through its, through its healthcare insurance reimbursement, but do you have any just, just maybe pros and cons just very quickly?

Etienne Nichols: Yeah, it is interesting. So of course it's the key fundamental differences when it comes to the UK and eu. You know, eventually we have free healthcare, you know, it's based on the government, whereas with the US it's usually work on insurance based system which you know is quite common for your employer to contribute towards that or you can have private insurance.

So I think those are the key differences here basically. So the benefits of course of the US compared to the eu, you have a large unified market, it's the whole of the US whereas the eu, we have different individual countries as I was alluding to earlier, which can make it very confusing.

So the benefit of the US is kind of it's just a large unified system and it's quite clear in terms of where you are and you don't have to apply from state to state, you know, which would be a complete different from nightmare if you had to do that as well.

Also again Etienne, because you're in this space as well, generally speaking the pricing is a lot less regulated, which means there are a lot of higher margins when it comes to the US and hence why you see there just for some reason tends to be a lot more investment in the US and it's not just a regulatory standpoint.

A lot of companies tend to go to the US as it just seems a lot more money floating out there and it's a lot more profitable comparing on the type of device that you're doing as well.

So effectively you can have a lot more premium pricing in compared to the eu. And because it's an insurance based system, they may be willing to pay these kind of prices, whereas if you have a government based system, they're trying to save as much money as possible because that's generally how the government would work as well.

And I generally find that there's a lot more flexibility as well. And also with the US you have possibilities of temporary reimbursement pathways, so it may be a way to just get you on the market a little bit quicker whilst you're working out what you're going to do.

But of course the cons now of a US based system is Medicare, Medicaid versus private insurers. Each of them have a different reimbursement requirements. I can't really dig into details of that, but then that can cause a little bit of confusion as well.

And devices covered by Medicare may not be covered by private insurers and vice versa. That's something that you have to consider as well.

The general process in the US can be quite slow and expensive initially. So you know, getting an FDA approval does not, and I repeat does not mean automatic reimbursement. 510 or de novo is not an automatic reimbursement.

The breakthrough designation is to do with regulatory and again is nothing to do with reimbursement. So that's very important the listeners realize that. And you know, getting things like new CPT codes can take years.

And I was mentioning earlier, you know, requires clinical and economic data and you know, it's kind of like then there's a higher out of pocket cost for patients as well when it comes to the US because it is an insurance based system.

And from what I've seen about US based systems as well, if you have insurance, sometimes this, in some cases you may have to make some contribution towards that and depending on the cost, you know, it could be quite expensive.

So the patient may be sort of reluctant to do that due to financial reasons. Then. Now if we compare it to the eu, of course, let's start with the pros of the eu.

Generally speaking there's faster market access when it comes to reimbursement. So you know, if you're a company out there and you're bootstrapped and it's a bit like, hey, look, the US may be more profitable, but we can get onto the EU maybe years quicker or months quicker, may think,

you know what, let's go to the eu, raise a bit of money and then we go to the US which is also a strategy which companies do in regulatory as well.

They may go to one market, raise a bit of money and then go to the other one and then Also, as I talked about the HTA regulation as well, in eu, there's aims to harmonize it, so it's going to be a bit more like the us.

So then companies that they may think, you know what, if the US EU is going to be harmonized like the us, we then may go to the eu. And then also again, government backed, because something is government backed, it means a lot more stability.

And compared to insurance, you know, if you've got a government backed system, when it comes to things like stocks and things like that, bonds as well, if something is government backed, it generally means it's a lot more stable in comparison to other markets.

So the stability is an important one as well. And the EU tends to be a lot more standardized as well. And the big benefit here is when it comes to the patient, there's no direct cut to the patient.

You know, if I was to go and have a surgical procedure on the nhs, I would have to put my hand in my pocket or worry about how much this medical device cost or anything like that.

The government's taking all care of that for me. All I do is turn up to my surgery, I get the service and I'm on my way. Whereas is where in the us where you have basically that there is some form of patient contribution, depending on the procedure that you're getting,

can generally drive how much out of pocket you're going to be as well. Now, of course there's cons. The biggest cons, of course, is the fragmented market, country by country, reimbursement requirements.

So the EU is made up of so many different countries and it can be a complete nightmare. So getting reimbursed in France doesn't mean that you can get reimbursed in Germany or in other parts of the eu.

So that's something that you have to look into, is like, you know, applying to each country as well. And then of course with the eu, it's a big factor here, languages.

Everyone in the US is speaking English and everything is in English. Whereas you go to Europe, you know, you have French, German, Spanish, Italian, you have all these different languages.

And Etienne, as you know as well, when you translate something from one language to another, things can get lost in translation. And, you know, if there's anybody out there who's a language expert and can speak multiple languages, go out and read the EU MDR in each and every different language.

And I would say to you, some of the requirements kind of come across as completely different and that causes a complete minefield. So, you know, you need different language experts, which again can get quite costly.

And somebody who understands how the government of that country works as well.

And also strict cost controls as well. Because it's a government based systems, it's generally going to be strict in terms of how much you can charge. And that's really it as well.

So I think those are the key systems here. It just seems that with the U.S. you know, you can maybe command higher prices and with the eu it's basically, possibly can be arguably safer because it's government backed.

But then you kind of cut in terms of how much there is. So again, just like with the regulatory spaces, there's pros and cons of the EU or the US but there's so many factors involved to say which is better than the other.

You know this, that's, that's the key question that your company has to ask is I don't think there's one better or the other. It's kind of what is the best for you as a company and what you're trying to do.

Karandeep Singh Badwal: That's really good. I love the amount of detail that you put into that. It's interesting that we're doing this at the, I mean we mentioned at the very beginning the, the, the relevance of the different topics that we're taking just at the, the amount of time that it's taken to get this episode out.

When I think about the U.S. and the changes that are happening at the U.S.

some of those things that you mentioned regarding the reimbursement due to the CPT codes, I mean just when I've looked into the CPT codes and the way it's determined, that's that the, the American Medical association is the one who appoints that editorial panel.

They meet three times a year and they determine how much is the CPT code going to cost and how much is this. And that's kind of an interesting thing. It's just this one group and I'll just mention this just because I just want to kind of highlight the potential changes that are even coming even yet,

you know, when we look at the, across the government, you mentioned today that some of the changes that are happening there in your country.

The new FDA commissioner being appointed, Marty McCary I believe his name is, if, if anyone has read his book the Price We Pay for Healthcare,

he is a big proponent of the way of changing a lot of those things. So I,

I, I'm a big believer in planning for the future, planning for today and, and what you have, what you, what you expect things to be as it is today, but also understanding where we could potentially be going.

No one really knows exactly where that is here in the US hopefully things are a little bit more stable in other places. But yeah, I just, I'll stop rambling or whatever this is.

But I just want to give that, just caveat that a lot of things, it is a, it is a changing market that we're seeing. But the one thing that I would take away, and maybe I'll ask you this question if, if your listeners, our listeners could take away one thing,

what would that be? I'm going to tell you what my takeaway is and that is there are layers to developing a medical device and the strategy of the medical device.

The regulatory layer is one that we preach a lot. You know, understand your regulatory pathway, understand your regulatory regions that you want to go to as far as your patient populations and clinical investigations, et cetera.

If it's to the US is it 5, 10k, is it DE novo? Do you need to go the PMA pathway, what class are you? What risk?

But this other layer of reimbursement is, is stratospheric. It's, it's, it's, it's very foundational to the development of your medical device, even to the very beginning in the product development space.

But I'd, I'd be curious what your thought is. What are, what are one of the one, if there's one major takeaway you'd like the listeners to come away with, what would that be?

Etienne Nichols: Yeah, so I suppose, yeah, reimbursement isn't just the final step of a regulatory approval. You know, consider it a core business strategy and it should be part of your business strategy from day, you know, you can have the most innovative, the most world changing medical device in the world, but if you don't have a clear reimbursement or regulatory strategy,

no hospital or no payout is going to buy it. So the earlier that you align this, the better off that you are. Whether that's the EU or whether that's the US the principles behind a regulatory strategy are more or less the same.

Of course, the way that you go about it in the way that you get reimbursed is going to be different. But this is basically what it is. And then as we were alluding to earlier as well, the world is very unpredictable at the moment.

What's happening in the uk, what's happening with the fda. So you know, by all means have that one jurisdiction that makes the most sense for you. But you know, don't discount on the parts of the world at least have them there in the back of your mind.

So if something does change, for better or for worse, at least then you can change your strategy. I think that's the key to a core business strategy. You know, if something doesn't work out, you can maybe take a different path.

Don't be too strict on just one. Have some sort of buyout clause or different way that you can just take a everything doesn't go to plan.

Karandeep Singh Badwal: I love that. And I love that you mentioned the agile approach. Just keep revising, keep moving, being agile, being flexible. So that makes sense. Karen Deep, thank you so much. This has been a great conversation.

I really appreciate all of the knowledge that you're willing to share. We'll put links in the show notes to just so show people how they can get a hold of you, kind of talk more if they have more questions and reach out if you haven't followed Karen Deep on LinkedIn,

I highly recommend that you follow him and check out the things that he shares. He has a. He has a global approach and a very systematic way of doing things.

And I always appreciate the About Karen Deep thank you so much. Thank you for listening and we will let you all get back to the rest of your day. Take care.

Etienne Nichols: Thank you very much.

Karandeep Singh Badwal: Ezio thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform.

If you've got thoughts or questions, we'd love to hear from you. Email us at podcastreenlight Guru. Stay connected. For more insights into the future of medtech innovation. And if you're ready to take your product development to the next level, Visit us at www.greenlight.guru.

until next time, keep innovating and improving the quality of life.