Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian

In this episode, host Etienne Nichols sits down with Ali Samiian, founder and managing principal of Popular Access Advisors, to demystify the critical and often misunderstood world of MedTech reimbursement. Far too many early-stage medical device companies treat reimbursement as a secondary, post-launch paperwork exercise, only to find that their brilliant, FDA-cleared technology fails because no one has figured out who will pay for it. Ali draws on his 20-plus years of experience in market access, health economics, and executive leadership to explain why reimbursement must be treated as a core product strategy long before submission.

The conversation explores how commercialization pathways are inherently dictated by the site of care—whether inpatient, outpatient, or home use. Ali highlights common and costly pitfalls, such as designing clinical trials solely for FDA clearance while neglecting the specific evidence endpoints that insurance payers demand. Payers do not just look at safety and efficacy; they look at long-term clinical value, accessibility, durability, and standard-of-care comparisons. Using practical, real-world examples, Ali demonstrates how simple adjustments to product design and clinical study lengths can proactively align a device with existing or novel code requirements.

Finally, the episode highlights the shifting regulatory landscape and new initiatives designed to accelerate market access for breakthrough innovations. Etienne and Ali discuss the FDA’s Total Lifecycle Product Advisory (TAP) program and the emerging CMS Regulatory Alignment for Predictable and Immediate Device (RAPID) program. By understanding these frameworks and embedding payer-relevant outcomes into early-stage research, innovators can significantly compress their revenue cycles, avoid product redesigns, and successfully deliver life-changing technologies into the hands of patients.

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Key Timestamps

• 00:03 - Introduction to MedTech reimbursement and guest Ali Samiian.
• 01:46 - The difference between clearing the FDA bar and achieving commercial success.
• 02:16 - Case Study: How product design and classification categories impact commercialization.
• 03:45 - The risk of ignoring durable medical equipment (DME) requirements during design.
• 05:22 - Categorizing sites of care: Inpatient, outpatient, ASCs, and home use (DMEPOS).
• 06:15 - Mistake #1: Postponing reimbursement strategy until after FDA approval.
• 07:35 - Mistake #2: Designing clinical studies for the FDA without considering payer-relevant endpoints.
• 09:02 - Understanding standard of care, durability data, and minimizing study bias for payers.
• 10:30 - Exploring the FDA's TAP program and the new CMS RAPID program for breakthrough devices.
• 12:15 - Mistake #3: Rushing regulatory pathways without assessing commercial and price-point implications.
• 13:50 - Identifying stakeholders and understanding the oblique nature of CMS and payer regulations.
• 14:38 - Deconstructing how to build new codes and establish premium pricing from scratch.

Top takeaways from this episode

• Incorporate Payer Endpoints Early: MedTech innovators should involve a reimbursement advisor during clinical trial design to incorporate payer-relevant endpoints (like durability and standard-of-care comparisons), avoiding the need for an expensive second study.
• Align Design with Code Descriptors: Ensure product features and testing durations match the strict regulatory definitions of your target site of care (e.g., verifying a home-use device meets the three-year durability testing threshold for DME classification).
• Evaluate Pathways Holistically: Assess regulatory pathways (510(k) vs. De Novo vs. PMA) not just by upfront cost or speed to market, but by their long-term implications on pricing, coding, and time-to-reimbursement.
• Leverage Breakthrough Programs: Companies with breakthrough device designation should actively follow and align with collaborative initiatives like the FDA's TAP and CMS's RAPID programs to secure immediate coverage upon clearance.

References:

• FDA TAP Program: The Total Lifecycle Product Advisory program designed to provide early, strategic communication with senior FDA leadership for breakthrough devices.
• CMS RAPID Program: Regulatory Alignment for Predictable and Immediate Device program, an initiative aimed at accelerating coverage pathways for breakthrough innovations.
• Etienne Nichols:Ali SamiianConnect with the host on LinkedIn.

MedTech 101 Section  

• Reimbursement vs. FDA Clearance: Think of FDA clearance as getting a driver's license—it proves your device is safe to be on the road. Reimbursement is like getting a toll pass; it determines who is actually going to pay for the journey so you can keep driving.
• Durable Medical Equipment (DME): This is a category of medical equipment used in the home that can withstand repeated use. Think of it like a sturdy pair of boots—if it isn't designed and tested to last a specific number of years (usually three), payers won't classify it as DME, even if it works perfectly.
• The "Cup" Analogy for Coding: Payers view similar items as identical commodities. A cup is a cup, whether it holds coffee or tea, and they want to pay one standard price for it. To get paid more, an innovator must prove their "cup" has unique technology that provides a fundamentally different, meaningful clinical outcome—like a cup that mechanically prevents spills for patients with tremors.

Memorable quotes from this episode

"Clearing the FDA bar is not really what gets us to commercialization. We need to have product and clinical differentiation... A lot of reimbursement is actually more of a strategy exercise." - Ali Samiian

"The FDA basically looks at is the product safe and effective? Payers look at is there value and is there accessibility for the product?" - Ali Samiian

Feedback Call-to-Action

We love hearing from our community of MedTech innovators! Do you have thoughts on this episode, questions about market access, or suggestions for future topics? Reach out to us directly at podcast@greenlight.guru. Every email is read by our team, and we look forward to providing you with a personalized response. 

Sponsors

This episode is brought to you by Greenlight Guru, the only dedicated medical device success platform. Moving from product development to commercial adoption requires absolute precision in data and compliance. Greenlight Guru helps medical device teams smoothly bridge the gap between regulatory approval and commercialization. By integrating both Quality Management Software (QMS) and Electronic Data Capture (EDC) solutions, Greenlight Guru ensures your clinical trial data is flawlessly captured to satisfy the FDA, while keeping your quality systems audit-ready for commercial scaling. Learn more at www.greenlight.guru.

Transcript

Etienne Nichols: 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 reimbursement. It's one of the more,

I guess popular or notorious, whichever one you want to look at it topics in MedTech right now. At least when I go to these different events because I've been learning you can build brilliant tech, clear the FDA, you can still watch your device fail.

The technology may work fine. The problem is nobody figured out how to or who is going to pay for it. So, reimbursement is what decides whether a product reaches patients or just sits on the shelf.

And far too many teams treat it as something to sort out later after launch, maybe once the quote unquote real work is done.

So, with me today to talk about this is Ali, the founder and managing principal of Popular Access Advisors, a market access and reimbursement consulting firm for MedTech and digital health innovators.

He spent more than 20 years figuring out how new technologies actually get paid for across pharma devices and government policy.

Ali, how do I say your last name? I should have asked this.

Ali Samiian: No, that's all good.

Etienne Nichols: Samiian. Okay. He's a. He holds a JD from Osgoode Hall Law School, an MBA from the is it Schulich School of Business and a Master of Science in Health Economics, Policy and Management from the London School of Economics.

With more than 20 years of experience across this pharma medical device, digital health, he's held global and executive leadership roles at Abbott, Novartis, Cala Health and multiple venture back startups. He's led reimbursement strategy for first in class technologies including wearable neuromodulation, continuous glucose monitoring and other innovative, innovative medical devices helping companies navigate the path from product development to commercial adoption.

So that mix is really the reason he's what I consider worth an hour on this topic. He sit at the payer table, run access from the manufacturer side and now helps early-stage companies avoid the mistakes that kill good products.

So how are you doing today, Ali? Great to have you with us.

Ali Samiian: Thank you again. Great to be here and super excited to talk to your audience about this.

Etienne Nichols: So, one of the things you talked to me about when we met, I think we met at LSI earlier this year at Dana Point, getting technology into patients’ hands. Can you walk me through a little bit about how reimbursement should influence product design and different aspects of that? Because I think most people, that seems very, a paperwork exercise in a lot of people's minds. But tell me where I'm wrong on this.

Ali Samiian: You know what, I love that question, Etienne. So just to give you a little bit of background, I think you did a great job. I won't get into the details, but once I transitioned out of Abbott after launching Freestyle Libre globally and then spending two years on the US side, I was approached by the team at Cala to say, look, we know you establish new coverage categories for, for new technologies and we have a great technology that doesn't quite fit into the healthcare system.

So, we need you to come on board and help develop coding, payment and coverage and help us identify what evidence do we need to get the product reimbursed ultimately? Right, and that's where I started identifying that.

Like you said, the FDA clearing the FDA bar is not really what gets us to commercialization.

We need to have product and clinical differentiation.

So, if I think about the Calla example, right, what ended up happening?

Kala had a great product, right. They had FDA clearance.

But once we got to the to CMS to get our coding, CMS said, well, you look and feel like a TENS unit, so I'm going to put you in the TENS category and solution.

That's a solution to a problem.

So, as I think of the problem, right, so the product design, if the product wasn't designed appropriately, if we didn't have the demonstrated clinical and technological differences, we would have ended up in a category that would not have commercialized, allowed the company to commercialize. So, as I think about product design, right, it's important to decide early on where is this product going to be used? Is this a home use device? Is this an inpatient, outpatient?

Because what each of those categories require is slightly different.

So, it's not a paper exercise, it's actually more of a strategy exercise. So, I actually work with clients now where they, as they're developing the product, we're identifying what are some of the differentiating indications, what are some of the differentiating technological components that they need to have to make sure that we're able to capitalize on the commercial potential of the product as well.

Etienne Nichols: Now I would assume they have the answer to those questions, but how do, if they don't, how do you, how do you go about getting the answers to those questions or prompting them to get those, I mean, technological. And what was the first one?

Ali Samiian: So clinical. Meaningful.

Etienne Nichols: Clinical. Yeah, yeah.

Ali Samiian: So, you need to have clinical, meaningful outcomes. Right. The product needs to help clinically. You can't just have a fancy device that, you know, the previous generation was blue, this one's red and that's our upgrade.

Etienne Nichols: Well, that's something that I think a lot of companies, they will tell you that. Yeah, this is, this is earth shattering. But the physician themselves is like, well, sort of. We don't actually care about that particular thing as much as, you know, it seems like.

How do they get that? I mean, is it just as a matter of getting the. Those calls to actually give them the honest feedback or what's. What are some of the best ways to get that?

Ali Samiian: No, so there's, you know, a lot of reimbursement is actually so depending on where you are. Right. So, let's say you're looking at home use durable medical equipment. As we're moving more and more in towards a home use scenario and wearables are becoming more prominent, there are regulations that actually spell out what products need to look like. So, we actually help companies make sure that their features match the requirements described in the regulations so that they don't get all the way to market.

And, you know, this is a terrible example to share, but I'll share it anyway. Terrible for the company.

I was at LSI three years ago and we're having dinner with the CEO, and he pulls out his device. He's very proud, as he should have been.

And he.

We start walking through the device and he tells us during dinner that this device is weeks away from being submitted to the FDA.

And as I look at it, it's a wearable device that will be used at home. And within minutes I tell them, unfortunately, this is not going to fit the criteria for the home use device category, which is the durable medical equipment category.

And he was shocked and he says, how dare you say this to me? I've talked to lawyers, I've talked to consultants and we are fine.

And I explained to him what the requirements are and he goes away and I see him the next day and he says, you know what? I am very, very disappointed because you're right and I now have an option. I have a decision to make. Do I get this product through the FDA and know that I won't get reimbursement, so I'll have to come up with the next generation or hold back for a couple of years, redesign the product and then submit to the FDA so that I can get reimbursement down the line.

And that's a terrible, terrible example. But it happens so often, unfortunately.

Etienne Nichols: So yeah. Did you have more to. Yeah, I have a question but go ahead.

Ali Samiian: Yeah, well, so I was going to say, so what we do is actually work with clients to identify from a design perspective what are some of the critical components that need to be on device versus off device versus coming off of different sources to really make sure that we fit the criteria's required by payers.

Etienne Nichols: I gotcha. Okay. So, in that instance, you said a lot of people get to that point and they have to make that decision, they reach that fork in the road.

I don't know what his decision was, but I would assume, you know, ideally you will be introduced to those companies much earlier than that. You'll be able to influence this. It can be a smoother road. You know, there's oftentimes that.

But if that. This is how you are introduced or just this mindset is now introduced in reimbursement, how do you actually make that decision?

And can you walk us through the. Just, just to kind of torture that metaphor, torture that illustration a little bit. Can you tell me, okay, two or three years down the road, maybe, maybe a best-case scenario is you are selling it and, and whether it's direct to consumer or however the case may be, however you get reimbursement that way versus and then you do the next gen that's going to be a prescription device. I don't know. What are your…

How do you, how do you look at that?

Ali Samiian: Yeah, so that's a commercialization strategy.

Etienne Nichols: Yeah, that's true.

Ali Samiian: Looking at. And again, I, I am a reimbursement expert, but I'm actually a commercialization launch specialist. I've launched a number of products on the pharma side, on the medical device side.

That's where my sweet spot is. So, looking at commercialization with a big lens on reimbursement, but also regulatory and evidence generation. So, putting it all together and making sure that founders and investors have practical approaches as opposed to.

Based on my PhD thesis, here's the study that you need to do. You know, I need a thousand patients in the study, and you know the product will never come to market.

So, I try to be practical that way. But what I will say is typically what you see. So, if in that situation, right, the patient, the company, and we've seen this happen again over and over, right.

Where products get in front of CMS. CMS says you've convinced us that you should actually have a new code. You are differentiated enough to have a code, but you don't fit the criteria for durable medical equipment because you don't meet the.

You know, there's my criteria to meet.

There's one or two that are missing. Your product isn't designed to last at least three years. You've tested it for two years, but not three years.

So, you don't meet criteria. Boom, you have a code, but you don't have payment. So no one's going to pay, right?

Etienne Nichols: Yeah.

Ali Samiian: Now the company has a choice. Do I sell in a cash pay market while I go back and redesign, do the testing and try to demonstrate that my product is good for three years and then come to market?

Right.

But you won't have that inflection point in your revenue until you have your coding and your payment and then ultimately your coverage in place.

Etienne Nichols: And feel free to pun on this question, but you've got me a little curious. So, you keep talking about the durable medical equipment classification category, I suppose.

Ali Samiian: Yes.

Etienne Nichols: How many are there and what. Can you give me an example of some of the other categories?

Ali Samiian: Yeah. So, a lot of reimbursement decisions are driven by site of care. So, is your product something that's going to be used in hospital? In the inpatient setting.

Outpatient setting. An outpatient can be outpatient to the hospital or ASC clinical offices. Right. Ambulatory surgical centers like cataract surgeries are often done outside of the hospital now in the clinics.

And then you have home use. And home use falls under durable medical equipment or prosthetics. Those are the two big categories. So demi posts or home outpatient and inpatient categories.

Etienne Nichols: Okay, very cool. Okay. So, when you talk to these different teams and they're trying to figure out which one of these we want to fit into and how to get there, what are, what do you, what are some of the patterns that you keep seeing?

Keep running into that. Whether that's mistakes or these are some things that maybe you can just do it this certain way. Maybe there's the mistakes that are just going to stop you and maybe there's a neutral middle of the road approach.

But then there's this other way that's just a stellar way to do things that, that helps you lead the pack. I don't know if you want to pick one of those.

Ali Samiian: Let me highlight some of the mistakes. Right.

Etienne Nichols: Yeah.

Ali Samiian: And I'll tell you what good looks like.

Mistake number one. Thinking I've got a path to the FDA. I'll figure out.

Unfortunately, I only have funding to get me to the FDA. I'll figure out reimbursement after that is one of the biggest mistakes because a lot of the decisions that influence reimbursement are made years before we actually get to the reimbursement discussion.

Right. So, as you think of the product design, the clinical studies, the regulatory pathways, all of those really impact reimbursement.

Right. So, saying I'll get to the FDA, and I'll figure out the rest after that, that's when my hands are tight. So, if you use the predicate of tens, let's say. Right again, going back to the home use device.

So, your predicate is a TENS unit, and you got to market really fast. Fantastic. Congratulations. Now your commercial capacity is a TENS unit and you're going to get 500 bucks over five years for your product.

Right. And that's where you see a big unfortunate cliff for a lot of technologies.

So, get a reimbursement advisor involved as early as possible so we don't have that issue.

Etienne Nichols: You know, I, yeah, in my mind, so the project manager in me, yeah, I got my PMP and I was working on a drug delivery combination product and I spent so many, so many hours in Microsoft Project talking about, okay, what has to work in parallel, what has some float, what's the critical path.

I'm just in my mind putting a Gantt chart together. So those of you listening, if you want something like that, hit me up. Maybe I'll actually put some work into doing something like this.

Work with Ali and figure out where do these people need to fit into. But don't mean to go too far down that path necessarily. It's just where my brain went.

So that was one thing you said. Okay, so that's one mistake people make where they're just focus on the next milestone, not thinking about what should have been prerequisites to that milestone.

What are some other mistakes that you've seen so, so commonly.

Ali Samiian: So, the next one is actually designing studies for the FDA, right. We are spending millions of dollars collecting data, potentially years collecting that data. Right. Collecting the evidence to get in front of the FDA. And I see this over and over again. And you know, advisors like myself are helping companies not make this mistake.

But the mistake is we get to the FDA.

Great.

Now I want to get coverage. I've got my coding. I used a precedent that had coding and payment. Great, that's, that's the easiest and I'm happy with the payment amount, by the way.

Now I go to submit the claim, and Payers say, well, your evidence isn't enough. Right. So, the FDA basically looks at is the product safe and effective?

Payers look at is there value and is there accessibility for the product? Right. So, is there clinical data that supports your product versus something else? So, if you have a sham controlled product that, that may not be the right comparator for payers.

It may be, it may not be. Right.

So, what we do with clients is as so and this is another point for your audience, right. As you're designing a clinical trial.

Typically, I get brought in at that point to say what are some payer relevant endpoints that we can incorporate in the study now so that when we come to market, we satisfy both FDA and payers.

So, I don't have to spend another two years running another six-month study. Right. So, running a six-month study will take two years to read out to collect all that information.

So how do we move the revenue cycle up that way a little bit?

Etienne Nichols: Yeah, that's, that's really interesting.

And when you're looking at those clinical studies, what are.

I'm just trying to think how do you look at that from a holistic lens? That's I. That seems like a very big job to understand those endpoints that are going to be pair relevance.

Can you, can you kind of enlighten us a little bit as to how you determine some of those things? Obviously beginning with the end in mind, knowing those different, whether it's durable and medical equipment in home versus in the, in the clinic, et cetera, what are some other things to think about?

Ali Samiian: Also, what payers really care about is does this product really work and how does it work compared to something to my standard of care. Right. So, we help identify what payers see as standard of care today and what are they paying for?

They care about durability. So, if you're coming up with a product that, that addresses a chronic disease like diabetes, right. Running pre and post study is great, but that's an acute study.

Payers want to see this is a chronic disease that the patient's going to live with.

How do I get durability data? Is the patient going to keep getting those benefits after that acute setting or is this going to fade away after a period?

So, we help identify what are some of the appropriate lengths of study that we should also be running.

The next one is actually so if you think of the overall strategy, right, payers want to make sure that your studies aren't biased. So, you want to try to minimize the risk of bias in the studies.

And that can come in the form of the end, right? The number of patients that are in the studies, the study design, the comparators, the durabilities.

So, what we do is we actually work with clients to identify what are those endpoints that are relevant from a payer perspective in those categories. And then we say this is what the payers will want.

Let's say they want 10 topics and they want the study to potentially be two years long.

Now from an FDA point of view, you, you may not want to run a two-year study, right? So, we'll identify and we'll help. We'll work with the regulatory and the quality teams to say and the commercial leadership to say what is it that we can include in this study to get us some of the information and then what are the gaps that still exist and how do we fill those gaps down the line with other evidence ideas.

Right. And that can be in the form of a randomized study, it can be in the form of database analysis, it can be real world evidence. So, there's a number of different factors, but we identify what is needed, what can we capture now and what do we, what can we afford to push down the line?

Etienne Nichols: So just to kind of recap a little bit of what you were saying that just go back to the beginning of what you said. I love that you, you talked about.

It's not just about the FDA. You almost have to be a little bit selfish and say, hey, what do I actually need to get paid and who's going to be paying it?

You need to know a lot of things in order to even ask that question. I would assume there's some that. The, the thing that I'm curious about is, is CMS is who we're trying to appease to a certain degree, but we're focused so much on FDA.

There's a program. Is it, is it the TAP Total Lifecycle Product Advisory Program or something like that that, that helps with that communication? Is that, can you tell us a little, do you know much about that?

I. Yeah.

Ali Samiian: So, I do, I do. I know enough just to be dangerous. It's certainly not my sweet spot. But what I would say. So, for companies that meet breakthrough device designation, that's step one, right?

So, you need to meet breakthrough device designation. Then you're able to fit into the TAP program within the FDA. And the TAP program actually says we're going to have a more senior leader look at your program and help guide you through the process, so you get access to.

And look everyone at the FDA is very qualified, but this actually brings in senior leadership to look at your product. Right. So that's actually. That gives you a slight advantage because they've seen different products and they can guide you.

So that opens up the discussion a lot more. And, you know, people that have gone through the tab say they have, you know, they're texting back and forth with their FDA reviewers and they're very pleased with that process.

The other real big benefit that's come to market recently is a new program called the Rapid program.

So, CMS is actually. CMS and the FD are rolling out a number of new initiatives to support and improve access as early as possible, unfortunately. So, there's an Alphabet soup out there, right. So, you used to have the T set, the M set, the Rapid. There’re all sorts of different programs out there.

Etienne Nichols: Right.

Ali Samiian: So Rapid is actually one that we're following very closely. Closely.

We anticipate feedback any day on what the pro. What the content of the program will look like. Unfortunately, nothing's out there available at the time of this recording.

But the key thinking is, how do we work with companies that have breakthrough device designation that are part of tap to help them get coverage as soon as they get FDA clearance?

Right.

So, what we're doing right now with clients is following Rapid and helping them make sure that once the information is out, the clinical requirements that are potentially spelled out in Rapid are incorporated in their studies so that they can actually try to fit into the Rapid process.

Etienne Nichols: Okay. Awesome. Yeah. I've not been familiar with this one. Regulatory alignment for predictable and immediate device program. Rapid.

Wow.

Yes. Definitely an Alphabet soup. Something to look into, though. That's very cool.

It looks like early alignment with CMS and FDA. Very cool. Okay. I know I kind of got us off track here a little bit. So, if we go back, I'm sure you have other mistakes that you've seen, and if not, we have other questions, but.

Yeah. Any others?

Ali Samiian: Yeah, so the. The third one I would say is running full speed ahead to get the regulatory approval without considering the different regulatory pathways and their implications from a reimbursement and commercial perspective.

The example I used, if, you know, my goal is to get to market as quickly as possible. And I have a device that, you know, electric, that stimulates the skin electronically, electrically. I would use the tense predicate and get to market, as, you know, within 90 days. That's fantastic.

If I want to actually consider a commercial perspective, I may actually say, do I need a de novo or not? What indication do I want to fit into because the implications from having a TENS unit versus as a predicate versus a de novo versus a potential PMA.

And I'm not saying those are the paths we have to take, but the implications of each is drastic from a commercialization point of view.

So, what we do with companies and investors oftentimes is when they're at the point where they're evaluating regulatory pathways.

We'll also come in and say if you have option A, B and C, what are the potential price points for each of those and what is the reimbursement and time to reimbursement for each of those.

And then the leadership can make a decision based on knowing what the implications are as opposed to rushing and then being stuck with something.

Etienne Nichols: What are some of the implications for risk class? I mean, that's interesting.

My brain immediately goes to MDUFA, and the fees associated with each one. Class II being something like 20 grand. Class III being order of magnitude 300 something grand.

Not thinking about the small business fees, but, but there's that initial upfront cost. But I'm sure down the line there's, you know, potential ROI. But what are some of the different implications?

Ali Samiian: So, I would say it all depends on whether you're home use. So going back to your side of care. Right. So, if your procedure, if you're a device used in a procedure or a key component of a procedure, chances are you're going to be much more high risk and you're going to be pushed on the PMA side.

But again, on that front, we, we want to identify who are the stakeholders, right. So, if you're a device that's used in a hospital inpatient setting, the requirements might be the payer might be different. Right. You may not care what CMS wants, but you may care what hospital administration wants.

Right. So, identifying who are the stakeholders in each of those settings.

Right. For your product and defining what their requirements are and then tying the clinical endpoints to what their drivers are.

Sometimes it's health economics outcomes. Right. So, looking at length of stay and you know, not coma, you know, reduction in infection.

Exactly. So those are all the different components that come together.

Etienne Nichols: Okay, now that makes sense. And does CMS have something like FDA's guidance?

I'm, this is completely outside my realm. The CMS is something I've never really delved into. So, I'm curious what, what kind of regulation they, they put out or, or documentation.

Ali Samiian: So, I would say typically people say the FDA is becoming a lot more transparent and easier and easier to work with the payer side is still very oblique. Right.

If you've lived it and you've gone through it a bunch of times, it's. You're like, oh, of course that makes sense. We've seen it.

But unfortunately, if you haven't gone through it, there's not a whole lot we can point to. There’re rules and regulations you can go start looking at, but it's. It's a lot of legal.

Etienne Nichols: Yeah, yeah, unfortunately, which is why we have people like you, which I'm thankful for.

Okay. Any other mistakes that you wanted to point out or any other thoughts there.

Ali Samiian: You know, the last thought there would be don't view reimbursement. And that's the point you made at the beginning. Right. Don't view reimbursement as paperwork.

It's not about filing prior authorizations and all of that. That is part of reimbursement.

But if we do everything right, it's more about product strategy upfront so we identify what the product needs to be and that allows us to have a clear path to ultimately reimburse.

Etienne Nichols: Yeah.

Ali Samiian: As opposed to thinking of it afterwards and saying, this is what I have. What can we do with it? And my hands are a lot more tight at that point. So, it's more, it's a lot more reactive at that point as opposed to proactively mapping out what we want.

Etienne Nichols: Yeah.

And I love, I love that what you talked about with the clinical trials and adding some of those simple endpoints to existing studies, because I, I would assume if I'm a founder and I hear that I need additional endpoints, that's another clinical study which is just more cash register, you know, the dollar signs going up when you talk about or I kind of mentioned some of the things that you've done in the past in the intro, I think it was Cala Health, you helped build new codes and win a CMS payment.

Yeah.

There was no existing pathway there for a novel device or digital therapeutic with no code.

How do you build that access from scratch? Can you talk a little bit about that process just to kind of demystify it just a little bit?

Ali Samiian: Sure. So again, it depends on what the site of care is. Right. So, let's. That's the first step.

Etienne Nichols: Yeah.

Ali Samiian: For simplicity, I can talk about home care or if you have another.

Etienne Nichols: Yeah, let's go home use. Yeah.

Ali Samiian: Just because there's a lot of new wearables coming to market. There's, you know, I think that's a hot area.

So as the product is coming to market. Right. We identified that we are going to be a home use device.

Right.

So, the, you know, as we do our landscape assessment, that's one of the things we do with the companies. Right. So, what codes could you fit into?

What are the payment amounts for those codes? Is that something that is satisfactory or not?

Right. So, if there is a very good code that you can fit into, and I'll give you another example, there was a product that was coming to market and their product had, I think two electrodes and the code was written for four electrodes.

And the design team was super excited, like we're even more efficient with two less electrodes. And they were very happy with the payment of the four electrodes. So, we identified, look, if we can actually have the four electrodes,

we can fit under the code. If we don't have the right electrodes, we're not going to fit into. So, matching the product design with the code descriptors is critical.

Etienne Nichols: Yeah, that makes sense.

Ali Samiian: If you don't fit into those codes. So, if, let's say you're unhappy with the payment amount of those codes,

then we say, okay, now we need to start identifying a different code we want to fit into.

If nothing fits, we need to actually identify why we need a different code.

Because the starting point for CMS, and this is actually the example I give all the time, CMS says this is a cup. A cup is a cup. Whether you have coffee in here or, you know, or coke, tea, whatever, whatever. Exactly. I shouldn't pay a price that's different for the cup.

Yeah, which makes perfect sense. Right. And that we want to be responsible with our funding and spending, which is what we want from CMS and all payers.

But as a commercial team, if we can actually, and I'll use essential tremor as an example. Right. So, if I, if we, if we develop a product, a cup that actually prevents patients with essential tremor from spilling or to allows them to have a better quality of life or change their activities of daily living or improve their activities of daily living.

All of those should allow us to get to a premium price compared to what's on the market. Right.

So, what we do at that point, we actually help companies identify what are the technological differences that they need to think about. Is it, are you producing green cup versus a white cup or are there additional arguments we can make? Right. So, is this a cup that prevents billing? So, it doesn't matter how much my hand tremors.

Etienne Nichols: Right.

Ali Samiian: I still prevent. Right. So those are some of the technological differences that we can come up with. And then how does that translate into meaningful clinical outcomes?

Etienne Nichols: Yeah, yeah, that makes sense.

Ali Samiian: Very good thinking's that need to go into it from early on.

Etienne Nichols: So. Okay, last question for me, if I'm serious.

Ali Samiian: Before you go there, sorry. I'm gonna just go down that rabbit hole a little, please.

Etienne Nichols: Yeah, I love it.

Ali Samiian: So that was the coding piece, right. So that's the coding.

Then we need to identify what price point do we want. So, once we have a path to establishing a new code, we also need to be mindful of pricing. And this is where CMS will say, well, you've got a cup, I've got a cup.

A cup is a cup. I'll pay you, I'll give you a new code, but I'll pay you at the same price as this code as this cup.

Or if we're able to differentiate enough between the technologies again, then we're able to establish our own pricing.

There's a huge commercial. So, as you think of your roadmap. Right. Just trying to demystify it here, you need to identify the code, you need to identify the payment amounts or help determine what that payment amount will be.

And lastly, we'll get into coverage.

Etienne Nichols: Now before we get into coverage, okay, determining that price amount sounds pretty subjective until I would assume, or we're going to be talking about cogs a little bit cost of goods sold and what goes into it, the technology and the, all of the overhead.

At least that from a business standpoint I would be thinking about those things. What does CMS think about and how do they go about negotiating?

Ali Samiian: So, it's not much of a negotiation.

Etienne Nichols: Okay.

Ali Samiian: At this point, the CMS does negotiate for pharma prices now, so there is a precedent for them to do that, which is fantastic.

But on the device side there are rules to follow. So, if you fit into an exist. So, I see this all the time in, in HCPCS meetings. So, in CMS meetings where payment and codes are determined, CMS will say, look, this looks like a red cup, so I'm going to pay you the same price as a red cup, even though it's a white cup.

And the price of the red cup is $500.

So, tens units, right? Tens units are something that a lot of products fit into.

So, CMS will say, I'll pay you 500, $500 over five years for this product.

And manufacturers, their feedback on the call is this does not cover my costs of the product.

And CMS says, well, if you come up with your cost of goods, then we'll look at it. And your cost of goods are 700. I'll pay you 800. Right.

That's kind of the game.

So, we recommend that clients do not talk about cost of goods when it comes to Medicare. We actually focus on the value that we bring to the system. Right, yeah.

Because our cogs aren't necessarily reflective of the value that we bring to the system. If you have a disease, a disease area with a high unmet need, very little options for a patient population, there's a big value there. If you're preventing, and this is an extreme. If you're improving mortality rates, reducing side effects, reducing risks, procedure risks, all of those things, those have values associated with them. So, we actually work with companies to identify what is the price potential they can charge for a product.

Right. And what the healthcare system is willing to pay.

Etienne Nichols: I like that because it incentivizes focusing on the value to the patient versus incentivizing driving down the costs of production, which can result in a lower quality. If you're really trying to cut corners and cut as many or increase throughput and so forth, and they're not mutually exclusive, you can actually maximize for patients while also focusing internally on reducing cogs over time.

Yeah, absolutely. I love that. Very cool. Okay, so you said the, The. The other component. The commercialization. No, the coverage. The coverage piece, yes.

Ali Samiian: So, we talked about coding, we talked about payment, and then the last one is coverage. And basically, coding says what number, you know, what alphabetical number do we use? Alphanumeric number do we use to identify that this product or this class was used?

Payments as, how much do we pay every time this product is used?

And coverage identifies which patient population is the right patient population to benefit from your product.

Right.

That's when evidence becomes critical.

So, evidence matters for the coding and payments, but it's critical for coverage.

Etienne Nichols: Okay. Because you're really proving that they need this. Yeah, that makes…that makes total sense.

Ali Samiian: Exactly. So, identifying early on what the patient population looks like is critical because you want to identify why the patient population requires this from a medical necessity perspective. Right. It's not the dollars and cents are required, but in the US our focus is on medical necessity.

If the product is medically necessary, the insurers will provide access to it.

Okay, so we want to identify what the patient is, and then what evidence do we have that the product works in that population?

Etienne Nichols: You've covered a lot of ground. At least in my mind, it covers a lot of ground. I almost. I'm. I'm just like picturing a one sheeter of all these different questions that I would expect a founder or someone to answer before coming to you.

Even so that you can do the best job that you can do. I mean, I don't know, maybe we can put something together like that. I'll. I'll have to see what I can do and run it past you and put it in the show notes or something if those of you are interested.

If you don't see that, reach out and both either to Ali or myself. If we can maybe answer some questions. Any other last piece of advice or thoughts you want to give the audience?

Actually, oh, I had one other thing, and you can answer that question next. If you, if you think about that, I'll. I'll stop for you.

Let's say I'm a series A founder because I think we met at you know, being meeting at lsi. We meet a lot of those founders. They may have a great device like you said, they'll pull it out of their bag, they want to show it off and so on.

They're on tight budgets; they're trying to meet with active investors right now.

If I'm one of those guys, where do I start on market access and what do I prioritize? What should I be prioritizing in this my first couple years versus what can wait?

Any thoughts there?

Ali Samiian: I would say step one, get a landscape assessment, right? Know what the landmines are that you, you could potentially step on, right. So, identify what codes could potentially apply to you.

What's the payment associated with those, and you know that's for an early-stage company. That's typically what we do. Right. So, what is the landscape assessment? What are the codes that you could fall into?

Do you like those payment determinations? If you don't, then let's try to make a plan to go away from them. The worst thing you can do is go really down the line and then be stuck with the decision that you didn't even know was facing you.

I'm actually going to answer that slightly differently as well. So, the answer depends on what stage you're at. I know you said series A. Right.

But if you're at the product design, that's what I would say. Get a landscape assessment. If you're at the.

I'm still at State, you know, Series A and I'm starting to design my clinical study for the FDA.

That's another approach, right. You want to make sure we identify what are payer relevant endpoints to minimize the data you need to come up with after the FDA, because that's another huge burn rate.

And if we can help you identify what you're incorporating into the FDA study from a payer perspective,

that actually alleviates a lot of the investor concerns as well.

Etienne Nichols: Yeah. Okay.

Ali Samiian: Those are the two key.

Etienne Nichols: Okay. I love it. Ali, this has been a really fun conversation. I've learned a lot. I'm gonna have to go back and think about some of these things and digest it.

Maybe at some point we can have another conversation if there's someone there who has a specific or even far-reaching reimbursement question and you would like to hear some more because I know I'm coming at this from a more of a beginner's mindset and I would like to go, I always like to go a layer deeper once I learn about something. Okay, there's. I know there's a lot more meat on this bone.

Feel free to reach out to me on LinkedIn wherever else. Reach out to me, reach out to Ali and say, hey, yeah, you do need to do this again because I need to know this other thing.

Any last piece of advice, I'll go ahead and throw that out there and give you that offer. Whether it's come find me here or I'll be at this event. Any calls to action, feel free.

Ali Samiian: Available online. Like you said, my mission and the company's mission is to make sure that technologies, innovative technologies get into patients’ hands.

And that's not done after the FDA. That's done from the beginning, and it's not done until the patient is using the device successfully and getting the benefit that we as founders intended for them to get.

So. And one last comment. There is the more innovative your technology and I love it because in the home care setting, we're coming especially in neuromodulation, we are coming up with some fantastic new devices and new technologies, but the more innovative the technology, the earlier commercialization should begin because we can't fit a, you know, a circular peg in a round. In a square peg. Yeah, a square peg in a round hole. So.

Etienne Nichols: Right. Yeah, yeah.

Ali Samiian: Start early here.

Etienne Nichols: Very cool. Well, I think you've given a lot of good advice. Definitely reach out to Ali if you have additional questions. Reach out to me if you'd like to hear more.

But Ali, thank you so much. Really appreciated this conversation. I enjoyed it. Those of you who've been listening, thank you so much for listening to the Global Medical Device Podcast and hopefully we'll get to see you in person at one of the upcoming events.

If not, reach out to us and we'll see you next time. Take care.

Ali Samiian: Excellent. Thanks Etienne

Etienne Nichols: 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 favor. Favorite podcast platform if you've got thoughts or questions, we'd love to hear from you.

Email us at podcast@greenlight.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.

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