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Cleared for Takeoff: Go-to-Market Insights from a MedTech First Officer

Thu, 28 May 2026 17:11:29 GMT

You Got Your 510(k). Now What?

Congratulations! You just got your 510(k) clearance. The champagne's been popped, your LinkedIn post got 200 likes (I was probably one of them), and your investors are thrilled. Now comes the part nobody warned you about: clearance doesn't mean commercialization.

I've watched this movie dozens of times. A MedTech startup spends two years and a significant chunk of their funding getting through FDA. The day they get that clearance letter, they think the hard part is over. They start hiring reps. They start booking meetings. They start talking about revenue projections.

And then they hit a wall. Because the market doesn't care that the FDA said yes. The market wants to know who's paying for it, how much, and whether the evidence justifies switching from whatever they're already using.

If you don't have answers to those questions on clearance day, you're already behind.

The Clearance-to-Commerce Gap

Here's what I mean by the gap. FDA clearance answers one question: is this device safe and effective enough to be legally marketed? That's it. It says nothing about:

Whether any payer will cover it
What code a provider should bill under
Whether a hospital can get reimbursed enough to justify the purchase
How your product fits into existing clinical workflows
What the economic argument looks like compared to the current standard of care

These aren't nice-to-haves. These are the questions that determine whether your cleared device generates revenue or collects dust. Yet, most startups treat them as Phase 2 problems. You know, something to figure out after clearance. That's the mistake. By the time you're cleared, you should already have a reimbursement strategy, a coding pathway, a payer engagement plan, and at least a preliminary health economic model. If you're starting from scratch on clearance day, you've handed your competitors a six-to-twelve-month head start.

Reimbursement Is Not a Sales Problem

This is where I see startups get it wrong most often. They treat reimbursement as something the sales team will "figure out in the field" or a hospital will “know how to deal with.” It's not. Reimbursement is a strategy problem, and it needs to be solved at the corporate level before a single rep walks into a hospital.

Here's what that means in practice:

Coding. Does your device have an existing CPT or HCPCS code that accurately describes the procedure? Or does it require a new code, a miscellaneous code, or a Category III tracking code? Each of those paths has wildly different timelines and implications for adoption. If you're relying on a miscellaneous code, you need to understand what that does to a provider's willingness to use your product.

Coverage. Even with a code, payers aren't obligated to cover your device. You need to understand the coverage landscape. What does Medicare say? What are the major commercial payers doing? Is there a National Coverage Determination, a Local Coverage Determination, or nothing at all? If the answer is nothing, your providers are going to face claim denials, and that kills adoption faster than any competitor.

Payment. Coverage doesn't guarantee adequate payment. If your device is reimbursed under an existing DRG that doesn't reflect its actual cost, hospitals lose money every time they use it. Understanding the payment math, and being able to show a hospital CFO that the economics still work, is essential. This is where health economic modeling becomes critical, and it's work that should start well before your clearance comes through.

The Payer Conversation Starts Earlier Than You Think

If you're waiting until post-clearance to engage with payers, you're too late. Payers want to see clinical evidence, economic data, and a clear articulation of the unmet need your device addresses. Building those relationships and that evidence package takes time.

For some devices, early payer engagement, even during the clinical trial phase, can shape your evidence generation strategy in ways that dramatically accelerate coverage decisions later. What endpoints are payers looking for? What comparators matter to them? What does the budget impact look like from their perspective?

These aren't questions you can answer from your own conference room. They require payer-specific research, and often direct engagement.

Your Go-to-Market Strategy Needs More Than a Sales Team

I've seen startups hire a VP of Sales as their first commercial hire. Doing this is like hiring a pilot before you've built the runway. Before you start selling, you need to answer some fundamental questions:

Who is your target facility? Not every hospital is your customer. Academic medical centers, community hospitals, ambulatory surgery centers, and IDNs all have different purchasing processes, different reimbursement dynamics, and different tolerance for new technology. If you're going after everyone, you're going after no one.

What does the adoption pathway look like? Most devices don't go from clearance to hospital-wide adoption overnight. There's usually an evaluation period, a trial, a Value Analysis Committee review, and then a contract negotiation. Each of those stages requires different materials, different relationships, and different conversations. Map the pathway before you start walking it.

What's your GPO strategy? Group Purchasing Organizations control a significant share of hospital supply contracts. Understanding which GPOs are relevant to your target customers, what their contracting timelines look like, and how to position your product within their portfolio is foundational work. Sadly, I see too many startups leave this as something to figure out after their first few deals stall.

What evidence do you still need? Sometimes your 510(k) clinical data is enough to drive adoption. Often it's not. Hospitals and payers may want real-world evidence, comparative effectiveness data, or health economic analyses that go beyond what you submitted to FDA. Knowing what's missing, and having a plan to fill those gaps, is part of your commercial strategy, not separate from it.

The Companies That Get This Right

The MedTech companies that commercialize successfully don't treat clearance as the finish line. They treat it as a checkpoint. By the time that letter arrives, they've already done the work:

Their reimbursement strategy is defined, with coding, coverage, and payment pathways mapped
Their health economic model is built, with data the committee and payer audiences actually need
Their target customer profile is clear, with a segmented approach that matches resources to opportunity
Their payer engagement has started, with at least a preliminary understanding of coverage dynamics
Their go-to-market plan accounts for the full adoption pathway, not just the first sales call

These companies don't move faster because they have bigger budgets. They move faster because they started the commercial planning work while the regulatory work was still in progress.

You have spent years getting cleared. Are you going to spend another year figuring out how to actually sell?

The gap between clearance and commercialization is where most MedTech startups lose momentum, burn cash, and watch their window of opportunity narrow. It doesn't have to be that way but closing that gap requires treating commercialization as a strategy discipline, not a sales exercise and it’s something you need to start working on today!

PRIA Healthcare helps MedTech companies build the reimbursement, health economic, and market access strategies that turn FDA clearance into commercial traction. If you've got your clearance (or you're getting close), let's talk : Contact Us

Suzy Engwall

Senior Director, Global Business Development & Strategic Growth

Reading the Water: Navigating What Matters in Regulatory and Quality

Thu, 21 May 2026 16:23:05 GMT

Right Sizing Your Quality System

Many small companies start their quality system the same way. They buy an SOP pack. Or they sign up for a popular eQMS marketed to startups and turn on the starter set that comes with it. It feels efficient. It feels like progress.

Much of the time, it creates a different problem.

Those systems are usually built to work for everyone. That means they rarely fit anyone especially well. For a small company, they are often too complex. For a larger company with a more complicated product, they may not go far enough.

The bigger issue is that most companies using those systems are not in a position to tell the difference. They do not know whether a given procedure reflects an actual requirement or just one company’s preferred way of meeting that requirement.

I saw this often when I was in the FDA. Some of the companies with the most resources still ended up in trouble, not because they ignored quality, but because they built systems they could not actually run.

One example that stuck with me was training. Under the old QSR, the training requirement itself was less than a paragraph. This company turned it into a nine-page procedure and built it into a complex custom LMS. On paper, it looked robust. In practice, it did the opposite of what it was supposed to do.

When I brought in the manager and asked a basic question, who is qualified to perform which job, she could not answer it clearly. She could not tell me what record she used to confirm that an employee was qualified. At the time, we could not even say with confidence whether the person running release QC testing was actually qualified to run that test.

That is the problem with overbuilt quality systems. They create activity without creating control.

A lot of young companies assume the safest thing to do is write more. More SOPs. More approvals. More workflow. More software.

That is not the same thing as having a stronger quality system.

A good quality system should do three things. It should meet the requirements. It should fit the company. It should be something the team can actually use and maintain.

This is where founders usually need help. Not because they are incapable of running quality, but because they need someone to separate what is required from one possible way of meeting the requirement. There is usually more than one acceptable way to build a compliant system.

The right quality system is not the biggest one. It is the one the company can live with, scale with, and defend when it matters.

You do not need the biggest boat in the marina. You need one you can actually run, maintain, and trust when the water gets rough.

If you'd like to learn more from Sam about quality systems for your novel medical technology compay, please contact us.

Sam Murray

Head of Regulatory & Quality

Cleared for Takeoff: Go-to-Market Insights from a MedTech First Officer

Tue, 19 May 2026 14:55:55 GMT

5 Mistakes MedTech Startups Make Before Their First VAC Meeting

Here's something most first-time MedTech founders don't realize until it's too late: when it comes to hospital Value Analysis Committees, you're probably not going to be in the room when they evaluate your device.

Value Analysis Committees don't typically invite vendors to present. Your product will be evaluated by a cross-functional group including clinicians, supply chain, finance, risk management, quality professionals and potentially others, based on the materials you submit to them and the case your internal champion makes on your behalf.

To be clear for those of you who are still wrapping your head around this - someone else is basically selling your product for you, using whatever you gave them to work with.

This should change everything about how you approach VACs. The mistakes that kill deals in Value Analysis aren't presentation mistakes, they are preparation mistakes. They're gaps in what you built, who you prepped, and what you sent into a room you'll never set foot in.

These are five of the mistakes I see over and over:

1. You Armed Your Champion With a Brochure Instead of a Business Case

Your physician champion believes in your product. They've used it, they like it, they want it on contract. This is necessary, but it is in no way sufficient.

When they walk into that committee meeting, they're not pitching to other physicians, they're defending a purchasing decision to supply chain directors, financial analysts, and risk managers. If all they have is your glossy sell-sheet or a pitch deck and a personal endorsement, they're likely going to get eaten alive.

What your champion actually needs is a concise, evidence-based business case: clinical evidence, healthcare economics, workflow impact analysis, and a clear implementation plan. Something the committee can review, circulate, score, and reference when they vote.

Your champion's credibility is on the line every time they bring a product forward. Please respect that by giving them something they're not just able, but proud to defend.

2. You Didn't Prep Your Champion for the Reimbursement Question

It is inevitable that someone on the committee is going to ask: "How does this get reimbursed?"

Your champion is a clinician. They probably don't know the answer. So, when they stumble, hedge, or say "the company is working on that," you just introduced uncertainty into a room that is fundamentally designed to eliminate it.

Before your champion ever submits a request for review, make sure they can clearly articulate:

Which CPT/HCPCS codes apply, and whether your device fits existing codes or needs new ones
Current payer coverage status, both commercial and Medicare
Whether your product changes the facility's DRG or reimbursement amount
Any prior authorization requirements that could slow adoption

Your champion doesn't need to be a reimbursement expert, but they do need enough of a command of the basics that they don't create doubt. Give them a one-page reimbursement summary they can reference or hand off to the committee. Make the hard question easy for them to answer.

3. You Built the Value Story for the Surgeon, Not the Committee

Your champion is excited about clinical performance. Better visualization. Faster procedure times. Superior outcomes. And they're going to lead with this, because it is what matters to them. But the committee is evaluating your product against a much wider scorecard. The CFO cares about total economic impact. Supply chain cares about logistics, shelf life, and compatibility with existing systems. Risk management cares about liability and post-market surveillance. Quality wants outcomes data and complaint history.

If your materials only speak the clinician's language, your champion is carrying a one-dimensional case into a multi-dimensional evaluation.

The fix: build a value dossier that gives your champion ammunition for every stakeholder in the room. Clinical outcomes for the clinicians. Healthcare economics (not just unit price) for finance. Workflow and staffing impact for nursing. Compatibility and logistics for supply chain.

One product with multiple value stories. All in one document your champion can hand over.

4. You Skipped the Pre-Meeting Groundwork

The VAC meeting is the formal vote; the real evaluation starts long before it. And if your champion submits a request without any groundwork, they're walking in cold, and so is the committee.

Before the request ever gets submitted, someone on your team needs to:

Start talking to supply chain early. They often control the intake process and can tell you exactly what the committee requires, what format they want it in, and what's tripped up other submissions
Work to gather insight into the committee's evaluation criteria and scoring methodology so your materials map directly to how they'll be assessed
Know the meeting cadence. Some VACs meet monthly, some quarterly. Missing a submission window can cost you months
Find out if there are other stakeholders beyond your physician champion who should be briefed before the meeting. A supportive supply chain director or nurse manager can shift the dynamic in the room

The companies that win don't just submit and hope, they do the work to make their champion's job easy, and the committee's decision obvious.

5. You Didn't Model the Economics, So the Committee Did It for You

Most startups hear "we need this to be cost-neutral" and think it means matching the price of the incumbent product. It doesn't.

Cost-neutral means the total economic impact nets out even or better (think acquisition cost, training, disposables, procedure time, length of stay, readmissions, complications). This is a much more complex argument than sticker price. And, it's a much more winnable one, if you do the work.

But here's the problem: if you don't provide that model, the committee will build their own. And their model won't include the downstream savings, the efficiency gains, or the complication reductions that make your case. It'll be a straight-line cost comparison, and you'll probably lose on price to the incumbent.

Give your champion a defensible economic model and show how it plays out over 12 to 24 months. Quantify the clinical and operational value. Make it easy for the committee to see the math because if they have to guess, they'll guess conservatively.

In Summary

Value Analysis Committees exist for a good reason. They protect hospitals from making expensive, poorly supported purchasing decisions. In most cases, they're making those decisions without you in the room.

This means your job isn't to deliver a great presentation or pitch deck, it's to build a great case and put it in the hands of a champion who's fully equipped to carry it.

Come prepared with a real business case, an economic model that holds up, a reimbursement story without holes, and materials that speak to every stakeholder at the table. Do that, and you won't just survive the VAC process, you'll make the committee feel smart for saying yes.

PRIA Healthcare helps MedTech companies build reimbursement strategies, health economic models, and market access plans that hold up in the rooms that matter — even when you're not in them. If you're preparing for your first (or next) VAC submission, let's talk : Contact Us

Suzy Engwall

Senior Director, Global Business Development & Strategic Growth

Reading the Water: Navigating What Matters in Regulatory and Quality

Thu, 14 May 2026 13:00:31 GMT

Using Regulatory as a Strategy and Not a Milestone

A lot of teams think about regulatory as a gate they need to get through. Pick the path. Build the package. Get the answer. Then move on.

That mindset leaves a lot on the table.

The better way to think about regulatory is as a way to create options. Good strategy is not just about getting to one answer. It is about reducing risk, preserving flexibility, and helping the company move forward without wasting time.

I saw this with a company that had a real opportunity to ask FDA a bigger question tied to a broader future indication. The path would have been harder. Nobody knew for sure how FDA would react. The company had already paid for the work, and we had already written the Breakthrough submission, but they hesitated because they were not sure the data was perfect.

So they waited.

By the time they came back around, the market had moved. About eight months later, a competitor received clearance, which effectively removed their ability to now qualify for Breakthrough. The company then shifted toward a narrower, more conventional strategy. That narrower path may still have made sense in the end. That was never the problem.

The problem was that they lost time and closed a door they did not need to close.

They could have asked the harder question earlier. They could have gotten FDA feedback. They could have kept multiple paths alive while continuing to build the business. They could have used that feedback to shape their study strategy, their investor story, and their next decision point.

Instead, they stayed tied up at the dock.

That is what happens when regulatory is treated like a single track instead of a sequence of strategic decisions.

Sometimes a 510(k) is the right move because it gets a product to market faster, creates early revenue, and helps de-risk what comes next. Sometimes a broader future path remains the real value driver. Sometimes a designation or a narrower initial use is worth pursuing simply because it gives the company more room to maneuver later.

The point is not to pick the biggest path or the fastest path just because it sounds better.

The point is to make each step do something useful:

Reduce uncertainty
Create leverage
Keep future options open

You do not catch much fish with bait sitting on the deck. No matter how good it is, you still need lines in the water.

Regulatory strategy should work the same way. Ask the questions that matter. Keep the right options open. Let each step set up the next one.

That is how you build momentum without boxing the company in.

If you'd like to learn more from Sam about regulatory strategies for greater adoption of your novel medical technology, please contact us.

Sam Murray

Head of Regulatory & Quality

Reading the Water: Navigating What Matters in Regulatory and Quality

Wed, 06 May 2026 22:21:06 GMT

Approval Isn’t the Goal, Adoption Is

I see this mistake all the time. Founders build their roadmap around getting FDA clearance.

It becomes the milestone, the moment everything is supposed to change...and it doesn’t.

FDA clearance just means you are allowed to sell something. It doesn’t mean anyone wants it. It doesn’t mean anyone will pay for it. It doesn’t mean it fits into how care is delivered.

I worked with a company developing a product in a crowded space. Dozens of alternatives already existed, many selling for less than $150. Their belief was that if they got FDA clearance, they could price their product at over $10,000. That was never going to happen. Even after multiple clearances (some to even try and “differentiate” them).

Providers don’t think in terms of regulatory pathways. They care about cost, workflow, and whether the product solves a real problem. Clearance doesn’t create demand. This is where companies get off track. They treat FDA authorization as validation of value. It’s not. It’s permission.

I see the same thinking with PMA products. There’s an assumption that because the bar is higher, the outcome is better. That FDA agreeing with safety and effectiveness is the “golden ticket.” It isn’t. A PMA doesn’t guarantee adoption. It doesn’t guarantee reimbursement. It doesn’t guarantee a viable business.

On the other hand, I’ve seen simpler pathways, 510(k)s and De Novos, lead to strong adoption because the product actually made sense for providers and fit into how care is delivered. When providers use something, reimbursement tends to follow. Not the other way around.

What actually drives success is much simpler. Indications, claims, and evidence need to align with something the market will adopt and pay for.

And regulatory is rarely the biggest cost in getting there. The real spend is product development, clinical work, and commercialization. If those are aimed at the wrong outcome, the mistake gets expensive fast.

The core issue is where companies start. They ask, “What can we get cleared?”

The better question is, “What do we need to sell?”

Marketing and product should define the target. What problem are we solving? Where is the revenue? What does adoption look like?

Then regulatory builds the path to support that. Not the other way around. That doesn’t mean taking unnecessary risk. It means being intentional. Sometimes a narrower or faster pathway makes sense as part of a broader strategy. But it should still point toward a commercial outcome.

You have to read the water… Know where the opportunity is. Know where the risks are. Know when to push and when to stay off the rocks.

Clearance is just a step. Adoption is the win.

If you'd like to learn more from Sam about strategies for greater adoption of your novel medical technology, please contact us .

Sam Murray

Head of Regulatory & Quality

CMS + FDA just announced RAPID. What does this mean for your new device’s pathway?

Fri, 24 Apr 2026 19:03:48 GMT

CMS + FDA just announced RAPID. What does this mean for your new device’s pathway?

The new Regulatory Alignment for Predictable and Immediate Device (RAPID) program aims to accelerate Medicare access for certain Breakthrough Devices by aligning FDA approval and CMS coverage earlier in development.

This new coverage pathway is another strong signal that Breakthrough designation still matters, and in some ways, matters even more now. As we wrote in our recent post on the value of Breakthrough , the real upside was never just NTAP. It was earlier alignment, earlier feedback, and earlier visibility into what evidence will matter downstream. RAPID builds directly on that idea by bringing CMS into the process earlier, and linking Medicare coverage more closely to FDA development and review.

And, RAPID looks like one more step toward a world where regulatory and reimbursement planning have to happen together from the beginning, not one after the other.

A step in the right direction, however, still limited in scope

For now, this program is for Breakthrough Devices that address unmet medical needs among Medicare beneficiaries, and is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) , and Class III devices regardless of whether they are participating in TAP. To be eligible for the RAPID coverage pathway, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS.

Early alignment on evidence that matters for Medicare

Through the RAPID coverage pathway, CMS will now be a part of the early and frequent engagement between the FDA and device innovators. The coverage pathway will link manufacturers to CMS experts early in development to understand what clinical outcomes are most relevant for Medicare beneficiaries.

This coordinated approach allows CMS and the FDA to rely on premarket evidence to inform both the FDA premarket review and Medicare coverage processes. Aligning evidence expectations earlier reduces duplication, improves efficiency, and provides increased transparency to innovators.

Regulatory considerations

CMS says the current path from market authorization to Medicare coverage can take about a year or more. In practice, companies often feel that gap much longer, especially when the evidence package was designed only for FDA, and not with future coverage in mind. RAPID is clearly meant to reduce that disconnect by allowing CMS and FDA to align earlier on the clinical outcomes that matter for Medicare beneficiaries and by targeting coverage as soon as about two months after authorization for eligible devices.

That does not make development easier. It likely means some IDE studies will need to carry more weight than they otherwise would, if a company wants both authorization and faster coverage. CMS says eligible devices must be in an IDE study that enrolls Medicare beneficiaries and studies clinical outcomes agreed upon by both FDA and CMS. That may push some sponsors to build endpoints or study elements that FDA alone might not have required.

However, if your target population is largely made up of Medicare beneficiaries, this is exactly the kind of tradeoff worth making. At the end of the day, clearance or approval is only part of the story -- what matters is getting paid.

In conclusion

The RAPID Program could be meaningful… but it’s far from a complete solution. And, it reinforces that regulatory and reimbursement planning should happen concurrently from the beginning, not consecutively.

PRIA is actively tracking how this evolves and what it means for clinical strategy, coverage, and payment pathways. If you’re thinking about how RAPID may impact your development or market access strategy, let’s talk.

Please reach out to our team if you'd like to discuss RAPID.

What CMS's Proposed NTAP Change Means for Your Breakthrough Device Strategy

Mon, 20 Apr 2026 20:06:31 GMT

What CMS's Proposed NTAP Change Means for Your Breakthrough Device Strategy

Tonya Dowd and Jessica Holmes' Strategic Reimbursement Perspective:

The Medicare Inpatient Prospective Payment System (IPPS) reimburses hospitals through fixed, bundled payments per discharge based on Diagnosis-Related Groups (DRGs), which often lag in accounting for new technology costs. To bridge this gap, CMS established programs like New Technology Add-on Payment (NTAP) and Transitional Pass-through (TPT), offering temporary incremental reimbursement for technologies that meet criteria for newness, cost, and substantial clinical improvement (SCI).

In recent years, FDA-designated Breakthrough Devices benefited from an alternative pathway that presumed they met the SCI requirement, easing access to NTAP. However, in the FY 2027 IPPS Proposed Rule, CMS proposes to eliminate this presumption, requiring all technologies to independently demonstrate meaningful clinical improvement—signaling a stronger emphasis on robust, outcomes-based evidence.

CMS May Eliminate the “Breakthrough Shortcut” for NTAP

In the FY 2027 IPPS Proposed Rule released on April 10, 2026, CMS proposes to repeal the alternative pathway that has helped certain FDA-designated Breakthrough Devices attain New Technology Add-on Payment (NTAP) for inpatient services and outpatient services under Transitional Pass Through Payment (TPT), without meeting the substantial clinical improvement hurdle.

Why this matters: If finalized, Breakthrough Designation may still open doors with FDA, but it may no longer open the same doors for Medicare incremental payment. For companies preparing for NTAP or TPT, this is a wake-up call to strengthen evidence, reimbursement strategy, and policy engagement early on.

The filing cut-off date for 2027 NTAP eligibility is May 1, 2026 . The operative date for TPT in 2027 is September 30, 2026. Thereafter, under the existing proposal, all Breakthrough Designation applications will need to demonstrate that a technology is new, costly, and supported by evidence showing a substantial clinical improvement over existing options.

This is still only a proposal, which means there is time to weigh in. If this change could affect your technology, your launch strategy, or patient access, public comments may be submitted to CMS by 5:00 pm EDT on June 9, 2026 -- See the proposed rule and submit comments here .

From Sam Murray's Regulatory Perspective: Focus on TAP, not NTAP, for long-term strategy

Most of the early reaction to CMS’s proposed NTAP change has, understandably, focused on reimbursement. If finalized, Breakthrough designation may no longer provide the same shortcut into NTAP or TPT. That matters, however, from our regulatory perspective, it does not change the bigger picture nearly as much as some people may think. Breakthrough was never valuable only because of NTAP.

Breakthrough still does a few important things very well. First, it gives a company meaningful third-party validation. While not a marketing authorization, it is the FDA agreeing that the product shows enough technical and clinical promise (“success”) to warrant the designation. That matters, especially for emerging companies trying to raise capital, build credibility, or show that their story is more than just an internal belief.

Second, it gives sponsors more access to FDA. Sprint discussions and related program features can help companies get targeted feedback earlier and avoid wasting time and money going too far down the wrong path. That is not just a speed benefit - it is a capital efficiency benefit.

Third, and maybe most important going forward, Breakthrough can open the door to TAP. That is where the long-term strategic value may now sit. TAP gives companies earlier opportunities to hear from payers and other stakeholders about the evidence they actually want to see. It can shape study design, evidence planning, and even fundraising strategy in a much more practical way than waiting until after launch to find out what the market will require.

NTAP was always helpful, but it was never permanent. TAP may actually prove to be the more important advantage.

So our view is pretty simple: Breakthrough is still a high-reward, relatively low-risk strategic tool. What may change under this proposal is not whether companies should pursue it, but how they should think about its value -- less as a reimbursement shortcut, and more as a way to validate their story early, get closer to FDA, and build a smarter evidence plan for the path ahead.

For more information on the proposed NTAP change, please reach out to our team: CONTACT US

PRIA Healthcare Welcomes Sam Murray as Head of Regulatory and Quality

Tue, 10 Mar 2026 14:14:54 GMT

At PRIA, we meet MedTech companies where they are in their journey and stay with them as they grow. For more than 14 years, that has meant helping innovators navigate the reimbursement and market access challenges that stand between promising technology and the patients who need it. It has meant building strategies that are practical, defensible, and rooted in the realities of the U.S. healthcare system.

And increasingly, it has meant our clients asking us for more.

Over the past several years, we've seen a clear pattern: the MedTech companies we work with don't just need a reimbursement strategy in isolation. They need it connected to their regulatory pathway from the very beginning. The decisions made early in a product's lifecycle, about device classification, intended use and claims, clinical evidence, submission strategy, have direct downstream consequences for coverage, coding, and commercial success. When those decisions are made in silos, companies pay for it later.

That's why we made the decision to formally expand our service offerings, adding regulatory affairs and quality, and why we are thrilled to announce that Sam Murray has joined PRIA as our Head of Regulatory and Quality .

Bringing Reimbursement and Regulatory Together

Sam's addition to the PRIA team is a designed strategic expansion of how we support the full MedTech innovation journey, from early concept through successful commercialization.

For companies navigating complex regulatory pathways, the stakes are high, and the margin for error is slim. Whether it's a 510(k) submission, a De Novo request, PMA, or emerging or novel technologies strategy, the regulatory decisions a company makes early on shape what's possible, commercially, clinically, and financially. At PRIA, we believe those decisions should be made with reimbursement and market access in mind from the start, not retrofitted after the fact.

Sam brings more than a decade of experience doing exactly that kind of high-stakes, high-impact regulatory work across medical devices, diagnostics, combination products, and software-enabled technologies. His background spans U.S. regulatory strategy, global submissions, quality system development and remediation, design controls, risk management, and direct engagement with regulatory authorities. Before joining PRIA, Sam founded and led his own independent regulatory and quality consultancy and held senior leadership roles at Advanced Instruments and Formlabs, where he built and scaled global regulatory and quality organizations and led acquisition due diligence across multiple transactions.

Perhaps most notably, Sam began his career as a medical device investigator with the U.S. Food and Drug Administration, conducting domestic and international inspections. That experience, seeing how the FDA operates from the inside, gives him a perspective on regulatory risk and compliance that is essential to navigating the U.S. regulatory environment.

What This Means for Our Clients

Jeff Sirek, CEO of PRIA Healthcare, put it simply:

"Our clients are building medical devices that impact patient lives; they require partners who can support their efforts at every stage of their journey. Adding world-class regulatory expertise to our “gold standard” reimbursement and market access services allows PRIA to go deeper, earlier, and have sustained, meaningful impact on their path to commercial success."

The essence of Sam's role at PRIA is designed not only as a standalone regulatory consultant, but to function as an integrated part of the broader strategic support we provide to our customers. Sam shared his own perspective on why this opportunity resonated with him:

"I've spent my career helping companies navigate some of the most complex regulatory challenges in MedTech, and what drew me to PRIA was the opportunity to do that work in a way that's truly connected to the bigger picture. Regulatory strategy doesn't exist in a vacuum — it must ladder up to access, adoption, and ultimately, patients. I'm excited to build something here that helps companies make smart, efficient decisions early and makes a real difference for the companies we serve."

A Team Built for the Full Innovation Journey

PRIA was founded on the belief that patient access is not an afterthought; it's the whole point. Over 40,000 patients have gained access to innovative care through PRIA-supported programs, and that number continues to grow as we expand the depth of support we can offer to our clients.

Sam's arrival marks a meaningful chapter in that story. It reflects both where our clients are asking us to go and where we believe the most important work in MedTech strategy is headed: toward integration, toward earlier engagement, and toward partners who can see the full picture and help companies navigate it with confidence.

We're proud to have Sam on the team, and we're excited about what we'll be able to build together for the innovators who trust us with their most important challenges.

Advancing Innovation. Unlocking Access. Delivering Impact.

Want to learn more about PRIA Healthcare's regulatory, reimbursement, and market access services? We'd love to connect!

Behind the Strategy: An Expert’s Perspective

Mon, 23 Feb 2026 16:06:17 GMT

Why PRIA?

Many people ask us, “Why PRIA? What do you offer that other consulting firms don’t?”

I’ve spent time reflecting on that question. It seems simple- but the answer goes deeper than reimbursement expertise, market access strategy, or regulatory experience alone.

The difference is this: we care- and we execute.

PRIA combines deep strategic insight with hands-on execution across reimbursement, regulatory, market access, patient access, and payer adoption. We don’t just develop recommendations; we stay to implement them, refine them, and see them through.

What Makes PRIA Different

1. We start with patients.
Access isn’t theoretical for us. We’ve helped 40,000+ patients gain access to innovative technologies that improve and extend their lives. That urgency shapes every engagement.

2. We think strategically and holistically.
We ask “ why ” before “ how ,” ensuring reimbursement, regulatory, evidence strategy, pricing, and commercialization are aligned- not siloed.

3. We partner from concept through commercialization.
Ideally, we’re in the game from Spring Training through the ninth inning of the World Series, helping build the full strategy early. But when we’re brought in mid-game, we quickly assess the field, clarify the signals, and help load the bases for a win.

In reimbursement and market access, you need two-way players, strategy and execution. Think Babe Ruth meets Shohei Ohtani. We help define the game plan and step up to the plate when it’s time to deliver.

4. We execute- especially when things get hard.
Reimbursement is rarely linear. Policies shift. Claims deny. Coverage lags. The difference is that we don’t disappear when it gets messy.

As one client shared:

“We talked to a few reimbursement groups, but we wanted a partner who could do both strategy and execution- not just give recommendations. The execution piece, especially patient access support, was really important to us. We also needed a team with real experience in the reimbursement areas we play in and the ability to problem-solve when things aren’t straightforward. PRIA fit that better than anyone else we spoke with.”

And another client weighed in on our long-term commitment:

“They’ve stayed engaged the whole time. PRIA brings in the right people when we need them, they understand our goals, and they work alongside us until things are resolved, not just until a deliverable is sent. When reimbursement gets messy (and it does), they don’t disappear. They stick with it.”

PRIA is not a recommendation shop. We are a strategic and execution partner.

In today’s environment, reimbursement and market access are not downstream considerations- they are core drivers of valuation, acquisition potential, and long-term viability and should be developed in sync with your regulatory strategy.

Let’s Connect at LSI 2026

We’ll be attending LSI 2026 in Dana Point this March . If you’re building innovative technology and want to ensure your reimbursement strategy strengthens, rather than limits, your valuation story, we would welcome the opportunity to connect.

Let’s step onto the field early and build the right game plan.

Our team of reimbursement and market access experts are here to guide innovators navigating the path to commercial success- how can we help you?

Tonya Dowd, MPH

Executive Vice President,Reimbursement, Health Economics, Market Access & Corporate Development

PRIA H2 Review - Q3 & Q4 Highlights

Tue, 23 Dec 2025 18:48:39 GMT

In this issue of PRIA Pages, w e've combined all of our many activities throughout the third and fourth quarters of 2025 into one, and it's an impressive look back at all we've been up to! LSI Europe, The MedTech Conference, & Medtech Strategist's Innovation Summit in San Diego were just some of the conferences that PRIA participated in over the past few months. We hosted two successful webinars -- one on the WISeR model, and what we knew early on; and one on the importance of a Patient Access Program, with clients who spoke from first-hand experience. PRIA is committed to staying abreast of industry news, with our team attending MDMA's annual meeting, and sharing our expertise in partner webinars and on live in-person panels. It has been a busy and exciting year, and we look forward to 2026!

Click to Read the PDF

PRIA Continues its Support of LSI in 2026

Thu, 06 Nov 2025 16:30:28 GMT

Continuing and Strengthening our Relationship with a Vital Industry Event

For 2026, PRIA Healthcare continues to be a Supporting Sponsor of LSI’s international events . MedTech market access, commercialization and investment all take root at these invaluable conferences. PRIA is honored to meet the world's most vibrant innovators, investors, and industry leaders, and to discuss how we can help groundbreaking technologies reach patients who need them most.

Our team, including Jeffrey Sirek, Tonya Dowd, and Stephanie DeFelice, look forward to attending and having meaningful conversations, about navigating the complexities of market access, reimbursement, and commercialization.

If you’re joining us at LSI in 2026, we invite you to connect with us via the partnering app.

See You in Dana Point and Barcelona!

Tonya Dowd, MPH, Executive Vice President, Reimbursement, Health Economics, and Market Access (RHEMA) and Corporate Development shared her insights on the importance of early strategic planning on the panel " Unseen Risks, Unlocked Value: Quantifying Regulatory and Reimbursement Barriers in MedTech Investment" at LSI Europe '25.

PRIA's Summary of the new WISeR Model Provider & Supplier Operational Guide from CMS

Tue, 21 Oct 2025 18:06:56 GMT

WISeR Model Operational Details Addressed by CMS in New Provider and Supplier Operational Guide

As a leader in Reimbursement and Market Access Services for the Medtech industry, PRIA has closely followed developments on CMS’ WISeR (Wasteful and Inappropriate Service Reduction) model. CMS has now released their Provider and Supplier Operational Guide , addressing many key questions from industry stakeholders.

Our Summary of the Guide

1. CPT and ICD-10 Codes Identifying WISeR Services

The WISeR model lists specific CPT, HCPCS, and ICD-10 codes (see Appendices A–C) that define the items and services subject to prior authorization or pre-payment medical review.
These codes correspond to procedures like Vagus Nerve Stimulation (VNS), Cervical Fusion, Epidural Steroid Injections, and Percutaneous Vertebral Augmentation, among others.
Appendix A identifies covered procedures and CPT/HCPCS codes; Appendix C lists related ICD-10 diagnostic indications. These collectively determine which services fall under WISeR oversight.

2. Refined focus for initial roll out of WISeR

Deep Brain Stimulation (DBS) is explicitly excluded from WISeR’s initial phase, as its CPT codes (e.g., 61867, 61868) remain on Medicare’s inpatient-only list. CMS intends to re-evaluate DBS for possible future inclusion.
NCD 160.1 will initially focus on nerolytic destruction of the trigeminal nerve
NCD 160.7 will initially focus on spinal cord stimulators but will not overlap with CPT codes for spinal neurostimulators. Prior Authorization be being implemented for the permanent implantation procedure.
NCD 230.10 will initially focus on mechanical/hydraulic incontinence control devices for the purposes of treating Stress Urinary Incontinence (SUI).
NCD 230.18 Prior authorization is being implemented for the permanent, not trial, implantation procedure
NCD 230.4 initially will implement prior authorization for the insertion of penile prostheses
L39741, L39758, L39793 will initially focus on CPT codes 22554 and 22585

3. Model Participants and Submission Methods

WISeR participants are six organizations contracted by CMS in six pilot states (AZ, NJ, OH, OK, TX, WA).
Although participants are identified by state, their specific company names are not yet announced.
These participants—and their associated Medicare Administrative Contractors (MACs)—will accept prior authorization requests and supporting documentation via fax, mail, esMD (Electronic Submission of Medical Documentation), or electronic portals.

4. CMS/CMMI Authority to Expand WISeR

CMS, through the Center for Medicare & Medicaid Innovation (CMMI), has authority under Section 1115A of the Social Security Act to expand the WISeR model to additional services or therapeutic areas during the initial phase.
This flexibility allows CMS to add or adjust covered procedures and codes to address new technologies or emerging areas of waste, fraud, and abuse without legislative action.

5. Settings of Care (POS Codes)

WISeR applies only to specific settings of care, identified by Place of Service (POS) codes:
11 – Office
12 – Home
19 & 22 – Hospital Outpatient Department
24 – Ambulatory Surgery Center (ASC)
These settings define where prior authorization and pre-payment review processes apply. Inpatient services are excluded.

Link to full document on CMS.gov

Notable future events:

AMA Webinar - Wed, Oct. 22 – Registration open to the public

PRIA WISeR Operations Webinar – Week of Nov. 10 ^th

Behind the Strategy: An Expert’s Perspective

Tue, 05 Aug 2025 13:00:02 GMT

U.S. Reimbursement Policy in Flux: What Medtech Needs to Know Now

Reflecting on some recent discussions with potential and current clients alike, I’m continually asked for my perspective on “how is the reimbursement landscape changing in the U.S. and will it impact market access for my technology.”

As a veteran reimbursement expert, I’ve tried hard not to answer with “it depends” (I can hear my fellow reimbursement colleagues chuckling). Joking aside, I can confidently say that one thing is clear: U.S. health policy is shifting, and MedTech companies can no longer afford to assume a status quo reimbursement environment. While the political landscape continues to evolve, recent CMS proposals focus on central key themes, related to payment equity, quality care, price transparency and reduction of fraud, waste and abuse. Let’s dig into these a little further and highlight key impacts which MedTech companies should consider as they plan reimbursement and commercialization strategies for their novel therapies.

1. Payment Equity: Site-Neutral Payment and Setting Efficiency . The 2026 Proposed Rules for the Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) reinforce CMS's commitment to payment equity across care settings:

Site-neutral payment policies aim to reduce reimbursement disparities between hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs).
CMS proposes alignment of clinical visit payments and outpatient procedures, aiming to eliminate financial incentives that drive care based on payment advantages rather than clinical need.
Geographic adjustments and increased support for rural care suggest a focus on equitable access.

Takeaway: Medtech companies should prepare for a shift toward site-neutral payment models that prioritize clinical need over setting, impacting where and how technologies are utilized and reimbursed.

2. Quality Care: Emphasis on Measurable Outcomes and Equity . CMS is doubling down on quality accountability:

The Hospital Outpatient Quality Reporting (OQR) Program is expanding with new measures on complications, follow-up, and social determinants.
Expect more public reporting of outpatient outcomes and increased emphasis on equity-driven performance metrics.

Takeaway : Medtech companies should frame their value in terms of measurable quality improvement—especially in areas tied to CMS reporting.

3. Price Transparency: Enhanced Disclosure Requirements . Price transparency is no longer a soft nudge—it’s a regulatory requirement with enforcement teeth:

CMS proposes higher penalties for hospitals not publishing standard charges and negotiated rates.
New formatting and machine-readable file requirements are designed to improve usability for patients and CMS itself.

4. Fraud, Waste, and Abuse: Stricter Oversight of Utilization and Payment . Prior Authorization is coming to Medicare Fee For Service. CMS recently proposed the WISeR (Wasteful and Inappropriate Services Reduction) Model, which aims to:

Focus health care spending on services that will improve patient well-being
Apply commercial payer prior authorization processes that may be faster, easier and more accurate.
Increase transparency of existing Medicare coverage policy.
De-incentivize and reduce use of medically unnecessary care

The initial model becomes effective Jan. 1, 2026, and imposes prior authorization requirements for select services, subject to an existing NCD (national coverage decision) or LCD (local coverage decision) in the clinical areas of skin substitutes/ tissue substitutes, electrical nerve stimulation, knee arthroscopy and cervical fusion, amongst others, confined to six states.

Key Takeaways

Payment Equity Is Reshaping the Economics of Site-of-Care
With CMS advancing site-neutral payment policies, the reimbursement differential between HOPDs and ASCs is narrowing. Medtech companies need to reassess their go-to-market and adoption strategies, especially for technologies heavily utilized in higher-cost hospital settings.

Accountability Is the New Value Standard
CMS's push for expanded quality reporting and equity-driven metrics means MedTech must go beyond efficacy claims. Technologies that demonstrate real-world outcome improvements and address disparities in care will have a strategic advantage.

Prior Authorization Is Coming for Fee-For-Service—Via WISeR
The WISeR model introduces commercial-style prior authorization to traditional Medicare for certain services in six states, starting in 2026. This signals a significant shift in how utilization management will be handled and reinforces CMS’s emphasis on reducing low-value care

Final Thoughts

In reimbursement, the only constant is change—and the best answer to most policy questions still remains: “It depends.” So be ready, be informed, plan early… and maybe keep a reimbursement expert (or the PRIA Team of experts) on speed dial.

Our team of reimbursement and market access experts are here to guide innovators navigating the path to commercial success -- how can we help you?

Tonya Dowd, MPH

Executive Vice President,Reimbursement, Health Economics,

Market Access and Corporate Development

PRIA Webinar: What You Need to Know About CMS's Proposed WISeR Model

Fri, 01 Aug 2025 16:08:04 GMT

Webinar: Prior Authorization is Coming to Fee-for-Service Medicare -- What You Need to Know About CMS's Proposed WISeR Model

CMS’s proposed WISeR Model is a game changer - and PRIA is here to help you navigate what it means for your providers, patients, and market access strategy.

Hosted by PRIA's EVP of RHEMA, Tonya Dowd and featuring panelists Victoria Wallace, JD, Partner at Hogan Lovells, and Rebecca Holley, Director of Market Access & Reimbursement, Saluda Medical, this webinar explored what the WISeR model is, what innovators need to know, and how they can prepare for the changes it brings to the MedTech landscape.

Bridging the Gap: Aligning Market Access with Commercial Success

Mon, 21 Jul 2025 15:55:20 GMT

Why KOL Engagement is Crucial for Market Access

By Tracy Davis MS, RD, Director of Market Access

Bringing a medical device to market is about more than just innovation, it’s about building trust, credibility, and alignment with real-world clinical needs. One of the most powerful ways to do that is by engaging Key Opinion Leaders (KOLs) early in the market access journey.

KOLs are the leaders other healthcare professionals turn to for guidance. They publish research, give talks at major conferences, and often sit on committees that influence treatment guidelines and healthcare policy. Their voices matter to clinicians, health systems, and payers.

These individuals, often respected physicians, researchers, or healthcare professionals, play a critical role in shaping how new therapies are perceived, adopted, and reimbursed. Their insights can help guide everything from clinical strategy to payer conversations. Payers also appreciate insights from their own in-network physicians and their patient populations.

Why Engage KOLs Early?

Getting KOLs involved early in the process isn’t just beneficial, it’s strategic. Their support can provide a critical credibility boost, helping validate the clinical and economic value of your product in the eyes of healthcare providers and payers. KOLs also play an important role in influencing policy, often contributing to the development of formularies, treatment guidelines, and reimbursement frameworks. When a KOL believes in your device, they can serve as a powerful advocate, helping to build awareness and momentum within the medical community. Just as importantly, their early feedback can improve your product, offering insights that make it more relevant, practical, and aligned with the real-world needs of both clinicians and patients.

So, how does KOL engagement work and why is it so essential?

A thoughtful approach makes all the difference. Here are the steps to successful KOL engagement:

1. Identify the Right KOLs

Start by identifying the voices that matter in your therapeutic area. Look for individuals who are well-published, frequently consulted, or involved in professional societies and advisory boards.

2. Define Clear Goals

Are you looking for clinical validation? Support with payer discussions? Product feedback? Knowing your goals helps shape the right kind of relationship.

3. Build Meaningful Relationships

Engagement isn’t just about outreach, it’s also about connection. That means meeting with your KOLs in person when possible, hosting advisory boards, and staying in touch through ongoing conversations (virtual or in-person).

4. Share Useful, Timely Information

Give your KOLs access to clinical trial data, peer-reviewed research, and other valuable information. The more informed they are, the more confident they’ll be in your product.

5. Ask for and Act on Feedback

Encourage honest input about your device, your messaging, and your go-to-market strategy. And most importantly, show that you’re listening to them by acting on what you hear.

Managing KOL Relationships Over Time: How to Keep Them Engaged

Engaging a KOL isn’t just a one-time interaction; it’s a long-term commitment. To get the most value from these relationships, companies need to focus on consistent, thoughtful engagement that builds mutual trust and benefit over time.

Here are some key strategies to maintain strong KOL partnerships:

Foster Ongoing Communication

KOLs want to feel connected and informed—not just when you need something. Make it a point to check in regularly with updates, new data, or relevant developments in your product’s lifecycle or the broader therapeutic landscape. This keeps them in the loop and reinforces their value to your organization.

Invite Continued Collaboration

Offer meaningful opportunities for involvement beyond early feedback. This can include participation in advisory boards, speaking engagements or panel discussions, co-authoring publications or white papers or involvement in clinical trials or real-world evidence studies. The more collaborative the relationship, the more invested the KOL becomes in your product’s success.

Recognize and Value Their Contributions

KOLs are busy professionals, so showing appreciation matters. Recognition can be as simple as a personal thank-you, a spotlight feature in company communications, or acknowledgment at an event. Where appropriate, ensure fair compensation for their time and expertise in accordance with compliance and transparency regulations.

Create a Two-Way Relationship

KOL engagement should never feel transactional. Encourage open dialogue where KOLs can share not just feedback, but also their own priorities and challenges. Find ways your organization can support them, whether that’s helping amplify their research, connecting them with peers, or providing access to data or tools that benefit their work.

Tailor the Experience

Not all KOLs want the same thing. Some are driven by research opportunities, others by patient outcomes or policy change. Customize the engagement experience based on their individual interests, whether that means focusing on clinical trial involvement, thought leadership, or shaping payer strategies.

Use Technology to Stay Organized

As your KOL network grows, it’s important to keep track of all interactions and engagement history. Tools like CRM platforms can help you manage communications, document feedback, and ensure no relationship falls through the cracks.

Share Outcomes and Impact

Let your KOLs see the results of their input. If they provided feedback that helped shape a trial protocol or influenced a payer strategy, tell them. Demonstrating the impact of their contributions helps strengthen the relationship and encourages future engagement.

Sustaining engagement with KOLs is about creating real partnerships, not just checking a box. When you invest in long-term relationships built on trust, transparency, and shared goals, your company gains not only external credibility but a strategic ally who can help guide your product’s success from development through commercialization and beyond.

Final Thoughts

At the end of the day, early KOL engagement isn’t just a tactic — it’s a long-term strategy that can shape the future of your product. By building trusted partnerships with clinical and industry leaders, medical device companies can improve adoption, support reimbursement efforts, and bring better solutions to the patients who need them most.

If you’d like to learn more about engaging key opinion leaders as part of a market access strategy for your medical device, please reach out to Tracy and the PRIA team!

Tracy Davis, MS, RD

Director of Compliance and Reimbursement,

Health Economics, and Market Access

PRIA Quarterly Review - Q2 Highlights

Thu, 17 Jul 2025 16:34:41 GMT

In this issue of PRIA Pages , read about all that the PRIA team was up to in the MedTech industry in Q2 2025! LSI Asia, LSX, & Medtech Strategist's Innovation Summit were major global conferences that PRIA was thrilled to participate in as a sponsor. The team also engaged in the ecosystem locally, mentored early-stage innovators, and stayed current with industry policy. We hosted a webinar on the changes coming to Medicare Advantage and how they impact MedTech. We also wrote articles, judged pitch events, and not least of all, moved to a beautiful new location!

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Notes from Your MedTech Co-Founder: Don't Make the Field of Dreams Mistake

Tue, 06 May 2025 15:12:26 GMT

Don’t Make the “Field of Dreams” Mistake

If you’re a MedTech entrepreneur, odds are that you’re an engineer, clinician, and/or scientist. And you have a vision for developing the next groundbreaking medical device based on your technical background experiences or knowledge. However, an all-too-common pitfall that unfortunately many promising technologies fall into is the MedTech “Field of Dreams” fallacy, as I like to call it.

What is the MedTech “Field of Dreams” fallacy?

Adapted from the famous line from the 1989 movie, this fallacy is the misconception that “if I build it, they will come.” In other words, aspirational entrepreneurs believe that if they build a superior product, customers will come. And assume that their product will naturally find its place in the market based on end user demand. While this mindset may work in other industries, it’s an all too lethal risk in U.S. MedTech. All because this mindset leads to overlooking a crucial element: the financial stakeholder.

Why Financial Stakeholders Matter

When developing a medical technology, it’s easy to become fixated on the patients and the clinician users of your product. While their needs and experiences are undeniably important, more often than not, they aren’t the financial stakeholder in the U.S. healthcare system, which poses a critical problem: If you’ve designed your product to only address unmet needs of the patient and/or clinician, but the implementation of your product doesn’t address a need (or more importantly a pain point) for the financial stakeholder, adoption of your product will be limited.

In the U.S. healthcare system, the financial stakeholders primarily include the following, all of whom have specific and distinct motivations that influence their decisions.

Clinic or Hospital Department Administrators in charge of a discretionary budget
Hospital Value Analysis Committee (VAC) in charge of evaluating technologies with a cost that exceeds the discretionary budget threshold and require a higher level of approval
Commercial Payers providing commercial and/or managed Medicare/Medicaid plans
Medicare providing health insurance for individuals aged 65 or older, or individuals with certain specific health conditions
Medicaid providing state-level health insurance for low-income individuals/families

How Early should I Invest in Understanding these Financial Stakeholders?

Understanding what drives these stakeholders is essential for achieving meaningful market penetration and ensuring that your innovative device is adopted. To avoid the MedTech “Field of Dreams” fallacy, I would recommend that entrepreneurs take a strategic approach as early in their product development as possible, funding resources permitting. Here are three practical tips to help successfully navigate this complex landscape, from my time as an entrepreneur, as well as working as a consultant for numerous MedTech clients:

1. Identify Your Financial Stakeholders Early

In parallel to your pre-market product development, you should conduct market research to identify who your financial stakeholders are. Doing this accurately is critical, so I would strongly recommend working with a MedTech reimbursement and market access consulting firm to identify who the relevant decision-makers are, and to understand their new technology evaluation processes, budget constraints, current reimbursement mechanisms, and possible pain points for which they’re looking for solutions. As an entrepreneur, there’s a time to roll up your sleeves and achieve milestones as leanly as possible -- this is not one of them. Identifying your financial stakeholders early is critical to establishing a foundation for your success.

2. Understand Your Financial Stakeholders Needs and Motivations

While improved patient outcomes are valued, financial stakeholders are primarily concerned with the return on investment and overall value that your medical device brings to their organization. The importance of your ability to effectively communicate this value cannot be overstated.

What I’ve seen work best is to start by clearly and accurately painting the typical patient’s healthcare journey under the standard of care. How many visits, procedures, resources, etc. are utilized? How long is the timeline? What are the short-term (<1 year) vs. long-term costs to the financial stakeholder(s)?

Then compare/contrast that typical patient’s healthcare journey to your proposed “future of care”. Specifically, how does utilization of your product change the clinician and/or patient behavior in a way that results in a net financial benefit to the financial stakeholder? E.g. are you reducing the number of expensive events, such as Emergency Department visits, surgeries, revision procedures, hospitalizations, etc.? And how quicky are those reductions realized on the patient timeline? Is your product less expensive than the current options? Does use of your product reduce total resource expenditure per patient? Do you improve clinical workflow efficiency?

But most importantly, as talked about in my first article, do you have proven clinical evidence to back up these Value Propositions with Value Proof?

3. Develop an Evidence Generation Strategy to Produce Value Proof

In order for your comparison of the standard of care vs. your proposed “future of care” to be compelling to a financial stakeholder, you must back it up with evidence to elevate it from just a Value Proposition. Peer-reviewed clinical trial publications are required and expected by all healthcare stakeholders.

Too often MedTech entrepreneurs only focus on the clinical trial endpoints that are necessary for FDA and clinician users of their product. They forget to consider that financial stakeholders will want additional clinical trial endpoints, particularly those related to tracking healthcare costs. Additionally, financial stakeholders want to see studies with longer patient follow-up. Don’t just focus on the immediate clinical and economic outcomes. Back up your entire proposed “future of care” timeline, ideally. And lastly, to convince your financial stakeholders that they should pay for your product instead of what they’re currently paying for, you’ll need multiple published clinical trials with several hundred total patients.

My advice would be to partner with a reimbursement consulting firm to help you develop a comprehensive evidence generation strategy to ensure you’re considering all stakeholders’ evidence requirements. Also, get financial stakeholder input on your clinical trial designs early in their development. Finding out after a study is completed that you missed a critical endpoint and need to repeat the study will cost you both time and money. So, plan early and plan intelligently.

In conclusion, navigating the MedTech landscape requires more than just technical prowess – it demands a deep understanding of the financial ecosystem into which your technology would be implemented. By avoiding the MedTech “Field of Dreams” fallacy and addressing your financial stakeholders’ needs and motivations with clinical trial-backed value proof, entrepreneurs and their medical device companies can better position their innovations for broader market acceptance and long-term impact.

As a former entrepreneur and biomedical engineer, I hope my point resonates, that it’s not enough to build a great product; you must also understand who will buy it and why. Then convince those buyers to adopt with your Value Proof.

If you’re a medical device innovator, I’d love to hear from you. What reimbursement and market access challenges—or questions—keep you up at night?

Ryan Nolan, MEng

Senior Director,
Reimbursement, Health Economics, & Market Access

PRIA Quarterly Review - Q1 Highlights

Thu, 10 Apr 2025 18:51:16 GMT

PRIA Pages is a quarterly publication highlighting PRIA Healthcare’s active involvement in key MedTech industry events. Our Q1 2025 issue includes the LSI Emerging MedTech Summit, Spine Summit, NANS Annual Meeting, and JP Morgan Healthcare Conference. It also features expert columns and workshops led by PRIA's experts in the fields of reimbursement and market access.

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Bridging the Gap: Aligning Market Access with Commercial Success

Tue, 01 Apr 2025 16:40:22 GMT

Why Device Manufacturers Should Care About Managed Medicaid: The Critical Role of Fee Schedules

In the ever-evolving healthcare landscape, device manufacturers often focus on the reimbursement strategies tied to private insurance and traditional Medicare. However, there’s an important area that many overlook: Medicaid Managed Care. This represents a growing portion of the U.S. healthcare system, which has grown rapidly to 90 million Americans with a range of healthcare needs.

But why is it important for device manufacturers to focus on not just Traditional but also Medicaid Managed Care? The answer lies in fee schedules.

The Power of Fee Schedules

Fee schedules are critical to understanding how Medicaid Managed Care Organizations (MCOs) reimburse healthcare providers for services, including use of medical devices. MCOs often have their own fee schedules that differ from state Medicaid fee schedules, but they are more likely to create a fee schedule if a device is already listed on the state fee schedule.

The differences between state and MCO fee schedules can significantly impact the reimbursement rates for the device manufacturers’ product. To maximize reimbursement potential, device manufacturers should build Medicaid into their Market Access strategy, particularly when the technology serves women and/or children. Together, women and children account for approximately 78% of all Medicaid beneficiaries. Including Medicaid Managed Care in your Market Access strategy can lead to improved market penetration, and greater opportunities in a market that continues to grow.

The Growing Importance of Medicaid

Medicaid has seen a significant expansion in recent years, with MCOs now serving most Medicaid beneficiaries. According to recent reports, over 75% of Medicaid recipients are enrolled in some form of managed care. This means that device manufacturers have a large and growing population to consider when developing pricing strategies and reimbursement models for their products.

Many device manufacturers still prioritize traditional payers like Medicare or private insurers, but with Medicaid spending expected to rise, especially in states with larger populations, managed Medicaid is becoming too important to ignore.

When signed into law by Lyndon Baines Johnson on July 30, 1965, Medicaid was based on a welfare model, and was restricted to people with low incomes and limited resources. However, throughout the decades, Medicaid evolved to cover more people, including those with substantial assets in need of health care services, including long-term care services.

An understanding of Medicaid today really requires a paradigm shift in thinking.

Medicaid is a joint program, funded 60% by the federal government and 40% by the states. There are many different programs, including long-term care, or nursing home Medicaid. Federal and state policymakers have changed the rules over the years, and have altered/made it into a middle-class program. Many people find it hard to let go of their conception of the Medicaid program from 1965, and it is common to see news reports mistakenly describing it as a program for those in poverty.

Why Fee Schedules Matter

Managed Medicaid plans negotiate their own reimbursement rates with device manufacturers, and the details of these agreements are often influenced by state-specific guidelines and healthcare policies. Fee schedules set the maximum allowable reimbursement for healthcare providers, and as these can vary by region or plan, manufacturers need to navigate these differences carefully.

The key is to understand not just the standard fee schedule for Medicaid in a particular state, but also the negotiated rates within managed care organizations. Manufacturers should partner with Medicaid MCOs to ensure their devices are competitively priced within these fee schedules, and work to advocate for reasonable reimbursement levels.

What Device Manufacturers Can Do:

Stay Informed – Medicaid fee schedules and managed care plans can change, and it’s crucial for device manufacturers to monitor these shifts regularly.

Engage with Medicaid MCOs – Building relationships with Medicaid Managed Care Organizations can help manufacturers influence fee schedules and ensure their products are reimbursed at appropriate rates.

Optimize for State Variability – Each state may have different Medicaid fee schedules and coverage rules. Customizing reimbursement strategies for each state’s plan can give manufacturers a competitive edge.

Advocate for Fair Pricing – Device manufacturers should be actively engaged in policy discussions at both the state and federal levels to ensure fair reimbursement practices for medical devices within Medicaid Managed Care.

As Medicaid continues to grow in importance, device manufacturers must recognize the significant impact that Medicaid Managed Care and its fee schedules have on their bottom lines. By staying proactive in understanding fee schedules, engaging with MCOs, and tailoring strategies for each state’s unique system, manufacturers can unlock the full potential of this market segment, ensuring long-term growth and stability in an increasingly competitive healthcare environment.

Source: https://www.medicaid.gov/

If you’d like to learn about engaging key opinion leaders as part of a market access strategy for your medical device, please reach out to Tracy and the PRIA team!

In Brief: An Attorney's Take

Wed, 19 Mar 2025 18:29:40 GMT

How Much Evidence Is Enough for Medical Technology to be Covered by Commercial Payers?

By Kristofer Munroe, JD

Director of Compliance and Reimbursement, Health Economics, and Market Access

Securing commercial insurance coverage for medical technology often hinges on one critical question: How much evidence is necessary to satisfy payer requirements? While "it depends" is a common, albeit frustrating, response, this article seeks to clarify this ambiguity and explain the factors driving the evidence requirements for the creation of medical policies.

Understanding the Framework: Law vs. Medical Policy

In the legal realm, evidence standards are clearly defined — “preponderance of the evidence” governs civil cases, and “beyond a reasonable doubt” applies in criminal law. In contrast, medical policy often requires "evidence sufficient to conclude the net impact of the technology on health outcomes." This standard guides medical directors and clinicians, key decision-makers in the insurance sector, as they evaluate new technologies. However, specific requirement and criteria vary from payer to payer.

The Role of Medical Directors

Medical directors, often with backgrounds in clinical practice, are pivotal in policy decisions. Their primary role is not to facilitate the sales of your product but to steward limited healthcare budgets effectively. They assess technologies on their ability to significantly improve health outcomes. Understanding their perspective is crucial; they view themselves as guardians of limited health resources, tasked with maximizing the utility of their expenditures.

Self-Reflection: Evaluating Your Technology

Before approaching payers, it's crucial to objectively assess your technology: What type of product do I have?

Is it a novel technology addressing an unmet need in current medical treatments? Is it a substantial or improvement product that offers substantial improvements over existing solutions? Or, is it a “me too,” a lower cost alternative entering the market? Product type will have a meaningful impact on the level of evidence that is required for coverage. Unmet needs will usually need comparative data to the standard of care even if the standard of care is a very different treatment mode. Incremental and substantial improvement products will need evidence directly comparative to the products which they are improving or competing with. Me too products are seldomly given policy attention by commercial payers.

Is there any baggage from technologies that came before?

Previous aggressive marketing tactics and the resultant payer skepticism or negative experiences can create significant barriers for subsequent technologies in similar medical spaces. For example, earlier wound healing technologies, such as autologous platelet cell preparations and negative pressure wound therapy (NPWT), were marketed aggressively without robust supporting evidence. This set a precedent that has made it challenging for newer technologies in this space, as payers now demand higher standards of evidence, often including randomized trials. Similar issues are seen in spine technologies, where earlier methods like intradiscal electrothermal therapy or laser discectomy were introduced with insufficient evidence, leading to negative payer policies. This has created an environment where even technologies for different indications, like percutaneous vertebroplasty, face heightened scrutiny and skepticism from payers. The historical context and prior experiences of payers heavily influence current reimbursement decisions, making it essential for manufacturers to understand and navigate these legacy barriers. The article suggests that new technologies must clearly differentiate themselves from their predecessors and meet higher standards of evidence to overcome entrenched skepticism.

What is the potential patient population size?

Technologies aimed at larger populations may face stricter scrutiny, as their widespread adoption has significant budgetary implications. While payers will not usually make medical policies for technologies that do not have provider demand demonstrated through authorization requests and appeals, by positioning out the gate with a large population payer medical directors may reflexively raise barriers if they perceive a large patient population.

Three key takeaways about the Evidence Burden for new technologies

Diverse Opinions Among Decision-Makers: Feedback from a single medical director represents just one perspective. Medical directors vary in their views and motivations, and understanding this diversity is key to navigating the approval process effectively.

Clinical Efficacy Over Cost: Initially, focus on proving clinical efficacy. Starting with economic arguments might suggest a lack of robust clinical data.

Economic Considerations: While some directors claim that cost is not a primary evaluation criterion, economic factors invariably influence decision-making processes. It's crucial to recognize how cost-effectiveness intersects with clinical benefits in shaping policy decisions.

Conclusion

The question of "how much evidence is enough?" is complex and influenced by multiple factors. Successful navigation of this landscape requires a deep understanding of both the decision-makers and the specific attributes of your technology. By being aware of the people making medical policy decisions, and by being self-aware, you can enhance your chances of achieving coverage for your medical technology.

Our team of experts are here to guide innovators navigating the path to commercial success -- how can we help you?

Kristofer C. Munroe, J.D.

Director, Compliance and Reimbursement, Health Economics,

Market Access and Corporate Development

Celebrating Five Years of Partnership with LSI

Thu, 06 Mar 2025 16:33:08 GMT

The Premier Gathering of Visionaries Dedicated to Advancing Healthcare Innovation

For the fifth consecutive year, PRIA Healthcare is honored to sponsor LSI’s Emerging MedTech Summit. LSI’s commitment to accelerate MedTech investment and commercialization resonates deeply with our own. At PRIA, we partner with innovators, investors, and industry leaders to bridge the gap between groundbreaking technology and real-world patient access. By navigating the complexities of market access, reimbursement, and commercialization, we help ensure that life-changing medical advancements reach the patients who need them most.

Our team Jeffrey Sirek, Tonya Dowd, Stephanie DeFelice, and David Goldstein will be attending and look forward to meaningful conversations. If you’re joining us at LSI, we invite you to connect via the partnering app to find time to meet.

See You in Dana Point!

Notes from Your MedTech Co-Founder

Tue, 25 Feb 2025 16:39:14 GMT

Value Proof, Not Proposition

Innovating in today’s medical device industry is insanely hard. The majority of the MedTech industry consists of small companies – over 80% have fewer than 50 employees. The funding market has gotten significantly tougher in recent years. Most MedTech entrepreneurs are first timers, navigating unknowns with a long list of questions. Few go on to launch a second company, making veteran co-founders a rare breed.

If you’re a co-founder, or part of a MedTech startup, you’ve probably asked yourself (or been asked) one or more of the following questions:

Who will purchase my product, and what do they need to see? Do they need to be reimbursed?

Will health insurance payers cover a premium for my technology? And how do I get them to do that?

How do I develop and use my clinical trials to achieve reimbursement without overcomplicating things?

How do I convince future investors of our go-to-market plan?

When is the right time to start planning my reimbursement and market access strategy, given my limited budget?

These are just a few of the tough and complicated questions you’ll face. I struggled with them too at one point.

You’re probably also wondering, “Who is this guy, and why should I keep reading?” If I may take a moment to introduce myself: I’m Ryan Nolan, and I co-founded a pediatric medical imaging device company called PhotoniCare back in 2015. This was my first company, and I was, admittedly, a naïve biomedical engineer with aspirations to revolutionize pediatric ear healthcare. It’s a tale as old as time – my co-founders and I developed an innovative device and felt called to commercialize it for the betterment of patients (especially our own kids, who had suffered ear infections).

I led all clinical and reimbursement efforts for nearly ten years, as we conducted multiple multi-site clinical trials, and leveraged those results to establish new reimbursement coding, coverage, and payment. Along the journey, we learned from not only our wins and losses, but also from our veteran MedTech advisors.

Honestly, I wouldn’t be where I am today without the guidance of the reimbursement and market access mentors who supported me. Their expertise was instrumental in helping me avoid the “potholes” and navigate the vast complexities of establishing new medical device coding, coverage, and payment.

So, what’s the point of this? My hope for this series is to pay it forward to the next generation of MedTech innovators. Too many promising and innovative medical technologies fail before achieving their intended patient impact. If I can help even one technology avoid those potholes, I’ll be elated.

Show me the value PROOF, not the value proposition

For today’s post, I’d like to discuss that phrase, as it’s one of my favorites (copyright pending—but not really, haha).

In today’s MedTech market, the days of early acquisition post-FDA approval are gone. If you’re a startup looking to get acquired, you should expect—and plan—not just to launch your product but also to establish market traction and growth. So how do you do that?

The expectation in today’s U.S. healthcare system is that you’ll have robust, published clinical trial data—not just a compelling story about your value proposition. This data must clearly demonstrate how your proposed “future of care” compares to the current standard of care—not just clinically, but economically as well.

While raising funds or applying for grants to conduct such trials is challenging, this reality applies to all stakeholders—not just the clinical users of your technology, but also the financial stakeholders and potential strategic acquirers. I could go on for pages about this (and possibly will in a later post), but here’s the key takeaway:

Common misconception: My clinical trials on safety and efficacy for the FDA will be sufficient for going to market (and getting acquired).

Reality: You NEED to design your clinical trial strategy, and each study protocol, with input from ALL of your product stakeholders, and address their specific needs.

Don’t fall into the “pothole” of having to repeat a costly clinical trial. Too many companies with promising technologies have failed due to post-market adoption issues that could have been prevented with a market-access-informed clinical trial design.

If you’re a medical device innovator, I’d love to hear from you. What reimbursement and market access challenges—or questions—keep you up at night?

Ryan Nolan, MEng

Senior Director,

Reimbursement, Health Economics, & Market Acces s

MedTech Innovator Press Release

Mon, 17 Feb 2025 16:47:29 GMT

Torrington, CT – (February 18, 2025) – PRIA Healthcare is proud to announce its partnership with MedTech Innovator, the world’s largest accelerator for medical device, digital health, and diagnostic companies. This collaboration brings together two organizations with synergistic missions. MedTech Innovator is dedicated to improving patients’ lives by accelerating the growth of companies transforming healthcare worldwide. PRIA Healthcare, a leading full-spectrum reimbursement services and market access firm, is committed to accelerating the adoption of healthcare innovation by advocating for consistent and reliable reimbursement. Together, this partnership will empower MedTech companies with the tools and guidance necessary to navigate complex commercialization challenges.

A Commitment to Driving Healthcare Innovation

“We are honored to partner with MedTech Innovator to support the next generation of healthcare innovators,” said Jeff Sirek, CEO of PRIA Healthcare. “Reimbursement remains one of the greatest challenges MedTech companies face. By providing strategic guidance and leveraging our expertise, we can help these companies navigate the complexities of coding, coverage, and payment, ensuring that breakthrough technologies reach the patients who need them most. This partnership allows us to align our expertise in reimbursement with MedTech Innovator’s mission of accelerating transformative healthcare solutions, ultimately creating a stronger pathway to market success.”

PRIA’s Executive Vice President of Reimbursement, Health Economics, and Market Access, Tonya Dowd, has been an important contributor to the MedTech Innovator Program for many years and instrumental in the advent of this partnership. PRIA’s strategic team, led by Tonya, will be active contributors by reviewing startup applications to identify promising technologies, judging pitch events to assess market viability, and mentoring cohort companies on reimbursement and market access strategies. Additionally, PRIA will provide in-kind services to selected companies, helping them develop their value story to prepare for successful commercialization.

“I’m thrilled to formalize our partnership with MedTech Innovator, which has been at the forefront for shaping the future of medical technology,” said Tonya Dowd. “Having been part of this incredible ecosystem for several years, I’ve seen firsthand how it accelerates innovation and transforms groundbreaking ideas into real-world solutions. This agreement marks an exciting new chapter in our mutual goals to advance MedTech innovation and drive meaningful impact in patient care.”

Partnership Accelerates Innovation

“ We are pleased to welcome PRIA to MedTech Innovator as an Innovation Sponsor after several years of collaboration with Tonya Dowd, who has provided mentoring and guidance to many of our startups as they navigate the complicated steps to securing market access ,” said Paul Grand, Founder and CEO of MedTech Innovator. “ PRIA’s experience working extensively with startup MedTech companies to define a reimbursement pathway for novel procedures will be extremely helpful to our cohort. Our respective organizations share a desire to accelerate healthcare innovation to improve human health, and we look forward to PRIA’s involvement with MTI to achieve this mission. ”

For more information on how PRIA Healthcare supports MedTech innovation and commercialization, visit www.PRIAHealthcare.com. To learn more about MedTech Innovator, visit www.MedTechInnovator.org .

About PRIA Healthcare: PRIA Healthcare is a leading full-spectrum reimbursement services and market access firm, instrumental in the successful commercialization of over 300 medical devices since 2012. As a trusted partner to innovators in MedTech and Life Sciences, PRIA delivers unparalleled expertise to navigate complex reimbursement landscapes.

Our experts in reimbursement strategy and healthcare economics outcomes research provide guidance to medical device companies by navigating challenging and uncertain reimbursement pathways, determining the coding, coverage, and payment for market access and adoption of new technologies. Our strategic approach accelerates the adoption of healthcare innovation, facilitating market access and appropriate reimbursement, today and into the future. PRIA is specialty-agnostic, supporting the entire product journey from concept development to successful commercialization.

PRIA Healthcare – Accelerating healthcare innovation

For media inquiries and more information, please contact:

Stephanie DeFelice

Vice President, Business Development & Marketing, PRIA Healthcare

Email: sdefelice@priahealthcare.com

Webinar: MedTech Trends to Watch in 2025

Fri, 14 Feb 2025 13:01:49 GMT

Webinar: MedTech Trends to Watch in 2025

PRIA Healthcare's team of experts discusses the trends they see for the year in this informative webinar.

Behind the Strategy: An Expert’s Perspective

Wed, 05 Feb 2025 13:15:39 GMT

Investment Trends in MedTech for 2025: Reimbursement and Market Access Perspectives

As we enter 2025, the MedTech industry is poised for significant transformation. Two key areas expected to drive growth are robotic surgery and artificial intelligence (AI), which are garnering increasing attention from investors, clinicians, and innovators. However, while these technologies hold immense promise, a critical challenge remains: the absence of separate reimbursement pathways, such as new codes or distinct payment categories. Instead, these innovations must navigate existing reimbursement frameworks, making market access and evidence generation essential for their adoption. Demonstrating their value through proof, rather than a mere proposition, is paramount.

Let’s examine these trends and explore the reimbursement and market access insights shaping their trajectory in 2025 and beyond.

Robotic Surgery: Scaling Accessibility

Robotic surgery has been a hot topic in MedTech for over a decade, with Intuitive Surgical’s DaVinci robot leading the way. While Intuitive has established itself as the market leader, competition is intensifying. Established players like Medtronic, as well as newcomers such as CMR Surgical and Moon Surgical, are entering the market. Though the initial capital investment for robotic systems remains high, the focus on value-based care is shifting the conversation toward cost efficiency and improved patient outcomes.

Reimbursement Considerations and ROI: For robotic surgery, there often isn’t a case for separate or higher reimbursement, as the robotic assistance is an integral part of the procedure. However, provider stakeholders are demanding that the clinical and economic value is established. So, the play is value proof vs. a value proposition.

“Hospitals are looking for solutions that demonstrate clear economic and clinical value,” says Michael Turner, a leading MedTech venture capitalist. “This means manufacturers must present strong health economic data showing reduced procedure times, shorter hospital stays, and improved recovery metrics.”

Investors are increasingly drawn to robotic systems designed for specific procedures, such as orthopedics or cardiovascular interventions and these niche focused specialty areas will come with a requirement of the clinical and economic value proof.

Artificial Intelligence: Beyond Buzzwords

Artificial Intelligence (AI) continues to dominate headlines, but in 2025, the focus has shifted from broad claims to tangible applications, especially in healthcare. Decision-support systems, predictive analytics, and imaging tools are among the most impactful uses gaining traction.

Market Access Challenge: While the FDA has led the charge for establishing streamlined pathways for software as a medical device (SaMD), the Centers for Medicare and Medicaid Services (CMS) and other third-party payers have lagged behind. Although these technologies show tremendous promise in diagnosing and treating health conditions, CMS still does not acknowledge them under a specific benefit category, thus, making it difficult to assess their proof of value and subject to a reimbursement pathway where new coding and payment methods may not apply or without a straightforward path. Oftentimes, reimbursement for these technologies is bundled into an existing service. Furthermore, the data required to secure “positive” payer coverage requires significant data, or proof as published in peer reviewed studies and/or through studies that rely on real-world evidence, however, without a separate coding mechanism or reimbursement pathway, it’s often difficult to assess and develop the necessary value proof.

One promising area is AI-powered diagnostics, particularly in oncology and rare diseases. Here, payers are beginning to recognize the value of earlier and more accurate diagnoses, which can reduce long-term treatment costs. However, demonstrating ROI remains critical to gaining widespread adoption.

Investment Considerations for 2025

Understanding the interplay between innovation and market access is more critical than ever. Here are a few takeaways to keep in mind:

A Solid Reimbursement and Market Access Strategy is Top of Mind for Investors: Companies with robust reimbursement and market plans, including evidence generation to demonstrate the value proof in clinical and health economic studies, are a critical imperative.

Regulatory Alignment is Key: Streamlined FDA pathways don’t always translate to immediate payer acceptance. Bridging this gap requires proactive planning and data generation.

Specialization Wins: Technologies addressing specific clinical or procedural gaps often face fewer market access hurdles and offer clearer value propositions.

A Final Word

The MedTech landscape in 2025 is brimming with opportunity, but success hinges on more than just innovation. Reimbursement and market access are critical levers that can make or break a technology’s commercial viability. As investors and stakeholders navigate this dynamic environment, staying informed and engaged will be the key to unlocking the potential of tomorrow’s MedTech giants.

Our team of reimbursement and market access experts are here to guide innovators navigating the path to commercial success -- how can we help you?

Tonya Dowd, MPH

Executive Vice President,Reimbursement, Health Economics,

Market Access and Corporate Development

PRIA Healthcare Announces the Acquisition of Argenta Advisors, Expanding Market Access and Reimbursement Expertise

Tue, 08 Oct 2024 09:36:58 GMT

Torrington, CT – October 8, 2024 – PRIA Healthcare, a leader in innovative patient access and reimbursement services, is proud to announce the acquisition of Argenta Advisors, a renowned consulting firm specializing in market access and reimbursement strategy. The acquisition, finalized on September 1, 2024, represents a significant step in PRIA Healthcare’s mission to enhance its comprehensive suite of services and further support medical technology companies in navigating the complexities of the healthcare landscape.

Co-founded in 2001 by Louise Guy, a registered nurse with decades of experience in healthcare delivery, Argenta Advisors has built a strong reputation as a trusted partner in the field of reimbursement. With a team that includes physicians, nurses, certified coders, and reimbursement experts, Argenta offers deep expertise across the reimbursement continuum. Their strategic approach has led to the successful launch of numerous medical technologies, securing coding, coverage, and payment across all payer types.

“ Joining forces with PRIA Healthcare is a natural progression for Argenta Advisors,” said Louise Guy, Managing Partner and Co-founder of Argenta Advisors. “Our shared commitment to actionable strategies and dedication to advancing patient access to innovative medical technologies make this partnership a perfect fit. We look forward to combining our strengths to better serve our clients and the healthcare industry. ”

Louise’s leadership and extensive background in clinical care, strategic business planning, and reimbursement have been instrumental in Argenta’s success. Her experience spans roles in biotechnology, health insurance, and medical technology, giving her a unique perspective on the challenges of commercialization and adoption in the healthcare sector.

“It has been an incredible honor to collaborate with Louise Guy over the years,” said Tonya Dowd, Executive Vice President of Reimbursement, Value Generation, and Market Access at PRIA Healthcare. “Her unwavering commitment to advancing patient access to innovative medical technologies, combined with her deep expertise in healthcare delivery and reimbursement, has set a gold standard in our industry. Louise’s ability to navigate the most complex challenges with compassion and precision is truly inspiring. As we embark on this next chapter together, I am committed to carrying forward her legacy of excellence and relentless advocacy for patient care.”

PRIA Healthcare’s Expansion

This acquisition aligns with PRIA Healthcare’s ongoing strategy to expand its capabilities in delivering data-driven, patient-centric solutions. PRIA Healthcare’s service offerings include services to support patient access to new and novel technologies during a period of reimbursement uncertainty. Offering benefits verification, prior authorization, appeals management, and patient access program analytics, all powered by a centralized, HIPAA-compliant platform . The addition of Argenta Advisors strengthens PRIA Healthcare’s position as a leader in providing comprehensive market access solutions that address the full lifecycle of medical technology products.

“We are thrilled to welcome Argenta Advisors to the PRIA Healthcare family,” said Jeff Sirek, CEO of PRIA Healthcare. “Argenta’s exceptional track record and deep industry knowledge will be invaluable as we continue to support our clients in overcoming reimbursement challenges and ensuring patient access to life-changing technologies. Looking ahead, our combined expertise positions us to lead the charge in accelerating healthcare innovation, driving successful outcomes from concept to commercialization.”

The combined expertise of PRIA Healthcare and Argenta Advisors will offer unparalleled support to clients seeking durable and predictable reimbursement pathways. Together, they are well-positioned to drive successful outcomes for innovative medical technologies, from concept to commercialization.

About PRIA Healthcare PRIA Healthcare is a full-spectrum reimbursement services firm based in Connecticut. Since 2012, PRIA Healthcare has been vital to the successful commercialization of over 250 medical devices, partnering with innovators in MedTech and Life Science. PRIA’s renowned experts in reimbursement strategy and healthcare economics navigate challenging reimbursement pathways, determining coding, coverage, and payment for market access and the adoption of new technologies. PRIA supports the entire product journey of healthcare innovations from concept through commercialization.

For more information about PRIA Healthcare and its portfolio of services, please visit www.priahealthcare.com

If you’re a medical device innovator, I’d love to hear from you. What reimbursement and market access challenges—or questions—keep you up at night?