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

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