Are you Really Ready to Commercialize?

Regulatory Clearance ≠ Market Readiness

For most MedTech innovators, FDA approval or strong clinical validation feels like the finish line. In reality, it’s just the starting gun. You’ve proven your science works, but that doesn’t mean your business will scale.

This is the gap too many companies miss. It’s why so many MedTech startups stall after a few impressive pilots.

The Hidden Gap Between Proof and Revenue

Regulatory approval means you can sell. It doesn’t mean customers are ready to buy. What happens next often looks like this:

• Pilots run — but they don’t convert into contracts.

• Clinical champions say “yes,” but finance, supply chain, and IT say “not yet.”

• A code exists, but reimbursement isn’t secured because coverage and payment aren’t aligned.

• Clinical champions endorse, but procurement, finance, and supply chain delay decisions.

  
  

This is the commercialization gap: proof without revenue.

At Pathova, we call it Pilot Purgatory, the stage where promising pilots stall instead of turning into paid adoption.

The Cost of Going Too Early

Commercial false starts in MedTech aren’t just costly missteps; they can derail your go-to-market strategy, drain critical resources, and compromise stakeholder confidence. Understanding and mitigating these risks early is essential to sustaining momentum from pilot to paid adoption.

Hiring a sales team before establishing strong go-to-market (GTM) foundations can quickly consume 12 to 18 months of runway. However, the deeper consequences are far more damaging:

• Stalled pilots drain both capital and credibility. Hospitals expect a well-supported, complete experience. If you fall short, they’re unlikely to engage again.

• Missed conversions leave lasting market scars. Failure to convert pilots into contracts signals that your solution lacks readiness.

• Investors start doubting the technology. When pilots don’t convert, it’s often not the product at all, but the absence of GTM infrastructure. Investors rarely make that distinction; they just see no traction.

  
  

Momentum is a fragile currency in MedTech. The wrong strategy doesn’t just jeopardize an opportunity; it erodes years of trust, capital, and market access. Recovering lost momentum is always more challenging than preserving it through disciplined GTM execution. Prioritize validating your commercial foundations before scaling your sales team to protect your runway, reputation, and long-term success.

What GTM Readiness Really Means

True commercialization readiness isn’t about sales headcount. It’s about whether your GTM system is wired to turn pilots into contracts across five critical dimensions:

• Reimbursement Strategy

  A CPT or HCPCS code alone isn’t enough. Hospitals need confidence that patients can actually get paid for your technology. That requires a credible reimbursement pathway — supported by payer engagement, economic models, and VAC-ready materials that show how reimbursement aligns with adoption. Without this, your solution is always a financial risk.

  
  

• Compelling Value Proposition

  Beyond clinical outcomes, your story must translate into CFO, supply chain, and VAC language: cost savings, workflow efficiency, reduced risk, improved HCAHPS scores. If your story doesn’t connect clinical results to financial and operational impact, wins stall in procurement.

  
  

• Stakeholder Engagement

  Success requires mapping the full buying group, not leaning on a single physician champion. Finance, IT, supply chain, nursing, infection control, risk management, and even patient advocates all influence the VAC decision. Miss one, and adoption falters.

  
  

• Robust Evidence Generation

  Regulatory approval clears the safety bar. Adoption requires health economics, real-world data, and comparative effectiveness studies that prove both outcomes and ROI. Hospitals expect the same rigor physicians apply in practice: valid, unbiased, relevant evidence — plus workflow fit to ensure adoption.

  
  

• Execution Blueprint

  Pilots must be designed with clear success metrics, change-management plans, and a defined path to conversion — supported by VAC-ready packets, ROI calculators, contracting playbooks, and sales enablement tools like talk tracks that move deals from pilot to paid.

  
  

Without these, every pilot is another expensive experiment. With them, you’re positioned to escape Pilot Purgatory and build a repeatable path to revenue.

Self-Diagnosis Is Step One

The good news: you don’t have to guess where you stand.

That’s why we created the Pilot-to-Paid Scorecard, a practical self-assessment that benchmarks your commercialization readiness. In just a few minutes, you’ll see where you’re strong, where the gaps are, and what to prioritize next.

Before you burn another quarter of runway, find out if you’re really ready.

Download Scorecard

Understanding the Importance of Market Readiness

Market readiness is more than just a buzzword. It’s the foundation of a successful MedTech venture. When you think about it, what good is a groundbreaking technology if it can’t find its way into the hands of those who need it?

The Role of Market Research

Conducting thorough market research is crucial. It helps you understand customer needs, preferences, and pain points. This knowledge allows you to tailor your approach, ensuring that your product resonates with potential buyers.

Building Relationships with Key Stakeholders

Engaging with key stakeholders early on can make a significant difference. Building relationships with healthcare providers, payers, and other decision-makers can pave the way for smoother adoption.

Creating a Compelling Marketing Strategy

A strong marketing strategy is essential for communicating your value proposition. It should highlight the unique benefits of your product and how it addresses specific challenges in the healthcare landscape.

The Importance of Feedback Loops

Feedback loops are invaluable. They provide insights into how your product is perceived in the market. Use this feedback to refine your offering and address any concerns before launching.

Conclusion: The Path to Success

In conclusion, achieving regulatory clearance is just the beginning. To thrive in the MedTech space, you must bridge the gap between proof and revenue. By focusing on GTM readiness, understanding market dynamics, and engaging stakeholders, you can turn promising pilots into successful commercial ventures.

Remember, the journey from pilot to paid is not just about having a great product; it’s about having the right strategy in place. Let’s ensure you’re ready to take that leap.