Blind Spots in MedTech Commercialization: Navigating the Pilot-to-Paid Journey and Escaping Pilot Purgatory

Regulatory approval is a milestone worth celebrating. Pilots showing strong clinical value are significant achievements. Yet, for most MedTech founders, these victories lead to a sobering reality: stalled traction, investor pressure, and a pipeline of pilots that never convert. This is the blind spot in MedTech commercialization. Clinical proof is the starting line, not the finish. The real challenge lies in crossing the divide between pilot success and paid, scalable adoption.

At Pathova, we call this space Pilot Purgatory, where strong science meets slow sales. Founders often say things like, “We’ve got pilots, but no one’s buying,” or “The level of interest is not the problem.” The solution is not more clinical validation. The solution is mastering the business realities of hospitals and health systems. Adoption barriers rarely stem from science alone. They revolve around budgets, workflows, and risk. Clinical proof gets a product in the door, but it doesn’t carry it through the maze of committees, fiscal cycles, and operational hurdles deciding whether pilots become purchases. That’s where most companies stall, and it’s why the same blind spots appear again and again.

The Gap Between “It Works” and “We’ll Buy It”

Founders often underestimate how wide the gap is between technical validation and a signed contract. Clinical excitement is necessary but not sufficient. Hospital decision-making is shaped by complex committees, budget cycles, and competing priorities.

Overcoming these blind spots requires mastering the pilot-to-paid journey. This includes designing pilots that capture commercial proof, preparing VAC-ready stories, aligning reimbursement strategies early, and building scalable contracting processes. Without this foundation, clinical validation alone won’t translate into enterprise adoption.

The Pitfall of the Single Clinical Champion

Many founders believe securing an enthusiastic physician or clinical leader is the hardest part of commercialization. In reality, it’s just the beginning. A clinical champion’s advocacy typically carries a deal only about 30% of the way to approval, according to a 2022 systematic review in Implementation Science Communications. The remaining weight sits with stakeholders like finance, IT, and operations who control budgets, workflows, and procurement.

The old model, where physician preference alone could push a device through purchasing, is gone. With nearly 80% of U.S. physicians now employed by health systems (AMA, 2022), their organizational influence is constrained. Champions still matter, but their requests are often sidelined in meetings where finance, supply chain, IT, and administrators drive the final call.

Each group views the same technology through a different lens. CFOs and service line leaders want ROI and budget fit. IT demands proof of integration and security. Supply chain looks at vendor stability and standardization. Compliance officers worry about accreditation risk, while administrators weigh multi-site operations fit. Even frontline nurses or schedulers—rarely in the room for the pitch—can block adoption if the product slows them down.

This is where many companies stall: excitement in the OR but no traction in the boardroom. Without engaging the full buying ecosystem early, founders are left with a single-threaded sale that almost always ends as a dead end.

Speaking Science When Buyers Hear Risk

For many MedTech founders, the instinct is to lead with science: mechanisms of action, p-values, trial results. It feels like the most compelling argument. But when hospital administrators and Value Analysis Committees (VACs) listen, they hear something entirely different: risk. Risk of added cost, workflow disruption, IT headaches, and misalignment with strategic priorities.

When innovators “speak science,” buyers hear unresolved questions. They wonder: How will this change throughput on short-staffed days? Does it fit within the fiscal cycle? Will it complicate procurement or integration with existing systems?

The barrier isn’t the evidence; it’s the story. Until founders learn to reframe clinical advantages into the language of cost, workflow, and risk mitigation, their strongest technologies will remain stuck in Pilot Purgatory.

Underestimating the Importance and Complexity of the VAC

For many founders, the Value Analysis Committee (VAC) is treated as a final hurdle once a clinical champion is secured. In reality, it’s the gatekeeper that determines whether a product escapes Pilot Purgatory.

VACs don’t exist to accelerate adoption—they protect hospitals from risk. They bring together finance, supply chain, IT, compliance, and clinical leaders, each assessing technology through distinct lenses: budget, integration, vendor stability, risk, or workflow. Their mandate is standardization and cost control, making them inherently conservative. Nearly 90% of U.S. hospital purchasing decisions pass through a VAC or equivalent body, yet approval rates hover around only 3–5% (ECRI, 2021).

The blind spot isn’t just a lack of evidence; it’s a lack of story. Success comes from translating proof into defensible narratives each stakeholder can carry into the room. Committees want more than comparative data; they expect ROI models, staffing implications, workflow impact, and IT/security validation, all packaged into a business case they can defend. Without that translation, even strong clinical evidence collapses into a stack of papers no one can champion.

Adding complexity, MedTech evolves rapidly, often outpacing supporting data. This gap erodes confidence and, in today’s cautious financial climate, pushes committees toward standardization over innovation.

The critical mistake is assuming the VAC’s role is to validate science alone. Its true function is to validate business viability. This means equipping stakeholders with a defensible value story tailored to each member’s specific criteria: finance, supply chain, IT, compliance, nursing, and clinical leadership. Without that story, the answer is nearly always no.

Misunderstanding Reimbursement

FDA approval is often mistaken for market readiness. Regulatory clearance is the first battle; reimbursement is the war. U.S. reimbursement involves coding, coverage, and payment, each with different gatekeepers. Newer pathways like CMS’s Transitional Coverage for Emerging Technologies (TCET) accept only a handful of devices annually, despite more than a hundred FDA Breakthrough designations each year. Digital health and AI innovators face added hurdles, lacking established benefit categories or clear payment pathways. International markets add variation, demanding tailored strategies.

Reimbursement strategy must be built in parallel with product development and evidence generation. MedTech’s iterative cycle makes this risky. Every new version invites fresh scrutiny and leaves openings for payers to delay or deny coverage. On average, it takes 4.7 years for novel technologies to achieve consistent reimbursement (AdvaMed, 2020). Nearly 80% of new MedTech products fail to secure adequate reimbursement within three years, and one in four novel diagnostics never achieves sustainable coverage (IQVIA, 2021; MedTech Europe, 2022).

The gap isn’t only strategic; it’s narrative. Reimbursement isn’t just mechanics of coding, coverage, and payment; it’s whether the economic story holds up under scrutiny. VACs and payers don’t just want proof points; they need a budget and value case they can defend, one that speaks finance, operations, and clinical at once. Without the proper framing, even strong reimbursement pathways stall, leaving promising technologies sidelined despite regulatory clearance.

Pilots Without a Path to Scale

Founders often struggle moving from KOL enthusiasm to installation and then consistent system-wide use. This is Pilot Purgatory. Too many pilots showcase clinical promise but miss what procurement and finance demand: clear operational success metrics, contracting readiness, and enterprise scalability. The result? Instead of springboards, pilots become dead ends, failing to provide the financial and operational proof committees need.

Data tells the same story: nearly 70% of digital health pilots never advance beyond testing (Rock Health, 2019), and over 75% of AI pilots fail to scale, with only one-third reaching full implementation (McKinsey, 2021). The culprit isn’t science; it’s pilot design. Many run in siloed or idealized settings that don’t reflect hospital complexity. Others lack a problem statement tied to organizational priorities, making governance defense difficult. Pilots that don’t capture financial, workflow, and scalability metrics upfront rarely meet enterprise adoption standards.

Successful pilots look different. They are commercial tests designed to prove not just feasibility, but financial impact, workflow integration, operational outcomes, and contract readiness. They build toward a scalable agreement, not just a positive trial. Done right, they generate the evidence procurement, finance, and VACs demand to move from pilot to purchase.

Overcoming these blind spots requires mastering the pilot-to-paid journey. This includes designing pilots that capture commercial proof, preparing VAC-ready stories, aligning reimbursement strategies early, and building scalable contracting processes. Mastery here turns clinical promise into contracts, laying a foundation for sustainable growth.

Ignoring Workflow and Implementation

Innovators often focus on the elegance of their idea, not the messiness of hospital workflows. But adoption depends on how seamlessly a product fits into the daily routines of nurses, technicians, and administrators. When a new technology adds steps, disrupts processes, or creates friction, enthusiasm fades—no matter how strong the clinical case.

Hospitals today are sensitive to workflow burden. Over 100,000 registered nurses left the U.S. workforce during the pandemic, largely due to burnout (National Council of State Boards of Nursing). Solutions that reduce workload or procedure time are disproportionately valuable; those complicating workflows are often rejected outright. VACs frequently cite integration concerns, competing priorities, or vendor consolidation as adoption blockers, all tied to operational disruption. Clinically superior products can falter if they create new headaches for frontline staff.

Misaligning Sales and Marketing vs. the Hospital Reality

Hospital commercialization doesn’t follow other markets’ rhythms. Yet many founders treat pilots as if they’ll naturally convert once clinical data looks strong. In reality, sales cycles stretch 12 to 24 months, shaped by budget approvals, consolidation, and competing priorities. A pilot isn’t a shortcut; it’s raw material for a business case committees can defend.

Missing this has real costs. Small MedTech companies leave as much as 25% of top-line revenue stuck in waiting rooms due to approval delays. When sales and marketing don’t adapt to hospital realities, even strong pilots stall, letting competitors define the narrative first. Compounding the problem: skills and messages that worked in MedTech sales no longer close deals. The old “clinical-first” playbook—arming teams with efficacy data to win physicians—doesn’t suffice. Commercial leaders need fluency in finance and operations, not just clinical detail. Throughput gains must be framed as revenue, downtime reduction as cost savings, and workflow improvements as staff retention.

Traditional marketing leans heavily on clinical data and KOL endorsements, but decision-making power has shifted. Companies still overspend on KOL campaigns while neglecting those who hold the pen. Procurement, finance, and operations leaders evaluate technologies through economic and operational lenses: ROI, budget cycles, workflow disruption—questions clinical champions can’t answer alone. Meanwhile, digital opinion leaders (DOLs), clinicians steering conversations across professional and online networks, shape perception before the VAC convenes, amplifying peer experiences and setting the tone for whether a product feels promising or problematic.

The blind spot isn’t just underestimating sales cycle length. It’s misaligning sales and marketing with how hospitals actually buy: slow, risk-averse, consensus-driven, and influenced by voices well beyond the OR.

Escaping Pilot Purgatory

The companies that break free recognize clinical validation as only one pillar. The real breakthrough comes from building commercialization infrastructure that closes crucial gaps:

• Multi-audience messaging frameworks speaking to clinicians, operators, and finance alike

• Pilot designs measuring feasibility and scalability, not just clinical endpoints

• VAC-ready evidence packets with clear ROI, cost narratives, and compliance documentation

• Reimbursement strategies aligned early or, if still evolving, packaged into a clear budget and value story stakeholders can defend

• Implementation playbooks giving buyers confidence the change will stick

• Stakeholder maps and engagement strategies turning a champion into a coalition

  
  

Commercial success isn’t about winning one approval. It’s about aligning with the entire buying ecosystem. That requires fluency in finance and operations as much as in clinical data, arming every stakeholder with a value story they can defend. It also demands new commercialization infrastructure: sales teams with financial acumen, marketing tailored to non-clinical decision-makers, and coalition-building strategies that grow single champions into system-wide support.

Every technology has two sides: the exciting clinical story and the “boring” operational proof. Hospitals don’t just buy innovation; they buy confidence it will reduce risk, fit budgets, and ease workflows. That’s why committees push beyond trial results. They expect ROI models showing real financial impact, staffing analyses proving time savings, supply chain assurances avoiding disruption, IT plans minimizing risk, and implementation strategies guaranteeing adoption sticks. The companies that scale are the ones that surround their science with this operational proof and translate it into language every stakeholder can defend—finance, IT, operations, nursing, and clinical alike. Without it, even the strongest technologies stall.

Mastering the pilot-to-paid jump turns proof into purchase, one scalable agreement at a time. For founders, the message is clear: regulatory approval signals your science is ready. Escaping Pilot Purgatory proves your business is.

The Takeaway

In healthcare, nobody buys innovation. They buy answers to risk. The blind spots keeping founders stuck are rarely scientific. They are commercial. Regulatory approval and strong clinical data are necessary milestones, but only the starting line. Hospitals don’t just ask, “Does it work?” They ask, “Will it fit our budget? Will it integrate with our systems? Will it make our staff’s lives easier? Will it reduce risk?”

This is where many companies stall—pouring more into science while leaving committees unconvinced, budgets misaligned, and workflows unaddressed. The result is Pilot Purgatory: a pipeline of interest with no conversions, months lost to approval cycles, and growth that never materializes.

Escaping requires a shift. Success comes from mastering hospital business realities: building VAC-ready evidence packets, designing pilots that prove scalability, aligning reimbursement strategy early, and arming every stakeholder with a defensible value story in their language.

For MedTech innovators, the message is clear. Regulatory approval signals your science is ready. Closing the pilot-to-paid gap proves your business is ready to scale. That’s the leap Pathova was built to help you make.