Why Proof ≠ Revenue in MedTech (and how to close the gap)

Chris St-Amour
Jul 15
2 min read

Regulatory clearance and strong clinical data are necessary—but not sufficient.

Hospitals buy through multidisciplinary committees that weigh clinical value and operational, safety, and budget impact, often via a formal value‑analysis process. Evidence consistently shows that device purchasing is a team sport that balances technical, financial, safety, and clinical requirements—user trials and hospital‑based HTA included. If your go‑to‑market assumes “good study → fast adoption,” you’re missing how decisions are actually made. BMJ Open

Where proof breaks down in the real world

Clinical story vs. economic story A randomized study may not answer the hospital’s day‑1 questions: What changes in workflow? Who’s trained? What’s the counterfactual cost? Where does the budget live? Value analysis teams explicitly require structured documentation on safety/efficacy and projected cost and utilization impact before approving new tech. ScienceDirect
Reimbursement alignment If your use is inpatient, NTAP can help bridge early costs while data accumulates; if outpatient, OPPS device pass‑through or New Technology APCs may apply. When reimbursement pathways are unclear, hospitals face immediate P&L exposure—stalling otherwise promising tech. Centers for Medicare & Medicaid Services+1
Operational and cybersecurity fit Digital and connected devices trigger security and IT reviews aligned with HHS’s 405(d) Health Industry Cybersecurity Practices. If you can’t speak to safeguards, patching, and integration, approvals stall regardless of clinical merit. HHS 405(d)
Stakeholder mis-sequencing Value analysis is multidisciplinary by design; without early physician engagement and coordination with supply chain/finance, even enthusiastic clinicians hit governance walls. symplr
Market access realities (GPOs) With most hospitals aligned to large GPOs (e.g., Vizient, Premier, HealthTrust), contracting pathways and credibility checks often flow through those relationships—especially past the pilot stage. OUP Academic

How to close the gap (a practical checklist)

Translate proof into value-analysis evidence. Package an exec summary (5–6 sentences), clinical literature and RWE, TCO/ROI, training and implementation plan, safety/quality data, and reimbursement path. This is the “VAC Pack” reviewers expect. ScienceDirect
Instrument pilots like mini‑studies. Baselines, counterfactuals, and pre‑agreed success triggers create decision‑grade evidence (and credibility) for committees. Hospital purchasing research advocates multidisciplinary involvement and user trials—mirror that in your pilots. BMJ Open
Align reimbursement early. Confirm whether NTAP or OPPS pass‑through status is relevant and communicate it clearly to finance; cite the CMS rule basis, duration, and coding implications. Centers for Medicare & Medicaid Services+1
Sequence stakeholders intentionally. Build support with physician champions and value analysis leaders; bring supply chain/finance into the pilot scoping so economics and workflow are addressed upfront. symplr
Anticipate IT/security. Map to 405(d) practices and document how you’ll maintain security posture in production use. HHS 405(d)