Operational Roadmap: Deploying FMTVDM and ITIRD at National Scale
- Richard M Fleming, PhD, MD, JD

- Oct 23
- 2 min read
Updated: Oct 25
Government and Ministerial summary
A phased national deployment preserves measurement integrity and sovereignty while accelerating capability. The roadmap sequences readiness scoring, calibrated pilots, governance provisioning, scale‑up, and regional leadership steps so ministries can reliably achieve a measurable 5+ year head start in outcomes.
Phase 1 — Readiness and pre‑assessment
Inventory: scanners, staff, IT, and sample volumes.
Governance nomination: institutional PI, ministerial delegate, and technical champion.
Pre‑assessment deliverable: readiness score, gaps, estimated timeline, and pilot cohort suggestion.
Phase 2 — Pilot commissioning and calibration
Reference site selection: single calibrated scanner with phantom baselines.
Protocol lock: harmonized acquisition and reconstruction parameters.
ITIRD alignment: define ITIRD diagnostic thresholds, lab panels, and clinical decision pathways.
Training: mandatory certification for technologists, physicists, and clinicians.
Phase 3 — Validation, governance, and evidence generation
Cross‑site concordance: inter‑site comparisons and statistical validation.
ITIRD validation cohorts: confirm thresholds across demographics and comorbidities.
Governance board: change control, update approval, and ministerial reporting cadence.
Public summary reporting: independent validation publications and policy briefs.
Phase 4 — Scale and regional leadership
Cascade training: reference center mentors partner sites with calibrated kits.
Operational independence: on‑site data custody, escrowed keys, and local validation labs.
Regional hosting: offer training, trials, and validation studies to neighboring nations.
Pilot vignette (concise)
A country completed a 9‑month reference pilot, validated ITIRD thresholds across two partner sites, and scaled to five sites within 18 months—achieving inter‑site concordance >90% and a validation brief.
CTA and next steps
Primary CTA: Request an SNS pre‑assessment that includes FMTVDM calibration and ITIRD cohort design.
Secondary CTA: Determine operational checklist and pilot protocol template.
KPIs to track
Time to calibrated clinical use from procurement.
Inter‑site concordance percentage for core biomarkers.
Number of certified personnel and trained partner sites.
Publication/validation output count and time to public report.





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