FMI iDEA Forecasting & Measurement - Medical Devices

1. Scope & Taxonomy

Scope is fixed at Product × Technology × Application × Channel × Region (7 regions, 30 countries). Units (value/volume) and currency basis are defined upfront. Monthly signals inform quarterly baselines; forecasts run at constant FX unless scenario analysis dictates otherwise.

2. Measurement & Brand Share

Shipments count once at vendor→channel dispatch; OEM transfers are not double-counted. Subsidiary inventory is excluded until channel entry. Re-exports are reassigned to country of final use when determinable. Manufacturer self-consumption and bona-fide donations are counted for installed-base integrity.

ASP is captured at distributor level; freight/insurance/import duties inside vendor/channel pricing are included; POS taxes are excluded. Outliers are normalized. Prices are weighted across international, domestic, and China-based vendors by geography and application. For bulk chemicals/intermediates, bulk distributor prices are used.

Brand share = Brand Value ÷ Category Value by geography and channel. In the absence of EPOS, brand value is triangulated from filings and public multi-signal proxies (SRAP/PII/RHI), calibrated to disclosed anchors and bounded by corridor tests.

3. Export–Import Calculation

Trade flows are compiled on HS codes with mirror-stat checks. Adjustments are made for re-exports via known hubs, FOB/CIF valuation differences, and reclassification events. Series are time-aligned and currency-normalized. Apparent consumption closes as Production + Imports − Exports ± Stock Change (where observable).

4. Channel Analysis

Revenue and volume are allocated across direct, distributor/wholesale, retail/mass, pharmacy/specialty, e-commerce, and tender/government. Margin stacks are modelled by channel. Leakage (grey/parallel trade) is estimated via guardrails and anomaly detection on pricing and availability.

5. Supply Chain Diagnostics

Nodes are mapped from input to end-use with capacity, utilization, lead times, yield loss, scrap, lane reliability, and inventory policies. Concentration indices and single points of failure are stress-tested under demand and supply shocks. Supplier scorecards reflect quality/on-time/cost/risk metrics.

6. Forecasting Methods

Method 1: Regression-based models — predictors from production/utilization/trade/capex/approvals/price corridors; stability and residual tests; structural break handling; backtesting. Method 2: Driver growth-rate models — weighted driver growth applied to audited baselines; weights tuned to realized outcomes; revisions on rebases and shocks.

Triangulation: Product Category Analysis; n-per-Population intensity; Economic Envelope guardrails. Outputs include value, volume, installed base, and price scenarios with confidence bands.

7. Accuracy & QC

Regression accuracy via MAPE with diagnostics; growth-rate models via correlation and backtests, with volatility-based tolerance bands. Reconciliation closes apparent consumption; price corridors and FX/capacity constraints are tested. Dual-analyst review is required; change logs capture rationale.

8. Industry-Specific Metrics (Tracked Signals)

• UDI/GUDID coverage and device family rollups
• Regulatory pathways (510(k), PMA, De Novo) and approval rates
• Procedure volumes by CPT/DRG and care setting mix
• Installed base by modality and age cohort (survival curves)
• Capex cycles and replacement intervals by device class
• Utilization rates by theatre/lab type and shift patterns
• Service revenue share (warranty, maintenance) and attach rates
• Hospital ownership mix (private/public/IDN/Group Purchasing)
• Tender win rates and framework agreements (by region)
• Adverse event signals (MAUDE) normalization and recall impact
• Distributor density and coverage heatmaps
• Import tariffs, HTS classifications and re-export corridors
• Clinical guideline adoption lags by country
• Sterilization capacity constraints (ETO/gamma) and lead times
• Consumables usage per procedure (kits, reagents)
• Connectivity/IT integration requirements (DICOM/HL7)
• Reimbursement schedules and payer coverage dynamics
• Average Selling Price corridors by configuration/bundle
• Grey-market leakage guardrails and warranty validation
• Post-market study incidence and evidence pipelines

9. KPI & Formula Reminders

Value = Units × ASP; Installed Base = Σ Shipments − Retirements; Apparent Capacity = Production / Capacity Factor; Brand Share = Brand Value ÷ Category Value; Channel Mix = Channel Revenue ÷ Total; Export–Import Balance = Exports − Imports.

10. Sources & Lineage Examples

UN Comtrade/ITC Trade Map; Eurostat/PRODCOM; US Census/BEA/BLS; OECD; IEA/EIA/USGS/UNCTADstat; FAOSTAT/USDA; FDA/EMA/PMDA/CDSCO; ClinicalTrials.gov/WHO ICTRP; OICA/ACEA/SIAM; EDGAR/SEMI/GSMA/3GPP; EU TED/SAM.gov; public retail signals (filings, store locators, circulars, app stores, public social). Lineage cards display pull dates, access type, transforms, confidence tier, and caveats.

11. Cadence & Deliverables

Quarterly baselines with monthly micro-updates for high-frequency shifts; rapid shock notes for policy/outage/recall/price spikes. Deliverables include executive memo, workbook/models, 16:9 dashboards with lineage, and a change log. Optional: weekly SRAP/PII/RHI tiles for retail.