MedTech Go-to-Market Risk Simulator
Quantify commercialization risk for medical device investments
Assessment Inputs
Configure your device and market parameters
Success Probability
78/ 100
Low Risk78%
Risk Profile Assessment
5-Axis evaluation across critical success factors
Risk Flags & Strategic Insights
No critical risk flags detected. Complete inputs to generate insights.
Market Sizing Estimate
Based on: TAM = $1000M (manual), Prevalence Rate = 25%, Market Penetration = 10%
| Metric | Year 1 | Year 2 | Year 3 |
|---|---|---|---|
| TAM (Total Addressable) | $1000.0M | $1050.0M | $1100.0M |
| SAM (Serviceable Available) | $250.0M | $262.5M | $275.0M |
| SOM (Serviceable Obtainable) | $12.5M | $18.8M | $25.0M |
| Projected Revenue | $10.0M | $15.9M | $22.5M |
Bottom-Up Revenue Validation
Based on actual procedure economics: 75000 procedures × $850 = $63,750,000/year
Year 1
$63.75M
Year 2
$76.50M
Year 3
$95.63M
Validated: Top-down projections align with bottom-up procedure economics, indicating realistic market capture assumptions.
Formula: TAM = Manual Input (Million USD) | SAM = Prevalence Rate (%) × TAM | SOM = SAM × Market Penetration (10%)
Bottom-Up: Annual Revenue = Procedure Volume × Reimbursement Rate
Bottom-Up: Annual Revenue = Procedure Volume × Reimbursement Rate
Potential Predicates / Competitors
Similar devices in FDA database (simulated data)
| Device Name | Manufacturer | 510(k) Number | Regulation |
|---|---|---|---|
| KardiaMobile | AliveCor | K183503 | 510(k) |
| Apple Watch ECG | Apple Inc. | K182470 | 510(k) |
| Withings ScanWatch | Withings | K201319 | 510(k) |