Assumptions & METHODOLOGY

This calculator models the financial impact of accelerating medical device development by comparing gross profit capture over 5 years between standard and accelerated timelines. Revenue Modeling: We use a 24-month S-curve adoption model to project revenue ramp-up after market entry. The accelerated timeline captures additional revenue through earlier market presence, with first-mover advantages varying by device classification (Class I: 10%, Class II: 20%, Class III: 35% revenue boost during the exclusive period). Profit Calculation: All ROI calculations are based on gross profit, not revenue. Additional revenue is multiplied by your gross margin percentage to determine additional gross profit. This ensures the ROI reflects actual profit impact, not just top-line revenue growth. Investment Return: ROI is calculated as (Additional Gross Profit - Investment Cost) / Investment Cost × 100, where: Additional Gross Profit = Additional Revenue × Gross Margin %; and Investment Cost = Development Cost × Additional Investment %. This means if you capture $10M in additional revenue at 65% gross margin, the ROI calculation uses $6.5M in additional gross profit, not the full $10M revenue. Competitive Dynamics: The model assumes competitors enter the market after your head-start period ends. Your first-mover advantage diminishes over 24 months as competitors establish market presence, reflecting real-world market dynamics where early advantages erode over time. Key Assumptions: Market share is captured gradually over 24 months following product launch; First-mover advantage applies at 50% strength during your exclusive market period; After competitors enter, advantage fades from 50% to 10% over two years; Gross margins remain stable throughout the 5-year projection period; Market size remains constant (conservative assumption excluding growth); All financial returns are calculated on gross profit basis, not revenue. Limitations: This model provides directional guidance for investment decisions. Actual results will vary based on market dynamics, competitive response, execution quality, and external factors not captured in this simplified model. Consider conducting detailed market analysis and financial modeling for final investment decisions. Methodology: 5-year cumulative gross profit comparison with S-curve adoption, diminishing first-mover advantages, and FDA classification-based competitive barriers.