For Founders & Execs
Predict your device's probability of reaching key milestones based on historical patterns from our proprietary database.
How It Works
Input your device parameters. Our proprietary analysis framework compares your device against documented outcomes to predict probability of reaching each milestone.
Probability of achieving 510(k), De Novo, or PMA approval based on your regulatory strategy and demonstrated clinical evidence.
Timeline and probability of generating initial revenue based on your market entry strategy and competitive landscape.
Likelihood of achieving reimbursement policy coverage and average reimbursement rate based on your category and evidence.
Probability of crossing adoption inflection point with physicians based on clinical adoption barriers and competitive context.
Projected pathway to profitability based on your market size assumptions, manufacturing costs, and unit economics.
Risk factors that most commonly derail scaling in your category and your mitigation strategy.
Sample Output
A redacted example showing how a device's risk profile evolves across key milestones.
Redacted example — Orthopedic implant company, 18-month assessment window. Shaded area represents confidence interval.
Sample Insight
Devices in the orthopedic implant category that lack a reimbursement strategy at 510(k) submission have a 78% probability of failing to reach profitability within 5 years — compared to 23% for those with payer engagement already underway.
Pattern Match
This company's pre-clearance profile most closely resembles 3 successful exits and 2 documented failures in our database. The differentiating factor: manufacturing scalability planning initiated before first commercial sale.
Your Vantage Score isn't static. As you clear FDA hurdles, your regulatory risk drops — but commercial risk often increases as you face reimbursement, adoption, and scaling challenges for the first time. Trajectory analysis tracks how each of the proprietary framework categories shifts as you progress, so you're always focused on the risks that matter now, not the ones you've already addressed.
Built on Our Framework
Trajectory analysis is built on our proprietary framework and grounded in documented device outcomes. We assess your device across all proprietary framework categories, identify probability gaps that impact each milestone, and provide concrete recommendations for improvement.
Retrospective Accuracy: Our framework achieves 96% accuracy in predicting which devices will encounter material risk factors based on retrospective analysis of documented outcomes.
Get a data-driven assessment of your path to major milestones. Schedule a consultation to discuss your device and what we're seeing in your category.
In a 20-minute call, we'll give you preliminary insights on your device's key risk categories.