Our Framework
A structured, evidence-based approach to medical device due diligence — four assessment domains, proprietary scoring.
Evaluated device outcomes
Retrospective accuracy
Assessment domains
Typical assessment timeline
How It Works
Your assessment moves through six integrated stages — each combining physician expertise with engineering rigor.
Our framework systematically evaluates medical devices across clinical, regulatory, engineering, and commercial dimensions — the areas where most device failures originate. Each domain contains proprietary risk categories refined through analysis of documented device outcomes.
Multiple categories assessing clinical need, evidence strength, adoption barriers, and physician workflow integration — the factors that kill 75% of medical device startups.
Physician-led reviewMultiple categories covering pathway risk, reimbursement viability, quality system maturity, and post-market readiness — where regulatory missteps create 12-18 month delays.
Pathway & complianceMultiple categories evaluating design maturity, manufacturing scalability, supply chain resilience, and IP defensibility — the silent portfolio killers.
Engineering-led reviewMultiple categories stress-testing market assumptions, unit economics, workflow integration, team execution capacity, and exit value — under real-world conditions, not pitch deck projections.
Market & exit analysisThe specific categories, evaluation criteria, and scoring weights are proprietary — refined through analysis of documented device outcomes and tailored by stage, device class, and intended market.
We share the full framework under NDA during discovery calls so you can evaluate our approach before engaging. Request a methodology briefing →
What Sets Us Apart
Every assessment domain receives a proprietary Vantage Score with detailed justification. Our scoring system distinguishes between risks that require immediate intervention and those that are manageable with appropriate resources and timeline. The composite Vantage Score gives you a single, calibrated number backed by domain-level detail.
Not all risks are equal. Our framework distinguishes between risks that can be mitigated through execution and those that represent fundamental structural barriers. This distinction is one of the most decision-relevant outputs of our analysis.
Our proprietary analysis combines physician and biomedical engineering domain expertise with a database of documented medical device outcomes. For each assessment, we compare your device against similar technologies in our database — both successes and failures — to contextualize risk and identify patterns that predict outcomes.
In 2-3 weeks, you'll have a comprehensive risk report and a clear roadmap for your next steps.
Not sure if you need an assessment? In a free 20-minute call, we'll identify the 3 biggest risks in your device category.
† Based on retrospective analysis of documented device outcomes in our proprietary database. Accuracy represents the proportion of devices correctly classified into risk categories compared to subsequent clinical and commercial outcomes.