Ten structured questions for evaluating diagnostic commercialization architecture. Built for investors conducting commercial diligence on diagnostic platforms.
Determine whether the test generates actionable information that directly alters patient management, treatment selection, or monitoring decisions.
Assess whether the company has identified a specific, reachable segment with quantifiable demand.
Evaluate the economic architecture: whether the test can be paid for at scale through established or emerging payment mechanisms.
Confirm the company understands its regulatory classification, submission pathway, and timeline.
Determine whether the evidence generation strategy satisfies physician adoption and payer coverage requirements.
Assess the depth of the technical moat through IP protection, proprietary methods, data assets, or platform architecture.
Evaluate whether the company has mapped the physical and commercial pathway from test to result.
Understand the behavioral and operational triggers that cause clinicians to order the test and laboratories to offer it.
Assess whether the leadership team includes individuals who have taken a diagnostic product through regulatory clearance, market launch, and commercial scale.
Determine whether the company can present a coherent, defensible commercial narrative that connects clinical value to economic sustainability.