Draft a Tech Evaluation Report that synthesizes Phase II SBIR datasets against TRL 7/8 readiness criteria for FDA-regulated MedTech out-licensing decisions

Generate draft a tech evaluation report that synthesizes phase ii sbir datasets against trl 7/8 readiness criteria for fda-regulated medtech out-licensing decisions for Scientific Research and Development Services industry

Scientific Research and Development Services

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Upload comprehensive Phase II SBIR technical documentation including prototype test reports, manufacturing data, clinical study datasets, and regulatory correspondence. This forms the primary evidence base for TRL 7/8 assessment.
Select the FDA device classification and regulation pathway. This determines applicable TRL criteria, submission requirements, and out-licensing valuation models.
Specify the target TRL level for out-licensing. TRL 7 indicates system prototyping in operational environment; TRL 8 requires actual system completed and qualified through test and demonstration.
Specify the primary audience for this evaluation report. Each stakeholder group requires different depth of technical data and commercial assessment focus.
Define the clinical and commercial risk tolerance for this evaluation. This calibrates the TRL assessment rigor and identifies critical gaps before out-licensing.
Indicate the current state of Quality Management System implementation. This is critical for TRL 7/8 demonstration and FDA out-licensing discussions.
Describe the specific clinical evidence needed for regulatory submission and out-licensing. Include clinical study types, patient populations, endpoints, and statistical considerations.
Document past FDA CDRH interactions including Pre-Sub (Q-Sub) meetings, breakthrough device designation, FDA feedback letters, and any formal agreements.
Identify the current manufacturing scale-up capabilities essential for TRL 7/8 demonstration. This affects licensing valuation and FDA readiness timelines.
Specify the commercial terms framework expectation for out-licensing. This includes upfront payments, milestone structures, royalty rates, and IP considerations.
Specify any custom evaluation criteria, regulatory nuances, stakeholder requirements, or contextual factors specific to this out-licensing evaluation.