OUR EXPERTISE
Comprehensive support across strategy, evidence, and regulatory success.
Regulatory Strategy for AI-Enabled Devices
We provide end-to-end regulatory strategy for AI/ML-enabled SaMD, imaging diagnostics, and digital health tools. This includes pathway selection (510(k), De Novo, PMA), FDA Pre-Subs, Predetermined Change Control Plans (PCCPs), labeling development, risk management, and alignment with evolving U.S., EU, and Health Canada regulatory expectations.
Portfolio Strategy & Innovation Roadmapping
We help teams refine product concepts, evaluate market needs, define clinical relevance, and align development milestones with regulatory and reimbursement expectations. FHA’s strategic roadmapping reduces risk, accelerates progress, and ensures innovation aligns with long-term commercial success.
Clinical Evidence & Study Design
FHA designs high-quality analytical and clinical validation programs tailored to AI-driven diagnostics. Our expertise includes MRMC study design, non-inferiority frameworks, data-quality plans, human factors, and post-market evidence strategies—ensuring regulator-ready, defensible evidence.
Clinical Due Diligence & Risk Assessment
We provide objective evaluations of product claims, validation evidence, study protocols, labeling strategy, and technical architecture. Our reviews support investors, acquirers, and leadership teams making high-value decisions in fast-moving AI and diagnostics markets.
Reimbursement, Coding & Coverage Strategy
With prior leadership roles at AMA’s CPT Editorial Panel, we guide AI innovators through coding, valuation, and coverage pathways. We support CPT strategy, payer dossier development, evidence alignment for coverage, and navigation of commercial, Medicare, and MolDX policies.
AI/ML Product Development & Technical Guidance
We advise across dataset strategy, annotation workflow, model training controls, evaluation metrics, drift monitoring, and system-level integration. Our team has led multiple AI device clearances, enabling robust, scalable, and compliant product development.
