About FHA

Frank Healthcare Advisors (FHA) is a specialized consultancy guiding innovators of AI-enabled medical devices and diagnostics from early concept through regulatory clearance, clinical validation, reimbursement, and adoption. We integrate regulatory science, clinical evidence, and AI/ML product development with a strong emphasis on due diligence, critical path management, and strategic decision-making frameworks that de-risk development for start-ups and investors. Our expertise spans FDA, BDD, CLIA/MolDx, CPT coding, clinical study design / biostatistics, and global digital-health policy, enabling us to design strategic pathways that accelerate time to market. With decades of leadership in agency engagement, clinical research, and healthcare innovation, FHA brings both strategic clarity and operational rigor to help companies navigate the evolving landscape of digital medicine.

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ABOUT FRANK HEALTHCARE

Our Mission

FHA’s mission is to guide innovators of AI-enabled medical devices and diagnostics from early concept through regulatory clearance, clinical validation, reimbursement, and adoption. Our work integrates regulatory science, clinical evidence, and AI/ML product strategy to accelerate safe, trusted, and commercially viable healthcare innovation.

Who We Are

Frank Healthcare Advisors is a collective of seasoned leaders in regulatory science, AI-enabled device development, clinical and statistical evidence generation, and global health technology innovation. Led by Dr. Richard Frank, a nationally recognized authority on AI policy, CPT coding, and evidentiary standards, the team combines executive-level industry experience with hands-on expertise across R&D, clinical trials, regulatory submissions, and reimbursement strategy.

Why Choose Us

FHA combines policy leadership, regulatory depth, biostatistical rigor, and real-world product development experience across AI-enabled devices, diagnostics, and digital medicine. We de-risk development using proven frameworks — including critical path mapping, workflow optimization, and decision-driven planning — that align technical, clinical, regulatory, and payer requirements.