Frank Healthcare Advisors

    Our Expertise

    The expertise you need. At every stage of medical technology development.

    Integrated regulatory, clinical, and commercial expertise to help medical technology innovators navigate complexity, reduce development risk, and accelerate the path to market.

    Explore Our Expertise

    What we do

    Six disciplines, one integrated team.

    Each engagement draws on the capability set below — calibrated to your stage, evidence needs, and pathway.

    01

    Regulatory Strategy for AI-Enabled Devices

    FDA Total Product Life Cycle

    End-to-end FDA Total Product Life Cycle strategy for AI/ML-enabled SaMD, imaging diagnostics, and digital health tools. Pathway selection (510(k), De Novo, PMA), FDA Pre-Subs, Predetermined Change Control Plans (PCCPs), labeling, risk management, and alignment with U.S., EU, and Health Canada expectations.

    02

    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 — reducing risk and accelerating progress.

    03

    Clinical Evidence & Study Design

    High-quality analytical and clinical validation programs tailored to AI-driven diagnostics. MRMC study design, non-inferiority frameworks, data-quality plans, human factors, and post-market evidence strategies.

    04

    Clinical Due Diligence & Risk Assessment

    Objective evaluations of product claims, validation evidence, study protocols, labeling strategy, and technical architecture — supporting investors, acquirers, and leadership teams making high-value decisions.

    05

    Reimbursement, Coding & Coverage Strategy

    Drawing on current voting membership of the American Medical Association's CPT Editorial Panel, we guide AI innovators through CPT strategy, payer dossier development, evidence alignment for coverage, and navigation of commercial, Medicare, and MolDX policies.

    06

    AI/ML Product Development & Technical Guidance

    Advisory across dataset strategy, annotation workflow, model training controls, evaluation metrics, drift monitoring, and system-level integration — informed by multiple AI device clearances.

    Align critical decisions with regulatory, clinical, and reimbursement realities.

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    In collaboration with

    BlueBridge Technologies logo

    An integrated path from strategy to execution

    FHA aligns regulatory strategy, clinical evidence, and reimbursement. For teams that also need to build, FHA collaborates with BlueBridge Technologies — a regulated medical-software development partner delivering Software as a Medical Device from concept to release. Together, strategy connects directly to compliant execution: design controls, verification and validation, Design History File, and FDA-ready evidence.

    • ISO 13485
    • IEC 62304
    • ISO 14971
    • ISO 27001
    • SaMD / SiMD / AIaMD
    • Since 2006

    A fuller BlueBridge Technologies overview and partner resources are planned for FHA's members area.

    Common questions

    Frequently Asked Questions

    What services does Frank Healthcare Advisors provide?
    Frank Healthcare Advisors (FHA) provides strategic regulatory, clinical development, and market access advisory services for medical device, diagnostics, imaging, and digital health innovators. Our expertise includes FDA and Health Canada regulatory strategy, clinical evidence planning, AI/ML-enabled technologies, quality and design controls, reimbursement strategy, and regulatory and clinical due diligence.
    Who does FHA work with?
    FHA partners with early-stage innovators, established medical technology companies, and investors evaluating healthcare technologies. We provide flexible support ranging from targeted strategic advice and regulatory submissions to ongoing advisory engagements, helping clients navigate development, regulatory authorization, reimbursement planning, and market adoption.
    When should a medical technology company engage a regulatory advisor?
    Ideally, early in product development, before key decisions about intended use, product design, clinical studies, or regulatory claims are finalized. Early regulatory planning helps identify potential challenges, reduce costly rework, and align development activities with FDA, Health Canada, and other applicable regulatory expectations.
    How can FHA help companies plan for reimbursement and market adoption?
    Regulatory authorization is only one step toward commercial success. FHA helps companies consider coding, payer coverage, clinical utility, and evidence requirements early in development. By integrating these considerations into regulatory and clinical planning, companies can build a more efficient path toward reimbursement and clinical adoption.
    How does FHA help develop clinical evidence strategies?
    FHA combines regulatory, clinical, and biostatistical expertise to design evidence-generation strategies that support regulatory authorization, clinical adoption, and reimbursement. Our team includes a Harvard-trained biostatistician with more than 30 years of experience designing and analyzing medical device clinical studies, including successful programs leading to FDA 510(k) clearances and PMA approvals. Together, we help clients establish scientifically rigorous, statistically sound study designs, appropriate comparators, meaningful endpoints, and robust analysis plans. By integrating regulatory and statistical expertise from the outset, FHA helps companies reduce development risk, optimize clinical studies, and generate evidence that supports both regulatory and commercial objectives.
    How should a company contact FHA?
    Use the Contact page to send a short message describing your product, stage, and the support you are seeking. FHA responds to inquiries within 1–2 business days. Please avoid sending protected health information or confidential product details until an appropriate process is in place.