Case Files

    Proven Architectures
    in Action

    Our portfolio reflects the structural integrity required to move diagnostics from the lab to the standard of care.

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    25+

    Years in Diagnostics

    IVD, POCT, Molecular & Clinical

    FDA

    Regulatory Pathways

    510(k), EUA, and De Novo strategy

    Full-Stack

    Commercialization

    Evidence through market adoption

    Experience across molecular diagnostics, decentralized testing, hospital laboratories, and global health system commercialization environments.

    Proven Architectures

    Diagnostic Commercialization Case Files

    01

    Project File 01

    STI Molecular Platform: U.S. Launch Architecture

    GTM StrategyCommercial DesignReimbursement

    The Structural Risk

    A venture-backed startup with strong molecular POC technology but no structured commercialization path. Unclear CLIA-waived positioning and fragmented strategy risked delayed post-clearance adoption.

    The Blueprint

    • Clinical Utility: Designed evidence framework aligned to payer coverage requirements for molecular POC diagnostics
    • Market Access: Built CPT reimbursement and pricing/ROI framework for urgent care, primary care, and pharmacy channels
    • Commercial Architecture: Created full U.S. go-to-market strategy with placement architecture and channel sequencing

    The Landmark

    "Established first U.S. commercialization architecture ahead of regulatory submission, positioning the company for immediate post-clearance market entry."

    02

    Project File 02

    Platform Panel Strategy: Global Expansion Architecture

    GTM StrategyCRO Study PlanningMarket Entry

    The Structural Risk

    Early-stage platform with broad panel potential, but no launch sequencing logic. Misaligned regulatory/commercial strategy and unstructured EU/UK entry risked overbuilding the initial product.

    The Blueprint

    • Clinical Utility: Separated initial launch evidence from expanded panel roadmap to prevent regulatory overreach
    • Market Access: Developed EU/UK reimbursement logic aligned to care settings and coverage pathways
    • Commercial Architecture: Built phased panel strategy with two-way regulatory framing for future submissions

    The Landmark

    "Defined phased expansion strategy enabling initial launch while preserving long-term panel differentiation across global markets."

    03

    Project File 03

    Urinalysis Point of Care Platform: U.S. Market Entry Architecture

    Point of CareGTM StrategyDistributionClinical Evidence

    The Structural Risk

    A U.K. diagnostic startup developing a second generation point of care urinalysis platform sought entry into the United States market without a defined commercialization pathway. Regulatory sequencing, clinical evidence planning, and distribution architecture had not yet been aligned, creating risk across regulatory approval, investor diligence, and early market adoption.

    The Blueprint

    • Go to Market Strategy: Developed a detailed U.S. commercialization strategy for physician offices, urgent care, and decentralized laboratory environments
    • Distribution Architecture: Designed a national distribution model aligned with major diagnostic supply channels and laboratory procurement pathways
    • Clinical Evidence Strategy: Coordinated CRO engagement, site management, and U.S. specimen collection for clinical study execution
    • Commercial Operations: Developed standard operating procedures for customer onboarding, technical support, and field service operations
    • Investor Preparation: Participated in investor calls supporting the company's Pre Series A fundraising narrative and commercialization roadmap

    The Landmark

    "Established the U.S. commercialization and clinical study framework required to support regulatory submission, investor diligence, and scalable point of care adoption."

    Engagements are described at the category level. Specific client details are held in confidence.

    Engagement Landscape

    Built Across the Full Diagnostic Spectrum

    Every engagement draws on deep operational experience across diagnostic categories, care settings, and commercial channels.

    Diagnostic Categories

    Molecular and PCR platforms

    Immunoassay and lateral flow

    Clinical chemistry and hematology

    Decentralized and point-of-care testing

    Care Settings

    Hospital and health system laboratories

    Urgent care and retail pharmacy

    Physician office and outpatient clinics

    Reference and specialty laboratories

    Commercial Channels

    National distribution (Cardinal, McKesson, Medline)

    GPO and IDN contracting

    Direct-to-institution sales

    International market entry

    Ready to build the foundation
    for your launch?

    Every engagement begins with a 30-minute diagnostic conversation to identify where your architecture gaps are.

    Commercial success in diagnostics is built, not discovered.