Solutions Built for the Journey Ahead
Clinical Research & Evidence Development
Design and execute clinical development plans aligned with payer and FDA requirements — including protocol development, site recruitment, and KOL engagement.
Regulatory Strategy & FDA Pathways
Develop regulatory strategy and manage submissions across 510(k), De Novo, PMA, and EUA — with CE Mark and international pathway support.
Health Economics & HEOR
Build the economic case for your device through cost-effectiveness modeling, budget impact analysis, real-world evidence, and AMCP-format value dossiers.
Reimbursement Strategies
Build value-driven reimbursement frameworks aligned with payer expectations — including coding strategy across CPT, HCPCS, and ICD-10 — from early development through commercialization.
Market Access
Align payer, provider, and patient channels to remove adoption barriers and move your product from clearance to covered — at scale.
Fractional CCO
Embed experienced commercial leadership into your organization. Go-to-market strategy, sales model design, KOL development, and market access readiness — without the cost of a full-time executive hire.
Fractional COO
Access senior operational leadership on a retainer basis. We build the infrastructure, processes, and reporting systems early-stage medtech companies need to scale — from vendor management and QMS to board reporting and investor readiness.
Appeals & Prior Authorization
Navigate payer coverage challenges with strategic, evidence-based support for appeals and prior authorization processes.
Reimbursement Support Services
Provide HUB-style support for provider offices and patients — prior authorization processing, benefit verification, reimbursement guides, and sales team support.
Field Reimbursement
Equip field teams with practical reimbursement education, tools, and support to drive product adoption at the account level.