Healthcare & MedTech Systems
We support healthcare, medtech, and digital health organizations as they navigate the intersection of innovation and regulation. Whether you’re preparing for FDA submission, scaling a digital health platform, or modernizing IT infrastructure, we help teams move with speed, compliance, and clarity.
Our experience spans diagnostics, SaaS-based health tools, clinical software, and regulated medical devices — delivering structured execution across pre-market planning, system integration, and strategic growth.
RHTP Plan Development for State Health Systems
We help states meet CMS timelines and submit compliant Rural Health Transformation Plans—leveraging FHIR modernization, oversight, and sustainable delivery models.
Core Capabilities
Interim Leadership for Healthtech Initiatives
Fractional CIO, CTO, or program leads to drive transformation in digital health, medtech, or clinical IT.
Regulatory Readiness for FDA, FNS, CMS & HIPAA
Strategy and documentation for SaMD, 21 CFR Part 11, FHIR, and other key compliance areas.
System Integration & Data Architectures
EHR, FHIR, and payer platform integration for seamless data exchange and value-based care readiness.
Go-to-Market Planning & Commercial Strategy
Support for clinical and diagnostic product launches, with a focus on regulated markets and adoption pathways.
Software & Device Interface Support
Bridge the gap between hardware, software, and compliance teams for connected medical technologies.
Public Health & Government Program Alignment
Support for agencies and vendors navigating Medicare modernization, CMS funding requirements, and ONC compliance initiatives.
Case Studies
Proven Outcomes in Regulated Health Environments
From digital health startups to public-sector health programs, we deliver structured support for compliance, modernization, and clinical innovation. Client names withheld for confidentiality. Full case study portfolio available upon request.
Ready to Advance Your Healthtech Strategy?
From regulatory readiness to product commercialization, we help medtech, digital health, and public-sector teams move with clarity, speed, and compliance.