US market entry
Bringing your innovation to US health systems
For companies and research organizations outside the United States that want to work with American health systems, hospitals, clinics, providers and research institutions. We find the right partners, plan the regulatory and data requirements, and build a sales path.
What we handle
The four things every US entry needs
Business development
Access to US institutions
- Identify the right health systems, provider groups, research centers and distributors
- Introductions to clinical champions and executive buyers
- Structure pilots, evaluations and research collaborations
- Enterprise sales process and contracting
AI technical development
Clinical-grade AI for the US market
- Clinical validation study design with US sites
- De-identified data access under data use agreements
- Annotation and physician-review programs
- Model documentation ready for FDA review
Regulatory and compliance
FDA, CMS and HIPAA
- FDA pathway planning: 510(k), De Novo, PMA, IND
- Translating CE/MDR files into a US submission plan
- Quality systems and GMP
- CMS coding, reimbursement and HIPAA privacy
IT and EHR integration
Fit into the hospital's systems
- EHR integration planning with HL7 and FHIR
- Hospital security and vendor-risk reviews
- Business associate agreements
- Deployment planning with hospital IT teams
How it runs
Assess, plan, introduce, execute
Assess
2–4 weeks
Product fit for the US, likely regulatory pathway, buyers and reimbursement, and the shortlist of institutions to approach first.
Plan
Engagement plan
Regulatory plan, partner list, budget, funding options and a sequenced timeline you can take to your board.
Introduce
Partners and pilots
Meetings with clinical and executive decision makers, and structured pilots, evaluations or research agreements.
Execute
Program management
Program management and fractional leadership through submission, validation, contracting and launch.
We commit to a process and a plan. Regulatory clearance, contracts and reimbursement decisions rest with the FDA, CMS and the institutions themselves.
Meet us
MEDICA 2026, Düsseldorf, 16–19 November. Florida Pavilion, Hall 16, Stand 16D03. Book a meeting.
Let's achieve your business goals, together.
Tell us where you are and where you need to get to. We will reply with how we would approach it.
Contact us today