Healthcare & Life Sciences
From FDA pathways to HIPAA and payor relationships, we guide healthcare technology and life sciences companies through the intricate U.S. healthcare ecosystem.
In U.S. healthcare, clearance and reimbursement decide the business case
A brilliant product isn't enough here. Whether you can sell in the U.S. – and at what price – is shaped by how the FDA classifies you, whether payors will reimburse you, and how long hospital and health-system buying cycles run. We help you sequence regulatory clearance, evidence, and commercial strategy so each one unlocks the next instead of stalling your launch.
Where we help
FDA pathways: 510(k), PMA, De Novo
Determine which FDA route fits your device or diagnostic, and what evidence each pathway demands before you can market it.
HIPAA compliance
Build the privacy and security posture U.S. providers and partners require before they'll touch protected health information.
Payor landscape
Map commercial and government payors and understand who actually pays for what you offer.
Hospital & health-system sales cycles
Plan for long, committee-driven buying processes, value-analysis committees, and the proof points that move them.
Digital health regulations
Navigate the rules around software as a medical device, telehealth, and remote patient monitoring.
Clinical trials & reimbursement
Design U.S. clinical and reimbursement strategy – from coding and coverage to the evidence that supports both.
Bringing healthcare innovation to the U.S.?
Let's line up your regulatory, clinical, and commercial path so they reinforce each other.
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