An Oxford-based digital health company had developed an AI-powered imaging tool but needed a clear path to regulatory clearance and commercial launch across multiple geographies.
We mapped the regulatory pathway for FDA clearance and CE marking simultaneously, developed the clinical evidence package, managed the cross-functional team of twenty spanning engineering, compliance, and marketing, and designed the market access and reimbursement strategy.
“Dual regulatory clearance across two geographies, and commercial revenue within twelve months.”
The product achieved FDA clearance and CE marking, was implemented across nine clinical trials, and generated its first commercial revenue within twelve months of the project's start.