This programme was led by Marc Goldfinger in an in-house leadership role at a UK digital health company, not as a GoldWhite client engagement. It is the experience he brings to GoldWhite's regulatory work.
A UK digital health company had developed an AI-powered imaging tool but needed a clear path to regulatory clearance and commercial launch across multiple geographies.
Marc mapped the regulatory pathway for FDA clearance and CE marking simultaneously, developed the clinical evidence package, managed a cross-functional team of twenty spanning engineering, compliance, and marketing, and shaped 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 programme's start.