I’ve spent 30 years in medtech and biotech—from the bench to the production floor to the C-suite—bringing more than 25 products to market across FDA 510(k), CE/MDR, and TGA pathways. I’ve seen exceptional science fail, not because the innovation wasn’t strong, but because the operational, regulatory, and governance foundations weren’t in place to support commercialization. That’s the gap I focus on closing.
I embed directly within teams to resolve the specific bottlenecks holding programs back: regulatory strategy, ISO 13485 design control, V&V planning, manufacturing pathways, and investor readiness. I attend program reviews, work alongside leadership, and am accountable at the board level—leading every engagement personally.
By building credible, well-structured programs, I align the path to regulatory approval with the path to investment. My goal is to de-risk execution, strengthen investor confidence, and accelerate the journey from concept to market.
