From first prototype to cleared product.
Over twenty years I've taken cardiac, neurovascular and urology devices from first prototype to clearance — as an executive R&D leader, and now fractionally, for the startups that need that judgment without the full-time seat.
Cradle-to-grave device development.
I've held design and development roles across several regulated industries — chances are the avionics I designed years ago were on an aircraft you've flown recently. For the last two decades that work has been medical devices: cardiac ablation and stroke prevention at AtriCure, urology and continence at CR Bard, and neurovascular catheters and guidewires at Stryker Neurovascular — with 18+ FDA clearances behind me.
My background is in cradle-to-grave innovative product development and portfolio management — building and leading high-performance teams to deliver specialized devices. I'm well versed in project management, design controls, innovation, and ideation. It is my passion to take an idea and turn it into a product that positively affects patients' lives.
As a fractional CTO — and Chief Product Officer at MedHive.ai — I bring that same discipline to startups a stage or two behind their first clearance: the ones who need senior engineering judgment in the room, not another deck.
ISO 13485:2016
ISO 14971:2019
IEC 62304
510(k)
QMSR
Three decades across MedTech and aerospace.
You talk to the engineer.
No account layer, no handoff. The person who scopes the work is the person who does it.