Navigate FDA pathways without burning your runway.
Senior R&D leadership for medical device startups — cardiac, neurovascular and urology programs led from concept to clearance by an engineer with 18+ FDA clearances and 18 US patents, engaged fractionally as your CTO.
Engineering judgment, not just extra hands.
I sit in the room for the design reviews and the audits. Three ways to bring twenty years of device development onto your team.
Fractional CTO
Senior R&D leadership without full-time overhead — architecting your regulatory pathway, design controls, and a product development process that scales.
Learn more →Technical due diligence
Independent assessment for PE/VC firms — regulatory risk, development timeline, manufacturing feasibility, and IP position, before the funding decision.
Learn more →Regulatory strategy
Targeted guidance on a specific hurdle — pathway selection, design control architecture, 510(k) strategy, or a risk framework that fits a startup timeline.
Learn more →A proven five-stage path to market.
ISO 13485:2016
ISO 14971:2019
21 CFR 820
IEC 62304
Regulatory route planning
Pathway selection and a dated clearance plan.
Design control architecture
A design history file that holds up under audit.
Risk management integration
ISO 14971 risk woven through the QMS.
Verification & validation
A V&V strategy that maps to your claims.
Submission readiness
A complete, defensible design history file, ready for your regulatory lead.
Led from concept to clearance.
Coolrail RF linear pen
Solved how to cool bi-polar electrodes in fluidic contact while keeping electrical isolation, and built the mathematical model of RF ablation on cardiac tissue.
LAA occlusion clip
Built every engineering specification and ran the animal and human studies for a Gen 1 left-atrial-appendage occlusion device, then led the Gen 2 redesign.
SureStep & DigniShield
Idea-to-production ownership of a Foley tray and continence system — VOC, test methods, verification, the 510(k), and overseas supplier audits.
First-hand notes from the practice.
The QMSR is not a rebrand: what actually changed
The deltas hiding inside FDA's "substantially similar" — and where SOPs break.
10 min read AI · Design controlsPopulating a design FMEA with AI
What it gets right, and where it still needs an engineer's judgment.
6 min read AI platformsWhat AI-native design control platforms actually automate
A skeptical technical read on what still needs a human reviewer.
8 min readBring twenty years of device development to your team.
Most engagements open with a fixed-scope, two-week gap analysis of your design history file.