Navigate FDA pathways without burning your runway.
Senior R&D leadership for medical device startups: cardiac, neurovascular, urology, and orthopedic programs led from concept to clearance by an engineer with 18+ FDA clearances and 18 US patents, engaged fractionally as your CTO.
Where I can help
Most engagements start with a fixed-fee review, so you see how I work before committing to more.
“Our grant application is due and nobody's checked the development plan.”
Grant and Proposal Technical Review
See how it works →“Investors keep asking how we get cleared and what it'll cost.”
Regulatory Pathway Assessment
See how it works →“We have test reports, but no user needs or design inputs behind them.”
Design Controls Gap Review
See how it works →“We're about to invest and need an independent technical read.”
Technical Due Diligence
See how it works →“We got a 483 (or a deficiency letter) and need help now.”
FDA Findings Remediation
See how it works →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 and development 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 and development file, ready for your regulatory lead.
Not sure where you are on the ladder? Start with a Design Controls Gap Review.
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.
Implant design controls
Design controls for an orthopedic implant: user needs and design inputs traced through verification, and a design FMEA built from the requirements matrix.
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 start with a fixed-fee review, so you see how I work before committing to more.