Three ways to bring senior device engineering onto your team.
Fractional leadership for the teams building the device, and independent diligence for the investors funding them.
Fractional CTO
Senior R&D leadership for startups who need executive technical depth without the full-time seat. I work alongside your team to architect the regulatory pathway, stand up design controls, and build a product development process that survives scale and scrutiny.
Best fit: Seed to Series A, preparing for FDA submission while managing burn.Technical due diligence
Independent technical assessment for PE and VC firms evaluating a medical device investment. A clear read on regulatory risk, development timeline, manufacturing feasibility, and IP position — so the technical picture is settled before the term sheet.
Best fit: Investors sizing technical viability and capital requirements. Typical turnaround, two to three weeks.Regulatory strategy
Targeted guidance for a specific challenge in your FDA pathway. Whether it's design control architecture, a 510(k) strategy, or a risk management framework, you get an actionable roadmap scaled to a startup's timeline and budget.
Best fit: Teams facing a defined regulatory hurdle or a key milestone.A proven five-stage path to market.
Every fractional-CTO engagement runs on the same ladder. We start wherever you are on it.
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 your regulatory lead can build from.
A two-week gap analysis, then a plan.
Gap analysis
A fixed-scope, two-week audit of your design history file and risk documentation against current FDA expectations.
Roadmap
Design controls, risk, and V&V sequenced into a dated clearance plan you can see.
Execute & close out
I lead the team through verification and validation, and hand off a design history file that's ready for submission.
Tell me where you are on the ladder.
A short discovery call is the fastest way to find out what the next step actually costs — in time and in risk.