A lean stage-gate process from concept to commercialization.
Each gate answers a different question: Is the concept worth pursuing? Does it work? Is it verified and clinically ready? Is it ready to manufacture, submit, and launch?
Four gates, one integrated technical strategy.
IP, risk management, engineering evidence, regulatory planning, and capital efficiency should evolve together rather than in separate workstreams.
Gate 1 — Initiation & risk
User needs, intended use, early design planning, preliminary risk management, concept viability, and initial IP landscape awareness.
Gate 2 — Feasibility
Computational, lab, and preclinical proof of function; refinement of design inputs; early prior-art and patentability support.
Gate 3 — V&V / First-in-human
Design outputs, prototypes, formal verification, initial validation, clinical-readiness evidence, and FTO/design-around support where relevant.
Gate 4 — Final validation & launch
Manufacturing readiness, final validation, regulatory submission, commercialization support, and competitive/IP monitoring.
Where WJH adds the most leverage.
Evidence strategy
Define the minimum and optimal credible testing and analysis required for the next gate — no less, and no unnecessary burden.
Program recovery
Root-cause work, redesign, verification recovery, and technical strategy when a program, submission, or trial stalls.
Technical decision support
Integrate product performance, risk, regulatory expectations, intellectual property, and available capital into one decision framework.