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Medical Device Development
Design, modeling, testing, verification, validation, and engineering documentation aligned to regulatory strategy.
See services →Medical Device Engineering · Fractional CTO · Technical IP Strategy
Engineering medical devices from concept to clinical reality.
Principal-led medical device development and R&D leadership for cardiovascular, structural heart, neurovascular, orthopedic, and spinal programs — from feasibility and patent strategy through verification, regulatory submission, and commercialization.
Track record
Senior engineering leadership at the stages that matter.
WJH Engineering supports medtech teams through high-consequence technical decisions, verification programs, clinical setbacks, regulatory milestones, and investor or acquisition diligence.
30+regulatory approvals supported
50+FEA & CFD studies
$500M+acquisition outcomes across portfolio companies
15IDE trial halts addressed through root-cause work
What we offer
Four connected ways to move a program forward.
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Fractional & Interim Leadership
CTO/VP-level R&D leadership without the full-time overhead: roadmap, teams, QMS, regulatory strategy, and diligence readiness.
Leadership support →03
Strategic Advisory
Technical diligence, root-cause strategy, capital-efficient value inflection planning, portfolio decisions, and M&A preparation.
Strategic advisory →04
Patent & IP Technical Support
Patentability support, prior art, FTO technical analysis, claim mapping, patent landscapes, and engineering design-around.
Patent & IP support →Device expertise
Focused on implant and delivery-system programs.
Deep domain experience in high-cycle vascular devices and load-bearing orthopedic systems, where fatigue, biomechanics, delivery performance, and verification strategy determine program risk.
Explore device expertiseCardiovascular & Structural Heart
Coronary, peripheral, valve, neurovascular, and transcatheter delivery systems.
Orthopedic & Spinal
Spinal constructs, large-joint implants, trauma fixation, instrumentation, fatigue, and material endurance.
Patent & IP strategy
Build IP awareness into engineering — not after the design is frozen.
WJH Engineering supports founders, product teams, investors, and patent counsel by translating concepts and patent claims into engineering features that can be compared, challenged, redesigned, and developed.
Concept patentability
Identify potentially novel technical elements and compare them with patents, publications, products, and known approaches.
Patentability & prior art →Freedom-to-operate support
Map proposed product features against relevant patent claims and identify engineering alternatives for counsel to evaluate.
FTO technical support →Design-around engineering
Explore alternate architectures, mechanisms, materials, geometries, and workflows when a claim creates a development constraint.
Design-around services →Development approach
A stage-gate process built to conserve capital and reduce risk.
Gate 1
Initiation & risk
User needs, concept viability, preliminary risk management, and early IP landscape awareness.
Gate 2
Feasibility
Computational, bench, and preclinical proof of function, plus prior-art and concept-differentiation support.
Gate 3
V&V / First-in-human
Design outputs, verification, validation, clinical readiness, and FTO/design-around support where needed.
Gate 4
Launch
Manufacturing readiness, regulatory submission, commercialization, and competitive IP monitoring.
WJH is structured for founders and leadership teams that need experienced technical ownership without adding unnecessary management layers. Engagements can be project-based, fractional, interim, or advisory.
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