Medical device consulting from engineering execution to CTO-level strategy.
Engage WJH for a defined technical workstream, fractional leadership, strategic advisory, or engineering-driven IP support.
Four engagement models.
Medical Device Development
Hands-on ownership of design, computational analysis, prototyping, bench testing, verification, validation, and submission-supporting engineering documentation.
- Design inputs and outputs
- FEA / CFD and fatigue analysis
- Bench and durability testing
- Preclinical study coordination
- Verification and validation strategy
Fractional & Interim Leadership
CTO/VP-level R&D leadership on a fractional or interim basis for startups that need experienced technical management before a full-time executive hire.
- R&D roadmap and budget
- Team and vendor leadership
- Quality-system implementation
- Regulatory pathway alignment
- Board and investor technical communication
Strategic Advisory
Board- and executive-level guidance around technology decisions, diligence, program recovery, capital efficiency, and value-inflection strategy.
- Technology due diligence
- M&A and data-room readiness
- Portfolio prioritization
- Root-cause and recovery strategy
- Development-risk assessment
Patent & IP Technical Support
Engineering-focused patent work to clarify technical differentiation, relevant claims, product-to-claim mapping, and design-around options.
- Concept patentability support
- Prior-art discovery technical review
- FTO evaluation and technical support
- Claim mapping and claim charts
- Patent landscapes and design-around engineering
Six technical disciplines that compound.
Least-burdensome R&D strategy
Sequence the optimal credible evidence needed for each development gate while protecting timeline and capital.
Computational modeling
FEA, CFD, fatigue and durability analysis, sensitivity studies, and design optimization.
Physical testing & verification
Proof-of-concept through static, fatigue, endurance, accelerated-life, and submission-ready verification.
Preclinical studies
Animal and cadaveric study scoping, CRO oversight, endpoint definition, and evidence translation.
Regulatory strategy
Engineering alignment across 510(k), EFS, IDE, PMA, and CE programs.
Patent & IP technical strategy
Prior art, patentability support, FTO technical analysis, claim mapping, competitive landscapes, and design-around concepts.
Not sure where the engagement should start?
Send a short description of your device, program stage, and next critical milestone. The first conversation can usually identify the highest-leverage workstream.
Discuss your program