Medical Device Fractional CTO Consulting
Experienced technical leadership for founders and medtech teams that need clear priorities, coordinated execution, and defensible development decisions.
When fractional leadership helps
A medical device program can outgrow founder-led engineering before it can support a full-time CTO. Teams may have several vendors, an evolving product architecture, and an approaching investor or regulatory milestone without one person connecting the work.
WJH provides CTO and VP-level R&D support through fractional or interim engagements. The scope can cover a defined development stage, an organizational transition, or an ongoing technical leadership need. Responsibilities and decision authority are agreed at the beginning of the engagement.
Responsibilities aligned to your program
Development roadmap and technical priorities
Translate the clinical objective and business milestones into engineering decisions, feasibility work, and verification evidence. Identify dependencies and make tradeoffs visible before they become schedule problems.
Team and vendor coordination
Align internal engineers, laboratories, manufacturers, and specialist vendors around clear inputs, outputs, review points, and ownership. Establish a cadence for decisions and escalation.
Verification and regulatory alignment
Connect design requirements, risk management, modeling, bench testing, and submission evidence. Coordinate engineering work with the company’s regulatory and quality functions.
Leadership and investor communication
Explain technical progress, unresolved risks, assumptions, and resource needs in terms that founders, boards, and investors can assess.
Typical engagement outputs
- Prioritized technical roadmap and milestone dependencies.
- Program risk register with owners and next decisions.
- Vendor workstream definitions and review cadence.
- Verification evidence plan and gap assessment.
- Technical updates for leadership and investment discussions.
The scope and deliverables are tailored to the device and development stage; the list is a starting point for discussion.
What to bring to the first conversation
Describe your device, current team and vendors, development stage, and next consequential milestone. A concise explanation of where decisions are stalling is more useful than a large document set at the outset.
Learn about Jim Harrison’s engineering leadership, the development process, and technical due diligence.