Service Overview
I help early stage medtech and digital health teams turn strong science and engineering into approvable, commercially successful products that delight users. Teams bring me in when they need senior product/program leadership but are not ready for a dedicated hire. I leverage my 15 years of hands-on leadership across Class III implants, diagnostics, neonatal respiratory, and surgical instrumentation, focusing my involvement on your biggest challenges.
Product Strategy
I help teams define what they are actually building and why it matters. My work starts with getting user needs right, then tying those needs to the regulatory expectations and technical constraints that shape a real product. From there I translate everything into clear, actionable roadmaps that engineering, clinical, and regulatory teams can execute against. The result is a grounded product strategy that avoids wishful thinking, reduces rework, and gives founders and investors a plan they can trust.
Program Leadership
I bring structure, clarity, and accountability to programs that are often moving fast without the systems to support them. I align engineering, clinical, and regulatory functions so teams stop working at cross-purposes and start driving toward the same milestone. My approach focuses on practical design controls, tight requirements, and clean verification paths, which prevents churn and cuts delay. I set the cadence, decision process, and cross-functional expectations that early stage teams usually do not have yet, which lets founders focus on strategy while the program moves forward with discipline.
Core Competencies
Tailored solutions in program structure, design, and team building.
Product and Evidence Roadmap
Build lean product development plans that tie user needs, intended use, early claims, technical feasibility, and the eventual evidence required to support them into one structure. Connect labeling claims to a clear regulatory and clinical evidence strategy to ensure the output satisfies regulatory filings and aligns with real, reimbursable market needs.
User Insights and Human Factors
Plan methodology and conduct user interviews and formative studies. Translate insights into actionable design inputs, critical tasks, and early Use-Related Risk Analysis (URRA) aligned with IEC 62366.
Program Structure and Execution Systems
Create clear execution structure for R&D and cross functional teams. Set up practical planning tools, goal tracking, and risk registers so teams understand critical path, dependencies, and decision points. The goal is faster decisions, fewer surprises, and predictable progress toward key milestones.
Right Sized Design Control and QMS
Develop and advance risk management (ISO14971) and design control documentation aligned to 21 CFR 820 and ISO 13485 for seamless regulatory agency review. Support integrated HW/SW development planning consistent with IEC 62304. Implement and administer traceability matrix tools to prevent missed requirements and testing in complex systems as often occurs when table based tools are used.
Support leaders with organizational structure and early hiring decisions. Define roles, interview candidates, and mentor new PM hires so capabilities remain in house after fractional support tapers down.