A 3D printer with orange and black components printing on a flat surface, surrounded by binder clips and small orange devices.

Prototype

You developed an idea, built a scrappy team, and now have a proof-of-concept prototype. The next step is refining it to reduce technical risks, deliver a meaningful user experience, and give investors confidence in your vision.

You’ve found the right vendors but face communication challenges—sometimes their explanations aren’t clear, and they may not fully grasp your needs. You might be considering bringing on a full-time Director of Engineering, CTO, or Technical Cofounder; or maybe part-time oversight by a startup veteran would suffice.

I specialize in effective communication between scientific, engineering, and commercial teams to keep efforts aligned.

I help finalize requirements and scope documents to ensure results meet your expectations.

By joining your status meetings and select work sessions, I provide focused support in just a few hours per week.

Development

Your feasibility and market research are complete, and you have funding to move from prototype to production. Vendors for industrial design, UX, engineering, verification, clinical trials, regulatory submission, design control, and project management are in place.

Each team member is making consequential decisions every day. While you focus on the big picture, you need a trusted partner with deep experience across the product lifecycle to anticipate challenges and prevent issues.

Instead of more senior management layers that increase complexity and hiring needs, you may consider targeted oversight where risks or unknowns are highest. This lean approach also provides impartial monitoring of schedule, budget, and risk.

My involvement is flexible and scalable, tailored to your needs, providing you with peace of mind during this complex phase.

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V&V

Your design is approaching finalization. You have engaged third-party labs, CROs, and testers to conduct verification and validation. Balancing speed, test coverage, a thorough technical file, and a problem-free launch creates inherent tension.

I collaborate with your teams to strike the appropriate balance among exploratory testing, stress-testing, and protocol adherence, ensuring confidence in your product and a clear verification record within your technical file.

I maintain alignment among your Regulatory, Quality, and Engineering departments to implement safety, privacy, and cybersecurity risk management in a compliant and practical manner.

By providing an independent evaluation of your test schedules, regression plans, and software V&V processes, I help optimize your workflow.

Through oversight of these activities, I enable your senior engineers to concentrate on design transfer, maintenance procedures, and managing post-submission design changes.

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Go-to-Market

Your product is taking shape, and it’s time to turn your high-level marketing forecasts and assumptions into a detailed launch plan. You’ve engaged marketing agencies, distributors, contract sales organizations, and other teams to design and implement your commercial infrastructure.

Big money is being spent and ambitious strategies are being proposed. It’s crucial to ensure these recommendations are tailored to your specific situation—not simply based on recycled methods from different categories.

I offer support in developing and modeling alternative scenarios, holding your vendors accountable for rigorous analytics, metrics, and data-driven tactics, and reviewing or creating comprehensive customer journey maps.

My part-time engagement helps you focus spending on activities that deliver ROI within the right time frame.

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Getting Unstuck

Sometimes members of a team each work hard yet progress stalls. This can occur at any project phase and is rarely resolved by simply adding or replacing personnel.

Whether the challenge involves team dynamics, unclear scope or roles, technical obstacles, or a specific drop-off in the sales funnel, I bring proven experience in diagnosing and resolving these issues efficiently.

I provide concise, focused interventions to identify and address the root causes, helping teams regain momentum.