MedTech Strategy & Usability Architecture
75% of venture-backed startups fail. Most collapse during late-stage regulatory rejection. The 2026 FDA mandatenow requires formative usability testing early in the cycle. Human-centric architecture is no longer optional. It is a survival requirement. We bridge the gap between breakthrough technology and a cleared medical product.
1
The "Blind Spot" Discovery Workshop
This is a rapid in-house strategy intensive. We study your technology and its intended use environment. Through a contextual thought exercise, we find safety-critical "blind spots." This prevents expensive late-stage technical debt.
The Result: A Preliminary Product Architecture and a discovery report. We provide a defined roadmap for regulatory compliance, such as the IEC 62366-1 process for MedTech. This aligns your design strategy with the next development phase.
2
Usability Architecture Sprints
This iterative sprint builds your formal Usability Engineering File (UEF). The scope and timing align with your development stage. We map user profiles and environments per IEC 62366-1. We identify safety-critical tasks and hazard scenarios. This integrates with your ISO 14971 risk management file. We conduct formative evaluations per FDA HF guidance. This de-risks your path to market at your own pace.
3
Development & DFM Execution
We take over your physical product development. I personally lead the Industrial Design and DFM process. We believe in Quality by Design (QbD). We integrate usability, safety, longevity, and environmental impact into the core architecture. We ensure your device is as easy to build as it is to use. This is the path for startups needing a dedicated, high-efficiency development arm to reach the market.
4
Fractional Development Executive
This is your path for rapid acceleration. I act as your internal development lead. I manage the relationship with global engineering firms on your behalf. I ensure your design architecture remains intact during scaling. I serve as your functional Project or Product Manager. We bridge the gap from prototype to a global rollout. This saves up to 30% in external discovery fees. We protect your vision and your capital as you grow.
