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About Inflexion

The Firm

Inflexion is an operator-led consulting firm — meaning our principals have built and run the functions we advise on. We bring practitioner judgment, not slide-deck recommendations: we have personally led ISO transitions, built integrated QMS and operational platforms, scaled Quality and Operations organizations, and managed P&L through high-growth and turnaround phases.

We work with small and mid-size biotech, medtech, and life sciences companies; SaaS/AI companies in the healthtech space; and other innovation-driven businesses that need to scale operations and quality without sacrificing speed.

We work with companies globally — remote worldwide, with on-site availability in the San Francisco Bay Area.

Our Approach

We deliver more than slide decks. Every engagement produces working systems, documented processes, and measurable KPIs — not just recommendations. We act as an extension of your leadership team: diagnosing root causes, redesigning operating models, fixing supply chain and quality bottlenecks, and driving outcomes you can measure.

Leadership

Sue-May Zhou

Sue-May Zhou

Managing Member

Operations and quality executive with 20+ years of experience in regulated companies in high-growth and turnaround phases. Sue-May builds integrated operating models that connect Supply Chain, Manufacturing, Quality, and Commercial functions — rather than optimizing individual silos. Her track record includes scaling regulated manufacturing 4× in three months at Cepheid, leading a global ISO 9001→13485 transition and QMS/PLM platform build at 10x Genomics, and driving measurable operational and quality outcomes across medtech, genomics, diagnostics, and consulting. Mechanical Engineering degree, MBA.

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Aggregate Outcomes

-68%complaints+115%margin95%OTD0audit findings-40%SaaS costs~6xteam scale