ABOUT THE PRINCIPAL

Ben Hsieh. Two decades operating automation through the moments that mattered.

Systemic Automation Strategy is led by Ben Hsieh — an engineering and operations executive who has built and run laboratory automation organizations through Series A growth, IPOs, FDA submissions, CLIA accreditation, M&A, and SPAC. The practice exists to give that operating experience to leadership teams making the same decisions for the first time.

Ben's approach treats the laboratory as one integrated system — instruments, software, middleware, and operations engineered together, not optimized in isolation. He builds technology roadmaps that align R&D velocity with regulatory rigor, embracing AI and cutting-edge automation to compress development cycles without compromising reliability. Every engagement starts with a clear architectural thesis: map the data flows, define the integration boundaries, and design for scale before the first vendor is selected.

Execution follows the engineering V-Model — user requirements and design inputs on the left, verification and validation on the right. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are treated as core engineering deliverables, not afterthoughts. Verification proves the system was built right; validation proves it meets its intended purpose under real-world load. That discipline is what lets an automation program survive FDA, CLIA, and CAP scrutiny — and scale from pilot to 40,000 samples per day.

He brings AI-augmented development practices to every engagement: clearly defined design inputs, written acceptance criteria, and a qualification path that protects first-pass rate and uptime as volume grows — without sacrificing the flexibility a biological assay demands.

Career

A record of scale, not just titles.

  1. 2025 — Present
    Founder & CEO
    ZdefLabs

    Redefine the instrument calibration standard across clinical and research labs to eliminate systemic operational waste and improve instrument reliability.

  2. 2020 — 2025
    Head of Operation — Automation Engineering
    Freenome (pending SPAC merger)

    Scaled team 5 → 28. $50M+ budgets. 335K sq ft lab. 35K-sample CRC clinical validation in <3 months, >99% first-pass. JAMA, June 2025. Anchored $870M Exact Sciences deal.

  3. 2019 — 2020
    Vice President, Automation Engineering
    CareDx

    Reported to COO. $7M CapEx / $2.5M OpEx. CLIA lab expansion. Advisor on CLIA, CAP, and FDA 510(k) inspections.

  4. 2013 — 2019
    Head of Automation Engineering
    Invitae (IPO 2015 → LabCorp)

    Built and led automation engineering teams. End-to-end workflow for 10K samples/day, scalable to 40K. CLIA/CAP technical advisor.

  5. 2011 — 2013
    Sr. Process Automation Engineer
    Complete Genomics (acq. BGI)

    Lab automation for production and R&D. Tech transfer to BGI post-acquisition.

  6. 2010 — 2011
    Lab Automation Specialist
    Codexis (IPO 2010)

    Cross-platform UI for Biomek and Tecan. Company-wide screening support.

  7. 2008 — 2010
    Bioprocess Engineer
    Pacific Biosciences (IPO 2010)

    Automated and completed campaigns of site-directed evolution. Protein modeling.

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