James Causey

Fractional VP R&D | Biomedical Engineer | Diabetes Device Expert (CGM, AID, Insulin Delivery) | 30+ Years Scaling Innovation from Concept to Commercial | FDA Strategy & Risk Mitigation

Simi Valley, California, United States

About

I help diabetes-technology companies accelerate development and mitigate technology and programmatic risks. As a fractional executive and coach, I leverage years of experience spanning technology roles as an engineer, manager, director, VP, and CEO.

Experience

  • SIMIMED, INC. (2 yrs 9 mos)
    • Consultant
      Mar 2026 - Present · 4 mos

    • Innovator
      Oct 2023 - Mar 2026 · 2 yrs 6 mos

      Advancing the state of the art in technologies to benefit people with diabetes

  • Insulet Corporation (2 yrs 5 mos)
    • VP, Hardware Engineering and Advanced Technologies
      Jul 2022 - Sep 2023 · 1 yr 3 mos

    • Consultant, Advanced Technology
      May 2021 - Jun 2022 · 1 yr 2 mos

      Advanced technology research

  • VP R&D, VP Innovation at Optiscan Biomedical
    Jan 2012 - Jun 2020 · 8 yrs 6 mos

    Led an extraordinary team of scientists, engineers, and technicians to develop the novel, FDA-cleared OS5000 (K162042) reagentless, critical care monitor for glucose. The OS7000 is CE Marked, providing continuous measurement of glucose, lactate and ScvO2 . Major innovations spanned mid-infrared, multivariate analyte measurement, sampling of blood automatically drawn from a central venous catheter, and an intuitive graphical user interface. The stellar team succeeded in bringing an unprecedented in vitro diagnostic device to connected critical care patients, earning a new FDA product code for a continuous glucose monitor. The company’s mission was impacted by the COVID-19 pandemic.

  • Innovator at Simimed, Inc.
    Apr 2007 - Jan 2011 · 3 yrs 10 mos

    Medical device innovation development Technical due-diligence for venture-funded stories Innovation facilitation

  • CEO/President at M2 Medical
    2005 - 2007 · 2 yrs

    Developed a novel insulin infusion pump system for people managing T1 diabetes. The architecture consisted of a durable component and a disposable drive assembly and a prefilled insulin cartridge.