Articles By Eric Larson

  1. POC Diagnostics: 4 Considerations For Bridging The Gap From Development To Commercialization 9/2/2026

    Scaling point-of-care diagnostics requires integrating microfluidics, chemistry, and automated assembly early in development. Aligning these pillars reduces risk and speeds time-to-market.

  2. QMSR Is Done. Now What? 9/1/2026

    Align with FDA QMSR requirements by integrating ISO 13485 standards, moving quality management upstream, and tracking process health metrics to ensure continuous regulatory compliance.

  3. What To Expect In The Next Revision Of IEC 62304 9/1/2026

    Prepare for updates to IEC 62304 by learning how revised process rigor levels and expanded health software scopes impact medical device software development and compliance.

  4. 09.01.26 -- Optimize Your eQMS And Strengthen Quality Systems 9/1/2026

    09/01/26 Med Device Online Newsletter

  5. The New Reality Of Particulate Risk: What Drug Manufacturers Need To Know 8/31/2026

    Particulate-related recalls account for 37% of US FDA injectable drug actions, and evolving FDA and EU GMP requirements are raising the compliance bar for manufacturers.

  6. Planning For Scale Up: Building For Long Term Flexibility 8/31/2026

    Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.

  7. Minimizing Particulate Risk: Designing For Control 8/31/2026

    Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.

  8. Protecting Your Drug Product: Integrating Engineering And Quality 8/31/2026

    Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.

  9. Establishing A Container Closure System — Engineering For Integrity 8/31/2026

    CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.

  10. Start Packaging Development Early: De-Risk Before You Build 8/31/2026

    When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.