Industry Insights

  1. A Risk-Based Approach To EO Residual Limits 9/29/2026

    ISO 10993-7:2026 replaces table-based EO residual limits with a risk-based framework that requires manufacturers to justify limits based on device-specific and patient-specific factors.

  2. Why Micro Manufacturing Needs "Architecture" Not Just Production 9/28/2026

    Discover why micro molding requires a complete manufacturing architecture integrating design, tooling, automation, metrology, production, and packaging to achieve predictable, repeatable results at scale.

  3. The People Who Turn An Idea Into A Deliverable Product 9/15/2026

    Drug developers and device engineers share more common ground than their distinct disciplines suggest, facing parallel pressures around design, safety, regulatory approval, and scalable performance.

  4. 8 Regulations Every Biotech & Pharma Quality Leader Must Know 9/14/2026

    Navigate essential biotech and pharma regulations safely. Learn how unifying global standards streamlines audits and accelerates development schedules.

  5. The Life Sciences Guide To AI In Quality & Compliance 9/14/2026

    Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you audit-ready for compliance.

  6. Advancing Biopsy Device Performance Through Precision Overmolding And Assembly 9/2/2026

    Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

  7. Six Key Challenges When Precision Has To Scale 9/2/2026

    Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

  8. 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.

  9. 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.

  10. 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.