Industry Insights

  1. ICH E6(R3) Annex 2: Navigating GCP Requirements For Decentralized Trials 7/24/2026

    Implementing decentralized components or real-world data requires proactive alignment with updated GCP standards for data access, remote consent, and multi-stream investigator oversight.

  2. MHRA's 2026 Devices Reform: What Changes And When 7/22/2026

    Great Britain’s draft medical device regulations realign requirements with EU MDR standards. Review transition timelines, technical document rules, and gap analysis strategies now.

  3. Common Questions When Sourcing Tubing For Medical Devices 7/20/2026

    Selecting medical tubing starts with the right questions. Explore materials, tolerances, customization options, and performance factors that support safe, reliable device designs.

  4. Eliminate Fluidic Complexity: A Better Path For Instrument Performance Starts With A Reliable Supplier 7/20/2026

    Simplify fluidic system design with leak-free fittings, high-purity tubing, and custom engineering that improve reliability, sensitivity, and scalability from prototype to production.

  5. FDA's Risk-Based Inspection Shift: What It Actually Rewards 7/20/2026

    FDA’s revised pre-approval inspection program prioritizes risk-based determinations over routine site visits. Review risk assessment factors and transition toward continuous audit readiness.

  6. Selecting A Prefillable Syringe System With Confidence 7/17/2026

    Prefilled syringe selection can stall drug development for months. This system integrates barrel, plunger, and needle shield from a single supplier, reducing complexity for emerging biotech.

  7. Mechanical Engineering Design Process For Combination Products 7/17/2026

    Mechanical engineering for combination drug-delivery devices demands more than good design — it requires data-driven risk management from specs through simulation. Learn how a structured phase approach ensures global manufacturing readiness.

  8. Considerations In Design And Development Of Novel Combination Drug-Delivery Devices 7/17/2026

    Poor scoping kills drug delivery device programs before they start. Learn how to define the right problem, assess risk early, and set boundaries that protect your timeline and budget.

  9. What The FDA's AI Device Software Guidance Signals For Your Traceability 7/13/2026

    FDA draft guidance sets lifecycle expectations for AI/ML medical device software. Review dataset provenance and post-market monitoring strategies to prepare your submissions.

  10. The Connectivity Crisis Blocking AI Deployment 6/30/2026

    Disconnected systems and siloed data block analytics in life sciences manufacturing. Learn to bridge the infrastructure gap and build a connected foundation for scalable intelligence.