Industry Perspectives

  1. How Does Robotics Aid Occlusion Testing For Drug Delivery Devices? 11/5/2024

    Robotic automation simulates, detects, and resolves occlusions under controlled conditions for drug delivery systems such as infusion pumps, catheters, IV lines, and insulin pumps.

  2. Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies 10/29/2024

    In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

  3. Life Sciences Cybersecurity Incident Management: The End-to-End Approach 10/24/2024

    Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.

  4. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

    When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

  5. Sterility Assurance: The Fundamentals 10/8/2024

    Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

  6. Improving Medical Device Testing With Robotic Automation 9/25/2024

    Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in verification testing can help with regard to precision, efficiency, and more.

  7. Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection 8/7/2024

    This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.

  8. Does My Medical Device Design Actually Work? 8/6/2024

    In medical device development, the proof of feasibility stage often includes preliminary testing, but also detailed technical, usability, manufacturability, regulatory, and commercial assessments.

  9. Q&A: Micro Molded Thin-Wall Cannulas 7/30/2024

    Discover how Accumold's approach is setting new standards in medical device manufacturing and what it means for the future of wearable health technology.

  10. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

    The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.