Guest Columns

  1. How To Stop (Most) Medical Device Recalls Before They Happen 4/8/2026

    Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.

  2. A Case Study: Control Strategies For A Multi-Dose Pen Injector 4/8/2026

    A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.

  3. Control Strategies For Injectable Drug Delivery Combination Products 4/7/2026

    Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.

  4. From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations 4/6/2026

    Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

  5. Why Medtech Should Retire The "One-Size-Fits-All" Mindset 3/23/2026

    A systemic bias in medtech design continues: a failure to account for female-specific data. Teams often resort to a dangerous shortcut: scaling down men's measurements. But we must design for the real-world diversity of human physiology for the future of care.

  6. Generative AI Can Write The Code, But Who Builds In The Quality? 3/23/2026

    Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

  7. 8 Tips To Make A Med Device Startup More Investable In 2026 3/19/2026

    U.S. medical device companies seeking funding this year will find that innovative tech and a stand-out prototype aren’t enough. These 8 tips can help startups become significantly more investable.

  8. 3 Emerging Trends In Drug Delivery Device Pipelines 3/18/2026

    When analyzing the drug delivery product pipeline, three key technologies stand out. Check out the latest market research.

  9. Closing The Adherence Gap: The Connected Health Era 3/13/2026

    Connected health is shifting healthcare from reactive to proactive by enabling providers to oversee drug delivery while allowing patients to actively engage in their care.

  10. Diagnostics Rewired: From Tests To Lifelong Digital Twins 3/12/2026

    As routine labs, imaging, and information from wearables and the environment stream in, a digital twin can model trajectories and suggest next actions, turning diagnostics into a living operating system for care.