Guest Columns

  1. Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network 4/17/2026

    Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

  2. Minding The Gap: Submission Strategies For Combined Use Combination Products 4/17/2026

    For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.

  3. New Sustainability Mandates In Brazil And Chile Are Quietly Disqualifying Medical Devices 4/15/2026

    The integration of environmental criteria into Latin American medical device procurement is not a temporary policy experiment; it represents a structural market transformation. 

  4. Drug-Device Combination Products: 4 Evolving Platforms For 2026 4/10/2026

    Biologic advantage won’t come from better biology alone, but from delivery technology and designing the full experience around patients, providers, and supply chains.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.