Guest Columns

  1. Transforming Medtech Company Workflows Through AI Adoption 5/4/2026

    Despite huge investment in intelligent tools, results are patchy. Ownership is unclear, integration is limited, and teams grapple with fear of replacement. So how can medtech companies escape this vicious cycle?

  2. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

    This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

  3. Selecting The Right eQMS To Maximize Quality Maturity 4/23/2026

    Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

  4. 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.

  5. 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.

  6. 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. 

  7. 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.

  8. 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.

  9. 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.

  10. 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.