Guest Columns

  1. Making The Call On Pre-Validated Packaging 10/1/2026

    The idea of pre-validated packaging sounds really good. Using packaging that has already undergone extensive testing seems fast, easy, and less expensive. Is it truly the answer? It depends.

  2. What Patients Actually Want From Connected Drug Delivery 9/29/2026

    A recent survey conducted with BioPhorum members revealed that the most critical aspect of digital healthcare for drug delivery devices. Let's take a closer look.

  3. Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery 9/29/2026

    Where can digital technologies can solve real problems for patients, healthcare providers, and industry, while avoiding unnecessary complexity? Here's where the strongest value propositions currently sit.

  4. Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's 9/25/2026

    P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.

  5. Everyone Is Only Reading The MDR Half Of Europe's Reform 9/21/2026

    The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.

  6. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  7. Who Exactly Owns Quality? 9/15/2026

    We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.

  8. Chile's Easy Market Ends In 2028 9/11/2026

    For years, Chile has been a comparatively easy to enter market for the medtech industry. That era now has an expiration date. High-risk, technically complex products will be the most affected by a new decree.

  9. Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals 9/10/2026

    Two approved GLP-1 pills validated the demand — and exposed the ceiling that only delivery devices can break.

  10. The Career Path Through QA Produces Better Medtech Engineering Leaders 9/9/2026

    Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on later. When they're tapped for leadership positions, this makes them better leaders.