Guest Columns

  1. Building World-Class Global Quality Teams That Break Down Silos 11/10/2025

    Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

  2. Mastering Cultural Intelligence In Global Quality And Regulatory Leadership 11/5/2025

    The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

  3. A Better Interpretation Of POH In ISO 24971 11/3/2025

    Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

  4. Beyond Recruitment: A Practical ROI Model For Integrating Community Health Workers Into Medtech Trials 10/22/2025

    The medtech industry desperately needs — and currently lacks — a practical trial-specific financial framework to build a compelling business case for community health workers.

  5. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

    This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

  6. The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device 10/3/2025

    The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

  7. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

  8. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

    One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

  9. The Companion Diagnostic Strategy That Combination Product Leaders Need 9/17/2025

    In the U.S., the Office of Combination Products assigns primary jurisdiction for in vitro diagnostics (CDER, CBER, or CDRH). This article shares regulatory and commercial considerations.

  10. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

    The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.