Industry Perspectives - Design & Development

  1. 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.

  2. 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.

  3. 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.

  4. The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail 2/20/2026

    While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

  5. Conducting A Medical Device Stability Study: A Practical Guide 1/7/2026

    Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

  6. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

    Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

  7. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

    A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

  8. 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. 

  9. 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.

  10. 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.