Industry Perspectives - Design & Development

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.