Industry Perspectives - Design & Development

1. Improving Execution Of Biological Evaluation Of Drug Delivery Devices 6/3/2026

   This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.

2. Risk Is the Spine: What The First 100 QMSR Inspections Reveal 5/29/2026

   The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

3. Rethinking CQV In A Digital, Agile Manufacturing Landscape 5/21/2026

   While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.