Industry Perspectives - Design & Development

  1. Are Document Approvals Consistent Across Sites And Appropriate? 7/9/2026

    Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers and document owners are defined appropriately, approval can be streamlined.

  2. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.