Guest Columns

1. 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.

2. The Need For Speed: Is Your Medtech Supply Chain Ready For The Next Disruption? 5/22/2026

   In a recent Deloitte Center for Health Solutions survey, 68% of medtech leaders said they lack confidence in their companies’ ability to restore disrupted supply chains quickly. Here are key practical action items to take.

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. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

   FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

5. The QMSR's Hidden ROI: LATAM's Device Trial Advantage 5/18/2026

   The FDA's new QMSR quietly created a harmonized quality framework between the U.S. and Latin America. With high recruitment performance and low cost, conducting medtech trials in the region has key benefits.

6. When Software Becomes Part Of The Medicine 5/15/2026

   Software is no longer just a support tool; it is central to real-world efficacy, transforming combination products by optimizing dosing, adherence, and technique.

7. Closing The MES Value Gap: Why Technology Isn't The Problem 5/14/2026

   Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

8. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

   Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

9. Why Your MES RFP Is Failing Before It Starts 5/6/2026

   Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

10. Complaints Into Practical Action: Human Factors Drug Delivery 5/5/2026

    Post-market HF are more than a quality metric, they help teams diagnose issues, guide fixes, and improve real-world usability of drug-device products beyond validation.