Guest Columns

1. Navigating Combination Products: Device Complexity And Software Integration 6/4/2026

   Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.

2. 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.

3. What Is Computer Software Assurance, And What Are Its Benefits? 6/2/2026

   Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.

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. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.