Guest Columns

1. Beyond Recruitment: A Practical ROI Model For Integrating Community Health Workers Into Medtech Trials 10/22/2025

   The medtech industry desperately needs — and currently lacks — a practical trial-specific financial framework to build a compelling business case for community health workers.

2. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

   This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

3. The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device 10/3/2025

   The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

4. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

   Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

5. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

   One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

6. The Companion Diagnostic Strategy That Combination Product Leaders Need 9/17/2025

   In the U.S., the Office of Combination Products assigns primary jurisdiction for in vitro diagnostics (CDER, CBER, or CDRH). This article shares regulatory and commercial considerations.

7. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

   The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

8. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

9. Considerations For Rapid Prototyping In Medical Device Development 9/15/2025

   Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider.

10. Emerging Markets Are Pioneering Hybrid Clinical Trial Models For Medtech Products 8/25/2025

    This article shares insights into how Latin America, southeast Asia, and Africa are pioneering hybrid clinical trial models for medtech products.