Guest Columns

1. The Synthetic Control Mirage: Why Your Medtech RWD Strategy Will Fail In Latin America 1/13/2026

   Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Here's why this is currently incompatible with Latin America's fragmented RWD infrastructure, though this will change in the years ahead.

2. Conducting A Medical Device Stability Study: A Practical Guide 1/7/2026

   Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

3. Electronic Drug Delivery Devices Market: Advancing Smart, Connected Healthcare 12/19/2025

   What is factoring into market growth for electronic drug delivery devices and why? New market research shares key insights.

4. Digital Surgery In 2026: The Data-Driven Operating Room 12/18/2025

   The operating room has evolved beyond just a sterile environment. Digital surgery in 2026 will be defined by the convergence of data, devices, and digitization.

5. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

   Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

6. AI Enters The 510(k) Submission World: What Device Developers Need To Know 12/15/2025

   The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Let's take a closer look at how this impacts 510(k) submissions and tips for preparing your submissions.

7. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

   MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

8. The U.K.'s MHRA Adds New Guidance To The Changing Regulatory Landscape For Digital Mental Health Technologies 12/12/2025

   The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies qualify as medical devices based on their intended purpose and functional impact. 

9. Accelerating Clinical Innovation With Open-Source Medical Platforms 12/8/2025

   Openwater CEO Aaron Timm shares how open source can reduce the cost of technology and extend its reach to more hospitals, researchers, and patients.

10. Wearable Medical Devices — What Should Your Contracts Look Like? 12/1/2025

    Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the outset.