Guest Columns

1. 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.

2. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

3. Duty Of Disclosure Considerations For Medical Device Patent Applicants With Parallel FDA Submissions 11/12/2025

   Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking to protect their intellectual property.

4. Building World-Class Global Quality Teams That Break Down Silos 11/10/2025

   Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

5. Mastering Cultural Intelligence In Global Quality And Regulatory Leadership 11/5/2025

   The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

6. A Better Interpretation Of POH In ISO 24971 11/3/2025

   Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

7. 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.

8. 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.

9. 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. 

10. 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.