Guest Columns

  1. 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. 

  2. 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.

  3. 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.

  4. 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.”

  5. 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.

  6. 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. 

  7. 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.

  8. 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.

  9. 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.

  10. 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.