Guest Columns

31. PMS And Supply Chain Visibility For EU Compliance 2/10/2025

    One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.

32. Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide 2/5/2025

    Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.

33. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

    Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

34. These Were FDA's Top Citation Issues For Data Quality In 2024 1/31/2025

    Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.

35. Enhancing Trust, Safety, And Performance Through Explainability In AI-Enabled Medical Devices 1/27/2025

    Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making processes, explainability is essential to enhance trust, safety, and performance.

36. Computer Systems Validation Pitfalls, Part 4: Inattention To Details 1/24/2025

    The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

37. Make It A No-Brainer: Designing For Electronic Medical Device Usability 1/14/2025

    When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple. 

38. Only DTx In Drug Delivery Can Take Us To The Next Level Of Diabetes Care 1/8/2025

    The convergence of advanced technologies and advancements in drug delivery is reshaping diabetes care. Digital therapeutics (DTx) deliver therapeutic interventions driven by high-quality software and mobile applications.

39. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

40. U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry 1/3/2025

    The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device companies?