Guest Columns

  1. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

    Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

  2. Telehealth In 2025 And Beyond: The Future Is Bright 2/14/2025

    The DEA has announced new rules for remote prescription of controlled substances. As telehealth adoption grows, regulatory frameworks and telehealth technologies are evolving.

  3. Harness MDIC's Collaborative Resources to Strengthen Clinical Trials and Patient Outcomes 2/13/2025

    Discover how resources from the Medical Device Innovation Consortium (MDIC) can help advance clinical trials for better patient outcomes.

  4. Roche Diagnostics Guides New Alzheimer's Test Through Trials 2/12/2025

    Roche Diagnostics’ Maria-Magdelena Patru, MD, PhD discusses their plasma test and how they’re approaching its clinical trials. 

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.