Guest Columns

  1. ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction 1/2/2025

    This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

  2. 5 Reasons Why 2025 Is The Year Pharma Companies Will Revisit Their Drug Delivery Device Strategies 1/2/2025

    2025 will be the year for pharmaceutical companies to revisit their drug delivery device strategies or risk being left behind. Here are the five reasons why.

  3. How To Optimize Reliability And Cost In Surgical Robotic Systems 12/19/2024

    The tension between reliability and cost has never been higher in robotically assisted surgery. Read this article for tips on balancing the two, management, and more.

  4. 9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond 12/17/2024

    Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change.

  5. 5 Trends In Digital Therapeutics For 2025 12/16/2024

    Digital health executive Acacia Parks, Ph.D. lays out five trends in digital therapeutics (DTx) for the new year.

  6. The 5 Major Regulatory Focus Areas For Medical Device Compliance In 2025 12/10/2024

    Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing.

  7. Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions 12/9/2024

    In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.

  8. How To Prevent Device Misuse Through Formative Studies 12/9/2024

    While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations.

  9. How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies? 12/5/2024

    FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

  10. What's Trending In Medical Devices And Diagnostics For 2025? 12/4/2024

    Four program directors from the Medical Device Innovation Consortium (MDIC) share their predictions on the trends that will drive innovation and reshape clinical research in 2025.