Guest Columns

  1. Improving Medical Device Testing With Robotic Automation 9/25/2024

    Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in verification testing can help with regard to precision, efficiency, and more.

  2. Your 510(k) Hasn't Sailed Through. Now What? 9/24/2024

    Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA. What can you do when the agency rejects your 510(k) or requests more information? How can a Q-Sub help? This article shares practical recommendations.

  3. Nuances Of The Growing U.S. Market For Advanced Wound Dressings 9/13/2024

    The U.S. market is continuing its shift away from traditional wound dressings (gauze, tape, etc.) toward advanced wound care (moist dressings, antimicrobial dressings, etc.).

  4. Pharma's Data Secret That Medical Device Companies Should Adopt 9/12/2024

    The pharma industry has invested greatly in IT systems and optimized data and content management. Medical device companies can learn from pharma's experience — and it will ease the regulatory burden.

  5. How Chile Is Shaping Medical Device Clinical Trials In Latin America 9/11/2024

    Chile's robust healthcare infrastructure and fast regulatory approval timeline have positioned it as an attractive destination for medtech companies seeking to conduct early feasibility clinical research. 

  6. Ensuring Privacy & Security In Smart Medical Devices 9/10/2024

    Smart medical devices and at-home care have gathered significant momentum. This article explores how medtech companies can build privacy, security, and ethics by design within medical devices.

  7. Breast Reconstruction In The U.S.: Procedure Preferences & Market Trends 8/21/2024

    This article shares new market research focusing on three segments of the U.S. breast reconstruction market: allografts, xenografts, and synthetics. 

  8. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

    The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

  9. Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection 8/7/2024

    This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.

  10. Does My Medical Device Design Actually Work? 8/6/2024

    In medical device development, the proof of feasibility stage often includes preliminary testing, but also detailed technical, usability, manufacturability, regulatory, and commercial assessments.