Guest Columns

81. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

    When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

82. Sterility Assurance: The Fundamentals 10/8/2024

    Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

83. Developing An Effective Patenting Policy To Protect AI-Enabled Medical Devices 10/7/2024

    The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical recommendations and considerations.

84. A Look Inside The Growing U.S. Market Landscape For Surgical Navigation & Robotics 10/3/2024

    Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States. Growth rates per clinical application varies.

85. 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.

86. 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.

87. 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.).

88. 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.

89. 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. 

90. 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.