Guest Columns

11. 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. 

12. 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.

13. 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. 

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 FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

    The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.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.

15. 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.

16. 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.

17. The Learned Intermediary Doctrine Sees Curious Change In California 8/5/2024

    U.S. courts have long recognized the learned intermediary doctrine, which holds that a manufacturer of a prescription medication or medical device discharges its duty to warn by providing an adequate warning to the doctor. In the recent Himes v. Somatics, LLC, the California Supreme Court may have opened the door to this argument. 

18. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

    The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

19. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

20. Is Your Lab Ready For A LIMS Implementation? 7/25/2024

    Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.