Guest Columns

  1. A Closer Look At FDA's Controversial Rule On Laboratory Developed Tests 12/3/2024

    Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of exercising enforcement discretion with regard to medical device regulations that would otherwise apply to labs that prepare and/or market LDTs. 

  2. Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies 11/25/2024

    The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

  3. Medtech: Capitalize On These 4 Trends To Thrive In 2025 11/21/2024

    Leaders from Ernst & Young deliver intel on the four biggest trends that impacted the medtech industry in 2024 that savvy medtech companies will seize for success in 2025.

  4. Defining When To Implement Technologies To Support Commercial Growth 11/20/2024

    Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

  5. How The EU AI Act Impacts Medical Device Manufacturers 11/18/2024

    The EU AI Act is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries. Here's how it impacts medical device manufacturers.

  6. We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead 11/13/2024

    The EU Commission had issued an extension to manufacturers to sign up with a notified body for EU Medical Devices Regulation (MDR) compliance, but instead, manufacturers have slowed down compliance activities, resulting in an upcoming bottleneck of approvals.

  7. Increasing Diversity In Medtech Innovation: A Personal And Professional Perspective 11/11/2024

    The author describes the hurdles with medtech innovation driven by homogenous groups and some practical strategies for the industry to improve diversity.

  8. How Does Robotics Aid Occlusion Testing For Drug Delivery Devices? 11/5/2024

    Robotic automation simulates, detects, and resolves occlusions under controlled conditions for drug delivery systems such as infusion pumps, catheters, IV lines, and insulin pumps.

  9. Surviving The Valley Of Death: The 7-Step Approach For Neurotech Startups 11/4/2024

    This article examines the key components that neurotech startups must address to traverse the Valley of Death and scale the “Mountain of Opportunity” to commercial success.

  10. AI-Enabled Medical Device Manufacturers: Are You Prepared for Evolving FDA Oversight? 11/1/2024

    As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare to navigate new legal challenges, as well as evolving safety and compliance risks.