Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies 10/29/2024

    In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

  8. Adaptive AI-Driven Medical Devices In The U.S.: Ethical Considerations 10/28/2024

    With the usage of AI in medical devices, ethical concerns center on patient health data, safety, and privacy, which adds an additional layer of complexity to design and development.

  9. Life Sciences Cybersecurity Incident Management: The End-to-End Approach 10/24/2024

    Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.

  10. A New Approach To ISO 14971 For Better Medical Device Risk Analysis 10/23/2024

    This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.