Guest Columns

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.