Guest Columns

  1. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

  2. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

    The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

  3. Neuromodulation Dominates The U.S. Market For Neurological Devices 6/6/2025

    Neuromodulation devices are used to manage conditions such as chronic pain, neurological disorders, epilepsy, and more. New market research shares U.S. market trends.

  4. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

    This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

  5. China's Medical Device Market: A Land Of Opportunity And Challenges 6/3/2025

    Government-led industrial policies and rapid technological advancements are reshaping market dynamics for medical devices in China.

  6. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

    As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

  7. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  8. Connected Drug Delivery Devices: Emerging Market Trends 5/29/2025

    Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration tools. New market research shares emerging growth and trends.

  9. Tips From A Biomedical Engineer For Medical Device Innovation And Compliance 5/20/2025

    Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

  10. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 2 5/13/2025

    This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices.