Guest Columns

  1. 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?

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. When To Outsource — And How To Pick The Perfect Clinical Trial Partners 5/9/2025

    EMED Technologies Director of Clinical Affairs Alex Nikanorov shares the company’s approach to deciding which clinical research functions to outsource and finding vendor partners that align with the company’s goals.

  7. Protecting Intellectual Property In The Genomics Revolution 5/9/2025

    Providing superior IP protection for genomics-related inventions already requires — and will require in the future — a more nuanced strategy combining patents, trade secrets, and copyrights.

  8. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

    Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

  9. Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis 5/5/2025

    Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

  10. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1 5/1/2025

    This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices.