Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 

  8. Unlocking Business Value In Digital Health Solutions In Pharma 4/30/2025

    Digital solutions provide a unique opportunity for pharma companies to differentiate themselves from competition — delivering new value to patients along their treatment journey and strengthening the core business.

  9. Medtech CEO Shares Lessons From FIH Implantable Glucose Monitor Trial 4/30/2025

    CEO and President Paul Goode, Ph.D., explores the implantable CBGM’s trial design, as well as the company’s approach to patient input, site selection, and more for its first-in-human trial.

  10. Smart Drug Delivery Systems: Emerging Market Trends 4/25/2025

    According to new market research, the global smart drug delivery systems market reached $12 billion in 2024 and is expected to grow at a CAGR of 17% from 2025 to 2034. Check out this article for product trends and more.