Guest Columns

  1. 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.

  2. 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.

  3. 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. 

  4. 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.

  5. 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.

  6. 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.

  7. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

    Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

  8. EC Rep To EU Rep: The Symbol Shift You Can't Ignore 4/23/2025

    The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling from the legacy “EC REP” symbol to a more flexible, jurisdiction-specific format: “XX-REP.”

  9. A Proactive 6-Point Approach To Security For Neurotech Developers 4/17/2025

    There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical compliance, as well as commercial success. 

  10. Unlocking The Potential Of Sensor-Based Digital Health Technologies For Mental Health Conditions 4/9/2025

    Sensor-based digital health technologies (sDHTs), including wearables, have great potential in the management of mental health conditions like anxiety, depression, and psychosis. Patient-centered design is key.