Guest Columns

  1. Protecting Implantable Medical Devices From Electromagnetic Interference
    4/24/2019

    While regulations are in place to help minimize EMI, some amounts are unavoidable, and larger amounts can be generated in rare circumstances, or in the event of device malfunction. Thus, preventative measures, including EMI shielding and filtering, must be employed to protect both implantable medical devices and their host patients.

  2. Understanding The FDA’s Final Guidance On Manufacturing Site Changes
    4/22/2019

    The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.

  3. Evolution In Prostate Cancer Diagnostics Creates New Opportunities For Medtech
    4/17/2019

    This article provides a high-level review of some existing prostate cancer diagnostic assays used for screening, risk stratification, and monitoring treatment response. It also discusses opportunities for development in prostate cancer diagnostics.

  4. Calculating Sample Sizes For Human Factors Studies: What’s The Magic Number?
    4/15/2019

    Although sample sizes for medical device usability testing are mostly defined by regulatory standards, it is important for manufacturers to understand the underlying principles, and to make sound decisions accordingly.

  5. Understanding Prototype Development Phases For Medical Products
    4/10/2019

    Medical device prototypes at each development stage have a utility that needs to be understood to justify the cost and time invested to develop them.

  6. What Is the Current State Of BREXIT, And What Happens Next?
    4/3/2019

    The United Kingdom’s plan to leave the European Union has devolved into a mess of shifting deadlines and what-ifs. Here, Zaid Al-Nassir breakdown for medtech leaders has been updated to include events taking place through April 11, 2019.

  7. Cybersecurity Bill Of Materials For Medical Devices: What’s Next?
    4/1/2019

    In October, the U.S. FDA published an updated draft of Premarket Cybersecurity Guidance and introduced the concept of a cybersecurity bill of materials (CBOM) for medical devices. Some medical device manufacturers have since raised concerns regarding mandating CBOMs in the 510(k) or premarket approval packet.

  8. Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
    3/27/2019

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  9. Chief Quality Officers: Redesigning Quality For The 21st Century
    3/27/2019

    With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.

  10. NESTcc At Two: Progress And Next Steps For Real-World Evidence For Medical Devices
    3/25/2019

    NESTcc was envisioned as a cooperative network of partners working to use data, advanced methodologies, and good governance to improve the state of medical device evidence generation. Find out what’s yet to come, and how you can weigh in.