Guest Columns

  1. How FDA, Industry, And Academia Are Guiding AI Development In Biopharma

    Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance. 

  2. Seeking Simultaneous Regulatory Approval In The U.S. And The E.U. — A Human Factors Perspective

    Three potential paths exist when seeking regulatory approval in both the European Union and the United States: E.U. first, U.S. first, and simultaneous. The simultaneous approach, while seemingly complicated, streamlines the process, condenses the documentation, and reduces time to market.

  3. Electronification’s Impact On Medical Device Manufacturers

    Rising demand for electronic components -- driven by the automotive, defense, aerospace, and industrial manufacturing industries -- could create supply challenges like price volatility, counterfeiting, relabeling, selling out-of-date parts, and double- or triple-booking orders

  4. Beyond Informed Consent — How To Better Engage Millennials (And Others) In Clinical Trials

    Companies developing new healthcare products for Millennials have implemented a lot of the pieces of the puzzle of how to serve them better; unfortunately, disconnects in how those pieces link together to track the entire patient journey reduce the effectiveness of those efforts.

  5. 5 Reasons Your Medtech Market Likely Is Smaller Than You Think

    It’s best to be sure you understand the defensible, fact-based market need for your great idea before investing significantly in an intuitive belief of its potential.

  6. 8 Key Changes To Understand In The New European MDR And IVDR

    The new European MDR and IVDR regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes, aiding organizations in their transition plans.

  7. Managing Risk For Medical Device Clinical Trials

    This article explains the basics of project risk management and how to execute it, and the vital role clinical data play in product risk management, so the clinical trial manager can be better prepared to both manage risks in their trial projects and participate more fully in the device's product risk management effort.

  8. Global Medical Device Development — Trends And Attitudes

    A survey of about 200 medical device professionals examined how challenging it can be to balance innovative product design with compliance and risk management; the survey also looked at time-hungry tasks, technological advancement, and design methodologies.

  9. Automation vs. Artificial Intelligence In Medtech: Where Are We, And Where Are We Going?

    As more stakeholders become involved with automation, AI, and general data management in healthcare applications, the move toward a combination of all three aspects will create healthcare solutions equivalent to sci-fi aspirations.

  10. Using Comic Books To Craft Effective Quick Reference Guides

    Thanks to the huge culture surrounding comic books and Japanese manga, a rich body of work has emerged investigating the comprehension of visual narratives. Here, we explain how some of the cognitive principles and theories resulting from this research can be straightforwardly applied to QRGs.