Guest Columns

  1. EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes

    Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.

  2. Startups Illustrating The Future Of Global Medtech

    Globally aware CEOs are looking beyond rich country patients for long-term growth. This article highlights a pair of startups attempting to bring innovation large, under-served populations, and analyzes the effectiveness of their approach.

  3. When To Use A Fishbone Diagram And Why You Should Do It More Often

    This article provides an in-depth and comprehensive explation one of the most broadly applicable and durable root cause analysis tools to investigate the quality of your manufacturing processes: the fishbone diagram.

  4. Asian Hip/Knee Implant Market Primed For Drastic Procedure Volume Increases

    The hip and knee replacement markets in India and China currently are underserved, and present tremendous opportunities for large joint device manufacturers.

  5. Training And Memory Decay In Simulated-Use Testing

    One topic that often generates confusion — and sometimes heated debate — is whether study participants should be trained on a product’s use prior to testing. Trained participants may be more likely to use the product as intended during testing but, as testing is intended to simulate real-life product use, training may not always be appropriate.

  6. Auditor Evaluations: A GMP Auditing Best Practice

    Given the importance of auditor performance, do managers responsible for audit programs solicit and provide feedback on auditors? Very rarely.

  7. 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. 

  8. 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.

  9. 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

  10. 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.