Guest Columns

  1. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

    We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

  2. Consistent And Clear Terminology, Best Practices Needed To Scale Sensor-Based DHTs 3/24/2023

    Sensor-based digital health technologies (DHTs) have been increasingly adopted in clinical research, clinical care, and everyday life, but a lack of clarity regarding usability best practices means that not all of these tools can be successfully implemented at scale.

  3. The Road To ISO 13485 Certification: Tips For Effective Audits 3/23/2023

    Follow these best practices to prepare for and conduct an audit for your medical device quality management system compliance with regard to ISO 13485.

  4. How Can Life Sciences Navigate M&A In 2023? 3/21/2023

    As we close out the first quarter of 2023, let's take a look at how life sciences executives can conduct better M&A deals despite this unpredictable business environment.

  5. How Is The Medical Wearable Landscape Evolving With Advanced Tech? 3/20/2023

    Conventional medical devices have revolutionized patient diagnostics and treatments. The future is heading rapidly toward a point where advanced software such as data science and AI techniques are driving a new wave of innovation and positive health impacts.

  6. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

  7. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

  8. The FDA Regulatory Landscape For AI In Medical Devices 3/3/2023

    This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the agency's priority list for releasing related guidances in 2023.

  9. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

  10. How To Maximize Your Medtech Booth At Trade Shows: Post-Show Follow-up 2/28/2023

    The previous two articles in this article series covered what to do before and during medtech trade shows. In this last article of the series, the author describes the activities to set up after the show in order to maximize your results, including organizing a post-show team debriefing and measuring your results.