Guest Columns

  1. Factors Shaping The Cardiac Marker, Hematology, And Hemostasis Test Markets
    2/13/2019

    Cardiac marker, hematology, and hemostasis tests are relied upon for a multitude of healthcare applications. This article explores these devices’ global market opportunity and analyzes issues expected to impact future sales.

  2. Reimagining Quality Operations In The Life Sciences
    2/13/2019

    This is the third of three articles focusing on an effort to address what appear to be systemic issues across quality departments, informed by a multinational group comprising chief quality officers (CQOs) from pharma, device, animal health, and consumer goods companies. It will examine how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.

  3. Take The Narrow Path To Wide Adoption — Here’s Why And How
    2/11/2019

    Segmenting patients, providing physicians with guidance on which ones your technology suits best, and clearly stating expected outcomes helps to drive use, preference, and — eventually — increased adoption rates.

  4. How To Write An Effective Validation Master Plan
    2/6/2019

    A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

  5. Back-Door De Novo? FDA Accepts Real-World Evidence For Expanded Use
    2/4/2019

    Obtaining early clearance with a narrower claim enabled this company to enter the market earlier, as well as use its own product as a predicate to collect real-world evidence — all while obtaining broader clearance and avoiding the requirement to document patient-informed consent during trials, since the device already had been cleared.

  6. 7 Elements To Consider When Designing Medical Products For Sterilization
    1/30/2019

    Many medical device project development teams either ignore sterilization challenges until confronted with failed tests late in development, or adopt conservative guidelines that increase cost and lead times. More deliberate, proactive efforts applied to the sterilization topics discussed here can lead to improved outcomes.

  7. Champions Against Nonsense: A Better Way To Talk (And Think) About Quality
    1/30/2019

    This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.

  8. Understanding The Inspector General’s Critique Of The FDA Over Cybersecurity — And What It Means For Manufacturers
    1/28/2019

    This article examines a report issued by the Office of the Inspector General of the Department of Health and Human Services, resultant of an audit of the FDA’s internal processes to ensure cybersecurity in the postmarket phase of medical devices – as well as the FDA’s disagreements with the findings and what this means for manufacturers going forward.

  9. Liquid Biopsy: Market Drivers And Obstacles
    1/21/2019

    This article examines present and near-term opportunities for liquid biopsy, as well as what’s needed to elevate this innovative diagnostic tool to a standard of care.

  10. Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House
    1/14/2019

    Given the costs, risks, and complexity of human factors engineering (HFE) usability testing studies, are you better off conducting such studies internally, or retaining a formal HFE testing agency?