Guest Columns

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

    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.

  2. Liquid Biopsy: Market Drivers And Obstacles

    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.

  3. Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House

    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?

  4. FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health

    I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.

  5. Separating, Optimizing Device Evaluation And Design Verification A Key To Medtech Success

    In medical device design and development, two critical development activities — device evaluation and device design verification — often are treated as one, and this behavior is shockingly detrimental to successful medical device development.

  6. The FDA, Device Cybersecurity, And What To Expect In 2019

     The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in medtech cybersecurity regulation?

  7. Strategies For Implementing An Improved Change Management Process

    In the first article of this two-part series, we provided an overview of a co-creation model for change management and the tools and methodologies that form the foundation for improved change management. This second part will look at strategies for implementing an improved change management process.

  8. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

  9. An Intro To Tools And Methodologies To Improve Change Management

    This is the first in a two-part article describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services. This first part discusses the tools and methodologies that provide a foundation for improving change management.

  10. Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing

    Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.