Guest Columns

  1. Strategies For Implementing An Improved Change Management Process
    1/4/2019

    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.

  2. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019
    12/26/2018

    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.

  3. An Intro To Tools And Methodologies To Improve Change Management
    12/17/2018

    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.

  4. Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing
    12/13/2018

    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.

  5. New Wound Closure Technology Set To Triple In Value By 2025, Cannibalize Competitors
    12/10/2018

    Traditionally, surgical wounds have been closed with sutures, staples, Steri-strips, Mastisol, or some combination thereof. There are multiple benefits to using these technologies, but new products are expected to significantly improve the way surgeons close wounds. Ethicon’s Dermabond Prineo mesh and cyanoacrylate-based skin closure systems, as well as Zipline Medical’s Zip Surgical Skin Closure, are new products that recently have become popular for surgical wound closure. This rise in popularity is cannibalizing older forms of wound closure, such as sutures, staplers, and skin closure strips.

  6. Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!
    12/5/2018

    Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  7. Digital Health Companies Chasing US, EU Markets Need To Move With The Regulatory Pendulum
    12/5/2018

    By addressing four areas of common requirement, medical device companies will be in a stronger position to secure authorization and maintain products on both the US and EU markets.

  8. Dos And Don’ts Of Assessing Usage Risk
    12/3/2018

    Effectively conducting a uFMEA not only facilitates correct identification of existing usage risk, it aids in the generation of crucial design updates for risk reduction or elimination.

  9. Understanding FDA’s Quality In 510(k) “Quik” Review Program Pilot
    11/28/2018

    On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.

  10. Advanced Auditing Strategies To Detect Data Integrity Risks
    11/26/2018

    Data integrity is essential in the pharma, biologics, and medical device manufacturing industries. Not only is complete, accurate, and reliable data necessary to assure drug safety and quality, the growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex.