Guest Columns

  1. Medical Device Usability Testing In The Age Of COVID-19 4/1/2020

    Organizations striving to validate their medical devices’ human factors performance have a massive new problem on top of testing programs already under attack for improper testing methods and overzealous risk-mitigation practices.

  2. How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials 3/31/2020

    It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.

  3. India To Regulate All Medical Devices 3/25/2020

    Expansion of notified device categories is poised to benefit savvy domestic and Western medical device companies by cutting out cut-rate operations.

     

  4. Remote Auditing Best Practices For GMP Compliance 3/25/2020

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

  5. Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time) 3/20/2020

    Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.

  6. Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits 3/19/2020

    While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.

  7. 8 Significant Risks COVID-19 Poses To Clinical Trials — And How To Mitigate Them 3/19/2020

    The impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity.

  8. 5 Reasons Direct-To-Consumer Marketing Fails Medtech 3/16/2020

    For most medical technologies, DTC marketing should be unleashed only as a last step to reach an untapped pool of patients — after converting all the relevant physicians.

  9. The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study 3/11/2020

    To illustrate how delivery device development is evolving in practice, we will use the example of respiratory inhalers. This is a well-established treatment modality, with mature technology solutions available, but one where you can envisage a number of future changes enabled by technology. 

  10. A SMART Approach To CAPA Effectiveness Checks 3/9/2020

    Many times, corrective and preventive action (CAPAs) fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. This article will look at using the SMART (specific, measurable, achievable, relevant, and time-bound) methodology for use in developing a CAPA verification of effectiveness plan.