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. 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.

5. 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.

6. 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.

7. 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.

8. 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. 

9. Market Assessment: PTA Balloon Catheters In The U.S., EU, And U.K. 3/4/2020

   This article analyzes the PTA balloon catheters market in the wake of recent data about their drug coatings and updated FDA / MHRA guidelines.

10. Medical Device Biocompatibility – Toxicological / Biological Safety Assessments 2/26/2020

    Despite ISO 10993’s utility, new technologies and materials may warrant additional considerations based on patient health risks. This article focuses on how to handle situations where deviating from recommended testing may be desired. In these cases, a biological safety / toxicological assessment is warranted.