Guest Columns

1. Ingestible Diagnostics: Technical Challenges, Regulatory Considerations, and Reimbursement 2/19/2020

   Innovation in material science, electrical engineering, computational tools, and data science, as well as widespread physician acceptance, has spurred development of ingestible diagnostic technology with expanded applications and, in some cases, improved diagnostic outcomes. Several factors must be considered to ensure the development of ingestible diagnostic devices that are clinically valuable, safe, and cost-effective.

2. What Is the Current State Of BREXIT, And What Happens Next? 2/12/2020

   It's official: The United Kingdom is headed out of the European Union. Now begins a transition period, during which the trade relationship between the UK and EU will be decided, and both the European MDR and the CTR are set to take effect. 

3. The European MDR: Impetus, Impacts, And Current Status 2/5/2020

   This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes, and discusses the anticipated impact on medical device markets. It has been updated through Jan. 30, 2020. 

4. The 10 Phases Of An Effective CAPA 2/5/2020

   Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

5. What Will The USMCA Mean For MedTech? 1/29/2020

   Analysts appear to agree that the USMCA represents an upgrade — albeit a modest one — over NAFTA for all parties included. This article has been updated with developments through January 2020. 

6. Why You Need A World-Class Quality Culture — And How To Build One 1/13/2020

   The quality culture of the organization has a clear and direct impact on the ultimate quality of the product. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

7. Developing A Smart Inhaler For Optimal Drug Delivery 12/16/2019

   While the development and design of inhalers has improved significantly over the last decades, the use of inhaled therapies for treatment of systemic diseases has been limited by a number of factors.

8. Analyzing The Changes To Risk Management Standard ISO 14971:2019 12/11/2019

   The third edition of ISO 14971 and its updated companion report are set for release this month. ISO 14971:2019 will provide clearer guidance and greater detail in the application of risk management concepts while aligning with essential safety and performance principles.

9. The IMDRF Cybersecurity Guidance: A Comprehensive Analysis 12/9/2019

   Principles and Practices for Medical Device Cybersecurity clarifies cybersecurity expectations for medtechs selling to a global market and is likely to serve as a blueprint for most regions’ local regulations, including the next round of FDA guidance documents.

10. Design Of Experiments 101: Understanding DOE’s Foundational Elements 12/9/2019

    DOE is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.