Guest Columns

1. 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, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

2. 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.

3. 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.

4. 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.

5. 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.

6. What Does IMDRF’s New Cybersecurity Guidance Mean For You? 12/2/2019

   Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.

7. Documentation Priority For Early Stage Medtechs — Part 1: User Specification 11/25/2019

   This article lays out considerations and a process for developing user specifications when developing a new medical device. It is the first in a series that examines – and prioritizes -- necessary documentation when creating early an proof-of-concept prototype.

8. What Is the Current State Of BREXIT, And What Happens Next? 11/18/2019

   The United Kingdom’s plan to leave the European Union, with PM Boris Johnson still at the helm, now hinges on the results of an early election taking place Dec. 12, 2019, and refinement a transition period effective through Dec. 31, 2020. Zaid Al-Nassir's breakdown for medtech leaders has been updated to include events taking place through Nov. 8, 2019.

9. People: The Most Persistent Risk To Data Integrity 11/15/2019

   HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

10. FDA's Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained 11/13/2019

    The ASCA Pilot is intended to provide increased confidence in testing results from ASCA-accredited testing laboratories, as well as decrease the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.