Guest Columns

  1. 3 Patient-Centricity Factors In Neurotech Device Development 5/25/2023

    Despite the advancements in medical devices and technologies targeting neurological disorders ("neurotech"), the sector has been hampered by suboptimal care pathways. Companies entering the space must differentiate themselves. Neurotech developers should consider these three key factors to build meaningful solutions.

  2. The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR 5/24/2023

    The FDA's proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, which is in its third edition. Let's take a closer look.

  3. An Overview of the 5 Types Of Neuromodulation Devices 5/23/2023

    This article provides an overview on the five types of neuromodulation devices: spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electric stimulation, as well as related market trends.

  4. All You Need To Know About Contamination Control Strategies, Part 2 5/22/2023

    In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

  5. FDA’s Digital Health Technologies Framework Addresses Important Challenges 5/16/2023

    In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

  6. All You Need To Know About Contamination Control Strategies, Part 1 5/12/2023

    In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.

  7. The Role Of Failure Mode In ISO 14971:2019’s Hazard-Based Approach 5/10/2023

    In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs, especially since this standard takes a hazard-based approach. In this article, Jayet Moon demystifies the topic.

  8. AI-Driven Medtech Begins To Deliver On Its Potential 5/9/2023

    The successful use of artificial intelligence (AI) has been a long time coming. Today, more than 530 AI/ML-enabled medical devices have been authorized by the FDA. This article highlights some promising examples.

  9. Why Is Femtech Software Unreliable? + 3 Strategies For Improvement 5/4/2023

    Femtech (female health technology) has made significant progress toward bringing women’s health to the forefront of medical attention. However, a significant number of software-based femtech devices are not reviewed and regulated by the FDA and do not have to prove accuracy. What can we do as medtech developers to improve clinical relevance of these devices and software?

  10. Harnessing The Future Of Digital And Smart Manufacturing Of Medical Devices 5/2/2023

    There are many benefits to medical device manufacturers that embrace digitalization and smart manufacturing. Not only does this transformation streamline work, which reduces errors and saves time and money, but it also expedites the expansion of a company’s product portfolio.