Guest Columns

  1. The Business Case for Healthcare Compliance Programs for Emerging Companies 6/9/2023

    For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead. 

  2. Breeze Through Surprise Audits — Take These 5 Actions Now 6/8/2023

    Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.

  3. The Landscape Of Medtech Clinical Research In El Salvador 6/6/2023

    El Salvador’s economy has transformed radically over the last half century. In recent years, the country now offers several advantages for medtech clinical research, such as a diverse patient population and a favorable regulatory environment.

  4. Quality Engineers: Are You Making The Right Call? 6/1/2023

    As a quality engineer, a lot of us have had a project leader ask us to sign off on a project when the data has too many outliers. How do you navigate that situation?

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.