Guest Columns
-
Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
2/6/2024
In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.
-
Foundational Human Factors Engineering Concepts For The Design Of Combination Products
2/5/2024
How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview.
-
EEG Technologies Grow Beyond Traditional Diagnostics
2/1/2024
A variety of nontraditional electroencephalography (EEG) methods and technologies popularized in recent years have created a buzz in this once predictable market.
-
Auto-injectors: Global Trends & Market Forecast
1/30/2024
Auto-injectors offer a dependable method for delivering medication, especially during emergency scenarios. This article shares new market research, including macro trends, smart features, disposable vs. reusable trends, and more.
-
Tips To Overcome 4 Challenges In The Neurotech Startup World
1/22/2024
These authors have seen that the downfall of neuroscience startups often arises from complex factors. They share tips related to regulatory, financial, clinical, and commercial challenges.
-
The Emerging Business Models For Digital Therapeutics
1/16/2024
Digital therapeutics (DTx) leverage technology to deliver evidence-based treatments. Due to reimbursement barriers and slow market adoption, players in the space are pivoting to new business models. This article shares details.
-
Product Liability Considerations For AI-Enabled Medtech
1/10/2024
This article explores how and under what circumstances a medtech manufacturer potentially could be held liable under traditional product liability theories for AI-enabled products, as well as possible available defenses.
-
Secure By Design And Default: Compliant Medical Device Development
1/8/2024
The Cybersecurity and Infrastructure Security Agency, National Security Agency, FBI, and international partners issued recommendations for tech manufacturers to ensure product security and, thereby, assist medical device designers and manufacturers in meeting the quality system cybersecurity considerations mandated by the FDA.
-
Driving Forces In The Laparoscopic Device Global Market
1/4/2024
Laparoscopic surgery is a type of minimally invasive surgery that enables surgical procedures to be performed through small incisions, aided by cameras and specialized instruments. This article delves into the drivers fueling the growth of the laparoscopic device market, including the increasing use of direct energy devices and the role played by ultrasonic devices.
-
The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA
12/21/2023
The U.S. FDA, Health Canada (HC), and the U.K.’s Medicines and Healthcare Regulatory Agency (MHRA) have come together and identified 10 guiding principles, with the aim of developing good machine learning practices (GMLP) that will address the unique nature of AI/ML-driven medical devices.