MD&M East

Human Factors Testing Is the Key to Approval & Profitability in the Medical Device Industry

U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...
MedTech Dive

Human factors isn’t a checkbox: What FDA’s eSTAR requirements mean for MedTech submissions

Most medical device manufacturers start their consultation with me asking one of two questions: “Do we need a human factors ...
Ohsonline.com

Systems Safety: The Critical Role of Human Factors and Ergonomics

A door plug blew off Alaska Airlines Boeing 737 Max 9 mid-flight in January 2024. Now the National Transportation Safety Board says it can happen again. When it comes to safety in the workplace, there ...
Nature

Integrating Human Factors in Manufacturing Systems

Integrating human factors into manufacturing systems encompasses the systematic consideration of human capabilities, limitations and interactions within production environments. It draws upon ...
MD&M East

FDA Finalizes Human Factors Guidance in Combination Medical Devices

Replacing a draft guidance issued in February 2016, FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices with a drug or ...
Forbes

Beyond The Code: Human Factors In Robotic Surgery Risk Management

In the ever-evolving landscape of healthcare technology, robotic surgery has emerged as a groundbreaking innovation, offering unprecedented precision and control in surgical procedures. Leading ...