Applied Human Factors in Medical Device Design: A Comprehensive Guide

Written by renowned author Mary Beth Privitera, this book provides an in-depth exploration of the human factors toolbox, featuring empirical and analytical methodologies that are essential for medical device design.

Understanding the Design Control Process

The book commences with a detailed overview of the design control process, highlighting the importance of integrating human factors as per AAMI TIR 59 guidelines and industry best practices. This comprehensive approach ensures that medical device designers and developers can create products that meet the highest standards of quality and safety.

Empirical and Analytical Methodologies

The author provides exhaustive descriptions of each methodology, explaining why they are crucial, their potential impact, ideal scenarios for application, and potential challenges that may arise. This information enables professionals to make informed decisions and overcome common obstacles in medical device development.

Overcoming Communication Breakdowns

The book also delves into the critical issue of communication breakdowns between users and design teams, offering practical solutions to ensure that all stakeholders are aligned and working towards a common goal.

A Valuable Resource for Professionals

This book is an indispensable reference for professionals working in human factors, design, engineering, marketing, and regulation. It provides expert insights into meeting agency requirements for the application of human factors in medical device development, covering both the US and European Union (EU) regulations.

FDA and MHRA Regulations

The author offers expert guidance on navigating FDA and MHRA regulations, ensuring that medical device developers can create products that meet the necessary standards and guidelines.

Case Examples and Technology Development

The book includes case examples to illustrate each methodology, providing a practical understanding of technology development and the application of human factors throughout the development process.

With its focus on meeting agency requirements and its comprehensive approach to human factors in medical device design, this book is an essential resource for anyone working in the medical device industry.

Publication Details:

Publisher: Elsevier Science

Publication Date: June 15, 2019

Language: English

ISBN: 9780128161630, 9780128161647