Optimizing Medical Device Design with Human Factors: A Comprehensive Guide

Written by renowned expert Mary Beth Privitera, “Applied Human Factors in Medical Device Design” is a thorough resource that delves into the intricacies of human-centered design in medical device development. This comprehensive guidebook provides a detailed exploration of the human factors toolbox, featuring an array of empirical and analytical methodologies to enhance the design process.

Understanding the Design Control Process

The book commences with an in-depth examination of the design control process, highlighting the significance of integrating human factors in accordance with AAMI TIR 59 guidelines and established best practices. This foundation sets the stage for a thorough understanding of the various methodologies employed throughout the design journey.

Mastering Human Factors Methodologies

Privitera provides an exhaustive overview of each human factors method, meticulously explaining the rationale behind its application, potential impact, ideal scenarios for use, and potential challenges. This systematic approach enables professionals to make informed decisions and navigate the complexities of human-centered design.

Overcoming Communication Barriers

The author also sheds light on common barriers to effective design, including communication breakdowns between users and design teams. By acknowledging these potential pitfalls, stakeholders can proactively establish strategies to mitigate them, ensuring a more streamlined and successful design process.

A Valuable Resource for Professionals

This book serves as an indispensable reference for professionals operating in human factors, design, engineering, marketing, and regulation. By focusing on the application of human factors in medical device development, “Applied Human Factors in Medical Device Design” provides a unique perspective on meeting agency requirements in both the US and European Union (EU).

The text offers insights into:

• Technological development and human factors integration throughout the design process
• FDA and MHRA regulations governing medical device development
• Case examples illustrating the application of each human factors method

Published by Elsevier Science in 2019, this book is an essential resource for anyone seeking to elevate their understanding of human-centered design in medical device development. With its comprehensive approach and real-world examples, “Applied Human Factors in Medical Device Design” is poised to become a seminal work in its field.