User Interface Requirements for Medical Devices Driving Toward Safe Effective and Satisfying Products by Specification 1st Edition by Michael Wiklund, Erin Davis, Alexandria Trombley 0367457474 9780367457471

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Product details:

ISBN 10: 0367457474

ISBN 13: 9780367457471

Author: Michael Wiklund; Erin Davis; Alexandria Trombley

This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths. The book presents the strong connection between user interface requirements and risk management for medical devices and instructs readers how to develop specific requirements that are sufficiently comprehensive and detailed to produce good results – a user-friendly product that is likely to be used correctly. The book’s tutorial content is complemented by many real-world examples of user interface requirements, including ones pertaining to an inhaler, automated external defibrillator, medical robot, and mobile app that a patient might use to manage her diabetes. The book is intended for people representing a variety of product development disciplines who have responsibility for producing safe, effective, usable, and satisfying medical devices, including those who are studying or working in human factors engineering, psychology, mechanical engineering, biomedical engineering, systems engineering, software programming, technical writing, industrial design, graphic design, and regulatory affairs.

User Interface Requirements for Medical Devices Driving Toward Safe Effective and Satisfying Products by Specification 1st Table of contents:

Chapter 1 What Is a User Interface?

Hardware

Software

Labeling

Soundscapes

Aromas (Odors)

Tastes

Integrated Forms

What Is Not a User Interface?

Chapter 2 Role of User Interface Requirements in the Design Process

Form Follows Function Follows User Need

Chapter 3 Why We Need User Interface Requirements

Satisfying Regulatory Requirements

Satisfying Commercial Objectives

Adding Structure to the Design Process

Chapter 4 Common Pitfalls When Writing User Interface Requirements

Lack of Data

No Means of Enforcement

Mutual Exclusivity

Incomplete

Too Specific

Compound Requirements

No Means to Verify

Chapter 5 Writing Top-Quality User Interface Requirements

Create an Outline

Add Technical Anchors

Maintain a Reasonable Scope

Write Clearly and Concisely

Add Illustrations

Ensure Verifiability

Example Improvements

Chapter 6 Example User Interface Requirements

About the Examples

Stethoscope

Anesthesia Workstation

Auto-Injector

Portable Patient Monitor

Diabetes Management Application

CT Scanner

Cancer Detection Test Kit

Dry Powder Inhaler

Electronic Medical Record

Robotic Arm and Software

Automatic External Defibrillator

Tonometer

Hospital Bed

Telehealth App

Respirator

Chapter 7 Conducting Research to Inform User Interface Requirements

Learn about Users

Learn about Use Environments

Converting User Inputs into Requirements

Chapter 8 Identifying Risks to be Mitigated through Design

Determine Potential Use Errors

Determine Risk

List Use Errors Warranting Mitigation and Develop Requirements

Chapter 9 Designing to Meet User Interface Requirements

Conceptualize Design Solutions

Iteratively Evaluate Potential Design Solutions

Revise Design Solutions

Chapter 10 Conducting Verification Activities

Chapter 11 Conducting Validation Activities

Design Verification versus Design Validation versus Human Factors Validation

Human Factors Validation

Design Validation

Combining Validation Activities

Chapter 12 Sources of User Interface Design Guidance

Standards

Human Factors and Ergonomics Society (HFES)

U.S. Food and Drug Administration (FDA)

Books

Other Sources

Websites

Chapter 13 Our User Interface Design Tips

Controls

Displays

Alarms

Warnings

Connectors and Connections

Colors

Cleaning

Instructions

Packages

Chapter 14 Expanded Example for a Glucose Meter

About the Expanded Example

About Glucose Meters

User Interface Requirements

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Michael Wiklund,Erin Davis,Alexandria Trombley,Requirements