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About this book

This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented.

This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs.

Teaches readers to design medical devices that are safer, more effective, and less error prone;Explains the role and responsibilities of regulatory agencies in medical device design;Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.

Table of Contents

Frontmatter

Chapter 1. Introduction

Abstract
This chapter introduces the issue of preventable medical error as well as the cost of this problem in terms of injury, death, and dollars. Next, it discusses the discipline of human factors engineering (HFE), which entails designing products so that they are compatible with human physical and cognitive capabilities and limitations. Finally, it discusses how the systematic application of HFE to medical device design can make products more useful, usable, desirable, and safer.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 2. Qualitative Human Factors Research Methods

Abstract
Human factors engineering (HFE) research informs how medical devices should be designed to provide a safe, effective, and satisfying experience. This research involves a human-centered approach—that is, keeping the user at the heart of all design decisions regardless of scope. This chapter begins by exploring what it means to follow a human-centered design (HCD) approach. It then provides the foundation for conducting qualitative HFE research, addressing specific methods, tools, and approaches. These topics include case studies, observational methods, interviews, questionnaires, focus groups, and contextual inquiry.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 3. Quantitative Human Factors Research

Abstract
Quantitative research collects and analyzes numerical data, rather than interview, observational, or video data, to answer research questions. Often quantitative methods, such as questionnaires, biometric research, correlational research, and experiments, are used to test hypotheses rather than generate them (which is often the domain of more qualitative methods). This chapter introduces quantitative research methods, discusses several of these methods, and describes how to analyze quantitative data.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 4. Usability Evaluation

Abstract
This chapter introduces methods and considerations for evaluating the usability of medical devices. It divides evaluation methods broadly into usability inspection methods and usability testing methods. Inspection methods are similar to editing a user interface or conducting a design review. Usability testing methods ask real potential users to conduct real tasks with a device or with a prototype. Along the way, researchers keep track of participants’ success rate, error rate, time on task, and other human-product performance measures. This chapter discusses exactly how and when to use each method, and provides guidance on how to get the most out of your activities.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 5. Visual Perception

Abstract
This chapter describes how people sense information and then turn those sensations into meaningful perceptions that we recognize and understand. This chapter focuses on visual perception, since we humans rely so heavily on vision, and because technology includes so many visual displays. Once we have discussed the mechanisms of visual perception, we can apply this knowledge to the design of visual displays that are useful, usable, and desirable.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 6. Hearing

Abstract
Hearing is fundamental to how we experience the world: It facilitates communication, helps identify the location of stimuli in our environment, and serves as a first line of defense in threat detection. It also has the potential to add hedonic value to our experience as humans. This chapter addresses what sound is, and how our auditory systems transform it into perceivable, localized, actionable information. The conclusion of this chapter discusses what happens when your auditory system strays from “normal hearing,” and ventures into the realm of abnormalities, impairments, and disorders. Applications and examples related to medical device design are discussed throughout.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 7. Cognition

Abstract
This chapter discusses how we think, covering topics from attention, memory, problem solving, judgment, and decision making. We review the considerable capabilities of each of these mechanisms, as well as their important limitations. More importantly, we review the implications of the capabilities and limitations for medical device design.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 8. Use-Error

Abstract
We all make errors, but some medical device designs make errors much more likely than others. Frustratingly, even when an error is made when using a poorly designed device, the user often takes the blame. Accident investigations often assign the blame on user error, a term that is not only overused, but that is just plain wrong. Often, the design poorly matches the capabilities and limitations of the users it was designed for in the first place, making errors more likely. The user is part of a human-device system. Errors result from the interaction of the device and that user, so the proper and honest term is use-error not user error. This chapter discusses the most common types of use-error and how to reduce their likelihood during medical device design.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 9. Human Factors Regulations for Medical Devices

Abstract
Medical devices, including drug-device combination products and in vitro diagnostics, sustain, and improve the lives of millions of people every day. To ensure these products have the positive effect intended and protect the public from potentially harmful products, government agencies around the world regulate how they are developed, manufactured, labeled, and sold. Manufacturers of devices that have the potential to cause serious harm to users or patients are required to show evidence that the device can be used safely and effectively by representative users in their intended environments through validation/summative usability testing. Additionally, regulatory agencies ask manufacturers to provide a Human Factors and Usability Engineering report (US) or Usability Engineering File (Outside US) to show the adherence to a human-centered design process that includes identification of device users, environments of use, and critical tasks, along with application of a formative research and design process prior to performing validation/summative usability testing.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 10. Controls: Designing Physical and Digital Controls

Abstract
Physical and digital controls are the bridge between the user and a medical device or system. This chapter addresses the fundamentals of effective physical and digital control design from a human factors engineering (HFE) perspective. It begins with a discussion of six control design guidelines widely researched and implemented across medical and nonmedical domains. Then, it presents a HFE perspective on several topics with respect to control design, including responsiveness, travel, size, placement, movement, and feedback. The chapter concludes with guidelines and recommendations specific to touchscreen controls.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 11. Displays

Abstract
Displays are an essential part of user interactions with medical devices. They present users with information to help make healthcare decisions quickly, safely, and effectively. Displays can be designed to accommodate any sensory modality (e.g., vision, hearing, tactile). This chapter examines visual and auditory displays in detail. It also provides introductory information and resources about tactile displays. The chapter begins with an overview of visual display technologies, then discusses use-related factors with each category. Afterward, the chapter explores auditory displays and alarms, as well as design tips to create discoverable, meaningful, and potentially urgent sounds in an auditory display. The chapter concludes with alarm-specific design recommendations and considerations.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 12. Human–Computer Interaction

Abstract
This chapter discusses the challenges of designing and evaluating human–computer interfaces. Computers are used in healthcare on everything from digital thermometers to robotic surgical systems. Because of their potential complexity, as well as the ability to present substantial amounts of information in a very small space, human–computer interaction design requires special attention to display legibility, information architecture, and interaction styles. These challenges, as well as some advice on design, are presented here.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 13. Designing Instructions for Use(rs)

Abstract
Instructions for use (IFU) are part of the medical device interface. As such, it is critical that they are designed to facilitate safe use and prevent use-errors. To ensure that IFUs are designed to support the end user needs, abilities, and scenarios of use, they must be developed using a human-centered design (HCD) process. We introduce a framework that models human interaction with IFUs and provides guidance for their design solutions: Find, Comprehend, Apply. IFUs designed for users will reduce opportunities for device use-related errors and increase capacity to provide safe patient care.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 14. Reusable Medical Devices, Reprocessing, and Design for Maintenance

Abstract
Besides instructions for use, maintenance and reprocessing are probably the last activities considered in the design of medical devices. Because of this, most reusable medical devices are terribly difficult to clean, disinfect and sterilize. This has led to inefficiency, lost productivity, and tragic consequences in terms hospital acquired infection and preventable deaths. Designing for reprocessing must follow the same human-centered design process that we advocate for every other component of the device. It should be considered early in the design process and should involve user research, iterative design, and frequent evaluation through usability testing. Design features that afford cleaning (e.g., easy-to-disassemble, disposable) and utilize labeling (e.g., color-coding, text, icons) to support reprocessing tasks should be implemented into the design of reusable medical equipment (RME).
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Chapter 15. Home Healthcare

Abstract
Many complex devices, including ventilators, infusion pumps, dialysis machines, and artificial hearts, are now being deployed in patients’ homes, and operated by lay users rather than professional healthcare providers. This presents difficult design challenges. For example, professional healthcare providers are likely to be able-bodied, relatively young, and adequately trained. Also, professional healthcare settings are consistent, well-lit, sanitary, configurable, with easy access to electrical power, and a reasonable amount of space. These assumptions are not valid in-home environments. This chapter discusses challenges, opportunities, and advice for designing medical devices for home use.
Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, L. Bryant Foster

Backmatter

Additional information