Medical Device & Diagnostic Industry
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An MD&DI June 1999 Column
FIRST PERSON
Human Factors and the Future of Telemedicine
A human factors specialist describes how human factors engineering can play a positive role in the development of telemedicine.
Barry H. Beith
Telemedicine will be an important component in the healthcare delivery system of the future because it addresses three significant and persistent problems in the delivery of medical care:
- The uneven geographic distribution of medical resources, including facilities and professional personnel.
- Inadequate access to medical resources and expertise by certain segments of the population.
- Continuing increases in the cost of medical care despite new business models and dramatic cost-cutting programs.
Through the use of telecommunications technologies and computer networking, telemedicine extends the reach of medical personnel over geographic areas and improves access to medical care. One impact of telemedicine will be to democratize the future of medicine. In effect, telemedicine will facilitate the involvement of patients in their own health and medical care to an extent never before imagined. The advent of high-definition television, broad bandwidth, high-speed transmission rates, and reliable low-cost devices for collecting biodata in the home will allow medical professionals to conduct triage, diagnostic consultations, and remote follow-up treatment with patients, as well as provide guidance to home caregivers. Interactive communications will allow patients and care providers access to information, advice, and guidance to improve home-based care.
The danger, however, is that the potential benefits of telemedicine could be lost if the users—professional and, especially, nonprofessional—cannot easily and effectively use such systems to meet their needs. The discipline of human factors and ergonomics can play an important role in making telemedicine a successful part of the medical industry.
AN OVERVIEW OF HUMAN FACTORS
Human factors focuses on system usability and designing system interfaces to optimize the users' ability to accomplish their tasks error-free in a reasonable time and, therefore, to accept the system as a useful tool. The discipline is rooted in understanding how people use tools, products, and systems to accomplish desired tasks, and it seeks to eliminate or, at least, manage the human errors that sometimes do occur.
Human factors engineering is an applied science that takes research about human abilities, limitations, behaviors, and processes and uses this knowledge as a basis for the design of tools, products, and systems. Applying human factors principles leads to designs that are safer, more acceptable, more comfortable, and more effective for accomplishing their given tasks.
Human factors engineering is often considered synonymous with other terms such as ergonomics, human engineering, human factors, usability engineering, and user-centered design. It is a multidisciplinary field in which individuals trained in human factors come from such diverse backgrounds as engineering, psychology, computer science, anthropology, and informational sciences. Specialists apply findings and principles from a range of disciplines including cognitive psychology, organizational psychology, industrial engineering, anthropometrics, biomechanics, motor skills, perception, and specific engineering areas such as vibration and noise.
Medicine is clearly an industry in which life and death can hang in the balance, and the consequences of a misadventure can be fatal. Since the 1980s, user-centered design has become recognized as a valuable approach to medical device design. From the late 1980s through the 1990s, several events reflected the growing importance of human factors and usability to medicine. The first was the development in 1988 of the guidelines for designing medical devices titled "Human Factors Engineering and Guidelines and Preferred Practices for the Design of Medical Devices" (ANSI/AAMI HE48–1993). It was revised in 1993 and under revision again in 1998. In 1996, FDA's Center for Devices and Radiological Health published a primer titled Do It By Design: An Introduction to Human Factors in Medical Devices to provide industry designers and developers with an overview of human factors, its perspective and techniques, and how it applies to their efforts. This publication was timed to coincide with the changes in CFR 21 (Food and Drugs) section 820, Good Manufacturing Practice for Medical Devices, regarding the incorporation of "design controls for intended use." These design controls refer to the documented process for ensuring that medical devices can be used as intended by the defined audience. Implementing usability test and evaluation techniques is an important approach to fulfilling this requirement.
THE FUTURE OF TELEMEDICINE
A critical hurdle must be overcome if telemedicine is to have an impact on the medical industry. The products and systems, processes, and procedures that make up telemedicine must be usable. The degree to which telemedicine's components are usable will either inhibit or facilitate its acceptance, use, and growth and its effectiveness as a model for medical care provision. Poor usability could at a minimum retard the growth of telemedicine and drastically reduce acceptance of telemedical technologies.
Poor usability has already had a negative effect on acceptance of these technologies by some medical professionals. Human factors is a key discipline for addressing interface design, human-system interaction, user performance, and usability. Moreover, human factors is the primary discipline for reducing and managing human error and its consequences, particularly for systems that require decision making and complex cognitive activities. The addition of nonprofessionals to the ranks of users will amplify the role of human factors in facilitating interaction in telemedical areas. This large audience will be less educated and less sophisticated than practitioners and will include a wide range of capabilities and limitations. As John W. Gosbee, director of the Center for Applied Medical Informatics at Michigan State University, has pointed out, human factors will contribute to the design and development of telemedicine systems in many ways.1
Video-Based Behavior and Communications. The use of video-mediated channels will require human factors specialists to address issues relating to communicating. Communication and interpretation over such media can differ greatly from face-to-face conversations. Understanding the effect on users and information exchange will be critical to telemedicine's acceptance.
Needs Analysis for a Broad Audience. When designing a telemedicine system, it is crucial to conduct a needs analysis to define the types of users, which will range from medical professionals to the patients. These audience definitions are critical to design and evaluation activities. Knowing who the users are and how they intend to use the system is invaluable for ensuring that the system acts and reacts the way each user expects it to. Another key aspect of the needs analysis is to understand specifically what users want the system to do. This particular task analysis will define the nature of the functions and their allocation within the system.
Designing Systems and Components. Human factors specialists apply a user-centered perspective to designing hardware, software, procedures, and interfaces. This perspective and process complements those of engineering and programming disciplines by ensuring that the user rather than the technology remains the focal point of the system. Design considerations range from the physical (biomechanics, anthropometrics) to the perceptual (audition, vision) to the cognitive (decision making, memory load, verbal comprehension). For telemedicine to be successful, usability must be addressed as early as possible in the design.
Choosing among Competing Systems and Components. Benchmarking the usability of a system is important for evaluating its effectiveness, but competitive usability testing is also a powerful approach to selecting the best systems and components. Head-to-head tests and evaluations ensure that usability is given equal weight as functionality at the design stage.
Identifying Good Candidate Applications for Telemedicine. The emergence of certain fields amenable to telemedicine —such as teleradiology, teledermatology, teleoncology, and telediagnostics—has represented selection based on the existence or development of technologies supporting that field. Selecting appropriate candidates for telemedicine applications for the more general user population will not be as straightforward. Human factors specialists must employ observational and requirements-gathering techniques to assist medical professionals in identifying and defining candidate activities. Techniques may range from surveys or interviews to ethnographic techniques of field observation. For example, should people be allowed to perform minor medical procedures such as drawing blood for analysis (even if the technology would allow home analysis)? Another question might be whether activities such as hospice-related counseling are viable through telemedicine channels.
Designing Interfaces for TV Use. It is important that the links and equipment for home-based systems demonstrate very good usability. Moreover, for most home users, the less computer based a system is, the better. For this reason, and with the technology on the foreseeable horizon, the more that telemedical functionality can be channeled through television, the more accessible and usable it will be. It will be critical to design TV interfaces to provide functionality through on-screen menus and set-top-box technology.
Designing Home Medical Devices and Protocols. Because capabilities and limitations vary widely for general users, home-use devices need to be designed to be simple, safe, and extremely usable. Devices must be designed to be nonthreatening and to inhibit, if not prohibit, incorrect or unsafe use. Over time, many such devices could enable biodata to be collected by home-care providers or medical professionals who visit periodically. Device hardware, software, documentation, and training should be designed for the lowest reasonably defined level of skill and ability.
Test and Evaluation of Applications and Components. Devices, systems, products, applications, documentation, and training all need careful scrutiny. Human factors specialists must test all components of a system to ensure that it meets the intended use provisions of the FDA regulations. Such systems will require test protocols for data collection and analysis to ensure the usability and safety of components. They will also require measures and measurement systems for assessing the usability and efficacy of telemedicine services and functions.
CONCLUSION
Although there are still issues to address, the need for an alternative operational and business model for medicine as well as the drive to democratize medicine will accelerate the development of telemedicine. More importantly, we must recognize that telemedicine systems must be designed and implemented to include the general population of care providers, patients, and other users. This means that telemedical systems, products, tools, functions, and interfaces must be usable as well as useful. Usability will play a critical role in the acceptance and efficacy of telemedicine applications. Human factors as a discipline can and will play an important role in ensuring that the user remains central to the design of a system and that usability is designed into the system and verified and validated through test and evaluation.
REFERENCE
1.John W Gosbee, The White Paper on Human Factors Engineering and Telemedicine, for the Focus Group on Clinician Acceptance Issues in Telemedicine Systems (Kalamazoo, MI: Federal Office of Rural Health Policy, Center for Applied Medical Informatics, Michigan State University, 1995).
Barry H. Beith, PhD, is vice president of Monterey Technologies Inc. (Cary, NC). [Online Update, April 2000: Dr. Beith is now president of HumanCentric Technologies Inc.]
