Eric Shaver

Human Factors Professional

Dear FDA Post at Human Factors MD

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Dear FDA

Earlier this week, I posted Dear FDA, which summarizes a panel discussion from the 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future, on the Human Factors MD website.

The panel was chaired by Tim Reeves, PhD CHFP, Managing Director of Human Factors MD, and included the following panelists:

Do Standard User-Centered Design Methods Work in Health Care?

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Next week the Human Factors and Ergonomics Society (HFES) will hold the 2015 International Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes (#HFESHealth2015) in Baltimore, Maryland.

The event, which is hosted by the John Hopkins Armstrong Institute for Patient Safety and Quality, will be held April 26th – 29th at the Baltimore Marriott Waterfront Hotel.  More than 450 attendees will have the opportunity to attend 77 oral presentations, 9 discussion panels, and 117 posters  (see full program here) in four tracks:

  • Clinical and Consumer Health-Care IT Track
  • Clinical Care Settings Track
  • Medical and Drug-Delivery Devices Track
  • Patient and Health-Care Provider Safety Track

One of the discussion panels is titled Do Standard UCD Methods Work in Health Care? and will take place on Tuesday the 28th between 3:30 and 4:30 pm.  The panel is chaired by Ross Teague, PhD, and will include Rollin J. (Terry) Fairbanks, MD, MS,  Christina C. Mendat, PhD, and Eric F. Shaver, PhD as panelists (see bios below for additional details).

This interactive panel will address the question Do Standard User-Centered Design Methods Work in Health Care? from the perspectives of a health care software vendor, consultant, clinician/researcher, and medical device vendor.  An additional bonus is that each of the panelists have extensive experience applying UCD methods in and outside of the health care domain.

We’re planning to include input from attendees in the form of Twitter questions and comments posed prior to and during the session using the #UCD4HC hashtag, along with questions from audience members.  Also, it’s our hope that the discussion will continue in the networking session that will follow our panel.

It should be a great panel (and audience) discussion!  We hope you’ll be able to join us.  But, if not, please tweet your questions and thoughts using the #UCD4HC hashtag – or post a comment – and we’ll attempt to answer them during the session.

Panelists

Ross Teague

Ross Teague, PhD

Dr. Teague is the manager of the User Experience organization at Allscripts where he leads a team of researchers and designers in the creation of products and services that improve patient and provider lives. He’s led the effort within Allscripts to create a User-Centered Design process that teams throughout the organization can follow to receive value whether they have expertise in UCD methods or not. Ross has been leading research and design efforts for medical devices and healthcare software for more than a decade. He’s also worked as a product design strategy consultant in the areas of consumer, industrial and commercial products.

 

Terry Fairbanks

Rollin J. (Terry) Fairbanks, MD, MS (@TerryFairbanks)

Dr. Fairbanks is the director of the National Center for Human Factors in Healthcare and of MedStar Health’s Simulation Training & Education Lab (SiTEL), Associate Professor of Emergency Medicine at Georgetown University, attending emergency physician at the MedStar Washington Hospital Center in Washington, DC, and Adjunct Associate Professor of Industrial Systems Engineering at the University at Buffalo. He is a human factors/safety engineer, board certified emergency physician, former private pilot, and former paramedic and EMS Medical Director. His work focuses on applying the science of safety to medical systems, based within MedStar Health, a 10-hospital $4.7B non-profit healthcare system in the Baltimore and Washington DC region.

 

Christina Mendat

Christina C. Mendat, PhD (@christinamendat)

Dr. Mendat is the Director of Human Factors at Human Factors MD. Her work is focused on leading clients successfully through the human factors regulatory process. Christina’s passion is helping clients who are new to human factors or have had unsuccessful human factors programs or submissions. She takes great pride in leveraging the science of human factors with a practical application. This year she is serving as co-chair of the Medical Device Track.

 

Eric Shaver

Eric F. Shaver, PhD (@ericshaver)

Dr. Shaver is a Human Factors Lead with FUJIFILM SonoSite.  His work has emphasized achieving an optimal fit between people, technology, and work systems to facilitate their safety, performance, and satisfaction.  His professional interests include health care innovation, leadership development, team performance, and applied decision making.  He blogs at ericshaver.com and actively engages with others on Twitter @ericshaver.

HFES 2015 Health Care Symposium Program

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2015 Health Care Symposium Program Cover

The program for the 2015 Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes is now available for download.  The event will be held next week (April 26th – 29th) at the Baltimore Marriott Waterfront Hotel.  It should be a great event!

IEC 62366 Replaced by IEC 62366-1 and IEC/TR 62366-2

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IEC 62366-1 (2015)

[Update: 9.1.15] For a more in-depth look at IEC 62366-1, check out IEC 62366-1:2015 – More Than A Checkbox at Human Factors MD.

Last month, the IEC (International Electrotechnical Commission) published IEC 62366-1, Medical devices – Part 1: Application of usability engineering to medical devices (purchase here or here).  As noted in the Forward:

This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). (p. 4)

IEC/TR 62366-2, Medical devices – Part 2: Guidance on the Application of Usability Engineering to Medical Devices, is still in draft form and should be published in 2016.  The Forward further explains the difference between -1 and -2 by stating:

Part 1 has been updated to include contemporary concepts of USABILITY ENGINEERING, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of RISK MANAGEMENT as applied to SAFETY related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of USABILITY ENGINEERING methods that can be applied more generally to MEDICAL DEVICES that go beyond safety-related aspects of MEDICAL DEVICE USER INTERFACES. (pp. 4-5)

I first learned about the standard being divided into two parts from a presentation (.pdf) Ed Israelski, PhD gave at the HFES 2012 Symposium on Human Factors and Ergonomics in Health Care: Bridging the Gap.

I’ll post a more in-depth review of the standard after I’ve had some time to fully digest it.

Human Factors – A Brief History

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Cocpit Vintage

Earliest Days

In the United States, the discipline of human factors and ergonomics, is generally considered to have originated during World War II (Wickens & Hollands, 2000), although advances that contributed to its formation can be traced to the turn of the 20th century. Prior to World War II, the focus centered on “designing the human to fit the machine” (i.e., trial and error), instead of designing machines to fit the human (p. 3). This can be found in Frederick Taylor’s work studying selection, training, work-rest schedules, and time & motion studies of industrial workers (Taylor, 1911), and through the extension of his time & motions studies, by Frank and Lillian Gilbreth (Gilbreth, 1914; Gilbreth & Gilbreth, 1917).

World War I

Many of the human factors and ergonomic advances originated from military necessity. With the start of World War I, the first conflict to employ the recently invented airplane in combat, the need arose for methods to rapidly select and train qualified pilots. This prompted the development of aviation psychology and the beginning of aeromedical research. Although advances were made in this time period, according to Meister (1999), the impetus for developing the discipline wasn’t met due to a lack of “critical mass of technology and personnel as there was in World War II” (p. 149).

Interwar Period

The time between World War I and World War II saw a reduction in research, although some achievements were realized. Aeromedical research continued to see advances in laboratories built at Brooks Air Force Base in Texas and Wright Field in Ohio. These laboratories performed studies that focused on further identifying the characteristics of successful pilots, and determining what effects environmental stressors had on flight performance. Also, the basics of anthropometry (the study of human body measurements) were applied to the design of airplanes in this time period. In the private sector, automobile driving behavioral research was also conducted (Forbes, 1939).

World War II

The outbreak of World War II, and the two inherent needs it generated, formed the catalyst for developing the human factors and ergonomics discipline. First, the need to mobilize and employ vast numbers of men and women made it impractical to select individuals for specific jobs. Thus, the focus shifted to designing for people’s capabilities, while minimizing the negative consequences of their limitations. Second, World War II witnessed the tipping point where the technological advances had finally outpaced the ability of people to adapt and compensate to poor designs. This was most evident in airplane crashes by highly-trained pilots due to problems with control configurations (Fitts & Jones, 1947a) and instrument displays (Fitts & Jones, 1947b). Also, enemy contacts were missed by motivated radar operators (Wickens & Hollands, 2000). Experimental psychologists were retained to study these issues by adapting laboratory techniques to solve applied problems. Consequently, the discipline of human factors and ergonomics was born, even if the people (e.g., Paul Fitts, Alphonse Chapanis, Arnold Small, etc.) involved didn’t realize it at the time (Meister, 1999).

Cold War

The two decades following the end of World War II saw the continuation of military-sponsored research, driven in large part, by the Cold War. Military research laboratories established during the war were expanded and additional ones were developed by the Army (Human Engineering Laboratory), the Air Force (Air Force Personnel and Training Research Center), and the Navy (Naval Electronics Laboratory). Universities also established laboratories, with the assistance of government funding, including ones at the University of Illinois (Aviation Psychology Laboratory) in 1946, and Ohio State University (Laboratory of Aviation Psychology) in 1949. The private sector saw the establishment of human factors and ergonomics groups in aviation companies (e.g., Boeing, McDonnell Douglass, and Grumman Corporation, etc.) and electronics and communication (e.g., Bell Laboratories, etc.).

HFES Formation

The Human Factors Society, the main professional organization for human factors and ergonomics practitioners in the US, was formed in 1957 with approximately 90 people attending the first annual meeting. The name was changed to the Human Factors and Ergonomics Society in 1992. Today the society has more than 4500 members, many of whom participate in one or more of the 23 technical groups, local and student chapters, and attend the Annual Meetings or Health Care Symposia.

Growth and Expansion

Starting in the mid-1960s, the discipline continued to grow and develop in previously established areas. Moreover, it expanded into other areas including computer hardware (1960s); computer software (1970s); nuclear power plants & weapon systems (1980s); the Internet & automation (1990s), and adaptive technology (2000s), just to name a few. Most recently, new areas of interest have emerged including affect, neuroergonomics, and nanoergonomics.

A Bright Future for Human Factors

A consistent theme that has emerged over the years is the ever expanding sphere of influence human factors and ergonomics has sought to encompass, as technology advances and grows. What started out as a narrowly defined breakaway of experimental psychology that focused on the interaction of people with machine controls has grown to encompass almost any interaction of people with their surroundings. With the rapid advances in science and technology, in such areas as bio- and nanotechnology, it’s interesting to speculate on what newly discovered problems human factors and ergonomics will be called on to solve. Several authors have theorized about the future direction for the discipline, including Brewer and Hsiang (2002), Cacciabue (2008), Dul, et al. (2012), Hancock and Diaz (2002), Karwowski (2006), Rasmussen (2000), and Vicente (2008).

Multidisciplinary Roots

Today, as it was at its inception, human factors remains a multidisciplinary profession. In the United States, the profession grew from the behavioral sciences, like experimental psychology, and certain engineering disciplines. Among European nations, the profession finds its roots in the physical sciences, like human physiology. Currently, individuals from a number of disciplines ranging from psychology, engineering and physiology, focus their unique skills and abilities to the study of how people interact with systems.

Further Reading

Readers interested in learning more about the formal history of the human factors and ergonomics discipline are encouraged to read the very informative text authored by Meister (1999). Also, the reader may want to consult O’Brien and Meister (2002).

References

Brewer, J.D., & Hsiang, S.M. (2002). The ‘ergonomics paradigm’: Foundations, challenges and future directions. Theoretical Issues in Ergonomics Science, 3, 285-305.

Cacciabue, P.C. (2008). Role and challenges of ergonomics in modern societal contexts. Ergonomics, 51, 42-48.

Dul, J., Bruder, R., Buckle, P., Carayon, P., Falzon, P., Marras, W.S., Wilson, J.R., & van der Doelen, B. (2012).  A strategy for human factors/ergonomics: Developing the discipline and profession.  Ergonomics, 55, 377-395.

Fitts, P.M., & Jones, R.E. (1947a). Analysis of factors contributing to 460 “pilot error” experiences in operating aircraft controls (Report No. TSEAA-694-12). Dayton, OH: Aero Medical Laboratory, Air Materiel Command, U.S. Air Force.

Fitts, P.M., & Jones, R.E. (1947b). Psychological aspects of instrument display. Analysis of 270 “pilot-error” experiences in reading and interpreting aircraft instruments (Report No. TSEAA-694-12A). Dayton, OH: Aero Medical Laboratory, Air Materiel Command, U.S. Air Force.

Forbes, T.W. (1939). The normal automobile driver as a traffic problem. The Journal of General Psychology, 20, 471-474.

Gilbreth, L.M. (1914). The psychology of management: The function of the mind in determining, teaching and installing methods of least waste. New York, NY: Sturgis & Walton Company.

Gilbreth, F.B., & Gilbreth, L.M. (1917). Applied motion study: A collection of papers on the efficient method of industrial preparedness. New York, NY: Sturgis & Walton Company.

Hancock, P.A., & Diaz, D.D. (2002). Ergonomics as a foundation for a science of purpose. Theoretical Issues in Ergonomics Science, 3, 115-123.

Karwowski, W. (2006).  From past to future: Building a collective vision for HFES 2020+.  Human Factors and Ergonomics Society Bulletin, 49(11), 1-3.

Meister, D. (1999). The history of human factors and ergonomics. Mahwah, NJ: Lawrence Erlbaum Associates.

O’Brien, T.G., & Meister, D. (2001). Human factors testing and evaluation: An historical perspective. In S.G. Charlton & T.G. O’Brien (Eds.), Handbook of Human Factors Testing and Evalution (pp. 5-20). Mahwah, NJ: Lawrence Erlbaum Associates.

Rasmussen, J. (2000). Human factors in a dynamic information society: Where are we heading? Ergonomics, 43, 869-879.

Taylor, F.W. (1911). The principles of scientific management. New York, NY: Harper & Brothers Publishers.

Vicente, K.J. (2008). Human factors engineering that makes a difference: Leveraging a science of societal change. Theoretical Issues in Ergonomics Science, 9, 1-24.

Wickens, C.D., & Hollands, J.G. (2000). Engineering psychology and human performance (3rd ed). Upper Saddle River, NJ: Prentice Hall.