Designing for Humans

Medical Human Factors Updates

In November AAMI is presenting three online seminars on Human Factors Approaches to Ensuring Safe Medical Devices.  The seminars are offered over three days and cover topics including FDA validation usability testing, designing error resistant devices, and identifying human-factors related hazards.  Instructors include Michael Wiklund (Wiklund Research & Design) and Ron Kaye of the FDA.

Meanhwhile MDDI (pictured) continues Preaching the Value of Human Factors, with an interview with Peter Carstensen, formerly the FDA's #1 human factors guru.  Carstensen talks about the pros and cons of human factors application in the current medical device industry, and discusses the (still) forthcoming AAMI HE75 guidelines:

"HE75 is a very comprehensive handbook describing almost everything a designer needs to know. It’s a one-stop shopping text with most all the information a designer would need to design a good user interface and validate it. But it still requires intelligent interpretation. It’s like someone could write a detailed text on how to perform brain surgery, but careful study and practice will be needed to pull it off. HE75 is a very good start but it’s not a substitute for expertise in the field. There is an even more comprehensive text based on HE75 which should be published before the end of the year. It’s around 700 pages and will sell for the remarkably cheap price of around $125."

5 Guidelines for Ergonomic Observation

In my work in medical product ergonomics (as well as other areas of product design), I frequently encounter product teams who are applying field observation in their product development processes.  This is great, but much of the time, the teams lack the skills for conducting effective observations.  Actually, not so much the lack of skills, but a lack of structure to guide what to observe and how to document observations.  This lack of structure typically results in two types of patterns of observation notes:

1. Write everything - In this case observers write down every event in an ultimately futile effort to document the entire task flow, procedure, etc. This is the professional version of those students from high school who write down everything the teacher writes, even if they don't know what it means. I always loved it when the teacher would write something on the blackboard and then quickly erase it, leaving these human Xerox machines bewildered.
2. Write what's interesting- The more common approach is to document events or ideas that are out of the ordinary or unusual as they contribute above and beyond the observer's current knowledge base. This is certainly a more manageable approach, but is highly variable due individual observer's thresholds for what is "interesting".

How do you overcome these note-taking habits?  When I provide training on "Minimally Invasive User Research", I emphasize a team-based approach where multiple observers take on distinct, but overlapping roles.  For example, one observer may track high-level task flows while another focuses on the detail interactions between a user and a medical instrument.  But even when attention is focused to a particular set of user interactions, one can fall back in the write everything/write what's interesting habit.

An effective way to break away from those observational note-taking traps is to use guidelines.  Guidelines fall between having no structure and an overly-constrained template, by giving a set of elements to pay attention to, but the flexibility to document them as the observer sees fit. 

For example, in the case of observing a medical instrument interaction, I created the guideline of FoRCePS.  Forceps are a common medical instrument, making the term a memorable acronym for medical product designers.  The acronym represents five ergonomic areas to consider during observations, and is a loosely-based expansion of Stephen Pheasant's cardinal rules of anthropometrics.   The guidelines are:

• Feedback - Identify where the user's access to sensory feedback (e.g. visual, tactile) is compromised
• Reach - Identify situations where the user's major limbs (arms, legs) and minor limbs (fingers) must over-extend in order to carry-out a task
• Clearance - Identify situations where the user's major limbs (arms, legs) and minor limbs (fingers) must function within a limited space, such as finger holes or a handle
• Posture - Identify situations where the user's overall body posture is deviated from neutral position, as well as deviations at key joints (e.g. shoulder, wrist)
• Strength - Identify situations where the user must apply excessive or prolonged force for movement or stability, relative to their strength capabilities

Observers are encouraged to consider each of these guidelines individually for both macro and mico ergonomic issues, but also to understand how they interact with each other. For example, if there is limited visual access, compromising feedback, then a user may change his or her body and limb postures to accommodatean improved field-of-view, but in doing so, increase the extent of reach and reduce the effective  transfer strength.  I recommend watching a brief segment of a medical procedure (or other task where ergonomic compromises are common) to practice paying attention to these 5 issues.

So even with a set of five key principles, there's a lot to pay attention to during live observations and in follow-up video review.  Fortunately, FoRCePS and similar mental "tools" give an observer guidance and provide a consistent way to track issues that can be shared with other observers who are focusing on different aspects of the observed task.

Qualitative vs. Quantitative Ethnography

Exploring Ethnography for Design Research in the February issue of MD&DI is more than a follow-up to the classic article Ethnographic Methods for New Product Development. 

According to author Stephen Wilcox (Chair of IDSA Human Factors section), ethnographic research is now common in medical device development.  The majority of this research is of course, qualitative, and primarily focused on identifying opportunities:

"Much so-called ethnographic research—perhaps most of it—is designed simply to generate ideas, that is, to stimulate creativity. Inevitably, when members of device-design teams go into the field and see directly how their devices and other devices are used, it generates insight and stimulates new ideas."

But there is another type of ethnographic research that is as much about the validity of findings as it is about generating ideas (Sidebar: simply put, in research, validity refers to the degree that you are actually measuring what you are intending to measure).  Typically validity is associated with quantitative measurement based methods such as performance testing.  But Wilcox suggests several ways to increase validity in ethnographic research including careful sample selection, quantitative measurement and objective data recording.  This more robust approach to ethnographic research comes with a price:

"conducting such research is difficult, time-consuming, and, frankly, expensive, in comparison with the idea-generation type of ethnographic research."

It's unlikely that most organizations will be able to accommodate all of the steps necessary to conduct highly valid ethnographic research - especially since many are just getting into the practice of doing any field research regularly.  But Wilcox's recommendations should really be taken as best practices for conducting any type of user research effort (whether validity is an explicit intention or not).  For example, making sure that the  "sample accurately reflects the population of interest" is a fundamental research planning step.  The deeper challenge when addressing validity is knowing what you know - for example determining whether your sample is truly representative.

The February MD&DI issue also contains an article on considerations for designing medical devices for home use, and another article on integrating human factors into the medical device development process.

Finally, for a less technical, down to basics overview of ethnography, see Design Meets Research, from GAIN, AIGA's journal of business and design.

Task Analysis in Surgery...and Wii for Surgeons

One of the most challenging aspects in conducting medical ethnography/observation for design research is constructing a complete and accurate task analysis.  Breaking down a complex surgical procedure into logical sub-tasks typically requires rigorous observations over multiple sessions, detailed video review and validation from subject matter experts. 

Constructing hierarchical task analysis in surgery*, which was published in the January 2008 issue of Surgical Endoscopy, provides a high-level description and concrete example of the process for creating a hierarchical task analysis in a surgical context.  Click on inset image for a process diagram from the article.

*Note - accessing the full article requires a paid subscription, or the individual article may be purchased for $32 - then again there's always the library.

On a somewhat related note, New Scientist reports on the development of surgical training simulations for the Nintendo Wii:

"Now they are designing Wii software that will accurately simulate surgical procedures. A training platform based on the console, which costs about $250, might be more practical for trainee surgeons in the developing world..."

For designer/researchers, lower cost training simulators may provide a way to simulate or test prototype surgical tools in the design process.

Designing Medical Device Touchpoints

In his most recent article in Medical Device and Design Industry, Michael Wiklund discusses the need to thoughtfully design every interaction, or touchpoint.  Refined Touchpoints Drive Quality Perceptions suggests that medical product purchasers are influenced by effective, high quality design as much as consumers might be when shopping for a new household kitchen appliance.

Wiklund emphasizes the industrial design aspect of touchpoints with a clear understanding of the influence of materials and mechanics on experience.  This makes the article a useful introduction for designers and usability specialists who might lack exposure to ID.  For example, his recommendations include:

• Minimize or hide molding defects (e.g., shrink marks, flow marks, color streaks) that give parts a plasticky look and give them an unrefined feel.
• Avoid exposed fasteners that give devices a more primitive appearance and can be hard to clean.
• Avoid sharp edges and corners. Instead, radius them—even if only slightly—so they feel better and do not pose a hazard to the skin or protective gloves. A slightly radiused edge can still look crisp if the device’s styling calls for it.
• Ensure that labels, whether they are printed, adhered, or molded in, are not subject to undue wear (e.g., rubbing off during the extended life cycle) that could make them illegible.

Key issues covered in the article include the obvious, like buttons and handles, but also less considered, but essential components such as wheels and connectors that can have a strong influence on the perception of design quality.  And while the focus is on medical devices, the suggestions are applicable to other product design fields.

IDSA District Conferences and Other Upcoming Events

• The IDSA site lists some dates for the upcoming regional conferences.  Note that many of these dates are still tentative and subject to change.  For example, the Northeast District conference is listed as April 18-20, but has already been moved up to April 4-6.  Also the conference themes/names and the links to the web sites may be leftover from last year or non-functional.  Your best bet is to contact the regional VP for your district (listed on the same page), to get the scoop.  We'll provide a more clear posting once things are locked-down.
• The web site for the 2008 Design and Emotion Conference (Hong Kong) is online.  "The International Conference on Design & Emotion is a forum where practitioners, researchers and industry meet and exchange knowledge and insights concerning the cross-disciplinary field of design and emotion."
• The web site for the 2008 Healthcare Systems Ergonomics and Patient Safety Conference (France).  "The first HEPS conference aimed at creating bridges among different disciplines (medicine and surgery, information technology, occupational psychology, clinical engineering and architecture, human factors and ergonomics) in order to share a strong interest in the promotion of human factors and ergonomics in healthcare and patient safety."

Eight Design Research Themes for 2008: Technologies and Methodologies

2007 has witnessed the continued maturity of user research practices in product design/development organizations. As this continues, we look to 2008 and key areas of growth and change in user research technologies and methodologies. What many of these themes have in common reflects a shift from how to conduct research, to how to manage all of the research findings and results – clearly a positive trend and a nice problem to have.   Stay tuned into 2008 as these themes are tracked in further detail.

Technologies

Even a casual reader of this web log will have observed the ever-growing options in data gathering technologies available for a variety of research applications. For 2008, the themes in technology are diverse – from high definition video to a new resource of anthropometric head measurements of the Chinese population. But the more compelling tools address needs in organizing and analyzing qualitative data:

1. High Definition (HD) Video- HD video cameras are rising in popularity while falling in price. Higher resolution video means larger file sizes and typically more time for video editing and file management. On the other hand, greater visual clarity can be extremely valuable for studying fine motor control tasks, small control/interface element usage and visually-rich environments. Surgical observation and consumer electronics usability are two applicable areas for HD video.

2. International Anthropometric References – Much of the reference anthropometric data used to guide designs is based on the body dimensions European and North American populations, limiting applicability and, ultimately fit, to a broader user population. The availability of three-dimensional scanning technology, while still time-consuming and expensive, is driving the inclusion of additional populations. Size China is a program to create the first-ever digital database of Chinese head and face shapes for helmets, sunglasses and surgical masks. Such resources will provide a richer starting point for guiding form and size in product designs, but of course are not a replacement for fit testing with real participants.

3. Qualitative Data Management Software – As research capabilities mature, organizations will deal with a new set of challenges around handling larger volumes of research data. Research teams will struggle with organizing, presenting and efficiently re-using findings across projects. With that “embarrassment of riches, there is a need for techniques and tools that support research data management. For example, QSR Internationals’s forthcoming NVivo 8 provides a structure for entering, tagging and querying various forms of multimedia, qualitative data across multiple projects. These types of tools will enable more effective collaboration amongst both localized and geographically distributed researchers, and can provide a centralized repository for observational data.
4. Qualitative Data Analysis Software – The value of well-conducted research is extremely limited if it is not easily organized for effective communication. It is especially challenging to organize, analyze and interpret qualitative data such as user interview transcripts and observational field notes. Following many years of adapting general purpose software and technology, we now have access to a variety of software and hardware tools to support planning, collection, analysis and sharing of research data. Several new technologies can support unstructured data analysis in various ways including searching speech via text and syntactically mapping information. For example, IBM’s Many Eyes application visualizes text in a tree-like branching structure to enable more efficient analysis and data mining.

 

Methodologies

Design research methods will continue to adapt for studying the wider range of user experiences, beyond the primary product. Frameworks and techniques for mapping out user touch points will assist research planning, which will become specialized to particular domains (e.g. medical vs. consumer). Threading across all of this is the need for guidelines for effective research communication and presentation:

5. Comparative Ethnography - While many organizations are using ethnographic observation to understand end-user perspectives and stimulate innovative thinking, such research is frequently focused on a limited set of tasks and users. But a growing trend is to use ethnographic methodology to identify differences between contexts. For example, in a study of automobile driving behavior, Bresslergroup’s research plan not only focused on the in-car driving experience, but studied related, non-driving activities. Observing how comparable tasks (e.g. planning a route, choosing music to enjoy) are conducted in disparate contexts (in this case, in car vs. in home) provides unique insights to inform creative solutions.

6. Service Design - Beyond the “total product lifecycle” approach, organizations will need to understand where they fit within the range of loosely tied user experiences beyond the product itself. For example, medical implant designers should expand user research beyond surgery to understand the touch points that potential patients, caregivers and healthcare providers utilize to make treatment decisions, prepare for surgery, and deal with recovery and beyond. The emerging discipline of service design provides a framework for understanding how multiple types of providers and users interact across the various products, interfaces and environments where interactions and decisions occur.

7. Domain-Specific Research Methods – Although research practices can vary among domains (e.g. medical, consumer, industrial), core methods remain consistent. But as research teams mature, there is a movement towards industry-specific user research and design techniques. For example, in appliance design, usability testing with high-fidelity simulations is frequently necessary to elicit reliable performance feedback from consumers. By contrast, healthcare professionals are typically more capable of responding to lower-fidelity prototypes, partly attributable to their professional problem-solving processes.

8. Presenting Design Research – Typically, product development organizations can effectively present and communicate their work and capabilities in design and engineering. But even when products are backed by quality user research, teams may struggle with effectively communicating its influence on product design. Similarly, organizations have difficulty evaluating the research capabilities of potential employees. The Industrial Designers Society of Americas (IDSA) is leading the way in developing guidelines for design research presentations, starting with the organization of design research portfolio workshop & review at the Northeast District conference this April in Philadelphia.

Medical Design Articles in Businessweek

The November 12 issue of Businessweek features two healthcare design related articles:

• Getting Hip to the Boomers discusses the development of market specialized products in the growing joint replacement business.  For example, knee replacement components designed to better fit female patients, or hip replacement joints targeted at younger, more active patients represent targeting more specific consumer categories in the medical market.
• My iPod, My Cell, My Insulin Pump highlights the trends in medical devices towards more user-friendly interfaces, reflecting the design of more familiar consumer electronics devices.  One such example, the GlucoPhone, is a glucose reader that works with a standard mobile phone, eliminating the need for an extra device and facilitating data sharing between patients and healthcare providers.

"Designing Medical Devices Requires a Pound of Flesh"

A brief article in Wired online about the development of medical instruments features the work of Mary Beth Privitera of the University of Cincinnati:

"Privitera said designers could cut training time and anticipate problems by getting involved earlier in the medical design process. But to do that, they have to increase their knowledge of anatomy and physiology by working in the field with doctors."

Mary Beth also presented at last week's IDSA Connecting '07 conference.

(Thanks to Core77 for calling attention to this article).

The State of Human Factors in Medical Device Design

A new article at Medical Device Link, Catching the Human Factors Fever, discusses the current state of human factors in the medical device industry.  The author, Erik Swain, who is the editor-in-chief of MD&DI, discusses successful examples of integrating HF processes into product development.  Industry trends, such as increased FDA enforcement and a shortage of healthcare providers have increased the need for usable medical products. Human factors is also playing a role at the supplier end, moving usable design further upstream in the product development process. 

Swain concludes that:

"More device companies are committing to human factors programs, and that will benefit caregivers and patients in the long run. But mere acceptance of human factors programs won’t be enough. The next step is to integrate usability findings with the risk management process. "

Human Factors Product Design Award

Two medical devices are the winners of the 2006 User-Centered Product Design Award. Submitted entries are judged in terms of application of Human Factors process and the effectiveness of the resulting design.  There was actually a tie this year between two medical devices:

http://www.hfes.org/web/DetailNews.aspx?Id=116

The winning devices are the Medtronic Straightshot M4^TM Microdebrider and Hospira's Symbiq™ Infusion System. Contributing to the winning designs were Metaphase Design Group (Straightshot M4 Microdebrider) and HumanCentric Technologies, Inc. (Symbiq Infusion System).

As a committee judge I can tell you that the overall quality of entries has increased over the years, a sign that HF and user-centered design has a growing presence in industry.

-Rob Tannen

Human Factors in Healthcare Newsletter

I'm posting the latest newsletter for the Human Factors & Ergonomics Society - Healthcare Technical Group.  The newsletter includes information on FDA Critical Paths Opportunities, as well as the program for healthcare sessions at the HFES 50th meeting in San Francisco this fall.

The file is downloadable:  Download spring_2006_newsletter.pdf

Patient Safety - Human Factors Journal

The latest issue of the Journal of the Human Factors and Ergonomics Society  (Volume 48, Number 1, Spring 2006), features a special section dedicated to Patient Safety.  There are ten articles covering a range of associated topics including medication labeling, information display and simulation.  Of particular note are two articles:

• "Describing Nurse's Work: Combining Quantiative and Qualitative Analysis" describes a method to study work processes combining link analysis (physical task flow) and cognitive pathways (mental task flow).
• "The Right Picture is Worth a Thousand Numbers: Data Displays in Anesthesia" discusses the us of graphic displays and data visualization to improve clinical information monitoring.

"Fitting Human Factors in the Product Development Process"

An article from earlier this year by By Patricia A. Patterson and Robert A. North discusses the necessity of applying Human Factors methods in the medical device design process.  It's a nice overview of how and why Human Factors can fit within the product design and FDA processes.

The article can be viewed at the Medical Device & Diagnostic Industry (MD&DI) site:

http://www.devicelink.com/mddi/archive/06/01/007.html

Medical Device & Diagnostic Industry - Design Articles

MDDI's site has an index of Design-related articles that covers a range of topics encompassing human factors, design, error avoidance, methods and case studies.

Articles are available online from 1996 to the present:

http://www.devicelink.com/mddi/categories/Design.html

Redesigning the Pill Bottle

Understanding the usability and design limitations of current medication bottles led to the invention of an innovative medication bottle that provides improvements in ergonomics, readability and safety.

FDA Human Factors Resources

Online Food & Drug Administration (FDA) resources, information and standards for  medical device usability and saftey:

FDA Human Factors Program