Article Focus:

  • Older physicians and patients drive medtech design changes
  • GUIs and PUIs present opportunities
  • FDA focuses on usability

Every day10,000 professional caregivers, patients, and future patients—in other words, the general population—turn 65. This will continue for the next 19 years, meaning in just two decade’s 72 million Americans will be 65 or older1.

As of this year the American Medical Association (AMA) reports 63% of all physicians are aged 45 years and older, with 20.7% of that group already aged 65 or older2. Additionally research shows that “older” (50 years or more) registered nurses are on the rise and comprised 44.7% of the total RN population in 2008, compared with 41.1% in 2004 and 33.4% in 2000. Further the percent of RNs, 60 years old or more, increased 1.9% between the years 2004 and 20083.

No other industry will be impacted as greatly by our aging population than healthcare. Medtech companies designing everything from surgical equipment to in-home monitoring devices must consider this population segment as they develop devices of the future.

The challenge for medical device designers is clear: create tools and devices that accommodate evolving physical and cognitive abilities while developing a deeper understanding of older user needs. Within this challenge there are competitive opportunities to be mined and better products to be created.

While age-related changes such as worsening eyesight are obvious, others are not. And it is to the provider’s and patient's benefit to mitigate the negative effects while retaining the positive. Coupling the diminishing physiological faculties shown in "Older RN" illustration with a keen understanding of the clinical environment and intended use of a device offers designers a great opportunity to create safer, more intuitive devices.

Graphical user interfaces (GUIs), which are among the worst design offenders for aging caregivers, and product user interfaces (PUIs), which could be the buttons, knobs, handles, and levers that need to be touched to operate a device, are great opportunities for designers to improve upon.

When it comes to GUIs, users desire a simple and relevant interface that controls or displays the states of use. However, current devices and software architecture often focus on the technology or technological advances rather than user needs. Nurses programming IV infusion pumps having to grab for their reading glasses while making inputs because the fonts are too small or not displayed brightly enough for the use environment is one result of such ill-conceived designs.

For clinicians having to deal with terminology that varies from device to device, the need to read information accurately and quickly is critical as is the need for the de-cluttering of information available at any one time on the screen.

And we've learned through our research the importance of intuitive task flow. For example, nurses working on infusion pumps find it disorienting to have a single programming screen and be expected to program multiple parameters. Instead, they want each task to have its own distinct screen in a step-by-step manner so they feel confident they are methodically going through the process.

This intuitive task flow is as critical, if not more, for in-home devices. Such devices will be used by patients and untrained caregivers. With the FDA focusing much attention on device safety for at-home use, it is more important than ever to develop products that address this segment's specific needs.

Key elements to consider when designing a GUI for older users

  • Readability should be considered within the use environments
  • Appropriate terminology should be used versus technology-based language
  • Device must be parsed for cognition and simplicity
  • Higher contrast is appropriate of displays and inputs particularly in low light settings
  • Familiar pictographs and clear text messaging aids cognition
  • Intuitive navigation through the operation of a device is critical
  • Feedback when selected settings have been implemented (such as bolding of function label) must be clearly understood
  • Prioritizing information on screens based on criticality is critical

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When we reference a product user interface (PUI) we consider all of the interfaces (buttons, knobs, foot controls, levers, etc.). The intent of a control with respect to who is operating it, where it is being used, and for what purpose it is used impact the size, weight, and form of the PUI. When such factors aren’t considered, heavy equipment such as hospital beds coupled with heavier patients take their toll on RNs, with many already experiencing the effects of age on strength. Likewise small operating controls on devices pose challenges for all users experiencing a decline in dexterity and vision.

Improvements are often simple and obvious, such as changing the clamp color on an IV tubing set to bright orange so that it is easily visible as the nurse hurries to start an infusion on a patient, or making sure there are audible clicks when the tubing is fully engaged in the device. Another example would be lengthening a trigger on a device enough to fully accommodate two fingers rather than one for added torque and a reduction in user fatigue. This would also work to alleviate any discomfort incurred from poor fit such as force on pressure points.

Concern also has been raised on instruments where the requirements of strength and dexterity coupled with long or repetitive procedures result in various stress issues such a carpel tunnel. In fact, a survey developed at the University Of Maryland School Of Medicine found that 87% of laparoscopic surgeons have experienced physical symptoms or discomfort. The reason for this rise in numbers is due to the constraints these surgeons face that are not part of an open surgery. For a start, the incision is that much smaller meaning movement while operating is extremely limited as the surgeon maneuvers long and oftentimes heavy instruments through tiny sites.

Key elements to consider when designing a PUI for older users

  • Appropriate ergonomics for scale and strength
  • Form factors based on function to aid dexterity and lower fatigue
  • Sensory feedback when operating blindly
  • Tactile feedback
  • Controls that can be distinguished by touch
  • Clear labeling and large print on all controls
  • Anthropometrics and biomechanics
  • Forces to activate controls

Conclusion
As medical device manufacturers meet the challenge of devices for aging healthcare providers and patients, they must also meet the increased scrutiny of FDA. The release of FDA's latest draft guidance on human factors engineering and usability evaluation last June stresses the necessity to understand and demonstrate human factors throughout all phases of the design development. Following these guidelines will allow the considerations of unique user groups such as seniors to be incorporated into the inputs of a product specification from all perspectives and will result in better, safer devices.

References:
1. He Wan, Manisha Sengupta, Victoria A. Velkoff, and Kimberly A. DeBarros, U.S. Census Bureau, Current Population Reports, p. 23-20965+ in the United States: 2005, U.S. Government Printing Office, Washington, DC, 2005. http://www.census.gov/prod/2006pubs/p23-209.pdf
2. Physician Characteristics and Distribution in the US 2011, American Medical Association
3. The Registered Nurse Population: Findings from the 2008 National Sample Survey of Registered Nurses http://bhpr.hrsa.gov/healthworkforce/rnsurveys/rnsurveyfinal.pdf

The rise of the in-home medical device market

Gartner Research reports that portable consumer medical devices such as blood glucose monitors, blood pressure monitors, insulin pumps, and heart rate monitors represent the fastest-growing segment in the medical equipment market. This is not surprising for two reasons: the health of the average 50-year-old man is worse than those of previous generations. He is reportedly taking four prescription medications every day. Compare this with previous generations at the same age, and it's apparent that Boomers suffer from many more chronic diseases than their forebears.1 Secondly, home use has significant benefits from improved quality-of-life to cost savings. For the boomers in particular the continued availability and improvement of in-home devices is paramount. They have expressed a clear desire to "age in place," within the walls of their own homes rather than in retirement homes or other facilities more geared towards age and waning health. The biggest implication here for medical designers is to understand the new use environment-the dynamic home setting and the variance of users therein.

For those households with caregivers present, the caregivers are largely untrained personnel.

As of a report published in November 2009, it was estimated that a total of 65.7 million people had served as unpaid caregivers over the last 12 months. Additionally, an estimated 36.5 million households had a caregiver.2

Adult care recipients not receiving care from paid providers are relying on untrained providers such as family member. Further, a recent AARP report showed that 20% of people aged 45-64 have caregiving or financial responsibilities for a parent, older family member or adult child.3

Caregivers are largely (66%) female.4

Additionally, key insights into the Boomer population indicate the need for simpler and more intuitive product. A recent ethnography undertaken by research firm D.I.G. (digsmarter.com) found that Boomers "will remove a lot of the unnecessary or over-complicated things from their lives over the next few years, and products that require lots of refills, maintenance, or accessorizing will be first on the list. Products that deliver more in performance than they require in time and money will be in demand because they lessen patient frustration [1] as evidenced by a recent study showing that 77% of patients who rely on devices such as insulin pumps are willing to pay a premium ($5 more out of pocket) for greater ease of use.5

References:
1 "sex, drugs and rocky road", CNN.com, May 10, 2011
2 (Source: Caregiving in the U.S. 2009, National Alliance for Caregiving in collaboration with AARP, http://www.caregiving.org/data/Caregiving_in_the_US_2009_full_report.pdf
3 AARP
4 (Source: Caregiving in the U.S. 2009, National Alliance for Caregiving in collaboration with AARP, http://www.caregiving.org/data/Caregiving_in_the_US_2009_full_report.pdf
5 Source: Dig, http://www.DigProjects_boomers-report.pdf

Researching an older population

Research involving an older population is vital, thought there are important nuances to consider. By default the research is conducted on a vulnerable population and therefore falls under Human Subjects research protocols on many levels. Therefore privacy, private information, openness of research intent, and considerations of frailty need to be planned into the entire research activity. Ethnographies, interviews, formative or summative studies need to be carefully conducted to ensure that the data is robust and that the right questions have been asked in the right way.

At Ximedica we often use a triangulated approach to research by asking participants what procedure requirements should be, what their interpretations are and then watch what they actually do. Often, there are clear contradictions between the requirements and processes versus what users actually do based on years of experience that has caused a migration away from initial intent.

Additionally we find it helpful to use workflow maps that break the use of a product down into individual steps and then through the creation of visual graphics representing the full life cycle. Typically the research group evaluates the workflow by applying a series of lenses such as time, handoff, waiting, instruction types, process steps, and duplication of efforts. The lenses that we might add when considering a product for use by a senior might bias toward cognition, hesitations, strength, and dexterity and complexity. The end result is the ability to turn insights into implications and implications into user needs and design inputs.