Tuesday, May 4, 2010

HE-75 Topic: Design First and Ask Questions Later?

I was planning on publishing Part 2 of my Medical Implant Issues series.  However, something came up that I could not avoid discussing because it perfectly illustrates the issues regarding defining and understanding your user population.

A Story

I live in the South Loop of Chicago - easy walking distance to the central city ("the Loop).  I do not drive or park a car on the streets in the city of Chicago.  I walk or take public transportation.

One morning I had to run a couple of errands and as I was walking up the street from my home, I saw a man who had parked his car and was staring at the new Chicago Parking Meter machine with dismay.  I'll tell you why a little later.

Depending on how closely you follow the news about Chicago, you may or may not know that Chicago recently sold its street parking revenue rights to a private company.  The company (that as you might imagine has political connections) has recently started to remove the traditional parking meters (that is, one space, one meter) with new meters.  Separate painted parking spaces and their meters have been removed.  People park their vehicles in any space on the street where their vehicle fits, go to a centralized meter on the block where they parked and purchase a ticket (or receipt) that is placed on the dashboard of the vehicle.  On the ticket is printed the end time wherein the vehicle is legally parked.  After the time passes, the vehicle can receive a citation for parking illegally.  Many cities have moved to this system.  However, this system has something missing that I have seen on other systems.

Here's a photograph of the meter's interface ...

Chicago Street-Parking Meter

I have placed black ellipse around the credit card reader and a black circle around a coin slot.  Do you see anything wrong in the photo?  ...

Getting back to the man who was staring at the parking meter ... he saw something that was very wrong ... there was no place to enter paper money into to the meter. 

I was surprised. This was the first time I had ever taken the time to really look at one of these meters.

As street parking goes, this is expensive.  One hour will cost you $2.50.  The maximum time that you can park is 3 hours - translated, that's 30 quarters if you had the change.  You can use a credit card. However, there are a lot of people in the City of Chicago who don't have credit cards.  And this man was one of them, nor did he have 30 quarters.

I have seen machines used other cities and towns, and they have a place for paper money.  Oak Park, the suburb immediately west of Chicago, has similar meters and they have a place to use paper money to pay for parking.  What gives with this meter?

I take the City of Chicago off the hook for the design of this parking meter.  I don't believe they had anything to do with the design of the meter.  I have parked in city garages over the years (when I was living in the suburbs), and the city garages have some pretty effective means to enable one to pay for parking - either using cash (paper money) or credit card.  But I think they should have been more aware of what the parking meter company was deploying.  I think they failed the public in that regard.

I can take the cynical view and suggest that this is a tactic by the private company to extract more revenue for itself and the city through issuing parking citations.  However, I think is the more likely that some one designed the system without any regard to the population that was expected to use it and the city fell-down on its responsibility to oversee what the parking company was doing.

Failure to Include a Necessary Feature

For the purposes of examining the value of usability research - that is, the research to understand your users and their environment, what does this incident teach?  It teaches that failure to perform the research to understand your user population could result in the failure to include a necessary capability - such as a means to pay for your parking with paper money.  

What I find interesting (and plausible) is that this parking meter design could have been usability tested and passed the test.  The subjects involved in the usability test could have been provided quarters and credit cards, and under those conditions the subjects would have performed admirably.  However, the parking meter fails the deployment test because the assumptions regarding populace, conditions and environment fail to align with reality of the needs of the population it should have been designed to serve.

Another Failure: Including the Unnecessary or Unwanted Features   

As I was walking to my destination, I started composing this article.  While thinking about what to include in this article, I remembered what a friend of mine said about a system wherein he was in charge of its development.  (I have to be careful about how I write this.  He's a friend of mine for whom I have great respect.  And, defining the set of features that are included in this system is not his responsibility.)

He said that "... we build a system with capabilities that customers neither need nor want."  The process for selecting capabilities to include in a product release at this company is an insular process.  More echo-chamber than outreach to include customers or users.  As a result this company has failed to understand their customers, users, their work environment, etc.  

Some might suggest that the requirements gathering process should reduce the likelihood of either failure occurring - failure to include or include unnecessary or unwanted features.  Again, I know that in case of my friend's company, requirements-gathering takes its direction largely from competitors instead of customers and/or users.  So what often results is the release of a system that fails to include capabilities that customers want and includes capabilities that customers do not want or need.
I don't know about you, but I see the process my friend's company engages in as a colossal waste of money and time.  Why would any company use or continue to use such a process?  

Ignorance, Stupidity or Arrogance - Or a combination?

I return to the title of this article "Design First and Ask Questions Later?" and the question I pose above.  I have seen company after company see design as an end in itself and failing to understand that creating a successful design requires an effective process that includes research and testing.  Failure to recognize this costs money and time, and possibly customers.  It is not always a good idea to be first in the market with a device or system that includes a trashy user interface.

So why to companies continue to hang on to failing processes?  Is it ignorance, stupidity or arrogance?  Is it a combination?  My personal experience suggests a combination all three factors with the addition of two others: delusion and denial.  These are two factors that we saw in operation that lead to the financial crisis of 2008.  I think the people will continue to believe that what they're doing is correct up to the point until the whole thing comes crashing down.

The Chicago Parking Meters has a user interface with poor and inconsiderate design ... inconsiderate of those who would use it.  (If I get comments from city officials, it will probably be for that last sentence.)  However, I don't believe that the parking meter company will face any major consequences such as being forced to redesign and redeploy new meters.  They will have gotten away with creating a poor design.  And they're not alone.  There are lots of poorly designed systems, some of the poor designs can be and have been life threatening.  Yet, there are no major consequences.  For medical devices and systems, I believe this needs to change and I hope the FDA exerts it's oversight authority to insure that it happens. 

Medical Device Design: Reader Suggested Books

One of my readers provided me the following list of books related to usable medical product designs.  I pass this list of three books on to you.  I do not yet have them in my library but these would be suitable additions.

Medical Design Article: FDA announces Medical Device Home use Initiative

As I was working on a human factors related article, this article from Medical Design appeared.  Here's the link to the article: http://medicaldesign.com/contract-manufacturing/fda-announces-medical-device-home-050310/

I thought that this article is interesting and telling with respect to how the FDA will assert it regulatory authority regarding usability issues. Here are a few quote from the article.

Recognizing that more patients of all ages are being discharged from hospitals to continue their medical treatment at home, the U.S. Food and Drug Administration announced an initiative to ensure that caregivers and patients safely use complex medical devices in the home. (My emphasis.) The initiative will develop guidance for manufacturers that intend to market such devices for home use, provide for post-market surveillance, and put in place other measures to encourage safe use of these products. The FDA is also developing education materials on home use of medical devices.
These home care patients often need medical devices and equipment such as hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators. 

Monday, May 3, 2010

HE-75 Topic: Risk Management

One more HE-75 topic before proceeding into design and design related activities.  The topic, risk management.

Reading HE-75, you will note that this document continually discusses risk management and reducing risk.  In fact, the entire document is fundamentally about reducing risk, the risks associated with a poor or inappropriate design.

If you drive a car, especially if you have been driving cars for more than a decade or two, you will note that a driving a car with well-designed controls and well-laid out and designed displays seems inherently easier than one that is poorly designed.  Furthermore, it has been demonstrated time and again that driving safety increases when a driver has been provided well-designed controls and displays, driving become less risky for everyone concerned.

Car makers now see safety as selling point.  (Look at a car that was built in the 40s, 50s or 60s and you'll note how few safety features the car included.)  Manufacturers are beginning to include in their luxury models driver-error detection systems.  For example, one manufacturer has a system that signals the driver of the existence of an other vehicle the space the driver wants to move to.  One of the qualities of a well-designed user interface is the ability to anticipate the user and identify and trap errors or potential user errors, and provide a means or path for preventing or correcting the error without serious consequences.  Car manufacturers have been moving in this direction.  I suggest that the adoption of HE-75 will be the FDA's way of pushing medical manufacturers in the same direction.

Risk Management: Creating a Good Design and Verifying It

My many blog postings on HE-75 will address the specifics of how to create a good design and verify it, and the process of incorporating these design and verification processes in the a company's risk management processes.  In this posting I want to address a two issues at a high level.

First, I want to address "what is a good design and how to do to create it." Creating a good design requires a process such as one outlined by HE-75.  I am often amused at hiring managers and HR people who want to see a designer's portfolio having no conception regarding how the design were created.  A good design for a user interface is not artistry, it is a result of an effective process.  It should not only look good, but it should enable users to perform their tasks effectively and with a minimum of errors.  Furthermore, it should anticipate users and trap errors and prevent serious errors occurring.  And finally, it should provide users with paths or instructions on how to correct the error.  This is what HE-75 teaches in that it instructs researchers and designs   And to that end, the design process should reduce risk.  Think this is not possible?  Then I suggest you spend some time in the cockpit of a commercial airline.  It is possible.

Second, HE-75 teaches that design verification should be empirical and practiced often throughout the design process.  This is an adjunct to classic risk management that tends to be speculative or theoretical in that it relies on brainstorming and rational analysis.  HE-75 teaches that medical device and system manufacturers should not rely just on opinions - although opinions provided by subject-matter experts can provide valuable guidance.  HE-75 instructs subjects drawn from the targeted population(s) should be used to guide and test the design at each stage of the process.  This becomes the essence of risk management and risk reduction in the design of user interfaces.

Additional Resources

I have this book in my library.  It provides some good information, but it's not comprehensive.  Unfortunately, it's the only book I know of in this field.  

These books I do not owe, but provide you with the links for information purposes.  I am surprised at how few books in the field of medical risk management there are.  It may go a long ways to explain the large number medical errors, especially the ones that injure or kill patients.

Risk Management Handbook for Health Care Organizations, Student Edition (J-B Public Health/Health Services Text) 

Medical Malpractice Risk Management 

Saturday, May 1, 2010

HE-75 Topic: Meta Analysis

The definition of a "meta-analysis" is an analysis of analyzes.  Meta analyzes are often confused with a literature search, although a literature search is often the first step in a meta-analysis.

A meta-analysis is a consolidation of similar studies on a single, well defined topic.  The each study may have covered a variety of topics, but with the meta-analysis, each study will have addressed the common topic in depth and collected data regarding it.

The meta-analysis is a well-respected means of developing broad-based conclusions from a variety of studies.  (I have included a book on the topic at the end of this article.)  If you search the literature, you will note that meta-analyzes are often found in the medical literature, particularly in relationship to the effectiveness or problems with medications.

In some quarters, the meta-analysis is not always welcome or respected.  Human factors (Human engineering) is rooted in experimental psychology, and meta-analyzes are not always respected or well-received in this community.  It is work outside of the laboratory.  It is not collecting your own data, but using the data collected by others, thus the tendency has been to consider the meta-analysis as lesser.

However, the meta-analysis has a particular strength in that it provides a richer and wider view than a single study with a single population sample.  It is true that the studies of others often do not directly address all the issues that researchers could study if those researchers performed that research themselves.  In other words, the level and the types of research related controls were employed by the researchers themselves.  But, again, the meta-analysis can provide a richness and the numeric depth that a single study cannot provide.

Thus the question is, to use or not to use a meta-analysis when collecting data about a specific population?  Should a meta-analysis be used in lieu of collecting empirical data?  

Answer.  There are no easy answers.  Yes, a meta-analysis could be used in lieu of an empirical analysis, but only if there are enough applicable studies recently performed.  However, I would suggest that when moving forward with a study of a specific, target population that the first response should be to initiate a literature search and perform some level of a meta-analysis.  If the data is not available or is incomplete, then the meta-analysis will not suffice.  But, a meta-analysis is always a good first step, and a relatively inexpensive first step, even if the decision is made to go forward with an empirical study.  The meta-analysis will aid in the study's design and data analysis.  And will act as a guide when drawing conclusions.

Additional Resources