Showing posts with label Usability. Show all posts
Showing posts with label Usability. Show all posts

Monday, November 11, 2019

Submission of the Human Engineering File to the FDA and Other Regulatory Bodies

Background

About a year ago I was asked what I thought was the most difficult phase of the medical device human engineering process. Frankly, I'd never before considered such a question. I could not identify any phase of the process that I considered more difficult than any other. I considered whether early phase formative research and testing or risk identification, use errors and risk management would be the most difficult. No, actually for me these phases have always proven to be the most interesting phases in the process. Challenging, yes; difficult, no.

The questioner had an answer in mind: she believed that the validation testing was the most difficult. I disagreed. I believe that the validation testing was most often the least difficult of all the phases of the process. Why? Because validation comes at the end of the entire process and is based on all of the work that you've done previously to get one to the point of validation testing. Thus the procedure of a validation test should flow naturally and easily from the earlier work.

In the end, we agreed to disagree. However, the question never left me. 

I have finally come up with the answer. The most difficult phase of the process is the creation of the narrative for the regulatory reviewers. What I refer to is more than putting together the folder of documents of all of the human engineering related activities. It is the construction of a cohesive and understandable narrative the provides to a reviewer an overall view of the reasoning and logic of the steps taken and that the procedures performed that will demonstrate that the human engineering process was sound and resulting from it is a system that will be safe to use. This is the most difficult phase of the human engineering process, especially if writing the narrative comes at the end.

Human Engineering Pre-Market Submission

Here is the outline of what the FDA expects in a Human Engineering Pre-Market Submission as provided by the FDA on their website:

Sec.Contents
1Conclusion
The device has been found to be safe and effective for the intended users, uses and use environments.
  • Brief summary of HFE/UE processes and results that support this conclusion
  • Discussion of residual use-related risk
2Descriptions of intended device users, uses, use environments, and training
  • Intended user population(s) and meaningful differences in capabilities between multiple user populations that could affect user interactions with the device
  • Intended use and operational contexts of use
  • Use environments and conditions that could affect user interactions with the device    
  • Training intended for users
3Description of device user interface 
  • Graphical representation of device and its user interface
  • Description of device user interface
  • Device labeling
  • Overview of operational sequence of device and expected user interactions with user interface
4Summary of known use problems 
  • Known use problems with previous models of the subject device
  • Known use problems with similar devices, predicate devices or devices with similar user interface elements
  • Design modifications implemented in response to  post-market use error problems
5Analysis of hazards and risks associated with use of the device
  • Potential use errors
  • Potential harm and severity of harm that could result from each use error
  • Risk management measures implemented to eliminate or reduce the risk
  • Evidence of effectiveness of each risk management measure
6Summary of preliminary analyses and evaluations
  • Evaluation methods used
  • Key results and design modifications implemented in response
  • Key findings that informed the human factors validation test protocol
7Description and categorization of critical tasks 
  • Process used to identify critical tasks
  • List and descriptions of critical tasks
  • Categorization of critical tasks by severity of potential harm
  • Descriptions of use scenarios that include critical tasks
8Details of human factors validation testing
  • Rationale for test type selected (i.e., simulated use, actual use or clinical study)
  • Test environment and conditions of use
  • Number and type of test participants
  • Training provided to test participants and how it corresponded to real-world training levels
  • Critical tasks and use scenarios included in testing
  • Definition of successful performance of each test task 
  • Description of data to be collected and methods for documenting observations and interview responses
  • Test results: Observations of task performance and occurrences of use errors, close calls, and use problems 
  • Test results: Feedback from interviews with test participants regarding device use, critical tasks, use errors, and problems (as applicable)  
  • Description and analysis of all use errors and difficulties that could cause harm, root causes of the problems, and implications for additional risk elimination or reduction 
Each one of the items listed will include one or more documents that address in some manner each one of the sub-points listed in each one of the items. You could place these documents into a folder, identify where they belong and submit this to the FDA or other regulatory body. However, I advocate something more: write an over arching narrative that takes the reader through the path of not only what was performed but why as well. The narrative can be and probably should be based on the outline above. (I'm sure there are exceptions, but beginning with the outline above should be your starting point.)
The narrative should provide a comprehensive flow that interconnects each of the phases and explains reasoning for what was done including the rationale behind the design and operation of the system as well as why it's appropriate for use by the identified user population as well as other likely populations who might encounter it.

Why Write a Narrative?

Is a narrative required as part of a submission? From all that I can tell: no, it's not a requirement as part of a submission to regulatory bodies. 

However, consider the fact that if you can't explain the logic of what you did to yourselves, how hard will it be for a reviewer to comprehend? And if the reviewer can't comprehend what you did -- including the reasoning and logic behind it -- could your submission be at risk for rejection? The answer is "yes," you may be putting your submission at risk for rejection.

The narrative is analogous to a completed jigsaw puzzle. A human engineering file without a narrative is analogous to just the jigsaw puzzle pieces. Yes everything is there, but what is it suppose to be? 

Submitting a human engineering file that includes a comprehensive narrative can insure that your submission is understandable: to you as well as your reviewers. It can insure that there are no gaps or issues that should have been included in your submission are left out. Again, going back to the jigsaw puzzle analogy, you don't know that you've got a missing piece or pieces until you've assembled the puzzle.

The narrative provides reviewers with framework to understand what you've done. Interestingly enough this will likely minimize any questions reviewer might have about your submission. And will likely minimize the likelihood that you'll get questions that you cannot answer.

One more thing to note: if your narrative is clear and comprehensive, it's likely that the reviewer or reviewers will often read no further or will simply scan the foundational documents to insure that the foundational documents do in fact support what is stated in the narrative. This could speed the regulatory review and acceptance. 

More Articles on This Topic

I'll be writing a series of articles on the topic of human engineering file submission narratives over the next week or two. I'll focus on specific areas of the narrative and discuss some of what I have done with regards to putting together narratives for submission to regulators. 



Saturday, December 1, 2018

Commentary: HE-75 and IEC 62366 and Cleaning Up the Messes

I received a reminder recently when I was made aware of the International
Consortium of Investigative Journalists' database of medical device recalls of what human factors professionals working in the area of human engineering for medical devices are often called on to do: clean up the mess created by a failed design process that somehow failed to incorporate research. (Note that medical device development isn't the only domain where this kind of failure occurs, however, the impact of medical device failures can often result in fatalities.) The persons responsible for designing an awful, unusable and in some case, useless user interface expect the usability expert to come in, take one look and create a beautiful user interface. This is absurd!

Writing from my own perspective, there is nothing that a usability professional likes to do less than to correct a failed design that resulted from a failed design process. This week I was asked to save a group of programmers and user interfaced designers from the monstrosities that they had created. What was particularly strange was that the leader of the project thought that I could just redesign something by looking at what they had created. It was bizarre. Unfortunately, I had to deliver several harsh messages regarding the design process and the design, that were not well received. (Nevertheless, that is my job.)

Here is the point I want to make clear to anyone who reads this: Process and the resulting design should be considered as two sides of the same coin. The outcome of a good design process generally results in a good design. A nonexistent or poor design process often times leads to a poor design and a design that gets worse with each design iteration when attempts are made to fix problems or incorporate enhancements.

The processes and design direction provided by HE-75 and IEC 62366 can serve as a foundations for research and designing systems with user impacts within nearly any industry, particularly in those industries where the potential for harm is likely.

Saturday, August 4, 2018

Article: Wearable Technology Is the Future of Healthcare

A bit of light reading about wearable fitness and medical devices.


An interesting quote from the article ...

There is no doubt that the adoption and retention of medical wearable devices will, at least for now and the foreseeable future, outrun that of general fitness wearable devices. This is understandable, as they fulfill a direct and current need for the consumer. However, my belief is, and I assume yours too, if you believe in prevention over treatment, that the more general one of these two has the feared but powerful potential to truly change the status quo. Where now, overall health goes down just before the age of 50, general fitness wearable devices could move up that number.  ...

Saturday, April 4, 2015

UK Perspective Regarding FDA Regulatory Requirements

A Linked-In colleague posted a link to this article. I read it and found it interesting enough to post the link and comment on it. It's by a UK publication and discusses the FDA regulatory process as it relates to Human Engineering requirements for device approval for commercialization.

Here's the link:
http://www.emdt.co.uk/daily-buzz/what-are-fda-usability-testing-requirements-device-approval?cid=nl.qmed01.20150325

In addition, I provide my own perspective on the article in the "Commentary" section below. I do not critique the article. I only attempt to expand on a few points from it.

But first, a brief summary of the article.

Article Summary


Medical errors have become an increasing concern of the FDA. I became interested in medical errors when I was a consultant at St. Jude Medical Cardiac Rhythm Division in Sylmar, CA. During my time at St. Jude (2009-2010), deaths by medical error were being reported as being 100,000 to 120,000 per year. Last year, I posted links to two articles that stated that deaths by medical errors could be closer to 400,000 per year. (http://medicalremoteprogramming.blogspot.com/2014/07/rip-death-by-medical-error-400000-year.html)

It has been noted by the FDA a large proportion of medical errors can be attributed to poorly designed medical device user interfaces. Since a fundamental mission of the FDA is increasing patient safety and reducing injuries and fatalities in the practice of medicine, the FDA has begun placing greater emphasis on improving the usability of medical device user interfaces.

This article provides measures that show the FDA's increasing emphasis on usability and human factors issues by showing the increasing frequency that companies seeking medical device clearance for the US market mention the terms "usability" and "human factors." Figure 1 from the article clearly shows the increasing usage of these terms in company filings.



The focus should be on the trends, not the absolute numbers because not all filing documents have been included in the count. But the trend clearly shows an increased emphasis by companies to increasingly use the terms "usability" and "human factors" in their filings with the FDA. The two figures that follow suggest the degree that companies have incorporated the FDA prescribed human factors engineering process and design guidance documentation.

The documents listed below are specifically targeted to defining and supporting the human factors engineering process and the development of the Human Engineer File that's included as part of a company's filing to the FDA.


  • ISO 62366, Medical Devices - Application of Usability Engineering to Medical Devices
  • AAMI / ANSI HE75:2009, Human Factors Engineering - Design of Medical Devices (General)

I'll discuss the documents above in greater detail and describe how they're intended to fit within the human factors engineering process when developing medical devices.


  • IEC 60601-1-6 Medical electrical equipment - Part 1-6 General requirements for Safety - Collateral standard: Usability
  • IEC 60601-1-8 Ed. 1, Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: Alarm Systems - Requirements, Tests and Guidance - General Requirements and Guidelines for Alarm Systems in Medical Equipment (General)

The two documents above are engineering standards. They're engineering specifications that medical devices must meet. They are technical and specific.

I show Figure 3 from the article before showing Figure 2. 



The increasing reference of 60601-1-8 is not surprising given the increased emphasis on safety. My real interest is in the significant increase in reference to ISO 62366. As mentioned, this is process standard the lays out how human factors engineering should be engaged to reduce "use errors." The emphasis in this standard is on the reduction of risk. Risk management is extremely well embedded in the medical device design and engineering process. It would seem that from a cultural perspective, ISO 62366 fits with the medical device engineering process. 

I want to contrast the dramatic, increasing references to ISO 62366 with the references to AAMI/ANSI HE75 shown in Figure 2 below.



References to AAMI/ANSI HE75 rise and fall from 2010 to 2013 instead of a steady upward trend that you see with ISO 62366 in Figure 3. I would like to emphasize that ISO 62366 and AAMI/ANSI HE75 should be considered as companion documents. (I'll expand on this in the Commentary section below.)

Commentary


The article does support the contention that the FDA and the companies it regulates are paying increasing attention to usability and human factors. That they're paying enough attention is another matter entirely. As new medical devices are introduced we should see two things. First, the use error rate for the newly introduced medical devices (once users have adapted to them) should decline in relationship to other similar devices currently in use. Second, we should see over time the number of per year of deaths and injuries from medical errors begin to decline. This will take time to detect.

Without a doubt, the push by the FDA to define a human engineering process in the design and testing of medical devices, and to press for testing under actual or simulated conditions is needed. In many ways the FDA is mirroring many of the processes that have already been adopted by the US Department of Defense (DoD) in the area of human engineering. Admittedly, the DoD doesn't always get it right, there is an understanding within the DoD that it is important ... life saving, battle-winning important ... to insure that those at the controls can do their jobs quickly, effectively and with as few errors as possible.  So from that standpoint, the FDA has adopted processes from programs that have proven effective. But the FDA has just passed the starting line. And much more will be required going forward.

ISO 62366 vs AAMI/ANSI HE75

As I mentioned earlier ISO 62366 and AAMI/ANSI HE75 should be consider complementary or companion documents. HE75 is a much larger document than 62366 and includes a significant amount of device design guidance and guidelines. 62366 is almost entirely a process document that's devoted to directing how to go about managing the research and development process of a medical device. In addition, the focus of 62366 is managing risks, risks in the realm of reducing use errors.

I found it interesting that references to HE75 were not increasing at the rate as references to 62366. I would have expected Figures 2 and 3 to have a similar appearance with respect to 62366 and HE75 in large part because the documents significantly overlap. In fact I might have reasonably expected references to HE75 to outpace 62366 because HE75 includes design specific guidelines in addition.

One possible reason for references to HE75 not being referenced in the same accelerated way as HE75 may have to do with the fact that the European Union has not adopted HE75, so it's required for medical devices that will be marketed in the EU (CE).  (I am currently unaware of the regulatory requirements of other countries on this matter.) Medical device companies are international companies and the documents that they file in one country are generally the same in each country. Thus since the EU hasn't adopted HE75, references to HE75 and HE75's use as a foundational process and design document may be less.

DESIGN RATIONALE

I'm not sure that this is true at this point in time, but I am certain that the following will be true going forward at some time in the future. I believe that the FDA will hold companies to account for their user interface designs. I believe that the FDA will demand that companies clearly define how they came up with their user interface designs and that those designs are well-grounded in empirical evidence.

This is what I mean ... the FDA will demand that the design choices ... these include: controls, placement of controls, number of controls, actions performed by controls, the way the control responds, methods for interacting with the device (e. g., touch screen, buttons, mouse), size of the display, etc. ... for medical device user interfaces must be grounded in empirical data.

Commercial websites are often designed by graphic artists. Often times the design of webpages reflect the artist's aesthetic sensibilities. Layout appear they way that they do because they look good.

I believe that the FDA will require that user interface designs for medical devices have an empirically grounded design rationale. Companies will be required to point to specific research finding to justify the design and the design choices that they made. Furthermore, as the design of the user interface evolves with each iteration of testing, the FDA will require that changes to the design be based on research findings.

Finally, I believe that soon if it is not occurring already, that the FDA will require:

  1. That companies submit documentation to show in detail the full evolutionary design process beginning from product inception, including ...
  2. Detailed pre-design research ... population(s), method(s), research questions and rationale, etc ... as well as the findings and what they suggest for the design of the user interface
  3. A design that includes with a full discussion of the design rationale ... why was it designed the way it was ... 
  4. A detailed description of the evolution of the design that include full and clear justification(s) for each change in the design ... and require that changes be grounded empirical data 
  5. A full description of pre-commercialization testing process and method ... with a clear justification for why this testing meets FDA testing requirements
  6. And a complete and clear analysis of the testing data.
What I'm suggesting above is that the process of designing and testing a medical device user interface should be more than going through the prescribed steps, collecting the data, doing the tests, etc. There should be a clear thread that ties all the steps together. When in a subsequent step, one should be able to point back to the previous steps for the rationale to explain why the user interface was designed to appear and operate the way it does ... to this point.

As near as I can tell, what I described above is rigorous than is currently required by the FDA. However, I believe that it would be in any company's best interest to follow what I've suggested because there may come a time when the FDA's enforcement becomes more rigorous. 

Another reason may be lawsuits. If a company can show that it went beyond the FDA's regulatory requirements at the time, those suing would likely have less of a chance of collecting damages. And if damages were awarded, they may likely be lower. Also, if the company went beyond the FDA requirements, it would be likely that there would be fewer people injured and that should lower damages.

FINALLY

This article has been a springboard for me to discuss a number of topics related to human engineering for medical devices user interfaces. This topic will remain a central part of this blog. I'll return this within a week or two, and discuss in depth other topics related to the human engineering process for medical device user interfaces. 




Sunday, August 1, 2010

HE-75 Topic: Cleaning Up the Mess

I received a reminder this week of what usability professionals are often called on to do – cleaning up the mess created by a failed process. Somehow, the persons responsible for designing an awful, unusable and in some case, useless user interface expect the usability expert to come in, take one look and create a beautiful user interface. This is absurd!  It was the "nightmare" come true - something related to one of my other postings: HE-75 topic: Design first and ask questions later

Writing from my own perspective, there is nothing that a usability professional likes to do less than to correct a failed design that resulted from a failed design process. This week I was asked to save a group of programmers and user interfaced designers from the monstrosities that they had created. What was particularly strange was that the leader of the project thought that I could just redesign something by looking at what they had created. It was bizarre. Unfortunately, I had to deliver several harsh messages regarding the design process and the design, that were not well received. (Nevertheless, that is my job.)

Here is the point I want to make to anyone who reads this. Process and the resulting design should be considered as two sides of the same coin. Good design process nearly always results in a good design. A nonexistent or poor design process leads to a poor design. HE-75's design process can serve as a foundation design process for designing user interface in nearly any industry, particularly in those industries where the harm is particularly severe. Where I am currently working, I plan to use HE-75 as one of the foundation documents to set user interface design standards. And as I mentioned, I am not currently working in the medical or medical device industry. However, I have come to believe that in this industry, the level of harm can be significant. Thus, I shall incorporate HE-75.
 
Next time, I'll review so of the literature that might be of some use to the community.

Saturday, July 24, 2010

Useful Verses Usable

This is a discussion that you are not likely to read in usability texts – the topic of useful verse usability, and the value of each. Just recently I had a discussion with someone on just this topic. Furthermore, I have had numerous discussions with others and each time it surprises me that people often do not know the difference between the two and the value of each.

Useful and Usable

If you go to the dictionary, you will discover that “useful” means “to be of serviceable value, beneficial” and in addition “of practical use.” Pretty straight forward.

On the other hand, the definition of “usable” is “capable of being used” and “convenient and viable for use.” Also a straightforward definition.

However, if you probe more deeply into the definitions, you will note that “useful” is the first, necessary quality of a tool or system. It must be useful or why use it? Usable is a quality of a tool or system. However, it is not primary in relationship with the quality of the being “useful.” It is secondary. Necessary, yes, nevertheless, it is still secondary.

The usefulness as a quality of a tool or system is not addresses in HE-75, or any other usability standard that I have encountered. (If any one knows of a standard where usefulness is addressed, please add a comment to this discussion.) Usefulness is assumed.

However, I have learned that in the real world, the usefulness of any tool or system should not be assumed. It should be tested. Furthermore, with complex systems, the fundamental capabilities of a system or tool are often useful. However, not all of the capabilities of that system may be.

I direct experience with a remote monitoring system where the primary or fundamental capabilities of the system have clear use. However, with each release of this system, as more capabilities are added, the useless capabilities may be on the verge of out numbering the useful ones.

Bottom Line


  • Usefulness is always more important than usability. If it is not useful, it is fundamentally worthless or at best, excess baggage, and a drag on the actual and perceived quality of the tool or system.

  • Usefulness should never be assumed. It should be demonstrated. I know of too many projects where usefulness was not demonstrated. This lead to capabilities being developed that waste time and money, and can damage reputations.

Sunday, July 18, 2010

HE-75, Usability and When to Prototype and Usability Test: Take 1

Prototyping and Testing will be a topical area where I shall have much to contribute.  Expect numerous articles to appear on this topic.

I had a discussion a few days ago with one of my colleagues who has worked as a user interface designer, but has little knowledge of human factors.  He was completely unaware of the concepts of "top-down" and "bottom-up" processes to user interface design.  I provide for you the essence of that discussion.

Top-Down Approach

The top-down approach begins with a design.  Most often the initial design is a best or educated guess based on some set of principles.  Could be aesthetics or "accepted" standards of good design, or something else.  The design is usability and/or acceptance tested in some manner.  (Anywhere from laboratory testing to field-collected data.)  In response to the data, the design reworked.  The process is continual.  Recent experience has suggested that the top-down approach has become predominant design methodology, particularly for the development of websites.

Top-down is a valid process, particularly for the deployment of new or unique products where the consequences of a failed design do not lead to serious consequences.  It can get a design into user hands more quickly.  The problem with a top-down approach (when practiced correctly) is that it relies on successive approximations to an ill-defined or unknown target.  To some degree it's similar to throwing darts blindfolded with some minimal correction information provided after each throw.  The thrower will eventually hit the bull's eyes, but it may take lots and lots of throws.

The top-down approach may have a side benefit in that it can lead to developing novel and innovative designs.  Although, it can have the opposite effect when designs are nothing more than "knock-offs" of the designs from others.  I have seen both coming out of the top-down approach.

Bottom-Up Approach

HE-75 teaches the use of a bottom-up approach where first one defines and researches the targeted user population.  Contextual Inquiry is also a bottom-up approach.  Since I have already discussed researching the targeted user population in depth, I'll not cover it here.  

With the bottom-up approach, the target is clear and understood.  And tailoring a design to the user population(s) should be a relatively straight forward process.  Furthermore, the bottom-up approach directly addresses the usefulness issue with hard data and as such, more likely to lead to the development of a system that is not only usable, but useful.

Useful vs. Usable

I'll address this topic more deeply in another article.  It suffices to say that usability and usefulness are distinctly different system qualities.  A system may be usable, that is, the user interface may require little training and be easy to use, but the system or its capabilities are not useful.  Or, and this is what often happens particularly with top-down approaches, much of what the system provides is not useful or extraneous.

Personal Preference

I am a believer in the bottom-up approach.  It leads to the development of systems that are both usable and useful sooner than the top-down approach.  It is the only approach that I would trust when designing systems where user error is of particular concern.  The top-down approach has its place and I have used it myself, and will continue to use it.  But, in the end, I believe the bottom-up approach is superior, particularly in the medical field. 

Saturday, July 17, 2010

The Return: The Value of Consistency

I have been distracted for a couple of months ... working to find and land another consulting contract.  I have completed that task.  However, it is outside of the medical device industry.  I am not completely happy with the situation, however, having a position outside of the medical device industry does afford some freedom when commenting on it.

Another reason for the significant gap between my last post and this one has been that I was working on a long and intricate post regarding hacking or hijacking medical device communications.  The post began to look more like a short story than a commentary.  The more I worked on it, the longer and more convoluted it became.  At some point, I may publish portions of it.

This experience with the article that would never end has lead me to change the way I'll be posting articles in the future.  In the future, my articles will be short - two to four paragraphs.  And will address a single topic.  I think that some of my posts have been too long and in some cases, overly intricate.  I still plan to cover difficult topics, but in a format that is more readable and succinct.

Consistency in User Interfaces

When it comes to making user interface "usable," the two qualities are 1. Performance and 2. Consistency.  Performance is obvious.  If the interface is slow, unresponsive, sluggish, etc. people will not use it.  Or those who are stuck with using it will scream.  Consistency is somewhat less obvious and more difficult to describe.  However, when you encounter a user interface that has changed dramatically on an application that you thought that you knew, you understand the value of consistency. 

Recently, I encountered a newer version of Microsoft Office.  Gone are the pull down menus, the organization of the operations and tools has changed dramatically.  Frankly, I hate the new version.  If I had encountered the newer version of Office as my first encounter with Office, I know that my reaction would be different.  The new version is inconsistent with the older version.  My ability to transfer my knowledge about how to use the newer version is being hindered by the dramatic changes that have been made.  

Consistency is about providing your users with the capability to reapply their knowledge about how things work to new and updated systems.  Operations work the same between applications and between older and newer versions.  In the case of the new version of Word, I am grateful that once I have selected a particular operation, such as formatting, it essentially works the same as the older version.  However, I have tried to use the newer version of PowerPoint and it's drawing capabilities.  I have not yet been successful and am a drawing tool that I know how to use.

Consistency has a side benefit for the development process as well.  When operations, layouts, navigation, etc. become standardized, extending the design of a user interface becomes easier, less risky and less likely to be rejected by users.  The effect of creating consistent user interfaces is similar to having a common language. More on consistency and HE-75 in a later post.

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.