Know Thy Target Population

Background

Members of the project core team including myself were sitting around a meeting table at St. Jude Medical.  We had received a sample of work from a well-known human factors and design consulting company.  It was a detailed design of a user interface of a web-based system that the consulting company had designed.  (I withhold the nature of the system because some of you may know this consulting company and have received the same sample system.  I want maintain the anonymity of this company.)

Most of the members of the core team were impressed by the design and the level of detail provided in the sample of work.  I was not impressed.  Why?  There was nothing in the design that tied back to the target population the system would serve, nor was their any reference to any research performed that justified the design or the services that would provide its users.  In other words, I had no way to evaluate whether the design was good or bad, whether it suited the user needs or not.  Furthermore, there was no information provided by the consulting company regarding the target population, its needs, skill-level, etc.


If I understand the objectives of HE75 correctly, then medical device companies will be required to demonstrate through research - it is unclear whether the research required will involve the need for empirical research or a literature search.  However, companies will be required to demonstrate a clear understanding of the targeted population and the use environment of that target population for whom their products and services are intended for use.  The consulting company who provided St. Jude Medical with work samples failed to demonstrate any knowledge of the targeted population.

Know Thy Target Population

And know the use environment of thy target population: objectives, distractions, dangers, skills, needs, etc.

There are few things that rankle a human factors professional more than an ascetically pleasing design that fails to take in account the population of the actual users.  I will not discuss any specific examples in this article.  However, you can look around the Web, around your home or office, or a hospital or clinic and see all kinds of products and displays that were designed without regard to the target user population.  Companies continue to build products with user interfaces ill-suited to the target populations.  Why?

Designing research, collecting and analyzing data and turning the analysis into appropriate products and in particular, well-suited user interfaces takes time and money.  In highly competitive environments, time can be more of a concern than money.  For companies that have adopted a "fast follower" business model, time often looms larger than money when planning and developing products, and designing user interfaces.  Products based on a fast follower approach can often be successful if the product or product upgrade does not require a user interface.  Development is nothing more than the implementation of a proven algorithm.  However, when there is a user interface, the lack of attention to understanding the target population can become painfully obvious once the product or service is introduced. 

When a company uses a "fast follower" model or does not want to devote the time, effort and money to research, the temptation can be to rely on opinion leaders, other companies' products, best guesses, or "expert" opinions.  These approaches often bring fast outcomes.  Furthermore, I have noticed that often times decision-makers believe that they can determine what is and what is not a good user interface - that a good user interface design is something that anyone can assess. 

I believe that some of the faith that decision-makers have placed in themselves comes from their experience with consumer products, such as the Apple's iPhone.  The iPhone is an combination of excellent physical design ascetics and small, touch-screen user interface design.  What many people forget is that Apple devoted copious amounts of time, money, expertise to research and development of the physical design and the user interface of the iPhone.

The iPhone was designed with the general public in mind.  Apple may have targeted the iPhone to a more youthful population, however, I have noticed that many, many older people pulling out their iPhones.  I have also noted that there are numerous medical applications targeted to iPhones, applications that would be of interest to older people.  The iPhone may have been targeted to a more youthful population, but its touchscreen interface with its large, wide buttons, high contrast and high resolution screen enables elderly users to access its capabilities.

When user interfaces are targeted to a specific population, it becomes imperative that the characteristics, needs, qualities, etc. of the target population be well-known and understood.  The user interfaces introduced to that population will likely be tied to a specific set of tasks with clear objective within a specified environment.  The use environment maybe more complex and stressful than the use environment of a consumer product.  Furthermore, and this is particularly true of many medical devices, the consequences of making an error can be significantly more harmful than any consumer product.

For decades, the Department of Defense has pressed its contractors to follow standards and demonstrate usability in the use environment.  The first step in that process is understanding the target population and the use environment.  Given the accumulating evidence that medical errors kill more people per year than automobile accidents and war, I believe that the FDA will take strong steps such as the steps taken by the Departments of Defense and Transportation.  Judgment will no longer substitute for data and analysis.  The evidence that I have seen is that HE75 and HE74 will provide significant guidance towards directing companies towards gaining a full understanding of the target population and their use environment.

One thing to note, target populations and use environments are dynamic, not static.  Continuing research is essential.

Next time: Now that you have an understanding of your target population and the use environment, what do you do next?  I shall come back to specific techniques for research a target population and their use environment in a later article.  However, I want to provide a process overview before diving into specifics and specific techniques. 
 

An another article on BANs

Another article on Body Area Networks and the Federal Government's continuing interest in furthering its development.  Here's the link to the article: http://www.informationweek.com/news/healthcare/mobile-wireless/showArticle.jhtml?articleID=224200068

Much of the work seems analogous vehicle telemetry research and development. One of the applications for the technology we developed at Rosetta-Wireless was for the transport of vehicle telemetry over the commercial wireless network in real-time or near real time.  The problem that we solved was handling gaps, faults and multiple types of wireless connections while the vehicle was in motion.  Again, body data will need to be transported over wireless using a robust logical connection to overcome the imperfections of the wireless network and perform the task without burdening the user - an extremely important consideration.

The next article will discuss the implications of HE75 and the means, methods and importance of not burdening or overtaxing the user.

Human Factors Issues in Remote Monitoring and Remote Programming

Series Overview and Background
 
Human factors issues related to remote monitoring and remote programming (remote patient care) will predominate in my postings over the next several months.  If I learned anything while working at St. Jude Medical, I learned the value of human factors engineering in relationship to remote monitoring systems.  Before I discuss what I learned, I want cover a few issues regarding remote patient care.

If you talk to a device clinic clinician, that person will have few difficulties in communicating to you the value of remote monitoring technology.  I heard stories from cardiologists that before remote monitoring technology was in place that device nurses would have to telephone device patients.  The emotional strain on the nurses was so great that device nurses would burn-out in two years.  

Remote monitoring provides a service to patients and their caregivers.  Most patients do not want to come to the device clinic and caregivers would rather that they did not.  Remote monitoring lengthens the time between clinic appointments.  Furthermore, remote monitoring can detect signs of potential problems much earlier than a visit to the clinic.  Remote monitoring can keep patients out of emergency rooms and can provide patients with a better quality of life.  Finally, remote monitoring can lower the cost of care while improving it.


Among the medical trail blazers, there is an interest in remote programming.  The ability to remotely make changes in the operation of a medical device could enable caregivers to be more proactive and provide patients with care where ever they are located, rather than just in the clinic.  This capability significantly lowers barriers and limitations on patients and their caregivers.  Patients can lead more free and independent lives and less tethered to clinic appointments.


Sounds wonderful, doesn't it?  Remote patient care technology does provide the underlayment, the enabling capability.  However, remote patient care system cannot be limited to the technology.  From my perspective working at St. Jude Medical, roles of caregivers and patients have been under valued, misunderstood or neglected in the development of systems to provide remote patient care.  I cannot speak for other medical device manufacturers.  I can say, because this is public information, that St. Jude Medical's remote monitoring system has come under fire because of issues related specifically to the performance and design of the user interface of their remote monitoring system.  

I am not singling-out St. Jude Medical regarding the design and implementation of their remote monitoring system.  St. Jude Medical implemented a beneficial and desired medical system.  However, it appears that they failed to understand two essential elements who are just as essential to the remote care system as the hardware and software.  Thus the current state of St. Jude Medical's remote monitoring system serves as a starting point for the articles that will follow this one.


My next two articles will focus on the new AAMI/ANSI standard HE75 due to be officially released in April 2010.  I cannot quote from the document at this time, however, I can say that HE75 is founded on the basic foundations of human factors. Thus, from that standpoint, there is nothing new about what is contained in HE75. I know several people on the HE75 committee and I can say that they are consumate human factors professionals, and dedicated to the profession. 


I can also say that should the FDA adopt this document (and all expectations are that the FDA will adopt it), the relatively lax approach that FDA approach to usability and human factors will come to an end.  There is a massive body of literature that documents the massive number of injuries and deaths from medical errors, and some of those medical errors can be traced back to poor device designs.  It may well be that the FDA will believe that it is time to "crack down" on poorly designed medical system user interfaces.  Furthermore, medical systems are becoming increasingly more powerful and complicated, thus the capability to do injury to patient will increase.  Thus, the need to insure that medical devices and their user interfaces will meet specific and unambiguous performance standards before being approved by the FDA.


I plan to focus specifically on medical devices related to remote patient care in this blog.  However, I may stray from time to time when there is something that seems particularly relevant or interesting.


I shall not discuss anything regarding future St. Jude Medical products or services in this blog.  However, I can discuss some of the issues I faced in general terms to illustrate points.  I suspect that the experiences I relate will resonate with others.


Next time: Human factors in the research and development of medical devices.