Thursday, April 8, 2010

More on Knowing Thy Target User Population

Before moving forward into product development, I want to elaborate on the issues in my first two articles. This article elaborates on the importance of knowing the target population and ways to gather that information.  

The next article will discuss  I have had some recent experiences that reinforced that importance of defining and clearing understanding the targeted user population. And the importance of fully understanding and documenting what those members of the user population do and the environment(s) wherein they live and work.

Before proceeding any further, please review my previous article on understanding your target population. The link to the article is below:

HE75 clearly emphasizes the importance of understanding your target population.   The standard instructs that companies who develop medical devices should:
  1. Know their targeted user population
  2. Involve users early and often
  3. Accommodate user characteristics and capabilities. And in order to do this, one must first know what they are.

The information gathered about a target population should enable one to clearly define the qualities and characteristics of that population.  This can be particularly important when designing medical devices, particularly when those devices are targeted to patients. 

I have seen organizations a company, organizations that include program management, marketing and engineering assume that they know the characteristics of the targeted population.  Once the product is deployed, the company comes to a rude awakening and learns that their assumptions were often times false.  Neither the company nor the targeted user population(s) benefit from such a failure.

Methods for Gathering Target Population Data

The target population data is the most elemental data in the product development process.  All the descriptions about the targeted user population, their characteristics, culture and capabilities originate from this step in the research and development process.

So, how is this crucial data gathered? First, a confession ... the amount of work I have performed at this stage of the process has been limited.  My training is in cognitive psychology and computer science.  Most often I have been the recipient of such information about the targeted user population.  I have used the results of this first step as a means for recruiting subjects in my usability experiments and evaluations.  The training that is most suited to gathering this kind of data is anthropology and sociology.  The process of collecting target user population data draws on ethnographic and participant observation research methodologies.  The research can be observational.  It can be based on questionnaires administered orally or in writing.  It can be structured interview.  It can participant observation where the observer becomes participates in the activities of the target population.  It can be a combination of a variety of methods and include methods not listed above.  

The objective is the development well-grounded description that captures the important, defining characteristics of the target population.  The description can be provided in variety of ways, verbal or graphic.  The description should use the clearest and most appropriate methods available to covey that information to the members of the product development organizations.

Interestingly enough, I have used the data gathering methods I listed above.  However, I used those methods to collect data for the second step, Knowing what the user does and where they do it.  In other words, to gather task and environmental data.

Potential Costs for Failure to Correctly Define the Target User Population

Consider the following scenario ... that I collect task and environmental data about the wrong population, about a population that is not the target population.  What is the value of the results of my research?  And what could be the cost to the company for this failure?  What could be the cost to the target user population, to have a device with a user interface unsuited to their needs?

In reality, the cost could be high, but the product may not be a dismal failure.  Given the fact that we are all human, we share a wide variety of characteristics.  However, in the more stringent regulatory environment that is anticipated, it could mean delay, additional research, engineering and product development costs.  If the product is intended to provide a new capability to providers and/or patients, a delay could mean that a competitor could be first to the market the product.  Thus company could miss the competitive advantage to being first.

I have recent experience with two products targeted to patients. In one case the target population was well understood and well defined, and members of that population were used in usability testing.  In another case, there was a limited understanding of the target population by the research and development organization. And no member of the target population involved at any stage of the research and development process or in the development of the user interface.   In the first case where the target population was well understood and well defined, the user interface research and development process was clear and logical.  On the other hand, the research and development process that did not have a clear understand of the target population is struggling, it is learning as it goes.  Each time it learns something new about its target population, the user interface has to be updated.  It has been a costly process with constant reworks of the user interface.  So many reworks that the integrity of the original design has been lost.  It appears deconstructed.  At some point the entire user interface will have to be redesigned and that will likely come at the behest of the FDA enforcing HE75.

A Final Thought

HE75 instructs that medical product user interfaces should accommodate a diverse groups of users and should be maximally accessible. I see this as design objective of any user interface in that vernacular should be limited as much as possible and that limiting qualities should not be designed in or should be removed when detected. However, all products may not be accessible to all users but should be clearly accessible to the target population.  And I believe that the FDA will insist on this.

No comments:

Post a Comment