David Lim, Mark <br/><br/>
Chapter 9 Starting with the End in Mind by Developing Diagnostics around User Needs 

 -  Taylor & Francis  2017 
 - 1 electronic resource (14 p.) 
<br/><br/> Open Access 
<br/><br/> As discussed in this chapter, the commercialization and adoption bottlenecks for these moderately complex diagnostics cannot be overcome by  technological innovation alone, particularly in the highly regulated and  payer-limited healthcare and public health markets. Diagnostics, unlike  other clinical products, is not an intervention but a decision-aid that guides  the use (or nonuse) of an intervention. It is important that the value proposition  for any technology-centric innovation in diagnostics include a strong  link to a gained efficiency in making a specific decision. Any assay developed  without context to the system, users, decision points, and downstream  interventions resembles one that is more targeted to the research community,  rather than clinical care or public health. 
<br/><br/><br/>Creative Commons 
<br/><br/><br/>English 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Medicine
<br/><br/><label>Subjects--Index Terms: </label>user needs developing diagnostics user needs developing diagnostics Decision problem Decision-making Global health Health care Infrastructure Product requirements document Public health Use case Workflow World Health Organization