Chapter 9 Starting with the End in Mind by Developing Diagnostics around User Needs

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.