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oapen-20.500.12657-310812021-11-12T16:12:47Z Chapter 9 Starting with the End in Mind by Developing Diagnostics around User Needs David Lim, Mark 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 bic Book Industry Communication::M Medicine 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. 2019-10-21 11:55:25 2020-04-01T13:23:16Z 2017-11-15 23:55 2019-10-21 11:55:25 2020-04-01T13:23:16Z 2017-10-01 23:55:55 2019-10-21 11:55:25 2020-04-01T13:23:16Z 2020-04-01T13:23:16Z 2017 chapter 639500 OCN: 1030822586 http://library.oapen.org/handle/20.500.12657/31081 eng application/pdf Attribution-NonCommercial-NoDerivatives 4.0 International 639500.pdf Taylor & Francis Diagnostic Devices with Microfluidics CRC Press 7b3c7b10-5b1e-40b3-860e-c6dd5197f0bb fa882344-efa4-4bf1-8cf3-0f74f566f8d6 CRC Press 14 1 open access
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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.
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