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Quickly Evaluating an Emerging Medical Technology Using Feedback From the Field: A Case Study of the BrainScope One
Stephen Krauss1, Sarah Sanjakdar2, Andrew Wilson3
1Research Transition Office, Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD 20910.
Introduction:
Gathering end-user feedback about candidate technologies in the operational environment prior to fielding helps to ensure that far-forward medical teams receive the most suitable technology. It is therefore a crucial step in the defense medical acquisition process. The current article reviews the methodology and provides an illustrative example of how end-user feedback was collected to evaluate the current suitability and future promise of two FDA-approved devices, the BrainScope One and Infrascanner 2000, that could potentially aid in the field evaluation of head injuries by far-forward medical teams.
Materials And Method:
The BrainScope One and Infrascanner 2000 end-user evaluation is used as an example to illustrate how to collect end-user feedback from the field in order to rapidly assess the candidate technology. In this evaluation of whether and how to implement FDA-approved technology candidates for head injury assessment by far-forward medical teams, end-user feedback was collected from 158 medical personnel at 8 bases in Afghanistan, Iraq, and Kuwait using focus groups and interviews.
Results:
The end users reported consistent concerns about the operational efficacy and suitability of the current versions of the devices as well as the areas where the devices showed promise for the Department of Defense (DoD). End-user feedback is shown in detail to demonstrate the depth and richness of feedback that can be gathered using this methodology.
Conclusion:
Overall, the BrainScope One and Infrascanner 2000 end-user evaluation shows the necessity and value of gathering end-user field efficacy and suitability feedback during the medical acquisition process. Limitations and best practices for this approach are discussed.
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