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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.
Collecting end-user feedback on medical devices like the BrainScope One and Infrascanner 2000 is vital for the defense medical acquisition process. This ensures far-forward medical teams receive suitable technology for evaluating head injuries in the field.
Area of Science:
- Military Medicine
- Medical Technology Assessment
- Defense Acquisition
Background:
- Ensuring far-forward medical teams receive suitable technology is critical for effective defense medical acquisition.
- End-user feedback prior to fielding candidate technologies is a crucial step in this process.
Purpose of the Study:
- To review the methodology for collecting end-user feedback on medical devices.
- To illustrate how feedback was gathered for the BrainScope One and Infrascanner 2000.
- To evaluate the suitability and future promise of these devices for field head injury assessment.
Main Methods:
- Collected end-user feedback from 158 medical personnel across 8 bases in Afghanistan, Iraq, and Kuwait.
- Utilized focus groups and interviews to gather data on two FDA-approved devices.
- The BrainScope One and Infrascanner 2000 served as an example to assess candidate technology.
Main Results:
- End users reported consistent concerns regarding the operational efficacy and suitability of current device versions.
- Identified specific areas where the BrainScope One and Infrascanner 2000 show promise for the Department of Defense (DoD).
- Demonstrated the depth and richness of feedback obtainable through this methodology.
Conclusions:
- Gathering end-user field efficacy and suitability feedback is essential during the medical acquisition process.
- The evaluation of the BrainScope One and Infrascanner 2000 highlights the necessity and value of this feedback.
- Discussed limitations and best practices for collecting end-user feedback in operational environments.
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