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Considerations for translating medical devices under development from the clinic to the home: A case study in providing chronic wound care
Event Type
Poster Presentation
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionA prototype medical device and protocol that work well in a clinic would not necessarily work reliably in the home setting. A wound care prototype being evaluated has been applied by well-trained and well-educated researchers. The researchers can ask for help from healthcare professionals during the execution of protocols. The device has been used in a well-resourced, quiet, clean outpatient wound clinic where patients sit still on a safe hospital grade examination table, supplies are plentiful, a hygienic workspace is accessible, and space for supply storage is available. The researchers understand the limitations of the device and have health care providers nearby if there are concerns about the patient, and have the engineers who designed and who maintain the device a text message away if help is needed.

The high level goal of this work is to identify factors to consider when translating a device design for use by home caregivers providing chronic wound care. An operational scenario is one that describes how a system is to be operated and maintained during a specific time, phase, operational mode, or critical sequence of activities (IEEE, 2018). Some scenarios may consider normative use cases, contingency operations, and operations in the presence of failures or degraded system capabilities (AIAA, 2018). Others should consider resilience to erroneous human behaviors. Toward developing such scenarios, one must consider the current device, the associated bundle, and the protocol and how they may need to be modified before the treatment can be delivered in home settings. Relevant questions include:
• How might the device design need to change?
• What other components may be necessary (such as for storage and maintenance)
• What type of protocol can a patient or caregiver be expected to reliably execute?
• What types of user manuals, education materials and other resources would be necessary?

The purpose of the semi-structured interviews with the researchers who have applied a protoype device was to generate a list of potential issues with the current clinical protocol as well as the device design with respect to the application. The approach included researchers simulating the use of the device on patient actors. We modified the traditional think aloud protocol (Lewis & Rieman, 1993). In this data collection, the researchers performed a set of specified tasks by following the current device protocol and explaining any difficulties including what was currently happening. They embellished the descriptions with details about what happened with actual patients in the clinic in the past. During this modified think aloud protocol, analysts interrupted participants and asked questions. One of the benefits of utilizing this type of modified think aloud protocol, as compared to the traditional think aloud protocol (a traditional semi-structured focus group, or traditional interviews with a list of predefined questions (Cooke, 1994 )is that the participants can mentally simulate what the protocol is like for cases beyond the simulated case.
The Drexel University IRB approved this work. The interviews were video and audio recorded Four data collection sessions occurred in a simulated wound clinic room. Each session lasted approximately 90 minutes. Four researchers facilitated the sessions. One analyst facilitated the session and asked prepared questions. One operated the video recorder. Two took notes. All asked follow up questions.

Participants completed a consent form and a demographics questionnaire. For each think aloud protocol, one participant would act as the researcher and another as the simulated patient. When two participants came to the session, first one would serve as the research assistant and the other one as the simulated patient. Then they would switch roles. When only one research assistant came to the session, one of the four analysts served as the simulated patient.
At the start of each think aloud protocol, one analyst informed the participant researcher what type of wound the simulated patient had. During the session, each participant researcher used the medical device and the associated supplies to simulate the clinical protocol. However the device was not turned on. Also the treatment period was shortened to a few seconds. During the protocol, analysts asked questions related to these topics:
• Device being securely positioned
• Environment such as lighting and space to work
• Materials used
• Variations based on wound characteristics
• Variation based on patient positioning
The analysts also prompted the participant researchers to think about any issues not already addressed.
The analysts used thematic analysis (Miles & Huherman, 1994) to analyze the data. Themes and subthemes included:
• System: Context, device design, education, environment or workspace, patient factors, protocol, protocol duration, safety, treatment decision, wound factors
• Object: device components, attachment\positioning components, maintenance\cleaning components, furniture
• Consequence: bleeding, caregiver, device handling (robustness), hygiene, patient comfort, experience, secure placement, supplies, safety, treatment performance
These results have been submitted to the device design team for use in future versions of the device.

References
AIAA. (2018). Guide to the Preparation of Operational Concept Documents (ANSI/AIAA G- 043B-2018).
Cooke, N. J. (1994). Varieties of knowledge elicitation techniques. International Journal of Human-Computer Studies, 41 (6), 801–849.
IEEE. (2018). Systems and software engineering - Life cycle processes - Requirements engineering (ISO/IEC/IEEE 29148.
Lewis, C., & Rieman, J. (1993). Task-Centered User Interface Design: A Practical Intro- duction (Tech. Rep.). (http://hcibib.org/tcuid/tcuid.pdf)
Miles, M. B., & Huherman, A. M. (1994). Qualitative Data Analysis, Second Edition. Sage
Publications.