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Beyond User Centered Design: Enabling Users to Have a Voice in New Product Development
DescriptionBackground and aim:
Medical Device users, particularly healthcare professionals (HCPs) and most patients, are not trained in design and/or product development. For them to participate meaningfully in design activities, the use of tools which enable clear communication regarding design processes and outputs must be used.
The end goal of this research was to design a user interface and workflow for a novel endotracheal tube (ETT) sensor technology that clearly and intuitively displays data to be perceived and used by a range of clinical users. To accomplish this, a multi-phased, co-design approach was developed to optimize user engagement with the design process. This presentation discusses the approach,
- Identifying how to best communicate with users regarding clinical information requirements and their visualization
- Designing appropriate tools to support non-designers to participate in medical device co-design activities
- Reflecting on enablers and barriers to clinical participation in design processes

Approach:
To ensure that co-design is successful in producing effective and safe medical devices, we need to ‘make it easy for non-designers to design’. This research study, therefore, took a two-phased approach, using two tools, to capture the use and information requirements for the innovative ETT. The study was undertaken in the UK, recruiting participants from multiple NHS trusts. Participants were practicing anesthetists, Operating Department Practitioners (ODPs) or respiratory therapists. The first tool was developed and implemented to understand the context of device use, serving as a proxy for other human factors such as hierarchical task analysis and contextual inquiry. The second tool was used by participants to identify design features and functions for the digital user interface of the device. This identified the way information should be displayed and the hierarchy of information. The development of each tool was undertaken in a contextually sensitive manner, underpinned by user-centered design principles to produce participant engagement experiences that were accessible and inclusive. This was important due to the nature of work of the target users. Notably, it was necessary to consider the possibility of plans changing due to clinical commitments and enabling these tools to be used in different formats or venues based on the availability of users and limitations associated with NHS IT systems. Each tool is described below:

Tool 1 was a digital care sorting tool; created in Miro, with the goal of delivering a participant activity in Phase 1 capable of capturing contextual information such as;
1. When different users interact with the device
2. Where the device would be used at different times
3. When they might connect the device/ disconnect from the device
4. What information was important at specific points during the procedure
5. Any features they would expect to have (history, alerts, etc)
This digital card sorting tool was developed to allow participants to produce and move around the order of events, add in or remove tasks, add different users associated with the task or subtasks, and identify and attribute information that would be needed for clinical decision making at each stage. Then, participants used the information cards they made to design an interface layout.
This tool delivered successful user engagement with the design process and captured useful insights for the ETT design process. However, a limitation was that it did not support HCPs (non-designers) in their communication of needs and preferences in how clinical information could be displayed and how the features/ alerts could be designed.

Using the knowledge of the information requirements elicited from the previous study, Tool 2 was created to produce a user activity that would:
1. Enable users to consider and select how they would want information displayed (style and color)
2. Support them in designing a mock-up interface layout, inclusive of where they would expect information to be displayed on the interface
3. Empower users to decide how alarm thresholds and alarm states are shown
4. Give users freedom to consider and design how they might access other features, such as how to access history, adjust alarm thresholds, and mark events.

The ‘build your own interface’ tool was created in Figma as sessions with users were anticipated to be remote. This gave them options for how the information was to be displayed, how alerts were to be shown, how other features looked, and where on the interface they would expect the information to be displayed. This evidenced how users wanted their information needs to be displayed and where on the interface, resulting in an interface design with a known hierarchy of information. Due to recruitment challenges, this tool was replicated and redeveloped into a physical interface tool to enable iterative design during in-person participant sessions.

Discussion and Take Away Points:
As a result of using the 3 tools participants were able to meaningfully contribute to a two-phased design process for a novel ETT technology.
Phase 1 saw the use of Miro elicit a better understanding of the overall user journey and design requirements (for the design of both physical and digital components of the medical device). Then, in Phase 2, using Figma and a physical interface tool, the study captured understanding about user information needs, with the communication of this also being translated into how information should be displayed in the future interface for the ETT device. The triangulation of all three design data sets together resulted in a series of user-made interface designs that helped create the final digital design of the device without having to make assumptions on how the users would use the device or how and where they would expect new information to be shown.

Key takeaways from this study:
- Tools that aim to involve HCPs in co-designing medical products need to be developed to ‘make it easy for non-designers to design’
- The tools used need to be flexible, accessible, and inclusive of the working conditions and workload of HCPs to enable meaningful participation
- With design tools that accommodate the needs of participants and partnership with HF/HCI practitioners, design processes can elicit essential and purposeful data which can go beyond current practice to inform better decisions in the design of physical, interaction, and information specifications for medical devices and systems.

Acknowledgments:
The authors would like to thank Professor Steve Morgan and Medical Photonics team for enabling this project in conjunction with their research. Thanks go to Professor MaryBeth Privitera for her professional insight and support throughout the research. We would also like to acknowledge the time and commitment from the participants of this study and the guidance from Micheal Tan and Carlos Peralta.