Presentation
Tracking the User Experience throughout the Design Cycle – A Retrospective View
DescriptionBackground:
In medical devices, safety and effectiveness is the main focus of the developer for good reason. It is crucial that devices are able to provide consistent patient outcomes that will not harm the users or their patients. However, with the need to control for hazardous scenarios comes the risk of overdesigning and creating a device sacrifices aspects of the user experience. For example, it could mean additional steps that a user needs to complete a task, adding complexity and opportunities for new use errors to occur. While complexity and the unknown of a new product may be mitigated by training, education is often not the best solution. There are some metrics that we can track throughout the product life cycle that will help gauge the user experience to ensure the device is not only safe and effective, but provides an experience that users will want to use and dare say, enjoy.
Suggested Methodology:
1. Determine key user needs – what does the device needs to do for the surgeon to be able to complete the procedure?
2. Determine measurement that can track the user need
a. Use Errors
i. How often are they occurring?
ii. How many close calls are occurring?
iii. What difficulty does the user perceive this work around to be?
iv. How many errors are occurring for a given task?
b. Task Length
i. How long does the task take?
ii. How many steps does the users need to take?
c. Simplicity
i. How repetitive is the task?
ii. What depth of training or educational materials does the user expect?
3. Get preliminary baseline of user experience with predicate or competitor device
4. Track measurements throughout iterative studies
a. Simulated Use Studies
b. Virtual Studies
c. Surveys
5. Towards the end of design phase summarize findings to date to show state of design
a. Which tasks are users struggling most to adopt?
b. Which aspects of the design require a large number of design controls?
c. What level of training is required for a user to understand the design’s function?
6. Repeat until Production Design is finalized
Example: Setting up Surgical Stapler
Initial Design
Average Time to Complete Task (minutes) 8
Total Number of Possible Use Errors 44
Occurrence of Use Errors 17
Training Required during Validation Testing Quick Start guide and In-service
Current Design
Average Time to Complete Task (minutes) 1
Total Number of Possible Use Errors 31
Occurrence of Use Errors 2
Training Required during Validation Testing Brief Introduction
Using the measurements outlined in the suggested methodology a redesign shows that users were able to complete set up faster with less use error and confusion while requiring less training which creates a better user experience. This redesign was started late in the product life cycle which as a result extended the project timeline. Therefore, it is crucial to start tracking and testing these measurements as early as possible, before finalizing major aspects of the design to avoid impacts to a project timeline.
In medical devices, safety and effectiveness is the main focus of the developer for good reason. It is crucial that devices are able to provide consistent patient outcomes that will not harm the users or their patients. However, with the need to control for hazardous scenarios comes the risk of overdesigning and creating a device sacrifices aspects of the user experience. For example, it could mean additional steps that a user needs to complete a task, adding complexity and opportunities for new use errors to occur. While complexity and the unknown of a new product may be mitigated by training, education is often not the best solution. There are some metrics that we can track throughout the product life cycle that will help gauge the user experience to ensure the device is not only safe and effective, but provides an experience that users will want to use and dare say, enjoy.
Suggested Methodology:
1. Determine key user needs – what does the device needs to do for the surgeon to be able to complete the procedure?
2. Determine measurement that can track the user need
a. Use Errors
i. How often are they occurring?
ii. How many close calls are occurring?
iii. What difficulty does the user perceive this work around to be?
iv. How many errors are occurring for a given task?
b. Task Length
i. How long does the task take?
ii. How many steps does the users need to take?
c. Simplicity
i. How repetitive is the task?
ii. What depth of training or educational materials does the user expect?
3. Get preliminary baseline of user experience with predicate or competitor device
4. Track measurements throughout iterative studies
a. Simulated Use Studies
b. Virtual Studies
c. Surveys
5. Towards the end of design phase summarize findings to date to show state of design
a. Which tasks are users struggling most to adopt?
b. Which aspects of the design require a large number of design controls?
c. What level of training is required for a user to understand the design’s function?
6. Repeat until Production Design is finalized
Example: Setting up Surgical Stapler
Initial Design
Average Time to Complete Task (minutes) 8
Total Number of Possible Use Errors 44
Occurrence of Use Errors 17
Training Required during Validation Testing Quick Start guide and In-service
Current Design
Average Time to Complete Task (minutes) 1
Total Number of Possible Use Errors 31
Occurrence of Use Errors 2
Training Required during Validation Testing Brief Introduction
Using the measurements outlined in the suggested methodology a redesign shows that users were able to complete set up faster with less use error and confusion while requiring less training which creates a better user experience. This redesign was started late in the product life cycle which as a result extended the project timeline. Therefore, it is crucial to start tracking and testing these measurements as early as possible, before finalizing major aspects of the design to avoid impacts to a project timeline.
Event Type
Oral Presentations
TimeTuesday, March 268:30am - 8:52am CDT
LocationSalon A-4
Simulation and Education