Case Study: Creating a Task Analysis for an Auto Injector.

In this post, I want to illustrate the practical application of Task Analysis in drug delivery devices, focusing on an Auto Injector, commonly used for self-administration of medications. This example will demonstrate how breaking down the injection process into detailed subtasks and examining user perception, cognition, and actions at each stage, can illuminate usability challenges and drive targeted design enhancements. To understand the basics on how to create a task analysis, you can check our initial post about best practices in tasks analysis.

Case Study: Auto Injector Task Analysis

Consider an Auto Injector, the most commonly used auto injectors are the so-called 2-step auto injectors (which interestingly need way more than two steps to be properly operated). The Task Analysis for this device can be seen in the table below. It methodically deconstructs the injection process, by examining each subtask and gaining insights into how users perceive instructions, understand the device’s mechanism, and physically interact with the device. This meticulous examination helps identify potential usability issues, which is fundamental for developing solutions that improve the user experience and safety. In addition, the task analysis is the pre-work needed to create a thorough use related risk analysis or URRA, which is the document you will finally use to demonstrate that all the potential risks have been mitigated and the device is safe and effective to be used by the intended users.

Tasks	Subtasks	User group	Use Environment	Perception	Cognition	Action	Potential Use Errors
Dispense	Receive and store product	Pharmacist	Pharmacy	The user must see the recommended storage condition information in the secondary package	The user must understand the recommended storage conditions in the secondary package	The user must store the product according to the recommended instructions	The user stores the product incorrectly
Dispense	Dispense product	Pharmacist	Pharmacy	The user must see the secondary package among comparators	The user must recognize the secondary package	The user must dispense the treatment	The user dispense the wrong treatment
Storage	Store the product	Patient Lay Caregiver	Home	The user must see the recommended storage condition information in the secondary package or in the labeling	The user must understand the recommended storage conditions in the secondary package or in the labeling	The user must store the product according to the recommended instructions	The user stores the product incorrectly
Preparation	Retrieve the product from storage	Patient Lay Caregiver	Home	The user must see the secondary package or device among comparators	The user must recognize the secondary package or device labeling	The user must take the treatment from storage	The user takes the wrong treatment from storage
Preparation	Open secondary package	Patient Lay Caregiver	Home	The user must see the access point of the secondary package	The user must understand how to open the secondary package	The user must open the secondary package as intended	The user has problems opening the secondary package
Preparation	Remove the product from the secondary package	Patient Lay Caregiver	Home	The user must see the device and the finger space in the secondary package	The user must recognize the finger space as a feature to help during retrieval	The user must take the device from the secondary package	The user experiences difficulty removing the product from its packaging or damages the product while unpacking
Preparation	Gather the caring supplies	Patient Lay Caregiver	Home	The user must see the information disclosing the recommended caring supplies	The user must understand what supplies are needed to take a safe injection	The user must take the recommended supplies	The user does not gather the recommended supplies
Preparation	Check the expiration date	Patient Lay Caregiver	Home	The user must see the expiration date in the labelling or secondary package	The user must understand the expiration date	The user must proceed with the treatment if it is within expiry date	The user uses an expired product
Preparation	Check the product for damage	Patient Lay Caregiver	Home	The user must see the information with the requirement for inspection	The user must understand the information provided and what is considered a damage	The user must proceed with the treatment if the device is safe of damages	The user uses a damaged device
Preparation	Check the quality of the medication	Patient Lay Caregiver	Home	The user must see the information with the requirement for inspection	The user must understand the information provided and what is considered a safe medication	The user must proceed with the treatment if the medication is not degraded	The user injects a degraded medication
Preparation	Wash hands	Patient Lay Caregiver	Home	The user must see the information recommending washing hands before the injection	The user must understand the information and why it is recommended	The user must properly wash and dry hands before the injection	The user does not wash and dry hands as recommended
Preparation	Choose injection site	Patient Lay Caregiver	Home	The user must see the information with the recommended injection locations	The user must understand what are the recommended injection sites	The user must inject in the recommended injection locations	The user chooses a wrong or compromised injection site or uses the same injection site as for the previous injection
Preparation	Clean injection site	Patient Lay Caregiver	Home	The user must see the information recommending cleaning the injection site	The user must understand the recommended cleaning process	The user must clean the injection site as recommended	The user does not clean properly the injection site
Administration	Uncap the device	Patient Lay Caregiver	Home	The user must see the cap of the device	The user must understand the cap must be removed prior to the injection	The user must remove the cap before the injection	The user does not remove the cap and proceed with the injection. The user removes the cap let the device sit uncapped for a long period of time
Administration	Activate the device delivery	Patient Lay Caregiver	Home	The user must see the injection end of the device	The user must understand that the injection is performed by pushing the injection end against the injection site	The user must activate the device against the injection site	The user cannot activate the device or presses the injection end assuming it is an activation button
Administration	Deliver the full treatment	Patient Lay Caregiver	Home	The user must see the medication window	The user must understand that the treatment is fully delivered once the medication window is fully covered	The user waits until the full treatment is delivered to retrieve the device from injection site	The user retrieves the device while the treatment is still being delivered
Administration	Care for the injection site	Patient Lay Caregiver	Home	The user must see the information detailing the recommended injection site care steps	The user must understand the recommended care steps	The user must take care of the injection site as recommended	The user does not clean or clean with non-sterile supplies the injection site
Dispose	Dispose the cap	Patient Lay Caregiver	Home	The user must see the information explaining how to dispose the cap	The user must understand that the cap should be disposed without recapping the device	The user must dispose the cap as recommended	The user recaps the device before disposing it
Dispose	Dispose the device	Patient Lay Caregiver	Home	The user must see the information explaining how to dispose the device	The user must understand that the device should be disposed in the appropriate sharps disposal container	The user must dispose the device as recommended	The user disposes the product in a normal bin

Tailoring Task Analysis to Diverse Medical Devices

It's important to clarify that while our Auto Injector case study offers a glimpse into the Task Analysis process, this approach must be customized for each intended user and use environment. Every human factors program comes with its unique set of requirements, influenced by its specific user population and the context in which it’s used. Designers and human factors specialists are tasked with adapting their analyses to these unique conditions. This tailored approach ensures a thorough consideration of user safety and compliance with regulatory guidelines.

In the development of drug delivery devices, Task Analysis is more than a design tool; it's a pathway to ensuring user safety and adhering to stringent regulatory standards. By meticulously analyzing tasks and user interactions, designers and engineers can create devices that not only meet medical needs but also enhance the overall user experience in terms of safety, efficacy, and usability.