Human Factors Study

21 March 2022

Problem

A pen injection manufacturer was developing a new injector platform which allows the user to choose between fixed dose volumes. Unlike competitors, the injector does not allow the user to choose a dose between the allowed volumes.  The manufacturer approached Springboard to help them engage end users of their product to better understand the usability of the device and receive impartial customer reviews.

They wanted the assurance that their device was doing its job for the end user in the best way possible and to answer the question: ‘Have we developed a device that patients would be able to use safety, and prefer over competitor devices?’ This in turn would assist them with optimising the device design and preparing submissions to regulatory authorities.

 

Solution

Springboard worked alongside a healthcare research company to recruit applicable candidates for this study. The pen injector was being used to administer drugs to people with diabetes or people undergoing fertility treatments, and therefore needed a specific user group. The group contained novel users as well as users with a lot of experience in administering injections at home.

With 360-degree user interaction and analysis in mind, the study also involved nurses as they would be another user group when training patients on how to use the device.

The study was filmed so that we could ascertain how the patients were using the devices and any nuances that may occur that would not necessarily be apparent in the written report alone.

We asked the patients a variety of questions including what they thought the pros and cons of using a pen injector for this medication, could they read the instructions well and did they have enough dexterity in their hands to use the device easily, because diabetes can impair the sensation in fingers1. We also needed understand how the patients felt about the injector that was pre-loaded with fixed doses (at manufacture stage) and how they would use the pen accordingly.

The interviews allowed us to gather:

Qualitative data

  • One-to-one patient feedback
  • Feedback from novice users
  • Feedback from experienced nurses who observed all patients

Quantitative data

  • Number of use errors
  • Duration of user steps

User error indication and interview setup

Conclusion

Springboard were the natural fit to conduct the human factor study because we had already worked on the design of the injector and therefore had in-depth knowledge that we could build on, such as the intended use and potential risks.

We were able to report back to our clients on how the users were successful in using the device, how they felt about the device, and identified some unexpected outcomes of the study. For example, the novel users followed the instructions closely and used the device as intended whereas the experienced users tended to assume that they knew how to use the device paid little attention to instructions.

Our research gave our clients the confidence that they had produced a pen injector that patients could use safely, was user friendly, and that nurses could recommend and train patients on.

Expertise that Springboard offered:

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1: Peripheral neuropathy (nerve damage) | Diabetes UK