medical device testing
Developing IFU's and user testing guides to ensure homogeneity in future device testing and seamless integration of the device into an existing clinical procedure
client
role
tools
methods
NeedleCalm - an Australian medical device startup
Clinical User Experience Researcher
Video recording, Illustrator, Google Docs
Contextual inquiry, user testing, lo-fi sketches, mocks ups of printed material
summary & problem
NeedleCalm is a new medical device that was in the process of gaining TGA approval. Instructions for use (IFU) needed to be developed prior to further large volume testing and were to be included in the product information brochure within the final device packaging.
The company needed to streamline its testing methods in order to conduct large scale testing of the device.
My role was to develop a moderation guide for repeat testing and to test and hone the IFU to ensure the process of using the device was smooth and seamless for all medical professionals incorporating the device in regular intravenous catheter insertion (IVC) procedures irrespective of facility protocol.
I collaborated with the company's founder and CEO to develop testing moderation guides, test the device and develop IFU mockups for handoff to the remote graphic designer.
preparation
The content for the v1 IFU in its v1 had been developed with some preliminary illustrations by the company graphic designer. I familiarised myself with this documentation as well as with the medical device in order to best design a moderation guide.
contextual inquiry
My background in nursing means I am native to IVC insertion policies and procedures. However, we needed to better understand the specifics of how the device would best slot into the process. There were issues to take into consideration with regards to the sterile field, the length of the procedure, the unpacking of the individual device, amongst other things. Therefore, I conducted a contextual inquiry of the IVC insertion process in order to analyse the procedure with the NeedleCalm team and better understand knot out these nuances.
developing a testing moderation guide
I developed a moderation guide for user testing in order to maintain consistent testing environments. This moderation guide was created and honed with the view of NeedleCalm also being able to utilise it in future large volume testing.
user testing - phase 1
I ran a user test with one participant who is a registered nurse and regularly completes IVC insertion as part of her daily tasks in order to gage whether the IFU alone would enable her to incorporate the device into the procedure without assistance and as intended, whether the illustrations in the IFU were helpful, and whether using the device added a significant amount of time to the procedure. The idea was to run the procedure from start to finish with multiple participants. However, after running one user test it became apparent that the entire IFU needed to be reworked to continue testing.
data extraction and analysis - phase 1
I revisited user testing phase 1 recordings and notes in order to understand the changes that needed to be made to both to the IFU and the user testing moderation guide. Phase 1 informed the decision to better illustrate potential injection sites, to create 3 steps instead of 6 that gave concise instructions, and to allow participants time to familiarise themselves with the device and its packaging before approaching the patient and commencing the procedure.
instructions for use v2
I modified the IFU and created new paper sketches to reflect the data collected in user testing phase 1 in order to implement what we had learned and move on to user testing phase 2.
user testing - phase 2
I ran further tests of the procedure with two homogenous participants (as per phase 1) in order to gain further insight into any modifications that needed to be made to the IFU and/or moderation guide. As with phase 1, video and audio of user tests was recorded.
data extraction and analysis - phase 2
I reviewed and analysed user testing phase 2 recordings and notes in order to understand the changes that needed to be made to the IFU to bring us closer to a finished set of instructions. Phase 2 testing data indicated that diagrams were needed to enhance the written instructions in illustrating the parts of device and in its positioning during the procedure.
instructions for use v3
I created new diagrams taking into account phase 2 testing data and incorporated these into a revised IFU using Sketch in order to incorporate participant insights into the IFU v3.
logo redesign
As a result of user testing, the decision was made to task graphic the designer with redesigning the NeedleCalm logo. Although the initial logo was representative of the device, testing participants found that it might mislead users as to what the device was for, with some clinicians thinking the device was actually a dressing.
user testing - phase 3
I tested v3 with two homogeneous participants in order to iterate changes and understand if anything else needed to be added or modified before sending the final version off to the graphic designer. Phase 3 demonstrated that the IFU was clear and allowed for a smooth incorporation of the medical device in the IVC insertion procedure.
design handoff
I created a handoff specs sheet of the v3 IFU in order for the remote graphic designer to create digital versions of all pen and paper diagrams and incorporate them into the product brochure along with the IFU.
to sum it up
I learned about the process of creating instructions for use for medical devices where it is paramount to create a seamless experience. Procedures tend to be time sensitive and the health of patients is at stake.
During the testing process, I was surprised to find that even known medical language can be interpreted in a variety of ways by different clinicians. I found that it was best to use simple language in every case, even if the device is designed for clinician use.
One of the challenges I encountered at the start of this project was that there was not a general understanding of the importance of recreating a testing environment that was as close as possible to a real life scenario. However, after Phase 1 testing and with the changes made to v2, everyone was quickly onboard. Another major challenge was finding participants as they needed to be busy shift-working clinicians that regularly inserted IVC’s as part of their work day, to be willing to attend testing and to sign NDA’s.
While working with a medical device was an interesting experience, I especially enjoyed watching how with each new phase the process became more and more seamless until no new iterations were needed.
other work
increasing conversion rates
