Due to the pandemic and also as part of cost saving measures for our nonprofit, I implemented novel remote methods in human factors. This enabled the project to continue at a time when many other medical device companies had paused their efforts.
Tidepool had never done human factors before, so I was also responsible for training moderators and leading planning and coordination for the studies.

The validation study configuration setup on Tidepool’s end (left) and the participant’s end (right). Dual camera view from the iPhone front-facing camera and video conferencing web camera, as well as tap interaction recording, allowed for realistic and detailed study conduct.
DESIGN ITERATION
After each round of usability testing, I analyzed task performance and prioritized features that needed further iterations. Design jam sessions were held to brainstorm mitigations, after which I worked with design to refine and development to implement. Some UX changes that led significant usability improvements touched features including:
- Pre-Meal and Workout glucose target Presets
- Temporary status banners
- Therapy settings safety mechanism

Pre-Meal Preset Before (Left), Pre-Meal Preset After (Right)
Upon completion of the validation study, I authored the validation study report containing the data analysis results submitted to FDA and assisted with the human factors engineering/usability engineering (HFE/UE) report. Participants who interacted with the product, were overwhelmingly positive, and had some of this to say about Tidepool Loop:
“Tis the magic device”
“Revolutionary”
“Peace of mind”
“It’s come so far. I used to have to pee in a bowl and dip a stick in it.”
Central to Tidepool Loop is the concept of interoperability, in which patients can mix and match between devices (insulin pumps and continuous glucose monitors) with Loop serving as the controller, thus freeing up patient choice.
With that in mind, I worked with a team of two product designers and two iOS developers to implement the product strategy for our device integrations (due to partner considerations, I’m unable to show any assets). I managed the sprint process and facilitated discussions with key stakeholders based on requirements from Tidepool’s device partners and feedback from usability testing.

Graphics courtesy of Tidepool Marketing
New user facing elements and flows introduced by our device partners with each integration created new scenarios involving critical tasks. I had to develop a strategy for continuous validation of UI enhancements and new features in Tidepool Loop moving forward post-510k submission to the FDA, in line with our commitment to interoperability.

INDUSTRY FRAMEWORK
I facilitated several workshops with industry partners on the developed framework for decentralized, remote human factors research. This work has been presented via poster at the ATTD 2021 conference and published in the Journal of Diabetes Technology & Therapeutics.

Parallel workstreams and different testing configurations led to progressively higher fidelity evaluations in the run up to the validation study.