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“Let’s make our app a medical device”

Usability testing strategy2023–2024

CardiaApp

Context

Cardia is a wearable ECG app. This project evaluated it through user testing, design strategy and validation planning for regulatory review.

Problem

New features turned Cardia into a regulated medical device. Before submission, we had to find the usability issues that could lead to harm.

The Goal

Validate the app’s core usability. The FDA requires usability testing, so every finding had to support a concrete design decision.

My Role

I led the project end to end: analysis and strategy, prototyping, test documentation, the usability studies and the final report.

01 / Overview

Let’s get to know the app

The app overview

I started by exploring Cardia, a wearable ECG app designed to help people better understand and manage their heart health. The app allows users to record their heart rate and rhythm, making it easier to track their readings and share insights with their clinicians. My goal was to understand the product, its users, and the challenges they face before diving into the UX design process.

Cardia app overview

02 / Planning

... and establish the process

The study followed eight steps, from regulatory review to an implementation-ready design. Open the timeline for the official version, then hover over a step for the real story.

03 / Feature assessment

Heuristic analysis

We audited the existing Cardia experience and assessed its most critical user journeys. By reviewing earlier research and mapping how people used the app, we found where it could be simpler without losing its core value.

Feature assessment map

04 / Scenarios selection

Selected screens and test scenarios

Because the final screens are confidential, I created low-fidelity concepts to illustrate the app’s key flows in this case study. The study covered ten tasks (A.4.1–A.4.10), grouped below into seven scenarios that follow ECG discovery, interpretation, history and sharing across the Cardia app. Each scenario lists its task numbers and mean difficulty rating (1 = very easy, 5 = very difficult), together with the screens people used to complete it.

  • A.4.1
    A.4.3

    Take your first ECG reading

    First use · difficulty 1.8 / 1.5

    With the app set up and the strap on your wrist, locate the ECG feature and complete your first reading.

    1. 1Home · ECG entry point
      Screen 1: Home, ECG entry point
    2. 2Intro · What is an ECG
      Screen 2: Intro, What is an ECG
    3. 3Intro · How it works
      Screen 3: Intro, How it works
    4. 4Intro · Why it matters
      Screen 4: Intro, Why it matters
    5. 5Intro · Understanding results
      Screen 5: Intro, Understanding results
    6. 6Intro · Good to know
      Screen 6: Intro, Good to know
    7. 7Eligibility check
      Screen 7: Eligibility check
    8. 8Prep · Position the band
      Screen 8: Prep, Position the band
    9. 9Prep · Choose wrist
      Screen 9: Prep, Choose wrist
    10. 10Reading · Touch the sensor
      Screen 10: Reading, Touch the sensor
    11. 11Reading · In progress
      Screen 11: Reading, In progress
    12. 12Symptoms · Add context
      Screen 12: Symptoms, Add context
    13. 13Result · Sinus rhythm
      Screen 13: Result, Sinus rhythm
  • A.4.2
    A.4.4

    Interpret the results

    Comprehension · difficulty 1.3

    Review the result of your first ECG reading and explain what the information on screen means.

    1. 1
      Screen 1 of task 2
  • A.4.5

    Email an ECG report

    Sharing · difficulty 1.3

    Find your ECG report and send it to your cardiologist by email.

    1. 1
      Screen 1 of task 3
    2. 2
      Screen 2 of task 3
  • A.4.6

    Share an AFib result from the heart data hub

    Health section · difficulty 3.1

    From the heart data hub, find an atrial fibrillation (AFib) result and share the record with your cardiologist.

    1. 1
      Screen 1 of task 4
    2. 2
      Screen 2 of task 4
    3. 3
      Screen 3 of task 4
    4. 4
      Screen 4 of task 4
    5. 5
      Screen 5 of task 4
    6. 6
      Screen 6 of task 4
  • A.4.7
    A.4.8

    Locate events in ECG history

    Two subtasks · difficulty 2.6 / 1.8

    Use the ECG history to find the information requested during a call with your doctor: the date of the last AFib episode and the count of high/low heart rate results.

    • AFind the date of your latest atrial fibrillation episode.
      1. 1
        Screen 1 of task 5
      2. 2
        Screen 2 of task 5
      3. 3
        Screen 3 of task 5
    • BFind low and high heart-rate events, plus the total number of ECG readings.
      1. 1
        Screen 1 of task 6
      2. 2
        Screen 2 of task 6
      3. 3
        Screen 3 of task 6
      4. 4
        Screen 4 of task 6
      5. 5
        Screen 5 of task 6
  • A.4.9

    Repeat an ECG reading

    Repeat use · difficulty 1.4

    As a returning user, start and complete another ECG reading from the app.

    1. 1
      Screen 1 of task 7
    2. 2
      Screen 2 of task 7
    3. 3
      Screen 3 of task 7
    4. 4
      Screen 4 of task 7
    5. 5
      Screen 5 of task 7
    6. 6
      Screen 6 of task 7
    7. 7
      Screen 7 of task 7
    8. 8
      Screen 8 of task 7
    9. 9
      Screen 9 of task 7
  • A.4.10

    Review an AFib reading

    AFib result · difficulty 1.3

    Review a reading marked as atrial fibrillation (AFib) and explain how you understand the result and its supporting information.

    1. 1
      Screen 1 of task 8
    2. 2
      Screen 2 of task 8

05 / Study design

Methodology and testing sessions

21

Participants

10

Tasks

3

User groups

5

Days of sessions

1–5

Difficulty scale

Simulated-use testing

Moderated, simulated-use sessions with a prototype band and app. Participants completed 10 tasks, rated each on a 1–5 difficulty scale and thought aloud while the moderator observed use errors.

User groups

Diagnosed with AFib: 7 people
Adults 22–64: 8 people
Adults 65+: 6 people

Location

Dry run: 5 people (online)
Formative testing: In person (USA)

Study goals

Identify the strengths of the interface, find use errors that could lead to harm, and learn where people expect to find their ECG data.

06 / Study results

Study results

A simulated-use study of the ECG feature and wearable sensor, tracing how people find, interpret, repeat and share readings.

Study boards

Difficulty rate

A.4.6Share an AFib reading from the heart data hub
3.1
A.4.7Find the date of the last AFib episode
2.6
A.4.8Count high/low heart rate results
1.8
A.4.1Instructions: record an ECG
1.8
A.4.3Take the first ECG reading
1.5
A.4.9Repeat the ECG reading
1.4
A.4.2Instructions: interpret results
1.3
A.4.4Describe the results
1.3
A.4.5Send the report
1.3
A.4.10Review an AFib result
1.3
≥ 2.5 hard1.5–2.4 some friction< 1.5 easy

3.1The hardest tasks were all about finding stored ECG data, not about the ECG itself. Recording and reading a single result felt easy (1.3–1.5); getting back to stored readings did not (up to 3.1).

Users rated each task on a 5-point scale, where 1 indicated “very easy” and 5 indicated “very difficult.” The figure above summarizes the results.

Main findings

Finding 01High priority

People couldn’t find their stored ECG readings

They didn’t connect the health metrics hub or the coaching tab with their ECG history, and found it by guessing.

A.4.6 · A.4.7 · A.4.8

Finding 02High priority

Counts and categories didn’t read as tappable data

Counts were too small to read, the latest reading wasn’t recognised, and AFib looked like every other result.

A.4.6 · A.4.8

Finding 03High priority

The chart dominated, but the words did the explaining

Most participants couldn’t interpret the waveform, yet it filled a third of the screen. They relied on the text.

A.4.4 · A.4.5 · A.4.10

Finding 04Medium priority

Small text and repeated steps slowed people down

Some participants needed glasses to read the instructions, and regular users repeated the same steps before every reading.

A.4.3 · A.4.9

Finding 05Medium priority

People wanted control and proof when sharing

Participants expected a confirmation that the report was sent and a history of past reports. The instructions had too much text and jargon.

A.4.1 · A.4.2 · A.4.5

“I like that you get results right away and can share them with medical providers.” — Participant voice

Keep:instant results, easy PDF sharing and a helpful “try again” after an interrupted reading were praised across all groups.

07 / Results

Recommendations

Each pattern in the evidence became a specific change to information architecture, labels or flow, shown here as low-fidelity concepts.

01

Give ECG a stable home

Risk: People didn’t connect the health metrics hub or the coaching tab with their ECG history.

Recommendation: Add a dedicated, always-visible entry point to ECG data, and make tiles and rows look tappable.

02

Lead with meaning, then detail

Risk: The waveform took most of the screen but explained nothing, and AFib looked like any other result.

Recommendation: Lead with a text-first, colour-coded result (highlighting AFib and abnormal BPM) and a compact, scrollable waveform.

03

Make sharing explicit and accountable

Risk: “Export to PDF” wasn’t understood as a way to share, and people wanted proof of what was sent.

Recommendation: Rename it “Share PDF with my doctor” and add a share sheet with clear content options. Sent-reports history is next.

04

Support both confidence and speed

Risk: Regular users had to click through the same instructions before every reading.

Recommendation: Offer skippable instructions for returning users, plus larger type and higher contrast for all age groups.

Full usability report

The complete formative study report, from study design and task ratings to findings, participant quotes and the status of every recommendation. Swipe or use the arrows to browse all 11 slides.

  1. Report title: ECG feature for a wrist wearable, 21 participants, 10 tasks, 3 user groups, 5 days of sessions
  2. About the study: goals, method and participants
  3. Task difficulty ratings: finding stored ECG data was the hardest part
  4. Summary: four problems to fix, one thing to keep
  5. Finding 01, findability: people couldn’t find their stored ECG readings
  6. Finding 02, results list: counts and categories didn’t read as tappable data
  7. Finding 03, result details: the chart dominated, but the words did the explaining
  8. Finding 04, reading flow: small text and repeated steps slowed people down
  9. Finding 05, sharing and instructions: people wanted control and proof when sharing
  10. What participants said: what worked and what didn’t
  11. Recommendations and status: what the redesign already solves, and what’s next

1 / 11

08 / Retrospective

What I Learned

Strong recommendations backed by solid evidence are not enough on their own: the harder part is convincing the client to adopt them. We delivered a comprehensive report with detailed visualisations and a 1:1 presentation. Some recommendations were implemented, others were not.

The project ended when the client’s organisation restructured. Even so, the evidence-led approach changed how the team talked about design priorities.

02 / Next steps

Design Process

Well, that’s the official version. If you hover over the step, you’ll see the true story.

  1. 01

    Regulatory Review

    Guidance & classification

    Hundreds pages of guidance...

  2. 02

    Feature Assessment

    Assessment of usage

    But what features matters in this context?

  3. 03

    Risk Identification

    Hazards & mitigation

    What does a hazard actually mean?

  4. 04

    Testing Strategy

    Planning

    Deciding what to test is half the study.

  5. 05

    Prototype Creation

    Functional build

    Although it was outside our scope, we went the extra mile and created it anyway.

  6. 06

    User Validation

    Study execution

    So many questions...

  7. 07

    Recommended Fixes

    Findings & next steps

    "...but we don't want to change our app"

  8. 08

    Formative Evaluation Report

    Our recommendations.

    And very long presentation.