Healios Technologies · Game-Based Digital Biomarkers

Overview

Healios builds a medical device app for people with multiple sclerosis. Patients play short games and challenges on their own phone. The phone sensors record how they move, balance, see and think, and the app turns that into clinical data their neurologist can use between visits.

I joined as Product Designer. I designed the games and the interface, built the design system, and ran the usability evidence that went into the product’s EU MDR submission.

The challenge

The data has to be clinically meaningful, so every game has a job to do. At the same time, the people playing are patients, often tired or with limited movement, and they use the app alone at home for weeks.

Three things had to work together:

• Reliable data. A game is only useful if it measures what it claims to measure.
• Patients who keep playing. Unclear instructions or a confusing game quickly lead to wrong results or dropped sessions.
• Regulatory proof. As a medical device, the interface had to be shown to be safe and usable, with evidence.

My role

• Designed the game interfaces and interaction patterns for the movement, balance, dexterity, vision and cognitive challenges.
• Defined the usability evaluation strategy and the SUS-based evaluation method, using established methods because of the clinical context.
• Wrote and signed the final usability report included in the MDR submission.
• Authored the patient Instructions for Use, including the update covering the cognitive games.
• Planned and reported the QA test runs for the release candidate.
• Consolidated the games and screens into a single design system.
• Produced regular strategy decks with UX predictions and recommendations for management.

Approach

1. Start from the people using it.
Study nurses and participants gave structured feedback from the field. The same themes came up again and again: instructions were not clear enough, countdowns and sounds were confusing, movement tasks had no levels, and people wanted to see their progress. I turned this into a short list of ideas and rated each one for effort and impact before deciding what to change.

2. Make every instruction impossible to miss.
Each challenge now explains itself with a short animation, written text and spoken audio, repeated every time the test is performed. This matters for patients doing a physical test alone, where a misunderstanding can ruin the data or put them at risk. Instructions and warnings were checked in five languages.

3. Make it feel like a game without losing the science.
Designing a new game meant two things at once: building the case for which biomarker it produced, and justifying why the game was effective for its category. The experience had to be rewarding, but nothing could be added that would change what was being measured. Ranks, rounds and clear feedback give patients a sense of progress. Warnings and precautions sit in front of any physical challenge.

4. One system instead of many games.
Games had been built with different palettes and components. I consolidated them into a single design system, so new games could be designed faster and still look and behave like the same product.

5. Test everything, then test it again.
We evaluated every game with representative users, first to improve the design and then to confirm it. I defined the targets before testing and compared the results against them. Findings from testers and evaluators fed directly into design changes, including instructions, sounds and feedback.

6. Document it the way a regulator expects.
Following IEC 62366-1, I worked through the use specification, hazard-related use scenarios (for example falls, collisions, fatigue and frustration), the user interface evaluation plan and the summative evaluation report.

Outcome

• The usability evidence and Instructions for Use I authored were part of the product’s EU MDR submission.
• The summative evaluation met the usability targets set in the plan.
• The design system gave the team one set of components for all the games, which made adding and changing games faster.

What I took from it

In a medical product, usability is evidence, not opinion. Setting the targets before testing, using known methods, and writing down why each design choice was made made the design easier to defend and easier to improve.

Details of the study and product are confidential, so this case study describes the process and my role rather than the results.