CASE STUDY

Medical Software for Cognitive Decline

We have designed and developed innovative medical software that helps detect and understand memory loss.

Projects
OptinaDX

OptinaDX Brain Health Module, a medical software that helps detect early signs of cognitive decline

Company

Optina Diagnostics

Industry

Healthcare

Sector

Ophthalmology

Product Type

Software

Expertise

Human Factors Engineering, Innovation Strategy, Quality Assurance, Software Development, UX & UI Design

A revolutionary tool for the diagnosis of Alzheimer’s disease

OptinaDX sees the eye as a window to the brain. The company uses the same technology that first studies the stars to examine the retina and detect early signs of Alzheimer’s disease. It has developed a device that can evaluate brain health by observing the eye using a cutting-edge camera and an algorithm coupled with artificial intelligence (AI).

CLEIO was mandated to develop OptinaDX’s Brain Health Module software that collects patient data and images for analysis.

How CLEIO designed a user-centered software that meets medical device standards

CLEIO designed and developed the key functionalities for the first version of the Brain Health Module software. The immersion and definition phases of our IDEAL methodology were decisive in getting a clearer picture of the users’ needs, requirements, and risks.

Getting to know the users and their context first

We needed to learn about the context, Alzheimer’s disease, and the users before jumping on development. Our user experience (UX) experts thoroughly examined each user’s journey. They created personas representing patients, doctors, and eye specialists to distinguish each ecosystem and understand their interactions.

Following a rigorous design process

Medical software development must be rigorous. For this reason, we have supported OptinaDX in complying with the standards. Our design, software development, and quality assurance teams worked closely with a rigorous process linked to our ISO 13485 certification, IEC 62304 and 62366-1 standards.

Our developers built the application architecture and produced all the required documentation for a class B medical software for future certification. They also performed a thorough inspection of the entire system.

The refined version of the Brain Health Module app is currently in the second phase of development

The first software version developed by CLEIO allowed the OptinaDX team to collect data and conduct hundreds of clinical research trials worldwide.

Based on the results obtained, OptinaDX is pursuing additional support from CLEIO to add new functionalities to the software and update the documentation to ensure that it continues to meet the requirements of the standards.