Core Cognitive Evaluation

Core Cognitive Evaluation/ Digital Clock & Recall [Software as a medical device]

The automated DCR assessment, a component of the CCE, detects cognitive impairment by analyzing patient performance in clock drawing and word recall tasks. Utilizing the scientifically-validated DCTclock™ test, it reveals subtle signs of impairment not visible to the human eye. The second part of the CCE is the Life and Health questionnaire, a patient survey revealing modifiable risk factors for dementia.

The flagship assessment inside the CCE/DCR is the DCTclock™️, a scientifically-validated digital upgrade to the long-established pen-and-paper Clock Drawing Test. The digital DCTclock surfaces subtle signs of cognitive impairment that could otherwise go undetected for years, while enhancing assessment objectivity and efficiency. As it is one of the Linus medical devices (FDA Class II), we closely replicated the pen-and-paper version to ensure it is still scientifically valid. The introduction of this scalable digital solution has unlocked new visibility into cognitive performance for clinicians and is offered in multiple languages.

Because intuitive, well-designed user interfaces are essential to life safety in medical devices, design is a critical part of the regulatory infrastructure at Linus. Healthcare is a compliance-heavy industry, requiring us to consistently validate the safe and effective use of our products through both formative and summative user research studies at various stages of the release cycle.

I believe that design is essential as a strategic differentiator. In healthcare, many products are outdated and painful to use, which slows down PCP’s ability to treat their patients effectively. Linus believes that this is something we must solve for outside of our core mission of helping people live longer and healthier lives with better brain health. I created a competitive advantage through design by offering consistent, adaptive and distinctive user experience within our platform.

How did we do this? Empathy. As a company building tools to help transform cognitive healthcare delivery, it's important that we have a deep understanding of both the people who will be using the product as well as the settings where our product is used. We not only strive to understand providers, but also the pain points of the patients completing our assessments. Among all the things that make up a good user experience, one of the most important is desirability - ensuring that we are creating something that not only solves users’ immediate pain points, but also something that delights them when used.

PERSONAS

• Older Adults/Patients (aged 55+): This user would be an older adult (him/her/them), who may live independently in the community or in an assistive facility and may visit clinics for regular or acute check-ups. In the Linus platform Patients will have the ability to take assessments and view patient facing reports.

• Practice Managers: The person who manages the operational aspects of a clinic or practice. In the Linus platform they will have a Clinical Administrator role and have the ability to add and deactivate users in the system.

• Clinicians (ex: MD, DO, NP, PA, RN, MA): This can be any healthcare provider or other qualified healthcare professional. In the Linus platform they will have the Clinician role which will give them the ability to add patients, administer assessments and view reports and recommendations.

• Primary Site Contacts, Manager Role: These are contacts at our clinical sites who may have responsibility across multiple sites and may want to view patients across many clinic locations within a parent organization. In the Linus platform, Managers have the ability to view the web portal for multiple clinic locations, but they cannot administer assessments.

• Linus Admin: A Linus Health employee in the Customer Support department who configures the software for customers and access the system data to help troubleshoot and guide customers through their use of the system.

• Researcher: An academic, pharmaceutical or clinical researcher interested in capturing and analyzing tremor or cognitive assessment data.

REGULATORY DOCUMENTATION

Each assessment classified as a medical device by my team necessitates specific documentation. We create User Definition Design Documents tailored for Product Designers and Software Developers involved in the design's implementation, verification, and maintenance. This document references incoming requirements containing the design, describes subsystem design details, and defines the deliverables. It excludes descriptions of hardware-user interactions.

Within this document, a section is dedicated to a UI Evaluation Plan, outlining usability validation for upcoming projects. For assessments, we typically conduct summative user studies post-implementation by engineering and before market launch. We validate safe and effective use through user research and show its effectiveness-or success or failure rate. During summative testing, we focus on use errors and usability risks, as our patient-facing assessments' design significantly influences results, impacting the understanding of the disease process. Consequently, the design and process of medical devices play a crucial role in Linus's regulatory infrastructure.

Go back to Assessment List | Go back to Assessment Library Overview