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Usability

Formative Feedback - Phase 1

Market Access Africa (MAA) assisted Global Health Labs (GHL) with the NAATOS TB V1 Formative Feedback - Phase 1 work, in which a voice of customer (VOC) analysis explored key thematic priorities (market landscape, policy considerations & regulatory pathways, product insights, and deployment considerations) for a successful launch in the public and private sector in four first-look countries and four second-look countries.

  • First-look countries

    • India
    • Kenya
    • Nigeria
    • South Africa

  • Second-look countries

    • Botswana
    • Democratic Republic of Congo (DRC)
    • Uganda
    • Zimbabwe

Voice of the Customer and Market Analysis

The MAA reports on NAATOS TB V1 Formative Feedback Phase 1 on VOC and Market Analysis for four first-look countries and four second-look countries outline key development milestones and market entry strategies in those countries.

Regulatory Pathway Assessment

The MAA report on NAATOS TB V1 Formative Feedback Phase 1 on Regulatory Pathways provides high-level insights from interviews with global regulatory exerts on the SRA pathway.

The ACT-IVD report on NAATOS TB V1 Regulatory Strategy is also available as a more detailed follow-up on the regulatory topic.

Formative Feedback - Phase 2

MArket Access Africa (MAA) also assisted Global Health Labs (GHL) with the NAATOS TB V1 Formative Feedback - Phase 2 work, in which clinic visits in Kenya and South Africa were conducted to gather end-user requirements in clinic settings. The Voice of the Customer analysis produced in Phase 1 highlighted the need for this work.

Clinic Visits and Health Care Worker Interviews

The MAA report on NAATOS TB V1 Formative Feedback Phase 2 provides a detailed usability assessment of an early prototype NAATOS TB V1 system.

  • Objectives

    • Assess the usability of the NAATOS TB device in primary healthcare settings
    • Identify the clinic characteristics, roles, needs, and challenges faced by potential users in TB testing processes
    • Provide actionable recommendations for effective integration of the NAATOS device into clinic workflows

  • Methodology

    • Collect formative feedback with 41 health workers on health facility characteristics, workflow, usability and end-user requirements.
    • Visit 13 health facilities in primary health settings within South Africa and Kenya.
    • Take systematic approach to collect and analyze data on NAATOS' usability and user requirements
    • Conduct surveys, audio- and video-recorded interviews.

Explore the feedback summarized in the table below or download it in the *.csv format.

Category Topic Feedback
NAATOS System (Device, Modules & Consumables) Temperature conditions variable and uncontrolled Sample prep tube contents, device & modules must be robust enough to handle varying and undocumented temperatures in Africa temperature settings.
Module configuration needs Single and two-test module systems would be sufficient for clinics visited.
Battery operated devices Rechargeable battery solutions essential since there is limited back-up power and on the odd occasion, long periods of power outages.
Module battery life indicator Add a clear battery life indicator (battery icon) to keep users informed about remaining power levels.
Module instrument labeling Require clear labeling of lights & user-friendly solution influenced by UI/UX design.
Securing devices in facilities With the potential for theft, the instruments should have an ability to be secured to a counter or table within the clinic environment.
Quick turnaround time Quick turnaround time is crucial to ensure testing is completed within the same clinical encounter, reducing patient wait times, improving TB case follow-up, and minimizing the need for additional modules to support high-traffic urban clinics.
Test Consumable Control lines understanding Explore options to visually guide users to read both control lines as one, such as minimizing the space between C1 and C2 or using a wash-away design. Provide clear quick reference guides and basic training to help non-laboratory users confidently interpret the two control lines and one test line.
Contamination risks NAATOS cartridges need a secure design to prevent contamination during disposal, due to potential incineration or off-site dumping.
Interfering substances There were concerns about alcohol and drug use potentially affecting test accuracy, and further investigation is recommended during the usability testing phase.
Abstaining from food and drink WHO recommends abstaining from food and drink 30 minutes before testing. Usability testing should assess the impact of this waiting period on clinic workflows and patient compliance.
Sample Preparation Module Sample module lid Redesign the sample module lid to be easier to locate and open, possibly with visual cues or ergonomic design improvements
Tube insertion guidance Implement a mechanism or visual guide to ensure users insert the tube fully, allowing the sample prep module to close properly
Power Module Test device insertion point Redesign the interface to make the insertion point for the test device more intuitive and easier to locate.
Correct test device insertion Implement a mechanism or visual guide to ensure the test device is inserted correctly to prevent incorrect insertion.
Connectivity Connectivity an add-on feature With majority of data management being paperwork for the clinic, but there being a strong element of electronic record keeping for monthly national reporting, connectivity should be a supplementary feature, with integration into national TB programs and centralized lab data systems.
Consider alternative communication strategies Connectivity solutions would work well where results can be shared via SMS to facilitate robust client communication and ownership of their own results.
Sample Collection Kit Contamination risks Design modifications (e.g., wider base for sample tubes) could reduce spillage risks. Proper training on sample handling is crucial to minimize contamination risks. Observations included practices like placing tubes on their sides when open.
Recommended Placement Placement and users The NAATOS device is ideally suited for Level 2 & 3 facilities in Kenya and PHC and CHC facilities in South Africa, which typically handle moderate patient volumes and are equipped with trained healthcare workers capable of operating diagnostic equipment. These facilities provide a balance between resource availability and high patient need. This will help reduce the reliance on sample logistics for TB tests that enable same day linkage to care.
Triage/observation/vitals room Placing the device in the triage room ensures early TB testing as soon as TB symptom screening questionnaire is done with the client, aligning with current symptom assessments and helping reduce transmission risk
Centralized testing area For centralized access, a dedicated testing area within the facility would enable nurses or clinical officers to efficiently manage testing away from patient traffic, facilitating a smoother workflow.
Primary Users of NAATOS Primary users Nurses, clinical officers, community health workers, and in rare cases, lab technicians, will be the main users of the device. These professionals often manage multiple responsibilities and face challenges, such as sample handling and a lack of timely access to test results.
User Needs - ease of use Users prefer minimal setup and simple instructions, particularly in facilities where multiple staff share responsibility for TB testing.
User Needs - quick results Faster testing and result turnaround are critical to prevent patients from needing multiple clinic visits, which affects adherence and follow-up.
User Needs - training and support Users need training on device operation and sample handling to avoid common errors observed during the usability study, such as difficulty with the sample module
Target Population for testing with NAATOS TB patients and symptomatic individuals Visiting primary care centers in high TB-burden areas, especially those with limited access to rapid testing.
Special population - PLHIV PLHIV and others who can't produce sputum
Special population - children Children at each facility children were mentioned as an important population that the tongue swab TB test would help considerably. It is traumatic to for the child and parent to collect samples via gastric aspirate or bronchial lavage, and how they avoided the procedure as much as possible.
Household contacts All community health workers asked about using the test for household contacts and taking NAATOS into the community. More would need to be done to explore the feasibility and performance capability for this use case.
Benefit to the target population By minimizing turnaround time and patient wait periods, NAATOS could significantly reduce delays in diagnosis, ensuring same day access to treatment and improving the overall patient experience. NAATOS also helps reduce the risk of transmission in waiting areas.