Preliminary Assessment of in vitro Diagnostic Device Accessibility

Overview

The National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx®) program works to support the development and commercialization of COVID-19 test devices. Within RADx, the RADx Deployment Core provides resources to COVID-19 diagnostic companies in order to help these companies bring their product to market. The RADx program is now turning its attention to the development of COVID-19 diagnostic tests that are accessible to those with an array of disabilities including visual impairment, motor impairment, and challenges that may affect older people.

As a first step, the RADx Deployment Core conducted a literature search to locate any pre-existing guidance on design for accessibility, reaching out to engineering design groups, and contacting advocacy groups and foundations with a deep base of knowledge on the experience and needs of people with these types of impairments. Specifically, the Core met with various engineering design groups who appeared to have previous experience in designing and producing products that had specific needs around usability such as impaired motor control to better understand their capabilities, what they had learned from previous projects in this space, and whether they had created or were aware of any public guidance documents to support accessible design.

This summary of the Deployment Core’s findings from the literature search, contacts, and sources is provided in advance of the listening session to provide initial context and a framework for the discussion. Note that this material should not be interpreted as representing the viewpoint of the U.S. Department of Health and Human Services, the National Institutes of Health, or the National Institute of Biomedical Imaging and Bioengineering. It should also be noted that this preliminary assessment was conducted over a brief twelve-day period and therefore represents preliminary insights only.

Preliminary Insights

In brief, the Core’s assessment is that there are no comprehensive in vitro diagnostic (IVD) guidelines or standards for accessible design of consumer products released to date. Design and development are consistently based on user feedback research studies conducted on a case-by-case basis for specific needs and are typically supported by basic tenets of good design and any prior experience in the accessible design space.

We have found no published standards associated with accessible design requirements, accessibility “certification” or accessibility “approval.”

Accessibility for our purposes here only includes specific user groups with vision impairments (blindness / low vision), physical impairments (reduced motor function / strength), cognitive impairments (mild / dementia), or auditory impairments (deafness / low hearing).

Existing products designed for accessibility appear to have been designed based on individual usability studies enrolling individuals of the target user group to identify user specific needs, followed by subsequent user feedback focus sessions to evaluate what design outputs adequately meet those needs.

While we have found guidance resources to reference when considering design for accessibility, most are limited.

None of these are tailored for diagnostic device form and function and at best cover communication of instructions and results. Examples are listed below.

Current Americans with Disabilities Act Access Standards:
- ADA Standards set by the Architectural & Transportation Barriers Compliance Board (U.S. ACCESS Board)
  - Standards for Accessible Medical Diagnostic Equipment
    - Section M306 - Communication: diagnostic equipment communicates instructions or other information to the patient in at least two of the following methods: Audible, Visible, or Tactile. Other standards defined mostly cover special requirements for accessibility of large equipment.
Web Content Accessibility Guidelines (WCAG) 2
- Series of accessibility technical documents developed by Accessibility Guidelines Working Group that explain how to make web content more accessible to people with disabilities.
- 21st Century Integrated Digital Experience Act - reinforces website accessibility requirements
National Disability Association (NDA) 7 Principles of Universal Design
- Equitable Use, Flexibility in Use, Simple and Intuitive, Perceptible Information, Tolerance for Error, Low Physical Effort, Size and Space for Approach and Use.
Evaluating Universal Design of Products
- Scorecard to evaluate the product against the 7 Principles of Universal Design and their guidelines.
Apple - Human Interface Guidelines
- Focused on layouts and color schemes for apps on consumer electronics products for accessibility.

Anecdotal reports have illustrated the limitations of at-home COVID-19 tests, specifically with regard to being able to use the test without assistance. Additional key points to consider from end users and end user support organizations regarding inclusion and exclusion when it comes to providing accessible products include the following.

The costs of “accessible” tests should be in line with the cost of “regular” tests, as any additional cost for accessibility is negatively viewed by end users as an unwarranted and unfair “accessibility tax”. While not an actual tax, the end user’s perception is that it is.
Appearance and use of the “accessible” test should provide the same user experience, as that of a “regular” test. There is a very strong emotional component, when being different is reinforced through product appearance or product experience.
Purchasing and using the “accessible” test should not impact one’s dignity, as there is often a stigma associated with “accessible” tests.

Several benchmark products were identified as examples of what has been / is being developed to address accessibility.

Some of the examples listed below have applicable crossover features.

Pregnancy Test for Blind and Partially Sighted People (Royal National Institute of Blind People): allows visually impaired people to be the first to learn their test results. Device form factor very similar to rapid antigen LFA tests.
Prodigy Voice (Prodigy Diabetes Care): totally audible device; no-coding; glucose meter designed for the blind, with audible test results, set-up, memory, repeat button. Hand-held diagnostic device.
Blood Glucose Meters That Are Accessible to Blind and Visually Impaired Persons: identifies hand-held diagnostic devices. Lists product design criteria for blood glucose monitoring to
be accessible to blind and visually impaired persons. Lists criteria for designing for use by individuals with low vision/blindness.
The “Fabulous 50” Accessible Products and Tech: an inventory of 50 accessible devise, as reviewed by Travelability.

Experience in design for accessibility is not abundant.

As part of this assessment, input was collected from design and development services companies to assess their level of experience and insights in designing for accessibility. Valuable insight was obtained from those who have performed user needs research specifically for motor impaired individuals and have institutionalized knowledge within their organization. Names of companies and organizations are listed for information purposes only. Inclusion below is not an endorsement or promotion for any products or services. Refer to website disclaimers.

Of the eight firms contacted, two demonstrated deep institutionalized knowledge and experience designing and developing hand-held medical devices:
- Metaphase: broadest knowledge with regards to designing for hand dexterity and cognitive impairments
- Symbient (Gener8): broadest knowledge with regards to designing hand-held devices for very specific user groups.
The majority of design and development experience related to accessibility follows the traditional design and development process of utilizing a combination of institutionalized knowledge and user needs to design prototypes, which are focus group tested and refined into a final device.
The complete list of design and development firms, companies, and labs contacted include:
- Metaphase Design Group, Inc., St. Louis, MO: experienced in ergonomic design for medical devices and consumer products for individuals with motor and cognitive impairments. Specific experience with blood glucose monitoring devices, finger lancing, and A1C home tests. Strong processes for incorporating user feedback and human factors analysis. May be able to assist with developing initial screening criteria for assessing “accessibility” candidates.
- Symbient (Gener8, LLC), Carlsbad, CA : deep experience in designing/developing diagnostic products with clients who are developing devices for mobility compromised use cases. Have worked on over 350 diagnostic projects including some current RADx companies. Diagnostic experience includes cartridges, sample collection and processing, and instrument driven devices. User needs identification mainly literature and institutionalized knowledge based.
- PDT (Astronics Corp.), Lake Zurich, IL: assisted in development of SMART Talking Brailler, iterating off of formerly developed devices that were considered outdated. Strong processes for developing research, behavior studies, and ethnographic studies to identify user needs.
- Trig, LLC, CHapel Hill, NC: experience in targeting user groups for user research and industrial design based on user feedback. Have some experience with developing hearing assistive devices, tools for weak motor function, and general accessible products.
- DCN Dx, LLC, Carlsbad, CA: deep experience with design and development of diagnostic products, including lateral flow assay tests and visual reader devices; limited accessibility specific design efforts; however, have developed multiple assay devices for challenging situations, such as veterinarians and farmers, where device is used in the field by those with no diagnostic testing experience and a gloved hand; emphasized their design and development process is applicable to this use case, as at a high level this use case represents a different but specific user group; internal usability testing, human factors engineering, and clinical trial capabilities.
- Toolbox Medical Innovations (TE Connectivity), Carlsbad, CA: deep experience with design and development of diagnostic products, including lateral flow assay tests; internal usability testing, human factors engineering, and clinical trial capabilities; limited accessibility specific design efforts; however, emphasized their design and development process is applicable to this use case, as at a high level this use case represents a different but specific user group.
- Triple Ring Technologies, Inc., Neward, CA: prior experience with mobility (wheelchair) impairments and motor impairments (utensils); emphasized their design and development process is applicable to this use case, as at a high level this use case represents a different but specific user group.
- Key Tech, Inc., Baltimore, MD: experienced in assay and reader design and development; limited accessibility specific design efforts; emphasized their design and development process is applicable to this use case, as at a high level this use case represents a different but specific user group.
- Georgia Tech Home Lab, Atlanta, GA: usability group identified as a possible vendor for evaluating the usability of products before and after eesigning for accessibility and for suggesting design changes to improve usability.