RADx Accessible Tests - RADx Accessible Tests
RADx Tech COVID-19 Funding Opportunity
COVID-19 Home Tests Accessible to People with Disabilities
Fast-Track Program to Advance U.S. COVID-19 Testing Capabilities
The RADx Coordination Center at CIMIT, on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (NIH), is soliciting proposals for accessible over-the-counter (OTC) testing technologies for COVID-19 under its Rapid Acceleration of Diagnostics (RADx) fast-track program.
Under this RADx Tech solicitation, NIBIB is seeking to accelerate the development of OTC COVID-19 diagnostic technologies that can be used independently by people with disabilities. To specifically meet the needs of populations with disabilities (e.g., blindness, low vision, fine motor skill difficulties, and aging-related disabilities) innovations should incorporate universal design features and provide significantly improved accessibility and ease-of-use compared to existing commercial platforms. Proposals should utilize universal design principles such that solutions will improve the usability of OTC tests for all users. Clinical and technical performance must be at least as good as current, best-in-class OTC technologies. Test platforms should return results quickly, demonstrate potential for integration with digital health reporting standards, and be capable of achieving regulatory clearance during both pandemic and non-pandemic periods.
Throughout the pandemic, there has been an increased focus on OTC tests for use in the home. However, home users can have a large range of physical, sensory, and cognitive capabilities and disabilities that should be considered in the test design. Currently, most tests on the market make heavy use of visual information with no alternative modalities such as auditory or haptic feedback available, inhibiting use by people with no or low vision. Many tests use small components, require precise manipulations, and/or require significant force for one or more steps of the workflow, creating additional challenges for users with fine motor control impairments or reduced hand strength. As a result, independent completion of OTC tests for users with these disabilities can be challenging or impossible.
Given these shortcomings, there is ample opportunity for new tests to support improved and more accessible use. Therefore, NIBIB is seeking to accelerate the development of OTC COVID-19 diagnostic technologies with improved features for non-visual use, use by individuals with fine motor control challenges, and use by those of the aging population. New test designs will incorporate the needs of the above populations in early stages of the design process and pay close attention to workflow and process complexity, design of kit components, packaging design, and instructions formatting. While smart technology may be employed in the operation of supported devices, there are limitations in availability and ability to use these technologies among accessibility groups. Therefore, technologies not leveraging smart technology will also be supported. Digital instructions should be readily accessible online, compliant with 508 Standards, compatible with common screen readers, and available in HTML format embedded on a webpage. Webpages should at minimum adhere to Web Content Accessibility Guidelines. Product designs and instructional content should make use of standards and guidelines such as ANSI/AAMI HE75 Human Factors Engineering – Design of Medical Devices, FDA Applying Human Factors and Usability Engineering to Medical Devices, Web Content Accessibility Guidelines 2.1, and the Revised 508 Standards and 255 Guidelines. Additional resources for producing accessible digital content are available through Section508.gov.
RADx has assembled a national network of expert technical, clinical, business, manufacturing, and regulatory advisors who will provide individualized assistance for funded projects. Funding for projects selected for this program will be dependent on successfully meeting aggressive project milestones. RADx will provide financial and in-kind support to accelerate commercialization of projects that meet milestones. To ensure that innovations are available to the public as quickly as possible, NIBIB will leverage established partnerships with federal agencies, such as FDA, CDC, CMS, and ASPR/BARDA, as well as commercial and private entities to propel technologies developed with RADx support toward FDA authorization and widespread use.
Submissions will follow a multi-stage process:
Stage: Rolling Review
Scope of Work: Project proposals will be accepted and reviewed through the online RADx Tech portal beginning on September 20, 2022. Proposals will be reviewed by an external panel of experts for technical, clinical, regulatory, and commercialization feasibility based on the Project Review Criteria stated below. NIBIB will make the final determination about which proposals will advance to the “Deep Dive” stage for work package development based on review criteria and competitiveness of the proposal.
It is preferred that application materials be submitted in accessible format, leveraging such resources as those available from Section508.gov or the National Federation of the Blind’s “Creating Nonvisually Accessible Documents” guidance.
Stage: Deep Dive - Work Package Development
Scope of Work: Following the Review, projects selected for further consideration by RADx Tech will be assigned a team of commercialization and subject matter experts to do a Deep Dive into the project with the applicant team. The Deep Dive will identify key risk factors that may impede the deployment of the proposed solution, as well as clear milestones that address these risks. During the Deep Dive, a group of experts will help identify additional resources needed to accelerate the project, including partnerships and/or collaborations with other applicants and/or outside organizations as appropriate. The output of the Deep Dive will be a proposal for two Work Packages (Work Package #1 and Work Package #2).
The proposed Work Packages will be reviewed by an external panel of experts for technical, clinical, regulatory, and commercialization feasibility based on the Project Review Criteria stated below. NIBIB will make the final determination about which proposals will advance to the Work Package implementation stage, with approved work beginning as soon as possible.
The proposed Work Packages will cover the full range of activities needed to re-risk, develop, verify, and validate the solution and to be ready for FDA regulatory review, manufacturing, and commercialization.
Stage: Work Package #1 - De-risking
Scope of Work: Work Package #1 is intended to address high-risk barriers to success which, when successfully resolved, will enable Work Package #2 which will focus on implementation. Project teams will work to meet the established milestones, aimed toward demonstrating that the solution is feasible within an accelerated timeframe.
The RADx Tech Deep Dive team will continue to support project teams during Work Package #1, and NIBIB and RADx Tech will provide milestone-driven financial and in-kind resources to maximally accelerate progress. NIBIB will closely monitor progress during Work Package #1, assess milestone achievements, determine if any adjustments are warranted, and evaluate the need for continued funding based on the achievement of milestones.
Stage: Work Package #2 - Implementation
Scope of Work: Work Package #2 will cover the full range of activities needed to be ready for FDA regulatory authorization, manufacturing, and commercialization. Funding for Work Package #2 will be contingent on meeting the milestones of Work Package #1, having a well-resourced commercialization plan, and the market competitiveness of the solution as assessed by the NIBIB.
The RADx Tech Deep Dive team will continue to support project teams during Work Package #2, and NIBIB and RADx Tech will provide milestone-driven financial and in-kind resources to maximally accelerate progress. NIBIB will closely monitor progress during Work Package #2, assess milestone achievements, determine if any adjustments are warranted, and evaluate the need for continued funding.
Budgets for this phase of the work are expected to be substantial. NIBIB will supply funding, partnerships, and in-kind resources needed for the solution to be ready for regulatory authorization, manufacturing, and commercialization. NIBIB will negotiate cost sharing with for-profit institutions as appropriate.
Project Review Criteria
Each application will be reviewed by an independent external expert panel.
IMPORTANT: All applications must clearly describe how the proposed technology will significantly improve accessibility and ease-of-use, compared to existing commercial platforms, in order to specifically meet the needs of populations with disabilities (e.g. blindness, low vision, fine motor skill difficulties, and aging-related disabilities).
Applications must provide details on improved approaches to workflow and process complexity, design of kit components, packaging design, and instructions formatting, and how the product will be verified to ensure appropriateness for target users.
Additional factors that should be addressed and will be considered:
- Time to commercialization readiness and ability to meet regulatory requirements for intended use (OTC): submissions for EUA within 12-18 months and standard clearance within 24 months
- Innovations that can potentially reduce manufacturing costs and retail prices, facilitate rapid scale-up during surge demands, and improve supply chain resilience.
- Support for digital health platforms including ability to communicate results to appropriate healthcare providers and, as appropriate or required, public health authorities
- Ability to work with/adapt to rapidly changing variants and be multiplexed and/or adapted for multiple pathogens/diseases
- Experience, resources, and commitment of the team and applicant organization
There will be a rolling submission and selection period beginning September 20, 2002 that has been extended until October 31, 2022.
Proposals submitted to RADx Tech will be reviewed rapidly as applications are received (see Project Review Criteria). Based on meritorious review, RADx Tech will select projects for a multi-phase process described above. Each phase will have a separate funded budget and deliverables that must be reached to move to the next phase. Successful completion of a phase does not guarantee funding for the next phase as this is a competitive program with limited funds.
Awards are milestone-based and selected teams must work collaboratively with assigned RADx experts and associated web-based tools, including the CIMIT's GAITS platform to continue. Full Federal overhead rates apply.
How to Apply
The deadline for this opportunity has passed.
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