The RADx Tech Deep Dive and Work Package 1 Process

Abstract

The RADx SM Tech program was a unique funding and support mechanism to accelerate the market introduction of diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. In addition to providing funding, the RADx Tech program provided unprecedented levels of non-monetary support. Applications were evaluated using a deep dive process which involved a 1-to 2-week intensive collaboration between the applicant and a team of experts from RADx Tech. The result of this deep dive was a very comprehensive understanding of the potential and risks associated with the proposed work, which was far beyond what can typically be understood in a written grant application. This detail allowed the deep dive team to provide a better-informed recommendation on how to proceed. In some instances, the recommendation was made to not fund the project; in other cases, the recommendation was made to provide the applicant with more funding or support to help maximize their probability of success. After the deep dive, the project moved to a Work Package 1 (WP1) phase that focused on further de-risking. The same RADx Tech team that conducted the deep dive also worked with the applicant through the WP1 phase of the program. This allowed for joint responsibility of the work with the common goal of rapid, successful product introduction.

The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech

“…The original CRC concept emphasized pre-meeting preparation including completion of an intake form by the company and a preparatory conversation between committee chairs and the RADx Tech Team Lead. [5] The intake form included structured questions to characterize the detection technology, specimen type, collection modality, device operation, performance, and human factors characteristics. Based on the rapid pace of RADx Tech and to avoid duplication of effort, all pre-meeting work including the intake form was later eliminated.…”

RADx Tech Viability and Steering Panels: A Model for MedTech Translational Grant Review

“…The Viability Panel is responsible for assessing whether the proposal is a good fit with the RADx Tech Program and whether it should be recommended to move into a Deep Dive. There are eight (8) members on the panel with three key areas of expertise: [7] in this special issue). The Deep Dive team works closely with the applicant to review, refine, and further assess the application over a 1-to 2-week period, involving many hours of interaction with the applicant and their team.…”

“…Instead of the typical process that selects projects based on reviews of what is written (“evaluate and select” process), RADx Tech employs an “assess, improve, and then select” process. After an initial assessment, RADx Tech assigns a team to work with the applicant to improve the application (called a Deep Dive; see article by Dempsey et al [ 7 ] in this special issue). Results from the Deep Dive are then used to recommend and select the projects with the highest chance of success.…”

“…The Steering Panel reviews the results from the Deep Dive and decides whether to recommend further funding (WP1 or WP2 – see article by Dempsey et al [ 7 ] in this special issue). There are nineteen (19) members on the panel across six key areas of expertise: Business/Technical (five panel members): All members have extensive business and technical expertise having served in senior technical and management roles in large companies and/or start-up operations.…”

“…The Deep Dive is conducted by a RADx Tech team comprised of a highly experienced Portfolio Executive, Team Lead, and Project Facilitators who are supported by SMEs as needed (see article by Dempsey et al [ 7 ] in this special issue). The Deep Dive team works closely with the applicant to review, refine, and further assess the application over a 1- to 2-week period, involving many hours of interaction with the applicant and their team.…”