In the wake of the COVID-19 pandemic, the need for rapid and accurate diagnostic testing across populations quickly became evident. In response, the National Institutes of Health (NIH) was determined not only to invest heavily in this area but to change the process by which grant proposals were reviewed and funded in order to spur faster development of viable technologies. The Rapid Acceleration of Diagnostics (RADx) initiative was designed to speed innovation, commercialization, and implementation of potential COVID-19 diagnostic technology. As part of this effort, the RADx Tech initiative focuses on the development, validation, and commercialization of innovative point-of-care, home-based, and clinical lab-based tests that can detect SARS-CoV-2. This effort was enabled through the NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB) Point-of-Care Technology Research Network (POCTRN).
POCTRN was established in 2007 by the NIBIB in order to develop clinical application technologies through multi-disciplinary partnerships. CIMIT, the Consortia for Improving Medicine with Innovation & Technology, is the Coordinating Center of POCTRN, and was responsible for establishing and connecting the processes from review and validation for applicants to the RADxsm program through to manufacturing and deployment of the diagnostic test platforms (Figure 1). The details on how this successful, innovative process was put in place in a short period of time, while under multiple pandemic restrictions, will be explored in a special section of the IEEE Open Journal of Engineering in Medicine and Biology (OJEMB), available April 29.
“I am delighted Dr. Schachter and the RADx Tech team decided to publish this collection of manuscripts in IEEE OJEMB” says Paolo Bonato, Ph.D., founding Editor-in-Chief of this gold open access journal. “The RADx Tech team played a key role in the fight against COVID-19. They did so by creating new ways to do and review science, which I believe will have a long-lasting impact on the scientific community and on how federal agencies select projects for funding.”
“The special section highlights the nuts and bolts of the processes and methods we designed and used,” says Steven Schachter, M.D., professor of neurology at Harvard Medical School and Chief Academic Officer at CIMIT. The “we” here refers to the 450-plus scientists, engineers, clinicians, and business leaders who comprised the multiple teams that made this effort possible in conjunction with the NIH. The extensive, nation-wide RADx Tech network worked hand-in-glove with the NIH to create rapid, flexible methods that would provide funding and support of technology design and implementation at key stages of development, relying on the expertise of health technology innovators, developers, and entrepreneurs as well as those experienced in clinical testing, regulatory affairs, usability, and virology.
Using an online software program developed by CIMIT named CoLab, a RADx Tech team known as the Viability Panel connected to review more than 700 applicants for funding grants. “Every single person on the Viability Panel read every application, and a decision on the application usually was made in one to two days,” explains Schachter. “There was incredible commitment by all,” especially when considering the limitations of working together virtually, with limited or no in-person contact, during the pandemic.
For these potential diagnostic technologies, the decision options included sending the application forward for a “deep dive” review, sending the application to outside expertise for further comments on project viability, rejection, or redirection—that is, sending a promising application that was outside the scope of the aggressive timelines of this solicitation to another funding opportunity within the NIH.
In addition, methods such as the “deep dive” stage demonstrate potential models for long-term processes. Here, a team of four individuals—two experienced career professionals from the medical technology industry and two recent biomedical engineering graduates—were assigned to work intensely with the project applicant(s) over a week to 10 days in order to investigate the technology in detail, looking not only at viability and evidence but also potential challenges to the supply chain and manufacturing of the technology.
The deep dive team then reported to a steering panel composed of NIH personnel, technical and industry leaders, and other specialists who reviewed the information to determine if a project proposal met the objectives of the RADx Tech program and also whether or not the technology could likely be manufactured and released in 2020. If the steering panel recommended funding and the NIH approved, the project was funneled to a derisking work package, and then if successful, to large-scale manufacturing. Otherwise, projects could be returned to the deep-dive stage, rejected, or redirected.
“The speed and features of the staged review are among many innovative features of RADx Tech and will likely become a model for grant review in the future,” Schachter says.
For approved projects, timelines were tight for bench-testing and commercialization, and challenges associated with manufacturing logistics and supply chain shortages during the pandemic seemed inevitable. However, the idea that a new health care technology at the translational stage would achieve FDA clearance—in this case Emergency Use Authorization (EUA)—and come to the market within the space of a few months, much faster than the usual 6-7 years, is stunning. “This process overall has been unique and transformational for the NIH, in my opinion,” states Schachter. “To move from early clinical translation to clinical adoption through the RADx Tech initiative in months rather than years is a game-changer.”
Now that it’s been proven that this can be done for COVID-19 diagnostic technology, the goal will be to consider ways that these processes become the new “normal” for healthcare technology approval and facilitation in general. The tremendous value gained from this initial effort of building multi-disciplinary collaborative teams and accelerating validation and commercialization of much-needed technology highlights future possibilities for streamlining processes and costs. Within the rapidly changing health care landscape, approving and funding needed technologies in a timely manner also has the potential to save lives.
Unique in its approach and success, this event in the history of medicine should be shared for its insights, and the OJEMB special section is just one of many efforts to catalog these novel methods. “We began with no roadmap, no playbook, for a project of this scale and complexity” Schachter explains. Some have described this effort as a “mini Manhattan Project”; others liken it to adventurers setting out with little idea of what is over the horizon. In many ways, it was a pioneering undertaking hinging on team effort and commitment to the mission.
“Everyone we asked to help was eager to do so, and for nearly everyone who participated, it felt as if we had been preparing our whole careers for this moment,” Schachter says. “All of the usual institutional barriers to collaboration were gone.” Entities such as POCTRN and CIMIT have worked to increase collaboration among academics, clinicians, technologists, and entrepreneurs for years, and the RADx Tech initiative has taken this to a new level. Now it appears we are at the beginning of a new phase in health care innovation, in which biomedical engineering has a major role to play.
“I would love to see the IEEE and EMBS help lead the way forward,” Schachter says. “It’s big and bold and although we have been focused on this concept of diagnostics, these processes could be adapted to other health care needs to support innovators and speed implementation of technologies over time.”