Our Impact

Impact Story: Hepatitis C

History

In March 2020, the nation was at a standstill. Cases of COVID-19 were escalating, hundreds were dying, and the country lacked the technology to determine if it was safe for individuals to go back to school, to work, or even to the grocery store. 

Then, in late April 2020, the National Institutes of Health (NIH) launched its Rapid Acceleration of Diagnostics (RADx®) Tech program. The launch happened just days after receiving an emergency supplemental appropriation of $1.5 billion from Congress to support technologies to make millions of COVID-19 tests available. 

RADx® Tech’s Mission

RADx Tech’s mission was to accelerate the development and commercialization of innovative point-of-care and home-based tests, as well as improve clinical laboratory tests that could detect SARS-CoV-2 — and provide the tools needed to get America running again. 

Cimit’s Role

Cimit played a central role in RADx Tech. They helped design and implement the program in its capacity as Coordinating Center for the Point-of-Care Technologies Research Network (POCTRN) in conjunction with the NIH, VentureWell, and four POCTRN centers. 

Due to the collective efforts of all involved, RADx Tech was a tremendous success in the following ways:

  • the applicant review time was reduced from the typical four to six months to 35 days.
  • 46 Emergency Use Authorizations were issued.
  • 3 billion tests were brought to market, including the first over-the counter test
All of this happened within two years of the program launch — an unparalleled achievement, given that most medtech projects take close to seven years for development and commercialization.
 In addition to rapidly delivering accurate tests on a massive scale, RADx Tech has fueled “a quiet health revolution,” says Bruce Tromberg, Ph.D., director, National Institutes of Biomedical Imaging and Bioengineering, which supports POCTRN. 
 
“Prior to COVID-19, invitro diagnostic tests were done in laboratories, required days to return results, and were designed to evaluate the presence of the disease in symptomatic individuals. Today, most COVID-19 tests are performed in point-of-care and home settings, produce results within 15 minutes, and can be used to screen large populations. Our goal is to leverage this unprecedented transformation into a modernized infrastructure that helps us realize the promise of personalized medicine for the entire spectrum of pathogens and diseases.”

The Distinctive RADx® Tech Process

The RADx Tech program process was an innovation funnel, built on methodologies developed by Cimit, that moved applications quickly through multiple review gates, increasingly pressure-testing ideas against technical, clinical, commercial, and regulatory criteria. 

Upon entering the funnel, each project was evaluated by a team with diverse expertise, ranging from scientific to clinical to technical to business. Instead of the traditional approach of reviewing proposals based primarily on a written application, RADx Tech employed an interactive approach with applicants that involved “assessing, improving, and then selecting” projects.

Projects that were considered promising (approximately 20 percent of applications) entered phase 0 and were evaluated by the team in consultation with the applicant in a one-to-two week-long “deep dive” or “shark tank” analysis, and the results were presented to an expert panel and then NIH. 

Thirty-four percent of phase 0 projects were selected to enter phase 1, which involved testing and validating the concept in a month-long, milestone-driven process. If a project was deemed successful in phase 1, rapid scale-up and clinical testing in phase 2 were undertaken, with financial assistance from the NIH. 

RADx® Tech Drives Innovation

Labeled as at “least a mini-Manhattan Project” in 2020 by then U.S. Senator Lamar Alexander, RADx Tech was unprecedented in many ways. Three of the most significant are outlined below. 

Speed: RADx® Tech revolutionized the standard medtech development pathway. Distinctive to this approach was collaboration among a wide range of experts that enabled rapid, informed decision-making at each stage of review, product development, and commercialization.

“To move from early clinical translation to adoption within months, rather than the usual six to seven years, was groundbreaking” says Steven Schachter, M.D., chief academic officer at Cimit and RADx Tech chief.  “RADx® Tech highlighted the tremendous value that engaging multidisciplinary, collaborative teams in a streamlined validation and commercialization process can bring to rapidly deploying life-saving technologies.”

Deep Dive/Shark Tank: To meet RADx Tech’s goals of de-risking and accelerating tests to market, RADx Tech transformed the NIH’s traditional linear application process (evaluate and select) into an interactive review process (evaluate, improve, and then select) aimed at quickly determining the potential and risk of specific projects. They did so by with a team that had extensive experience in disciplines ranging from science to engineering to business. The outcome of this fast-tracked analysis was a realistic view of the technology, an understanding of what resources would be needed for the project to succeed, and the determination of the most promising projects — all of which were conveyed to the NIH for funding consideration. 

“Through our decades of work on health innovation projects, we had learned that lack of early, granular feedback can lead to development bottlenecks created by unanticipated clinical challenges, engineering flaws, cumbersome workflow, and insufficient validation,” says Michael Dempsey, Entrepreneur-in-residence at Cimit. “The deep dive was designed to identify — and where possible solve for — these challenges early, helping us to advance the strongest projects and eliminate or redirect projects that did not align with RADx® Tech criteria.”

Expert Facilitation: Central to RADx Tech’s success was the consistent leadership and facilitation provided by what RADx® Tech called “Team Awesome” — a team consisting of a medtech portfolio expert, C-level management, a project facilitator, and individuals with business and technical skills that worked with applicants during the deep dive and continued supporting funded teams throughout the innovation cycle until the product went to market. The team’s job was to facilitate the advancement of the project, and each team brought a rich combination of experience, judgement, and contacts that was invaluable to each project’s trajectory. 

“The creation of ecosystems that have labs and business working together to drive forward innovation was one of the great outcomes of RADx®Tech, a model that I hope will become the gold standard for MedTech development,” says Harvey Fineberg, M.D., Ph.D., president of the Gordon and Betty Moore Foundation and former president of the U.S. National Academy of Medicine. 

Cimit’s Unique Contributions

With more than 25 years of expertise in health innovation, Cimit was well positioned to play a number of leadership roles in RADx Tech:

  • Designed and Implemented RADx® Tech: Cimit co-designed and managed the innovation funnel from soliciting ideas to overseeing test deployment. This process included co-designing the funnel based on Cimit’s proven methodology, building the applicant portal and soliciting applications, managing application review, creating teams to review project ideas and support selected teams, structuring review meetings, coordinating the POCTRN center’s work, and managing the teams overseeing manufacturing and deployment.
  • Fast-Tracked Applicant Review: Cimit was extensively engaged in the applicant review process by defining criteria, co-designing a short application, soliciting applications, overseeing staged review, engaging highly experienced experts in the evaluation, and presenting projects, with teams, to the NIH. 
  • Leveraged its Network of Experts: Unique to the RADx® Tech process was the infusion of facilitation and guidance from experts, most of whom had more than 30 years of experience in medtech and/or business. Many experts were new to Cimit, and they joined Cimit’s existing extensive network and helped project teams understand what they needed to do, when they needed to do it, and what and who were the “best in class” resources to support their efforts.   
  • Employed its Custom-Designed Tools: Cimit customized two of its signature tools to serve as the platforms for project management and risk assessment throughout RADx Tech:
    • Guidance and Impact Tracking System (GAITS), Cimit’s innovation framework platform measures the maturity of a project across 10 maturity levels and four key domains (clinical/workflow, market/business, regulatory, and technology) provided a consistent way to assess project status and progress against workplans and ensure that teams were demonstrating balanced progress in all four domains. 
    • Cimit’s CoLab tool manages workflow in the application review, assignment of experts to teams, contributions of hundreds of people to the deep dive and review efforts, and a variety of administrative tasks, such as conflict-of-interest documentation.

A New Era of Diagnostic Test Development

Cimit’s Contributions

While hundreds participated in the RADxTech Program, Cimit’s unique contributions included:

  • employment of its extensive expertise in rapid medtech product development. 
  • proven methodology.
  • deep bench of experts.
  • tools that supported project management and risk assessment throughout the process. 

To learn more about RADx® Tech, read the special issue “RADx® Tech: A New Paradigm for MedTech Development” in IEEE Open Journal of Engineering in Medicine and Biology and “Accelerating Diagnostics in a Time of Crisis” by Steven C. Schachter and Wade Bolton.