Expedited COVID-19 Diagnostics: Driving Rapid Innovation

COVID-19 has significantly impacted the world and caused many deaths (more than 4.6 million and counting). In March 2020, U.S. Congress passed the “CARES ACT,” the first major piece of legislation to address the pandemic. Included in this legislation was funding for RADx (Rapid Acceleration of Diagnostics), a “Shark Tank”-inspired program designed to speed the development and commercialization of novel home-based tests as well as improve clinical high-throughput laboratory tests to detect the COVID-19 virus.

Mark Bonifacio, president of BCS LLC, was among the 12 members of a steering panel to assess the merits of each proposal (in other words, Bonifacio was one of the “sharks”). Bonifacio was selected for his knowledge and years of experience in the global medical device and life sciences manufacturing and supply chains. The other “sharks” included leading U.S. scientists and experts in the IVD testing market.

RADx came together so quickly mainly because of existing links between government, academia and private industry. Such organizations include the Biomedical Advanced Research and Development Authority (BARDA); CIMIT (Consortia for Improving Medicine with Innovation and Technology), comprising Harvard Medical School, Massachusetts General Hospital, MIT, and Draper Labs; and POCTRN, a network of institutions already working on diagnostics technologies including Johns Hopkins University, UMass Medical/UMass Lowell, Emory University and Northwestern University. Many of the scientists and others involved in RADx hailed from these organizations.

Shark Tank
Applicants making it through an initial screening were assigned a team lead, usually a doctorate-level expert with extensive industry experience. The team leads and their assistants performed a deep dive assessment on the technology, company, and potential. Once completed, the assessment was uploaded to a shared folder, where it was reviewed by Shark Tank members. The team leads would then go before the Shark Tank panel to deliver a timed, technical presentation and answer questions from the sharks.

If the project was approved by the panel it would go to the NIH for final approval. Applicants who received NIH approval were assigned technical, regulatory, business and manufacturing experts to increase their odds of success.

Commercialization
Each team was also assigned a project manager (PM) to help applicants quickly commercialize their products. BCS provided most of the PMs, with each PM typically working on six to eight projects. Some technologies and applicants were further along than others; the advanced tech was fast-tracked into commercialization while the more rudimentary innovations were given additional development time.

Many of the established OEM applicants (Quidel, among them) needed minimal assistance due to their vast internal resources. The big OEMs sought expedited regulatory approval—those in the RADx program were given priority for FDA review and funding for accelerated facility expansions or new production lines.

The first stage of each project involved passing a third-party verification level of detection, which was performed primarily at Emory University and UMass Medical. The next stage was a verification and validation stage in which the product’s final design was completed and validated. In many cases, teams had to complete a lot of product work before design lock. This was challenging because in many cases design for manufacturing hadn’t been performed before PMs solicited vendors for tooling, automation and other long lead time tasks. Upon successfully completing clinical trials, the teams applied for FDA Emergency Use Authorization (EUA).

Early on, PM and the commercialization teams focused on larger, well known contract manufacturers (CMs) like Flex, Jabil, and Molex. But the big CMs were quickly overwhelmed by COVID-19 projects from the RADx program and non-applicants (either their own efforts or via the World Health Organization). The major CMs swiftly ruled out projects that didn’t meet their internal criteria or those with little chance of successful commercialization. After a while, some CMs stopped taking on new COVID-19 programs.

This led RADx teams to smaller CMs with fewer resources to develop the technology in-house, which of course, complicated the supply chain. Rather than working with one supplier, teams had to find independent product design firms, utilize multiple molders, and coordinate all other vendors instead of relying on a larger CM that could handle most of it on its own.

Many applicants were smaller startups that needed significant support. Some had only a few employees, and a good many had little or no commercialization experience. Such inexperience often forced RADx teams to establish quality systems from scratch (under an EUA, fully approved ISO 13485 systems are not required), select and implement ERP systems, build facilities, etc.

Swabs
In the pandemic’s early stages, specimen swabs were in short supply. Nearly all swabs used in the United States are manufactured by Puritan Medical in Maine but the company was overwhelmed with demand and couldn’t ramp up supply fast enough. The only other major U.S. swabs supplier is Copan of Italy. To help alleviate the shortage, the U.S. government invested heavily in new equipment and production equipment at Puritan’s operations in Maine and a lesser amount at Copan’s operation in Puerto Rico.

Nimble companies such as Durham, N.C.-based Yukon Medical (a RADx firm, assisted with EUA, financial and other resources) designed and quickly began production of injection-molded swabs as an alternative to Puritan and Copan swabs. Some tests approved later used saliva so swabs weren’t needed.

Other Challenges
NIH teams: Early on, internal NIH teams were not ideally composed. Sometimes applicants required skill sets that teams didn’t possess such as product design expertise. However, over time there was a better understanding of team members’ backgrounds and strengths, and team composition improved as new projects were assigned to those with the necessary skill sets and experience.

Applicant teams: Some teams with very little experience in business or commercializing products were learning on the fly, which added time and missteps to the process. The amount of resources the NIH could bring to RADx teams wasn’t always clear; some teams wanted to go their own way and take the lead on making commercialization decisions.

Private companies: RADx teams couldn’t force private companies to do anything they didn’t want to do. There were a few instances where RADx tried to acquire, license, or otherwise work with companies that developed potentially helpful technologies but the firms’ principals didn’t want to be part of RADx.

Capacity: With most U.S. companies operating with lean principles, open capacity was a challenge. There were situations that required 20-30 open injection-molding presses that no CM possessed.

Results
More than 800 submissions came through the RADx program. Of those, approximately 200 made it through to the Shark Tank for a deep dive assessment and vote by Shark Tank members. Conclusively, over 30 companies received commercialization assistance—money for manufacturing equipment, inventory, and other resources needed to ramp up production and market products as quickly as possible.

Conclusions
It was wonderful experience for everyone at BCS to be involved in this program and it was a great honor to work with many top U.S. scientists to make a difference in the COVID-19 pandemic. It’s impossible to communicate the level of time and commitment that went into this effort. The results of this effort will last long beyond COVID-19, as many technologies developed under RADx are applicable to various other diagnostic tests. Furthermore, contract manufacturers and others in the diagnostics supply chain will likely benefit for years to come as these new technologies continue to be commercialized and used to test other dangerous pathogens. 

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Andrew Potter is managing director of BCS, a consultancy that assists medical device OEMs and contract manufacturers optimize their manufacturing operations as well as help them grow organically and through M&A. Potter has been involved in the manufacturing of medical products for more than 25 years and started his career at Netstal Machinery, a provider of injection molding machines. Along with many of his BCS colleagues, he has served as a RADx project manager during the COVID-19 pandemic.