Published in Fall 2021 MPO Magazine
Since early 2020, COVID-19 has deeply impacted our lives and has sadly resulted in many deaths. In March of 2020, Congress passed the “CARES ACT”, which was the first major legislative action to address the COVID-19 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 improving clinical high throughput laboratory tests that can detect the COVID-19 virus.
Mark Bonifacio, President of BCS, was one of the 12 members of a “Steering Panel” to assess the merits of each proposal. In other words, Mark was one of the Sharks. Mark was selected for his knowledge and years of experience in the global medical device and life sciences manufacturing and supply chains. The other sharks are the country’s leading scientists and experts in the IVD testing market.
One reason RADx was able to come together so quickly was 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 of Harvard Medical School, Mass General Hospital, MIT, and Draper Labs; 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 came from these organizations.
Applicants making it through an initial screening were assigned a “Team Lead”, usually a PhD 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” where they delivered a perfectly timed, technical presentation and then got interrogated by the Sharks.
If the project was approved by the Shark Tank it would go on to the NIH for final approval. Applicants that got NIH approval were assigned technical, regulatory, business and manufacturing experts to increase the odds of success.
Each team was also assigned a Project Manager (PM) to assist applicants get to commercialization as quickly as possible. BCS provided a majority of the PMs. Each PM typically worked on 6-8 projects. Some technologies and applicants were further along than others. The advanced ones were fast tracked into commercialization while others needed more time to develop their technology.
Many of the applicants were established OEMs – such as Quidel – and didn’t need much assistance as they had deep internal resources. The big OEMs were looking for expedited regulatory approval – RADx companies had a priority at FDA – and funding for acclerated facility expansions or new production lines.
The first stage of each project was to pass 3rd party verification level of detection (LOD). This 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 locked in and validated. In many cases, teams had a lot of product work to do before design lock. This was a problem from a manufacturing perspective as in a lot of cases design for manufacturing (DFM) hadn’t been performed before PMs were lining up vendors for tooling, automation and other items that had long lead times. Upon successful completion of the clinical trials, the teams applied to the FDA for an Emergency Use Authorization (EUA).
Early on Project Managers and the commercialization teams focused on the larger, well known CMs such as Flex, Jabil, Molex. But quickly the big CMs got overwhelmed by COVID-19 projects, not just from the RADx program but from companies working on their own or through other COVID-19 testing initiatives such as through the World Health Organization (WHO). The major CMs quickly began to screen out programs that didn’t meet their internal criteria and ones they didn’t feel would successfully commercialize. After a while, some CMs stopped taking on new COVID-19 programs.
This led RADx teams to smaller CMs that didn’t have the resources to ramp the entire program in-house. This, of course, complicated the supply chain. Rather than working with one supplier now teams had to find independent product design firms, utilize multiple molders and coordinate all other vendors rather than rely on a larger CM that could handle most of it on their own.
Many of the applicants were smaller, start-ups which required tremendous support. There were startups that only had a few employees. And it wasn’t uncommon for these groups to have little or no commercialization experience. RADx teams in some cases had to establish quality systems from scratch (under an EUA fully approved ISO 13485 systems aren’t required), select and implement ERP systems, build facilities, etc.
In the early stages of the pandemic, specimen swabs were in short supply. Nearly all swabs used in the US are manufactured by Puritan Medical in Maine. Puritan was overwhelmed with demand and couldn’t ramp supply quickly enough. The only other major supplier of swabs in the US is Copan of Italy. The US government quickly 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 Yukon Medical (RadX company, assisted with regulatory EUA, financial and other resources) in North Carolina, designed and quickly began production of injection molded swabs as an alternative to Puritan and Copan swabs. Some of the tests approved later used saliva so swabs weren’t needed.
NIH Teams – Early on, internal NIH teams weren’t ideally composed. Sometimes applicants required skill sets that teams didn’t possess such as product design expertise. However, as time went on and there was better understanding of team member’s backgrounds and strengths, team composition improved as new projects got assigned to people with the necessary skill sets and experience.
Applicant Teams – Some teams had very little experience in business or commercializing products. They were learning on the fly. This resulted in extra time and going down the wrong path on numerous occasions. In some cases, I think it wasn’t always clear the amount of resources that the NIH could bring to RADx teams. In other cases, some teams appeared to want 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 had technologies that might have been helpful but the principals didn’t want to be part of RADx.
Capacity – With most US companies operating with lean principles open capacity was a challenge. There were situations that required 20-30 open injection molding presses that no CM has.
In total, over 800 submissions came through RADx program. Of these, approximately 200 made it through to the Shark Tank for a deep dive assessment and vote by Shark Tank members. In the end over 30 companies received commercialization assistance – money for manufacturing equipment, inventory, and other resources needed to ramp and get product into the market as quickly as possible
It was wonderful experience for all us at BCS to be involved in this remarkable program. It was a great honor to work with many of the country’s top 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 of the technologies that were developed under RADx are applicable to many other diagnostic tests. Furthermore, I expect contract manufacturers and others in the diagnostics supply chain to benefit for years to come as these new technologies continue to commercialize and be applied to tests other than COVID-19.
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 mergers and acquisitions. Potter has been involved in the manufacturing of medical products for over 25 years and started his career at Netstal Machinery, a leading provider of injection molding machines. Along with many of his BCS colleagues, he has served as a RADx project manager during the COVID pandemic.