This is one more example of how Silicon Valley companies are lining up collaborations with in vitro diagnostics companies to gain a foothold in the clinical laboratory marketplace
For years, Apple, Google, and other Silicon Valley companies have taken progressive steps to become more engaged in healthcare. One recent example of a Silicon Valley company willing to invest in clinical laboratory testing came last year in the form of a $10 million grant Apple (NASDAQ:AAPL) made to COPAN Diagnostics of Murrieta, Calif., to increase the speed and production of the company’s COVID-19 sample collection and transport products.
The interesting aspect of this collaboration was that Apple’s primary role was to help COPAN:
streamline workflow and speed of throughput,
help with the incoming supply chain, and
help develop outgoing supply chain solutions—along with some capital investment.
From the start of the pandemic in the winter of 2020, SARS-CoV-2 sample collection kits were one of many items that were in short supply here in the United States. To help address those shortfalls, teams at Apple, COPAN, and multiple other companies across the US worked to improve the work processes, automation, and machinery COPAN uses in its manufacturing and production sites. This collaboration increased production by nearly 4,000% between April 2020 and February 2021, an Apple news release reported.
In the news release, Jeff Williams (above), Apple’s Chief Operating Officer, said, “We are proud our Advanced Manufacturing Fund is supporting companies like COPAN who are playing a critical role in the fight against COVID-19 and assisting healthcare professionals and communities across the country. This collaboration helped produce, ship, and deliver millions of sample collection kits to hospitals from coast to coast—and we believe it is this unique combination of American manufacturing and innovation that will help us emerge from this crisis and build a safer world for us all.” (Photo copyright: Apple Insider.)
Healthcare Has Long Been a Target for Big Tech
Investment in different sectors of the US healthcare system by one of the Big Tech companies is not unusual. Apple, Google, Amazon, and Microsoft have looked for ways to expand their respective footholds in the healthcare marketplace for years.
In “How the ‘Big 4’ Tech Companies Are Leading Healthcare Innovation”—published a full year before the COVID-19 pandemic began—Healthcare Weekly noted that, “At a high level, each of the ‘Big 4’ tech companies are leveraging their own core business strengths to reinvent healthcare by developing and collaborating on new tools for patients, care providers, and insurers that will position them for healthcare domination.”
In 2017, Apple announced the launch of the Advanced Manufacturing Fund, saying that the $1 billion fund was a way to give back to communities through job creation. “By doing that, we can be the ripple in the pond. Because if we can create many manufacturing jobs around, those manufacturing jobs create more jobs around them because you have a service industry that builds up around them,” Apple’s CEO Tim Cook told CNBC at that time.
In 2018, Apple boosted the fund from $1 billion to $5 billion, the Mac Observer reported.
Apple’s $10 million investment enabled COPAN Diagnostics to expand into a new facility as well as hire 250 new employees. “We are proud our Advanced Manufacturing Fund is supporting companies like COPAN who are playing a critical role in the fight against COVID-19 and assisting healthcare professionals and communities across the country,” Williams said in the news release.
COPAN and the On-Going Need for COVID-19 Test Kits
COPAN Diagnostics was founded in 1979 in Mantua, Italy, and is now a global force in the manufacture of many sample collection and transport products such as instruments, automation, swabs, pipettes, and, of course, SARS-CoV-2 sample collection and transport kits. At the time of Apple’s investment, COPAN was producing sample collection and transport products at its Murrieta, Calif., facility. But demand for these products far outweighed the supply.
In an interview, Norman Sharples, CEO of COPAN Diagnostics and head of operations for North and South America, said he was hoping to increase production in the earliest days of the pandemic when Jeff Williams, COO at Apple, contacted him regarding the Advanced Manufacturing Fund. Along with the $10 million grant, Williams offered experts in engineering and sourcing to help COPAN increase production, the San Diego Union-Tribune reported.
The result was a new manufacturing facility in Carlsbad, Calif., which increased COPAN’S production of its sample collection and transport products used in SARS-CoV-2 testing by nearly 4,000%.
“From taking the keys to the building to actually getting the California department for public inspection, which allows us to go live and sell the product, that was just over 30 days, which is an incredible campaign that Apple helped us with,” Sharples told the San Diego Union-Tribune, adding, “It wasn’t just the funding. It was [the experts from Apple] applying their know-how and expertise to tilt this up very fast.”
Even as COVID-19 vaccines roll out, demand for SARS-CoV-2 tests—along with the necessary specimen collection and transport supplies—will likely continue. As the economy reopens, workers return to offices, and students return to in-person schools, precautionary screening for COVID-19 will remain necessary. “I think demand is going to flatten a little bit, but in any case, the baseline is going to be high because of surveillance,” Sharples said. “The back-to-work programs will drive more surveillance.”
Pandemic Increases Big Tech’s Dominance in Healthcare
Where many businesses and entire industries struggled with the pandemic, Big Tech apparently did not. In late October 2020, CBS News reported, “America’s largest technology companies are thriving despite the economy’s woes, according to earnings posted by Google-parent Alphabet, Amazon, Apple, Facebook, and Twitter on Thursday.”
Along with growing profits, Big Tech companies also consolidated their dominance. “As the pandemic made us even more dependent on digital technology, it has made the systemic importance and enormous power of the tech giants even more apparent,” according to an article in SciencesPo, titled, “Is the COVID-19 Pandemic a Victory for Big Tech?”
Might Big Tech Investments Target Clinical Laboratory Testing?
There’s no reason to believe that the big technology companies will slow their investment in healthcare anytime soon, and that investment may benefit clinical laboratories. In fact, in “11 Recent Big Tech Partnerships in Healthcare,” Becker’s Hospital Review listed several technology companies that will likely affect pathology laboratories.
Big Tech investment in genetic testing, artificial intelligence, telehealth, and other technologies may alter how clinical laboratories operate and revolutionize the healthcare industry.
While working to increase turn-around-times for STAT tests, Florida’s first coronavirus patient arrived, requiring SMH’s clinical laboratory team to adapt its plans
Despite the COVID-19 pandemic, the clinical laboratory team at 839-bed Sarasota Memorial Hospital, part of the Sarasota Memorial Health Care System (SMH) in Sarasota, Fla., not only implemented a new automated microbiology system, it also installed a new mass spectrometry analyzer, along with new instruments to support large volumes of SARS-CoV-2 testing.
How SMH’s microbiology laboratory team accomplished this while shelter-in-place directives in Florida caused many patients to stop visiting emergency departments and physicians’ offices—and as hospitals and medical laboratory facilities restricted access to staff and essential personnel—provides useful lessons for pathologists and clinical laboratory managers.
“Florida reported its first positive SARS-CoV-2 infection on March 2, marking the beginning of an outbreak that continues today,” he noted, adding, “This created the need to support the hospital in identifying infected patients in Sarasota County by having the microbiology lab acquire and set up more instruments. Also, the micro lab needed space for a new mass spectrometry analyzer to speed up pathogen identification this year.
In the same TDR interview, Olevia Fulkert, Microbiology Technical Supervisor at SMH said the microbiology lab had to reconfigure its layout to be prepared for the new COPAN system. “Our team had to arrange space for these new instruments, while protecting the space needed for the microbiology automation.”
“The WASPLab (above) literally went right into the middle of the busiest area of our lab,” said SMH’s Director of Laboratory Services, Harold Vore, MS, MT. “That’s the room we call COVID central, because that’s where we process all SARS-CoV-2 specimens.” SMH’s medical laboratory team began this implementation in the early months of the COVID-19 pandemic and relied on Lean processes to accomplish its goals. (Photo copyright: Sarasota Memorial Health Care System.)
Return of the ‘Snowbirds’
In August, SMH’s microbiology laboratory staff was busy validating the WASPLab instruments so the lab would be ready to process patient specimens when Florida’s snowbirds—out-of-state residents who arrive for the winter—return to Sarasota.
Vore knew several elements would be required for SMH’s microbiology automation project to succeed:
He had to assure the microbiology lab’s staff that adding automation would not cause any loss of jobs.
Timing of the implementation was critical, because lab test volume rises in the winter when tourists and part-time residents return.
Lean methods would be important because lab staff was familiar with them and they would help the vendor to arrange the physical layout and workflow to optimize productivity, reduce errors, and decrease turnaround times.
Vore needed documentation that showed automating the microbiology lab met and exceeded the return-on-investment projections he and his lab team used to persuade health system administrators of its value.
According to Vore, to date the installation has gone smoothly. “The staff in the microbiology lab has been phenomenal,” he commented. “They have continued to do what they always do, while at the same time we’re installing this large new system right in their midst.
“And they did not complain. In fact, they were eager to make progress in improving production,” he continued. “That attitude is common among our laboratory staff, because we saw the same thing happen when we automated our core lab.”
Increasing Microbiology Lab Capacity without Increasing Staff
Vore estimates automation will expand SMH’s microbiology laboratory capacity by up to 40%. “We measure that 40% in terms of the number of plates our techs can read per day with the WASPLab versus how we did it manually with our existing staff,” he explained. “We may still need to increase some staff. But even without adding staff, we thought we could move the peg further down the road in terms of throughput and improve our turnaround time too.
“We cannot make bacteria grow any faster and yet our specimen volume continues to increase,” he noted. “That makes automating microbiology the right strategy. Also, if we hadn’t automated the core lab starting in 2015, we might not have been able to handle the increased volume that we saw last year and this year’s additional surge in COVID-19 tests.”
How Lean Helped with the Implementation
Workflow in microbiology has traditionally been mostly manual. Therefore, combining Lean and automation can generate substantial benefits for a lab. “By definition, the design of the WASPLab is Lean,” Vore explained. “By that I mean the person who touches each specimen the least wins. That’s why the WASPLab is designed the way it is. Once we load a specimen in the front end, theoretically, no one needs to touch those plates until the testing is complete.”
“That’s the ideal we’re trying to reach,” he added. “At the moment, we still need to pull the plates to, as we say, ‘pick them.’ But we just introduced a way to improve that part of the process.
Adding Mass Spectrometry
“Along with the microbiology automation, we now read specimens digitally and we tell the machine to take a certain plate off so we can spot it,” Vore continued. “To speed up that process, we got some additional funding and bought a mass spec analyzer that uses MALDI-TOF to identify pathogens. Now we get the boost from the WASPLab, and we also use mass spec to cut six hours off our first read,” Vore added.
“The WASPLab and the mass spec give us higher quality incubation and better harvest of pathogens. Once we spot the plate, the mass spec can identify the pathogen in about two minutes,” he said.
“After going live with the mass spectrometry in August, we’ve made huge progress versus the normal process, where we would plate the specimen manually under a hood and then put the specimen in the incubator and pull it out to read 24 hours later,” he said.
“That whole step-by-step process to identify the pathogen could take 48 hours,” he continued. “But now we can move to a 24-hour, seven-day-a-week operation, where we can do first-in-first-out of pathogens in about 18 hours. That cuts six hours off the time to do the first plate read. Then we can spot it and get a result from the mass spec in two minutes. The impact for patient care can be tremendous.
“In a recent case, for example, we had to identify a specimen from an infant and used the mass spec to identify salmonella in two minutes,” Vore noted. “Normally that would take at least a day or more. That’s what I mean about making tremendous impact on patient care by using automation in microbiology.”
Clearly, this would be a challenging project for any medical laboratory to complete during the best of times, let alone during the early months of the COVID-19 pandemic. But through determination, the use of Lean, and a positive approach, SMH’s microbiology lab team implemented the first WASPLab in the state of Florida. And it will improve SMH’s ability to care for patients for years to come.
