Medtech has really stepped up this year to respond to medical device shortages brought on by the COVID-19 pandemic. Despite these impressive efforts, there remains a growing list of medical device shortages.
FDA maintains a publicly-available, up-to-date list of the medical device shortages tied to the pandemic. This list is part of FDA's obligation under the CARES Act, which was signed into law on March 27.
Of the 20 products that FDA listed on Friday, eight are categorized as testing supplies and equipment, nine are considered personal protective equipment, and three are ventilation-related products.
The testing-related shortages include: Clinical sample concentrator; Transport culture medium; Sterile swabs; microbiological specimen collection and transport devices; instrumentation for clinical multiplex test systems; real time nucleic acid amplification system; general purpose reagents for in vitro diagnostic tests; and microbial nucleic acid storage and stabilization devices.
The ventilation-related products include both non-continuous and continuous for both home and facility use.
COVID-19, China, and the tangled web of globalized supply chains
The severe medical device shortages revealed by the pandemic has led a number of companies to reevaluate their supply chains.
PlasticsToday Editor-in-Chief Norbert Sparrow wrote in May that when much of China’s manufacturing shut down earlier this year, OEMs with a globalized supply chain had a come-to-Jesus moment. There are no simple alternatives, however, Sparrow noted. China has a skilled labor force and highly developed infrastructure that is unavailable at scale in most other low-wage countries. Reshoring and near-shoring can be options — and perhaps they will become more consistent ones in the wake of the pandemic — but there is a cost involved that some will find hard to bear.
“If the U.S government provides direct and proper support and incentivizes domestic manufacturers [of PPE], I believe there will be some reshoring of production,” Mark Bonifacio told PlasticsToday, MD+DI's sister publication. “There will be at least a short-term effort to address reshoring and localization of supply chains. In medtech as in other industries, we have been talking about this for at least the last four years. There is a need to manufacture the right products in the ‘right’ places — Asia for Asia, EU for EU, and North America for North America."
Bonifacio added that when global conditions return to some sense of normalcy, “market forces will be back at work in terms of availability, labor, and material costs."
Bonifacio's firm Bonifacio Consulting Services works with medical device OEMs and contract manufacturers. He readily concedes that he has ties to a Hong Kong business with operations in China, which may color his thinking, and is an investor and board member of several U.S. manufacturing companies.
For Paul Sturgeon, CEO of recruitment firm KLA Industries and author of the weekly Talent Talk column in PlasticsToday, current talk about revisiting our working relationship with China is the continuation of a trend. Companies started looking for alternatives to China a few years ago as the cost advantage began to shrink, Sturgeon said.
“Not all of that manufacturing will come back to the United States, but there are other countries in Asia, and I feel like a lot of companies are looking at Mexico again because of the new trade agreement,” Sturgeon said. “I was shocked to learn that 90% of our antibiotics are made in China along with such products as face masks."
Rushing supplies to the COVID-19 forefront
As MD+DI reported in April, the Global Healthcare Exchange (GHX) set up the COVID-19 Information Center to help healthcare organizations and manufacturers of medical supplies manage any shortages and navigate a shifting supply chain. The group has also developed a Critical Supply Reference List to help providers identify supplies and potential alternatives as well as offer greater visibility into the fluctuating demand for products.
“The COVID-19 pandemic places intense pressure on manufacturers to get critical products into market faster,” Denise Odenkirk, vice president of supplier sales at the GHX, told MD+DI. “GHX is leveraging several solutions and has created a few resources to help manufacturers.”
MD+DI asked Odenkirk how GHX can help these manufacturers get their products into the supply chain faster.
“As providers rapidly create overflow care locations—hotels, conference centers, outdoor areas — GHX has enabled a team to configure and enable these new locations and ensure supplies reach them,” she said. “Manufacturers can leverage standard GHX tools to enable their order-to-cash processes with these overflow locations in a fast, seamless manner.”
Supporting agile scale ups to address medical device shortages
Also in April, MD+DI reported on ATS Automation Tooling Systems' efforts to assist medical device manufacturers in scaling up production of critical devices during COVID-19. ATS is also working to enable manufacturers in other industries to quickly pivot to making products used in treating or diagnosing the disease.
With more than 40 years in business, roughly 55% in life sciences, ATS has experience in manufacturing medical devices requiring the highest product quality. “This is the world we live in — we are used to this,” said Andrew Hider, ATS Automation’s CEO, in an interview with MD+DI. “We are a global organization and we own many different companies under our umbrella,” he said, noting that in addition to life sciences, the company has experience in the nuclear and automotive spaces. “The machines, the process, and the technology—we can build the entire production line, whether it's a portion or the full assembly,” he said.
Manufacturing opportunities born from disruption
While COVID-19 has been brutal to the global manufacturing and supply chain ecosystems, the companies that survive will be the ones that recognized the innovation opportunities in the mix — not just the problems.
Dubbed the Amazon Web Services of hardware manufacturing by TechCrunch, Fictiv is a cloud-based network of hundreds of manufacturers, primarily in the United States and China. Conducted with Dimensional Research, the fifth annual manufacturing industry report released this week polled hundreds of senior manufacturing and supply chain decision makers at companies producing medical device, robotics, automotive, aerospace, and consumer electronics products.