Medical technology manufacturing companies in China that were expecting a profitable first quarter are in for a shock. The coronavirus has evolved into a global crisis that brings about overwhelming challenges and many new opportunities for non-medical industries across the world.
Within the first week of lock down in the United States, which was permitted in an attempt to slow the spread of the coronavirus, nine companies have received emergency use authorization from the FDA to test for the virus. Test developers are struggling to boost test kit manufacturing speed despite having inadequate supplies.
Non-contact package drop-offs are the only way to currently transport crucial medical supplies, and this poses an additional security threat. Medical companies are looking into secure ways to implement an unattended transfer of medical supplies to ensure that the packages arrive safely and do not expose workers.
Critical care supply manufacturers that make personal protective equipment and ventilators are also being pressured into making more as healthcare workers fear that their lack of supply will lead to unnecessary deaths.
In a series of chain-like events, medical device companies are feeling the impact of COVID-19 related crises trickling down from authorities and healthcare workers. This includes a massive decrease in stock values, which leads to many medical suppliers being unable to conduct in-person sales transfers and operations. As a result, many critical medical devices are being put on hold until a safer strategy is reached.
Here is how some other agencies are responding to the COVID-19 pandemic emergency:
New York public health laboratory is running out of reagents and swab supplies needed for COVID-19 test kits despite having adequate staffing, indicating a nationwide struggle among similar companies facing pandemic. The U.S Surgeon General is advising hospitals to cancel elective surgical procedures or move them to outpatient locations when feasible to free up space for COVID-19 patients and reduce exposure while also urgently decreasing essential equipment and supplies used to treat non-life threatening patients.
According to CDC Director Robert Redfield, some reagents that are essential for conducting COVID-19 tests are now in short supply. The government is trying to support faster production of tests that can detect the virus in one hour from other manufacturers after the Department of Health and Human Services funds $679,000 to DiaSorin Molecular and $598,000 to Qiagen.
Swiss pharma and diagnostics company Roche is the first company to reach EAU status for a COVID-19 commercial diagnostic test. The FDA stated that more than 60 developers worked with Roche on this project and more than 30 labs also plan to begin testing under a recently issued coronavirus policy. Roche expects to make millions of tests per month. Tests will be able to deliver results within 3.5 hours.
Vice President Mike Pence stated that more than one million COVID-19 tests have been distributed across the United States for public use and another four million are expected. However, lawmakers acknowledge that medical labs are becoming overwhelmed trying to meet the demands of the pandemic and they are trying to remedy this by providing financial support. For example, Hologic manufacturing company received support for a diagnostic test that is capable of processing up to 1,000 tests within 24 hours. This test is expected to be available within weeks.
LabCorp is another company stepping up to make public tests. The company announced that it would begin offering test services shortly after the market shutdown began. This comes after the FDA gave approval for lab developed tests or LDTs to start assessing people for the virus before getting EAU approval. Some of these changes may be permanent, according to the bipartisan Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020. The FDA is also tasked with seeking the proper balance to help permit the immediate use of these tests. For example, labs are still required to submit an emergency use authorization request to the FDA 15 days after a new test is created.
Despite these many changes, hospital workers are still concerned about running out of supplies. They are seeing staff shortages and do not have the equipment needed to properly treat their patients. The FDA is working to free up the supply chain so that hospitals have what they need. The American Hospital Associated asked congress for an extra $1 billion to aid support. This is on top of the $2.5 billion approved by President Trump to support the urgent need for hospital supplies. In the meantime, hospitals are reviewing their plans to take action when COVID-19 patient numbers inevitably increase and stress the system.