6 Challenges Companies Face with COVID-19 Test Kit Production

6/10/2020 Cóbhan Phillipson

As the uncertainty created by the global pandemic rumbles on, one thing there is widespread agreement on is the need for more testing. Increased testing and quicker identification of COVID-19 cases can help to prevent spread by isolating infected people.

Health authorities can then start to identify close contacts of infected people and respond appropriately as more positive cases emerge. Increased testing also provides investigators with more data on the level of contagiousness of COVID-19 and the true scope of the outbreak. 

However, as we have witnessed, ramping up testing to the required levels is far from simple. Such an unprecedented surge in demand for test kits brings its own set of problems including component and equipment shortages. The time, labor, and logistical planning required to meet the demand for COVID-19 testing also present a considerable challenge. Laboratories wishing to develop new diagnostic tests had to obtain regulatory approval before they could launch.

The challenge(s) with meeting demand

Meeting this challenge requires a coordinated response from both the public and private sector. The FDA, for their part, fast-tracked the approvals process of a number of diagnostic tests. Meanwhile, in the private sector, leading companies have gone about retooling their production lines towards equipment, diagnostic tools, and hand sanitizers to help in the battle against COVID-19. 

However, companies still face a number of difficulties ramping up test kit production. There are a number of issues:

• Requirements for Covid-19 testing are rapidly increasing globally. While the level of testing has increased, there is still a worldwide demand for increased testing including antibody testing, according to the CDC, which can show if people have had a past infection with the virus that causes COVID-19. Antibodies can help provide protection against getting the disease again.  
• Companies may not have the knowledge or resources to kit the test kit and bring all elements of the solution together. The pandemic has seen many companies without a background in test kit production launch their own COVID-19 tests. One potential issue that may arise here is that while companies may have the expertise needed to develop an approved test kit, they may not have the additional resources needed to bring it to market. Launching and ramping test kit production requires a robust supply chain incorporating elements such as test kit assembly, kitting, packaging, fulfillment, and distribution. 
• COVID-19 wasn't in companies' product planning roadmaps so they are having to scramble for a solution. The speed with which COVID-19 spread means that many companies had given it little or no consideration in their product roadmap. As a result, we are now in a situation where companies are hastily reallocating resources towards COVID-19 test kit production - and considering the demand for test kits, these additional resources still might not suffice. 
• COVID-19 test kits have regulatory requirements. Healthcare is a highly regulated industry and companies launching new test kits must first gain regulatory approval. Production must then take place in regulatory compliant facilities - which may prove difficult to companies who are new to the space or even established companies who are maxing out on test kit production capacity. 
• There is a worldwide shortage of some COVID-19 test kit components. We have already seen component shortages slow down testing earlier in the pandemic. Companies that do not possess Strategic relationships with key global commodity suppliers may run into difficulties sourcing test kit components.
• The kits are complex. There is a high level of supply chain complexity involved in the production of a test kit. Assembly can be difficult as each kit contains a number of components such as vials, swabs, conjugate release pads, test lines, control lines, and adhesive backing.

One effective, holistic solution 

One way companies can overcome these hurdles is to work alongside a supply chain partner who can take ownership of the entire test kit process. By working with a supply chain partner, companies can navigate their way around issues such as labor shortages, component sourcing, kit assembly, and regulatory compliance. Additional benefits may include:

• Reduced time-to-market for kits with a single interface and global reach
• Reduced total supply chain cost from design through to final kit delivery
• Ensure brand consistency with attractive kit packaging
• Streamline national and global processes with enhanced planning and forecasting

Companies who are new to the test kit space can benefit from working with a partner who has the knowledge and expertise required to produce and scale test kit production. Other companies who are struggling to meet demand will benefit from the extra capacity a supply chain partner can provide. 

 

Cóbhan Phillipson is Market Development Executive of Supply Chain Solutions at RRD. With over 20 years experience in medical manufacturing, this division has the capabilities and scope to help companies quickly ramp up test kit production. RRD’s global footprint means we can quickly bring capacity online. We are a one-stop-shop for test kit production — managing the entire product life cycle including print, packaging, labels, commodities, kitting, fulfillment, and logistics.