COMPONENTS & ASSEMBLY
STEP UP TO SCALING UP ADVANCEMENTS IN DETECTING AND PREVENTING COVID-19 BODE WELL FOR SIMILAR TESTS FOR OTHER MEDICAL CONDITIONS. KEVIN YOUNG, VICE PRESIDENT OF CORPORATE DEVELOPMENT & MEDICAL, WEB INDUSTRIES, INC., EXPLAINS HOW MANUFACTURERS CAN SCALE UP TO KEEP PACE WITH CURRENT AND POST-COVID DEMAND FOR RAPID DIAGNOSTIC TESTS.
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n response to COVID-19, medical device OEMs and their suppliers are facing demand for vast quantities of reliable diagnostic tests that yield timely results. The demand will likely outlast the current pandemic and extend well beyond the many tests developed to detect the virus. The widespread distribution of COVID-19 tests, such as lateral flow immunoassay (LFI) antigen tests, is already generating increased interest in rapid tests for other medical conditions. Advancements in COVID-19 detection and prevention will assist in their development. Scaling up to produce millions of rapid tests often requires manufacturers to make significant operations changes, especially in three categories: • Technology and automation • Supply and infrastructure • Staffing and workforce development. TECHNOLOGY AND AUTOMATION Before COVID-19, diagnostic tests were usually made manually and in small quantities (Figure 1). Production took place in separate batches as
components moved from one process to the next. This was fine for making thousands or even tens of thousands of test devices per week but inadequate for largescale production. For large quantities, manufacturers and their suppliers need fully automated and integrated production lines, including those that assemble multiple test device components. Each step of the test-making process must be mechanized, from the preparation of test chemistries to the application and lamination of test formulations to materials. Reel-to-reel (Figure 2) and pickand-place systems are examples of equipment that provide accuracy and speed, with little need for human intervention. Beyond this, the sheer pace of production necessitates automated camera and vision systems to monitor the process. Such cameras use sensors and software algorithms to produce images and automate visual inspection tasks. They can quickly identify defects and alert operators when problems arise.
Figure 1: Pre-pandemic, LFI diagnostic test manufacturing was a highly manual batch-based process. (Photo courtesy of Web Industries)
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SUPPLY AND INFRASTRUCTURE Manufacturers may need to overhaul their plant infrastructure to house new production lines,
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