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    Case Study: Expedited Medical Device Assembly for COVID-19 Self-Test Kits

    medical device assembly

    Introduction

    A manufacturer of COVID-19 self-test kits based outside the United States was searching for a logistics partner with specialized medical device assembly capabilities to kit and introduce their product to the American market. Recently, an overwhelming demand for Coronavirus self-test kits is spurring expansion of kit production. The client scope of work included a large initial quantity of kits in a short time period followed by an expedited ramp-up to increase capacity. The solution was for WDSrx to implement a successful ongoing program to provide necessary kits to the public.

    Challenges

    medical device assembly

    WDSrx needed to construct additional assembly lines to accommodate the increased production of rapid COVID-19 self-tests.

    One of the primary challenges with this medical device assembly project was the high volume of kits required to be made on a daily basis. The large quantity meant the need for more people, more resources, and more time to accommodate the heavy workload.  The acquisition of labor is an ongoing challenge during pandemic conditions.

    Another challenge was the inclusion of multiple components in each kit. The test kit’s accuracy relies on having all the necessary parts put together correctly. Incomplete kits could result in low customer satisfaction due to a broken device or one that reads incorrectly.

    medical device assembly

    Production Technicians assemble kits accurately and efficiently.

    Required was a facility reconfiguration in advance to support the scale of the project. The recommendation was for the employment of new equipment for the project to increase efficiency.  The timeline for project completion was very tight. Necessary quick approval of project design, resource allocation and testing ensured the team would finish the production run and meet client expectations.

    Large-scale medical device assembly required consistent inbound deliveries to feed the production effort. Additionally required was the coordination and delivery of high quantities of individual components, manufactured in multiple countries.  To avoid production delays, WDSrx ensures delivery of necessary components within short time frames.

    Solutions

    COVID Kit Assembly

    A semi-automated medical device assembly line strategy eases production technician workload, while circumventing ongoing labor shortages.

    With advanced planning, WDSrx together with the client mapped out strategies based on sales forecasts to develop the most efficient solution to manage kit assembly with quality and speed. Purchasing specialized machinery and automated equipment to support the project ensured the production team met deadlines. WDSrx opted for a semi-automated solution to increase productivity and ease workload for human labor.

    WDSrx redesigned the flexible production suites inside the warehouse to maximize productivity. Teams organized interior stations and configured them to resemble assembly lines. WDSrx utilized existing labor resources as well as adding new labor as needed. Technicians installed equipment and machinery including conveyor systems, scales, scanners, labelers and printers.

    medical device assembly

    A conveyer equipped with a scanner maintains a consistent flow of fully assembled kits for packaging and immediate fulfilment.

    The WDSrx production team coordinated with the client to create an inbound delivery schedule for each of the 12 components included within each test kit.  Technicians check deliveries upon receipt to confirm the correct order quantities and contents.  Discrepancies are immediately relayed to the client.

    Constant communication with the client allowed the WDSrx inventory management team to schedule inbound deliveries and feed components to the production line when required. This process assured consistent and sufficient inventory at all times to maximize production output. When changes were made in the packaging process, the client was able to communicate to the team for immediate response.

    Conclusion

    Successful planning produced a solution for ongoing production of COVID-19 test kits. The production blueprint established in the original facility expanded to multiple warehouses for efficient increases in product quantities. The measured approach to project conception and implementation reinforced client confidence and increased the supply of test kits to the public.

    Capabilities Utilized

    Kitting and Assembly – Gathering  individual items for consolidation into a single unit enabled a medical device manufacturer to satisfy demand for COVID-19 self-test kits when they entered the U.S. market.

    Warehousing and Fulfillment The WDSrx team works with clients to plan inbound deliveries and forecast outbound fulfillment.  Precise quantities of multiple components were scheduled for receipt and provided to the production team for maximum output of COVID-19 self-test kits.

    For further information contact WDSrx at info@wdsrx.com or (561) 998-3885.

    Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at jsolomon@wdsrx.com or (561) 998-3885 x316.