Collaboration Helps Accelerate Launch of New Malaria Test

The recent launch of a new in vitro diagnostic (IVD) assay, CE-marked for detection of Plasmodium spp. DNA in whole blood samples, was accomplished on an accelerated schedule via collaboration with “lean principles” experts.

The accelerated product transfer and launch of the innovative “illumigene Malaria” test by Meridian Bioscience, Inc. (Cincinnati, OH, USA) was facilitated by collaboration with Lean Continuous Improvements, LLC (LCI; Cincinnati, OH, USA), a consulting firm expert in applying “lean principles” in conjunction with project management, to help minimize wasted time while maximizing product quality, and to facilitate team energy and conflict resolution. Meridian recognized a need to streamline the tasks and activities required to move its new test from product development phase through to final regulatory approval, and ultimately to clinical laboratories.


John A. Kraeutler, Chairman of the Board & CEO, Meridian, said, “The development of diagnostic tests is a highly complex process that involves multiple operating departments within Meridian. For us to achieve the highest efficiency in product transfer without sacrificing quality, we knew that we needed outside assistance. The team at LCI has a deep background in “Lean Transformation,” having worked with many diverse companies in many diverse areas such as Health Care, Lean Accounting, Product Development, Manufacturing, Supply Chain, and Total Maintenance. Our collaboration on the malaria test launch was a true partnership in which Meridian’s product-transfer team worked hand-in-hand with our LCI consultant to achieve a 3-month improvement in the final timeline. By increasing ownership, the team became a more disciplined, cohesive group.”

Gregory Battle, president and CEO of LCI, said, “The Meridian Bioscience C-Suite management team gave us great support all the way through the project. Lean Transformation is a ‘Systems’ approach designed so that clear standards are established and hidden problems surface, are identified, and resolved. With Lean Transformation, solutions are not ‘implemented,’ but rather problems are solved.”

He continued: “We start with grasping the situation where the work is done. We identify a problem area—a key business challenge with opportunities to demonstrate lean as a transformational system. [...] Leadership is the key for success; the top leaders within the facility must be actively, visibly involved in the vision-setting session and implementation.”

Related Links:
Meridian Bioscience
illumigene Malaria