We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

Download Mobile App




Collaboration Helps Accelerate Launch of New Malaria Test

By LabMedica International staff writers
Posted on 07 Feb 2016
The recent launch of a new in vitro diagnostic (IVD) assay, CE-marked for detection of Plasmodium spp. More...
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



Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Magnetic Bead Separation Modules
MAG and HEATMAG
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
Gold Member
Automated Staining Unit
RAL Stainer
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: The 3D printed miniature ionizer is a key component of a mass spectrometer (Photo courtesy of MIT)

3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models

Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more

Molecular Diagnostics

view channel
Image: Signs of multiple sclerosis show up in blood years before symptoms appear (Photo courtesy of vitstudio/Shutterstock)

Unique Autoantibody Signature to Help Diagnose Multiple Sclerosis Years before Symptom Onset

Autoimmune diseases such as multiple sclerosis (MS) are thought to occur partly due to unusual immune responses to common infections. Early MS symptoms, including dizziness, spasms, and fatigue, often... Read more

Hematology

view channel
Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)

Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more

Immunology

view channel
Image: Exosomes can be a promising biomarker for cellular rejection after organ transplant (Photo courtesy of Nicolas Primola/Shutterstock)

Diagnostic Blood Test for Cellular Rejection after Organ Transplant Could Replace Surgical Biopsies

Transplanted organs constantly face the risk of being rejected by the recipient's immune system which differentiates self from non-self using T cells and B cells. T cells are commonly associated with acute... Read more

Microbiology

view channel
Image: Microscope image showing human colorectal cancer tumor with Fusobacterium nucleatum stained in a red-purple color (Photo courtesy of Fred Hutch Cancer Center)

Mouth Bacteria Test Could Predict Colon Cancer Progression

Colon cancer, a relatively common but challenging disease to diagnose, requires confirmation through a colonoscopy or surgery. Recently, there has been a worrying increase in colon cancer rates among younger... Read more

Pathology

view channel
Image: A new study has identified patterns that predict ovarian cancer relapse (Photo courtesy of Cedars-Sinai)

Spatial Tissue Analysis Identifies Patterns Associated With Ovarian Cancer Relapse

High-grade serous ovarian carcinoma is the most lethal type of ovarian cancer, and it poses significant detection challenges. Typically, patients initially respond to surgery and chemotherapy, but the... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.