Cardiff, UK – 16th July 2015 – EKF Diagnostics, the global in vitro diagnostics company, announces the appointment of a number of senior personnel to key new roles to drive new product introductions. Craig Wilson joins as Global Director of Product Development, Process and Governance, and Yvonne Middlefell has taken up the role of Global Director of Quality Assurance and Regulatory Affairs.
These new roles have been created following a series of acquisitions in recent years which has seen the evolution of EKF from a specialist manufacturer of a small range of analyzers with niches in diabetes, sports medicine and blood banks, to a global business with expertise across three core divisions: Point-of-Care, Central Laboratory and Molecular Diagnostics. Building on a leadership team overseeing EKF’s new product pipeline, Craig and Yvonne’s new roles will help to ensure the continued and efficient delivery of new quality products from this expanding IVD business.
Craig has more than 20 years’ experience across Pharma, Consumer and Medical Devices industries and joins from Johnson & Johnson where he held leadership positions in new product development, portfolio and program management. He will work closely with EKF’s Chief Technology Officer, Tito Bacarese-Hamilton, to bring process standardisation and improvements for the effective delivery of EKF’s new product portfolio.
Yvonne will provide leadership to the Quality Assurance and Regulatory Affairs organization across EKF and will champion the integration of the QA/RA function. This in turn will ensure best practice and keep the organization abreast of the latest regulatory intelligence to support the rapid introduction of new products. Yvonne holds 26 years of Global RA experience having worked in a number of key multinational IVD and medical device corporations. Prior to joining EKF, she worked as an Executive Director at NSF Health Sciences Ltd.
In addition to creating the new roles bringing structure and discipline in product development governance as the company continues to grow, EKF has also restructured its organization into the three aforementioned divisions of the IVD sector. These are further segmented into key markets; for example, the Point-of-Care division is made up of: Hematology; Diabetes Care; and Maternal and Women’s Health. Each of these business units are overseen by an experienced director. For example, holding over 20 years’ experience in international medical technology companies, Karin Dahllof has recently joined EKF from CellaVision as EKF’s Business Unit Director for Hematology.
“It is essential to have the right structure and people in place so that we are able to deliver the products and services that satisfy our customers,” commented Julian Baines, EKF Diagnostics CEO. “It is also crucial that we have a strong understanding of the regulations that guide new product introductions. For example, several of the key regulations that affect Medical Devices and IVD products are due to change this year. These changes will have far reaching implications for the industry and EKF as a whole. An early understanding of the pending changes coupled with good planning can ensure that we remain successful and in a state of compliance.”
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Editors’ notes
About EKF Diagnostics - www.ekfdiagnostics.com
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, Separation Technology Inc., DiaSpect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases. Its new molecular division, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.
Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.
Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.
Molecular Diagnostics: In March 2013 EKF set up a new division to focus on molecular and companion diagnostics following the acquisition of UK-based 360 Genomics. EKF Molecular Diagnostics’ technology, PointMan™, is capable of detecting mutant genes from tiny biopsy and blood samples and has recently entered a partnership with the world renowned cancer research center at Massachusetts General Hospital, USA.
EKF Diagnostics’ strengths lie in its multi-national research and manufacturing facilities, teams of experienced analysts and engineers in Germany, Ireland, USA and the UK, and a board led by some of world’s foremost authorities in medical diagnostics.
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