Santa Clara, Calif. - October 25, 2018 - Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that the company has been recognized for Operational Excellence from The Shingo Institute, part of the Jon M. Huntsman School of Business at Utah State University. Based on a thorough assessment of organizational culture and operations, Cardiva’s manufacturing facility in Guaymas, Mexico was awarded the Bronze Medallion as recognition of the site's ongoing commitment to operational excellence throughout all levels of the organization.
“Receipt of the Shingo Bronze Medallion signifies an organization’s mastery of fundamental tools and techniques for improving an organization's operations,” said Ken Snyder, executive director at the Shingo Institute. “Organizations such as Cardiva that receive the Bronze Medallion are making great progress on their journey to achieving enterprise excellence.”
Built in 2014 to support growing sales volume of Cardiva’s vascular closure technologies, the Guaymas, Mexico facility is dedicated to manufacturing Cardiva’s VASCADE® Vascular Closure System and CATALYST® Closure Wire. Led by plant manager Jesus Beltran, the facility started implementation of the Shingo Principals as it was being designed and staffed, and since opening has grown the number of employees by over 700 percent. The plant has also supplied product for the recently completed AMBULATE Clinical Trial and will be the future manufacturing site of VASCADE® MVP - a first-of-its-kind mid-bore venous vascular closure device designed for multi-access electrophysiology procedures.
“True to the Shingo principles, Cardiva is committed to creating value for our customers by driving quality and delivering innovative vascular closure devices that help patients receive the best care possible,” said Justin Ballotta, Cardiva’s chief operating officer. “Implementing the Shingo principles has helped us create a culture committed to growth, continuous improvement, and lean processes, and we are grateful for the recognition and guidance from the Shingo Institute throughout this process.”
By implementing the Shingo Principals, Cardiva’s manufacturing facility has been able to support a three-year growth rate of 183 percent – a sales growth that recently earned Cardiva recognition on Inc. Magazine’s Inc. 5000 list as one of the fastest growing private companies in the United States.
Cardiva Medical, Inc. designs and develops vascular access management products that facilitate rapid hemostasis following diagnostic and interventional endovascular procedures. Since its founding, Cardiva has introduced a series of advanced vascular access management technologies that have been adopted by hundreds of leading medical centers.
Cardiva Medical will receive Shingo’s Bronze Medallion award during the Awards Gala at the 31st Shingo Conference held April 28–May 3, 2019, in Cincinnati, Ohio.
VASCADE is a fully integrated, extravascular, bioabsorbable femoral access closure system that is easy to use, leaves no permanent components behind, and has demonstrated safety and efficacy in a wide range of patients. The system combines Cardiva’s proven proprietary collapsible disc technology and a thrombogenic resorbable collagen patch in an integrated design. For patients and healthcare providers, VASCADE enables secure and rapid hemostasis while minimizing complications, including bleeding at the access site.
VASCADE works by placing a small, collapsible mesh disc against the inside of the vessel wall to temporarily stop the bleeding, releasing a collagen patch into the tissue and then removing the mesh disc. The collagen patch expands, providing a mechanical and physiological seal to stop the bleeding, and then absorbs into the body, leaving nothing behind and allowing further access to the vessel if additional procedures are required.
The VASCADE MVP System is a new, investigational device built upon the established and clinically proven VASCADE system.
Cardiva Medical, Inc. is a privately held medical device company focused on developing and commercializing innovative vascular closure technologies. The Company is headquartered in Santa Clara, California. For further information, visit our website at www.cardivamedical.com and follow up on Twitter at @CardivaMedical.
VASCADE® and Cardiva Catalyst® are registered trademarks of Cardiva Medical®, Inc.
The Shingo Institute is home of the Shingo Prize, an award that recognizes organizations that demonstrate an exceptional culture that fosters continuous improvement. Part of the Jon M. Huntsman School of Business at Utah State University, the Shingo Institute is named after Japanese industrial engineer and Toyota advisor, Shigeo Shingo. Dr. Shingo distinguished himself as one of the world’s thought leaders in concepts, management systems, and improvement techniques that have become known as the Toyota Production System.
Drawing from Dr. Shingo’s teachings and years of experience working with organizations worldwide, the Shingo Institute developed the Shingo Model™ which is the basis for its several educational offerings, including workshops, study tours, and conferences. Workshops are available in multiple languages through the Institute’s licensed affiliates. For more information on workshops, affiliates, or to register to attend the International Shingo Conference, please visit www.shingo.org.
Chief Financial Officer
Cardiva Medical, Inc.