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FDA-compliant outsourced manufacturer brings complex, highly integrated medical devices to market faster
PowerFoot BiOM by iWalk. Photo courtesy of iWalk, Inc.
Online PR News – 12-April-2011 –Coghlin Companies, a privately held company specializing in helping companies cost effectively improve their time-to-market, today announced a partnership with iWalk to commercially manufacture its PowerFoot BiOM - the first bionic lower leg system to replicate lost muscle function and allow amputees to walk with reduced stress to the rest of the body.
Driven by its vision to become the leader in bionic technology that transforms physical disability into ability, iWalk selected Cogmedix as its FDA-compliant medical device manufacturer based on the company's proven ability to bring complex, highly integrated finished medical devices to market faster - with total compliance adherence. The BiOM is the first in a series of advanced bionic products by iWalk that can potentially emulate physiological function through robotic replacement.
"The PowerFoot BiOM is the only prosthetic system to allow amputees to walk as if their legs were biological once again," said Tim McCarthy, President and CEO of iWalk. "There is a tremendous need for this technology among US veterans, soldiers and civilians. By partnering with Cogmedix, we can reduce our time-to-market and bring this innovation to the people who need it most."
iWalk selected Cogmedix based on the company's FDA QSR compliant medical device manufacturing capabilities, greater Boston location and experience with complex technologies. As a subsidiary of Coghlin Companies, Cogmedix leverages 126 years of contract manufacturing history, experience and financial stability.
Cogmedix's precise and compliant manufacturing of the PowerFoot BiOM includes extremely advanced technologies and test protocol such as:
• advanced Printed Circuit Board Assemblies (PCBAs) with integral inertial sensing;
• sensors including force, torque, and position;
• a lithium polymer battery and quick charge technology;
• advanced materials such as titanium;
• a specialized high-energy spring;
• servo motor technology;
• intertial testing with SCARA robots;
• automated torque testing; and
• spring constant verification.
iWalk also called upon Coghlin Companies' subsidiary DCI Engineering Services to document, make improvements to, and build additional test systems for deployment into manufacturing.
"iWalk's technology is nothing short of amazing. The PowerFoot BiOM includes extremely sophisticated technologies that when applied together change peoples' lives," said Matt Giza, General Manager, Cogmedix. "Cogmedix and Coghlin Companies are honored to be part of such a progressive initiative and are committed to putting our FDA compliant manufacturing resources and processes toward bringing the PowerFoot BiOM to commercialization quickly, safely, and cost-effectively."
About iWalk, Inc.
Founded in 2006 and based in Cambridge, MA, iWalk Inc. is a developer of advanced bionic systems designed to improve the quality of life for all people afflicted with limb pathology. The PowerFoot BiOM is the first product in the iWalk scientific platform designed to normalize human function through bionic science. For more information please visit www.iwalk.com.
About Coghlin Companies, Inc.
Coghlin Companies, Inc. is a privately held company specializing in helping companies cost effectively improve their time-to-market. Based in Worcester, Massachusetts, Coghlin Companies spans four generations representing more than 126 years of manufacturing experience and leadership. Subsidiaries include: Columbia Tech, which provides turnkey manufacturing services to a diverse customer base, including OEMs in the bio-science, semiconductor, LED, medical device, green energy technology, data storage, and automation systems and controls industries; DCI Engineering, an engineering design and pre-production support services company; and Cogmedix, an FDA compliant and ISO 13485 certified medical subassembly and finished medical device contract manufacturer. For more information, please visit www.coghlincompanies.com or sign up for the Coghlin Companies e-Newsletter at http://coghlincompanies.com/newsletter-signup.php.
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