Innovative Technology Manufacturing Infrastructure to Scale with Demand, Support Quality Control and Regulatory Compliance
FOOTHILL RANCH, Calif – iBASEt announced today that Earlens Corporation, Inc., a Silicon Valley-based medical technology company that has created a revolutionary hearing aid, will implement iBASEt’s Solumina software as its Manufacturing Execution System (MES).
Unlike conventional hearing aids, Earlens is pioneering a fundamentally new design using light and a small lens placed in the ear to create a rich, natural sound, delivering the broadest frequency range of any hearing aid on the market.
Earlens has created a breakthrough manufacturing infrastructure using 3D printing to improve design flexibility and support faster time-to-market. Solumina will be installed at the company’s corporate headquarters in Menlo Park, CA, to manage production in this innovative environment while focusing on quality control and cost efficiency.
“We are excited to work with iBASEt to put in place an innovative technology manufacturing infrastructure,” said Mark Bishop, VP of Operations of Earlens. “We believe it is a smart move for us to implement an MES/QMS solution now, in the early stages of our business, so that we can rapidly scale production to meet growing demand for our product and keep pace with design changes and improvements.”
Working with iBASEt, Earlens will put in place the necessary systems to manufacture its innovative new product, improving the average completed device lead time and quality of data entry. The manufacturing system will also reduce batch file administration efforts of electronic device history records (eDHR), which keep a full record of the products produced to ensure quality and compliance of 21 CFR Part 11 and Part 820 throughout the process. Solumina will also help increase product yields and provide visibility into current work order status by manufacturing supervisors and office personnel.
“Additive manufacturing, using 3D printing technology, is a fundamentally new approach that offers manufacturers a number of advantages over traditional methods for better design flexibility, time to market and cost control,” said Vic Sial, President of iBASEt. “We appreciate the confidence Earlens has placed in iBASEt by choosing our software and team of experts to put in place the innovative manufacturing infrastructure the company needs to manage production, streamline operations and meet changing design and regulatory requirements.”
Earlens Corporation is a privately held medical device company committed to providing hearing impaired patients a hearing solution designed to revolutionize the current standard of care. The company has developed the Earlens Light-Driven Hearing Aid, the first hearing device to use light to transmit sound. In late 2015, the FDA granted a De Novo allowing Earlens to market their Light-Driven Hearing Aid. Incorporated in 2005, Earlens Corporation is headquartered in Menlo Park, California.
iBASEt is a leading provider of software solutions to complex, highly regulated industries, like Aerospace and Defense, Medical Devices, Nuclear, Industrial Equipment, Electronics, and Shipbuilding. iBASEt’s Solumina software streamlines and integrates Manufacturing Execution Systems and Operations Management (MES/MOM), Maintenance, Repair and Overhaul (MRO)and Enterprise Quality Management Systems (EQMS) for operations and Supplier Quality Management. Solumina is implemented by many industry leaders in the Aerospace and Defense sector, including agencies of the U.S. Government.
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