Medical Devices • November 4, 2016

Why Earlens Selected Solumina as Their MES Solution

Tom Hennessey Tom Hennessey

The Earlens hearing aid uses light and a small lens placed on the eardrum to directly activate the natural hearing system. The result is rich, complete sound that typically makes it easier to understand people in noisy environments and participate in group situations. With this revolutionary hearing aid, Earlens (Menlo Park, CA) is changing the way the world thinks about hearing aids. iBase-t helped Earlens change the way it thinks about the manufacturing process.

While Earlens is a young company, the promise of its new technology is likely to make a very big impact in the hearing aid market. What’s more, the company also created breakthrough manufacturing infrastructure using 3D printing to improve design flexibility and support faster time-to-market.

Earlens will be installing iBase-t’s Solumina at its corporate headquarters to manage production in this innovative environment while focusing on quality control and cost efficiency.

“We are excited to work with iBase-t to develop this leading-edge technology manufacturing infrastructure,” says Mark Bishop, VP of Operations at Earlens. “We believe it’s a smart move for us to implement an integrated 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.”

Selecting Solumina with a Tailored Product Demonstration

“Earlens may not have known very much about Manufacturing Execution Systems (MES) when they began their investigation; but they knew they needed to go integrated-paperless on the shop floor,” says Lou DeMatteo, Medical Device Manufacturing Account Executive at iBase-t. “They hired an independent consulting firm to help them with their MES decision.”

An RFP was sent out to numerous Manufacturing Execution System vendors. “We were probably the only company that tailored a demonstration specifically to Earlens,” says DeMatteo. “We asked them to send a copy of their work order instructions and everything else they were using to define and control the work. We keyed all that data into our standard product, then went on site and released work orders to the shop floor and sent them through the entire operations cycle. Consequently, they were able to see their product being produced in every situation they had identified as critical on the shop floor.”

The whole process was built into the software for the demonstration. So when iBase-t made its presentation, it was “a day in the life” of Earlens, presented to them in two or three hours.

After the product demonstrations, Earlens narrowed the selection to Solumina and one other Manufacturing Execution System package. They compared both in terms of features, functionality, and pricing, and in both cases, Solumina came out on top. “With our solution, Earlens had everything they needed out of the box, whereas the competitive MES had a toolset that needed development,” DeMatteo explains. “The other issue was price. The other product was way out compared with Solumina due to the extensive tailoring effort they required. We understood that Earlens was a young company, not a global multinational, and we knew Solumina pricing matched where they were right now in terms of development.”

Earlens Builds its Future with Solumina

Working with iBase-t, Earlens will put in place the necessary systems to manufacture its innovative new hearing aid product, improving the average completed device lead time and quality of data entry. The Solumina Manufacturing Execution System will also reduce batch file administration efforts of electronic device history records (eDHR) that keep a full record of the products produced to ensure quality and compliance of 21 CFR Part 11 and Part 820. Solumina will also help increase product yields and provide visibility into current work order status by manufacturing supervisors and office personnel.

“Additive manufacturing, using 3-D 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,” says Vic Sial, President of iBase-t. “We appreciate the confidence Earlens has placed in iBase-t by choosing our software and team of experts to put in place the cutting-edge manufacturing infrastructure the company needs to manage production, streamline operations, and meet changing design and regulatory requirements.”

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