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FDA certified EEG Device

Project Background

Our customer Ceribell set out to develop the most cost-efficient brain monitor. Replacing the traditional conventional EEG system, our customer is changing the way healthcare providers operate and monitor patients' treatment. Beginning with wearable apparel sourcing, our customer was ultimately to find the right partner to engineer and develop the product for manufacturing.

LKKER SCM Service Content

This was by no means an easy feat. There were several elements that increased the complexity of the product development. 

Wearable Apparel Sourcing

The product requests an extremely high elasticity of apparel. Therefore, LKKER SCM firstly sources apparel suppliers in our existing qualified supplier network and quickly matches with a suitable one. The customer are satisfied with the elasticity of apparel. Also, the apparel also need pass the FDA certification. After several pre-test and pre-trial of multiple colorant of the apparel, the apparel still fails to reach FDA requirement.  In the end, LKKER SCM helps our customer develop a colorant supplier who follows traditional tie and dye to ensure all natural material and process without industrial pollution. And the wearable apparel passes the FDA requirement together with the complete set of product.

Conductive Gel Manufacturing Process Improvement

Conductive gel is also an important part of the device operation to improve electrode connection. Therefore, how to produce conductive gel fast and secure is LKKER SCM next supply chain management task. LKKER SCM helps our customer source conductive gel, design the package of the conductive gel, carry out the test plan to verify the design and set up the quality control and inspection standard. To improve the manufacturing efficiency, LKKER SCM also develop a conductive gel automatic assembly equipment to lower the cost of gel production and increase assembly efficiency. 

Tooling of Device Enclosure

The brain monitor is portable device with plastic enclosure as well as soft rubber industrial design. LKKER SCM analyze the tooling technology of the design, complete the DFM (Design for Manufacturing) and mechanical design optimization, review the tooling sample and be responsible for the mold quality improvements and process verification to reach ultimate industrial design requirement. 

Supply One-stop

LKKER SCM works with the client to manage the product supplier chain including material sourcing (from key materials to accessories and package) and the complete product assembly. LKKER SCM ensures material supply follows customers' supply plan, consistently monitors supplier risk, carries out incoming QC, and solves any supply chain contingency. 

The result

With LKKER SCM's help, the client largely shortens the product development lifecycle and successfully launches products in the market. With the success of development and market launch, the client successfully closed several rounds of fundraising. The strong, simple, and reliable product also wins positive feedback in the medical device market, and the client experiences high growth and size expansion.

We provide one-stop product development services:industrial design, mechanical design,  rapid prototyping,small batch production,DFM,Mold design and manufacturing, Validation&Certification,  mass production, etc

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