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Case Studies

Design to FDA Contract Manufacturing: Surgical Visualization

by EmbedTek - EmbedTek LLC

Medical device manufacturers drive innovation that is drastically improving the quality of diagnosis, treatment, and procedural outcomes for patients. They would like to spend the bulk of their product development time perfecting the clinical efficacy and market acceptance of a device or solution, and less on the technology platforms that enable the solution, logistics, and supply chain that will be needed to take it to market.

EmbedTek’s expertise in creative engineering, integration, supply chain management and Good Manufacturing Practices as a registered manufacturer with the U.S. Food and Drug Administration provides medical device manufacturers with the operational infrastructure they need to grow their business.

A medical device manufacturer first engaged EmbedTek in 2012 to evaluate the communication inside an image generator for a new line of surgical visualization tools. We developed a new computer system that incorporated powerful graphics technology and conformed to the physical and design standards of the rest of the device. This included a new, specialized positioning of the visualization tools ergonomics for the surgeon; and a slim console that left a very small opening for the chassis, and little room for airflow.

Our engineering team worked closely with the customer to design the computer system using commercial-off-the-shelf (COTS) central processing units (CPUs) and video processing components. We created a flow-through chassis that included a large fan with a low acoustic footprint.  And, we worked with the appropriate regulatory agencies to help the customer get the needed approvals for the medical device.

It was not long before we had a comprehensive view of their entire system, and were able to identify additional ways their supply chain could become more flexible, scalable, and cost-controlled.

Flexible

EmbedTek took the responsibility for sourcing the entire bill of materials (BOM), managing the purchasing function and ensuring that component availability was aligned with the program life. Most of the COTS components were embedded products with extended product availability of 5 to 7 years. We used our purchasing and inventory resources to extend the lifetime of selected video cards. This work on the front end resulted in the customer only having to manage one SKU. Our highly flexible production capability reduced their cost of purchasing and allowed the customer to address variations in demand, including end-of-quarter upside.

Scalable

We have registered with the FDA as a Contract Manufacturer of Medical Devices, which means we can provide advanced embedded technology capabilities, complete manufacturing, and delivery on behalf of medical device manufacturers. Our scalable, cellular manufacturing facility in Waukesha, Wisconsin, operates to the ISO 13485 and ISO 9001 standard and maintains electrostatic discharge (ESD) controls. Cleaning, engineering test and validation equipment, and multiple production cells are all within steps of the manufacturing area.

Cost-controlled

EmbedTek addressed cost controls in three ways:

  1. Providing prompt, experienced design and validation at a non-recurring engineering (NRE) that compared favorably to in-house development, without taking resources away from the customer’s core competency.
  2. Reducing the cost of procurement and providing lifecycle management over the program lifecycle.
  3. Providing scalable manufacturing capacity operating to ISO 13485 standards with no capital outlay.

The end result is a cutting edge technology that is quickly gaining acceptance, with a manufacturing and supply chain that has the flexibility and scalability to keep up. Our trusted, long-term partnership means that the customer can drive to the next innovation in the medical device field without having to also be an expert on how to get here.

 

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