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The Pressure Is On – The Medical Device and Race to Scale

Medical device manufacturers are revolutionizing healthcare treatment and patient outcomes, from advancements in diagnostic images and data collection to 3D visualization and robotic assistance. The core technology of each device is what makes it special. But there is a lot more to the device than the technology, including protective housing, quality standards and regulation, communication, and integration with a larger equipment system. Throw in the constant pressure for release dates and/or price points, and suddenly there is a lot more to getting the device into clinical use than the breakthrough technology it holds.

Take for example an EmbedTek customer that had developed an aberrometer – an instrument which provides information on a patient’s eye during cataract surgery – but needed a small, quiet, high performance image processor, a display that could be seen clearly under operating room lights, and a touch screen that could withstand frequent wipe-downs.

Or another customer that excelled in building review and replay programming but could not move forward with a project unless multiple audio/visual components could be consolidated into a single package.

Device manufacturers benefit most when they are able to spend the bulk of their product development time perfecting the clinical efficacy of their core technology. They know the healthcare market best and they know what they want and need their device to be. Adjunct manufacturing experts, like EmbedTek, can be brought onboard to focus on what they do best – designing how a device will be produced and maintained, through a supply chain, over the course of its lifetime.

To solve the image processor and display challenge for the aberrometer manufacturer, EmbedTek leveraged previous designs, best practices and its network of commercial-off-the- shelf (COTS) component suppliers.

  • We used a chassis that protected internal components from RF and EM interference, limited emissions and regulatory compliance and addressed thermal management.
  • Our engineers tested and tuned a capacitive touch screen for a gloved surgeon to use.
  • A plastic bezel and glass laminate over the touch screen provided protection from disinfectant liquids.
  • We paired an Intel™ processor with a chipset and motherboard that had the video assets to run the display.
  • We selected COTS components based on their production roadmaps and a confidence that they would be available through most of the product’s lifecycle.

In the case of the A/V review and replay programming device, the original device consisted of several components connected to a computer via multiple connections and power supplies. EmbedTek consolidated these disparate devices into a single, more ergonomic solution at a lower cost with an improved supply chain, reliability and end user experience.

(Complicating things further,) EmbedTek’s design solution needed to fit within nonnegotiable software and lifecycle requirements and work within the customer’s demand schedule.

Here’s how we solved it:

  • Our engineering team leveraged an existing image capture device that met all of the requirements except Linux driver support. Our software team wrote new drivers.
  • The audio on the original device involved four high quality balanced XLR inputs with a discrete power supply. We designed a 4-port balanced XLR audio board via USB that does not require a discrete power supply. It came with excellent reliability and indefinite availability because we control the design.
  • We leveraged a long life Power over Ethernet (PoE) solution to provide power and connectivity to cameras without a separate box.
  • EmbedTek selected COTS computing components from our existing supply chain, which passed volume discount pricing, consistent availability, and revision control onto our customer.
  • Our custom chassis design accommodated all of the components and offered an optimized thermal environment.
  • Not only did the resulting solution cost $1,600 less, but the custom components represented less than $100. That means the customer can apply them to other embedded computers without modification, allowing them to participate in new computing developments and software releases.

These types of solutions are not built in a day’s work. Even with seasoned experts on the project, they require trial and error and months or years to plan and perfect. The timeline only multiplies when a manufacturer is new to the large scale production side of a program. Compromising these mid-to-long-term business requirements can impede growth and have lasting effects on a company’s ability to compete.

Our engineering and manufacturing teams at EmbedTek have seen and solved all different types of challenges that would have prevented medical device manufacturers from scaling up production. Our new white paper outlines how to avoid the most common hurdles in the early stages of product development. Download the white paper today.

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