TechFlex has increasingly seen customers trying to incorporate these popular Single Board Computers (SBCs) into their devices. While these devices definitely serve a purpose in prototyping and hobbies, we recommend against using them in production designs for a number of reasons.

  • Given the nature of medical devices, the build quality and more importantly the consistency of these products may not be sufficient for medical device production.
  • Using these devices may pose regulatory issues or increase the regulatory burden in terms of risk management, and source control.
  • While these SBC’s are low cost, you are incorporating a lot of functionality that you may not require in the device that you might have to disable etc. This may actually add to your Cost of Goods as opposed to designing only the features you need using a custom design.
  • These components are difficult to control from a supply chain perspective, most medical devices require components to be available for up to 10 years. The supply of these SBC’s are not reliable and any changes to the product could trigger the need for recertification. The open source nature of the systems is both a positive and a negative.

In summary, we prefer to use standard available microprocessors to control most medical devices. Having done this hundreds of times, the cost in development time is negligible while the control and production cost benefits are numerous.