Use of Arduino or Raspberry Pi in Medical Devices

In the past year Omnica 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 are recommend against using them in production designs for a number of reasons.

  1. Given the nature of Medical devices, the build quality and more importantly the consistency of these products are not sufficient for medical device production.
  2. Using these devices may pose regulatory issues or increase the regulatory burden in terms of risk management, and source control.
  3. 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.
  4. 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 SBC’s are not consistent and the design is always changing. 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.