Risk Management of a Low-cost Insulin Infusion Pump: A Case Study with a Brazilian Company

The Federal University of Sao Paulo is developing a low-cost insulin infusion pump in cooperation with a Brazilian company to provide an affordable treatment option for individuals with type 1 diabetes, especially from low-incoming countries. Risk management according to standard ISO 14971 is required for certification and safe use of the insulin pump. This paper describes the risk management performed to include safeguards in the architectural design of the insulin pump in development. The risk management process activities were carried out simultaneously and integrated with equipment development, generating requirements to protect against adverse effects on safety due to physical components failures, development errors, and user errors. Design solutions for the safety requirements, implemented in hardware and software, were incorporated in the low-cost insulin pump architecture. Comparison with applicable standards and certified insulin infusion pumps showed that these safeguards align with the best practices adopted for this type of equipment.