Framework proposal including HFE in product development process: A suitable approach for the Brazilian medical equipment industry

Abstract

Brazilian Medical Industry is mostly comprised of small to medium-sized manufactures Small changes on requirements can pose a big challenge on their process. From December 2015 the IEC 60601-1-6 has become mandatory for all new medical equipment registration in Brazilian market. These two facts led to the development of this research, aimed at provide a framework to include HFE methods inside the product development process, while confirming with the standards. The framework should be simple to implement and provide practical information showing which tool to use at the right time, considering a device in development. The methods were selected based on previous Brazilian experiences and literature review. The final framework is constituted of 4 steps using 6 HFE methods, linked in such way that the information generated by one method can be used as input to the other method, minimizing work overhead, and documentation to the standard requirements.