Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results

Abstract

Quality and risk management have evolved with the advancement of pharmaceutical and technological development in healthcare, allowing greater control of each biomedical device's manufacturing processes. Failure Mode and Effect Analysis (FMEA) has been widely used in healthcare to ensure the quality of manufactured products. It is dedicated to preventing adverse events or incidents, identifying failures to prioritize risk, and optimizing resources, for better quality in medical devices or equipment. Quality by Design (QbD), in turn, has been applied in the pharmaceutical industry for product quality assurance since the development stage. This work integrates QbD and FMEA for application in the development of electromedical equipment. Preliminary results of the proposed hybrid method applied to the development phase of a low-cost and high-sensitivity magnetic measuring system for metallic foreign bodies' location in patients are presented.

Keywords

• Electromedical technology
• Foreign body location
• FMEA
• Magnetic measurement
• QbD
• Quality