Medical Product Development Process and Risk Management

The medical product development (MPD) process has been highly multidisciplinary in nature, which increase the complexity and the associated risks. Managing the risks during MPD process has been very crucial. This book gives an insight to MPD process through relevant literature. It decomposes MPD process using longitudinal case study approach and showcases Risk management in MPD process through case study. In case study, the existing MPD process for the case under consideration is mapped into customized phase gate process. Risks during five phases of MPD are identified and categorizd based on source of occurrence, and the risks are prioritized using traditional FMEA and fuzzy FMEA. The results of traditional FMEA and fuzzy FMEA are compared. The risks are further categorized based on criticality and risk treatments for each risk along with a risk mitigation plan are proposed. Finally, a risk mitigation model is developed. Methodology used in this book can be applied for any kind of Product development to minimize the effect of risks.