Application of risk management frameworks to medical device production development

Abstract

Effective risk management is critical when manufacturing medical products to avoid any potential impact to patients due to supply disruptions or quality excursions. As Flex LTD, an end-to-end manufacturing solutions provider, continues to grow its medical device portfolio, they have a need to take a more proactive and systematic approach to managing project risks. This research applies several project risk management frameworks and interventions to one of Flex's medical device programs as a pilot study. First the current state of existing risk management practices is evaluated. The frameworks and interventions are then implemented over a period of 6 months and their effectiveness analyzed at the end of the study. The results found that the interventions and frameworks applied during the pilot study improved overall understanding of fundamental risk management concepts.

It also showed that key activities, such as training workshops and the intervention of a risk management "champion" impacted risk tracking activities and were effective for overcoming adoption barriers. In applying the Risk Driver framework to the data generated during the pilot study, it was determined that identifying commonalities and trends across risk drivers can be used to proactively inform risk management decision-making and establish new metrics. These results also show that useful insights can be derived from risk drivers without knowing the outcome of the risk event. The study concludes that while risk management has both cultural and structural components, changes to the structural aspects (tools and processes) enable cultural change. Additionally, it concludes that frameworks can be used facilitate proactive risk management if they are integrated into a robust overarching risk management process.

Recommendations for future work include improving training programs to educate team members about project risk management, as well as the development of simple frameworks that are integrated into the overall risk management process to enable more proactive risk management. Certain risk management interventions such as trainings and having an assigned "Champion" for risk management are effective in the near term, but further study is needed to evaluate their impact on long-term sustainability.