Presentation
MDD21 - Risk Management in Human Factors: Best Practices and Lessons Learned from Applying Risk Management to Medical Devices and Combination Products
DescriptionAbstract:
In the dynamic space of medical device and combination product development, effective risk management in human factors is foundational to a successful program. This presentation delves into best practices and key lessons learned in conducting use-related risk assessments (URRAs) and use-related failure modes and effects analyses (FMEAs) through the lens of human factors professionals working in conjunction with subject matter experts in a cross-functional team.
Best practice is to characterize use-related risk in the context of first understanding the intended users, uses, and use environments. Additionally, a comprehensive task analysis of the user and user-interface interaction is a crucial step in beginning risk assessment. URRAs and FMEAs also overlap in the necessity of defining the potential hazards and harms involved in the system.
In practice, URRAs and FMEAs often have unique structures and roles within the context of the full design controls process as well as in FDA submissions. While FMEAs might initially appear to be a more complex form of a URRA, it may be argued that the two methods differ on a deeper level in their process, purpose, and their end-product.
The URRA explores the interaction between the user interface and the user on each use step, defines criticality in a binary manner for each use task, and ultimately produces a table with which a reviewer can understand the identified potential use errors for each critical task, the mitigations, and the justification that mitigations are sufficient to reduce use-related risk as far as reasonably practicable.
The FMEA explores the ways in which the product or system might fail on a given step within the context of use-related scenarios, characterizes risk with consideration of multiple variables (such as occurrence, detection, and probability estimates), and ultimately produces compiled data, including a heat map, to allow a company to construct a safety assurance case for a product or system and allows risk to be characterizes not only prior to marketing the product, but also to characterize residual risk and monitor risk post-market as well.
Lessons learned for this topic include a discussion of the technical complexities of how to reconcile differences between URRAs and FMEAs, including issues encountered when using a slimmed-down FMEA in FDA submissions, challenges associated with using severity scores to identify critical tasks, and the complexities of compounding failure modes.
During product development, professionals are faced with a decision-making process of choosing the most appropriate risk assessment method for a given product. In situations where both a URRA and a FMEA are required, there are additional considerations when determining actionable ways to execute and harmonize the two assessment methods.
In conclusion, this discussion seeks to present an industry perspective on best practices and lessons learned from when applying risk assessment, as part of the human factors engineering process, to the development of medical devices and combination products.
In the dynamic space of medical device and combination product development, effective risk management in human factors is foundational to a successful program. This presentation delves into best practices and key lessons learned in conducting use-related risk assessments (URRAs) and use-related failure modes and effects analyses (FMEAs) through the lens of human factors professionals working in conjunction with subject matter experts in a cross-functional team.
Best practice is to characterize use-related risk in the context of first understanding the intended users, uses, and use environments. Additionally, a comprehensive task analysis of the user and user-interface interaction is a crucial step in beginning risk assessment. URRAs and FMEAs also overlap in the necessity of defining the potential hazards and harms involved in the system.
In practice, URRAs and FMEAs often have unique structures and roles within the context of the full design controls process as well as in FDA submissions. While FMEAs might initially appear to be a more complex form of a URRA, it may be argued that the two methods differ on a deeper level in their process, purpose, and their end-product.
The URRA explores the interaction between the user interface and the user on each use step, defines criticality in a binary manner for each use task, and ultimately produces a table with which a reviewer can understand the identified potential use errors for each critical task, the mitigations, and the justification that mitigations are sufficient to reduce use-related risk as far as reasonably practicable.
The FMEA explores the ways in which the product or system might fail on a given step within the context of use-related scenarios, characterizes risk with consideration of multiple variables (such as occurrence, detection, and probability estimates), and ultimately produces compiled data, including a heat map, to allow a company to construct a safety assurance case for a product or system and allows risk to be characterizes not only prior to marketing the product, but also to characterize residual risk and monitor risk post-market as well.
Lessons learned for this topic include a discussion of the technical complexities of how to reconcile differences between URRAs and FMEAs, including issues encountered when using a slimmed-down FMEA in FDA submissions, challenges associated with using severity scores to identify critical tasks, and the complexities of compounding failure modes.
During product development, professionals are faced with a decision-making process of choosing the most appropriate risk assessment method for a given product. In situations where both a URRA and a FMEA are required, there are additional considerations when determining actionable ways to execute and harmonize the two assessment methods.
In conclusion, this discussion seeks to present an industry perspective on best practices and lessons learned from when applying risk assessment, as part of the human factors engineering process, to the development of medical devices and combination products.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives