Presentation
MDD18 - Kicking Off Your Medical Device’s Human Factors Journey: Thinking Ahead to Root Cause Analysis and Residual Risk Analysis Starting From Documentation Development
SessionPoster Session 1
DescriptionComplex medical devices inherently have more critical risks to evaluate than simpler medical devices. As such, the probability for the residual risk level of certain usability findings remaining unacceptable – although seemingly all possible risk mitigations have been implemented – can be significantly greater. Accordingly, this presentation will focus on the value of manufacturers of complex medical devices thinking of root cause and residual risk analyses throughout the development of their product. Particularly, during human factors (HF) documentation development (e.g., inception of a use-related risk analysis), rather than towards the end of the complex medical device development lifecycle alone, increasing their ability to simplify justification efforts relating to risks that might appear during HF validation testing. This approach could also strongly support a manufacturer’s goal of submitting their market applications sooner rather than later.
In accordance with the Food and Drug Administration’s (FDA) guidance on applying HF to medical devices and the International Electrotechnical Commission’s (IEC) international standard on the application of usability engineering to medical devices (IEC-62366-1), it is a regulatory imperative for medical device manufacturers to perform root cause and residual risk analyses. However, the tone in these regulatory documents generally suggest that these analyses are only performed for any finding related to a critical risk after conducting HF validation testing. Conversely, this presentation will shed light on how considering potential root causes and residual risk-supporting research / data before reaching the HF validation stage of development can be key when generating a complex medical device’s HF documentation, including, but not limited to, the product’s labeling (e.g., instructions for use), risk analysis file, and formative usability test protocol(s). The presentation will leverage recent examples across a variety of medical devices where these considerations proved valuable and/or could have been introduced earlier to limit rework.
This proactive approach fosters a thorough assessment of potential user interactions and encourages a culture of safety and collaboration within any medical device’s multi-disciplinary development team. By anticipating root causes and residual risks, teams can gather valuable data that shapes design decisions and reduces the likelihood of encountering hurdles later in the medical device development lifecycle. Lastly, this early focus on root cause analysis and residual risk analysis will help demonstrate a commitment to safety and efficacy to regulators.
In accordance with the Food and Drug Administration’s (FDA) guidance on applying HF to medical devices and the International Electrotechnical Commission’s (IEC) international standard on the application of usability engineering to medical devices (IEC-62366-1), it is a regulatory imperative for medical device manufacturers to perform root cause and residual risk analyses. However, the tone in these regulatory documents generally suggest that these analyses are only performed for any finding related to a critical risk after conducting HF validation testing. Conversely, this presentation will shed light on how considering potential root causes and residual risk-supporting research / data before reaching the HF validation stage of development can be key when generating a complex medical device’s HF documentation, including, but not limited to, the product’s labeling (e.g., instructions for use), risk analysis file, and formative usability test protocol(s). The presentation will leverage recent examples across a variety of medical devices where these considerations proved valuable and/or could have been introduced earlier to limit rework.
This proactive approach fosters a thorough assessment of potential user interactions and encourages a culture of safety and collaboration within any medical device’s multi-disciplinary development team. By anticipating root causes and residual risks, teams can gather valuable data that shapes design decisions and reduces the likelihood of encountering hurdles later in the medical device development lifecycle. Lastly, this early focus on root cause analysis and residual risk analysis will help demonstrate a commitment to safety and efficacy to regulators.
Authors
Event Type
Poster Presentation
TimeMonday, March 314:45pm - 6:15pm EDT
LocationFrontenac Foyer
Digital Health (DH)
Simulation and Education (SE)
Hospital Environments (HE)
Medical and Drug Delivery Devices (MDD)
Patient Safety and Research Initiatives (PS)