Presentation
MDD11 - Coordinating Human Factors studies and medical device clinical trials to minimise potential pitfalls linked to human error
DescriptionThis presentation aims to guide HFE representatives and decision-makers in what to consider when determining what type of HFE study to conduct ahead of each clinical trial phase as well as providing insights into the reciprocal benefits of HFE and clinical trials.
Ahead of clinical trials, HFE summative validation studies are typically required by the regulators and provide the opportunity to minimise risk of harm to users and/or subjects within the clinical trial. However, the stringent requirements of participant, environment and task representation for HFE summative validation studies may be financially and temporally expensive to achieve, as well as being impractical in some cases, to conduct ahead of every clinical trial phase. It is therefore crucial to understand the benefits, drawbacks and regulatory requirements of HFE summative validation studies such that the most efficacious path to market may be navigated, culminating in the greatest number of optimal devices on the market to support the delivery of care.
Whilst HFE summative validation studies are strongly recommended ahead of clinical trials by regulators, allowances are made where the prescribed methodology may be excessive to satisfactorily protect the safety of trial participants. In particular, devices where there are a limited number of end users, users are highly trained or where there will be significant medical device manufacturer monitoring and control of clinical trial conduct may be taken into consideration.
However, in addition to minimising risk to clinical trial users and/or subjects, HFE studies are valuable in supporting the design of an effective clinical trial, reducing risks of poor compliance and clinical outcomes. An unsuccessful clinical study will in all likelihood be much more expensive than a potentially pivotal summative validation study.
This presentation provides a decision-point roadmap as a guide for medical device manufacturers when determining what level of HFE study to conduct ahead of each clinical trial phase.
Ahead of clinical trials, HFE summative validation studies are typically required by the regulators and provide the opportunity to minimise risk of harm to users and/or subjects within the clinical trial. However, the stringent requirements of participant, environment and task representation for HFE summative validation studies may be financially and temporally expensive to achieve, as well as being impractical in some cases, to conduct ahead of every clinical trial phase. It is therefore crucial to understand the benefits, drawbacks and regulatory requirements of HFE summative validation studies such that the most efficacious path to market may be navigated, culminating in the greatest number of optimal devices on the market to support the delivery of care.
Whilst HFE summative validation studies are strongly recommended ahead of clinical trials by regulators, allowances are made where the prescribed methodology may be excessive to satisfactorily protect the safety of trial participants. In particular, devices where there are a limited number of end users, users are highly trained or where there will be significant medical device manufacturer monitoring and control of clinical trial conduct may be taken into consideration.
However, in addition to minimising risk to clinical trial users and/or subjects, HFE studies are valuable in supporting the design of an effective clinical trial, reducing risks of poor compliance and clinical outcomes. An unsuccessful clinical study will in all likelihood be much more expensive than a potentially pivotal summative validation study.
This presentation provides a decision-point roadmap as a guide for medical device manufacturers when determining what level of HFE study to conduct ahead of each clinical trial phase.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives