Presentation
DH9 - How to make sure your SaMD conforms to HF standards post-release
DescriptionTopic: Using a risk-based process to evaluate proposed changes to approved devices (pre- or post-release) and the need for HF testing
Application: For manufacturers of SaMD and other medical devices that may be updated post-release
Background: As software becomes more and more ubiquitous in the medical device space (whether as the device itself or as companion to a device), there is an opportunity and expectation to improve and update this software on an ongoing basis after FDA approval and subsequent release. This can present a challenge of how to balance HF requirements and integrate any required HF assessments and testing within a more fluid development lifecycle.
Overview of Presentation: This poster will present a model for evaluating updates made to a SaMD post-approval to assess whether a release of updated components or features would pose any potential new risks or change existing risks, and thus would require HF testing to further assess said risk. The model breaks down into several component pieces, which are to be further defined in the poster:
1- Align with key stakeholders to develop a framework to evaluate proposed design updates (this framework should build upon an existing task analysis and risk assessment, which we assume are in place for a product to have been approved).
a. The framework should include paths to commercial release based on the likelihood and severity of the risk associated with each proposed change. I.e., will this change require a new critical or non-critical task? Will this change impact an existing task? If so- what are the HF requirements that need to be met before the change can be commercially released (i.e., validation study, formative study or no study)?
2- Assess proposed design updates as they are developed to understand impacts to existing tasks, or the need for a new task.
3- Parse out which updates require testing, and which may be released without testing. For changes that require testing, the team can weigh whether the proposed change is impactful enough to justify the cost and time needed to conduct testing.
4- If testing is required and approved by the team, align on the scope of the study and what study outcomes must be seen in order for the change to be approved for commercial release (i.e., is there a threshold for success that must be met).
In addition to the model itself, the poster will discuss suggestions for how best to work between the product and HF teams to ensure continued alignment.
Application: For manufacturers of SaMD and other medical devices that may be updated post-release
Background: As software becomes more and more ubiquitous in the medical device space (whether as the device itself or as companion to a device), there is an opportunity and expectation to improve and update this software on an ongoing basis after FDA approval and subsequent release. This can present a challenge of how to balance HF requirements and integrate any required HF assessments and testing within a more fluid development lifecycle.
Overview of Presentation: This poster will present a model for evaluating updates made to a SaMD post-approval to assess whether a release of updated components or features would pose any potential new risks or change existing risks, and thus would require HF testing to further assess said risk. The model breaks down into several component pieces, which are to be further defined in the poster:
1- Align with key stakeholders to develop a framework to evaluate proposed design updates (this framework should build upon an existing task analysis and risk assessment, which we assume are in place for a product to have been approved).
a. The framework should include paths to commercial release based on the likelihood and severity of the risk associated with each proposed change. I.e., will this change require a new critical or non-critical task? Will this change impact an existing task? If so- what are the HF requirements that need to be met before the change can be commercially released (i.e., validation study, formative study or no study)?
2- Assess proposed design updates as they are developed to understand impacts to existing tasks, or the need for a new task.
3- Parse out which updates require testing, and which may be released without testing. For changes that require testing, the team can weigh whether the proposed change is impactful enough to justify the cost and time needed to conduct testing.
4- If testing is required and approved by the team, align on the scope of the study and what study outcomes must be seen in order for the change to be approved for commercial release (i.e., is there a threshold for success that must be met).
In addition to the model itself, the poster will discuss suggestions for how best to work between the product and HF teams to ensure continued alignment.
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