Presentation
So You Want to Update the System: Tips and Tricks for Design Updates Starting with Proactive HF Documentation
SessionRobotics Summit - Session 3
DescriptionManufacturers of surgical robotic systems are constantly challenged with the prospect of keeping up with the accelerated rate of technological advancement, evolving user needs, and steep market competition. The days of slowly and steadily releasing a system to the market have long since passed. Now, manufacturers need to begin system “version 2” development – and beyond – before version 1 has even received de novo authorization.
Imagine having just received the good news of de novo launch! The entire company is thrilled, but has already been working on system updates and are now pursuing an aggressive submission timeline for the next version. R&D teams are often prepared to continue designing and readying updated product versions and software releases, but what happens when those advancements affect the system’s critical tasks? Is it true that manufacturers must prepare to re-validate the entire system? And, if so, should these validation tests include all user groups?
Importantly, are these preparations exclusively the focus of post-de novo authorization or can HF documentation be developed proactively to create a smooth 510(k) – or Special 510(k) – pathway? Robotic systems in particular are rather complex and have robust applications, so how do manufacturers balance pursuing strategic and focused de novo authorization with impending design updates and potential indication expansions (e.g., marketing another applicable procedure)?
This presentation will define the different strategies manufacturers and consultants can take to balance the desire for robust system development approaches while up against potentially expansive usability testing cycles, regulatory review timelines, and associated time and monetary “costs.” It will also explore these differences as they apply to varying submission types (e.g., 510(k), Special 510(k), letter to file).
Specifically, we plan to:
• Describe strategies for proactive HF documentation (e.g., indications for use, user and use environment descriptions, use-related risk analysis) development during the de novo authorization preparation process while enabling flexibility for future design updates as they are applicable to robotic systems.
• Define and provide examples of what types of robotic system updates might require supplemental HF validation testing (e.g., critical task changes, indication expansions, user group modifications, UI design changes for both software and hardware)
• Explain how to leverage HF documentation (e.g., known problems analyses, literature reviews, use-related risk analyses, task analyses, previous usability testing data) to determine the scope for supplemental testing.
• Provide strategies for navigating different robotic system updates. For each update, we provide guidance on how to determine the proper testing scope, or develop a justification to forgo testing if applicable. Below, we describe specific types of updates and how we recommend navigating them:
o Affected critical tasks, including new or modified essential tasks: consider only re-evaluating essential and critical tasks affected by design updates, and justifying that remaining critical tasks are not affected because they have already been validated. Furthermore, consider evaluating these impacted tasks with a limited number of participants per user group (e.g., 8 rather than 15).
o Indication expansions: consider justifying that the added indication does not affect the user population and/or workflow. For example, if the product is a surgical robotic system that is intended for general surgical procedures, consider justifying that the same user population would use the system in the same way even with another surgical procedure.
If the added indication does affect the user population or intended use specifications, prepare a list of sub-tasks that might be affected by the additional indication and develop a justification to solely evaluate those tasks.
o User group modifications: Consider developing a justification that the altered and/or additional user group(s) are not different with regard to Human Factors. For example, the expanded indication of use might have distinct clinical applications, but those applications do not extend to usability (i.e., the user interactions with the system).
If there are distinct user interactions with the expanded indications of use, prepare a usability study that focuses only on tasks that would be completed by the altered and/or added user group(s).
o UI design changes: consider justifying that these design changes either do not affect critical tasks, or that they can only serve to reduce harm/design out use errors for critical tasks. For example, something like changing the background from a pure while to a pale cream color on a GUI might not have a significant effect on usability but changing the color of a button or adding an indication light might.
• Discuss recent FDA feedback about testing devices undergoing updates
o For indication expansions, manufacturers should focus on proving that individual procedures are still safe and effective, such as by demonstrating clinical backgrounds and applications do not impact user interactions with the system
o Consider which user groups are “procedure-agnostic” and could be considered “proxy” participants for other user groups. For example, if there are some tasks that both sterile and circulating nurses are responsible for, consider whether including only one type of nurse is sufficiently representative for both user groups
Imagine having just received the good news of de novo launch! The entire company is thrilled, but has already been working on system updates and are now pursuing an aggressive submission timeline for the next version. R&D teams are often prepared to continue designing and readying updated product versions and software releases, but what happens when those advancements affect the system’s critical tasks? Is it true that manufacturers must prepare to re-validate the entire system? And, if so, should these validation tests include all user groups?
Importantly, are these preparations exclusively the focus of post-de novo authorization or can HF documentation be developed proactively to create a smooth 510(k) – or Special 510(k) – pathway? Robotic systems in particular are rather complex and have robust applications, so how do manufacturers balance pursuing strategic and focused de novo authorization with impending design updates and potential indication expansions (e.g., marketing another applicable procedure)?
This presentation will define the different strategies manufacturers and consultants can take to balance the desire for robust system development approaches while up against potentially expansive usability testing cycles, regulatory review timelines, and associated time and monetary “costs.” It will also explore these differences as they apply to varying submission types (e.g., 510(k), Special 510(k), letter to file).
Specifically, we plan to:
• Describe strategies for proactive HF documentation (e.g., indications for use, user and use environment descriptions, use-related risk analysis) development during the de novo authorization preparation process while enabling flexibility for future design updates as they are applicable to robotic systems.
• Define and provide examples of what types of robotic system updates might require supplemental HF validation testing (e.g., critical task changes, indication expansions, user group modifications, UI design changes for both software and hardware)
• Explain how to leverage HF documentation (e.g., known problems analyses, literature reviews, use-related risk analyses, task analyses, previous usability testing data) to determine the scope for supplemental testing.
• Provide strategies for navigating different robotic system updates. For each update, we provide guidance on how to determine the proper testing scope, or develop a justification to forgo testing if applicable. Below, we describe specific types of updates and how we recommend navigating them:
o Affected critical tasks, including new or modified essential tasks: consider only re-evaluating essential and critical tasks affected by design updates, and justifying that remaining critical tasks are not affected because they have already been validated. Furthermore, consider evaluating these impacted tasks with a limited number of participants per user group (e.g., 8 rather than 15).
o Indication expansions: consider justifying that the added indication does not affect the user population and/or workflow. For example, if the product is a surgical robotic system that is intended for general surgical procedures, consider justifying that the same user population would use the system in the same way even with another surgical procedure.
If the added indication does affect the user population or intended use specifications, prepare a list of sub-tasks that might be affected by the additional indication and develop a justification to solely evaluate those tasks.
o User group modifications: Consider developing a justification that the altered and/or additional user group(s) are not different with regard to Human Factors. For example, the expanded indication of use might have distinct clinical applications, but those applications do not extend to usability (i.e., the user interactions with the system).
If there are distinct user interactions with the expanded indications of use, prepare a usability study that focuses only on tasks that would be completed by the altered and/or added user group(s).
o UI design changes: consider justifying that these design changes either do not affect critical tasks, or that they can only serve to reduce harm/design out use errors for critical tasks. For example, something like changing the background from a pure while to a pale cream color on a GUI might not have a significant effect on usability but changing the color of a button or adding an indication light might.
• Discuss recent FDA feedback about testing devices undergoing updates
o For indication expansions, manufacturers should focus on proving that individual procedures are still safe and effective, such as by demonstrating clinical backgrounds and applications do not impact user interactions with the system
o Consider which user groups are “procedure-agnostic” and could be considered “proxy” participants for other user groups. For example, if there are some tasks that both sterile and circulating nurses are responsible for, consider whether including only one type of nurse is sufficiently representative for both user groups
Authors
Event Type
Robotics Workshop Submission
TimeSunday, March 301:45pm - 2:15pm EDT
LocationHarbour A/B