Presentation
MDD18 - Human Factors Strategy for Harmonizing Software Platforms of Existing Medical Devices
SessionPoster Session 2
DescriptionPlatforming medical device software has countless advantages to a business: it can improve user experience, decrease learning time across devices, streamline workflows, and decrease cost of maintenance throughout the product lifecycle. Implementing such a platform, especially across a fleet of already existing medical and non-medical systems creates practical challenges that merit discussion, especially in the realm of Human Factors (HF). The process requires ongoing efforts to gather, synthesize, and align requirements and design directions with a sizeable cross-functional team.
Based on our collective experience, here are some important considerations when strategizing the Human Factors approach for the design of a harmonized software platform:
1.Using a proactive analytical HF approach to help inform your project scope:
a. Task analysis and initial critical task determination can help the team scope the platforming effort appropriately and know which
designs will present the highest risk to the user and/or patient.
b. Performing Known Use Problems analysis for existing systems (and competitor systems) can help inform the program scope.
c. Performing Heuristic Evaluation on the existing systems can help you and your team determine where your current designs shine and
fall short.
2. Collecting, aligning, and resolving any conflicts between all requirements from the existing systems that would need to be replicated in the platform and/or would be important in determining scope:
a. Hardware: Are hardware changes part of the platforming effort, or must the team design for existing systems?
b. Software: Identify required vs. desired software elements and determine if/how each trace into the risk assessments.
c. Standards Compliance: Determine applicable standards for each medical device and their relevance to the platform's graphical user
interface (GUI).
d. Regulatory Strategy: Assess whether introducing the platform necessitates resubmission to regulatory bodies or if it depends on design
choices.
e. Multi-Regional Use: Collect data on how the current devices and new platform inform user needs and requirements.
3. Performing analysis and formative testing during platform development (prior to software integration), and soon after the platform software integration for early detection of issues.
a. Use your task analysis as a basis to complete a Use Failure Mode Effects Analysis (UFMEA) or Use-Related Risk Assessment (URRA) as the
design progresses to help identify areas that might require further mitigation, and to help inform your formative test cases.
b. Collaborate with cross-functional teams to determine ownership of product usability testing at each development stage and its
integration with other ongoing programs.
4. Consider how the platform documentation will be integrated with the system Design History File
a. How does the platform UFMEA or user specifications integrate with any existing system level documents?
b. What processes are in place for managing changes to a product’s risk assessment due to design modifications driven by the platform?
Based on our collective experience, here are some important considerations when strategizing the Human Factors approach for the design of a harmonized software platform:
1.Using a proactive analytical HF approach to help inform your project scope:
a. Task analysis and initial critical task determination can help the team scope the platforming effort appropriately and know which
designs will present the highest risk to the user and/or patient.
b. Performing Known Use Problems analysis for existing systems (and competitor systems) can help inform the program scope.
c. Performing Heuristic Evaluation on the existing systems can help you and your team determine where your current designs shine and
fall short.
2. Collecting, aligning, and resolving any conflicts between all requirements from the existing systems that would need to be replicated in the platform and/or would be important in determining scope:
a. Hardware: Are hardware changes part of the platforming effort, or must the team design for existing systems?
b. Software: Identify required vs. desired software elements and determine if/how each trace into the risk assessments.
c. Standards Compliance: Determine applicable standards for each medical device and their relevance to the platform's graphical user
interface (GUI).
d. Regulatory Strategy: Assess whether introducing the platform necessitates resubmission to regulatory bodies or if it depends on design
choices.
e. Multi-Regional Use: Collect data on how the current devices and new platform inform user needs and requirements.
3. Performing analysis and formative testing during platform development (prior to software integration), and soon after the platform software integration for early detection of issues.
a. Use your task analysis as a basis to complete a Use Failure Mode Effects Analysis (UFMEA) or Use-Related Risk Assessment (URRA) as the
design progresses to help identify areas that might require further mitigation, and to help inform your formative test cases.
b. Collaborate with cross-functional teams to determine ownership of product usability testing at each development stage and its
integration with other ongoing programs.
4. Consider how the platform documentation will be integrated with the system Design History File
a. How does the platform UFMEA or user specifications integrate with any existing system level documents?
b. What processes are in place for managing changes to a product’s risk assessment due to design modifications driven by the platform?
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer