Presentation
MDD10 - Challenges and best practices for FDA submissions: Further insights from the BioPhorum MedTech HF practitioner survey
DescriptionBackground
MediPhorum’s Human Factors workstream is gathering global insights towards generating harmonized industry best practices in human factors study design and aligning approaches for FDA submissions, initially focusing on combination products. This group consists of subject matter experts and leaders from global MedTech companies including AbbVie, Eli Lilly, GSK, and Regeneron.
Topic overview
In preparing regulatory submissions, application of Human Factors (HF) regulation, guidance, standards, and best practices may vary across the industry, particularly in areas of the discipline where there is a perceived lack of clarity or consistency around methodology.
Concurrently, recent trends in regulatory feedback can conflict with industry understanding of good practice. Examples include the appropriate use of IFU (Instructions For Use) in knowledge testing and the application of root cause analyses, resulting in differential experiences and discrepancies in agency information requests.
HF studies are a significant part of the product design process, and the lack of a harmonized understanding and application of regulations can cause significant delay in time-to-market. Six-month delays are common, with further inconsistencies in the agencies’ review process introducing additional risk to planning, timelines and outcomes.
Background
The team developed a cross-industry survey to assess key topics where most discrepancies in HF practice were identified to assess where HF professionals seek to find alignment with regulators, seeking consistency and transparency in industry. Questions were created to broadly address issues across 7 topics, with a focus for this presentation on user groups, and validation study design/protocols.
This team previously presented a high-level overview poster of the survey’s findings at the HFES HCS in March 2023. The team is still collecting data with the survey and at time of submission has received feedback from HF practitioners across the industry.
This presentation proposal for HFES 2024 builds upon the team’s previous presentation to examine in detail a more robust data set as more responses to the survey have been received.
Application / overview of presentation
The group will give a deep dive presentation on the survey responses and data, relating specifically to the topics of study design, user groups and validation protocols. The presentation will highlight areas of key challenge, current practices across industry and provision for aligned industry approaches and best practices. This is aimed to advancing industry knowledge, generating solutions to common issues, and highlighting the value of collaboration.
Take aways
The purpose of the survey was to identify common practices in HF, key areas of industry challenge relating to study design, user groups, and validation protocols. By cross-examining industry responses to the survey against regulatory guidance and feedback, the team has identified areas where industry can align and build best practices, with the intent of publishing a best practice guideline. It is hoped that the presented guidance will inform a consistent HF approach across the industry, and ultimately accelerate HF processes.
MediPhorum’s Human Factors workstream is gathering global insights towards generating harmonized industry best practices in human factors study design and aligning approaches for FDA submissions, initially focusing on combination products. This group consists of subject matter experts and leaders from global MedTech companies including AbbVie, Eli Lilly, GSK, and Regeneron.
Topic overview
In preparing regulatory submissions, application of Human Factors (HF) regulation, guidance, standards, and best practices may vary across the industry, particularly in areas of the discipline where there is a perceived lack of clarity or consistency around methodology.
Concurrently, recent trends in regulatory feedback can conflict with industry understanding of good practice. Examples include the appropriate use of IFU (Instructions For Use) in knowledge testing and the application of root cause analyses, resulting in differential experiences and discrepancies in agency information requests.
HF studies are a significant part of the product design process, and the lack of a harmonized understanding and application of regulations can cause significant delay in time-to-market. Six-month delays are common, with further inconsistencies in the agencies’ review process introducing additional risk to planning, timelines and outcomes.
Background
The team developed a cross-industry survey to assess key topics where most discrepancies in HF practice were identified to assess where HF professionals seek to find alignment with regulators, seeking consistency and transparency in industry. Questions were created to broadly address issues across 7 topics, with a focus for this presentation on user groups, and validation study design/protocols.
This team previously presented a high-level overview poster of the survey’s findings at the HFES HCS in March 2023. The team is still collecting data with the survey and at time of submission has received feedback from HF practitioners across the industry.
This presentation proposal for HFES 2024 builds upon the team’s previous presentation to examine in detail a more robust data set as more responses to the survey have been received.
Application / overview of presentation
The group will give a deep dive presentation on the survey responses and data, relating specifically to the topics of study design, user groups and validation protocols. The presentation will highlight areas of key challenge, current practices across industry and provision for aligned industry approaches and best practices. This is aimed to advancing industry knowledge, generating solutions to common issues, and highlighting the value of collaboration.
Take aways
The purpose of the survey was to identify common practices in HF, key areas of industry challenge relating to study design, user groups, and validation protocols. By cross-examining industry responses to the survey against regulatory guidance and feedback, the team has identified areas where industry can align and build best practices, with the intent of publishing a best practice guideline. It is hoped that the presented guidance will inform a consistent HF approach across the industry, and ultimately accelerate HF processes.
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