Presentation
MDD2 - A Collaborative Approach to Creating Labeling, Instructions for Use, and Packaging Materials
SessionPoster Session 2
DescriptionRegulatory Agencies require a labeling system (i.e., instructions for use, quick reference guide, packaging, instructions for use video, symbols, markings, etc.) accompanying a medical device to ensure safe and effective use. However, the scope of the labeling system and the process to achieve a successful labeling design are often left to each individual organization to create.
In this poster, we will describe an approach used to identify stakeholders and collaboratively build a labeling, IFU, and packaging material process that leverages knowledge and expertise from different fields (such as Human Factors Engineering, Graphic Design, Regulatory, Risk, etc.). The poster will also illustrate the concept maps of the labeling system and high-level process steps we arrived at, with practical tips, challenges, and suggestions.
First, the poster will describe the approach our team took to collaboratively creating a labeling system process. It will illustrate how we used the "Double Diamond" model (discover, define, develop, and deliver) to plan and conduct a series of workshops and interviews to solve the problem. How by decomposing the high-level problem statement, we were able to quickly gather input and co-create a process that addressed three central questions:
1.Why: Aligning on the objectives that a successful labeling system should achieve.
2.What: Creating a common understanding and language around what labeling for medical device manufacturers means.
3.How: Co-create a process with key stakeholders, taking time to describe what must be done and who is responsible .
Second, the poster will illustrate the process flow and decision points that our team arrived at, creating an opportunity for the audience to engage in conversation with our team on the differences and similarities, challenges and opportunities, they might encounter with their own processes and stakeholders.
We believe sharing this knowledge may create the following value for the audience's organizations and product end users:
1.Short-term value: may improve work predictability by (1) improving the precision of project scope planning regarding labeling, IFU, and packaging, (2) making achievable commitments to the project with visible task distribution to responsible disciplines and team members, and (3) facilitating communication of progress and team member collaboration by avoiding misunderstanding and misalignment on labeling-related terminology and scope.
2.Medium-term value: may enhance product quality or "cost of quality" by (1) increasing useful and meaningful design for end users starting from early design or development stages with higher iteration flexibility, (2) decreasing project schedule risks and re-design costs in the development stage (under full Change Management and Design Controls) and (3) complying with the Change Management Process when labeling, IFU, packaging changes happen after commercialization stage, ensuring responsible team members are consulted.
3.Long-term value: may increase product users' quality of life by creating a meaningful system of instructional and packaging materials that are best considered for them and their unique needs.
We hope this poster provokes an exchange of ideas and facilitates discussion about the best practices for planning activities for designing a labeling system from early user research, through Human Factors validation and submission.
In this poster, we will describe an approach used to identify stakeholders and collaboratively build a labeling, IFU, and packaging material process that leverages knowledge and expertise from different fields (such as Human Factors Engineering, Graphic Design, Regulatory, Risk, etc.). The poster will also illustrate the concept maps of the labeling system and high-level process steps we arrived at, with practical tips, challenges, and suggestions.
First, the poster will describe the approach our team took to collaboratively creating a labeling system process. It will illustrate how we used the "Double Diamond" model (discover, define, develop, and deliver) to plan and conduct a series of workshops and interviews to solve the problem. How by decomposing the high-level problem statement, we were able to quickly gather input and co-create a process that addressed three central questions:
1.Why: Aligning on the objectives that a successful labeling system should achieve.
2.What: Creating a common understanding and language around what labeling for medical device manufacturers means.
3.How: Co-create a process with key stakeholders, taking time to describe what must be done and who is responsible .
Second, the poster will illustrate the process flow and decision points that our team arrived at, creating an opportunity for the audience to engage in conversation with our team on the differences and similarities, challenges and opportunities, they might encounter with their own processes and stakeholders.
We believe sharing this knowledge may create the following value for the audience's organizations and product end users:
1.Short-term value: may improve work predictability by (1) improving the precision of project scope planning regarding labeling, IFU, and packaging, (2) making achievable commitments to the project with visible task distribution to responsible disciplines and team members, and (3) facilitating communication of progress and team member collaboration by avoiding misunderstanding and misalignment on labeling-related terminology and scope.
2.Medium-term value: may enhance product quality or "cost of quality" by (1) increasing useful and meaningful design for end users starting from early design or development stages with higher iteration flexibility, (2) decreasing project schedule risks and re-design costs in the development stage (under full Change Management and Design Controls) and (3) complying with the Change Management Process when labeling, IFU, packaging changes happen after commercialization stage, ensuring responsible team members are consulted.
3.Long-term value: may increase product users' quality of life by creating a meaningful system of instructional and packaging materials that are best considered for them and their unique needs.
We hope this poster provokes an exchange of ideas and facilitates discussion about the best practices for planning activities for designing a labeling system from early user research, through Human Factors validation and submission.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer