Presentation
MDD11 - Dollars and Sense: Understanding What Drives the Cost of Human Factors Research
SessionPoster Session 2
DescriptionThe timelines for medical device development and the budgets available are always debated and often in tension. It is a common misconception that human factors activities are time intensive and very expensive, and therefore should be delayed until clinical trials are complete, formulation is final, and/or decisions to commercialize have been made. Unfortunately, starting human factors activities at this point often leads to more expensive programs.
As human factors consultants, we provide hundreds of proposals to conduct research every year and have current, experience-based knowledge of what drives the cost of research. Members of industry who request these proposals have intimate knowledge of their budget and project needs, but may not have the insight for how to make the two work together when budget constraints and research goals don’t align. Whether we like it or not, cost is a main driver of what type of research gets conducted and the quality of the data collected. Many times, consultants and sponsors have to make compromises, but it’s important to focus on the things that will actually make a difference. In this presentation, we will discuss research factors that drive cost and those that have minimal impact. The goal is to help all parties involved learn how to make informed decisions about study design to minimize cost while maintaining the integrity of the research.
We will talk through case studies that illustrate how changing certain research parameters affect the cost and feasibility of the research. For example, we’ll discuss how the following changes may or may not result in significant changes to study cost: adding a user group, extending session time, adding training, requiring experience with a specific medication, or requiring a specific diagnosis. We will also provide examples of how timeline considerations may also impact (or not impact) project cost and feasibility.
It’s not uncommon for a regulator or a project stakeholder not directly involved in HF activities to make decisions that have substantial impact on the cost of a project. Therefore, we will also provide discussion points for in-house practitioners to use when planning human factors activities in a cross-functional team.
With the understanding that all human factors consultants have different strategies and all human factors sponsors have different needs, we will discuss areas of common ground and provide information to both groups for meaningful cost considerations when designing human factors research.
As human factors consultants, we provide hundreds of proposals to conduct research every year and have current, experience-based knowledge of what drives the cost of research. Members of industry who request these proposals have intimate knowledge of their budget and project needs, but may not have the insight for how to make the two work together when budget constraints and research goals don’t align. Whether we like it or not, cost is a main driver of what type of research gets conducted and the quality of the data collected. Many times, consultants and sponsors have to make compromises, but it’s important to focus on the things that will actually make a difference. In this presentation, we will discuss research factors that drive cost and those that have minimal impact. The goal is to help all parties involved learn how to make informed decisions about study design to minimize cost while maintaining the integrity of the research.
We will talk through case studies that illustrate how changing certain research parameters affect the cost and feasibility of the research. For example, we’ll discuss how the following changes may or may not result in significant changes to study cost: adding a user group, extending session time, adding training, requiring experience with a specific medication, or requiring a specific diagnosis. We will also provide examples of how timeline considerations may also impact (or not impact) project cost and feasibility.
It’s not uncommon for a regulator or a project stakeholder not directly involved in HF activities to make decisions that have substantial impact on the cost of a project. Therefore, we will also provide discussion points for in-house practitioners to use when planning human factors activities in a cross-functional team.
With the understanding that all human factors consultants have different strategies and all human factors sponsors have different needs, we will discuss areas of common ground and provide information to both groups for meaningful cost considerations when designing human factors research.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer