Effectively identifying, prioritizing and translating user needs into design guidance is critical to successfully developing a safe, effective and desirable medical device.

The process of interacting with users iteratively from early discovery research to Human Factors formative testing is the key to successful needs characterization. These user research activities are inextricably linked to the design and development process and can be optimized by understanding the goals, tools and outputs at each stage of research.

We have developed a User Needs process map that clearly illustrates how Insight integrates with and supports our clients’ stage gate process.

This map outlines

  • goals of each touchpoint
  • types of research collateral that can best assist the team
  • suggested environments and sample sizes for each effort
  • typical deliverables that the team can expect for each round of research

user-needs-in-med-device-1The map also illustrates how the User Experience and Technical Teams interact and support each other in the product development process. It also highlights the activities that are best addressed together like the numerous risk analysis efforts and Human Factors testing.

We can also see from the map that as time progresses on the project, the number of concepts, divergent at first, begin to converge and narrow. This is made possible through research which helps the design team determine which options to pursue and also identify risk factors for each concept and how to mitigate them. As the number of concepts narrow and the overall risk begins to fall, we are able to increase the fidelity of the research collateral further refining concepts and identifying and reducing risk.

Along the bottom row, we describe the different types and fidelities of prototypes that we develop and utilize for the effective performance of user research.User Needs Indentification

Extensive integration of all disciplines involved in development including the effective use of iterative research, will result in solutions where risk has been identified and mitigated and where the final concepts will provide the safest, most effective use while optimizing the user experience. This is where true success exists, delivering better healthcare outcomes.

Receive a hi-res poster of our User Needs Identification Process Map.

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