Presentation
MDD13 - Enhancing Medical Device Development: The Collaborative Power of Systems Engineers and Human Factors Specialists
SessionPoster Session 2
DescriptionFor human factors (HF) specialists working in medical device development, collaboration with systems engineers (SE) can be pivotal. Systems engineering is an interdisciplinary approach that ensures complex systems meet stakeholder needs. Usability engineering focuses on human behavior, capabilities, and limitations to optimize design and ensure devices are intuitive and safe. By working together, HF and SE disciplines create products that are not only functional but enhance the user experience, safety, and overall performance.
The earlier HF specialists integrate with systems engineering teams, the more influence they have over design decisions that impact usability. This early involvement reduces the likelihood of costly late-stage redesigns and ensures usability isn't just an afterthought. As HF experts, it’s critical to advocate for this collaboration from project inception, ensuring both user experience and functionality are prioritized, which positively impacts manufacturing, operations, and long-term sustainability.
During the conceptual phase, systems engineers are responsible for converting customer requirements into technical design goals. HF specialists must actively engage during this phase to ensure user needs are properly considered. This goes beyond basic use cases—using methods like key opinion leader interviews, user requirement analyses, and focus groups, HF experts can shape early design concepts. By aligning use specifications (intended use, environments, and user demographics) with system constraints, they help ensure the device is functional and user-friendly. This early collaboration informs the system design, reducing friction later in development when usability challenges are harder and more expensive to fix.
Once initial design concepts are established, HF experts should work with systems engineers to translate user needs into detailed workflows, user stories, and task analyses. This process allows them to influence critical design decisions—such as how tasks are assigned to users or automated systems—and helps determine how information will be displayed and interacted with. By partnering with SE teams to conduct trade studies, they can ensure that usability considerations are balanced with technical feasibility, budget, and timeline constraints. The ultimate goal is a device that is not only functional but intuitive and efficient for the user, without excessive technical complexity.
As the development progresses, HF specialists play a key role in risk management activities alongside systems engineers. While SE-led risk assessments focus on system failures, HF experts must drive the evaluation of use-related risks—those tied to how the device will be operated by real people in real environments. They can leverage tools like use-related risk analysis, formative evaluations, and reviews of known user errors in similar devices. By identifying potential user errors early, HF specialists can suggest design improvements that mitigate risk before it becomes embedded in the final product. Collaborating with systems engineers on risk mitigations ensures that both technical and user-related risks are addressed in a balanced way.
Another area where collaboration is essential is in verification and validation testing. HF specialists should be involved not just in usability validation (summative testing) but also in setting criteria for system verification tests that consider human performance limitations. For example, an HF expert might define the acceptable torque for a hand-operated knob based on ergonomic data. This helps systems engineers understand the physical constraints users face and ensures that device components are designed with real-world user limitations in mind.
Throughout the process, HF experts should consistently advocate for design solutions that reduce reliance on training or user instructions as a risk mitigation strategy. While systems engineers may focus on technical solutions, it’s the responsibility of HF specialists to ensure that the device is usable without overburdening users with complex instructions or training. They should push for design changes that simplify interaction, making devices as intuitive as possible while addressing risks from the earliest stages of development.
In conclusion, the collaboration between HF specialists and systems engineers results in a more holistic approach to medical device design. By working closely with SE teams, they can ensure that human considerations are embedded in the technical fabric of the device. This leads to safer, more effective products that meet both technical requirements and user needs, ultimately driving better outcomes for patients and healthcare providers alike.
The earlier HF specialists integrate with systems engineering teams, the more influence they have over design decisions that impact usability. This early involvement reduces the likelihood of costly late-stage redesigns and ensures usability isn't just an afterthought. As HF experts, it’s critical to advocate for this collaboration from project inception, ensuring both user experience and functionality are prioritized, which positively impacts manufacturing, operations, and long-term sustainability.
During the conceptual phase, systems engineers are responsible for converting customer requirements into technical design goals. HF specialists must actively engage during this phase to ensure user needs are properly considered. This goes beyond basic use cases—using methods like key opinion leader interviews, user requirement analyses, and focus groups, HF experts can shape early design concepts. By aligning use specifications (intended use, environments, and user demographics) with system constraints, they help ensure the device is functional and user-friendly. This early collaboration informs the system design, reducing friction later in development when usability challenges are harder and more expensive to fix.
Once initial design concepts are established, HF experts should work with systems engineers to translate user needs into detailed workflows, user stories, and task analyses. This process allows them to influence critical design decisions—such as how tasks are assigned to users or automated systems—and helps determine how information will be displayed and interacted with. By partnering with SE teams to conduct trade studies, they can ensure that usability considerations are balanced with technical feasibility, budget, and timeline constraints. The ultimate goal is a device that is not only functional but intuitive and efficient for the user, without excessive technical complexity.
As the development progresses, HF specialists play a key role in risk management activities alongside systems engineers. While SE-led risk assessments focus on system failures, HF experts must drive the evaluation of use-related risks—those tied to how the device will be operated by real people in real environments. They can leverage tools like use-related risk analysis, formative evaluations, and reviews of known user errors in similar devices. By identifying potential user errors early, HF specialists can suggest design improvements that mitigate risk before it becomes embedded in the final product. Collaborating with systems engineers on risk mitigations ensures that both technical and user-related risks are addressed in a balanced way.
Another area where collaboration is essential is in verification and validation testing. HF specialists should be involved not just in usability validation (summative testing) but also in setting criteria for system verification tests that consider human performance limitations. For example, an HF expert might define the acceptable torque for a hand-operated knob based on ergonomic data. This helps systems engineers understand the physical constraints users face and ensures that device components are designed with real-world user limitations in mind.
Throughout the process, HF experts should consistently advocate for design solutions that reduce reliance on training or user instructions as a risk mitigation strategy. While systems engineers may focus on technical solutions, it’s the responsibility of HF specialists to ensure that the device is usable without overburdening users with complex instructions or training. They should push for design changes that simplify interaction, making devices as intuitive as possible while addressing risks from the earliest stages of development.
In conclusion, the collaboration between HF specialists and systems engineers results in a more holistic approach to medical device design. By working closely with SE teams, they can ensure that human considerations are embedded in the technical fabric of the device. This leads to safer, more effective products that meet both technical requirements and user needs, ultimately driving better outcomes for patients and healthcare providers alike.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer