Before your next human factors study for medical devices begins, ask these 12 questions to ensure clarity, compliance, and confidence.
In human factors research for medical devices, the margin for error is small and the stakes are high. Each study represents months and sometimes years of preparation and countless hours of collaboration among cross-functional teams. We know this because for decades we’ve had the privilege of partnering with medical device manufacturers, usability engineers, and regulatory teams to bring these studies to life.
Our experience has taught us that even the most seasoned human factors professionals benefit from a clear, thoughtful checklist before their project kicks off or a new partner is chosen. Over the years, we’ve evolved alongside this industry by building medical simulation centers, refining recruitment protocols, and adapting facility spaces. We did all of this because we listened to what clients needed most: a partner who truly understands the work and helps it run seamlessly.
Below are key questions to consider as you prepare for your next human factors study. Each one can help save time and reduce risk, ensuring that you have what you need for success.
✔️ Are surrogate or proxy participants acceptable if the primary user type is hard to reach?
Understanding flexibility early helps determine feasibility and market recommendations. Clarifying whether surrogate users are allowed, and under what conditions, prevents last-minute surprises.
✔️ How are you defining“injection experience”?
In studies involving self-injection or device handling, definitions matter. Are you capping experience at a certain number of years? Does previous participation in a similar market research study qualify as “experienced”? Clear definitions help ensure the right participant mix from the start.
✔️ How nuanced is experience among adolescent participants?
Adolescents often assist in parts of a task, such as pressing a button, rather than completing it independently. If they’re part of your target user group, it’s important to clarify what counts as meaningful experience for this age range.
For context on regulatory expectations, you can refer to the FDA’s guidance on human factors studies for medical devices. Or for more specific information when adolescents are involved, see the National Library of Medicine's notes here.
✔️ Are there specific medication or dosage requirements?
Establishing medication-based criteria or quotas upfront ensures that recruiting teams target the right segments and markets. If you have access to incidence or market share data, sharing it early helps confirm feasibility and sample availability.
From rare conditions to device-specific user groups, our medical recruiting experience showcases that even the most complex inclusion criteria are met with precision and care.
✔️ Can caregivers and patients be related?
For studies involving both patients and caregivers, define whether those groups must be independent or if caregiver-patient pairs are permitted. This distinction impacts both recruitment design and analysis.
✔️ Will your study include multiple visits or a decay period between sessions?
If there’s a break between training and testing, define both the minimum and maximum duration. These details affect scheduling, feasibility, and participant retention, especially when coordinating multiple markets.
✔️ What compensation or reimbursement approach will you use for participants?
Clarify whether your study will follow FMV guidelines or if alternative compensation or reimbursement approaches are appropriate. Understanding this early helps teams maintain flexibility while supporting compliance, feasibility, and participant engagement.
✔️ Are there country-specific role considerations for HCPs?
Titles and scopes of practice can vary widely from country to country. For example, “Nurse Practitioner” and “Physician Assistant” roles don’t exist in Germany or France. Clarifying equivalent roles helps avoid screening errors and delays.
If you are managing multi-market work, our global recruiting and coordination capabilities can help streamline this process.
✔️ What will participants experience during the session?
Whether the study involves simulated use, hands-on device interaction, or observation-only tasks, outlining participant expectations ensures ethical alignment and logistical preparedness for all parties involved.
✔️ What facility resources or equipment are required?
Make a list of essential tools such as sinks, power access, extra tables, refrigeration, or storage space, and identify who will provide them. A dedicated research venue or medical simulation center can simplify setup and ensure compliance with safety and privacy requirements.
✔️ Where will the study take place, and is the space built for this kind of research?
Environment can make or break a session. Purpose-built research facilities often provide the privacy, cleanliness, and technical support that hotel meeting rooms or borrowed spaces cannot. Consider whether your location enhances the experience for both participants and clients.
✔️ How will your partner support you beyond recruitment?
Human factors studies demand more than logistics. They require flexibility and deep operational understanding. Choose a partner who anticipates challenges, communicates clearly, and adapts quickly when protocols shift. At Fieldwork, we see ourselves as an extension of your team, helping you navigate the logistical and human elements that make every study unique.
✔️ Have you planned for device shipping and logistics across markets?
If your study requires shipping devices to another city or country, it’s important not to leave logistics planning until the last minute. Sharp objects, liquids, and early-stage prototypes can easily be delayed or flagged in transit, particularly for cross-border shipments.
Confirming shipping requirements early, including customs considerations and handling restrictions, can prevent costly delays. In some cases, partnering with a specialized logistics provider can save time and reduce risk. For especially sensitive devices or timelines, hand-carrying equipment with a team member is often the most reliable option.
A Final Thought
Human factors research for medical devices continues to evolve, and so do the expectations placed on those who conduct it. By asking the right questions before launching, you not only streamline execution but also protect the integrity of the research and the safety of the users who depend on it.
We’ve seen firsthand how preparation and partnership can transform a complex study into a confident success.
From our dedicated medical device usability research support, to our medical recruiting experience, and our global recruiting expertise, we’re experts in this space.
No matter the project, our goal remains the same: to help your research run smoothly so you can focus on what matters most: the device, the user, and the data.
Bonus: Fieldwork's Exploratory Period
Our Exploratory Period is a specialized service designed to help clients understand feasibility when researching an unknown or rare target population. This unique offering allows teams to test assumptions, identify viable participants, and create a clear path to successful research– before full-scale recruitment begins.
Looking for a partner who understands the nuances of human factors research?
Explore our medical research capabilities or contact our team to discuss your next study.
