By Laura Haxton, Head of Operations at Med Planet
What to Consider Before Starting Your Human Factors Project
Human Factors research is a crucial step in ensuring that medical devices, pharmaceuticals, and healthcare products are safe, effective, and user-friendly. However, a poorly planned study can lead to unreliable data, regulatory setbacks, and wasted time and resources. To set your Human Factors project up for success, you must consider three key areas: sample size and participant criteria, logistics for in-person testing, and compliance with regulatory standards.
1. Defining the Right Sample Size and Participant Criteria
Your study’s validity depends on recruiting the right mix of participants and ensuring the sample size is large enough to generate statistically significant results. Key considerations include:
- User Demographics: Define whether your study requires healthcare professionals, patients, caregivers, or a combination of these groups. Each audience has unique insights that can impact usability and safety assessments.
- Quotas and Representativeness: Establish quotas for specific demographic and professional segments. A diverse and well-balanced sample ensures that results reflect real-world use. For patient groups, quotas may also include specific physical or cognitive attributes depending on the prototype being tested—such as dexterity levels, left- or right-handedness, or visual impairments—to evaluate usability across a range of user capabilities.
- Screening and Eligibility: Implement a rigorous screening process to verify that participants meet the necessary criteria and have relevant experience with the device or product.
Missed quotas or a poorly defined participant pool can lead to incomplete or biased data, making it difficult to draw meaningful conclusions.
2. Planning Logistics for Multi-Day, In-Person Testing
Unlike virtual research, Human Factors studies require in-person testing to capture real-world interactions, decision-making processes, and potential usability issues. Effective logistical planning is essential for smooth execution.
Key logistical elements to plan for:
- Location and Facilities: Choose a research site that mimics the real-world environment in which the product will be used (e.g., hospitals, clinics, or home settings). Ensure facilities are equipped for secure and efficient data collection. Additional items may need to be purchased or rented for the specific set up required for the project.
- Participant Scheduling: Carefully coordinate multi-day testing to maximise engagement while avoiding fatigue. Staggered scheduling allows for comprehensive analysis without overwhelming participants.
- On-site Management: Have an experienced team on the ground to oversee sessions, troubleshoot issues, and ensure smooth participant flow.
- Data Collection and Security: Plan for the secure collection and storage of data, ensuring confidentiality and compliance with industry standards.
Without proper logistical planning, studies can face delays, participant dropouts, or incomplete data collection, compromising research outcomes.
3. Ensuring Compliance with Regulatory Standards
Regulatory bodies such as the FDA, MHRA, and ISO 62366 set stringent guidelines for Human Factors research. Meeting these requirements is non-negotiable for product approval and market entry.
Regulatory best practices:
- Align with Industry Guidelines: Design your study in compliance with regulatory frameworks, ensuring that usability testing addresses critical safety and performance concerns.
- Document Everything: Maintain detailed records of study design, participant recruitment, data collection, and analysis to provide regulatory agencies with clear evidence of compliance.
- Risk Mitigation: Identify and address potential safety risks during testing. If usability issues arise, document corrective actions and refine the product design accordingly.
- Over-recruit to Meet Sample Size Requirements: To meet FDA and other regulatory minimum sample size requirements, consider over-recruiting participants. This helps account for potential dropouts, incomplete sessions, or screen failures—ensuring your data remains robust and compliant.
- Regulatory Submission Support: Work with experienced regulatory consultants to ensure that your Human Factors data supports a seamless submission process.
Failure to meet regulatory expectations can delay product approvals and increase development costs, making early compliance planning essential.
Why Med Planet?
At Med Planet, we specialise in custom recruitment, seamless logistics, and regulatory-compliant research execution. Many companies struggle with participant quotas and fail to deliver complete, reliable data, but we ensure every project is executed with precision and efficiency.
