Explore the impact of team size in human factors for medical device development. Large teams provide specialized expertise and collaborative synergy, while smaller teams offer agility, cost-efficiency, and faster decision-making. This post examines how to choose the right team size based on project complexity, balancing resources and expertise for optimal device design outcomes.

Explore the critical role of human factors in designing medical devices for pediatrics. This post highlights the need for devices that are safe, intuitive, and suited to the unique physical, cognitive, and emotional needs of children and adolescents.

Discover key factors for successfully integrating human factors into pharmaceutical device design. This post outlines essential considerations such as user-centric design, addressing physical characteristics, and ensuring clear instructions. It also highlights the importance of usability testing, risk assessments, and regulatory compliance, offering valuable insights to create safe, effective, and user-friendly drug delivery devices.

Explore the key factors distinguishing formative and summative evaluations in human factors for drug delivery devices. Formative evaluations focus on refining design throughout development, while summative evaluations validate safety and usability at the end of the process. Understand the differences in planning, methodology, and data analysis, and how both evaluations ensure devices are user-friendly, safe, and compliant with regulatory standards.

Explore the essential steps for conducting successful summative evaluations in medical device and combination products. Summative evaluations validate the safety and efficacy of the medical devices and pharmaceutical products, focusing on user interactions under real-world conditions. Key factors include selecting representative participants, setting clear evaluation objectives, and adhering to regulatory guidelines like IEC 62366 and FDA requirements.