Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Creating a Task Analysis for a Drug Delivery Device

Explore the critical role of Task Analysis in designing user-friendly and safe drug delivery devices. This method helps identify potential use errors, optimize usability, and create intuitive interfaces, ensuring devices meet user needs while enhancing safety and performance.

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Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Introduction to Human Factors in the Pharmaceutical Industry

Explore the evolution of human factors and usability in pharmaceutical drug delivery devices. This post highlights the role of user-centered design in ensuring devices are safe, effective, and tailored to patient needs. From FDA guidelines to global regulatory standards like IEC62366, it traces how usability testing and human factors have become essential in designing patient-friendly devices.

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Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Leading language in Human Factors

Explore the importance of using unbiased scripts in pharmaceutical human factors evaluations. Unbiased scripts help prevent leading participants toward unnatural behaviors, ensuring accurate and impartial results. This post covers best practices for creating neutral scripts, controlling bias, and ensuring scientific rigor in human factors studies, which are crucial for developing safe and effective drug delivery devices

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Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Large vs Small Human Factors Team Size in Medical Device

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.

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Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Adolescents in Human Factors for Pharmaceutical products

Explore the critical role of human factors in designing pediatric drug delivery devices. 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. By incorporating human factors evaluations, developers can create user-friendly products that enhance safety, usability, and patient experience, while ensuring these devices meet the specific requirements of young users.

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Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Human Factors Key Considerations for Pharmaceutical Companies

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.

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Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Differences between formative and summative evaluations

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.

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Horacio M. Pace Bedetti Horacio M. Pace Bedetti

Effective Summative Evaluations in Pharmaceutical Industry

Explore the essential steps for conducting successful summative evaluations in pharmaceutical product development. Summative evaluations validate the safety and efficacy of drug delivery devices, 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.

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