Original Insights: Success Factors of Human Factors Validation in Medical Device Development

What Are Success Factors?

Success factors are elements or variables that significantly contribute to the achievement of desired outcomes or goals. In essence, the idea of success factors has evolved over time through the contributions of various thinkers, researchers, and practitioners across different domains. It reflects a collective understanding of the elements that are crucial for achieving positive outcomes in different areas of life and work.

Many experts in each field have contributed to our understanding of success factors in diverse domains.  Their work often forms the foundation for best practices and frameworks within specific fields. Here are a few examples:

Business and Management:

  • Peter Drucker: Often regarded as the “father of modern management,” Drucker’s works, such as “The Practice of Management,” have significantly influenced the understanding of management principles and success factors in business.
  • Michael Porter: Renowned for his work in competitive strategy, Porter has identified key success factors in industries through frameworks like the Five Forces analysis.

Project Management:

  • Henry Gantt: Known for the Gantt chart, Gantt made significant contributions to project management by visualizing project timelines and tasks.
  • David Allen: His work, especially the “Getting Things Done” (GTD) methodology, has been influential in personal and project productivity.

Usability and User-Centered Design:

  • Donald Norman: A pioneer in the field of human-computer interaction, Norman’s work, such as “The Design of Everyday Things,” focuses on the importance of user-centered design.
  • Jakob Nielsen: An expert in web usability, Nielsen has identified key principles and factors for creating user-friendly websites (e.g.: Nielsen’s Heuristics).

Medical and Healthcare:

  • Atul Gawande: A prominent surgeon and author, Gawande’s work, including “The Checklist Manifesto,” emphasizes the importance of systematic approaches and checklists in healthcare for improved outcomes.
  • Don Berwick: A leading figure in healthcare quality improvement, Berwick has contributed to identifying success factors for patient safety and quality improvement initiatives.


  • John Hattie: Known for his research on visible learning, Hattie has identified factors that contribute to effective teaching and student learning outcomes.
  • Carol Dweck: Her work on mindset, particularly the concept of a growth mindset, has influenced educational approaches and success factors in fostering learning and resilience.

These are key players, researchers, and thought leaders who are known and given due credit for their contributions in identifying and elucidating key success factors within their fields.

The Keys to Successful Human Factors Validation – Pioneered by Dr. Rojas

In the specialized domain of FDA Medical Device Human Factors Validation Projects, Dr. Katia M. Rojas (Founder & Principal Consultant of Successful Human Factors) is the trailblazer. She meticulously identified, characterized, organized, and structured the key success factors in a systematic manner within the SHF 2.0 framework. In other words, Dr. Rojas utilized a comprehensive and structured approach to identifying and defining these success factors, ensuring that they are clear, coherent, and interconnected. This systematic approach enables stakeholders to easily understand and implement the success factors in their HF validation projects for optimal outcomes.

Dr. Rojas’ comprehensive approach involved drawing insights from rigorous scientific research, soliciting expert input, conducting thorough studies, adhering to regulatory standards (particularly FDA requirements), and integrating industry best practices. The culmination of her efforts is exemplified in the creation of the Successful Human Factors Framework (SHF 2.0), a testament to her leadership and innovative contributions in this field (see references below).

Success Factors and Best Practices for Successful Human Factors – Exploring the SHF 2.0 Framework

In the SHF 2.0 framework, success factors refer to the key elements and practices that contribute to the successful implementation of human factors engineering (HFE) activities in medical device and combination product development, translating into overall product success. The SHF 2.0 framework provides a structured approach to assess capabilities and ensure successful implementation of HFE activities in medical device and combination product development. 

As mentioned before, the success factors within the SHF 2.0 framework are based on a combination of scientific research, expert feedback, regulatory guidance (with a particular emphasis on FDA requirements), and industry best practices. These success factors encompass critical practices and critical components that cover various aspects of human factors in medical devices and combination products, relating two key dimensions: human factors engineering and project management. 

These key success factors are essentially groups of best practices, including Planning & Documenting, Tools & Methodology, People, Timing & Integration, and Communicating & Reporting.  

Each group or category is carefully linked to tailored PM processes, and consists of specific activities (best practices) that contribute to the overall success of HF validation projects. For example, within Timing & Integration, it is essential to align the human factors engineering work with the different milestones of product design and development, as early as possible. This involves considering the specific phases of the HFE work, such as market research, usability testing, HF test protocol review by the FDA, risk mitigation, interface testing, and design validation.

Within  “Communicating & Reporting,” best practices such as user-usable language and formats, engaging sponsors/stakeholders are crucial for effective communication and presentation of HF validation results. Similarly, within “Planning & Documenting,” activities like ensuring accuracy of plans and proposals, Traceability Management, and Completeness Management play vital roles in the success of HF validation projects.

Each success factor addresses specific areas of focus to ensure a comprehensive and effective approach to HF validation. Implementing these success factors helps ensure compliance, traceability, effective communication, qualified personnel, appropriate tools and methods, and alignment with regulatory expectations, ultimately leading to successful HF validation projects.

Want to Learn More?

This is only a short overview of some components within the SHF 2.0 framework. To unlock its full potential, understand and apply all key success factors and best practices, connect with us today for personalized assistance and optimize your human factors engineering approach! 


  1. Rojas, K. M. (2023, March). Validating a Project Management Maturity Framework Based on the Emerging Best Practices for Successful Human Factors Projects that Require FDA Approval -Summary of Key Findings (pre-print).

  2. Rojas, K. M (2020). Project Management Practices and Key Factors for Success in FDA Human Factors Validations of Medical Devices and Combination Products. Doctoral dissertation, State University of New York at Binghamton. ProQuest Dissertations Publishing. Publication No.  2020. 27963841

  3. Rojas, K. M., Cosler, L., & Santos, D. L. (2020). Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects–Preliminary Findings. In Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care (Vol. 9, No. 1, pp. 166-175). Sage CA: Los Angeles, CA: SAGE Publications.

  4. Rojas, K. M. (2020). Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care9(1), 156–169.

  5. Rojas, K. M., Cosler, L., & Santos, D. L. (2019). A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool. In Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care (Vol. 8, No. 1, pp. 222-233). Sage CA: Los Angeles, CA: SAGE Publications.

  6. Rojas, K. M., Sharareh, N., Cosier, L., & Santos, D. L. (2019). Considering the Dynamics of FDA Human Factors Validation Requirement: Implications of Failure and Need to Ensure Project Success-A Conceptual Framework. In Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care (Vol. 8, No. 1, pp. 234-247). Sage CA: Los Angeles, CA: SAGE Publications.

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