Renée Bailey

Renée is the Senior Manager of Human Factors Engineering with nine years of experience in human factors engineering and 26 years as a Certified Instructional Technologist (CIT) and Performance Improvement consultant. Renée has a background in leading high-profile, large-scale programs in Fortune 100/500 companies and multiple regulated industries, including medical device manufacturing, pharmaceutical, utilities (oil & gas, electric), finance, and food safety.

Renée has demonstrated experience applying regulatory-focused human factors best practices to leading project teams, project strategies, use-related risk analysis, threshold analyses, and human factors study execution for pre- and post-market programs. Significant experience includes projects related to drug-delivery combination products, instructional design for lay users with low health literacy, ophthalmic drug delivery instructions with clinical training video, surgical-assisted robotics, point-of-care and central lab diagnostics with training video, implantable drug-delivery pumps, healthcare professional training and evaluation, sterile processing instructions and evaluation, left-ventricular assist device (LVAD) training, and evaluation, biologic treatment implant procedure evaluation and optimization of instructions, surgical stapler, and implantable blood flow monitoring device.

As a CIT, Renée is an expert in applying a scientific, systematic, and scalable methodology based on Human Performance Technology (HPT) to produce effective instructional materials for healthcare professionals, lay user patients and caregivers, and clinical educators. Her process focuses on achieving safe and effective interactions between end-users and medical devices. Renée’s instructional design expertise includes instructions for use, quick reference guides, training materials and programs, and instructional videos. Renée has designed and optimized instructional interfaces for in vitro diagnostic kits, an ophthalmic drug delivery device, pen injectors, auto-injectors, inhalers, on-body drug delivery devices, point-of-care and central lab diagnostics, a left-ventricular assist device (LVAD), reprocessing, over-the-counter medical products, biologic implants, implantable blood flow monitoring device, and robotic systems.

Renée is an industry thought leader and an active conference speaker on topics related to human factors engineering processes, regulatory requirements, and evidence-based instructional labeling. In addition to being an active member of the Human Factors and Ergonomics Society (HFES) and Regulatory Affairs Professionals Society (RAPS), Renée is also a co-author and former faculty for the AAMI workshop “Applying Human Factors to Instructional Materials as Part of the User Interface,” the RAPS workshop “Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?” and contributing author to the book “Applied Human Factors in Medical Device Design.”