Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?

Renée Bailey joined the Agilis Consulting Group in 2017 as the Director of Instructional Design & Creative Solutions, after 5 years of consulting in the medical device industry. Renée brings with her more than 20 years of experience designing and developing instructional materials and strategies for medical device manufacturers, pharmaceutical companies, and other high-profile companies.

As a Certified Expert Practitioner in evidence-based instructional design, Renée is part of a team dedicated to helping its clients navigate the changing landscape of product regulatory pathways, including FDA and international human factors submissions. She also serves as Faculty for AAMI’s human factors course for evaluating instructional materials and enjoys engaging with other medical field professionals on how to implement data-driven changes for improved usability and end-user performance.

As a thought leader in the industry, Renée is an active conference speaker on topics related to human factors engineering and regulatory guidance, evidence-based instructional labeling and training, post-market surveillance, and processes related to product clearance, approval and market success.

Dr. Jessie Huisinga is a Senior Human Factors Consultant with Agilis Consulting Group, LLC and an expert in assessing human performance with extensive experienceworking with individuals with neurological impairments. She has a background in Biomedical Engineering and Biomechanics, with specialized training in Neurology in order to evaluate movement patterns and task performance in persons with performance limitations. Dr. Huisinga works with Agilis clients to develop and optimize medical device and combination product user interfaces by applying various human factors methodsas well as accessible design considerations. Dr. Huisinga has experience designing and conducting human factors formative and validation studies to help clients achieve successful human factors regulatory submissions and bring safe and effective medical devices and combination products to the market. She has experience assessing a diverse spectrum of home and professional use medical devices and products as well as conducting in-home and actual use usability studies. Dr. Huisinga earned a PhD in Biomechanics from the University of Nebraska Medical Center. She also earned a M.S. in Exercise Science from the University of Nebraska at Omaha and a B.S.in Biomedical Engineering from the University of Iowa. Dr. Huisinga also currently holds an appointment as a Research Associate Professor in the Department of Physical Therapy and Rehabilitation Science at the University of Kansas Medical Center. She is excited to apply scientific methods in order to assess the usability of products that people will use to maintain their health and improve their quality of life.