Human Centered Strategies

Robert A. North, PhD is Chief Scientist for Human Centered Strategies and an expert on human performance modeling and prediction. Bob helps clients apply these techniques to create use error analysis, prediction and prevention for home and hospital medical devices. Prior to his consulting career, he managed the human factors departments at Medtronic and Honeywell International.

Dr. North is a co-author on FDA human factors standard: ANSI/AAMI HE-75 Human Factors Design Guidelines for Medical Devices (under development with an early 2008 publication date). He is also a recognized expert on IEC-60601-1-6 Collateral Standard, Electronic Medical Devices – General: Usability and ANSI/AAMI HE-48, Human Factors Design of Medical Devices.

In 2007, Dr. North served as an adjunct faculty member for AdvaMed's short courses on Design Controls for manufacturers, representing the FDA's position on human factors and use error management. He also served as moderator for an AAMI webinar entitled Human Factors in Medical Device Design: Lessons Learned which drew over 500 on-line participants.

Bob has authored over a dozen scholarly articles on human factors including co-authorship with the FDA’s Human Factors group entitled UPCARE: An Analysis, Description, and Educational Tool for Medical Device Use Problems, published in the International Journal of Industrial Engineering. This paper forms the basis of the core analysis methods provided by HCS in idetnifying and managing use errors and use-related hazards in medical device interactions.

Dr. North holds a doctorate in Engineering Psychology from the University of Illinois at Urbana Champaign. Products

Patricia A. Patterson, CPT is a collaborating scientist for Human Centered Strategies, and is President of Agilis Consulting Group and a Certified Performance Technologist. After 25 years of consulting with the Fortune 500 and government, her focus is now directed toward medical, an area that has captured her heart and her head.

Ms Patterson's expertise includes helping clients focus on the end user; from concept to commercialization. She does this by designing systematic and integrated labeling and training systems that develop as the product matures. This fast and flexible approach to labeling enables clients to obtain early stage study results confident that any problems are not related to misleading or confusing instructions. Later, in preparation for final submission, the labeling is ready to adapt with minimal rework. In clinical trials, her methods have proven to accelerate competent, first-time performance, reduce errors and earn high praise when compared to other labeling and training methods. Clients have found that when people like what they learn and how they learn, they translate those positive feelings to their product. The results are improved customer satisfaction and lower after-sales support costs.

Pat practices in a hybrid field called Human Performance Technology (HPT). HPT applies research-based methods and procedures from human factors, instructional systems design and information design.

Ms Patterson is also a current member of the FDA's Home Health Care Committee, which is responsible for identifying key issues in medical products used in the home environment in terms of training requirements and human limitations imposed by disease related disabilities and aging factors.