HCS provides a unique niche in medical device human factors consulting. From our founding in 2003, we decided to focus on knowledge of the regulatory requirements for human factors in the pre-market device approval process. We work closely with the FDA’s Human Factors team in the development of human factors device standards and in the development and delivery of educational programs for manufacturers.
Core Beliefs
The application of Human Factors in device design has multiple benefits. It helps improve a product’s usability, facilitates a better customer experience providing market discrimination for your products. Application of human factors ultimately diminishes use risk and your liability while improving the quality of life for patients.
Information sharing. Knowledge of the human factors regulatory process should be generously shared with the device community.
Transfer of the human factors and usability process into your organization is our goal. We want you to have the skills and knowledge to successfully build human factors and usability engineering as core competencies.
Dr. Robert A. North, Chief Scientist
Dr. Robert A. North, PhD Engineering Psychology, has more than 35 years of experience in the strategic and technical direction of human factors programs in the medical, aerospace and defense industries. After managing the Human Factors group at Medtronic’s Cardiac Rhythm Management Division, Bob formed HCS in 2003.
Bob is a member of AAMI’s Human Factors Standards committee, and is a joint author of HE-75, Human Factors in the Design of Medical Devices, published in 2010.
From 2009-2016, Bob has served as the lead faculty of the AAMI three-day course, on Human Factors in Medical Devices. This course has trained more than 1200 participants from medical device and combination product areas since the 2009 course launch.
As a consultant, Bob has worked with more than 100 device and pharmaceutical companies.
Carol McIntyre: Education and Training Specialist
Carol A. Mcintyre, MS Educational Psychology, is an integral part of the HCS human factors workshop delivery team, serving as coordinator and manager of training materials and workshop agendas, and facilitator of group exercises during workshops.
Carol has extensive experience in training management for several high-tech companies and has designed and delivered both classroom and online programs.
Along with adult learning and psychological testing expertise, Carol is an award-winning visual artist who exhibits and teaches color theory for artists live and online.
Colleagues/Collaborators
Agilis Consulting Group
Agilis Consulting, located in Cave Creek, AZ, is a full-service human factors consulting firm focused on medical device usability and testing, and the design of instructional material. Ms. Patricia Patterson, President, is currently an instructional design technical expert to FDA, and serves as an Industry advisor to FDA’s Home Healthcare Initiative. Patricia is also a primary author of AAMI’s TIR 49:2013 Design of training and instructional materials for medical devices used in non-clinical environments.
Agilis provides human factors testing and analysis services for a variety of clients in the device and combination product arenas. Agilis’ unique niche in instructional material design has been a valuable asset on several HCS client projects.
Human Factors Focus, LLC
Human Factors Focus, recently founded by Ronald D. Kaye, former Group Leader of the FDA/CDRH Human Factors Pre-Market Evaluation Team, provides human factors regulatory consulting and education. Human Centered Strategies and Human Factors Focus have developed a collaborative education/training/workshop format for device and combination product sponsors based on principles described in the FDA’s 2016 guidance. Watch this space for more details on this service offering!
Rational Healthcare, LLC
Rational Healthcare is a human factors and systems engineering consulting firm located in Hertford, NC. The Chief Executive Officer, Mr. Steven Harris, is a retired US Navy Medical Service Corps Aerospace Experimental Psychologist with forty years’ experience in technology development and system acquisition in Navy medical laboratories, research & development, test & evaluation centers, and headquarters commands and in private enterprise. Rational Healthcare has collaborated with HCS on several recent medical device client programs focused on the analysis of post-market adverse event reports including the extraction of usability ahd human factors data from the FDA’s MAUDE database.