Patricia A. Patterson, CPT is President of Agilis Consulting Group and a Certified Performance Technologist. For more than 25 years Pat has applied the systematic, research-based methodologies of Human Performance Technology (HPT) to improve how people learn to use information and technology to produce measurably superior results. After decades working with the Fortune 500 and NASA, her focus is now with the medical industry.
As one of the first professionals to obtain the CPT designation, Pat is driven to help make medical science and technology more accessible for patients, partners, educators and customers to improve the quality of life. In this fast changing industry, she recognizes that companies must succeed amidst rising costs, shrinking resources and widening regulations, where risks can often outpace profits.
Pat’s expertise includes helping clients focus on the end user; from concept through post-market. Her systematic and integrated performance-based training and labeling systems ensure results, reliability and a return on investment. In clinical trials, her performance-based methods have proven to accelerate competent, first-time performance, reduce errors, and earn high praise when compared to other training and labeling 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 post-market support costs.
Pat has been an industry advisor to the FDA’s Home Health Care Committee focused on reducing the number of adverse events in this growing segment of the medical device industry. She is also a contributing author to the user documentation/training chapter in ANSI/AAMI HE 75: Human Factors Design Guidelines for Medical Devices, recently published by the Association for the Advancement of Medical Instrumentation (AAMI). The FDA is expected to adopt HE75 later this year. Pat is a member of AAMI’s Medical Devices and Systems in Home Care Applications committee. She is a frequent speaker and author and on the subject of human factors and performance-based training and labeling in the medical industry. Her latest article co-authored with Agilis’ Chief Scientist, Dr. Bob North is a preview to HE75 and appears in the January 2010 edition of Medical Device & Diagnostic Industry magazine.
Robert A. North, PhD is Chief Scientist for Agilis Consulting and an expert on human performance modeling and prediction. In 2008, Dr. Robert North was recognized as one of the 100 Notable People in the Medical Device Industry by Medical Device & Diagnostics Industry (MD&DI) magazine - one of only two human factors engineers to receive this distinction. Bob helps clients apply human factors techniques to create use error analysis, prediction and prevention for home and hospital medical devices. Prior to his consulting career, Dr. North’s industry leadership has included serving as department head of the human factors group at Medtronic, Inc. where he managed a team designing software human interfaces for complex medical devices including implantable cardiac devices (pacemakers and defibrillators). Prior to this, Bob managed the human factors lab for Honeywell Aerospace.
As a member of the Human Factors Standards Development Committee for the Association for the Advancement of Medical Instrumentation organization (AAMI), Bob is an author on FDA human factors standard: ANSI/AAMI HE-75: Human Factors Design Guidelines for Medical Devices currently under development and eventual adoption by the FDA. 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.
Bob has authored over a dozen scholarly articles on human factors including a recent paper 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.
Dr. North holds a doctorate in Engineering Psychology from the University of Illinois at Urbana Champaign.
Ron Paul is Senior Consultant – Medical IT Consulting for Agilis. Ron has more than thirty years experience in this fast paced often complex environment. Ron brings his strong experience in working with clients and stakeholders to define effective solutions to business problems and to deliver those solutions in a timely and cost-effective manner. His experience ranges the gamut of healthcare software including inpatient, outpatient, clinical trial, insurance, organ bank and call center environments.
Ron has helped clients successfully pass audits in the FDA 21 CFR part 11 regulated environment. He has integrated diverse healthcare systems using a variety of standards including HL7 and CCOW. Ron is able to bridge the communication gap that sometimes exists among clinical, administrative and technical personnel to develop risk management techniques to bring high-tech projects to a successful conclusion. Ron has extensive experience in all aspects of software solution delivery including: Project Management, Technical Management, Requirement Analysis, System Architecture, Design, Coding, QA, Testing, Implementation and Support. Ron has a Master of Science in Electrical Engineering from Cornell University and is the author of more than ten patents in the healthcare IT arena.
Agilis Consultants are proud members of the following organizations:
- American Diabetes Association
- Arizona Bioindustry Association
- Association for the Advancement of Medical Instrumentation
- FDA Home Health Care Committee
- Human Factors and Ergonomics Society
- Industrial Designers Society of America
- International Society for Performance Improvement
- Southern California Biomedical Council
- Regulatory Affairs Professionals Society
- Rehabilitation Engineering and Assistive Technology Society of North America