Human Centered Strategies

cozmo

AAMI Webinar 2007
Standards & Guidances
RAPS Horizon 2008

HCS Services and Products Include Analysis, Testing, Benchmarking, and Corporate Education

Use Error Risk Management - Human Centered Strategies offers a range of Human Factors services to the medical device community concerned with managing the risks of use error. Central to our services is an FDA accepted task analysis process that identifies the critical device user requirements in terms of information processing and human performance criteria. This approach is a unique blend of understanding of human perception, cognitive processes, and skill acquisition knowledge. The Task Analysis provides the foundation for our test and evaluation planning services, because it identifies what needs to be tested at key points in the design process.

Human Factors Training - Human Centered Strategies now offers a one to two day seminar covering the basics of Human Factors processes and best practice in the design of user interfaces. This course covers the basics of human factors methods and when they should be carried out during each phase of the Design Controls process.

Regulatory Interactions - Regulatory interactions with the FDA concerning Human Factors are on the rise. HCS is prepared to help companies answer questions from reviewers and plan responses to streamline the process and turn these interactions into problem solving partnerships.

Strategies for Best Practice - Educational and strategic planning services for companies seeking to build excellence in medical device human factors and use error risk management has become one of our most important products as the FDA continues to review PMA, 510K and other submissions for their attention to use error control and management. We apply knowledge of current and upcoming standards and FDA expectations in assessing a company's strengths and weaknesses regarding the overall application of human factors within the Design Controls Process.

Task and Use Error Analysis - The Task and Use Error Analysis identifies the user task requirements in terms of perceptual inputs, cognitive processing, and physical responses. This allows us to pose use errors at each step based on human limitations and environmental factors that may limit user capabilities to process data and respond correctly. Important inputs to this analysis will be User Profiles and Scenarios of Use which describe user characteristics and the various situations where the device is used, both typical and abnormal.

Use Error Priority Analysis - Based upon potential, observed, or known use errors in user- device interactions, we prioritize the management of the use errors through a combination of the use error frequency (likelihood of occurance) and severity (patient or user safety impact) . This analysis tells us what to focus on in terms of design mitigations and user testing. Existing Hazard Analysis, FMEAs, and HCCCP outputs will be key inputs to this analysis as well as the Task Analysis.

Test & Evaluation Planning, Conduct, and Reporting - Based upon the above analyses, we help the design team plan test and evaluations that allow additional opportunities to identify potential use errors. These include formative studies, early in Design Inputs, and more formal summative user tests later in design when more complete models are available of the human interface. HCS will write the testing protocol, determine sample sizes and subject populations, and conduct these studies including post-study data analysis and reporting. HCS also will assist the manufacturer in the conduct of these studies, if requested. This allows the testing methodology to be easily transferred to the design team so that it becomes a core competency of the company.

Use Error Mitigation Strategy and Validation Plan - Based upon the above analyses and results of obervational evaluations, HCS can help the design team formulate the best strategy for mitigating and controlling use error and subsequent validation activities. Strategies are based on both the FDA's preferred heirarchy of mitigation methods and the realities of the team's time/cost resources, realizing that the most preferred mitigation may not be practical or feasible. Validation of any proposed mitigation for critical use errors is critical to success in regulatory evaluations, and carefully planned observational studies of the effects of design modifications, safeguards, training, or labeling fixes will be crucial in providing evidence of risk management.

Education: Workshops and Seminars - We offer several seminar and workshop formats to accomodate a variety of training needs for understanding the role of Human Factors in device design including a review of processes for each Design Controls phase, standards review and applicability, and practical exercises with case histories or products in development. Special in depth sessions, covering Task and Use Error methods and protocol planning for formative and summative user studies are available on request. Shorter modules are available to educate upper management on the benefits of Human Factors and the FDA's current position on Human Factors as a critical risk management discipline.

FDA Submissions, Interactions and Response Strategies - HCS applies knowledge of the regulatory review process to assist manufacturers with their overall approach to human factors in the use error risk management process including the preparation of device submissions and answering of letters of inquiry pertaining to use error risk. Often, this can involve identifying certain activities differently or providing a clear presentation of analyses that may have been done but not cast in a use error management light. HCS is also prepared to accompany the manufacturer when telecons or face-to-face interactions with FDA or other regulatory bodies are necessary to clarify plans and negotiate next steps in resolving use error risk management issues.

Human Factors Process Benchmarking - Clients often want to know how their approach to human factors and use error risk management compares with regulatory expectations or industry norms. HCS can assess a company's current position with respect to each step in the Design Controls process of the Quality System Regulation identifying both strengths and weakness of the current process. Often, HCS recommends certain augmentation of the company's current user interface design process without totally changing the process or adding multiple new steps to the process. One of the key facets of this analysis is learning how departments (marketing, clinical, engineering, R&D, and customer support) interact. An overall human factors process strategy usually can be formulated from work being done by each of these areas and by adding specfic expertise from human factors professionals.