Medical device developers are increasingly subject to requirements that incorporate user needs assessment into their product design and development processes. A detailed understanding of user needs and expectations is essential to ensure the safety and effectiveness of the end product. This mastery of the user’s needs is essential to determine the user satisfaction criteria and to characterize the future determinants of the adoption of the product.
MCP brings you both a methodological support and the tools to study and analyze the needs and expectations of users. MCP’s contribution is based on knowledge of medical practices and care.
Task analysis is the analysis of how a task is accomplished, including a detailed description of both manual and cognitive activities, task and element durations, task frequency, task allocation, task complexity, environmental conditions, and any other unique factors involved in or required for medical device users to perform a given tasks.
The focus of functional tasks analysis is on the description and the content of each tasks to be achieved to produce safe and efficient device functions and subfunctions. Each taks and groups of task are groupe according the expected effets of the device to satisfy user’s need and expectations
The focus of the cognitive walkthrough is on the understanding of new device learnability for new or inferents new users.
The focus of contextualenvironmentanalysisis on the identification and characterization of all factors present in the user’environment in which the medical device is used such as (hopital ward, home, travel, climat, sport activities and so forth).
A systematic and early human risk analysis and a usability evaluation allow medical device developpers and manufacturers to identify and control risks within the human-device interaction very efficiently. FDA and EMEA pay a great attention on the identification and the elimination of human-induced errors and risk mitigation to achieve reliable design and error-tolerant device interface.
In this contex MCP has developed tools and corresponding standardised operating procedures for model-based human risk analysis supported by HF & usability studies. The MCP tools and procedures can be used from early developmental stages up to validated product.
Formative research studies focus on testing concept designs with targeted users to identify which concept is the best direction to pursue. It is designed to measure and study all facets of usability and identify refinement opportunities to be integrated into the final design. We conduct simulations of use with all targeted user groups using a combination of rapid print models, storyboards, annotated drawings, IFUs, and training to evaluate all concept options and individual features within each concept with the goal of down-selecting to the best final design. Each project is different and it’s very common to conduct multiple Formative Research Studies as you continue to evolve your design thinking.
Summative evaluations are the formal validation studies conducted for the final version of the device. These studies are your Human Factors Validation Testing that must follow the requirements of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. These studies consist of a minimum of 15 participants for each defined user group and must be performed in actual or simulated use environments.
Human factors data exploitation for technical files development and registration filling
The validation of the user documentation that includes the instructions for use is a requirement of the Health Agencies. This validation is carried out by observation tests of the instructions and training guides to check whether the user, particularly the layman, understands and can correctly follow this information. It is no longer acceptable to register a new medical device with the risk of error of the user as an explanation of the problems of use of the device. AAMI has recognized that the application of good human factors methods, including improved labeling and notes and user guides, helps optimize user performance.