Services
Human Factors Engineering
A successful and robust product develop process relies heavily on Human Factors Engineering (HFE) activities and deliverables. By executing activites that focus on your end user, usability and user interface design, your teams will be able to improve the user experience, increase safety and decrease risk during device use. Additionally, regulatory bodies around the world expect a human faqctors engineering process so whether you are a part of new product development, sustaining engineering, or remediation of general safety and performace for the Medical Device Regulation, Human Factors is a key element to success.
Our HFE services include the analyses, tests and evaluations listed below, including the full gamet of deliverables such as creating study protocols and recommendding and executing research methodologies that uncover user needs, test moderation, and ensuring that your regulatory submissions have human factors data to support notified bodies and agency requirements.
User Research
At each point in the development process, the questions you have are different. User research is key to getting answers to these questions, understanding your user and getting a holistic view of the environment of use. User Research helps us understand our users and their context better.
What are their working conditions?
What workarounds are they doing to get the job done?
How many people are involved in the completion of a task?
Where are the gaps in knowledge transfer?
What are the gaps in technology?
What other tools are our users using with our product?
Task Analysis
A Task Analysis describes the step-by-step use of a device in a normal use environment. Task analysis defines the start and end points of a use scenario, detailing the sequence of sub-tasks that are necessary for a successfully completed task. The goal is to identify the sources of potential use errors that could be hazardous or hinder task completion. Where could a user potentially make a mistake? With this knowledge, we can modify designs to mitigate the hazards, increase usability and ensure safety and a positive user experience.
Heuristic Evaluations
Heuristic Evaluations are a quick and cost effective systematic review of the user interface of a product using industry standard heurisitcs to identify usability problems. These evaluations should be conducted by a trained human factors engineer at early stages of the design process.
Formative Usability Testing
The intent of formative testing is to obtain user feedback while a device is still in development. It tests groups of intended users on the operation of early prototypes of a device to determine how well the design is working and where it may be failing. As such, formative testing is iterative in nature. Designs are repeatedly tested and then modified based on test results. This data driven design process is critical to the development of a usable device.
You should expect to conduct a minimum of two or three formative tests for every product. But often, depending on the complexity of a device and the number of intended user groups, more tests may be needed before converging on a final design.
Human Factors Validation Testing
Human Factors Validation Testing has many regulatory requirements, both in the United States and outside the US. Human Factors Validation has very clear requirements that must be met. Testing must be conducted with intended users, in a simulated use environment. All critical tasks must be performed during the test and you must test a production equivalent product. That is, testing must use the final design of the product, which includes the device, the IFU, labels and training materials.
If development has been informed and shaped by iterative Formative Usability Testing, we can be hopeful that Validation results will confirm that the new device is in fact safe and effective to use.