What is HE-75?
HE-75, Human Factors Engineering – Design of Medical Devices provides development teams with guidance on human factors and usability engineering that is mandated by the FDA in the development of any medical device, from inception through to commercialization. The goal of these guidelines is to provide a reliable framework for systematically integrating and studying users throughout all stages in the new product development process, in realistic work scenarios to measure, evaluate, and improve usability, in an effort to reduce human error, and to optimize the user experience.
A typical development program includes a multi-step research and testing process:
- Generative Research Studies are used to explore and identify unique user groups and their need states, human factors and design inputs, and innovation opportunities.
- Formative Research Studies are used to test concept designs with targeted end users to assist in down-selecting to a final design direction to pursue.
- Summative Research Studies (Validation Studies) are for testing your final design using high fidelity functional prototypes with targeted end users.
- Expert Analysis are ergonomic and design audits conducted by specialists in human factors, usability, and industrial design used to identify design issues and inputs throughout development and design optimizations in the final stages of development.
Why do you need it?
You can’t afford to be wrong.
Integrating HE-75 best practices into your company’s Quality Management System (QMS), ensures that your medical device design takes into account all human factors that impact user performance, comfort, safety, efficiency, and human error, and provides necessary Design History File (DHF) documentation required by the FDA.
How do you integrate it?
We adapt to your needs.
Metaphase is an approved vendor of numerous Fortune 500 medical and pharmaceutical companies. Because our clients are all different, we tailor each program to meet the specific requirements of their Design Control Process. Our deliverables are formatted to directly feed into their Design History Files (DHF) and whenever necessary or required by our client, we manage submission of our research protocol to an Institutional Review Board (IRB) for review and approval prior to research.
How does it work?
HE-75’s scope includes everything that impacts usability and safety, extending beyond the physical product design to include all digital interfaces (graphical user interface, displays, mobile apps, companion software, etc.), instructional materials (IFUs, Quick Start Guides, User Training materials and Operator Manuals), and any packaging (primary, secondary, shippers, etc.) that impact usability. A typical usability research program revolves around a multiphase process including:
Generative Research Studies
Generative research studies are designed to gain deep insight into user behaviors and needs to identify key problems to be addressed in the new design. Tools and techniques may include combinations of ethnographic, observational & usability research, VELCRO® modeling, deep dive one-on-one and group interviews. Generative research shapes and informs the conceptual design process, identifies root causes of behavior and use errors, and initiates the definition of metrics by which you will test your designs downstream.
Formative Research Studies
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 Research Studies (Validation Research Studies)
Once you finalize your design you need to conduct usability testing with targeted end users using the metrics you established in your Formative Research Study(s). These are high-fidelity usability studies testing picture-perfect functional prototypes, IFUs, packaging or specific user interfaces. The research methodology must mirror the test protocol and test metrics established in most recent Formative Research Study.
Our specialists in human factors, usability, behavior, and industrial design provide independent expert audits addressing all aspects of product design and usability. These audits can be used to provide design inputs throughout development or in the final stages of a project to identify design optimizations, and typically include benchmarking with leading competitor products.
HE-75 provides information, design criteria, guidelines and methodologies for the research & design of medical devices from initial conceptualization through post-market surveillance.