Metaphase has been conducting Generative, Formative & Summative Custom research programs for 25+ years.

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:

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.

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Formative Research Studies

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.

Click edit button to change this text.

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,