Human Factors

The science of fitting products to people.
Arrow Down Icon
Logo

At the heart of healthcare device and system development is our AGILE process of collaboration that involves all stakeholders. We recognize that diverse stakeholder segments have unique needs, job responsibilities and challenges. Our human factors team work hand in hand with you throughout the entire development journey, from identifying early user needs through to summative usability validation. With our global experience in field observations and in-depth interviews, we turn user insights into actionable design opportunities that afford competitive differentiation in your market.

Our team possesses a deep understanding of human factors science, as well as a detailed knowledge of the regulatory framework in which human factors engineering needs are operationalized. We understand the safety risks associated with complex medical devices and as such, our human factors team is expert in mitigating safety hazards and documenting the process to meet efficacy requirements and regulatory standards.

MIDI’s process allows us to effectively apply human factors methods, design principles and usability practices that are tailored specific to our client’s healthcare domains for the delivery of safe and effective products within the markets served.

The MIDI team operates under the guidance of IEC 62366 standard for the Application of Usability Engineering to Medical Devices and AAMI/ANSI HE75 Human Factors Principles for Medical Device Design.

  • Expert reviews/heuristic evaluation
  • Focus groups
  • Usability testing
  • Competitor benchmarking
  • Usability validation testing
  • Clinical submissions
  • Commercial submissions
  • FDA/CE Mark
  • Design History File Artifacts
  • FDA and IEC 62366
  • Use-related risk analysis
  • HE75 & HFE/UE Reports

MIDI WHITE PAPER

The Role of Usability Research and Human Factors in Medical Device Design

Overview, History, Fundamentals, Essentials, Considerations, Top Guidance Docs, HE75, and Research Methods

Logo DOWNLOAD
null

MIDI WHITE PAPER

The Role of Usability Research and Human Factors in Medical Device Design

Let’s get started on your project

Our product experts can help you bring your innovation to market.

How can we help? *

Stay informed about MIDI's expertises, new projects and our unique approach

Discover the Power of DevelopmentDNA™:
Your Strategic Advantage in Medical Device Innovation

Discover the Power of DevelopmentDNA™: Your Strategic Advantage in Medical Device Innovation