BlackHägen Design Archives - Medical Design Sourcing

Human factors engineering for medical device packaging is increasingly important as more patients use devices at home. [Photo courtesy of Mockup Graphics via Unsplash]

Sean Hagen, BlackHägen Design

Human factors engineering (HFE) determines human behavior, abilities, limitations and other characteristics of medical device users and is utilized in the design of medical devices. It involves mechanical and software-driven user interfaces (UI), systems, tasks, instructional documentation, packaging, labeling and user training.

The movement to develop more innovative and advanced devices for in-home and the clinical environment makes device packaging more instrumental for improving the user experience and clinical outcomes. And you can expect more packaging innovations in the future, such as 2-D barcodes with unique numbering/serialization, UV identification codes, holograms and hidden text printed using secu…

[Image courtesy of BlackHägen Design]

Medtech device engineering for distance care involves complex patient usability requirements, tech challenges and people management skills.

Philip Remedios, BlackHägen Design

Systems design, wireless design, cloud architecture, usability engineering, integrated artificial intelligence (AI) and machine learning (ML), cybersecurity — the list of technical requirements to consider seems endless when it comes to designing a connected medical device.

While an existing product might look the same as a connected device, the product design is fundamentally more complicated. Connectivity requirements launch the design process into a larger network of associated products and processes in a wider and interdependent ecosystem.

This article highlights development strategies for patient-operated devices that embrace technology (AI, ML, sensors) and meet regulatory requi…

BlackHägen Design

Improve medical device packaging with human factors engineering

Connected device design for the real world: Managing the development process