human factors Archives - Medical Design Sourcing

Intuitive’s Kathryn Rieger on human factors design in surgical robotics

Kathryn Rieger, head of human factors and user research at Intuitive Surgical, explains how the surgical robotics developer approaches product design.

Intuitive Surgical Senior Director for Human Factors and User Research Kathryn Rieger [Photo courtesy of Intuitive]

Intuitive Surgical Senior Director for Human Factors and User Research Kathryn Rieger credits the Presto Hot Dogger for her career in medtech.

“If you Google it, you will see it is not a very well-designed product,” she recalls. “It was designed to cook six hotdogs in 60 seconds. Essentially, it had these big spikes that you impale the hotdogs onto [and it] was a circuit that you completed like a good old-fashioned science project to cook the hotdogs.”

So what’s the connection between meat-tech and medtech? Rieger found herself facing the frankfurter-frying contraption in her first day of “Bad Product Desig…

Improve medical device packaging with human factors engineering

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…

Applying the FDA’s new human factors engineering guidance for medical device submissions

Emergo Group’s Human Factors Research & Design team takes a closer look at new FDA HFE guidance for medical devices.

Emilee Stanczyk, Emergo Group

The FDA issued a new draft HFE guidance document, Content of Human Factors Information in Medical Device Marketing Submissions, on Dec. 9, 2022. The guidance aims to help medical device manufacturers determine what evaluation information should be included in marketing submissions for medical devices. This post summarizes the guidance and describes the submission categories and evaluation information needed for each category.

The new guidance is intended to complement the FDA’s final HFE guidance from 2016, Applying Human Factors and Usability Engineering to Medical Devices. The new guidance outlines what evaluation information to include in a marketing submission, as noted above, but does not describe how to perform a human factors evaluation; this is where the 2016 draft guidance remains particularly rele…

3 critical starting points for medical device design usability research

The future of healthcare lies with the development of devices with designs centered on the safety, needs, desires and challenges of their users. [Photo courtesy of the FDA]

Medical device usability research and human factors engineering starts with device users, the use environment and user interfaces.

Gregory Montalbano, MIDI Medical Product Development

Designing a medical device is not a lighthearted or straightforward task. Every design choice during the development process can influence how the device is used, whether it is effective and if it has the potential to cause its user or intended patient harm.

The vast majority of medical device failures stem from use errors. While this may lead some to believe that the blame lies on the user, the fact is that use errors are frequently the result of unintuitive device design choices.

With this in mind, the FDA and its supporting standards organ…

How Stryker includes users for product design in the digital age

“Focus on UI/UX (user interface and user experience) is paramount,” said Siddarth Satish, VP of Digital Innovation for the Surgical Technologies business at Stryker. [Photo courtesy of Stryker]

Medical device developers and manufacturers like Stryker (NYSE:SYK) are changing how they approach design as digital technology becomes more crucial.

Four Stryker executives shared how the Kalamazoo, Michigan–based orthopedic device giant is thinking differently about medical product development and how health care providers and patients will ultimately use them.

The DeviceTalks Boston panel of Stryker executives was moderated by Stryker Orthopaedics and Spine Group President Spencer Stiles this week. Read our earlier coverage on their discussion of medtech trends and more from leaders at Medtronic and Harvard University.

The following has been lightly edited for space and clarity.