Priority Issues from the 2013 AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings

A summary report of the findings of a recent AAMI/FDA symposium on home health care issues and direction. Very informative for anyone looking to build home healthcare devices or market existing clinical devices for home use.

Consultants See Challenges, Changes in 2014

Over the past few years, the demand for human factors consultants has grown. Dean Hooper, owner and principal at HE Consulting, said he is seeing a big change in this area.

User-Centered Design For Medical Devices: If It Isn’t Documented It Doesn’t Exist

The regulatory pressures are increasing to demonstrate that products are safe and easy to learn and use. Given the recent addition of the human factors discipline to the Office of Device Evaluation (ODE), the medical device industry is in a state of flux. For some devices, a development program may just be nearing transfer to manufacturing only to be halted by new, user centered design requirements for regulatory submission, i.e., a usability validation study. This article will provide solutions for meeting newer FDA requirements for validation studies without mandating that a client start anew or lose too much development time.

From the Marine Corps to Human Factors Consultant

Principal Human Factors Scientist, Dean Hooper was recently featured in AAMI News, a monthly on-line magazine that keeps the industry in the know about AAMI events and activities.

FDA Human Factors Expectations

CDRH, and for the most part CEDR, of the FDA are getting serious about device manufacturers submitting evidence that the design of a new or modified product does not induce use error. This link leads to a presentation by the FDA human factors team on what is expected, the most common deficiencies, and why compliance to IEC62366 is not the whole story.

Are we designing for expert use or just really good beginners?

Are we truly designing for expert users or are we just focusing on very good beginners? And if so, do we need to pay attention to the needs of experts? This question goes beyond semantics to be one of possible neglect. This paper examines the characteristics of novices vs. experts and delivers a set of design heuristics to meet the needs of all users.

Use Error Analysis in a Product Development Cycle: Proactive assessment to drive design

FDA quality and regulatory guidelines require development organizations to provide evidence they have investigated potential use error due to product design. This paper introduces a formal method for assessing and reporting errors and their respective root causes.

So you want to automate? A guide for when and how to automate clinical tasks

Task automation is a tool that, when used correctly, can enhance use efficiency, increase patient safety, and increase overall product acceptance. However, if not implemented appropriately, can lead to frustration and increased patient risk. This paper provides initial guidelines for determining if automation is appropriate for your product and how it should be managed.

Use Error Analysis during Medical Device Development

Presentation slides from the 2013 HFES HealthCare symposium. A formal method is introduced that assesses root cause of use error. Results can be used for initial design control FMEA, CAPA resolution, and usability validation studies for FDA submission.

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