Human
Factors Seminar Series Human Factors MD offers
a seminar series tailored to the needs of your product development teams. This
series of 90 minute presentations is designed to educate your teams on the important
role human factors can play in creating safe, highly-usable, and innovative products.
Scheduled over several months, the series will help keep human factors "front
of mind" and support your efforts to promote a more user-centered focus within
your organization. Not every medical device manufacturer
confronts the same issues. We'll work with you to develop a series of seminars,
each focused on a topic directly relevant to your organization's current or future
needs. Possible seminar topics include:
What
Everyone Should Know About Human Factors Creating simpler,
safer, more user-friendly products is a key objective for medical device manufacturers
wishing to be competitive in today's medical device markets. Human factors can
help. This seminar provides an introduction to human factors and its application
to product design. Utilizing examples of good and bad design in every day life,
from consumer products to medical devices, we'll lead participants on a discovery
of what makes well-designed products user-friendly. We will go on to describe
how human factors - the science of making technology better fit the people who
use it - can be applied by companies to create more usable medical devices. The
seminar ends with a discussion of the costs and benefits of embracing human factors,
and how to evaluate the "usability ROI". Meeting
Human Factors Regulatory Requirements
Medical device manufacturers
are now required by FDA and other international regulatory bodies to demonstrate
how human factors considerations were met during their product's development.
This seminar will help manufacturers understand their regulatory obligations with
respect to human factors. We'll review the rationale behind these regulatory requirements,
provide an overview of the FDA's human factors initiatives and expectations, outline
the similarities and differences between international jurisdictions, and review
relevant Human Factors Standards. We'll provide guidance on the difficult issue
of how to determine the right level of investment in human factors given a device's
inherent risk, and discuss how to strengthen regulatory submissions by highlighting
human factors activities and findings.
Understanding
Use-Related Errors According to the oft-cited Institute
of Medicine report, To Err is Human, medical errors cause as many as 98,000 deaths
each year in the United States alone, more than traffic accidents, breast cancer
or AIDS. Medical error is a undeniable problem. But the reality of medical errors
is that they are seldom due to carelessness or negligence. More commonly, errors
are caused by faulty systems: by basic flaws in the way healthcare technology
and systems are designed and organized. In this seminar, we'll discuss the psychology
of error, and provide a framework for understanding why people make errors when
using medical devices - why they misread displays, ignore important warnings,
and push the wrong buttons. We'll move on to demonstrate how the application of
human factors can lead to better designs that substantially reduce the likelihood
of errors or minimize their effects should they arise.
Designing
Medical Devices for Older Users Changes in population demographics
coupled with the push toward home-based delivery of healthcare is resulting in
an increasingly older population of patients and family caregivers. This poses
special challenges to medical device manufacturers creating products for the home
market. Creating safe and effective products for older users means designing to
accommodate the cognitive, perceptual, and physical changes that accompany aging.
This seminar provide of overview of age-related changes in our mental and physical
capabilities. We'll review how our ability to see, hear, learn, remember, and
interact with our physical environment change as we grow older, and what product
designers can do to better accommodate older users. To
create your Human Factors Seminar Series, contact
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