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Human
Factors:
User-Centered
Design in the Medical Industry
by
Elizabeth Bacon
Compliance
with Federal Drug Administration (FDA) guidelines can actually help
speed delivery of your products to market, and offers a variety
of benefits to marketing, development, and sales organizations.
The FDA desires medical device manufacturers to thoroughly document
their processes and rationale around product design and development,
with specific regard to Human Factors (HF) considerations. Proper
compliance with FDA regulatory guidelines allows the agency to evaluate
whether sound thinking went into the product, and so determine whether
it will be safe for both patients and medical staff.[1] Ultimately,
the success of your product in the marketplace might depend upon
its fundamental usability.
FDA's Human Factors Approach
When evaluating products, the FDA looks for good Human Factors design.[1]
What is HF? Human Factors is a discipline devoted to determining
the cognitive and perceptual issues that affect different kinds
of users, and understanding the environmental context of a specific
product's use. The FDA specifically cites mental models as
a tool for understanding how people conceptualize their environment
as well as their general goals and tasks. One of the key ways to
gain insight into people's mental models is by interviewing and
studying customers in their own environment. The data obtained with
such field research can be modeled as personas, contexts of use,
and usage scenarios. Personas are archetypes that represent the
needs of a group of users, and they encapsulate interactive experience
goals that drive good technology development.
Developing
Clear Product Requirements
A company that performs research and persona development to create
good, HF-informed products equips itself with clear user-centered
requirements even before the process of building a product has begun.
The FDA notes that "these efforts reduce the necessity for
modifications during implementation and reduce costly updates."
[2] With less potential for change during the development process,
the result is a shorter development cycle, which gets your product
to market faster and saves money. In addition, having a clear understanding
of customer requirements from the beginning of the development process
better prepares companies to assess the potential impacts of any
necessary adjustments to the product definition. This shared vision
helps internal sales, support and educational staff, as well.
Benefits
of Human Factors Education
In its paper, "Do It by Design: An Introduction to Human Factors
in Medical Devices and Radiological Health," the FDA states:
"Educating both technical and managerial staff about human
factors also provides long-term benefits to the organization."[1]
By training employees in the values of a human approach to technology,
people working on interactive products can become more fully invested
in both the safety of patients and the quality of the user experience,
two aspects of product design with which the FDA is vitally concerned.
This customer-centric approach to technology development also results
in a product that is intuitive and user-friendly, which reduces
the amount of user training needed and thereby cuts associated costs.
Documenting
Design & Development
The FDA, and international regulatory agencies such as TUV, usually
evaluate medical products solely on the basis of their documentation,
and occasional auditing of corporate practices. For this reason,
documentation of both product and process must begin at the onset
of development, rather than while or after the product is built.
Medical device documentation needs to delve deeper into design substance
and rationale than standard requirements documents or user manuals.
For the benefit of regulatory agencies, these specifications should
detail HF considerations for target users, and describe how the
product eliminates potential errors through good user-centered design
practices such as usability testing.
What
HF Means for Your Company
Ultimately, the Human Factors processes that the FDA recommends
provide advantages above and beyond FDA approval to the companies
that use them. Investment in field research to understand users'
goals and needs solidifies the definition of a successful product,
while awareness of human considerations sets the right priorities.
Creating documentation capable of meeting FDA guidelines can supply
a great deal of source material for marketing and sales collateral.
Finally, Human Factors processes can significantly reduce the duration
of the product development cycle, and deliver a fundamentally better
product more quickly to market.
REFERENCES
[1]
Sawyer, Dick, Officer of Health and Industry Programs, et al. "Do
It by Design: An Introduction to Human Factors in Medical Devices."
Center for Devices and Radiological Health, U.S. Food and Drug Administration,
Public Health Service, U.S. Department of Health and Human Services.
http://www.fda.gov/cdrh/humfac/doitpdf.pdf
[2]
Kaye, Ron and Crowley, Jay. "Medical Device Use-Safety: Incorporating
Human Factors Engineering into Risk Management: Identifying, Understanding
and Addressing Use-Related Hazards." Division of Device User
Programs and Systems Analysis, Office of Device and Industry Programs,
Center for Devices and Radiological Health, U.S. Food and Drug Administration,
Public Health Service, U.S. Department of Health and Human Services.
http://www.fda.gov/cdrh/humfac/1497.pdf
Original white
paper written while
Principal Design Consultant at Cooper, 7/2002
Revised 10/2003
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