Integrating Human Factors Engineering into the Design Process
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Design Partners publication outlining a proven process that integrates human factors engineering into the design process. An accompanying poster can be downloaded online or hard copies can be requested by emailing [email protected].
Transcript of Integrating Human Factors Engineering into the Design Process
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Validation Testing
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Validation Testing
Subjective assessment is a critical part of validation
testing. Subjective assessment provides test participant
perspective on all critical and essential tasks as well
as identification of either performance difficulty or
failure which may not have been recorded in testing.
Subjective assessment is a good technique for capturing
unanticipated use errors. In a clinical environment
observation and performance data collection cannot
be intrusive, it may be limited, and therefore subjective
assessment is critical.
Purpose
The collection of primary evidence for regulatory
bodies to demonstrate that the design is safe for use
and use environment
Validation of critical tasks (tasks that if performed
incorrectly can cause harm)
Validation of essential tasks (tasks that do not cause
harm but affect the medical benefit of the device)
Validation of user training level
Compliance with HE75 / ISO-62366 HFE Annex to DHF
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Methods
Validation testing using realistic scenarios and
conditions with acceptance criteria
Creation of test scenarios that include all critical and
essential tasks
Creation of test scenarios designed to include
challenging situations
Observational and other objective methods to
collect data on performance
Systematic collection of user perspective assessment
for essential and high risk tasks
Directed and interview based subjective assessment
by test participants
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Validation Testing
Output
Number and type of test participants with
rationale for inclusion
Rationale for the tasks included in the testing
Test results in table form including number of device uses,
success and performance failures
Description and evaluation of unanticipated
errors based on subjective assessment
Statementofmitigations
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In software design, the goal is to cause the software to function the way its intended users think and process information. In hardware design, a human-centered design approach also enables the development of machines, tools and consumer products having greater usability, maintainability and operational safety than might otherwise occur.
Hal W. Hendrick, Applied Ergonomics Vol. 34, 2003
Validation
Review
User Needs
Design Input
Design Process
Design Output
Medical Device
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Human Factors / Usability Report
The final output of this process is the creation of a Human
Factors / Usability Report. This document records process,
methods and the rationale that informs usability design
decisions made during product development.
This report addresses regulatory perspective on
usability safety and optimisation supporting submission
documentation for FDA / CE approval.
The report is part of the design history file (DHF) and
contains the following information:
Identification of device use, users, use environments
and training
Device user interface
Summary of known use problems
User task selection, characterisation and prioritisation
Summary of formative evaluations
Validation testing
Conclusion
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Human Factors/Usability Report
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Characteristics of a Good Human Factors Engineering Test Plan
HFE should be applied during the early stages of the
product development life cycle. Applying HFE early
reduces the risk of problems surfacing during the latter
project stages when corrections are costly and often
extend time to market.
In Design Partners experience, early application increases
the likelihood of meeting user needs with innovative
solutions and affords our clients commercial advantage
with unique IP and better performing systems.
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A good HFE test plan will have the following characteristics
and benefits:
End user perspective and needs
are maintained through the process
Design decisions are informed by end
user interaction tasks and needs
HFE activity is tied to the overall device
development process
HFE activity is tied to the design controls
process and risk management
HFE process provides for an iterative
optimisation process and for risk assessment
Builds in ample time to fix problems as they arise,
rather than at the end
Calls out actionable risk management activities
Documents a separate HFE test plan and
links plans to design history file (DHF)
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PMA Submission of Design History
Folder
FDA CR820.3Design Controls
Guidance for Industry and FDA Premarket and Design Control
Reviewers (2000)
Draft Guidance for Industry and Food and Drug Administration Sta
(2013/2014) ANSI/ AAMII HE75
ANSI/ AAMII/ ISO 14971 : 2007 IEC 62304 : 2006 IEC 60601-1-8 : 2006
AAMI/ ANSI HE75 : 2009
AAMI/ ANSI HE48 : 1993
ISO/ IEC 62366 : 2007
Medical device use safety: incorporating human factors
engineering into risk management.
Applying human factors and usability engineering to optimise medical
device design.
Human factors design process for medical devices.
Medical devices - application of risk management to
medical devices.
Medical device software - software life cycle processes.
Medical electrical equipment.
Human factors engineering - design of medical devices.
Human Factors Engineering guidelines and preferred
practices for the design of medical devices
Medical devices - application of usability engineering to
medical devices.
Medical Device Standard Relationships
Note: Standard Relationships was established in
consulatation with the Ergonomics Department at
the University of Limerick.
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In short, the documents HE74 & HE75 make usability testing a de facto requirement, if not an explicit law. Moreover, medical device manufacturers are practically required to conduct usability tests as a matter of due diligence
Usability Testing of Medical Devices, M. Wiklund et al 2011
PMA Submission of Design History
Folder
FDA CR820.3Design Controls
Guidance for Industry and FDA Premarket and Design Control
Reviewers (2000)
Draft Guidance for Industry and Food and Drug Administration Sta
(2013/2014) ANSI/ AAMII HE75
ANSI/ AAMII/ ISO 14971 : 2007 IEC 62304 : 2006 IEC 60601-1-8 : 2006
AAMI/ ANSI HE75 : 2009
AAMI/ ANSI HE48 : 1993
ISO/ IEC 62366 : 2007
Medical device use safety: incorporating human factors
engineering into risk management.
Applying human factors and usability engineering to optimise medical
device design.
Human factors design process for medical devices.
Medical devices - application of risk management to
medical devices.
Medical device software - software life cycle processes.
Medical electrical equipment.
Human factors engineering - design of medical devices.
Human Factors Engineering guidelines and preferred
practices for the design of medical devices
Medical devices - application of usability engineering to
medical devices.
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Conclusion
The human element providing the intelligence behind
product performance should not be left to chance. HFE is a
recognised methodology ensuring the human component
is understood and that this perspective is maintained
throughout the product development life cycle. HFE
should be applied during the early stages and throughout
the product development process.
Applying HFE early in the development cycle reduces the
risk of problems surfacing during the later stages when
corrections are costly and where delay will extend time
to market. As designers we have found that in practice
HFE also helps us to identify and meet user needs and to
reduce the risk of potential product failure and recall. HFE
is a regulatory requirement, but applied well, it is also a
strategic product development and cost containment tool
essential to commercial success.
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About the author
Eugene Canavan is a Design Director and leader of the
medical device team at Design Partners. He maintains
close relationships with clients and the academic and
professional medical community.
Eugene is an accomplished designer and ergonomist with
over 20 years experience in human factors and mechanical
engineering. His work has been recognised by many
international awards including the prestigious iF Product
Design award in Europe, The Good Design award in Japan
and the American IDEA award. He is a tutor at the Centre
for Medical Device Design at NCAD and external examiner
for Product Design and Innovation at Carlow IT.
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It would be unheard of to put a mechanical design into production without extensive prototyping, verification and validation. However, the human element providing the intelligence is often left to chance.
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