BEST PRACTICES FOR USE-RELATED RISK ANALYSIS THROUGH COLLABORATION OF HUMAN FACTORS AND CLINICAL

Abstract

Integrating the Human Factors Engineering (HFE) process, and its user-centered approach, into the medical device and combination Product Development Process (PDP), has been an ongoing challenge for its respective industries and Human Factors (HF) practitioners within it for decades. Yet, despite continuous process adaptation and evolution of the HFE process, as well as the introduction of standards and health authority guidelines, the early integration of a risk-based and user-centered approach within the development and design process remains an ongoing practical challenge occupying the minds of most. With the introduction of the European MDR 2017/745 in 2017, an additional emphasis was put on the importance of use-related risk identification, assessment, and data based evaluation within the clinical evaluation process, and with such introduces clinical teams to (new) ‘use-related risk challenges’ as well.
This paper provides a framework for early integration of an iterative use-related risk analysis approach, addressing common practical challenges, and providing best practices for such. Furthermore, it highlights how applying a collaborative approach between HF and clinical efforts would permit for collection of more robust use-related data sets, thus potentially optimizing use-related risk, residual risk, and risk-benefit analyses and their processes.

Full text

Mehrzad, H.M., Stüdeli, T. & Quie, H. (2023) Best practices for use-related risk analysis through collaboration of human
factors and clinical, In: 12th International Symposium on Human Factors and Ergonomics in Healthcare (HCS 2023),
March 26-29, 2023, Orlando (FL). Online: https://www.hcs-2023.org/
BEST PRACTICES FOR USE-RELATED RISK
ANALYSIS THROUGH COLLABORATION OF
HUMAN FACTORS AND CLINICAL
Heidi M. Mehrzad, HFUX Research, LLC, hmm@hfuxresearch.com
Thomas Stüdeli, Hoffmann-La Roche Ltd., thomas.stuedeli@roche.com
Helene Quie, Qmed Consulting A/S, hq@qmed-consulting.com
Integrating the Human Factors Engineering (HFE) process, and its user-centered approach, into the medical
device and combination Product Development Process (PDP), has been an ongoing challenge for its
respective industries and Human Factors (HF) practitioners within it for decades. Yet, despite continuous
process adaptation and evolution of the HFE process, as well as the introduction of standards and health
authority guidelines, the early integration of a risk-based and user-centered approach within the development
and design process remains an ongoing practical challenge occupying the minds of most. With the
introduction of the European MDR 2017/745 in 2017, an additional emphasis was put on the importance of
use-related risk identification, assessment, and data based evaluation within the clinical evaluation process,
and with such introduces clinical teams to (new) ‘use-related risk challenges’ as well.
This paper provides a framework for early integration of an iterative use-related risk analysis
approach, addressing common practical challenges, and providing best practices for such. Furthermore, it
highlights how applying a collaborative approach between HF and clinical efforts would permit for collection
of more robust use-related data sets, thus potentially optimizing use-related risk, residual risk, and risk-benefit
analyses and their processes.
Introduction
Integrating Human Factors (HF) and its user-centered
approach and corresponding Human Factors Engineering (HFE)
process, into the medical device, and pharmaceutical
combination Product Development Process (PDP), has been an
ongoing challenge for its respective industries and HF
practitioners within it for decades.
For medical device, and pharmaceutical combination
products this journey of integration started in the 80s when the
U.S. Food and Drug Administration (FDA) proposed a risk
management approach to its respective industry product
development processes (FDA 2000; FDA 2016a; FDA 2016b;
Israelski & Muto 2011). Key importance of an early integration
of a combined risk-based and user-centered design approach was
subsequently identified in FDA’s 2000 guidance “Incorporating
Human Factors Engineering into Risk Management”. Within
such, the authors Kaye and Crowley stressed that “rare or
unusual use scenarios resulting in hazards with serious
consequences often prove to be the greatest threat to safe and
effective medical device use after a device becomes available for
general use,” as “users are often not prepared for infrequent,
unexpected use scenarios because they are often not dealt with
adequately in device design, training, or operating
instructions,” and with such highlighted that while “infrequent
but dangerous use scenarios are often difficult to identify,” it
“underscores the necessity for careful application of the
analytic and empirical approaches early in, and throughout
the design process.”
And while HF as a scientific discipline remains constant
in its principles and foundation; technology, tools, and materials,
as well as PDP approaches, e.g., waterfall model, agile
developments, and digital healthcare, as well as various other
factors have evolved and directly impacted the demands and
expectations of and on the HFE process. Intensifying the
challenge of a combined risk-based and user-centered design
approach is the evolution of healthcare itself, as such has
introduced new types of medical devices with the widespread
adoption of computerization, further adding yet another layer of
complexity to an already complex environment (Easty 2018).
Easty further explains that often these newly complex systems
and devices are introduced in ways that fail to take into account
the environment of care, and/ or the skills, abilities, and training
of the users, leading to new possibilities for (use-related) error
(Easty 2018).
At the 2022 Healthcare Systems Ergonomics and Patient
Safety (HEPS) conference, the “EU HF forum” reiterated these
ongoing challenges in a special session for ‘use-related risk
management for medical devices and combination products.’
Here, Stüdeli (2022) presented peer feedback of collected
interviews and discussion rounds with human factors engineers
(n=15) within the industry, echoing the sentiments in challenges,
and identifying current key practical challenges regarding use-
related risk management:
 When to perform use-related risks analysis, and in what
depth?
 From a sequence of events perspective: what are reasonable
hazardous scenarios?
 How to deal with probability numbers for use-related risks?
 How to deal with those hazard-related use scenarios not
selected for (summative) evaluation?
 How to define acceptance criteria (for critical and non-
critical tasks)?
 When is a use-related risk mitigation achieved? What is a
reasonable and/ or practical mitigation?

Mehrzad, H.M., Stüdeli, T. & Quie, H. (2023) Best practices for use-related risk analysis through collaboration of human
factors and clinical, In: 12th International Symposium on Human Factors and Ergonomics in Healthcare (HCS 2023),
March 26-29, 2023, Orlando (FL). Online: https://www.hcs-2023.org/
 How to deal with residual use-related risks and the risk-
benefit analysis?
Thus, recapping, that despite continuous adaptation and
evolution in the field, e.g., IEC 62366-1, from its original draft
in 2005 to its latest amendments in 2020 (FDA 2020), as well as
various publishing around the topic by multiple health
authorities (US, UK, China), the early integration of a combined
risk-based and user-centered approach within the medical PDP,
including implementation and execution of appropriate use-
related risk management, remains an ongoing practical
challenge occupying the minds of most practitioners.
The impact of continuous adaptation and evolution
within the medical device and combination PDP though has not
been exclusive to the HFE process. It has also affected the
clinical evaluation process and its requirements, as with the
progression of human factors and usability (engineering)
standards and guidelines, the European Medical Device
Directive also underwent an evolution addressing “usability”
and its associated risks.
Furthermore, as industry is increasingly learning the
nuances and advantages of “real world” over “simulated-use”
data, a convergence of HFE and clinical efforts has become
unavoidable; and the demand for guidance on how to execute
such convergence and collaborate amongst HFE and clinical
teams has soared.
While US FDA answered with draft guidances such as
“Human Factors Studies and Related Clinical Study
Considerations in Combination Product Design and
Development” in 2016 (FDA 2016a), and “Comparative
Analyses and Related Comparative Use Human Factors Studies
for a Drug-Device Combination Product Submitted in an
ANDA” in 2017 (FDA 2017), the European Medical Device
Directive (EU MDD) did as well with the publication of its
Medical Device Regulation (MDR) 2017/745, in which it
introduced an increased demand on usability requirements
within the clinical evaluation process.
While under the original MDD 1993/42/EEC initial
usability requirements were addressed, with the issuance of IEC
62366:2007, progression was introduced when first amendments
were made and published under MDD 2007/47/EC to further
highlight the importance of usability and its associated risks by
specifically including essential requirements for manufacturers
to address and carefully evaluate risks caused by “non-usable
medical devices”, i.e., use-related risks.
Then, in 2017, and in response to the 2015 IEC 62366-
1:2015 standard, the European MDR 2017/745 directive sought
further alignment with usability standards by specifically
highlighting risks associated with:
 “ergonomic features of the device”,
 “environment in which the device is intended to be used”,
and
 “technical knowledge, experience [...] and training, and
where applicable, the medical and physical conditions of
intended users”
One of the European Commission’s purposes for the
MDR was to ensure transparency and data sharing between
teams during product development, with the goal of further
increasing patient safety. Accordingly, and with the same goal
of increasing patient safety, language changes within the MDR
now require manufacturers of lower risk class products to
provide clinical evidence directly from the patients and/ or users,
where previously they might have been able to provide such via
literature review, thus creating a greater burden on clinical
evaluation for such manufacturers.
With this publication and its emphasis on the importance
of use-related risk identification, assessment, and data based
evaluation of such within the clinical evaluation process, it also
introduces clinical teams to new ‘use-related risk challenges’ as
well.
And while MDR 2017/745 usability requirements are
evaluated during human factors summative usability studies,
such is done predominately without any interaction between
human factors and clinical teams; missing out on opportunities
to harmonize usability and clinical evaluation efforts and collect
more robust data sets, in which usability and clinical evaluation
activities take into consideration one another’s requirements and
goals.
Likewise, clinical risks are evaluated (and mitigated)
predominantly with clinical data, with no input from HF teams;
despite, residual risk and risk-benefit determination being
equally dependent on HFE’s use-related data collected during
human factors usability studies, addressing the evaluation and
validation of risks associated with intended use, user, and use
environment. Here again, the lack of interaction between clinical
and human factors teams proves a clear disadvantage for both.
In particular, Annex I of MDR 2017/745 requires clinical
evaluation to adequately address the qualitative and quantitative
aspects of clinical safety with clear reference to the
determination of residual risks and undesirable side effects to
provide confirmation of the relevant safety and performance
requirements provided related to such (MDCG 2020). These
safety and performance requirements are intertwined between
clinical and usability requirements and activities, and thus
naturally lead to the need for usability and clinical specialists to
work together to identify and assess remaining residual risk(s).

Mehrzad, H.M., Stüdeli, T. & Quie, H. (2023) Best practices for use-related risk analysis through collaboration of human
factors and clinical, In: 12th International Symposium on Human Factors and Ergonomics in Healthcare (HCS 2023),
March 26-29, 2023, Orlando (FL). Online: https://www.hcs-2023.org/
This intertwining of requirements is again amplified in
one of the MDR’s key technical documents, the Instructions for
Use (IFU), as such provide the essential information to the final
user. As the IFU is based on input from clinical evaluation data
regarding safety, it also describes residual risks and any
undesirable side effects, and includes these identified residual
risks based on the analysis of the use-related and clinical risks
“Information on any residual risks and any undesirable effects,
warnings and precautions (MDR, Article 32. 2, h).”
This again demonstrates the intertwining of usability and
clinical, and shows the dependency to one another, which again
is also shown under Section G in the MDCG 2020-7 (MDCG
2020), as the clinical evaluation should consider the above
points, but also clearly answer use-related questions, such as:
 Is the device to be used by healthcare professionals or lay
users?
 Does the IFU provide all the appropriate/relevant
information for the intended user?
 Has the manufacturer taken into account the technical
knowledge, experience, education, training and use
environment, where applicable, and the medical and
physical conditions of intended users (design for lay,
professional, disabled or other users).
 Is any training for users required as a risk control measure?
If not, is this justified with respect to the risk management
file and the clinical evaluation?
When looking for a direct link between usability and
clinical requirements within the MDR, Annex II describes
contents of its technical documentation, which are directly taken
from the Human Factors/Usability Engineering (HF/UE) file:
 A definition of the intended users,
 A description of which other devices the device can/should
be combined with/connected to, and
 Tests and test results.
This further substantiates that measures to evaluate and
validate these (clinical) requirements could be merged into one
shared (study) protocol, collecting data for both, clinical and
usability requirements.
Evolution however did not stop at pre-market PDP alone.
The MDR also stresses the importance of usability input into
clinical evaluation within post-market surveillance
requirements. It uses and highlights the term “usability” directly
under Article 83(3), stating that manufacturers are expected to
“gather data” within a “post-market surveillance system”, with
respect to “the identification of options to improve the usability,
performance and safety of the device.” Annex III further
clarifies and specifically outlines which information must be
collected and analyzed with respect to such, e.g., information
concerning serious incidents, including information from
PSURs, and field safety corrective actions, records referring to
non-serious incidents and data on any undesirable side-effects,
information, including feedback and complaints, provided by
users, distributors, and importers, etc.
Part of the Post-Market Surveillance (PMS) plan is the
Post-Market Clinical Follow-up (PMCF) plan. The PMCF
requires continuous updating to clinical evaluation, in which the
manufacturer shall
 proactively collect and evaluate clinical data with the
objective of verifying the safety and effectiveness of the
product throughout its expected lifetime,
 identify previously unknown side-effects,
 monitor identified side effects and contraindications,
monitoring emerging risks based on factual evidence,
ensuring the continued favorable benefit-risk ratio, and
 identify and address any systematic misuse or off-label
use, taking appropriate preventive and corrective actions if
and when necessary.
Here, the PMCF as well integrates both usability and
clinical evaluation together. It’s mandating the documentation
of specific activities within its framework, one of which entails
the identification and description of the general methods and
procedures to be implemented in the PMCF, such as the
collection of clinical expertise acquired, user feedback, a
thorough examination of scientific literature, and an
examination of other sources of clinical data.
The comprehensive implementation of these activities
results in the availability of data that the manufacturer can utilize
for further risk mitigation and future product development.
Hence, it is of paramount importance to ensure all required
information is collected and analyzed involving risk
management, clinical, and HFE experts, during all phases of the
PDP, including planning, execution, and analysis stages, to
ensure appropriate and robust data. This process should ideally
be documented to allow for evaluation of further opportunities,
e.g., product usability enhancements, to allow the manufacturer
to demonstrate such with examples. Furthermore, the findings of
the PMCF should be analyzed by the manufacturer and
documented in a PMCF evaluation report, which is incorporated
into the clinical evaluation report and technical documentation.
Considering this, a collaborative approach between
human factors and clinical teams has become a necessity to
ensure compliance with MDR. §33 states (MDR 2017): "The
risk management system should be carefully aligned with and
reflected in the clinical evaluation for the device, including the
clinical risks to be addressed as part of clinical investigations,
clinical evaluation and post-market clinical follow up. The risk
management and clinical evaluation processes should be inter-
dependent and should be regularly updated." In addition, it could
allow for potential hybrid data collection activities and studies
addressing evaluation of both, clinical and use-related risks, and
with such optimize residual and benefit-risk analyses, and
subsequently enhance HFE and clinical evaluation processes and
reporting. Moreover, it would provide for a more robust data set
being available to the manufacturer to use for advanced device
development, as well as potential further risk mitigation.

Mehrzad, H.M., Stüdeli, T. & Quie, H. (2023) Best practices for use-related risk analysis through collaboration of human
factors and clinical, In: 12th International Symposium on Human Factors and Ergonomics in Healthcare (HCS 2023),
March 26-29, 2023, Orlando (FL). Online: https://www.hcs-2023.org/
Best practices for early integration of iterative use-related
risk analysis into the PDP and successful execution through
collaboration of human factors and clinical evaluation
The following framework is based on the regulatory
requirements discussed above and addresses the discussed
prevailing key practical challenges by pointing out their common
pitfalls and offering best practices to mitigate such within each
phase of the commonly applied five phases of the medical device
development process. Though these best practices may serve to
facilitate the integration of a combined risk-based and user-
centered approach, and its early and iterative use-related risk
analysis development within the medical device development
process, each product development process (PDP) is singular,
and must be tailored to the specific requirements of the product
in question. Thus, not all recommended practices will be
applicable to each PDP. Accordingly, HFE activities should
always be carefully adapted and scaled to the actual need of the
product applicable.
Figure 1: The typical 5 phases of the Product Development
Process (PDP) within medical device
development.
Phase 1: Discovery and Concept
Pitfalls:
The initial phase of the PDP is often characterized by
the absence of a systematic evaluation of risks and a
preoccupation with market appeal, business prospects, and
user experiences. Discussing hazardous use scenarios and
the possibility of use-related issues and potential use
problems during this phase is often viewed as a deterrent to
innovation.
Good practices:
● Conduct early exploratory research identifying current use-
related issues within the field. Ensure data collected in
early research includes current and potential hazardous use
scenarios with respect to current products on market
addressing your intended use concept, e.g., known use
problems analysis.
● Use clinical resources, e.g., literature, patient groups etc. for
the planning of your observational field research with
respect to use-related risk perception and safety aspects.
 Leverage a systematic, task-based analysis approach to
identify both potential hazards and/ or hazardous situations,
as well as design (and corresponding mitigation)
opportunities.
Phase 2: Formulation and Planning
Pitfalls:
It is not uncommon for development teams to operate in
isolation, with a primary emphasis on their own tasks and
documentation. This tendency results in the formation of discrete
silos for each team, e.g., human factors engineering, clinical
evaluation, and risk management. This fragmented approach to
critical planning documents, such as Human Factors/Usability
Engineering (HF/UE), Clinical Evaluation, and Risk
Management Plans, lacks coordination and inter-team input,
resulting in superficial "checklist" documents that do not
contribute substantially to the development process or plans.
Good practices:
 Draft an initial framework of the device task analysis and
identify potential use problems, e.g., use errors, close calls,
and use difficulties, related to all tasks within.
Note: Ensure to identify potential use scenarios that could
lead to tasks not being performed and/ or being performed
incorrectly by the (intended) user.
 Ensure to include use-related risks, usability, clinical, and
risk management requirements sections in HF/UE, clinical
evaluation, and risk management plans, clarifying
identification, integration, evaluation (and potential
validation) activities within their processes, and how such
can supplement and support the other.
Phase 3: Design and Development
Pitfalls:
Occasionally, the device design process prioritizes use(r)
preferences, acceptance, and performance above all else during
(early) design evaluation, leading to a “tabling” of safety-critical
use scenarios and associated potential risks, often determining
them as “out of scope.” This tendency is often driven by a
perception that addressing use-related issues constitutes a

Mehrzad, H.M., Stüdeli, T. & Quie, H. (2023) Best practices for use-related risk analysis through collaboration of human
factors and clinical, In: 12th International Symposium on Human Factors and Ergonomics in Healthcare (HCS 2023),
March 26-29, 2023, Orlando (FL). Online: https://www.hcs-2023.org/
hindrance to the project and its (timely) progress, rather than an
opportunity to enhance the design, improve usability, and
proactively mitigate use-related risks.
Good practices:
● Utilize formative human factors usability studies
(simulated-use) to assess early prototypes, often and
iteratively, to gain insight into their actual use in both
positive and negative use scenarios with respect to use(r)
preferences, acceptance, performance, as well as potential
use-related risks.
● Document any use problems, including use errors, close
calls, and difficulties, whether observed and/ or reported,
and subject them to a level of analysis equivalent to that
performed for use(r) preferences, acceptance, and/ or
performance.
● Employ the realism of real-world settings in clinical studies,
when feasible and appropriate, to evaluate the efficacy of
your early design concepts.
Phase 4: Validation and Product Launch
Pitfalls:
Again, in some instances device design undergoes
only partial evaluation in later stages as well, prioritizing
use(r) preferences, acceptance, and performance, while
safety-critical scenarios fall outside the scope of testing.
Here, again., use-related issues are viewed as obstacles to the
project's progress, rather than opportunities for
improvement.
Furthermore, when the siloed approach persists into
verification and validation phases, validation plans are
frequently devised in isolation, with limited inter-team
collaboration among human factors engineering, clinical
evaluation, and risk management teams. This approach
precludes the possibility of jointly planning, designing, and
conducting activities and studies to evaluate and validate
usability, clinical evaluation, and risk mitigation
requirements, thus limiting the scope and robustness of
generated data, including the capacity to capture more
elusive data points, such as those addressing knowledge
tasks for example.
Good practices:
● Collaborate between human factors engineering,
clinical evaluation, and risk management teams and
provide input to another’s evaluation and validation
plans.
● Align goals of human factors and clinical evaluation
studies with respective requirements, e.g., identify
opportunities for hybrid data collection studies.
● Conduct hybrid data collection studies when possible,
addressing evaluation and validation of clinical and
usability requirements, including use-related risks. Aim
to capture typically difficult and elusive data points,
e.g., use-related risk mitigations addressed by
“knowledge tasks”.
● Employ the realism of real-world settings in clinical
studies, when feasible and appropriate for the validation
of your final designs.
● When appropriate (and possible), use a staggered
approach for your device design validation process,
employing simulated-use data combined with real
world data.
Pitfalls:
Global introduction of devices with uniform designs
and standard safety information in some cases fail to employ
comprehensive risk management approach and assessment
for regional adaptations, potentially leading to a decrease in
device quality and usability and an increase in safety-related
risks on a regional scale.
Good practices:
● Share data amongst global device developments and their
teams, e.g., known use problems, use-related risks, effective
design mitigations, etc. to avoid missing out on
opportunities to enhance product usability, quality, and
safety.
● Exercise the same degree of scrutiny in the design of
regional adaptations and their respective "information for
safety" as in device master record (DMR).
Phase 5: Market Introduction and Post-Market
Surveillance
Pitfalls:
Post-market activities are frequently viewed as solely
regulatory compliance tasks, missing and/ or often ignoring the
potential for leveraging and maximizing use-related
opportunities and risk data derived from real-world settings.
Good practices:
● Coordinate and synchronize Post-Market Clinical Follow-
up (PMCF) and post-market surveillance activities
(PDP/HFE) within PDP between HFE, clinical evaluation,
and regulatory teams to enhance the integration of (post-
market) feedback into subsequent generations of (your)
devices.

Mehrzad, H.M., Stüdeli, T. & Quie, H. (2023) Best practices for use-related risk analysis through collaboration of human
factors and clinical, In: 12th International Symposium on Human Factors and Ergonomics in Healthcare (HCS 2023),
March 26-29, 2023, Orlando (FL). Online: https://www.hcs-2023.org/
Conclusion
In this paper, we highlighted the ongoing practical
challenges within the HFE process to combine risk-based and
user-centered design thinking and approaches and to merge such
into the PDP. We showed how such challenges have affected the
early and successful integration and execution of an iterative use-
related risk analysis and we presented a framework outlining its
pitfalls and providing best practices to resolve such.
Additionally, we detailed how the evolution of industry
standards and regulations have necessitated the collaboration
between human factors and clinical specialists. We illustrated
how this collaboration can facilitate the collection of hybrid data
for the parallel assessment of usability and clinical evaluation
requirements, including use-related risks, and how such an
approach could potentially result in more robust data that
optimize residual and benefit-risk analyses, facilitate
comprehensive development documentation, and strengthen
HFE and clinical evaluation processes and reporting.
Key takeaways of our proposed framework:
● Start early! An early integration of use-related risk analysis
into the PDP, HFE and clinical evaluation, is key for
successful and effective planning and subsequent validation,
and aids in the prevention of unmitigated risks and the late
detection of design deficiencies.
● Collaborate! Applying a collaborative approach between
HFE and clinical specialists will lead to more robust data,
and optimized analysis of use-related risks and benefit-risk
analyses. It will also facilitate the development of
comprehensive documentation, and strengthen HFE and
clinical evaluation processes and reporting.
● Be transparent! Share knowledge and data amongst
development teams and within the community to allow for
the advancement of safer and more effective and usable
products, as well as aid in the continuous learning amongst
practitioners.
● Communicate! The continuous progression of technology
will necessitate the ongoing evolution and adaptation of
development tools and processes. Therefore, it is imperative
to continue the critical discussion on use-related risk
analysis, including its early integration and execution within
the PDP, and ensure both, HFE and clinical specialists,
participate within it.
Lastly, not only could such a framework and cross-
functional collaborative approach furnish the manufacturer with
a data set that could be utilized for the advancement of potential
further risk mitigation and the development of future device
(generations), but it could also potentially provide additional
advantages, such as improved decision making, better quality
control, and enhanced patient outcomes.
References
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