Usability Engineering Plan

Exon Therapeutics

 Device: Drug-Eluting Stent (DES) System

 Purpose: To define the Usability Engineering (UE) process to ensure that the user
interface (UI) of the Drug-Eluting Stent (DES) system is safe and easy to use. This
plan is designed to be in compliance with the requirements of IEC 62366-1:2015,
MDCG 2021-6, and EUMDR 2017/745.

1. Usability Engineering Process Scope

This plan applies to all aspects of the DES system's UI, from packaging and labeling to the
catheter delivery system and any related accessories or software. The UE process will be
integrated into the overall product development lifecycle, following a risk-based approach to
identify and mitigate use-related risks.

1.1 Team and Responsibilities

 Usability Engineering Lead: Responsible for planning, execution, and reporting of

all UE activities.
 Project Manager: Overall project oversight and resource allocation.
 Clinical Affairs: Provides input on intended use, user profiles, and clinical workflow.
 Regulatory Affairs: Ensures compliance with all applicable standards and
regulations.
 Design & Engineering Team: Responsible for UI design and implementation.
 Quality Assurance: Reviews and approves UE documentation and reports.

2. Use Specification
This section defines the intended use and context of the DES system to establish the
foundation for all subsequent UE activities.

 Intended Medical Purpose: The DES is intended for the treatment of coronary artery
disease by maintaining vessel patency following percutaneous transluminal coronary
angioplasty (PTCA).
 Intended Patient Population: Patients with symptomatic ischemic heart disease due
to de novo or restenotic coronary artery lesions.
 Intended User Profile:
o Primary Users: Interventional Cardiologists and Cardiac Catheterization Lab
Nurses/Technicians.
o User Training & Knowledge: Users are highly trained, skilled medical
professionals with extensive experience in sterile procedures and cardiac
catheterization. They must be familiar with the principles of coronary
interventions.
 Intended Use Environment: Cardiac Catheterization Laboratory ("Cath Lab"). The
environment is sterile, well-lit, and typically high-pressure. Potential hazards include
low light, distractions, and time constraints during a procedure.
3. Identification of Characteristics Related to Safety & Use-
Related Risks
This section describes how potential use errors will be identified and analyzed. This is a
critical step for a device of this nature, as a use error could have catastrophic patient
consequences.

 Initial Risk Analysis: A preliminary risk analysis will be conducted to identify

potential hazards and foreseeable use scenarios. This will be informed by a literature
review, competitor analysis, and feedback from clinical experts.
 Identifying Foreseeable Use Errors: Potential use errors will be systematically
identified through:
o Task Analysis: A step-by-step breakdown of all tasks, from device
preparation to deployment and retrieval.
o Heuristic Evaluation: A review of the UI by human factors experts against
established usability principles.
o Preliminary Use-Related Hazard Analysis: A structured analysis (e.g.,
FMEA) to link foreseeable use errors to potential harms.
 Hazardous Situations: Examples of foreseeable hazardous situations include:
o Incorrect sizing of the stent: User selects the wrong stent diameter or length,
leading to vessel damage or restenosis.
o Premature deployment: Stent is released before reaching the target lesion.
o Incorrect catheter manipulation: User struggles to navigate the catheter,
causing vessel perforation.
o Misreading of labeling: User misinterprets a label, leading to use of an
expired or incorrect device.
 Considerations from MDCG 2021-6: The UI analysis will also consider security-
related usability issues, such as ensuring the user can correctly and securely input any
necessary data into connected software or devices, thereby preventing errors that
could lead to unauthorized access or data corruption.

4. User Interface (UI) Development and Formative Evaluation

This section outlines the iterative process of designing and improving the device's UI.

 UI Design & Prototyping: The UI design will be based on the use specification and
risk analysis. Prototypes, including physical models, packaging mock-ups, and
interactive software interfaces (if applicable), will be created.
 Formative Evaluation: These are iterative, "learn-as-you-go" evaluations intended to
identify and fix design problems early.
o Methodology:
 Cognitive Walkthroughs: A team walks through the user tasks to
identify potential points of confusion or error.
 Think-Aloud Protocols: A small number of target users (e.g., 5-8
interventional cardiologists) will be asked to perform a simulated use
task while verbalizing their thoughts.
o Participants: A diverse group of target users will be recruited to participate in
the evaluations.
 o Output: The findings from formative evaluations will be documented and
used to refine the UI design. This process is repeated until the UI is mature
and all major usability issues are addressed.

5. Summative Evaluation (Usability Validation)

This is the final, formal validation of the UI to demonstrate that the device is safe and
effective for its intended use by the target user population.

 Objective: The primary objective is to confirm that the identified use-related risks
have been reduced to an acceptable level and that the UI meets its usability
requirements. This evaluation is not for design refinement but for formal proof of
safety and effectiveness, serving as a critical piece of evidence for regulatory
submission.
 Methodology: A simulated-use test will be conducted. This involves a realistic
mock-up of the DES system and a simulated patient anatomy (e.g., a vascular model)
within a high-fidelity mock Cath Lab environment. Participants will be
representative of the target user profile (e.g., at least 15 interventional cardiologists,
including those with varying levels of experience, and a representative sample of
nurses/technicians). Participants who were involved in formative evaluations should
not be included to avoid bias.
o Test Protocol: A pre-defined protocol will be used to guide participants
through a series of critical tasks, such as:
 Correctly identifying the stent dimensions and expiry date from the
packaging.
 Performing the sterile prep and removal of the device from its
packaging without damage.
 Navigating the catheter through a simulated tortuous coronary artery.
 Precisely positioning and deploying the stent at the target lesion.
 Troubleshooting a foreseeable use-related issue (e.g., a kinked
guidewire).
 Data Collection: Data will be meticulously collected by trained observers.
o Performance Metrics: This includes quantitative data like task completion
rates, time to completion, and the number of use errors observed.
o Use Errors: Observed errors will be classified by a pre-defined scale (e.g.,
critical, major, or minor). A critical use error is one that could lead directly
to patient harm, such as premature deployment of the stent. The observers will
document the context and cause of each error.
o Subjective Feedback: Post-test questionnaires and interviews will capture
user satisfaction, perceived ease of use, and any unexpected usability issues
that didn't lead to a formal error.
 Success Criteria: The summative evaluation will be deemed successful if it meets
predefined criteria, which may include:
o Zero Critical Use Errors: No participants commit a critical use error on any
of the pre-defined critical tasks.
o Acceptable Error Frequency: The frequency of major and minor errors is
within pre-established limits. For example, "no more than 5% of participants
make a major error on any given task."
 o High Task Completion Rate: All critical tasks are completed successfully by
all participants within a reasonable time.
 Compliance with EUMDR 2017/745: The comprehensive results of the summative
evaluation will provide the necessary clinical evidence to support the device's safety
and performance, as required by Annex I of the EUMDR. The final usability
engineering report will be a key component of the technical documentation for
regulatory submission.

6. Usability Engineering Report

This final document will summarize the entire UE process and its outcomes. It is a critical
component of the medical device's technical documentation file and is required for regulatory
submissions under standards like IEC 62366-1 and regulations like the EUMDR.

6.1 Report Structure and Contents

The report should be a self-contained document that tells the complete story of the device's
usability from initial planning to final validation. It should include, at a minimum:

 Introduction: A brief overview of the medical device, its intended use, and the
purpose of the report.
 Use Specification: A full reproduction of the use specification, including the intended
user, patient, and use environment.
 User Interface Description: A detailed description of the device's UI, including all
physical components (e.g., packaging, delivery catheter, handle) and any software
interfaces.
 Risk Management Summary: A summary of the preliminary and detailed use-
related risk analysis. This section should link identified use errors to the design
mitigations implemented in the final UI.
 Formative Evaluation Summary: A brief summary of all formative evaluations
performed. While detailed reports are not typically included, the summary should
show how findings from these evaluations led to specific UI design changes.
 Summative Evaluation Details: This is the most critical section. It must include:
o Methodology: A full description of the simulated-use test, including the
environment, participant recruitment criteria, and a step-by-step test protocol.
o Results: A complete presentation of all data collected, including quantitative
metrics (task completion rates, time data) and qualitative findings (observed
use errors, subjective feedback). All observed use errors must be documented
with their severity classification and an analysis of their root cause.
o Analysis and Conclusion: A thorough analysis of the results to demonstrate
that the device's UI is safe for its intended users. The report must explicitly
state that the success criteria defined in the plan were met.
 Traceability Matrix: A matrix that traces identified use-related risks to the
implemented design controls and the verification activities (i.e., summative test tasks)
that confirmed their effectiveness.
 Conclusion: A final statement that the usability engineering process was completed
in accordance with the plan and that the device is safe and effective from a usability
perspective.
6.2 Regulatory Importance

The Usability Engineering Report provides a clear and traceable line of evidence for
regulatory bodies, demonstrating that the manufacturer has:

 Identified and understood the risks associated with the device's use.
 Designed a user interface that mitigates those risks.
 Formally validated the safety and usability of the final design with a representative
group of users.

This report is reviewed by notified bodies as part of the conformity assessment procedure
under the EUMDR to confirm that the device meets the General Safety and Performance
Requirements (GSPR) of Annex I, particularly those related to use error and human factors.

Document Control

 Document No.: EXON-UE-DES-001

 Revision History: | Revision | Date | Description of Change | | :--- | :--- | :--- | | 01 |
2025-08-19 | Initial Release |