Protocol
868 Cordis ARTS Deliverability Research
Study:
Formative User Preference Study
Date:
August 26, 2010
Originator:
Sean Hägen
Overview
The following study protocol dictates the process in which BlackHägen Design (BH) will
identify, document, and analyze (benchmark) User Preference input for a double-blind,
qualitative design research study to understand physicians’ current and ideal definition
of stent “deliverability” and it’s associated system solution attributes for percutaneous
coronary intervention (PCI) stent delivery systems. This study is intended to benchmark
user requirements to support the Cordis Arterial Revascularization Therapies Study
(ARTS) from the perspective of the physician in PCI treatment markets – specifically the
drug eluting stent (DES) delivery portion. The study methodology will include
ethnography (contextual observation) of PCI procedures and brief face-to-face
interviews. A comprehensive understanding of the environment, communication
between clinicians, procedure protocol, hand biomechanics and user tendencies when
delivering DES will be documented in the subsequent Benchmark Report.
Objectives
► Map the PCI Usage Characteristics during the DES Delivery Steps
Characterize and codify the optimal stent delivery experience from the user’s
perspective, key current facilitators and barriers, and identify target design
criteria for successful delivery system development from device removal from
package to device disposal.
Note: emphasis will be placed on actual stent delivery in context. While other aspects of
the procedure will be noted e.g. introduction sheath insertion, etc. this will not be
described with extensive fidelity
► Characterize User Sample
Identify and rank User Personas in order to augment the User Preference Inputs.
► Document User Preference Rationale
Capture how physicians define deliverability, what procedural factors influence it,
how it is measured, and ultimately, what are the attributes of a PCI-system that
enables optimal deliverability (deliver significant design input rationalization for
future development of ARTS Device Requirements by Cordis).
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Recruitment Criteria
The user (Respondent) qualification criteria and recruitments are based on an
interventional cardiologist (physician) practicing in two domestic regions (East and West
coast), the lead physician’s experience level performing arterial revascularization
procedures, the respondent’s volume of cases per year and the diversity of device
brands utilized annually. Sample size is also influenced by the project schedule, budget
(honoraria) and available access to participating institutions.
Respondents: N = 15-20
Inclusive Screening Criteria:
 Performs at least 120 PCI procedures per year (on average)
 The sample population should breakdown as follows:
 Expert (Podium Speaker)
10%
 Veteran (<155 PCI/yr or 5 yrs tenure)
30%
 Educator
30%
 Common Interventionalist (less experienced)
30%
 Device Usage proportions (objectives)
o Uses Cordis Device
30%
o Uses Boston Science Devices
30%
o Uses Abbott Devices or other
30%
 2-4 Transradial approaches
Exclusive Screening Criteria:
 No more than 2 respondents that primarily uses Cordis devices only
Methodology
The number of attending BH observers will be no more than two (2) in order to minimize
intrusion bias and maintain a relaxed, uninhibited environment for the respondents. In
order to facilitate minimally invasive contextual observation, the researchers will set-up
the video equipment during lab instrument set-up (prior to the patient and primary
physician entering the lab). One observer will be in the lab operating the camera
equipment the second observer will remain in the control room capturing time metrics.
During each site visit, BH will employ a multi-channel video approach which
simultaneously captures activity at both the proximal and distal ends of the devices in
use. The videos will be synchronized post production. Observations of the user’s focus
of attention will also be noted and captured with still images. The site visit will be
concluded by interviewing research participants. Interviews will be digitally recorded and
the data documented (transcribed) for analysis and archiving. Permission will be
obtained ahead of time from the lab manager for filming/photography. Participating
physicians/lab managers will be responsible for obtaining patient consent. All data
(video, still photography, audio, etc.) will exclude any patient specific (identity) data in
order to conform to HIPAA compliance requirements.
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Methodology continued…
A Discussion Guide and the supporting Datasheet are intended to provide the BH
researcher with guidelines and a checklist of metrics to capture, measure and
characterize during site visits. The following is an example of an introductory
discussion with a Respondent. It should not be read verbatim, rather as a reference if
Respondents want more information on why or how we are conducting the study:
We are a design consultant for a medical manufacturer that is developing a PCI stent
delivery system that optimizes usability. Our client must remain undisclosed in order to
maintain a double-blind study requirement. We are here today to observe you,
specifically the usability aspects of delivering a stent.
Your experience and opinions will help us learn what criteria can insure future devices
are meeting you needs, so it is very important that you give us your honest opinions—
good or bad. In general, we are interested in:

Any particular challenges, bottle-necks you experience during the procedure.

If the performance of any device involved is less than optimal, and why?

Your ideas for improving the experience for yourself, your team, and the patient.
After the completion of the procedure, we’d like to spend no more than 15 minutes with
you to clarify some of our observations and also take you through an exercise where
you will have the opportunity to share some of your experiences with us in more detail.
This is certainly not a test of your abilities! We are interested in knowing how and why
you personally do things a certain way.
At this time, we’d like to know if it is ok for us to ask you questions during the procedure.
If there are any specific parts of the procedure that you feel are difficult to understand,
from our point of view, feel free to describe what you are doing.
If at any time you need us to leave the room, we are prepared to shut-down the
cameras and leave the room immediately.
Thank you for the opportunity to learn from you and your team!
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Methodology continued…
At the convenience of the cardiologist, BH will conduct a brief interview. A methodology
for obtaining the step by step breakdown of the procedure and the associated emotive
connections used is called projective mapping. The projective mapping exercise
utilizes metaphoric images to enable the respondent to better articulate their
experiences and aspirations through storytelling and projective association. The
researcher will ask the respondent to describe his or her experience during the
procedure. Using this type of exercise, it will become apparent the number of steps
and emotions involved for each task. Once collected a procedure map will be created
using the steps and emotional metrics shown with this exercise, time metrics and
devices used, and data collected through video.
Interview Guide
1. Please describe the steps in delivering stent. Probe for:
a. Major milestones within the procedure
b. Specific techniques to advance (stent) catheter over guide wire, around
tortuous anatomy
c. Key feedback throughout the procedure, what lubricity is appropriate?
(this may need physical aids to really dive into e.g. set of tubes with predetermined friction for comparison)
d. What attributes are associated with pulling the stent back into guidecath,
balloon inflation/over-inflation, stent deployment
e. As the stent opens (is deployed) what feedback is most important?
f. What do they use a reference guide to confirm that delivery is on target?
2. What are the most difficult challenges regarding the delivering a stent? Why?
3. Can you define any “rules of usage” or tips that you usually give to novice users?
4. What constitutes easier stent delivery?
5. How do you define tracking? How important is tracking?
6. How do you define pushability?
7. How important is pushability?
8. Why do you choose to use one stent brand over another?
9. Do they choose to use a different stent for radial access vs. femoral access?
Why?
10. Which stent has the best deliverability? Why?
11. What might improve deliverability?
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Observation Guide




Overall room layout
Personnel identification and work flow path
Set-up of instrumentation: where possible provide a list of all catheters used,
including brand names
Observed procedure steps including challenges and mitigations
o Challenges to be defined as any portion of the procedure which takes
excessive amounts of time, obvious mood changing events, trials/re-trials
on device performance, and any device interchanges e.g. disposal of one
catheter for another
Metric Objectives of Study
1. Establish User Requirements for preparation of Stent Delivery Systems (opening
package and prepare additional equipment, i.e. syringes/stopcock, flush etc.)
2. Determine the unique behavior steps (technique) during delivery
3. Correlate device characteristics with behavior modalities (user inputs to device
outputs)
a. Describe opinions, thoughts, and perceptions regarding actions e.g. what
works, what doesn’t and why.
4. Characterize device response from navigation, lesion access to deployment
a. Describe challenge and ease of use areas
b. Describe stent visibility issues
5. Capture relative perception/emotion/opinion that correlate with use
characteristics during delivery scenarios.
6. Evaluate current device deliverability through distal and tortuous vessels
7. Specific product interaction attributes to be assessed include the following:
a. Lubricity of the outer body
b. Perception of system behavior with regards to feedback and response
e.g. tracking and pushability
c. Attributes of use interaction at critical points in the procedure including
reaching lesion site, deployment and device removal.
d. Stent visibility
e. The usefulness of catheter marker bands (indicating location/spacing of
stent on balloon), understand the design constraints around marker
placement and the appropriate degree of radiopacity
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Equipment
The following equipment will be utilized for this study:
1. Digital Still Camera
2. Digital Video Camera (2)
3. Audio Recorder
4. Tripod (2)
5. Protocol
6. Data Collection Sheets
7. Projective Mapping exercise
8. Discussion Guide
9. Note pad
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