Exploring the benefits of collaboration between Business
Process Models and Fact Based Modeling – ORM
A business analyst’s practical experience
September, 2012
Agenda
 Presenter Background
 The Message
 The Project
 The Approach
 Collaboration Examples
 Benefits of Approach
 Questions and Answers
2
Presenter Background
Worldwide developer, manufacturer and
marketer of medical devices
– Cardiology, Rhythm and Vascular (CRV)
• Stents, Leads, Pacemakers, Implantable
Cardioverter Defibrillators (ICDs), Cardiac Resynchronization
Therapy (CRT) Devices
– Endoscopy
– Urology and Women’s Health
– Neuromodulation
http://bostonscientific.com
3
Presenter Background
Clinical Information Systems
• Supports Clinical Sciences Organization
• Responsible for set-up and management of clinical and
preclinical trials
• 600 employees
• ~75 active or planned clinical studies
• ~30 systems supported
4
The Message
Collaboration of Lean Business
Process tools and ORM helped us
capture our requirements
Process
Maps
ORM
Decision
Tables
Requirements
5
The Project
Clinical Device Tracking System
(CDTS)
• New system to bring device tracking
in house
• Internal and external users
• Tracks clinical devices once it leaves
the BSC distribution center (shipment,
receipt, use, return)
• Users scan one or more barcodes on
label
• Automates the replenishment process
• Manages expiring devices
• Current status: requirements
complete
6
Lean Business Process Tools and ORM
THE APPROACH
7
Lean Business Process Tools
• Project Charter
• SIPOC
• Current State Process Maps
• Scope Diagram
• Future State Process Maps
8
Created Current State Process Maps
Level 1 - Overview
Clinical Supply Chain (CSC) – 3rd Party Vendor Process – AS IS
Start
Prepare and
Ship Product
3rd Party Vendor
Clinical Supply
Chain
Overview
Plan and
Prepare for
Study
Study Close
Out Activities
A
Serialize
Product
Set-up System
Load Data
Ship Devices to
Site
Yes
A
Return Device
Check
Replenishment
Needs
Yes
Yes
Replenishment
Needed
Yes
Replenish
Device
B
Notify IVRS/
IWRS of Device
Status,
Availability,
Usage
B
C
No
End of
Enrollment
Yes
A
Yes
No
Clinical Site
No
Receive
Shipment
Damaged
Product
No
Monitor
Inventory
Needed at
Alternate Site
No
Use Device
Check Usability
Opened/
Unusable
No
Verify Device
Correct Device
Chosen
C
Return to
Inventory
Return Device
Correct Device
Chosen
No
FCE
Yes
Transfer
Device
Customer Account Info
Data
Device Info
Product Info
Par Levels
Shipment Info
Shipment Info
System/Study Access
Device Info
Device Info
Device Info
Device Info
Shipment Info
Device Info
Device Info
Patient Info
Device Info
Shipment Info
Device Info
Par Levels
Shipment Info
Device Info
Device Info
Shipment Info
Device Info
Study Info
Site Info
Device Receipt Checks
Word
BRINM PCC
Database
Current
Tool
Current
Tool
Current
Tool
Tools
Word
FedEx
9
Current
Tool
Current
Tool
Current
Tool
Current
Tool
Current
Tool
Current
Tool
Current
Tool
Current
Tool
Device Info
Device Info
Patient Info
End
Current State Process Maps
Level 2 - Detail
Ship Device (To Site) - Replenishment
Monitor 3rd Party Vendor Levels
Start
Review
Replenishment
Report
#=
PT = 30 min
Create
Shipment
Request
#=
PT = 15 min
Package
Product
#=
PT = 30 min
Ship Product
to Site
#=
PT = 15 min
Update IVRS
Vendor
#=
PT =
Start
End
Clinical Site
Data
Tools
10
End
No
Clinical Supply
Chain
3rd Party Vendor
Replenish
Check 3rd Party
Vendor
Inventory Level &
Exp Dates
#=
PT =
Receive
Shipment
#=
PT =
Site
Site ID
ID
Device
Device ID
ID
Quantity
Quantity
Device
Device Status
Status
UPN
UPN
Expiration
Expiration Date
Date
Current
Tool
Fedex
Report:
Inventory Report
Current
Tool
Current
Tool
Replenishment
Needed
Yes
Plan for
Additional
Product
#=
PT =
Kaizen Event
• 2 Day Event
• Review
• Project Charter
• Scope Diagram
• Current State Process Maps
11
SWOT Analysis
Record
SWOT
ID Item
Category
Electronic Audit Trail for
1
All Transactions
Strength
Long set-up times for
2
the system
Weakness
Improve management of
3
short expiry products
Opportunity
4
Reliance on one vendor Threat
Benefits of SWOT
System
People
Data
Tool
Process
X
Compliance
X
X
Process Maps
X
Overview
Plan and Prepare for Study,
Set-up System
X
Plan and Prepare for Study
X
X
Overview
• Identify strengths of the current system that should be retained
• Identify weaknesses of the current system that should be improved
• Identify opportunities for improvement that don’t exist in current
system
• Identify threats that could derail the project
12
Created Future State Process Maps
• Determined who will absorb 3rd Party Vendor
responsibilities
• Overall process remained relatively unchanged
• Made a few process improvements/streamlined process
Clinical Supply Chain (CSC) – CDTS Process, Future State
Clinical Supply
Chain
Distribution
Center
Overview
Transfer to
Depots
Start
Set-up System
Ship Devices to
Site
Check
Replenishment
Needs
Load Data
A
C
A
Clinical Site
Replenishment
Needed
No
Yes
Return Device
Yes
Yes
Replenish
Device
B
B
C
A
Update Product
Status
Return Device
Notify IVRS/
IWRS of Device
Status,
Availability,
Usage
Study Close
Out Activities
Yes
Yes
Yes
Receive
Shipment
Damaged
Product
No
Monitor
Inventory
End of
Enrollment
No
Check Inventory
Needs
Needed at
Alternate Site
No
Use Device
Check Usability
Opened/
Unusable
No
Verify Device
Correct Device
Chosen
No
Correct Device
Chosen
No
FCE or Stocking
Location
Yes
Transfer
Device
Data
Device Info
Customer Account Info
Product Info
Par Levels
Shipment Info
Shipment Info
System/Study Access
Device Info
Device Info
Device Info
Device Info
Shipment Info
Device Info
Device Info
Patient Info
Device Info
Shipment Info
Par Levels
Shipment Info
Device Info
Device Info
Device Info
Shipment Info
Device Info
Device Info
Device Info
Patient Info
Study Info
Site Info
Device Receipt Checks
Tools
CDTS
SAP
CTMS
13
CDTS
CDTS
SAP
CDTS
SAP
CDTS
CDTS
CDTS
CDTS
CDTS
CDTS
CDTS
CDTS
CDTS
SAP
CDTS
CDTS
CDTS
IVRS Vendor
Database
CDTS
End
Data Modeling Session
• Enterprise Information Architect recommended ORM for
the project
• Four day on site session
• Attendees: Architect, BA, Business Users
• Used Future State Process Maps as framework during
the sessions
• Structure
• Benefits of ORM sessions
• Semantics
• Efficiency
• Validation
• Gap Identification
14
Decision Tables
COLLABORATION
15
Examples of Collaboration
1. Device Movement
• Transactions of a device throughout its lifecycle

Between locations
2. Inventory Management
• Quantity of a device at an inventory location
• Inventory levels must be incremented and
decremented


16
As a device moves from one location to another
As a device moves through its lifecycle at a specific location
Device Movement
A
No
Start
2.1 Transfer
Devices to
Depots
2.2 Ship
Devices to
Sites
2.3 Receive
Shipment
Usable Product
Yes
2.5 Monitor
Inventory
Device Needed
On Site
No
2.6 Transfer
Device
2.8 Replenish
Device
Yes
Replenishment
Needed
B
B
2.7 Use Device
No
End
2.9 Study
Close-out
Activities
No
17
Yes
End of Study
2.4 Return
Device
A
Yes
Device Movement - ORM
18
Device Movement - ORM
19
Collaboration
A
No
Start
2.1 Transfer
Devices to
Depots
2.2 Ship
Devices to
Sites
2.3 Receive
Shipment
Usable Product
Yes
2.5 Monitor
Inventory
Device Needed
On Site
No
2.6 Transfer
Device
2.8 Replenish
Device
Yes
Replenishment
Needed
B
B
2.7 Use Device
No
End
2.9 Study
Close-out
Activities
No
20
Yes
End of Study
2.4 Return
Device
A
Yes
Movement Type Matrix
Ship To
Ship From
SAP DC
21
SAP DC
Clinical Site
Field Rep
non-SAP
Stocking
Location
Inventory
Shipment
Shipment
Shipment
Clinical Site
Return
N/A
N/A
Return
Field Rep
Return
Transfer
Transfer
Return
non-SAP Stocking Location
Return
Transfer
Transfer
Transfer
Inventory
snapshot from SAP, update to inventory levels
Shipment
initiated within SAP, completed within CDTS
Transfer
initiated within CDTS, completed within CDTS
Return
initiated within CDTS, completed within SAP OR CDTS
N/A
not allowed
Inventory Category
• A device is assigned a number of statuses throughout its
lifecycle
• The system must appropriately decrement and increment
each status to ensure that accurate numbers are
maintained
-
-
22
Example: when a device usage occurs, the system must
decrement the “Available” status and increment the “Used”
status
Final Reconciliation
#Shipped = #Used + #Returned
Inventory Category
• Initial ORM models identified
• Shipping condition
• Device status
• Usage disposition
• Availability status
23
Inventory Management
24
Transition
Physical
Disposition
Inventory
Category
Inventory
Category
Inventory
Category
Allowable Transactions for
Physical Inventory
Increment Inventory
Physical Inventory Category
Decrement Inventory
Available
On-hold
Damaged
Expired
Opened/Used
Explanted
Pending Return
Return Received3
exception rules
25
Available
√
√
√
√
√
NA
NA
NA
On-hold
√
NA
NA
NA
NA
NA
NA
NA
Damaged
√
√
NA
√
NA
NA
NA
NA
Expired
√
√
NA
NA
NA
NA
NA
NA
Opened/Used Explanted
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Disposition Inventory Category
Pending
Return
√
√
√
√
√
√
NA
√
Return
Received3
NA
NA
NA
NA
NA
NA
NA
NA
Lost in Transit Discarded
NA
√
NA
NA
NA
NA
NA
√
NA
√
NA
√
NA
NA
NA
NA
Used1
√
NA
NA
√
NA
NA
NA
NA
Returned
NA
NA
NA
NA
NA
NA
√
NA
Transferred2 Destroyed
√
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
√
Additional Decision Tables
Clinical Site, FCE, Stocking Location
INTRANSIT for Shipments,
Returns
Increment SHIP TO Inventory
Transition Inventory Category
Decrement SHIP FROM
Pending
Inventory
Order
In Transit
Unfulfilled
NA
NA
N/A
√
Clinical Site, FCE, Stocking Location
INTRANSIT for Transfers
Increment SHIP TO Inventory
Transition Inventory Category
Decrement SHIP FROM
Pending
Inventory
Order
In Transit
Unfulfilled
NA
NA
Available
√
REPLENISHMENT for
Stocking Locations, Sites,
FCEs
Increment Inventory
Physical Inventory Category
Decrement Inventory
Pending Order
Unfulfilled Order
In Transit
Available
NA
NA
√
On-hold
NA
NA
√
Damaged Expired
NA
NA
NA
NA
NA
NA
Disposition Inventory Category
Opened/Used Explanted
NA
NA
NA
NA
NA
NA
Pending
Return
NA
NA
NA
Received
NA
NA
√
3
Allowable Transactions
for Disposition Inventory
(Consumable Devices)
Lost in Transit Discarded
NA
NA
NA
NA
NA
√
Used1
Returned
Transferred2
exception rules
Used
NA
NA
NA
Returned
NA
NA
NA
2
Transferred Destroyed
NA
NA
NA
NA
NA
NA
In Transit
NA
√
NA
Available
√
√
√
√
√
On-hold
NA
NA
NA
NA
NA
Damaged Expired
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Disposition Inventory Category
Opened/Used Explanted
NA
NA
NA
NA
√
NA
NA
√
NA
NA
Pending
Return
NA
NA
Pending Order
NA
NA
NA
Unfufilled
√
NA
NA
√
NA
NA
Transition Inventory Category
Return
Received3
NA
NA
NA
NA
NA
Lost in Transit Discarded
NA
NA
NA
NA
NA
NA
NA
Allowable Transactions
for Disposition Inventory
(Re-Usable Devices)
NA
NA
NA
Used1
NA
NA
NA
NA
NA
Returned
NA
NA
Transferred2 Destroyed
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
In Transit
NA
NA
Pending Order
NA
NA
Unfufilled
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Increment Inventory
Physical Inventory Category
Decrement Inventory
Lost in Transit
Discarded
1
Increment Inventory
Physical Inventory Category
Decrement Inventory
Lost in Transit
Discarded
Transition Inventory Category
Return
Available
√
√
On-hold
NA
NA
Damaged Expired
NA
NA
NA
NA
Disposition Inventory Category
Opened/Used Explanted
NA
NA
NA
NA
Pending
Return
NA
NA
Transition Inventory Category
Return
Received
NA
NA
3
Lost in Transit Discarded
NA
NA
NA
NA
1
Used
NA
NA
Returned
NA
NA
2
Transferred Destroyed
NA
NA
NA
NA
In Transit
NA
NA
Pending Order
NA
NA
Unfufilled
NA
NA
Used1
Returned
√
√
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Transferred2
Return Return3
exception rules
√
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
26
√
Collaboration
Process
Maps
ORM
27
Decision
Tables
Inventory Category Snapshot - ORM
2.
1.
28
Inventory Category Change
29
Benefits of this Method
Multiple
discussions,
different
perspectives
Framework
for user
acceptance
tests
Efficiency in
business
process/data
gathering
30
Stable
database
framework
Key
Benefits
Driver for
capturing
business
rules
Conclusion
31