1. Exploring the benefits of collaboration between Business Process Models and Fact Based Modeling – ORM A business analyst’s practical experience September, 2012

2. Agenda  Presenter Background  The Message  The Project  The Approach  Collaboration Examples  Benefits of Approach  Questions and Answers 2

3. 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

4. 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

5. The Message Collaboration of Lean Business Process tools and ORM helped us capture our requirements 5 Requirements Decision Tables ORM Process Maps

6. 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

7. THE APPROACH Lean Business Process Tools and ORM 7

8. Lean Business Process Tools Project Charter SIPOC Current State Process Maps Scope Diagram Future State Process Maps 8

9. Created Current State Process Maps Level 1 - Overview 9

10. Current State Process Maps Level 2 - Detail 10

11. Kaizen Event 2 Day Event Review Project Charter Scope Diagram Current State Process Maps 11

12. SWOT Analysis 12 Benefits of SWOT 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

13. Created Future State Process Maps Determined who will absorb 3 rd Party Vendor responsibilities Overall process remained relatively unchanged Made a few process improvements/streamlined process 13

14. 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

15. COLLABORATION Decision Tables 15

16. 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  As a device moves from one location to another  As a device moves through its lifecycle at a specific location 16

17. Device Movement 17

18. Device Movement - ORM 18

19. Device Movement - ORM 19

20. Collaboration 20

21. Movement Type Matrix Ship To Ship FromSAP DCClinical SiteField Rep non-SAP Stocking Location SAP DCInventoryShipment Clinical SiteReturnN/A Return Field RepReturnTransfer Return non-SAP Stocking LocationReturnTransfer 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 21

22. 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 -Example: when a device usage occurs, the system must decrement the “Available” status and increment the “Used” status -Final Reconciliation #Shipped = #Used + #Returned 22

23. Inventory Category Initial ORM models identified Shipping condition Device status Usage disposition Availability status 23

24. Inventory Management 24 Transition Inventory Category Physical Inventory Category Disposition Inventory Category

25. Allowable Transactions for Physical Inventory 25

26. Additional Decision Tables 26

27. Collaboration 27 Process Maps Decision Tables ORM

28. Inventory Category Snapshot - ORM 28 2. 1.

29. Inventory Category Change 29

30. Benefits of this Method 30 Key Benefits Multiple discussions, different perspectives Stable database framework Driver for capturing business rules Efficiency in business process/data gathering Framework for user acceptance tests

31. Conclusion 31