Why is your new product launch behind schedule?

1. Why is your new product launch behind schedule? A frozen bubble created at -9F by Angela Kelly using homemade bubble solution near her home in Arlington, Washington. http://bit.ly/Anatomy-of-DesignPlan

2. 4 Biggest Mistakes Procrastination of Tasks Flexible Phases of Design Incorrectly Defining Inputs Repeating Past Mistakes

3. Writing Your 510(k)

4. Regulatory Affairs“The Anti-Sales Team” Design Plan Should Include Section 13 (i.e., labeling) Marketing Me Regulatory Me

5. What’s Left?

6. Design Controls Equivalent to 21 CFR 820.30 Clause 7.3 – “Waterfall Diagram”

7. Examples User Need = Implant must fit expected range of adult patient anatomy Input = ISO/IEC 62366:2007, Application of usability engineering to medical devices Output = Tabulated drawing showing 10 different sizes Verification = In silico analysis of fit between patient anatomy and different sizes Validation = cadaver studies and clinical studies

8. Typical Phases of Design D R Product Launch 510(k) Concept Phase Feasibility Phase Development Phase Pilot Phase Release Phase Design Transfer DHF Begins

9. Phase / Gate Design Process Gate Gate Gate Gate

10. 6 Recommended Gates Each Gate is a Design Review Meeting 7.3.1 – Design Plan Approval 7.3.2 – Design Inputs Approval 7.3.3 – Design Outputs Approval 7.3.5 & 7.3.6 / 1st in Humans Study Approval Pilot Launch Approval Commercial Launch Approval

11. When to Start Your DHF? X After the design plan has been developed Upon approval of the design project It’s not uncommon to start a DHF late and to retroactively assemble the file from documents that were already created in team meetings.

12. Design Inputs

13. Design Planning Requirements Concept Phase • Clause 7.3.1 • The plan shall… • Define stages of design & development • Define the review, verification, validation & transfer activities for each stage • Define responsibilities & authorities • Management shall manage interfaces • Document planning output and update as needed

14. Design Plan Contents Team Charter Strategic Marketing Plan Business Justification Reimbursement Strategy Gantt Chart Regulatory Pathway

15. Team Charter

16. Strategic Marketing Plan Which markets have unmet needs? What is the market size? Is the market growing or shrinking? Who are the competitors? Do we have a sustainable competitive advantage? (e.g., patents)

17. Business Justification • Competitive Analysis • Regulatory Can Help with TPLC database searches • Recent 510(k) • Product Malfunctions • Adverse Events • Recalls • Pricing (outright purchase, per use, etc.) • Distribution Models (stocking, consigned, etc.)

18. Reimbursement Strategy CMS – Medicare / Medicaid Private Payers Global Purchasing Organizations (GPOs) Large Hospital Chains (e.g., Kaiser)

19. Gantt Chart “Theory of Constraints” Identify each stage / gate in the project Identify cost of each stage Identify resources Identify the critical path Create buffers

20. Regulatory Pathway Each is Country Specific Classification Rationales Guidance Documents Harmonized Standards Predicate Device Languages Country of Origin Performance Testing

21. Auditing Design withAdjacent Link / Turtle Diagrams With What Equipment Facilities & Materials? Who? Process Inputs Process Outputs Describe the Process How Done? Metrics

22. Audit Agenda Conclude with Sampling of DHF & TF/DD

23. Standardize Work & Trend Analysis • Standardize your format for: • Every section of a regulatory submission • Every protocol • Every report • Every design plan • Measure task variability and duration

24. Lessons Learned • Just because management wants it completed by March doesn’t it mean it can be. • How long did it take last time? • What is the variability of tasks? • What is the longest task? • Which tasks are critical path items? • e.g., how long will it be before we have molded parts?

25. Q&A

26. Need help with yourRegulatory Strategy?