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.

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 Clause 7.3 – “Waterfall Diagram” Equivalent to
21 CFR
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 DesignR D
Product
Launch
510(k)
Concept
Phase
Feasibility
Phase
Development
Phase
Pilot
Phase
Release
Phase
Design Transfer
DHF
Begins

9. Phase / Gate Design Process

10. Each Gate is a Design Review Meeting
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 & / 1st in Humans Study Approval
Pilot Launch Approval
Commercial Launch Approval

11. X When to Start Your DHF? 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. X

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

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

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

22. Conclude with Sampling of DHF & TF/DD
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 your Regulatory Strategy?