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Why is your new product launch behind schedule?

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Presentation on theme: "Why is your new product launch behind schedule?"— Presentation transcript:

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 Design
R 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?

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