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

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

Writing Your 510(k)

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

What’s Left?

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

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

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

Phase / Gate Design Process

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 & 7.3.6 / 1st in Humans Study Approval Pilot Launch Approval Commercial Launch Approval

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

Design Inputs

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

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

Team Charter

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)

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.)

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

“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”

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

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

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

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

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?

Q&A

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