Robert Packard, Consultantwww.MedicalDeviceAcademy.com
[email protected] 12, 2014
Slide 1 of 26
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
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
[email protected] 12, 2014
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4 Biggest Mistakes
1. Procrastination of Tasks
2. Flexible Phases of Design
3. Incorrectly Defining Inputs
4. Repeating Past Mistakes
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
[email protected] 12, 2014
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Writing Your 510(k)Section # Guidance Document for 510(k)
4 Indications for Use Statement5 510(k) Summary or 510(k) Statement6 Truthful and Accuracy Statement7 Class III Summary and Certification8 Financial Certification or Disclosure Statement9 Declarations of Conformity and Summary Reports
11 Device Description12 Substantial Equivalence Discussion13 Proposed Labeling14 Sterilization and Shelf Life15 Biocompatibility18 Performance Testing – Bench19 Performance Testing – Animal20 Performance Testing – Clinical
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Regulatory Affairs“The Anti-Sales Team”
Marketing Me Regulatory Me
Design Plan Should
Include Section 13
(i.e., labeling)
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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What’s Left?Section # Guidance Document for 510(k)
1 Medical Device User Fee Cover Sheet (Form FDA 2 CDRH Premarket Review Submission Cover Sheet3 510(k) Cover Letter
10 Executive Summary16 Software17 Electromagnetic Compatibility and Electrical Safety21 Other
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Design Controls
Clause 7.3 – “Waterfall Diagram”User Needs
Design Input
DesignProcess
DesignO utput
MedicalDevice
VALIDAT ION
VERIFICAT ION
REVIEW
Equivalent to21 CFR 820.30
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Slide 7 of 26
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
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Typical Phases of Design
8
DHFBegins
ProductLaunch510(k)
Design Transfer
ConceptPhase
FeasibilityPhase
DevelopmentPhase
PilotPhase
ReleasePhase
DR
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Phase / Gate Design Process
Gate Gate Gate Gate
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6 Recommended Gates
• 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
Each Gate is a Design Review Meeting
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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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
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Design Inputs
User Need Typical Design Input Better Design Input
Biocompatible Material = Teflon ISO 10993-1
Easy to Use Pictorial User Interface IEC 62366-1
Won't Puncture Nylon Reinforced Pouch ISTA 2A
Connects with Monitor RS232 Connection Protocol P123
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Slide 13 of 26
Design Planning Requirements• 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
ConceptPhase
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Design Plan Contents
• Team Charter
• Strategic Marketing Plan
• Business Justification
• Reimbursement Strategy
• Gantt Chart
• Regulatory Pathway
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Team CharterRole in project Name, Role Project Leader Approval of Commercial File documents This is most applicable for contract design
work. Approval of Design Plan Approve of Risk documents Refer to Risk Plan for this project Approval of all other documents May require further breakdown, or may refer
to another document that lists such approval authorities generically
Participants in Design Review (minimum):
Break this down further if required, e.g. to capture a requirement that the R&D Manager shall always be present at the final review before product release
Independent participant at Design Reviews:
May be different for different types of review
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Slide 16 of 26
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)
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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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.)
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Reimbursement Strategy
• CMS – Medicare / Medicaid• Private Payers• Global Purchasing Organizations (GPOs)• Large Hospital Chains (e.g., Kaiser)
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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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”
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Regulatory Pathway
• Classification Rationales• Guidance Documents• Harmonized Standards• Predicate Device• Languages• Country of Origin• Performance Testing
Each is Country Specific
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Auditing Design withAdjacent Link / Turtle Diagrams
Metrics
Process OutputsProcess Inputs
Who?
How Done?
With What EquipmentFacilities & Materials?
Describe the Process
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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Audit Agenda
Conclude with Sampling of DHF
& TF/DD
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
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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
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
[email protected] 12, 2014
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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?
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
[email protected] 12, 2014
Slide 25 of 26
Q&A
Robert Packard, Consultantwww.MedicalDeviceAcademy.com
[email protected] 12, 2014
Slide 26 of 26
Need help with yourRegulatory Strategy?
Rob Packard
+1.802.258.1881
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