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
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 2 of 26
4 Biggest Mistakes
1. Procrastination of Tasks
2. Flexible Phases of Design
3. Incorrectly Defining Inputs
4. Repeating Past Mistakes
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 3 of 26
Writing Your 510(k)
Section #
4
5
6
7
8
9
11
12
13
14
15
18
19
20
February 12, 2014
Guidance Document for 510(k)
Indications for Use Statement
510(k) Summary or 510(k) Statement
Truthful and Accuracy Statement
Class III Summary and Certification
Financial Certification or Disclosure Statement
Declarations of Conformity and Summary Reports
Device Description
Substantial Equivalence Discussion
Proposed Labeling
Sterilization and Shelf Life
Biocompatibility
Performance Testing – Bench
Performance Testing – Animal
Performance Testing – Clinical
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 4 of 26
Regulatory Affairs
“The Anti-Sales Team”
Marketing Me
February 12, 2014
Regulatory Me
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 5 of 26
What’s Left?
Section #
1
2
3
10
16
17
21
February 12, 2014
Guidance Document for 510(k)
Medical Device User Fee Cover Sheet (Form FDA
CDRH Premarket Review Submission Cover Sheet
510(k) Cover Letter
Executive Summary
Software
Electromagnetic Compatibility and Electrical Safety
Other
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 6 of 26
Design Controls
Clause 7.3 – “Waterfall Diagram”
User Needs
Equivalent to
21 CFR 820.30
REVIEW
Design Input
Design
Process
VERIFICATION
Design
Output
Medical
Device
VALIDATION
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
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
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 8 of 26
Typical Phases of Design
R
Concept
Phase
DHF
Begins
February 12, 2014
Feasibility
Phase
D
Development
Phase
Pilot
Phase
Release
Phase
Design Transfer
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
8
rob@13485cert.com
Product
Launch
510(k)
Slide 9 of 26
Phase / Gate Design Process
Gate
February 12, 2014
Gate
Gate
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Gate
Slide 10 of 26
6 Recommended Gates
• 7.3.1 – Design Plan Approval
Each Gate is a Design
Review Meeting
• 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
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 11 of 26
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.
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 12 of 26
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
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 13 of 26
Design Planning Requirements
• Clause 7.3.1
• The plan shall…
Concept
Phase
– 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
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 14 of 26
Design Plan Contents
•
Team Charter
•
Strategic Marketing Plan
•
Business Justification
•
Reimbursement Strategy
•
Gantt Chart
•
Regulatory Pathway
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 15 of 26
Team Charter
Role 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
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
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)
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 17 of 26
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.)
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 18 of 26
Reimbursement Strategy
•
•
•
•
CMS – Medicare / Medicaid
Private Payers
Global Purchasing Organizations (GPOs)
Large Hospital Chains (e.g., Kaiser)
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 19 of 26
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”
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 20 of 26
Regulatory Pathway
•
•
•
•
•
•
•
Classification Rationales
Guidance Documents
Harmonized Standards
Predicate Device
Languages
Country of Origin
Performance Testing
February 12, 2014
Each is Country
Specific
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 21 of 26
Auditing Design with
Adjacent Link / Turtle Diagrams
With What Equipment
Facilities & Materials?
Who?
Process Inputs
Process Outputs
Describe
the Process
How Done?
February 12, 2014
Metrics
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 22 of 26
Audit Agenda
Conclude with
Sampling of DHF
& TF/DD
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 23 of 26
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
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 24 of 26
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?
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 25 of 26
Q&A
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 26 of 26
Need help with your
Regulatory Strategy?
rob13485
rob@13485cert.com
+1.802.258.1881
Rob Packard
February 12, 2014
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com