How leveraging these 4 approaches to FDA design controls will allow you to use them as a competitive advantage to reduce risk and get devices to market faster. Read the full post: http://blog.greenlight.guru/business-case-design-controls

1. The Business Case for
Integrated Design Control
Presented by:
Jon D. Speer
Founder & VP QA/RA of greenlight.guru
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2. Concepts to Cover
Design control integration as a competitive advantage
Improved product quality and speed to market
Learning from others and from experience
Aligning design control with the business process
2

3. About the Presenter
Jon D. Speer is the founder
and VP of QA/RA of greenlight.guru.
• 17+ years in medical device industry
• Product development engineer,
quality manager, regulatory
specialist
• 40+ products to market
• Expert at QMS implementations
• Dozens of ISO audits & FDA
inspections
greenlight.guru produces beautifully simple
quality, design control and risk management
software exclusively for medical device
manufacturers.
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280
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4. Design Controls – Overview
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5. Design Controls FDA 820.30 Design & Development ISO
13485:2003
Design & Development ISO
13485:2016
(a) General 7.3.1 Design and
development planning
7.3.1 General
(b) Design and development
planning
7.3.1 Design and
development planning
7.3.2 Design and
development planning
(c) Design input 7.3.2 Design and
development inputs
7.3.3 Design and
development inputs
(d) Design output 7.3.3 Design and
development outputs
7.3.4 Design and
development outputs
(e) Design review 7.3.4 Design and
development review
7.3.5 Design and
development review
(f) Design verification 7.3.5 Design and
development verification
7.3.6 Design and
development verification
(g) Design validation 7.3.6 Design and
development validation
7.3.7 Design and
development validation
(h) Design transfer 7.3.1 Design and
development planning
7.3.8 Design and
development transfer
(i) Design changes 7.3.7 Control of design and
development changes
7.3.9 Control of design and
development changes
(j) Design history file No reference 7.3.10 Design and
development file
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6. 6

7. What is Design Control?
• SAFE
• EFFECTIVE
• MEET INTENDED USE
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8. Did I design my
medical device
correctly?
Design Input
(Requirement)
Design Output
(Specification)
Design Verification
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9. Did you design the
correct medical
device?
User Needs Medical Device Design Validation
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10. 10

11. It is my responsibility
to document design
controls and maintain
the DHF.
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12. Design Controls – Myths
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13. Myth: Design Controls Impede
Product Development
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14. Truth: Design Controls Aid
Product Development
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15. 15

16. Myth: Design Controls Should
Be Delayed Until After A
Working Prototype Has Been
Established
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17. Truth: Design Controls Should
Start During Prototyping
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18. 18

19. Myth: Documenting Design
Controls Is Too Rigid A Process
19

20. Truth: The Design Controls
Process Should Be Flexible
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21. 21

22. 22

23. Myth: Design Controls Are
Optional
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24. Truth: Design Controls Are
Required
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25. Class I Class II Class III
not intended to help
support or sustain life or be
substantially important in
preventing impairment to
human health, and may not
present an unreasonable
risk of illness or injury
more critical than Class I
but designed to perform as
indicated without causing
injury or harm to patient or
user.
support or sustain human
life, are of substantial
importance in preventing
impairment of human
health, or present a
potential, unreasonable risk
of illness or injury
LOW RISK MEDIUM RISK HIGH RISK
General Controls General Controls +
Special Controls
510(k)
General Controls
+ Premarket Approval
(PMA)
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26. 510(k) Data
http://www.meddeviceonline.com/doc/how-to-avoid-having-your-fda-submission-rejected-and-what-to-do-if-it-is-0001
69%
510(k)s rejected 1st time
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27. 510(k) Data
1.0 Medical Device User Fee Cover Sheet (Form FDA
3601)
11.0 Device Description
2.0 CDRH Premarket Review Submission Cover Sheet 12.0 Substantial Equivalence Discussion
3.0 510(k) Cover Letter 13.0 Proposed Labeling
4.0 Indications for Use Statement 14.0 Sterilization and Shelf Life
5.0 510(k) Summary 15.0 Biocompatibility
6.0 Truthful and Accurate Statement 16.0 Software
7.0 Class III Summary and Certification 17.0 Electromagnetic Compatibility and
Electrical Safety
8.0 Financial Certification or Disclosure Statement 18.0 Performance Testing – Bench
9.0 Declarations of Conformity and Summary
Reports
19.0 Performance Testing – Animal
10.0 Executive Summary 20.0 Performance Testing – Clinical
Sections of a 510(k)
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28. 510(k) Data
http://www.emergogroup.com/resources/research/fda-510k-review-times-research
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29. • Myth: Design Transfer is an event
• Truth: Design Transfer is an iterative, continuous process
• Myth: Design Transfer is Operations’ responsibility
• Truth: Design Transfer is a collaborative effort between all of
the functions involved in design and development
• Myth: Design Transfer occurs after “design freeze”
• Truth: Design Transfer begins early in design and
development, and is part of design refinements (design
changes) that lead to a “final” design. Design Transfer can not
end until the DMR is finalized.
Design Transfer Myths
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30. Source of Misconceptions
21 CFR Part 820.30 Design Control
b) Design & Development Planning
c) Design Input
d) Design Output
e) Design Review
f) Design Verification
g) Design Validation
h) Design Transfer
i) Design Changes
Which gets visualized as:
Planning
Design
Input
Design
Output
Design
Review
Design
Verification
Design
Validation
Design
Transfer
But the process really looks more like this:
Design & Development Planning
Design Input
Design Output
Design Verification
Design Validation
Design Transfer
Design Review
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31. Design Transfer Completion
• All Device Master Record (DMR) elements reviewed,
approved, and production released
• All (DMR) elements are managed under formal
change control
• Risk assessments completed and all identified risks
appropriately dispositioned
• Defined and implemented test strategy for incoming,
in-process, and final acceptance testing
• Plans in place to monitor and/or control features
identified as critical to quality
• Process validation complete
• Test methods validated and complete
• Inspection procedures, visual inspections, and
workmanship standards are complete
• Installation and servicing procedures are complete
• All equipment identified and calibrated and
maintenance procedures are in place
• Manufacturing personnel and inspectors have been
trained
• All supplier agreements and qualifications are
complete
• Procedures in place to ensure control of device
handling, storage and distribution of product
• Procedures in place to ensure identification and
traceability of product
• Design verification testing performed and
demonstrates design outputs meet design inputs
• Design validation testing performed demonstrates
design meets user needs & intended uses
• All elements of the Design Transfer Plan have been
completed or otherwise addressed
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32. Design Controls & FDA Inspections
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33. 510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTranspare
ncy/UCM490768.pdf
FDA Medical Device QS Surveillance
Inspections CY2008 – CY2015
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34. 510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTranspare
ncy/UCM490768.pdf
FDA Inspectional Observations CY2004-
CY2015 by QS Subsystem
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35. 510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTranspare
ncy/UCM490768.pdf
CFR Clause QS Subsystem # 483 Observations % of 483s
820.30 - Design Controls DES 536 15%
820.100 - Corrective and Preventive Action CAPA 474 13%
820.198 - Complaint Files CAPA 435 12%
820.90 - Nonconforming Product CAPA 222 6.3%
820.80 - Receiving, In-Process, and Finished
Device Acceptance
P&PC 195 5.5%
820.75 - Process Validation P&PC 180 5.1%
820.70 - Production and Process Controls P&PC 153 4.3%
820.184 - Device History Record DOC 152 4.3%
820.22 - Quality Audit MGMT 145 4.1%
Top 9 Reasons for 483 Observations by CFR Clause in 2015
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36. 510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTranspare
ncy/UCM490768.pdf
CFR Clause QS Subsystem # WL Citations % of WL
Citations
820.100 - Corrective and Preventive Action CAPA 171 25%
820.30 - Design Controls DES 101 15%
820.198 - Complaint Files CAPA 76 11%
820.50 - Purchasing Controls P&PC 54 7.8%
820.90 - Nonconforming Product CAPA 48 7.0%
820.75 - Process Validation P&PC 45 6.5%
820.70 - Production and Process Controls P&PC 45 6.5%
820.80 - Receiving, In-Process, and Finished
Device Acceptance
P&PC 41 5.9%
820.22 - Quality Audit MGMT 38 5.5%
Top 9 Reasons for Warning Letter Citations by CFR Clause in 2015
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37. 37

38. Design Controls – Other Indicators
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39. How many product complaints?
How many product changes?
How many product CAPAs?
What about competitor products?
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40. Concepts to Cover
Design control integration as a competitive advantage
Improved product quality and speed to market
Learning from others and from experience
Aligning design control with the business process
40

41. Questions?
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280
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