the business case for integrated design controls
TRANSCRIPT
The Business Case for
Integrated Design Control
Presented by:
Jon D. Speer Founder & VP QA/RA of greenlight.guru
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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
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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
+1 317 960 4280
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Design Controls – Overview
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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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What is Design Control?
• SAFE
• EFFECTIVE
• MEET INTENDED USE
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Did I design my medical device
correctly?
Design Input (Requirement)
Design Output (Specification)
Design Verification
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Did you design the correct medical
device?
User Needs Medical Device Design Validation
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It is my responsibility to document design
controls and maintain the DHF.
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Design Controls – Myths
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Myth: Design Controls Impede Product Development
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Truth: Design Controls Aid Product Development
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Myth: Design Controls Should Be Delayed Until After A
Working Prototype Has Been Established
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Truth: Design Controls Should Start During Prototyping
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Myth: Documenting Design Controls Is Too Rigid A Process
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Truth: The Design Controls Process Should Be Flexible
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Myth: Design Controls Are Optional
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Truth: Design Controls Are Required
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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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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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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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510(k) Data
http://www.emergogroup.com/resources/research/fda-510k-review-times-research
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• 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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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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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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Design Controls & FDA Inspections
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510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM490768.pdf
FDA Medical Device QS Surveillance Inspections CY2008 – CY2015
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510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM490768.pdf
FDA Inspectional Observations CY2004-CY2015 by QS Subsystem
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510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/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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510(k) Data
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/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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Design Controls – Other Indicators
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How many product complaints?
How many product changes?
How many product CAPAs?
What about competitor products?
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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
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Questions?
@creoquality @greenlightguru
+1 317 960 4280
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