The Business Case for Integrated Design Controls
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The document presents a business case for integrated design control in the medical device industry, emphasizing its role as a competitive advantage that improves product quality and accelerates time to market. It addresses common myths about design controls, arguing that they are essential and should be initiated early in the product development process. The document also outlines regulatory requirements and the importance of effective design transfer and verification processes.
The Business Case for Integrated Design Controls
- 1. The Business Case for Integrated Design Control Presented by: Jon D. Speer Founder & VP QA/RA of greenlight.guru 1
- 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 3
- 4. Design Controls – Overview 4
- 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 5
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- 7. What is Design Control? • SAFE • EFFECTIVE • MEET INTENDED USE 7
- 8. Did I design my medical device correctly? Design Input (Requirement) Design Output (Specification) Design Verification 8
- 9. Did you design the correct medical device? User Needs Medical Device Design Validation 9
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- 11. It is my responsibility to document design controls and maintain the DHF. 11
- 12. Design Controls – Myths 12
- 13. Myth: Design Controls Impede Product Development 13
- 14. Truth: Design Controls Aid Product Development 14
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- 16. Myth: Design Controls Should Be Delayed Until After A Working Prototype Has Been Established 16
- 17. Truth: Design Controls Should Start During Prototyping 17
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- 19. Myth: Documenting Design Controls Is Too Rigid A Process 19
- 20. Truth: The Design Controls Process Should Be Flexible 20
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- 23. Myth: Design Controls Are Optional 23
- 24. Truth: Design Controls Are Required 24
- 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) 25
- 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) 27
- 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 29
- 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 30
- 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 31
- 32. Design Controls & FDA Inspections 32
- 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 33
- 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 34
- 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 35
- 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 36
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- 38. Design Controls – Other Indicators 38
- 39. How many product complaints? How many product changes? How many product CAPAs? What about competitor products? 39
- 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