1. Chapter 19 Manufacturing and Quality Control
Design of Biomedical Devices and Systems By
Paul H. King
Richard C. Fries

2. GMP: History
Good Manufacturing Practices - Series of requirements that prescribed the facilities, methods, and controls to be used in manufacturing, packaging, and storage of medical devices
Medical Device Amendments of 1976
Unchanged since 1978 (except interpretation, methods used …)

3. Current Good Manufacturing Practice (CGMP)
Assure medical devices are compatible with specifications for quality systems contained in international quality standard ISO 9001.
Quality system requirements: design, purchasing, and servicing controls
Clarify record keeping requirements for device failure and complaint investigations
Clarify requirements for qualifying, verifying, and validating processes and specification changes
Clarify requirements for evaluating quality data and correcting quality problems

4. Design Controls Lack of = Major cause of device recalls
Intrinsic quality established during design phase
FDA concerned that current regulations don’t provide an appropriate level of assurance

5. Purchasing controls
Unacceptable components = recalls due to device failures
Unacceptable components due to failure of manufacturer to adequately define and establish requirements
Purchasing of components, finished devices, packaging, labeling, and manufacturing materials must be conducted with same level of planning, control, and verification as internal activities

6. Servicing Controls
Maintenance and repair data provide insight into adequacy of the performance of the device
Use to evaluate and monitor adequacy of device design, quality system, and manufacturing process
Use as part of overall device experience data in manufacturer’s quality system

7. Design for Manufacturability (DFM)
Assures that a design can be repeatedly manufactured while satisfying the requirements for quality, reliability, performance, availability, and price.
Less costly due to
Simpler design with fewer parts
Simple production processes
Higher quality and reliability
Easier to service

8. DFM Process Eliminate nonfunctional parts Reduce functional parts
Process for a defect rate of no more than a few parts per million

9. Design for Assembly (DFA)
Overall Design Concept
Component Mounting
Test Points
Stress Levels and Tolerances
Printed Circuit Boards
Miscellaneous

10. Manufacturing Process
Pre-production activity
Pilot run build
Production run
Delivery to customer

11. Pre-Production Activity
Selection of Suppliers
Develop Pilot Run plan
Develop Manufacturing Strategy
Production plan
Quality plan
Test plan
Materials plan
Supplier plan

12. Pilot Run Build
Validate manufacturing process against objectives set forth in manufacturing strategy and product specification
Standard cost
Product quality
Documentation
Tooling
Training
Process control
Validates supplier plan and contracts
Internal failure analysis and corrective action

13. Production Run
Produce high quality product on time, while continuing to fine tune the process
1st order manufactured
Verification of Product cost

14. Customer Delivery Deliver 1st production units to customer
Refine manufacturing process based on first build
Monitor field unit performance to correct any problems