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

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 …)

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

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

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

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

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

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

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

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

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

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

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

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