Chapter 19 Manufacturing and Quality Control Design of

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

GMP: History Ø Good Manufacturing Practices - Series of requirements that prescribed the facilities, methods, and controls to be used in manufacturing, packaging, and storage of medical devices Ø Medical Device Amendments of 1976 Ø 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. Ø Quality system Ø Clarify requirements for requirements: design, qualifying, verifying, and purchasing, and validating processes servicing controls and specification changes Ø Clarify record keeping requirements for device Ø Clarify requirements for failure and complaint evaluating quality data investigations and correcting quality problems

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

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

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

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

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

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

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

Pre-Production Activity Ø Selection of Suppliers Ø Develop Pilot Run plan Ø Develop Manufacturing Strategy l l l 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 l Standard cost l Product quality l Documentation l Tooling l Training l Process control Ø Validates supplier plan and contracts Ø Internal failure analysis and corrective action Ø

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

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