1. Product Development Chapter 6

3. Definitions needed: Verification: The process of evaluating compliance to regulations, standards, or specifications. Validation: The process of documenting that a solution or process is correct or suited for its intended use.

4. Product Development A product development process ensures that the design, development, and transfer of a new or modified medical device will result in a product that is safe, effective, and meets user needs and intended use requirements.

5. The Product Development Process, details to follow…

6. Product Requirements – Page 1: User / patient / clinical performance characteristics Privacy and security Safety Regulatory Quality Reliability

7. Product Requirements – Page 2: Compatibility with accessories / auxiliary devices or products Compatibility with the intended environment Human factors Physical characteristics Sterility Manufacturability

8. Product Requirements – Page 3: Serviceability Labeling, packaging, storage Requirements for intended markets (domestic or international). …includes the needs of users & patients & intended use of the device

9. Design & Development Plan Program Goals Design and Development Elements Organizational and Key Interfaces Deliverables and Responsibilities Design and Development Schedule Approve Design and Development Plan Incorporate Updates to Design and Development Plan

10. System Requirements Specification Functional Requirements Physical and Performance Requirements Interface Requirements System Architecture Software Requirements (if applicable) Resolve problems in design reviews… Logs kept in design history file

11. Design Input Each product program must establish Design Inputs to ensure that design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. There should be a mechanism for addressing incomplete, ambiguous, or conflicting requirements.

12. Design Output: Intermediate Preliminary design specifications Models and prototypes Software source code Risk analysis results Traceability documents Biocompatibility and bioburden test results Other intermediate design outputs as appropriate.

13. Design Output: Final, part 1 Device Specifications Device Drawings Component Assembly Finished Device

14. Design Output: Final, part 2 Composition, formulation, component specifications Sub-assembly specifications (if applicable) Component and material specifications Product configuration documents Parts list Bill of Materials

15. Design Output: Final, part 3 Software specifications (if applicable) Software machine code, such as a diskette or master EPROM. Production Process Specifications Critical Production Process Specifications Equipment Specifications

16. Design Output: Final, part 4 Production methods and procedures Test protocols Work instructions Production environmental specifications Quality Assurance Procedures and Specifications Acceptance criteria Purchasing and acceptance requirements Quality assurance equipment to be used

17. Design Output: Final, part 5 Production methods and procedures Test protocols Work instructions Production environmental specifications Quality Assurance Procedures and Specifications Acceptance criteria Purchasing and acceptance requirements Quality assurance equipment to be used

18. Design Output: Final, part 6 Packaging and Labeling Specifications Including Methods and Processes Used Installation, Maintenance, and Servicing Procedures and Methods Installation instructions Service and maintenance instructions

19. Formal Design Review Formal Design Reviews are performed at major decision points or milestones in the design process as specified by the Design and Development Plan. They are intended to be a systematic assessment of design results and to provide feedback to designers on existing or emerging problems. Each Formal Design Review must ensure that design outputs meet design inputs & track resolution.

20. Design Verification Design Verification Plan (including requirements & displays & packaging…) Design Verification Test Methods (integration, functional, accuracy, etc.) Design Verification Report (summary of above)

21. Design Validation Design Validation Plan (software, external, process, risk, labeling, packaging,…) Design Validation Test Methods (simulated use, workload, safety, etc.) Design Validation Report

22. Design Transfer Design Transfer ensures that the device design is correctly translated into production specifications and that the finished device is successfully transferred from design to production and service. Production specifications ensure that devices are repeatedly and reliably produced within product and process capabilities.