Corey Beth Monarch Lindsey Novak Michael Seikel Whitney Young Design Documentation Corey Beth Monarch Lindsey Novak Michael Seikel Whitney Young

Importance of Design Documentation Creates paper trail tracing design development Maintains product design knowledge base Meets governing body requirement Communicates design planning and implementation

What needs to be documented? General Meeting minutes Phone calls E-mails Technical Preliminary design sketches CAD drawings Tolerance stack-ups Testing -All meetings need to be documented – whether in-house development meetings, surgeon meetings, or meetings with government officials. Everything needs to be traced!

Minimum Necessities of Documentation Date and time Parties present Discussion items Action items Date & Time – self explanatory Parties present – A list of the people who attended the meeting, and a list of absentees who were supposed to attend Discussion items – A list of everything discussed pertaining to the project Action items – A list of activities discussed that need to be completed for the project to proceed

Good Documentation Practices http://www.youtube.com/watch?v=Q7bnVkshW Rc http://ezinearticles.com/?Learning-Good- Documentation-Practices&id=2071847

Documentation Methods and Examples Engineering Notebooks Preliminary sketches Meeting discussions Concept developments and ideas Microsoft Word and Excel documents Memorandums Analyses E-mail messages Design development discussions

Important Design Documents Drawings Design Changes Design and Process Validations/Verifications Risk Management Documentation Process Routers Inspection Criteria Design Control Plans Material Specifications Sterility and Cleaning Process Verifications Tolerance Stack-ups Device Master Record (DMR) FDA Submissions List of examples of design documents that are needed by governing bodies. Each document serves a specific purposes and needs traceability

Design History File (DHF) Compiles records describing the design history of a finished device Complies with FDA requirements for marketing medical device Specific to each company FDA Requirement: “Each manufacturer shall establish and maintain a DHF for each type of device. The Device shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approval design plan and the requirements of this part.” Code of Federal Regulations, Title 21 – Food and Drugs, Chapter I – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices.

Design History File (DHF) Items can include: Customer Requirements Design Inputs Design Outputs Design review meeting information Test Procedures Biocompatibility Reports

Design Planning Outlines the activities to be taken during the design control process Sets target dates for finishing each stage of development, as well as design reviews Gantt Chart Identifies team members from each necessary department -Design plan/Gantt chart must be updated during development -Dates for completion can be adjusted as needed if problems arise -Proper planning ensures all necessary activities for development are completed and can be reported to FDA properly

Customer Requirements Defines the use for the product in the market Drives the development process Typically gathered by marketing team Customer requirements are typically seen as the most important part of product development – without customers, no revenue

Design Inputs Translate customer’s needs into design Reduce miscommunication between engineering and marketing teams if used effectively Improve efficiency of the design process Require documentation and approval Define performance and function requirements

Design Inputs Functional requirements Performance requirements Lists all functions the final product must perform Lists compatibilities with mating parts Performance requirements Benchmarks the final product must meet Include strength, durability, and lifespan

Design Inputs Sterilization Method Packaging/Labeling requirements Defines how product will be cleaned Packaging/Labeling requirements Defines specifications that labeling/packaging must meet Human Factors Specialized inputs to define how people interact with a medical device Sterilization Method Provide the ISO/ASTM specifications for cleaning the product Define whether product should be packaged sterile or be cleaned by end user Packaging/Labeling requirements -Provides ISO/ASTM standards for labeling and packaging -Must include special packaging/labeling requirements for sterile products (labeling – word STERILE visibly seen, packaging – asceptic barrier, etc.) Human factor examples Design of handles on an instrument Size of important text on an implant/instrument

Design Outputs Bring design inputs to life Outline what happened in design process Items include: Product specifications, drawings, packaging, labeling, instructions for use, design rationale

Risk Management Evaluates all risks of product and production process Identifies actions to manage unacceptable design and process risks

Risk Management Design Failure Mode Effects Analysis (DFMEA) Process Failure Mode Effects Analysis (PFMEA) Potential product failures Effects of product failures Causes of failures Corrections of failures

FMEA Example http://www.qualitydigest.com/aug06/articles/04_article.shtml

Design Review Identifies and evaluates design Utilizes knowledge base of multi-function team representatives concerned with the design stage Includes reviews conducted at specified stages of development Approved by multiple departments in order to proceed with development Packaging, Labeling, Product Development, Quality, Regulatory, etc.

Design Change Communicates and documents changes Creates links between revisions Traces development of new product Approved by appropriate departments during development

Design Verification/Validation Ensures that outputs conform to inputs Consists of tests, inspections, and analyses Documents verification activities Requires documentation of acceptance criteria and protocols

Device Master Record Compilation of records containing the specifications and procedures for a finished device Device specifications including appropriate drawings, composition, formulation, component specifications, and software applications Production process specifications including appropriate equipment specifications, production methods, production procedures, and production environment specifications

Device Master Record Items include: Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment used Packaging and labeling specifications, including methods and process used Installation, maintenance, and service procedures and methods Device master record is the end product of the design process.

Device Master Record

Design Transfer Documentation Facilitates transfer of product from design engineering to manufacturing engineering Includes detailed production specifications Increases efficiency and quality of production

Summary http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirem ents/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122416.htm

Summary Assume everything you hear, say, think, write, read, and create is important no matter how insignificant, trivial, irrelevant, immaterial, or inconsequential you might think it may be Record, date, sign, and save everything Document as though an audit will occur

Questions?