Design Documentation

Joel GerberZachary Reaver

Kurt Schilling

Provides physical proof of development Maintains product design knowledge base Meets government and corporate

requirements Communicates design planning and

implementation Enables smooth project transitions

Why?

Collaboration◦ Meeting minutes◦ Phone calls◦ E-mails

Technical◦ Preliminary design sketches◦ Calculations◦ Tolerance stack-ups◦ Testing records

What needs to be documented?

Date and time Parties present Discussion summary Action items

Collaboration Documentation

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

Technical Documents

Engineering Notebooks◦ Preliminary sketches◦ Meeting notes◦ Concept ideas and development

Microsoft Word and Excel documents◦ Engineering Analysis◦ Summaries

E-mail messages◦ Design discussions

Documentation Methods and Examples

Good Documentation Practices

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:◦ User Needs◦ Design Inputs◦ Design Outputs◦ Design review meeting information◦ Design Verification◦ Design Validation◦ Design Transfer◦ Design Changes

Design History File (DHF)

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 Planning

Customer Requirements Defines the use for the product in the

market Drives the development process Typically gathered by marketing team

User Needs

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◦ 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 ◦ 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

Design Inputs

Bring design inputs to life Outline what happened in design process Items include:

◦ Product specifications, drawings, packaging, labeling, instructions for use, design rationale

Design Outputs

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

Risk Management

Other Examples:•Predicate Device•Testing Standards•Clinical History•Engineering Analysis•Surgical Technique•Intra-op feedback•Design Controls

FMEA Example: Toothbrush

Identifies and evaluates design at several stages of the development process (Design Review I, II, III, etc.)

Each review has a series of checklists and criteria that must be met

Utilizes knowledge base of multi-function team representatives concerned with the design stage

Approved by multiple departments in order to proceed with development◦ Packaging, Labeling, Product Development, Quality,

Regulatory, etc.

Design Review

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

during development

Design Change

Validation – “Are you building the right thing?”◦ Make sure product meets user needs

Verification – “Are you building it right?”◦ Ensure that final product meets initial design

specifications Ensures that outputs conform to inputs Consists of tests, inspections, and analyses Requires documentation of acceptance

criteria and protocols

Design Verification/Validation

Compilation of records containing the specifications and procedures for a finished device

The DMR for each device should include or refer to the location of:◦ 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 (DMR)

Other 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

Device Master Record

Facilitates transfer of product from design engineering to manufacturing engineering

Includes detailed production specifications Increases efficiency and quality of

production

Design Transfer Documentation

Summary

• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122416.htm

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 Include timestamps and revision numbers

on all documents

Summary

QUESTIONS?